Section IA - Concepts

This volume commences with chapters that address key concepts that are embedded in health research regulation (HRR). Many of the concepts considered – autonomy, proportionality, the public interest – may feel familiar and could even be described as ‘regulatory buzzwords’. However, although they may be often used, they can also be elusive and ill defined. Here, the contributing authors explore these contours and provide the reader with the lie of the land in these areas. However, the chapters in this section go beyond this. The authors also challenge the operation of these concepts and provide their own views on how they may be deployed in HRR. This is not a ‘definitions’ section: the concepts explored may be used in different ways by authors in the course of the volume. However, the value of exposing these to scrutiny at the outset is twofold. First, this orientates the reader (whether they be a researcher, regulator, or engaged citizen) in the context of contemporary HRR and sets the scene for these familiar concepts to be approached with a critical eye. Second, this reveals the range of perspectives that may be brought to bear on these shared concepts in HRR, thus promoting productive interdisciplinary engagement and discourse in this and subsequent sections of this volume.

The section opens with Rogers’ chapter on Vulnerability. Rogers positions vulnerability as a widely accepted and relevant concept in HRR, but one that is also challenging to conceptualise and define. She engages with the difficulties that have arisen in conceptualising vulnerability, reconciling universal and special notions of vulnerability, and identifying the distinct duties and obligations that are triggered. In particular, she points to newer analytic approaches that conceptualise vulnerability as relational and dynamic, and identifies multiple potential sources of vulnerability, thus offering a more nuanced way of thinking about protections against the risks of research-related harm and wrongs. Stoljar’s chapter on Autonomy also addresses a pervasive concept in HRR. Stoljar challenges the individualistic conception of autonomy implicit in the current health research ethics guidelines and outlines a contrasting ‘relational’ approach to autonomy. Stoljar posits that the social conditions that a person inhabits, including their available options and interpersonal contexts, all affect the ability to make autonomous decisions. She identifies some of the implications of this for health research ethics, including the relationship between autonomy and vulnerability, and the claim that informed consent is sufficient for accordingly due respect to autonomy.

A similar interconnectedness can be seen between the next two chapters in this section. Schaefer’s chapter considers Proportionality in the context of HRR. He approaches this in terms of a justificatory relationship and underlines that, while a necessary part of responsible HRR, assessing proportionality is no easy task. In particular, it involves the weighing of different values that are non-commensurate and often non-quantifiable. Moving forward, Schaefer suggests several procedural approaches that can help improve the reliability and legitimacy of those assessments. Coleman further addresses risk–benefit analysis later in this volume (Chapter 13). Schaefer’s consideration of how to integrate the social value of research into proportionality is also complemented by van Delden and van der Graaf’s chapter that takes Social Value as its focus. The authors define the social value of an intervention as the value that it could eventually have on the well-being of groups of patients and/or society. However, they note, too, that to state a requirement for social value is one thing; to actually evaluate the social value of a research project is another. Overall, they find that social value has matured from an attractive but elusive idea into something that has to be assessed, evaluated and optimised, and can be used to address some of the justice issues in healthcare.

Three chapters follow that speak to the role of the individual and the collective in contemporary HRR. These begin with Kieslich and Prainsack’s chapter on Solidarity. This builds on existing and emerging research to explore the analytical and normative roles solidarity can play when designing HRR regimes. Kieslich and Prainsack illustrate their argument by reference to the European Union regulatory regime for research on rare diseases and orphan drugs. Through this discussion, the authors show how the concept of solidarity can be used to reframe the regulation of research from a market failure problem, which needs to be addressed through financial incentives, to a societal challenge in which the nature of barriers is not just financial. Next, Sorbie considers the Public Interest in HRR. This chapter provides an introduction to this elusive concept and considers two key ways that the public interest is constructed in HRR, namely as a legal device and through empirical evidence of the views of publics. Both conceptualisations are analysed with reference to the key challenges and opportunities that they present before a holistic concept of the public interest in HRR is proposed and consideration given to how this may be operationalised in practice. Townend’s examination on Privacy completes this trio of chapters. Here, he examines privacy as a well-established concept that has become a mainstay of good practice in research, yet also one that remains nebulous in character. Townend offers an explanation of why privacy is a difficult concept to express, how the law approaches the concept, and how it might be explored as a broader normative concept that can be operationalised by researchers. In the course of their analyses, Sorbie and Townend both consider matters at the intersection of governance and public involvement. Readers who wish to know more about the latter in HRR are directed to Aitken and Cunningham-Burley’s chapter, which specifically examines Forms of Engagement (Chapter 11) and to Burgess’ consideration of Mobilizing Public Expertise in Health Research Regulation (Chapter 25) later in this volume.

The final two chapters of the section consider key concepts specifically in their institutional and political contexts. Kerasidou’s chapter on Trustworthy Institutions in Global Health Research Collaborations delineates the differences between trust and trustworthiness, and argues that institutions committed to advancing the aims of global health should aim to promote fair and trusting collaborations. More specifically, she proposes that being trustworthy requires more than just the observation of rules or the incorporation of moral principles in policies and structures; it also demands attention to the relational aspect of trust. Finally, this section concludes as it started: with consideration of vulnerability. In Brassington’s chapter on Vulnerabilities and Power: The Political Side of Health Research, he argues that there is a political dimension to research, and that accounts of health research regulation that ignore political relations between stakeholders are therefore incomplete. He concludes that research promises us a way to address human vulnerabilities, but it may exacerbate others in the process and that the relationship between researcher and participant can only really be understood when its own inherent political dynamic is acknowledged too.

Each of the chapters in this section illustrate that HRR provides a dynamic area of study where even well-established concepts may be in various ways disputed and unsettled. In examining these dynamics many of the authors also address the relationship between the individual and the collective in HRR. As these and subsequent chapters show, this tension at the heart of HRR is accentuated by the drive towards data-driven and population-level biomedical research. Finally, many authors call for further work to deepen both how these concepts are understood in context and how they are operationalised in the health research endeavour. A response to this can be found in the pages that follow.

1 Vulnerability

Wendy A. Rogers

1.1 Introduction

Vulnerability is widely accepted as a relevant concept in human research regulation. Reflecting this, influential international research ethics guidelines require identification of, and protections for, participants who are deemed vulnerable.¹ Nonetheless, vulnerability is challenging to conceptualise and define, with ongoing disputes about the nature and extent of moral obligations to the vulnerable. This chapter maps the history of vulnerability in human research ethics guidelines and explores current debates regarding the role of vulnerability in guiding ethical deliberations about research participation.

1.2 Vulnerability in Research Ethics Guidelines

Concerns about vulnerability are implied rather than explicitly mentioned in some of the first formal research ethics guidelines such as the Guidelines for Human Experimentation (the Guidelines) issued by the German government in 1931, and the Nuremberg Code (the Code).² These early documents were concerned about experimentation on non-consenting individuals, especially those susceptible to exploitation due to various hardships. Both emphasised the importance of informed consent. The Code required the decision of the potential participant to be fully informed and ‘without the intervention of any element of force, fraud, deceit, duress, over-reaching, or other ulterior form of constraint or coercion’.³ Similarly, the Guidelines prohibited exploiting social hardships to secure research participants, as to do so would be ‘incompatible with the principles of medical ethics’.⁴ Without explicit use of the term vulnerability, these documents pinpointed concerns about exploitation and whether voluntary informed consent could protect participants suffering hardships. In subsequent guidelines, these concerns are conceptualised as indicators of vulnerability.

Vulnerability is first explicitly identified as a characteristic of individuals and groups who thereby require special protections in the 1979 Belmont Report (the Report). The Report intended to provide a comprehensive framework for resolving ethical problems arising from human research.⁵ Its three principles – respect for persons, beneficence and justice – offer protection to all research participants without exception. In addition to these universal protections, the Report identified three areas where participants may be especially vulnerable. The first, echoing the 1931 Guidelines, concerned the voluntariness of consent in situations where ordinarily acceptable inducements may become undue if the subject is especially vulnerable.⁶ The second required increased scrutiny of risks and benefits for research involving vulnerable populations, arguing that their involvement is more or less appropriate depending upon the nature and magnitude of risks, the anticipated benefits and the condition of the population involved.⁷ The third concerned the potential injustice of recruiting participants ‘solely for administrative convenience, or because they are easy to manipulate as a result of their illness or socioeconomic condition’.⁸ Here the Report referred to ‘racial minorities, the economically disadvantaged, the very sick, and the institutionalized’ whose ready availability may lead to their exploitation.

Thus the Report characterised the vulnerable as individuals and groups with potentially limited capacity to give consent and/or those liable to exploitation for various reasons. It required greater justifications for the inclusion of vulnerable participants, and identified exclusion altogether from research as one way of protecting the vulnerable.

Subsequent research ethics guidelines follow the Report in linking vulnerability to consent, exploitation and special protections. For example, the Declaration on Bioethics and Human Rights stipulates the following:

In applying and advancing scientific knowledge, medical practice and associated technologies, human vulnerability should be taken into account. Individuals and groups of special vulnerability should be protected and the personal integrity of such individuals respected.⁹

The Declaration of Helsinki requires ‘specifically considered protection’ for all vulnerable individuals and groups.¹⁰ Likewise, the current Council for International Organizations of Medical Sciences (CIOMS) guidelines invoke ‘specific protections’:

When vulnerable individuals and groups are considered for recruitment in research, researchers and research ethics committees must ensure that specific protections are in place to safeguard the rights and welfare of these individuals and groups in the conduct of the research.¹¹

This brief survey of research ethics guidance demonstrates that for nearly ninety years there have been concerns that some research participants are more vulnerable than others, and that vulnerable participants require special considerations. Despite the agreement that vulnerable participants require something more than routine ethical consideration, there is little consensus as to what characteristics make some participants more vulnerable than others and whether ‘special consideration’ is the appropriate moral response to vulnerability.

1.3 Vulnerability: An Ambiguous Concept in HRR

There is an ambiguity about vulnerability running through the heart of research ethics. Prima facie, research ethics guidance provides protections for all participants who are potentially exposed to research-related harms such as deception, coercion, injury, misuse of their data and other harms. Requirements such as informed consent and balancing benefits and risks aim to mitigate this vulnerability. Yet this universal vulnerability to the potential harms of research is not explicitly named. Instead, the category of ‘special’ vulnerability attributes vulnerability to groups or individuals such as those identified in the Belmont Report: ‘racial minorities, the economically disadvantaged, the very sick, and the institutionalized’.¹² This ‘special’ vulnerability approach reflects ambivalence about overtly acknowledging universal vulnerability and simultaneous recognition that some research participants do bear greater risk of harms than others. Ambivalence about the concept of vulnerability can be traced back to competing philosophical accounts.

The universal account takes vulnerability to be a type of fragility or susceptibility to suffering, linked to human embodiment. According to Fineman, vulnerability is an ontological necessity of our humanity, an ‘inevitable, enduring aspect of the human condition’.¹³ Understanding vulnerability as a universal feature reflects the shared human capacity for experiencing pain, frailty and other harms of existence and the inevitability of death for all humans. The notion of universal vulnerability underpins ethical concern for all research participants. The requirement for informed consent arises because all participants are potentially vulnerable to deception as they lack relevant skills to distinguish experimentation from accepted treatment. Similarly, requirements for pain relief in pertinent protocols reflect universal vulnerability to suffering pain. But universal vulnerability is not explicitly identified in research ethics guidelines. Instead, there is an assumed ‘normal’ research participant for whom standard ethical protections are adequate. This baseline normal research participant is characterised by Luna as ‘mature, moderately well-educated, clear thinking, literate, [and] self-supporting’.¹⁴ Vulnerable participants are identified against this implicit norm.

In contrast to universal vulnerability, accounts of special vulnerability claim that vulnerability is essentially specific and relational: individuals are vulnerable to particular agents regarding particular threats to their interests.¹⁵ Although everyone has interests that may be threatened, some individuals or groups have little or no capacity to protect themselves. On this account, vulnerable persons have a reduced capacity to safeguard their interests relative to others. Whereas the universal account stresses our common embodied humanity and equal susceptibility to suffering, the special vulnerability account emphasises the ways in which various inequalities make some individuals (‘the vulnerable’) especially susceptible to harm or exploitation by others.¹⁶

Within research ethics, the notion of special vulnerability is dominant. However, despite widespread requirements for special protections for the vulnerable, vulnerability is rarely defined in research ethics guidance. Bracken-Roche and others found that only three of eleven national and international guidelines contained definitions of vulnerability.¹⁷ Both CIOMS and the Canadian Tri-Council Policy Statement define vulnerability in terms of decreased ability to protect one’s own interests, secondary to intra-personal factors (e.g. reduced capacity to give informed consent) or contextual factors (e.g. limited access to social goods including rights, opportunities and power). The third guideline, the International Conference on Harmonisation – Good Clinical Practice guideline, does not define vulnerability per se, but defines vulnerable subjects in a glossary entry as those who may be unduly influenced either by expectations of benefit, or due to their subordinate place in a relevant hierarchy.¹⁸

The common approach in these and other guidelines is to rely upon lists of individuals or groups with characteristics that are taken to be indicators of vulnerability. The eleven guidelines analysed by Bracken-Roche and others list thirty-two characteristics signifying vulnerability. Individual indicators include being a prisoner, homeless person, woman, economically disadvantaged person, person lacking in political or social power, refugee, neonate and so forth. Identified vulnerable groups include very sick persons, children, minors or young persons, pregnant or breastfeeding women, the elderly, persons with mental illnesses, persons with limited capacity to consent and others. This dominant approach of labelling vulnerable participants has been subject to various critiques.

1.4 Problems with the Labelling Approach to Vulnerability in Research

The aim of labelling individuals or groups as vulnerable is to trigger special protections over and above those offered to all research participants, to prevent or decrease the risk of harms triggered by the vulnerability in question. Nevertheless, this approach is problematic as it leads to stereotyping, discrimination and unwarranted exclusion from research. Critics have argued that the labelling approach is both too narrow and too broad.¹⁹

One effect of the labelling approach is to focus narrowly on questions about capacity, and whether or not vulnerable individuals are able to give competent, informed consent for research participation.²⁰ This results in ethical review that attempts to identify all possible factors that might render consent less than fully valid, such as cognitive impairment or coercive circumstances. For individuals who lack capacity to provide valid consent, the proposed remedies for this vulnerability are proxy consent or exclusion from research. However, conceptualising vulnerability primarily in terms of incapacity to provide informed consent is ethically inadequate.

First, this approach fails to address the full range of moral issues raised by vulnerability, such as susceptibility to exploitation.²¹ Some research participants who are capable of providing informed consent may, nonetheless, be vulnerable to exploitation, due to poverty, power imbalances in the researcher–participant relationship or other circumstances. For example, pregnant women may be vulnerable to exploitation regarding participation in research aimed at benefitting the fetus. In this situation, pro-natalist pressures may unduly exacerbate women’s understandable concerns for foetal well-being, thereby creating opportunities for exploitation.²² Attention to informed consent processes will not necessarily resolve this kind of exploitation. Nor will it protect those who are vulnerable due to a lack of basic human rights.²³ For example, better information about a research protocol fails to mitigate participants’ vulnerability to coercion from local power brokers who stand to profit from the research.

Second, the narrow approach ‘can divert attention from features of the research itself, the institutional environment, or the social and economic context that can put participants in harm’s way’.²⁴ Informed consent does not provide protections against dangerous protocols, researchers with conflicts of interest or dysfunctional institutions, all of which make participants vulnerable by increasing their risk of harm. External factors such as these contributed to the deaths of Ellen Roche, a healthy volunteer who died in an asthma research trial,²⁵ and Dan Markingham, who died in an anti-psychotic medication trial.²⁶ These participants were made vulnerable by deficiencies in the manufacturing standards of the inhalant, poor standards in the research protocol review process by the institutional review board, inadequate oversight, and significant conflicts of interest at researcher and institutional levels. These factors affect the safety of all participants rather than reflecting specific vulnerabilities of these particular participants.

A third problem with a narrow focus arising from the labelling approach is that concentrating on informed consent offers few options for mitigating vulnerability. For individuals who lack capacity – such as unconscious persons, babies, young children or individuals with severe cognitive deficits – it may not be possible to develop valid consent processes, leaving the alternatives of proxy consent or exclusion from research. Exclusion from research results in inadequate information about therapeutics for affected individuals and groups.²⁷ Rather than exposing a small number of individuals to specific risks within a regulated clinical trial, exclusion from research increases risks for all members of excluded groups who then must rely on off-label prescribing of therapies with unknown effects for their patient cohort.²⁸

Despite the labelling approach to vulnerability being criticised for being too narrow, a second critique claims the opposite: that an over-inclusive approach to identifying vulnerability leads to virtually everyone being labelled as vulnerable.²⁹ Lists compiled from research ethics guidelines by Bracken-Roche and others and Hurst leave few who are not classified as vulnerable.³⁰ This apparently over-inclusive approach to vulnerability labelling renders the notion of vulnerability ineffectual for two reasons. First, despite its breadth, there is no recognition of the features that might underpin a universal conception of vulnerability; the focus remains on special vulnerability. Second, the over-inclusiveness of the labelling limits the utility of invoking protections for special vulnerability, because the context-specific needs of individuals or groups are obscured rather than identified. Vulnerability cannot be a useful marker for providing extra protections if all research participants are deemed vulnerable. The concept becomes so broad as to be meaningless, and certainly impractical for mandating specific responses.³¹

Critics of the over-inclusive labelling of vulnerability note that this approach can lead to stereotyping, discrimination and failure to consider the specifics of each case. Stereotyping occurs when whole categories of individuals are labelled vulnerable, in contrast to the rest of the – presumably invulnerable – population. Labelling has a homogenising effect as all members of the group are assumed to be equally vulnerable. But it is unreasonable both to divide the general population into exclusive vulnerable and non-vulnerable categories, and to obliterate relevant differences between those labelled vulnerable. The impacts on individuals of factors associated with special vulnerability such as educational disadvantage, cognitive impairment or dependent relationships vary enormously. For example, young people under sixteen years are usually labelled vulnerable as they are held incapable of giving valid informed consent. However, the capacity to understand complex information and make considered decisions is highly variable in adolescents; some are capable of consenting and some are not. In addition, vulnerability is not a dichotomous state such that individuals are either vulnerable or not. Rather, vulnerability occurs on a spectrum, with different levels or degrees. But this distinction is lost when labels are applied: regarding vulnerability, ‘you are either in or you are out’.³²

Once individuals or groups are labelled vulnerable, this can be a source of discrimination, used to justify unwarranted and unjust paternalistic policies.³³ Such discrimination is evident regarding pregnant women, who have historically been labelled vulnerable and excluded from research notwithstanding their evident capacity to give informed consent. Routine exclusion of pregnant women from research undermines their autonomy by removing the opportunity to make decisions about research participation. Further, exclusion of pregnant women from research is harmful as it results in a lack of information about safe and effective treatments in pregnancy, especially when pregnant women who are given untested treatments mistakenly believe they are receiving a therapeutic intervention.³⁴ Exclusion from research is especially problematic where access to treatment is premised on evidence of the safety and efficacy of that treatment. Where groups are systematically excluded from research, the evidence base is correspondingly meagre and their treatment options limited.³⁵

Given these problems with the labelling approach to vulnerability in research ethics, I now turn to analytic approaches to conceptualising vulnerability.

1.5 Analytic Approaches to Defining Vulnerability

Analytic approaches to vulnerability seek to explain the concept in ways that foster understanding of what vulnerability is, and what moral responses are owed to the vulnerable. One analytic approach to conceptualising vulnerability identifies characteristics that serve as criteria for vulnerability,³⁶ while a second examines what is owed to the vulnerable.³⁷ More recently, Luna has proposed the metaphor of layers to explain multiple forms of vulnerability,³⁸ while Lange and others focus on sources of vulnerability in their taxonomy.³⁹

Kipnis takes vulnerability to be ‘a certain precariousness’ that leaves the individual open to being harmed or taken advantage of by researchers. Rather than labelling, he asks researchers to consider participants’ circumstances as sources of vulnerability. His taxonomy focuses on circumstances – medical, cognitive, deferential, juridic, allocational, infrastructural and social – that threaten the validity of consent.⁴⁰ Similarly, Rogers and Ballantyne identify extrinsic and intrinsic – to the individual – sources of vulnerability that render participants unable to safeguard their own interests.⁴¹ On their account, extrinsic vulnerability arises from power inequalities in the researcher–participant relationship.

Nickel argues that in addition to consent considerations, vulnerability is a justification for special protections in research for two fairness-related reasons. The first concerns the unfair burden of research participation imposed on disadvantaged or dependent groups who lack the power to refuse participation. The second concerns the unfair distribution of research benefits, especially those arising from exclusion from research. Consent-based and justice-based reasons for special protections can be mutually reinforcing, as, for example, members of dependent groups may be targeted for inclusion in research because they have limited ability to refuse participation, but the research may not address problems relevant to the groups to which they belong. In considering what is owed to those who are especially vulnerable on these grounds, Nickel appeals to the principle of equal respect, asking researchers to engage in empathic consideration of the circumstances of the vulnerable to better understand their viewpoint.⁴²

Luna proposes the metaphor of ‘layers of vulnerability as an alternative to labelling. She argues that this relational and dynamic conception of vulnerability avoids the stereotyping and essentialism of the labelling approach. Her account is relational in that it identifies each layer of an individual’s vulnerability by closely examining the context in which she is situated, and dynamic because it recognises that layers of vulnerability may come and go as the context changes. Since Luna’s account assumes that vulnerability is dynamic and inessential, it does not stereotype or stigmatise individuals when describing them as vulnerable, while the complexity of a person’s situation can be recognised through considering multiple layers of vulnerability.⁴³ More recently, Luna specifies that layers of vulnerability may be related to ‘physical problems, consent, dependency, exploitation, [and] socioeconomic situations’, and that these layers should be understood as dispositions for harm or exploitation. Finally, she introduces the notion of cascade vulnerabilities that can trigger a series of events with harmful consequences.⁴⁴

Lange and others propose a taxonomy of vulnerability.⁴⁵ Their taxonomy aims to reconcile universal and particular conceptions of vulnerability by postulating inherent and situational sources of vulnerability.⁴⁶ Inherent sources include human corporeality, our affective and social natures and neediness, and our dependence on others. These sources of vulnerability are ineliminable features of the human condition. Inherent sources of vulnerability produce variable risk of harm or wrongs depending on age, health, gender and disability, as well as individuals’ capacities for resilience and the presence of social supports. Situational sources of vulnerability are context specific and include personal, social, political, economic or environmental features affecting individuals or social groups. As they are context specific, situational sources of vulnerability may be persistent or fluctuate over time. Situational vulnerability has a sub-category of pathogenic vulnerability. Pathogenic vulnerability refers to vulnerability arising from dysfunctional relationships characterised by prejudice, abuse, neglect or disrespect, or from political situations characterised by injustice, persecution or political violence. In addition, pathogenic vulnerabilities arise when policies designed to protect against existing vulnerabilities have the perverse effect of exacerbating existing, or generating new, vulnerabilities. On this account, the exclusion of pregnant women from research creates the pathogenic vulnerability experienced by ill pregnant women for whose conditions there is inadequate evidence about safe and effective treatments. These three types of vulnerability may co-exist, overlap and be occurrent (immediate and present) or dispositional (latent or background).

Like Kipnis’s approach, this taxonomy provides a systematic way to identify existing and potential sources of vulnerability in order to put in place mitigating strategies. By identifying different sources of vulnerability, researchers are required to attend to the wider context of the research as well as to the characteristics of participants. Vulnerability considerations are not limited to consent, exploitation, or unduly circumscribed safety assessments, but must take account of a full range of harms that research participation may involve. As well as protecting against harms, Lange and others postulate a positive duty to foster participants’ autonomy that is more onerous than seeking informed consent or avoiding unjust paternalism.⁴⁷ On their account, the duty to respect autonomy requires engaging with and furthering the interests of participants such that research participation actively supports autonomy and promotes resilience. Finally, the notion of pathogenic vulnerability grounds a duty to ensure that well-intended extra protections do not exacerbate existing or create new vulnerabilities.

1.6 What Work Can the Concept of Vulnerability Do?

To be useful in research ethics, the concept of vulnerability should draw attention to a set of concerns that are distinct from other moral concerns, and which are identifiable in non-stigmatising or stereotyping ways. The first step is to settle on a definition of vulnerability that encompasses both the universal and special conceptualisations, and is not implicitly comparative regarding some unstated norm of invulnerability. That is, we need a definition that acknowledges a universal capacity to be harmed or wronged in various ways related to our embodiment, shared needs and relationality, but that also recognises that the likelihood of those harms and wrongs does not fall equally on all individuals due to varying capacities and circumstances. Based on this understanding, vulnerability in research can be thought of as a disposition to, or risk of, suffering harms or wrongs arising from a range of inherent and situational factors. As these factors will independently vary across individuals and groups and change over time, vulnerability ascriptions must be specific, contextualised and reviewed.

The question remains as to whether vulnerability raises its own moral concerns, or is merely a marker for existing harms or wrongs. Hurst adopts the latter view, defining vulnerable research participants as those who are especially likely to incur an already defined research-related wrong. On her account, vulnerability does not generate new moral obligations, but rather serves as a heuristic to draw attention to existing obligations. The point of drawing attention to vulnerability is to flag that special steps may be necessary to fulfil existing research obligations for those who are especially vulnerable.⁴⁸ However, this does not seem to be a very satisfactory approach as it effectively renders the concept of vulnerability redundant. Despite the difficulty of defining vulnerability, the concept is valuable in highlighting morally salient features of our humanity that are central to everyday practices and notions of obligation.⁴⁹ The concept of vulnerability triggers us to think empathetically and humanely about others in a holistic way; to consider their situation, their strengths and weaknesses, and their liability to harm. These are important moral considerations that can readily be obscured by a procedural focus on informed consent or balancing research benefits and burdens.

In the context of research, researchers have a duty to consider the vulnerability of participants in a systematic and comprehensive way. This includes not only identifying specific risks of harm that may arise from experimental interventions, but also investigating the interactions and potentially cumulative effects of different sources or layers of vulnerability. In this process, researchers should be aware of the dangers of stereotyping and discrimination and actively seek to avoid labelling groups or individuals in essentialist ways. In addition, there is a need to consider the potential for protections in research to have counter-intuitive effects and create their own pathogenic vulnerabilities. Often, these may be more visible to participants than researchers, creating an obligation for meaningful consultation with participants and their communities. As being vulnerable implies a lack of power in some regard, this creates a duty for researchers to foster and support autonomy to the extent possible. This is more onerous than respecting autonomous decisions, as it requires investigation on the part of researchers and more comprehensive actions in terms of capacity building.

1.7 Conclusion

The recognition that vulnerable research participants should be protected is longstanding. However, difficulties have arisen in conceptualising vulnerability, reconciling universal and special notions of vulnerability, and identifying distinct duties and obligations triggered by vulnerability. The dominant approach of labelling vulnerable participants and groups is subject to increasing critique, because it can lead to stereotyping, discrimination and exclusion, and fail to be action-guiding. Newer analytic approaches conceptualise vulnerability as relational and dynamic, and identify multiple potential sources of vulnerability. These approaches offer a more nuanced way of thinking about vulnerability and protections against the risks of research-related harm and wrongs. Further work is needed to bridge the gap between these newer conceptualisations of vulnerability and practical guidance for research.

2 Autonomy Relational Conceptions

Natalie Stoljar

2.1 Introduction

This chapter argues that the conception of autonomy implicit in the current health research ethics guidelines is an individualistic one. On this model, people are autonomous when they voluntarily exercise their deliberative capacities to make choices based on their values. They can fail to be autonomous either for psychological reasons, when their deliberative capacities are impaired; or for epistemic reasons, when they do not have access to all the information that is relevant to a decision. The chapter outlines a contrasting ‘relational’ approach to autonomy. On the relational model, people can fail to be autonomous for social reasons. The social conditions that a person inhabits, including their available options, and the interpersonal context – such as family relationships and social expectations – all affect the ability to make autonomous decisions. The chapter also identifies some of the implications of the relational model for health research ethics. It examines two issues implicit in the guidelines: the relationship between autonomy and vulnerability, and the claim that informed consent is sufficient for autonomy.

2.2 Autonomy in Health Research Ethics Guidelines

Autonomy is a one of the fundamental ethical principles identified in documents that provide ethical guidelines for health research using human subjects. Section 9 of the Declaration of Helsinki states that ‘[i]t is the duty of physicians who are involved in medical research to protect the life, health, dignity, integrity, right to self-determination, privacy, and confidentiality of personal information of research subjects’.¹ The Belmont Report outlines three fundamental ethical principles: respect for persons, beneficence and justice. Respect for persons requires that ‘individuals should be treated as autonomous agents’ and that ‘[a]n autonomous person is an individual capable of deliberation about personal goals and of acting under the direction of such deliberation’.² These documents propose explicitly or implicitly that the principle of respect for autonomy can by satisfied by obtaining informed consent. Section 25 of the Declaration of Helsinki states that ‘no individual capable of giving informed consent may be enrolled in a research study unless he or she freely agrees’.³ The Belmont Report provides that respect for persons requires that ‘subjects be given the opportunity to choose what shall or shall not happen to them. This opportunity is provided when adequate standards for informed consent are satisfied’.⁴ And the Government of Canada guidelines state that ‘[i]ndividuals are generally presumed to have the capacity and right to make free and informed decisions. Respect for persons thus means respecting the exercise of individual consent’.⁵

As has been often noted, these ethical codes were initially formulated in response to notorious examples of exploitation and autonomy-denial of vulnerable people in medical research, such as the Nazi medical experiments and the Tuskegee syphilis study of the US Public Health Service. The latter took place from 1932 to 1972 to ‘record the natural history of syphilis’. Researchers recruited 600 Black men – sharecroppers who had not received medical care before – of whom 399 had syphilis and 201 did not. The men consented to participate in exchange for free medical care but were never informed about the true purpose of the study – they were told they were receiving medical treatment for ‘bad blood’. They did not receive penicillin when it became available in 1947, nor were they offered the opportunity to leave the study.⁶ The ethical guidelines aim to protect such vulnerable populations. The Belmont Report states that ‘[c]ertain groups, such as racial minorities, the economically disadvantaged, the very sick, and the institutionalized may continually be sought as research subjects, owing to their ready availability in settings where research is conducted. Given their dependent status and their frequently compromised capacity for free consent, they should be protected against the danger of being involved in research’.⁷ The document also associates vulnerability with a lack of autonomy: ‘Respect for human dignity entails high ethical obligations towards vulnerable persons – to those whose diminished competence and/or decision-making capacity make them vulnerable’.⁸

The ethical guidelines therefore raise three important questions. First, what is the understanding of autonomy implicit in the guidelines? Second, is the ‘autonomy of the vulnerable’⁹ possible, and, if so, how does vulnerability intersect with autonomy? Third, what is the connection between informed consent and autonomy? The next section claims that the conception of autonomy implicit in the guidelines is an individualistic one on which it is sufficient for autonomous decision-making that people have deliberative capacities and exercise them in appropriate ways. However, the individualistic model is limited both in its conception of autonomy and its recommendations regarding the ethical obligations of health researchers. I therefore outline a contrasting ‘relational’ model of autonomy that has been developed over the last several decades by feminist philosophers and others.¹⁰ The final sections examine the implications of relational autonomy for the notions of vulnerability and informed consent. The relational model suggests that the ethical obligations of health researchers to respect autonomy are more demanding than the requirement to secure informed consent.

2.3 The Individualistic Conception of Autonomy

Autonomy is the ability of people to ‘fashion’ their own destiny through ‘successive decisions throughout their lives’.¹¹ The challenge is to identify the conditions that are required to secure this ability and to promote its exercise in particular cases. The philosophical debate about autonomy offers both individualistic and a variety of relational answers. On a standard individualistic view, the conditions of autonomy are purely internal or psychological: autonomy corresponds to a capacity for rational deliberation. Gerald Dworkin argues that a person is globally autonomous when they have a higher-order capacity for critical reflection. A particular decision is locally autonomous when the capacity is exercised to evaluate, endorse or repudiate first-order preferences.¹² This view assumes that most people are rationally competent agents who engage in critical reflection and generate endorsed or ‘authentic’ decisions.¹³ People are nonautonomous only when critical reflection is defective – when the capacity for rational deliberation is undermined by a psychological impairment such as being under the influence of drugs or alcohol, hypnosis, brainwashing or similar forms of psychological manipulation, or pathological psychological conditions, like delusions, that interfere with mental competency. The individualistic conception of autonomy has been highly influential and has led many later authors to adopt variants of Dworkin’s approach.¹⁴

The health research ethics guidelines do not explicitly elaborate a notion of autonomy. The Declaration of Helsinki refers to respecting a ‘right to self-determination’.¹⁵ The Government of Canada Guidelines state that ‘individuals are generally presumed to have the capacity and right to make free and informed decisions’.¹⁶ Only the Belmont Report adopts the individualistic model explicitly, stating that ‘[a]n autonomous person is an individual capable of deliberation about personal goals and of acting under the direction of such deliberation. To respect autonomy is to give weight to autonomous persons’ considered opinions …’¹⁷ However, all the guidelines refer to informed consent as the ethical requirement that will secure subjects’ ‘free choice’ or autonomy. This implies that, for individuals who are ‘capable of deliberation’, the only additional thing needed for autonomy are optimal epistemic conditions in which to deliberate. It is reasonable to assume, therefore, that the health research guidelines do not go beyond the individualistic model, and that the conditions that undermine autonomy are limited to the psychological (impaired cognitive capacities) or the epistemic (inadequate information). On this model, ethical obligations are also limited to ensuring that subjects are mentally competent and have all relevant information. However, this narrow account of ethical obligation does not fully explain the ethical failures of the research in cases such as the Tuskegee study. There is no reason to think that the Tuskegee subjects were mentally incompetent or lacked autonomy due to cognitive impairment. The individualistic model – and the guidelines – imply that these subjects could, in principle, have made an informed decision to participate in the study and therefore that the obligation to respect their autonomy could have been discharged. This model fails to address the social context of choice and is both an implausible characterisation of autonomy and an impoverished account of the researchers’ ethical obligations. I now turn to the relational model of autonomy to address these problems.

2.4 Relational Autonomy

The starting point of relational approaches to autonomy is the observation that people are not disembodied rational subjects who, absent psychological impediments, function as fully autonomous agents. Rather, autonomy is an ability that develops and is exercised in a social context. Social relationships, as well as social and historical conditions – such as gender socialisation – foster or impede autonomy.¹⁸ In short, the social conditions that a person inhabits, the interpersonal context of family and community relationships, as well as norms and interpersonal expectations, can all promote or undermine the ability to make autonomous decisions.

Relational autonomy is a popular framework in clinical ethics¹⁹ but so far has received little attention in health research ethics. One exception is offered by Edward S. Dove et al., who advocate a relational approach to understanding consent to placental sampling in pregnant women.²⁰ Some women request to consult their partners before providing consent to placental sampling. The authors propose that such requests are better accommodated within a relational model than an individualistic model because the former acknowledges the impact of social relationships on agency and hence recognises that ‘joint decision-making [could] be built into the consent process’.²¹ This illustration of an application of the relational model is quite limited, however. First, it seems to conflate joint decision-making with relational autonomy. Joint decision-making implies that the author of a decision is a collective (the woman and her partner), whereas the relational model aims to characterise individual autonomy that takes into account the decision-maker’s social context. Second, the potential of the relational model, both to identify social conditions that hamper individual autonomy, as well as to identify strategies to promote autonomy, is considerably richer than suggested here. There is a complex set of factors elaborated by relational theories that potentially affect subjects’ autonomy and hence should be considered in the context of health research ethics. In what follows, I sketch three varieties of relational approach.

The first set of views argues that although autonomy is primarily a psychological capacity, social conditions play a significant causal role in its development. Marilyn Friedman offers a psychological test of autonomy on which being autonomy requires ‘self-reflective affirmation’ with respect to one’s preferences and values.²² She emphasises, however, that family relationships serve to either promote or hamper the development of the critical reflection that allows people to engage in self-reflective affirmation.²³ Similarly, Diana Tietjens Meyers argues that a person has ‘autonomy competency’ when she exercises a ‘repertoire of skills’ of critical reflection to engage in ‘self-discovery, self-definition and self-direction’.²⁴ Social conditions, particularly lack of education or oppressive socialisation, can affect whether or not such skills develop in the first place, erode them even if they do develop or fail to promote a person’s exercise of these skills. For instance, gendered expectations might deter the development or exercise of autonomy skills in girls but promote it in boys. Boys are more likely to be encouraged to debate their points of view and adopt an attitude of ‘authority over their own voice’. For Meyers, well-honed autonomy competency can also counter oppressive socialisation. She comments that autonomy skills ‘endow women with the capacity to fashion self-portraits and self-narratives in their own voices and to lead their own lives’.²⁵ Meyers’s account is relational because it recognises the many ways in which deliberation is itself moulded by socialisation. She also identifies a rich array of deliberative skills that are required for autonomy competency including those of introspection, imagination, communication and memory.²⁶ These include emotional, bodily and interpersonal components and hence, on Meyers’s approach, relationality is built into critical reflection itself.

A second category of relational views claims that the presence of certain external options is a necessary condition of autonomy. Joseph Raz argues that autonomy – and hence a flourishing life – will be thwarted if a person lacks a sufficient range of meaningful external options.²⁷ For instance, a ‘hounded woman’ on a desert island, who is pursued by a carnivorous wild animal that is hunting her down – and whose every move is determined by the need to protect herself from the beast – cannot be autonomous, even if her powers of critical reflection are fully intact. Marina Oshana also advocates an externalist approach, on which autonomy is incompatible with external conditions that interfere with the ‘de facto power and authority’ that is necessary for people to direct their own lives.²⁸ For example, when young African American men are routinely subjected to police profiling or arbitrary stop-and-search policies, this is autonomy-undermining because it unjustifiably constrains their options and diminishes their power to direct the course of their daily lives. Therefore, on externalist views, autonomy is not only a matter of genuine self-affirmation or of exercising skills of critical reflection; it also requires meaningful external options and the absence of severely constraining external conditions.

Finally, there is a category of relational approaches that focuses on the importance for autonomy of self-regarding attitudes, such as self-trust and self-esteem. Carolyn McLeod identifies the role of self-trust – an ‘attitude of optimism about our own competence and moral integrity’²⁹ – in autonomy through the example of ‘Anna’, who suffered a miscarriage at six weeks’ gestation and afterwards felt considerable emotional turmoil. McLeod analyses Anna’s sense of incompetence to articulate her emotions as in part a result of others’ lack of sympathy for her grief and corresponding failure to reinforce her feelings: ‘[O]ften women and their partners are pressured not to grieve after miscarriage because people tend not to view the fetus’s death as an event that warrants grief’.³⁰ Comments such as ‘it was a blessing in disguise’ or ‘it could have been worse; you could have lost a baby’ fail to ‘give uptake to [women’s] feelings’.³¹ Self-regarding attitudes – people’s sense of their own competence, sense of self-worth and self-trust – are thus particularly sensitive to interpersonal conditions and the attitudes of others.

Catriona Mackenzie has extended this proposal, arguing that self-regarding attitudes such as self-trust are constitutive components of what she calls the ‘normative authority’ required for autonomy.³² Mackenzie elaborates contrasting examples from the clinical context of decisions to withdraw life-preserving medical treatment. Ms B. was a forty-three-year-old single woman who had had a career in social work in a hospital before her illness. Ms B. suffered from a spinal condition that left her paralyzed from the neck down. After an attempt to improve the condition through surgery had failed, she requested that her ventilator be switched off. She was fully aware of all treatment options and thoughtful and articulate about her decision to have treatment withdrawn.³³ Mackenzie claims that she ‘clearly regarded herself as a moral equal’ and that ‘she was motivated by an attitude of self-worth; that is, by a sense that her life should be meaningful, worthwhile, and valuable, and by a conviction that it could no longer continue to be so given her medical condition’.³⁴ Contrast Mrs H., who suffered an aggressive form of bone cancer that required amputation of a leg below the knee. Her husband left her as a result of her disability. Mackenzie comments that ‘she does not have the kind of strongly developed sense of basic self-confidence that might enable her to envisage a different future for herself than the one she had anticipated; and she does not have a sense of her life as worth living in its own right, independently of her relation to her husband’.³⁵ By hypothesis, Mrs H.’s capacity for self-trust and self-esteem was damaged by both her socialisation – Mrs H. was influenced by cultural norms and gender stereotypes that seemed to suppress her sense of self-assurance – as well as gendered relationships within her family – her husband left her when she was no longer able to occupy the traditional role of a supportive wife. Mackenzie argues that self-regarding attitudes are not just the outcomes of the social context; they are also ‘intrinsically relational’ because they are ‘enmeshed in interpersonal relationships and social structures of mutual recognition and it is for this reason that our autonomy can be impaired by failures of recognition’.³⁶

The different relational conceptions of autonomy that I have just outlined convey the complexity of the social–relational factors that potentially affect whether subjects of health research will be autonomous or not. In the next two sections, I outline the implications of the relational model for vulnerability and informed consent. I suggest that the relational model generates more demanding ethical obligations on health researchers than those derived from the individualistic model.

2.5 Relational Autonomy and Vulnerability

Relational conceptions of autonomy help to illuminate the connection between autonomy and vulnerability (see Rogers, Chapter 1 of this volume). Recall that the Belmont Report says that vulnerable persons are ‘those whose diminished competence and/or decision-making capacity make them vulnerable’.³⁷ Vulnerability is here being characterised as (individualistic) non-autonomy, namely as non-autonomy due to (psychologically) diminished competence. This suggests that vulnerability and autonomy are incompatible and that therefore that it is unethical for vulnerable agents to be the subjects of healthcare research. However, rather than treating vulnerability and autonomy as always opposed, the relational model potentially provides a more nuanced account of how to evaluate and ultimately promote the autonomy of members of vulnerable groups.

Theorists of vulnerability have observed that vulnerability can be inherent or situational.³⁸ Certain vulnerable groups, such as pregnant women, are vulnerable due to intrinsic, bodily aspects of being human. Others, such as the subjects of the Tuskegee study, are situationally vulnerable. As impoverished Black sharecroppers in the American South who had never received adequate education or medical care, these subjects were situationally vulnerable. Poverty and racist discrimination afforded them few real options and disposed them to manipulation by the medical personnel conducting the study. The situational vulnerability of subjects of the Tuskegee study generates global non-autonomy. Even if such subjects have the deliberative competence to make informed, locally autonomous decisions, they lacked minimally adequate options, and could not direct the course of their lives. Is health research using subjects who are situationally vulnerable and globally non-autonomous always ethically indefensible? Mackenzie disputes this conclusion. Vulnerability and autonomy are not always opposed, because ‘ethical responses to vulnerability should be guided by the value of autonomy … to counter the sense of powerlessness and loss of agency that is often associated with vulnerability … and to counter the risks of objectionable paternalism’.³⁹ If she is right, it would not be impossible to conduct ethical studies using subjects who are situationally vulnerable, but the obligation to respect autonomy would be demanding in such cases. Researchers would have to actively ameliorate subjects’ autonomy by, e.g. ensuring that participation in the research itself provides meaningful options and fosters positive communication to promote subjects’ self-trust and sense of self-worth.

The situation is different for groups that are defined as vulnerable due to their inherent characteristics, such as pregnant women. It has been pointed out that the assumption that there is homogeneity among members of vulnerable groups is problematic (see Brassington, Chapter 9 and Rogers, Chapter 1 in this volume). Labelling a group a ‘vulnerable population’ can lead to ‘unfettered protectionism’ with respect to health research on this population, which in turn can have adverse consequences for their health.⁴⁰ For instance, there is no effective malaria drug that can be used by pregnant women, thus leading to unnecessarily high rates of death from the disease.⁴¹ The relational model of autonomy challenges the assumed homogeneity of groups that are characterised by inherent vulnerabilities. Although the conditions causing situational vulnerability often coincide with those that undermine autonomy, this is not the case for inherent vulnerability. Individual women do not have diminished mental competence due to pregnancy; nor do social conditions render pregnant women as a group globally non-autonomous. From the perspective of relational autonomy, there is no impediment to ethical research using pregnant women merely due to the inherent vulnerability of pregnancy.

2.6 Relational Autonomy and Informed Consent

The ethical guidelines mostly treat informed consent and autonomy as interchangeable and suggest that securing informed consent is both necessary and sufficient to respect autonomy. The relational model challenges both assumptions.⁴² On the relational model, it is possible to respect and promote autonomy without obtaining informed consent. Consider children or people with a cognitive disability who cannot provide genuine informed consent. Relational conceptions of autonomy imply that there are many ways in which autonomy can be fostered, such as providing meaningful options and reinforcing self-regarding attitudes of self-confidence, self-trust and self-worth. The ethical obligation of respect for relational autonomy is therefore distinct from the requirement to obtain informed consent. If health research on children or people with cognitive disabilities were envisioned, it may be necessary to secure informed consent from a parent or guardian. But this would not imply that the ethical obligation of researchers to respect the autonomy of subjects themselves has been discharged. Researchers would have an additional obligation to foster the relational autonomy of the subjects of the research.

The relational model also questions the assumption that informed consent is sufficient for autonomy.⁴³ The obligation to obtain informed consent requires health researchers to provide relevant information and an opportunity for subjects to weigh up costs and benefits on the basis of the information. This obligation is not onerous, as McLeod comments vis-à-vis informed consent in clinical contexts: ‘[r]arely does significant communication about a patient’s options occur’ besides either recommending the procedure, or in cases in which a recommendation is not possible, ‘[saying] to the patient that she has to choose based of her beliefs and values’.⁴⁴ As we have seen, an informed decision is not always an autonomous one. The Tuskegee subjects did not suffer cognitive impairments, so in principle they had the capacity to evaluate information and decide to participate in the study. On the relational model however, this decision is unlikely to be even locally autonomous. The Tuskegee subjects lacked recognition by others of their status as moral equals; they likely also lacked self-trust or a sense of themselves as the equals of the researchers conducting the study. If so, even informed decisions would not count as autonomous. The relational model implies therefore that health researchers have additional ethical obligations than simply to obtain informed consent. Consider again the example of placental sampling. Dove et al. suggest that requests by some women to consult their partners indicate a form of relational rather than individualistic decision-making. This may be true, but it would be wrong to assume that the requirement to respect relational autonomy would be discharged by providing subjects an opportunity to consult family members. Indeed, it has been argued that respecting relational autonomy implies quite stringent obligations, for instance an epistemic obligation to understand the woman’s subjective point of view.⁴⁵ For instance, in the placental sampling case, will consulting a partner foster the woman’s autonomy, or does it indicate a disposition to defer to a male partner’s wishes due to lack of self-trust or self-worth? (Recall the case of Mrs H. above.) In general, respecting relational autonomy requires the provision of meaningful options – including the option to say no – and an environment that promotes rather than undermines the necessary competencies and self-regarding attitudes.

I have argued that securing informed consent, as understood on the individualistic model, is insufficient to respect relational autonomy. However, could the obligation to secure informed consent itself be revised in ways congenial to the relational approach? Guideline 9 of the 2016 International Ethical Guidelines for Health-Related Research Involving Humans states that informed consent should be a ‘two-way communicative process’, and that persons obtaining the consent should ensure that subjects comprehend the relevant information. For example, the information must be in ‘plain language understandable by the applicant’, and ‘the researchers must make themselves available to answer questions’.⁴⁶ These latest guidelines therefore adopt some of the lessons of relational autonomy. They focus attention on the ways on which the availability of researchers to answer questions could facilitate a better-informed process and hence on the effects of interpersonal attitudes on individuals’ decision-making. Yet they do not fully articulate the potential for understanding informed consent in relational terms. One promising avenue of research is the framework of ‘epistemic injustice’, which argues that people can suffer injustice due to unjustifiable disregard for their status as full epistemic agents.⁴⁷ For example, due to their social subordination, the epistemic agency of the Tuskegee subjects was ignored and there was no attempt to secure informed consent. Epistemic injustice can also occur in cases in which the need for informed consent is recognised. Indeed, it may be especially likely to occur in the context of health research due to the privileged epistemic position that researchers occupy as experts in the research field. As José Medina has argued, having privileged status – epistemic or otherwise – tends to make one more likely to display epistemic vices such as epistemic arrogance, or the expectation of ‘not being called into question in one’s opinions, that is having an undisputed cognitive authority’.⁴⁸ Such epistemic vices potentially will interfere with obtaining appropriate consent. Attention to the relational context in characterising informed consent reinforces the conclusion of previous sections that the ethical obligations of researchers who study human subjects are more demanding than set out in the current guidelines. In addition to the obligation to foster the social and interpersonal conditions that promote autonomy, they may have special epistemic obligations, namely to cultivate epistemic virtue and attempt to eliminate epistemic vice.

2.7 Conclusion

This chapter has argued that that the current guidelines for health research ethics are implicitly committed to an individualistic conception of autonomy. This is an implausible conception because it does not recognise ways in which people’s capacities for autonomy depend on social conditions, family and community relationships, and interpersonal attitudes. The chapter outlined a competing relational model of autonomy and argued that the ethical obligations derived from the relational model are more stringent than those derived from the individualistic conception.

3 Proportionality in Health Research Regulation

Owen Schaefer

3.1 Introduction

Proportionality in health research regulation can, at its broadest level, be understood as an attempt to balance two considerations that sometimes compete: the protection of individuals affected by research – especially, but not limited to, human subjects – and the promotion of socially valuable research. This chapter will explore the concept of proportionality through three sections: First, a clarification on what I mean by proportionality in this context and why it is important; second, an exploration of how particularly challenging it is to assess proportionality; and third, a proposal for a procedural approach to proportionality that may assist with those challenges. In particular, I will propose that adopting a facilitative attitude, undertaking rigorous justification, ensuring transparency and engaging with relevant stakeholders may be effective procedural means of overcoming the challenges of proportionality.¹

3.2 What Is Proportionality?

The term ‘proportionality’ has several meanings even within the context of health research regulations. We can roughly distinguish between the first-order or study-level sense of the term, and second-order or policy-level sense.

First-order proportionality refers to the benefits of a study – inclusive of benefits to the subjects as well as society as a whole – being proportionate to its risks and burdens. It is interchangeable with ‘favourable risk-benefit ratio’ as found in the classic article ‘What makes clinical research ethical?’,² and a variety of authors have followed suit.³ On this understanding, the benefits of a given study need to be of sufficient strength or magnitude to justify the risks individuals are exposed to. Research Ethics Committees (RECs), Institutional Review Boards (IRBs) or equivalent are routinely tasked with making such assessments on a case-by-case basis for human subjects research.

I will set aside assessment of first-order proportionality in this chapter, as risk–benefit ratios will be covered elsewhere in this volume.⁴ Instead, I will focus on second-order proportionality in health research, which operates primarily at the policy level (inclusive of national and institutional policies).

Second-order proportionality refers to whether the burdens of a given rule or policy governing research are proportionate to its benefits. The burdens and benefits can further be delineated along two axes: effects on the process of research including monetary/staffing costs, researchers’ time, efficiency and scientific validity; and the effect on protection afforded to individuals affected by research (including, but not limited to, human subjects). As will be discussed below, this is not only limited to physical effects, but extends to other impacts such as the wrongdoing of privacy violations.

Proportionality assessments then, will involve evaluating the benefits of a regulation in terms of both protection and promotion, and weighing those against the burdens, also in terms of protection and promotion. While we might typically expect research regulations to impose burdens in terms of process while affording benefits in terms of protections, we should keep in mind that regulations can also have beneficial effects on processes, and deleterious effects on protections, as seen in Table 3.1.

Table 3.1 Matrix of regulations’ potential effects on research

	Process (monetary/staffing costs, researchers’ time, efficiency, and scientific validity)	Protection (relating to the interests of human subjects or other individuals directly affected by research)
Benefits (positive effects)	e.g. streamlining research review	e.g. data security protocols to protect confidentiality of subject data
Burdens (negative effects)	e.g. substantial time from researchers to ensure compliance	e.g. retaining sensitive study data for years, increasing risk of breach

Like first-order proportionality, there is a justificatory relationship: the benefits of a rule or policy must be sufficient to justify the burdens imposed. But unlike first-order proportionality, second-order proportionality is not evaluated on a case-by-case basis. Rather, it concerns the total effect a given policy has on the research enterprise. It is the responsibility of policymakers – including regulators and institutional leaders – along with institutional bodies like RECs and IRBs, to ensure that their policies are proportionate in this way.

Still, context will be important in assessing the proportionality of a given policy. Rules will have different impacts on different institutions, fields of study, countries and cultures. For example, a rule requiring written informed consent from subjects – which ensures consistent provision of information and ease of auditing – may be quite proportionate in societies with high literacy. But in societies with low literacy, the requirement would lead to the exclusion of many subjects, potentially endangering the scientific validity and depriving already-marginalised groups of potentially beneficial interventions. This could tip the rule from being proportionate to being disproportionate.

3.3 Proportionality of Review and Proportionality of Harms

Discussions around second-order proportionality typically focus on two related aspects: proportionality of review, and proportionality of harms. Proportionate review involves tailoring the degree of scrutiny to the amount of risk subjects may be exposed to.⁵ Proportionality of harms defines those risks in terms of probability of physical or psychosocial harms.

In regard to proportionality of review, low-risk research may be reviewed under expedited or exempted pathways, where only one or two members of a REC are directly involved in assessing and approving a study. Higher-risk research would instead go to a full board.

Full board reviews take more time, potentially reducing the efficiency of research with potential social benefits. However, they also are more likely to pick up on potential ethical failings, due to both the larger number of eyes on a proposal, and the greater diversity of expertise brought to bear on it. This will be more proportionate for studies with higher risks to subjects, and so in need of closer attention. For low-risk studies, there may not be much reason to apply that extra scrutiny, as the marginal benefit to subjects of correcting a failing is relatively small. At the same time, the study will still consume resources, which may be separate grounds for some scrutiny.⁶

However, ethics review is just one component of research oversight. Many policies governing health research operate using different mechanisms, including rules that bind researchers directly, regardless of the scrutiny applied. These include policies delineating the contents of informed consent, confidentiality protections, documentation and authorisation. All these requirements have the potential to slow down research or increase its costs, and so must be justified in terms of the benefits they afford. Stratifying the stringency of a wider variety of rules is more common in Europe, while US regulations only stratify the review process.⁷

Additionally, approaches centred around proportionality of harms capture only part of the justifications for rules governing health research. The four principles approach can help illustrate this. Beauchamp and Childress identified four central mid-level ethical principles that underpin bioethics in general, and research ethics in particular: beneficence, non-maleficence, respect for autonomy and justice.⁸

Beneficence in this context relates to the impetus to ensure that socially beneficial research is conducted in an efficient manner; inefficiencies resulting from over-regulation increase the overall cost of research, in turn reducing the amount of research – and thus social benefits generated – that can be conducted on a given budget. Non-maleficence refers to the potential harms of research mentioned above. On the above understanding, proportionality would primarily involve balancing beneficence – in terms of promoting valuable research – against non-maleficence (avoiding harms caused by research).

This leaves out autonomy and justice, which are also relevant to proportionality assessments. Consider the following examples of informed consent – as an illustration of respect for autonomy – and subject selection (illustrating justice concerns).

Informed consent may in part be aimed at harm mitigation, so subjects can avoid participating in trials whose risks are unacceptable to them personally. But it also aims at respecting the ability of subjects to govern their own lives – here, to ensure that participating in a study is in accordance with their values. This includes risks, but may also relate to other factors such as how much they identify with the aims of the study, trust researchers, or believe it will produce social benefits.⁹

Fair subject selection might also have a risk-mitigation aim, insofar as subjects particularly vulnerable to harm from a study may be excluded. But this must also be balanced by justice considerations in excluding certain groups from a study. A case in point is the routine exclusion of pregnant women from research. This is done in the name of non-maleficence, as fetuses are frequently thought to be at higher risk of harm from experimental interventions. But the result is a lack of evidence for the safety of a wide variety of drugs on pregnant women, forcing them into an uncomfortable dilemma: accept substandard care with a more proven safety record, or go for proven interventions that have an uncertain risk to their children. As such, a rule meant to protect pregnant women arguably perpetuates injustices against them.¹⁰

Assessments of proportionality should go beyond benefits and harms to incorporate considerations of justice and respect for persons. These considerations may factor in on both sides of the proportionality equation: the burden of regulation may be necessary to prevent an injustice and promote autonomy, or – as with the case of preventing research with pregnant women – a regulation’s burdens may be shown to be unjustifiable by virtue of the injustice and disrespect that it promulgates.

3.4 The Challenge of Social Value

From the preceding discussion, it should already be evident that assessments of proportionality of a given policy governing health research will be quite complex. Further challenges emerge upon closer analysis, one of which is how to integrate the social value of research into proportionality assessments.

Up until this point, it has been assumed that greater efficiency, lowered cost and improved scientific validity in health research are unquestionably valuable. This is predicated on a potentially contestable notion – that the outputs of research have substantial social value. If policies slow down research, then in turn society’s access to valuable outputs – more effective treatments, better prevention of disease, mitigation of symptoms and side-effects, etc. – will slow down. Increased costs mean less research can be done, and thereby fewer valuable outputs are produced. Further, detriments to scientific validity – such as limitations on the use of placebo-controlled trials – may undermine the robustness of those outputs.

It is often held that all health research must contribute to social value in order to be ethically justified.¹¹ For present purposes, it is sufficient to note that if a given study really has no social value, proportionality is irrelevant – it should not be permitted in the first place.

Meeting the minimal threshold of social value masks the larger, much more intractable issue of assessing the magnitude of that social value. This magnitude is important in proportionality assessments to get an understanding of how problematic a given inefficiency or other detriment really is. For low social value research, barriers to research may more easily be outweighed by ensuring protections for subjects; vice-versa for high social value research.

But there is no reliable formula for quantifying the social value of a given study. The results of all studies are by nature uncertain – if we knew the results ahead of time, there would be no need to engage in a study in the first place. Much health research is not directly translatable; it instead builds a base of understanding that over time, in combination with other studies, will eventually lead to improved practice down the road. It is also unclear how we should judge the impact of health research. Some measures like Quality-Adjusted Life Years are relevant here, but these have been disputed as too abstracted a way from patient experiences and values,¹² and being potentially discriminatory.¹³

Still, some reasonable estimates of possible social benefits of a given study must be possible. This is the routine task of agencies that disburse grants for research, after all. Moreover, research regulation can itself play a role in improving the social value of a study. For example, beyond risk assessment, a REC/IRB review of scientific validity and value can play a role in promoting sound knowledge generation from studies.¹⁴

3.5 Complexities of Analysis

The evaluation problem is compounded at the policy level, where broad categories of research are being considered, rather than individual studies. Furthermore, the social value of research is just one piece of a proportionality assessment. We need to ascertain not only the social value of the research, but the extent to which a given policy will detrimentally impact this research. While it is routine for policymakers and academics to perform economic impacts of regulations, these analyses have been questioned in terms of their rigor and real-world validity.¹⁵ In the research context, a full analysis would have to take into account the extent to which increased cost of research would crowd out further socially valuable studies, assuming total budgets for research are independent of regulatory policy.

There are similar uncertainties and complexities in relation to assessing protections. Only a few policies will be relatively easy to assess: prohibitions of activities that would almost certainly harm or wrong participants. Failure to obtain informed consent from competent adults for interventional research may be an example, insofar as it would be a clear violation of autonomy.

But often, harms or wrongs are probabilistic, with the probabilities themselves unknown or uncertain. Policies may only reduce the likelihood of such harms or wrongs, rather than prevent them entirely. For example, a requirement that researchers provide their CVs to review boards has some use – ethics board members can ensure that they have the relevant qualifications to carry out the study procedures. At the same time, it would be difficult to articulate exactly how much harm (qua adverse outcomes) is actually prevented by such a policy. In theory, one could perform a comparative analysis of researchers with different qualifications and assess correlations with adverse study outcomes. But such analyses have not been done for the wide array of subfields and procedures that ethics committees may encounter, so those setting policies on the matter must instead rely on personal judgment.

Finally, there is the question of how to bridge the two sides of proportionality, namely, burdens and benefits. That is, how to determine if a given burden on research is justified by the benefits it affords? A potential approach is to leverage decision theory, where the gains and losses to individuals’ well-being from a regulation are quantified and aggregated, and a determination is made as to whether a given regulation or policy overall improves expected utility.¹⁶

Here, incommensurability is a particular issue. Even if one side or the other can be somehow defined and explicated, the values on either are likely not commensurate – they are not easily compared and weighed up against each other. Perhaps the burden of requiring informed consent for some secondary data research can be quantified in terms of the increased cost, delays and potential bias of only including those who would consent. But those measures are of an entirely different nature from the autonomy interests of individuals to maintain control over data about them, one of the main values being protected by informed consent requirements. Unfortunately, again, there is no formula to make such assessments, and a good deal of individual judgment on the part of policymakers is necessary.

3.6 Procedural Approaches to Proportionality Assessments

There is an old joke that philosophers like to kick up dirt in front of their eyes, then complain they can’t see. The above may appear to be like so much dirt, pointing out all the difficulties in doing a proper proportionality assessment of health research regulations. So, at this point, I will be somewhat more constructive and propose some ways that proportionality assessments can be made more reliable and legitimate.

The following will primarily be procedural proposals. That is, they are not explications for how to determine whether a given regulation is proportionate. Rather, they are a series of structures and systems governing the process of assessing proportionality that should have two desirable features: they will improve the reliability of proportionality assessments, by prompting systems that are better able to assess whether a given rule’s protections really justify the burdens imposed; and they will help engender legitimacy in those assessments, by adopting systems that can earn the confidence of stakeholders – including researchers and participants – in the proportionality of rules that are ultimately produced.

At the most general level, it is important for those involved in regulation to have a facilitative attitude towards proportionality. A view that their role is solely to protect subjects may engender the perception that they are there to get in the way of valuable research.¹⁷ This will not only engender hostility towards regulations and regulators but is also fundamentally mistaken. It ignores the crucial consideration of proportionality; to ensure that any burdens are adequately justified by the benefits they bring about. As a result, proportionality requires consideration of both the positive and negative sides of the research enterprise.

A more useful way for regulators to frame their role would be as facilitators of responsible research. This is not to say that they are there to make research easier than it might otherwise be; almost any regulations will have some costs in terms of efficiency, expense or validity, and regulators should be up front about that. However, enforcing reasonable rules that are proportionate to the burdens they accrue is a means to ensure that the research that does occur is responsible in terms of the benefits to those affected. The term ‘facilitation’ gives explicit emphasis on the need to ensure that the regulations are as minimally intrusive as necessary to achieve a given protective aim.

This framing has both inward-facing and outward-facing benefits. Looking inwards, regulators are reminded of the need to consider burdens of regulation along with benefits, and the balancing effort between the two in the proportionality assessment. This will help avoid blatantly one-sided approaches to regulation. Also, looking outwards, expressing this attitude in engagement with stakeholders can help assure them that their interests are being adequately accounted for. Such engagement is not merely limited to top-down communication of regulatory decisions, but active engagement as will be discussed further below.

A related procedural approach is actually doing the work of a proportionality assessment – that is, providing rigorous justification of a rule or policy’s proportionality. It may be tempting to give up in the face of the uncertainties and ambiguities discussed. Nevertheless, responsible regulation must proceed. Ignoring proportionality can lead to one-sided policies, which either produce overly protective regimes with unacceptably burden research, or overly permissive regimes that do not adequately provide protections out of fear of inhibiting research.

And it will be work, indeed. When a given rule is under consideration, a non-trivial amount of research and analysis will be needed. Is there evidence on the magnitude of the harms or wrongs being prevented? What about the effectiveness of the proposed rule? And on the flip side, what effects will it have on the research enterprise? What are the quantifiable and non-quantifiable costs? Finally, when all those considerations are taken into account, can the regulation’s protective effects truly justify the burdens imposed? And if not, can it be refined so that it does?

The final justificatory step may be the most uncertain and challenging. In some ways, it is an ethical or normative question relating to the values promoted and inhibited by a given policy. Regulators are not typically trained in philosophical analysis that may assist here, but some features of decision-making can be highlighted. These include articulation of the competing values at stake; scrutiny of any empirical evidence adduced; consistency between different judgments; clarity in terms of the reasons a given rule is justified, or not.

There is not space to elaborate here on such analytical tools. Indeed, no single article could adequately do so. Instead, it may be that regulators – or at least, some individuals in the regulatory process – should receive training in these analytical tools. As it stands, many relevant degrees like Masters of Public Policy or Masters of Public Administration do not routinely integrate such analytical training into their curriculums, focusing instead on social sciences. Reform of these curriculums might help boost competence in performing proportionality assessments. Alternative educational systems should also be considered, such as short courses, blended learning modules and ad hoc training workshops that may be more practicable for working professionals.

Especially because of the difficulty of making proportionality assessments, transparency in justificatory analyses will be crucial. Transparency here refers to some public promulgation of the reasoning process behind the decision that is reached. This would not only be easily accessed by stakeholders, but promulgated to relevant stakeholder groups so they are aware it exists in the first place.

Almost any rule will involve some trade-offs between protection of individuals and minimising burdens on research. As such, criticism from some affected stakeholders is inevitable. Having the reasoning and evaluation of a proportionality assessment will not eliminate that criticism, but it can go some way towards blunting suspicion that such an assessment was one-sided or ignored their concerns.

Moreover, there is good reason to suppose that stakeholders are owed this sort of transparency. For researchers, regulations have coercive force – failure to abide by them will result in penalties, whether criminal, civil, or – in the case of instructional policies – professional. It is a matter of respect to those individuals who are liable to such punishments that the reasoning process behind the rules is laid out in full. Other individuals like research subjects have a different relationship with regulations; while regulations do not directly bind them, they are carried out in their name. And if a regulator decides against enacting a given protective rule, that regulator is deciding to permit a certain degree of risk of harm to accrue to participants or others. Those affected individuals deserve to know the reasoning process behind this decision, as they may well be harmed by it.¹⁸

Another benefit of transparency is that it can prompt regulators to ensure their reasoning is truly defensible. Behind closed doors, there may be a temptation to wave away concerns that are too difficult or complex. By making their reasoning public, they are compelled to seriously reckon with all the considerations that stakeholders may find relevant. If not, they will be open to – legitimate – scrutiny and critique for inadequate analysis that will undermine confidence in the rules that are put forth.

Promulgation of reasoning and justification from regulators to stakeholders is important, but limited insofar as it is top-down and one-way. A more thoroughgoing and robust way to ensure adequate consideration of competing interests and earn public trust in proportionality assessments is to directly engage with those groups, to allow the co-creation of rules and collaborate assessment of the thorny issue of proportionality.

There are a myriad of ways that stakeholders can be engaged in proportionality assessments. For more details on approaches to and justifications for public engagement, see Aitken and Cunningham-Burley, Chapter 11 in this volume (on public engagement and access), and Burgess, Chapter 25 in this volume, (on public engagement and health research regulation).

These approaches are especially valuable for complex and uncertain issues like proportionality assessments. A small group of regulators may have parochial approaches or biased analyses that can be avoided by the involvement of a larger body of stakeholders. It may also relieve some of the pressure to make such complex judgments on their own, by soliciting assistance from a wider group.

This engagement should not be seen as one-off, or only occurring prior to rulemaking. A truly proportional approach to regulation must recognise the potential fallibility of initial judgments, and the fact that the situation on the ground may change. Protections previously seen as adequate could become threatened. For example, DNA profiles have recently been shown to be re-identifiable, which means previous protections merely stripping names and other extraneous information from such profiles are no longer sufficient to guarantee anonymity.¹⁹ Previously burdensome compliance can be made easier by new technologies, as arguably occurred with the advent of digital compilation of ethics review documents allowing for more rapid collation and assessment.

For this reason, engagement should be a continual process, with the proportionality of a given rule periodically up for review and re-evaluation. Regulators may not be equipped to maintain such active review, so instead being open to updates and comments from stakeholders may be optimal. This both relieves regulators of some burden to keep regulations’ proportionality up to date, and ensures stakeholders have a continued ability to positively impact the rules that affect them.

To be sure, there are limitations on how much engagement can do. It was noted earlier that regulators may need additional training to adequately undertake proportionality assessments. This would already be practically difficult with regulators; with broader stakeholder groups, it is probably impossible. As such, there may be some limit on the extent to which co-creation is achievable for matters as complex as proportionality assessments. Still, we should not allow the perfect to be the enemy of the good; engagement has substantial value, as explained, that can supplement the deep analysis that regulators are responsible for.

3.7 Conclusion

In this chapter, I have explored the notion of proportionality in the context of health research regulation. Proportionality was defined in terms of a justificatory relationship: the benefits afforded by a given rule must serve to justify the burdens imposed by it. Assessing proportionality is no easy task; it is beset by uncertainties and challenges of analysis at a variety of levels, and involves weighing of different values – relating to beneficence, non-maleficence, justice and autonomy – that are non-commensurate and often non-quantifiable. The task of proportionality assessment is not impossible, however. Indeed, it is a necessary part of responsible regulation of health research. I have suggested several procedural approaches that can help improve the reliability and legitimacy of those assessments: a facilitative attitude; rigorous justificatory analysis; transparency in reasoning; and engagement in decision-making. These procedures recognise that we cannot formulaically produce an answer as to whether a given regulation is proportionate, and judgement is required. Hopefully, the contents of this chapter – in conjunction with the other material in this volume – can go some way to assisting those involved in regulation in understanding the nature, importance and practice of proportionality assessments.

4 Social Value

Johannes J. M. van Delden and Rieke van der Graaf

4.1 Introduction

This chapter starts from the assumption that science is a matter of co-creation. To open up science to democracy means that we have to think about the social value of research, which in itself we cannot leave to science to evaluate. This raises detailed questions around patient and public involvement (PPI) in deciding which research to perform, and about how to handle conflicts between individual and public interests. These are addressed elsewhere in this volume.¹

In this chapter we focus on social value in health-related research involving humans, including data driven research. We first describe the background to the concept of social value and its meaning. Then we examine the concept itself and define the social value of an intervention as the value that an intervention could eventually have on the well-being of groups of patients and/or society. We also discuss some of the open issues in the scholarly debate about the concept of social value.

We find that to state a requirement for social value is one thing; to actually evaluate the social value of a research project in a Research Ethics Committee (REC) is another. We therefore elaborate on how the requirement of social value can be applied. We argue, first, that it is important to have this requirement as a separate condition. To increase systematisation, we further discuss how social value can be assessed in the steps that together constitute the risk-benefit task of RECs.

Returning to our opening statement, we argue that the addition of the requirement of social value can be seen as a consequence of a change in the sociology of science. It illustrates the move away from a science–internal understanding of scientific validity into an inclusive understanding of social value. Accepting social value as a requirement for research to be evaluated by a REC means that social value has matured from an attractive but illusive idea into something that has to be assessed, evaluated and optimised and can be used to address some of the justice issues in healthcare.

4.2 Social Value in the 2016 CIOMS Guidelines

Social value is a key principle in the 2016 version of the International Ethical Guidelines for Health-related Research prepared by the Council for International Organizations of Medical Sciences (CIOMS) in collaboration with the World Health Organization (WHO). The account of social value in this chapter has been largely influenced by the wording in the 2016 CIOMS Guidelines. Its very first guideline reads:

The ethical justification for undertaking health-related research involving humans is its scientific and social value: the prospect of generating the knowledge and the means necessary to protect and promote people’s health. Patients, health professionals, researchers, policy-makers, public health officials, pharmaceutical companies and others rely on the results of research for activities and decisions that impact individual and public health, welfare, and the use of limited resources. Therefore, researchers, sponsors, research ethics committees, and health authorities, must ensure that proposed studies are scientifically sound, build on an adequate prior knowledge base, and are likely to generate valuable information.

Although scientific and social value are the fundamental justification for undertaking research, researchers, sponsors, research ethics committees and health authorities have a moral obligation to ensure that all research is carried out in ways that uphold human rights, and respect, protect, and are fair to study participants and the communities in which the research is conducted. Scientific and social value cannot legitimate subjecting study participants or host communities to mistreatment, or injustice.²

The entry of the requirement of social value in the 2016 CIOMS International Ethical Guidelines for Health-related Research involving humans was certainly not unprecedented. Many scholars trace its origins back to the Nuremberg Code of 1947, which states that ‘The experiment should be such as to yield fruitful results for the good of society’.³ Also, it is commonly understood that the social value of a research project may be part of the evaluation of risks and benefits of such a project.⁴ The concept also plays a key role in the Belmont Report, the World Medical Association’s Declaration of Helsinki, and the Common Rule. Furthermore, social value is considered to be of relevance when international collaborators are conducting health research in resource-limited settings. The concept also plays a key role in frameworks for research ethics, such as the ‘7- principle-framework’ of Emanuel and colleagues⁵ and the component analysis framework of Weijer and Miller.⁶

4.3 Social Value as Indication for a Change in Sociology of Science

The addition of social value to the 2016 CIOMS International Ethical Guidelines at this point in history can be understood as part of a broader movement within the sociology of science, which describes how people come to accept certain scientific statements. Elements of this movement can also be seen in other guidelines within the 2016 CIOMS Guidelines, such as those on Community Engagement (7) and Public Accountability for Health-related Research (24). A first example of this broader movement within the sociology of science is the current critique of science and scientific knowledge.⁷ Part of the critique concerns the replicability of research results, which in some areas is disturbingly low. Another part concerns the way in which scientists are evaluated: in many areas of science this is done, at least until recently, by looking at the number of articles produced and/or the number of times an article is cited – e.g. combined into the Hirsch-index – creating an incentive to produce enormous quantities of papers. But the most important critique – also implied in the former point – is that science appears to be concerned more with producing science as such, than with furthering socially valuable goals through research. The term ‘research waste’ was coined to describe the result of this way of doing research.

In response, we currently see programmes such as the EU programme on Responsible Research and Innovation, movements such as that for Open Science – which is certainly about more than just open access publishing – and Science in Transition.⁸ These programmes try to reinvent the sociology of science in order to enable it to perform the tasks society has entrusted to scientists. They also encourage the involvement of all stakeholders in the production of science, including patients and publics, in order to increase the relevance of research results. Present-day problems in society are simply too complex to think we can solve them without cooperating across borders. Science cannot continue to take its own interests as primary, instead of living up to its societal task. Science needs to earn and deserve a so-called social licence for research.⁹ PPI in research is an essential means to mitigate concerns on research waste.

There are a number of reasons why we need PPI in research – as addressed in more detail elsewhere in this volume.¹⁰ First, this is because research is about all of us! And nothing should be done ‘about us, without us’. We therefore need a model in which patients consider themselves as partners in a trustworthy system, not just passive sources of information. Second, the purpose of patient involvement is ultimately to improve our health. By this we do not mean through individual healthcare. Rather, we suggest that this can come about by ensuring that those who conduct research projects ask the right questions, use the right endpoints, make the right choices and effectively implement their findings. This illustrates the efficiency argument as applied to input from patients – and wider publics – who are similarly motivated to find answers to health and disease-related questions. It is believed that this will help science to become more socially valuable and thus to reduce research waste.

These developments also point to important questions in the area of the philosophy of science. It is common to think that science produces facts that are independent of public preferences. Shouldn’t science inform democratic decision-making rather than being influenced by it? What is left of scientific independence if we allow PPI in research? It is generally understood why democracies need science, but why would science need democracy?¹¹

To answer these questions we turn to Science and Technology Studies (STS) where several schools of thought can be discerned. The first (1900–1960) was a positivistic one: it was believed that science was a way of knowledge-making and that its knowledge was absolute and universalistic.¹² The correctness of scientific research needed no social explanation, it was simply true. What needed explanation was how false beliefs were mistakenly taken to be correct, typically by pointing at prejudice, bias and so on. This is what Nowotny calls Mode 1 research.¹³ Although this view is no longer supported by social science, it remains the common-sense view of many scientists and the public. One needs only to watch an episode of CSI to see how a forensic scientist reveals ‘the truth’ about the case.

The second school of thought (1960–2000) started when others took the work of Kuhn and other researchers to show that scientific truth is best seen as an outcome of negotiation and agreement located within social groups. Science is a human activity subject to all the strengths and flaws of humans. Nowotny speaks about Mode 2 research in which interaction between science and society is taken as a starting point and science has become a matter of co-creation.¹⁴ Science needed to be democratised. This second school illuminated the constructivist side of science, in order to deconstruct science, but did less to provide an alternative.¹⁵ A risk of this type of thinking is that this may produce the kind of relativism in which scientific claims have become ‘just another opinion’ and alternative facts are as good as any other account.

To counter this, the third school (after 2000) emphasises that we do not need to end up in relativism, and that there are more arguments in favour of some claims about states of the world than there are for others. Textbook science is not perfect, and remains open to revision, but is more reliable than primary research, because we have more reasons to accept the claims in a textbook than in primary research. In ethics, the Rawlsian understanding of ethical claims as provisional fixed points captures the same idea: claims are always open to revision (hence ‘provisional’) but we have good reasons to accept them (hence ‘fixed’). It is important to note that the last school of thought accepts the rationale established by the former, but tries to make the next, constructive step.

We think that the addition of the requirement of social value into the CIOMS Guidelines can be seen as a consequence of this change in the sociology of science. It clearly illustrates the move away from a science–internal understanding of scientific validity into an inclusive understanding of social value. It sends the message that science needs to be cognisant of its societal role and should explain how it aims to fulfil that role. That message is reinforced by guidelines on community consultation and public accountability. Placing social value as a requirement in a list of conditions to be evaluated by a REC means that social value has matured from an attractive but illusive idea into something that has to be assessed, evaluated and optimised. In other words: social value has gained ‘teeth’.

4.4 Meaning of Social Value

We will now zoom in on the meaning of the concept ‘social value’ itself. According to Wendler and Rid, the standard view on social value is that ‘it is an ethical requirement for the vast majority of clinical studies’.¹⁶ They also argue that there is ‘strong support’ that social value of research is important ‘for protecting participants who cannot consent, preventing inappropriate research that poses high net risks, and promoting appropriate investigator behaviour’¹⁷ (see also below).

Here is the description of the meaning of the term social value according to the 2016 CIOMS Guidelines:

Social value refers to the importance of the information that a study is likely to produce. Information can be important because of its direct relevance for understanding or intervening on a significant health problem or because of its expected contribution to research likely to promote individual or public health. The importance of such information can vary depending on the significance of the health need, the novelty and expected merits of the approach, the merits of alternative means of addressing the problem, and other considerations.¹⁸

We next examine separately the concepts of value and social value. We understand value to mean the potential of a study to improve health, broadly construed as biological, psychological or social well-being.¹⁹ Health value can be categorised along two dimensions: immediate versus future health value, and the population that receives this value.²⁰ It is also important to note that social value is attributed both to information that has direct relevance in promoting health, and to the contribution this information may have for subsequent valuable research.

The concept ‘value’ has been scrutinised in many different research fields such as sociology and philosophy. However, little agreement exists on how ‘value’ should be defined. Consensus does exist on the fact that values arise out of human experience. Whereas the term ‘benefit’ refers to an advantage or profit gained from something, the concept of value refers to the regard that something is held to deserve. The latter is thus a relational concept; both the object to be valued, and an evaluator are necessary preconditions for value to exist.²¹

Turning next to ‘social value’, this functions in two main ways in our everyday use. First, social value can be seen as values shared by a community of individuals; they are values held by society and are contrasted with individual (non-shared) values. By social value, we refer to socially collective beliefs and systems of beliefs that operate as guiding principles in life. Second, besides values of society, the concept can also be used to refer to values for society. Here, social value is an assigned predicate or property of an object, and, in our case, of health-related research.²² This implies that we have to assess the importance of the information in terms of the nature and magnitude of the expected improvement an intervention – as assessed in the study – is expected to have on society. Note that benefit for the individual research participant would be called a direct benefit. Social value is not about rewarding careers for scientists, employment for citizens or a sense of fulfilment for participants.²³

We conclude that the social value of an intervention encompasses the value that an intervention could eventually have on the well-being of groups of patients and/or society. In case of early phase trials, this value may lie in the distant future; in those cases, RECs may also assess the ability of trials to promote progression to later stages of research in which successful clinical translation becomes more likely.

It is important to note that the CIOMS guideline on social value also explicitly talks about what social value cannot do, as follows:

Although scientific and social value are the fundamental justification for undertaking research, researchers, sponsors, research ethics committees and health authorities have a moral obligation to ensure that all research is carried out in ways that uphold human rights, and respect, protect, and are fair to study participants and the communities in which the research is conducted. Scientific and social value cannot legitimate subjecting study participants or host communities to mistreatment, or injustice.²⁴

This provision is a reformulation in human rights language of the so-called primacy principle. This is the ethical principle stating that the individual shall have priority over science, found, for instance, in guideline 8 of the 2013 Declaration of Helsinki: ‘While the primary purpose of medical research is to generate new knowledge, this goal can never take precedence over the rights and interests of individual research subjects’.²⁵ There is an ongoing debate about the tenability of this primacy principle²⁶ which deserves a separate discussion.

4.5 Social Value in Scholarly Debate

Whereas the merits of the social value requirement have been largely uncontested, over the past few years the concept of social value has received increasing scholarly attention. Among others, the journal Bioethics launched a Special Issue (2017, 31(2)) on social value. Also Danielle Wenner’s²⁷ analysis of social value in the Hastings Center Report led to several responses.²⁸ The attention has not only led to improved understanding of the meaning and scope of social value but also to more critique. Next, we will consider some of the key points from this ongoing debate.

Traditionally, social value has been located in the context of clinical research, but more recently the concept has also been introduced in health systems research and into the global health ethics debate.²⁹ Whereas the concept, as discussed above, in clinical research focuses on the knowledge to be gained for society in general, in public and global health ethics the requirement seems to have a different role. For instance, according to Nicola Barsdorf and Joseph Millum, social value should be seen as ‘a function of expected benefits of the research and the priorities that beneficiaries deserve’.³⁰ Social value then also becomes a means to address questions of priority setting,³¹ promotion of health equity and addressing health inequality.³² At the same time, in the context of health systems research, some argue that its social value can also be justified ‘in pragmatic systems rather than linked only to priority setting’.³³

Further discussion centres on whether the concept of social value should be located in the traditional account of research ethics that has a focus on clinical trials and observational research. According to Wendler and Rid, there are eight reasons that ‘taken together provide strong support’ that social value must be obtained in the context of clinical research: (1) to protect participants who cannot consent; (2) to ensure the acceptability of high-risk research with competent adults; (3) to maintain researcher integrity; (4) to avoid participant deception; (5) to safeguard against exploitation; (6) to exercise stewardship of public resources; (7) to promote public trust; and (8) support for clinical research.³⁴ Others, like Wenner,³⁵ Wertheimer³⁶ and Resnik,³⁷ ground the social value requirement in other principles and outside of the traditional scope of research ethics. According to Wenner, the current view on research ethics is primarily about protection. Instead, she believes it should be grounded in justice-based considerations. She argues that certain developments in research, such as the inclusion of pregnant women, cannot be understood only from a protectionist view towards research subjects but has to be explained from underlying issues of justice.³⁸

Whereas some, like Wertheimer and Resnik, argue that studies must have ‘significant’ social value, Wendler and Rid³⁹ argue that studies should have ‘sufficient’ social value. The first group of authors expresses concern that without the qualification of significance, the concept becomes too weak, whereas Wendler and Rid argue that their understanding is also able to distinguish between studies with and without social value. Whether a study has sufficient social value should always be determined in relation to the risks of research. In some cases participants may face significant risks. However, if there is no social value to be gained, they argue that the study should not be approved even if participants consent to participation. At the same time, if the social value is limited but the risks are minimal as well, they argue it is not unethical to offer participation.

4.6 Application

In the preceding analysis we have considered both what the term social value means and the discussions that it has sparked. As such, we can now go on to look at its role in the set of requirements for acceptance of a research protocol. First, we would like to point to the importance of having this as a separate requirement. It could be argued that the social value of a research project is already being taken into account in the classical requirement in research ethics to have a favourable balance of benefits over risks and burdens. The 2013 version of the Declaration of Helsinki for instance reads: ‘Medical research involving human subjects may only be conducted if the importance of the objective outweighs the risks and burdens to the research subjects’.⁴⁰ One could conclude from this that it would not be necessary to have a separate guideline on social value. However, the problem with including social value in this so-called risk/benefit ratio is that in research projects without risks or burdens, a lack of anticipated benefit would not be sufficient grounds for a REC to deny approval of the project. If one thinks that the main aim of research ethics guidelines is to protect the individual, then one might be satisfied. If one takes a broader view and includes justice among the ethical principles that are relevant to such a deliberation, then allowing a project without benefit is unacceptable from a societal perspective. Projects still use time, money and energy in addition to contributing to more research waste. Therefore we argue that it is necessary to have social value as a separate requirement.

Some might object on the basis that social value cannot be a necessary requirement for research to be ethical since certain medical discoveries have been made by coincidence, and that requiring social value may limit medical advancement. However, accidental findings cannot be planned, nor does requiring social value mean that we will no longer find accidental findings by restricting clinical research to interventions with expected social value.

Having made the preceding claim, we now turn to the role of RECs, which are currently tasked with judging whether a favourable risk-benefit balance is achieved to ultimately decide whether a research project can proceed. This judgement has to be systematic, transparent and grounded in evidence. Evaluating the social value of a particular research project can be seen as part of this task. To increase systematisation we draw upon insights from decision-theory and propose that the risk-benefit tasks are divided into the following steps: (1) analysis; (2) evaluation; (3) treatment; and (4) decision-making.⁴¹

4.6.1 Benefit Analysis

It is the primary responsibility and expertise of investigators to map and characterise benefits, including the social value of research. However, evaluators should be able to judge whether they agree with the reasoning that supports the presented characterisation of benefits.⁴² To map benefits, we divide these into direct, collateral and aspirational benefits.⁴³ Social value can be regarded as one of the aspirational benefits. We further divide social value into: (1) the direct social value of the intervention; (2) the progressive value; and (3) the translational value of a trial.

In characterising the social value of an intervention we draw upon the proposal by Habets and colleagues.⁴⁴ They argue that at least three steps should be followed. First, the nature and magnitude of efficacy of the intervention studied in humans has to be critically assessed. Second, the anticipated clinical improvement in actual patients should be assessed, assuming that the intervention is efficacious. This means that it has to be asked whether treatment effects are meaningful, both from a medical and individual perspective, and that they have to be weighed against factors that may hamper beneficial effects, such as adverse effects and ease of use. Third, the nature and magnitude of the anticipated improvement on the well-being of patients, individuals in society and society should be evaluated. This assessment is contextual: the social value of the intervention is the expected improvement relative to other considerations, such as treatment alternatives, number of patients and costs etc. Ultimately, determining what has social value constitutes a moral judgment.⁴⁵

To characterise progressive value⁴⁶ we argue that at least two elements should be evaluated: (1) whether there is a reasonable probability that an intervention could progress to the next stages of research at all; and (2) whether the trial is designed such that the yielded results can contribute to progression to the next stage of research (typically Phase II). The assessment of estimated efficacy can contribute to the assessment of both elements. Evaluators should therefore judge whether they find the estimated efficacy as presented by investigators to be substantive.

For trials to have translational value they should be hypothesis-driven. Preclinical and reference class evidence form the basis for the generation of hypotheses and the context for the subsequent interpretation of both positive and negative findings.⁴⁷ For instance, if a positive result in animals is followed by a negative result in humans, this difference can lead to further explorations of this difference and/or which modifications to the intervention have to be made to overcome translational hurdles. Furthermore, the determination and evaluation of reference class evidence helps researchers to put their findings in a broader context and to communicate their findings to other areas of research. Evaluators should thus judge whether investigators base their hypotheses on a solid assessment of preclinical and reference class evidence.⁴⁸

4.6.2 Benefit Evaluation

We contend that investigators and evaluators should be transparent about the weight they ascribe to the different types of benefits (and harms). Progressive and translational value are not necessarily mutually exclusive, however, they may require a different trial design.⁴⁹ Therefore, it should be made explicit how a trade-off between different types of benefits and harms are made.

4.6.3 Benefit Treatment

After benefit assessment, RECs need to judge whether measures need to be implemented to modify – and ideally to maximise – benefits. The following measures can be taken to enhance the translational value of a trial. If hypotheses are insufficiently supported by evidence, investigators can be prompted to conduct additional preclinical testing. Alternatively, evaluators can demand more thorough gathering and assessment of existing preclinical and reference class evidence. Methods of PPI can show whether or not patient-relevant outcome measures have been used. Furthermore, open sharing of the assessed preclinical and reference class evidence can enhance the collateral value of a trial. Additionally, amendments to the trial design can spur the translational value.

4.6.4 Decision-Making

Finally, RECs have to decide whether benefits truly outweigh the risks. The three steps of benefit analysis, evaluation and treatment contribute to the transparency of decision-making. It has been claimed that it matters whether the research is funded with public money or not. We disagree: even when privately funded, we can see no justification for burdening participants with research that has no social value.

4.7 Conclusion

The term ‘social value’ strikes the necessary balance between scientific advancement, equitably responding to human conditions and realising the human right to health. The requirement of social value bridges the gap between conducting commendable science and making a contribution to the health of the populations where health research is being carried out. The concept of social value is the ethical justification for doing health research involving humans.

5 Solidarity in Health Research Regulation

Katharina Kieslich and Barbara Prainsack

5.1 Introduction

This chapter explores the analytical and normative roles that solidarity can play when designing health research regulation (HRR) regimes. It provides an introduction to the meanings and practical applications of solidarity, followed by a description of the role solidarity plays in HRR, especially in fostering practices of mutual support between patient organisations and between countries. We illustrate our argument in a case study of HRR, namely the European Union (EU) regulatory regime for research on rare diseases and orphan drugs. The current regime aims to decrease barriers to research on orphan drugs by creating, predominantly financial, incentives for research institutions to take on the perceived increased risks in this area. We show how the concept of solidarity can be used to reframe the purpose of regulation of research on orphan drugs from a market failure problem to a societal challenge in which the nature of barriers is not just financial. This has specific implications for the types of policy instruments chosen to address the problem. Solidarity can be used to highlight the political, social, economic and research value of supporting research on rare diseases and orphan drugs.

5.2 The Meaning of Solidarity

The concept of solidarity underpins many social and healthcare systems in Europe.¹ While it could be argued that solidarity – in the form of policies and institutional structures facilitating mutual support, with special emphasis on supporting the vulnerable – has come under pressure with the spread of nativist and other sectarian political ideologies, there are also forceful counter-movements under way. These include people standing up with and for others,² may it be newcomers to our society, victims of wars and natural disasters or people who suffer from our economic and political system. As such, it is fair to say that solidarity is seen by many as having a lot to offer to how we frame and address societal challenges.

What is solidarity? At first sight, it might seem an elusive concept. For decades, solidarity has been used to justify a wide variety of policies and practices ranging from vaccination programmes to biobanks to the penalisation of undesirable behaviours. Another reason for the elusiveness of solidarity lies in the practical and embodied nature of solidarity. Solidarity is, first and foremost, a relational practice: its full meaning unfolds only when it is enacted, in concrete practice, by – at least one – giver and a receiver, and its nature cannot be exhaustively captured by language. For the same reason that poetry, art or nature are so much more powerful in conveying the meaning of love or friendship, words alone struggle to convey the full meaning of solidarity.

Acknowledging that part of the meaning of solidarity resides in its embodied- and enactedness does not mean, however, that we cannot spell out what makes solidarity different from other types of prosocial practice. Building upon a long history of scholarship on solidarity we have, in our own work, proposed that solidarity is best understood as a practice that reflects a person’s – or persons’ – commitments to support others with whom the person(s) recognise(s) similarity in a relevant respect.³ The similarities with others that people recognise are, however, not ‘objectively’ existing properties, but they are characteristics that we have learned to attribute to ourselves and to others. The first step in this process is that we use categories that have been developed to sort people in different groups, such as separating them into women and men, children and adults, Jews, Buddhists and Muslims, or Koreans and Croatians. While these categories clearly have an expression in material reality, such as the correspondence of national labels with specific territories, or – in the case of children and adults, even stages in human biology – these categories are not merely material. To whom the label of ‘Korean’ or ‘Croatian’ is applied has not been stable in history but it has depended on changing territorial rule, changing understandings of nationality and different perspectives on who can legitimately claim belonging to such a label. Similarly, the notions of children and adults are not clearly delineated in biology in the sense that every person neatly fits into one or the other category. In this way, the categories that we use to describe characteristics that we and others hold are lenses through which we have learned to see reality.

For solidarity this means that when a woman supports another person because she recognises her as a fellow woman, then ‘being a woman’ is the ‘similarity in a relevant respect’ that gives rise to solidaristic action – despite the fact that the two people in question are many more things than women. They may be different in almost every other way. In this sense, the recognition of similarities in a relevant respect is a subjective process – I recognise something in you that you may not recognise in yourself because you have not learned to see it. At the same time it concerns shared social meaning – as societies have shared conventions about how they classify people.

Solidarity happens when people are guided in their practices by the similarities they recognise with each other, despite everything that sets them apart. It is the similarities, and not the differences, that give rise to action in the sense that they prompt people to do something to support somebody else. This ‘doing something’ could consist of something big – such as donating an organ – or something small, such as offering somebody a seat on a bus.

In sum, what makes solidarity different from other pro-social practice is the symmetry between people in the moment of enacting solidarity. This symmetry is not an essentialist ontological statement that glosses over claimed or ascribed differences and structural inequalities. Instead, it is the description of a relational state in the moment of enacting solidarity. In this way, solidarity is distinct from other pro-social supportive behaviours such as cooperation and charity, for example. The notion of cooperation describes pro-social supportive behaviour without saying anything about how and why people engage in it. The notion of charity describes an asymmetrical interaction between a stronger entity giving something and a weaker entity receiving something. In contrast, solidarity refers to entities that are different in many respects but make the thing they share in common the feature upon which they act: I do something for you because I recognise you as a fellow woman, a co-worker who struggles to make ends meet, as I do, or a fellow human in need of help.

5.3 The Three Tiers of Solidarity: Applicability and Adjustments in the Context of Health Research Regulation

Having defined solidarity as practices that reflect commitments to support others with whom a person – or persons – recognise(s) similarities in a relevant respect, in previous work one of us identified three main tiers of solidarity, capturing the societal levels where solidaristic practice takes place.⁴ Tier 1 is the interpersonal level where solidarity is practised between two or more people without that practice having become more widespread. An example from the field of health research would be a person with diabetes signing up to a biobank researching the disease because she wants to support others with similar health problems.

If this practice were to become more widespread, so that it became common or even normal behaviour within a group, then we speak of solidarity at Tier 2 solidarity, which is solidarity at the group level. The group within which solidarity is practised could be a pre-existing group – such as a self-help group around diabetes where it becomes normal practice, for example, to also volunteer for disease research – or a group that is created through the solidaristic practice itself. An example for the latter would be a patients’ rights organisation created in response to the effects of harmful medical practices such as the blood contamination scandal in the 1970s and 1980s in the United Kingdom (UK).

If solidaristic practices become so commonplace that they are reflected in legal, administrative or bureaucratic norms, then we speak of Tier 3 solidarity. This is the ‘hardest’ form of solidarity because it has coagulated into enforceable norms. Tier 3 solidarity could be seen to contradict the idea held by many scholars in the field that solidarity cannot be demanded, but only appealed to.⁵ In this understanding, contractual and legal obligations are incompatible with solidarity. While we agree with these authors that solidarity is typically a more informal, voluntary ‘glue’ between the bricks of formal institutional arrangements, we also believe solidarity to be a toothless, if not empty, concept if it cannot also denote practices that are so deeply engrained in society that they become legally enforceable in some cases.

Ruud ter Meulen and colleagues very helpfully distinguish between solidarity as a community value and solidarity as a system value:⁶ the latter can contain articulations of solidarity in formal, often legal arrangements. The key here is to consider enforceable – and thus not always voluntary – solidarity in conjunction with more informal, voluntary forms of solidarity, and not see them as isolated from one another. An example would be tax or contribution-based financing of universal healthcare where those with higher incomes contribute more than others.

A problem arises when legally enforceable solidarity is still in place while the actual practices that used to underpin them are breaking away. This is becoming apparent at the moment in many countries where certain features of welfare states, such as transfer payments in the form of as child allowances or income support for those considered undeserving, have come under attack. The argument is often that the people benefitting from this are ‘free riders’ as they have not contributed towards the system that they are now using – perhaps because they are new immigrants or people who have never been in paid employment. What is happening here is that the basis for solidaristic practice – namely the ‘recognition of similarity in a similar respect’ (see above) – is breaking away. The people who are receiving financial support, or benefitting from a solidaristic healthcare system, are no longer seen as belonging to ‘us’ – because of something that they supposedly did, or failed to do, or because they do not have the same passport as we do.

While it will often be the case that solidarity prescribed at Tier 3, in the form of legal, contractual, bureaucratic and administrative norms, will have evolved out of solidarity practised at group (Tier 2) and interpersonal (Tier 1) levels, the reverse is not necessarily true: interpersonal solidarity can, but does not necessarily, scale upwards. The ‘higher’ the level of solidarity, the more important reciprocity becomes. Here we refer not to direct reciprocity, where one gives something in return for something else – this would be a business transaction instead of solidaristic practice – but indirect, systemic reciprocity. Institutional arrangements of solidarity work best when people give because they want to support others, but they also know that when they are in need they will be supported as well.

5.4 Solidarity in Health Research Regulation

How do the aforementioned conceptualisations of solidarity apply to HRR regimes? The first aspect we need to acknowledge is that HRR regimes are complex and varied. There is no such thing as one regime that applies to all areas of HRR, but rather there are multiple and sometimes overlapping legal and ethical requirements that need to be fulfilled by those planning, funding, supporting and undertaking research. HRR is a multidisciplinary endeavour that involves different actors such as policymakers, researchers, health professionals, industry and patients. HRR also spans a large variety of ‘objects’ that are regulated, such as data, tissue, embryos, devices or clinical trials.⁷ This means that it occupies regulatory spaces beyond health, such as in data regulation, research financing, in fostering innovation and in the obligation to protect research recruitees.

At the start of this chapter we suggested that solidarity can be thought of as ‘enacted commitments to accept costs to assist others with whom a person or persons recognise similarity in one relevant respect’.⁸ Thus the question arises: what are the shared practices that reflect a commitment to carry costs – emotional, financial, societal – in HRR, and what are the similarities that give rise to these practices? The two tiers of solidarity most relevant in HRR are Tiers 2 and 3. Tier 2, or group solidarity, is reflected, for example, in the way patients, patient groups and other stakeholders advocate for, inform about, and partake in research endeavours and regulatory steps to make them happen. The question of who partakes in research is not just important for methodological reasons but is also connected to the concept of solidarity. It is considered good scientific practice to carry out research in the populations for whom an intervention is intended, but there may be instances in which it is justified to conduct research in populations other than the intended beneficiaries. According to the Council for International Organizations of Medical Sciences (CIOMS) and the World Health Organization (WHO) such instances are ‘important demonstration[s] of solidarity with burdened populations’,⁹ for example in 2014 when Ebola vaccines were tested in communities not affected by the Ebola outbreak.

The costs and the similarities that are at the heart of these – predominantly clinical – research practices are comparatively easy to identify. The costs commonly consist of individuals giving up their time to become research participants or to become involved in a patient advocacy group. They accept the burden of cumbersome regulatory steps to partake in research, such as navigating consent forms, risk assessments, data ownership and other issues. The similarity that motivates people to assist others despite the costs they incur is often the experience of suffering from a particular disease or the acknowledgement that we, as members of society or those close to us, all run the potential risk of illness in the future. It is a recognition that temporary sacrifices can result in long-term gains from the generation of new knowledge about health conditions and treatments.

A feature that distinguishes HRR from other areas of policy, regulatory and societal processes is that group solidarity is often not just confined to a small group of patients who are afflicted by the same illness. Rather, other members of the public – so-called healthy recruits – partake in the solidaristic practice of research and are directly affected by the associated regulatory procedures. The underlying ‘similarity in a relevant respect’ that, in Prainsack and Buyx’s definition of solidarity gives rise to solidaristic practice, is then typically a broad sense of human vulnerability that we all have in common. In other words, the nature of Tier 2 solidarity in HRR is not necessarily restricted to suffering from the same illness, but it can arise from the recognition that in a universally funded healthcare system, we all carry a commitment to carry costs because we all carry the risk that we might one day become ill.

To explore how Tier 3 solidarity, or institutional solidarity, is reflected in HRR, we trace the logic that forms the basis for understanding HRR through the lens of solidarity. The logic runs something like this: A solidaristically financed healthcare system is built on the principles of fair access to healthcare, protection against financial risks due to illness and quality. Ensuring access, provision and high-quality healthcare requires efforts to advance knowledge through research. Implicitly entailed in the social contract between governments, citizens and residents is the acceptance that mandatory financial contributions – i.e. costs – in the form of taxes or health insurance contributions will not only be used for the day-to-day provision of services but also for the fostering of research activities. With this implicit acceptance of carrying costs collectively comes a recognition that the health research area needs to be regulated to safeguard against unethical, harmful, and wasteful practices, and to foster innovation. This recognition translates into public policies that regulate the field.

But there are also regulatory burdens arising from such public policies that might negatively affect solidarisic practices in HRR. For example, the cumbersome, and often time-intensive, process of giving consent for a research participant’s data to be used for research purposes might deter some people from taking part in a study, especially if the use of the data is not explained or communicated clearly. Moreover, the predominant lens through which data ownership – in a moral and in a legal sense – is currently viewed is that of the rights of individuals, who, in turn, are conceptualised as bounded and independent entities.¹⁰ This view is problematic because it fails to acknowledge the deeply engrained relational characteristics of data. This is so because the meaning of most data only unfolds once the data is interpreted in relation to other data, and that this meaning is often relevant for a wider range of people than only the person from whom they came. Currently, this relational nature of data is not reflected in most data governance frameworks in the health domain; even those frameworks that give people more control over how their data is used typically give this control to individuals. Instruments of collective control and shared ownership of personal data are rare. The ‘individualisation’ of data governance sits squarely within a system that relies on people’s willingness to make data about themselves available for research. It is a missed opportunity for showing how control and use of data can reflect both personal and collective interests and rights.

5.5 Solidarity in Research on Rare Diseases and Orphan Drugs

An example of how solidarity can be used to change the way we approach a policy problem in HRR can be found in rare diseases and orphan drugs research. The European Commission (EC) defines a rare disease as ‘any disease affecting fewer than 5 people in 10,000 in the EU’.¹¹ It estimates that there are approximately 5,000–8,000 rare diseases in the world. The challenge around rare diseases is that the comparatively small numbers of people affected by them translate into the neglect or the unavailability of diagnoses and treatment options. It can be explained by drawing on the notion of issue characteristics, famously developed by political scientist Theodore Lowi.¹² Lowi posited that different types of policies – e.g. regulatory, distributive or redistributive policies – give rise to different policymaking or decision-making processes through which distinct patterns of political and societal relationships and behaviours emerge. Just as the categories we use to describe characteristics that we hold – women and men, adults and children, Koreans or Croatians – we can use categories to describe characteristics that policies or policy fields hold. For example, the depiction of European healthcare and welfare systems as solidaristic has arisen from their embeddedness in redistributive policies that allow the state to redistribute taxes and other welfare contributions in the pursuit of policy goals. Different types of policies give rise to different forms of state action, but also to different types of public participation, or even political controversy and contestation. The latter is what we frequently observe when a change in redistributive policies is suggested. Following Lowi’s rationale, the key to understanding patterns of behaviours, in this case the lack of attention given to rare diseases, is to identify the characteristics of the issues to which they give rise. The more complex the regulatory or policy area, the more difficult it is to develop policy solutions.

The issue characteristics for rare diseases are complex. We know relatively little about the factors and processes that underlie these diseases. This stems from a lack of basic research into rare diseases¹³ which is mostly due to a lack of available funding for research that a relatively small number of people suffer from. From a public policy perspective, the question of how and if to prioritise research for rare diseases is an intrinsically complex issue because of the low numbers of patients and the high costs for research and treatment. It begs the (redistributive) policy question how spending a large proportion of overall research or healthcare budgets on a few patients can be justified if the opportunity costs are such that other patients may lose out as a result. The low patient numbers also result in difficulties in the design of clinical trials that meet the evidentiary hurdles of most regulatory agencies in Europe.¹⁴

Solidarity offers a lens through which these difficult questions surrounding research on rare diseases can be reframed. Patients suffering from rare diseases are characteristically vulnerable (please see Rogers’ Chapter 1 in this volume for more detail on the concept of vulnerability). Their vulnerability results from the severity and the chronicity of their conditions, the inadequate access to appropriate diagnoses and treatment options, societal isolation and a lack of representation of their interests.¹⁵ Coming back to the importance of Tier 3 solidarity in HRR (the institutional and legal level), the solidaristic principles upon which healthcare systems in Europe rest suggest a duty to care for society’s most vulnerable members, which patients with rare diseases undoubtedly are. Policies or regulations to support research and service provision for patients with rare diseases can therefore be viewed as solidaristic practices.

However, despite initiatives such as the introduction of Regulation (EC) 141/2000 on orphan medical products, access to adequate services and research for patients is still falling short of expectations. Following Lowi’s approach, as outlined above, we can observe that the more complicated the issues to which a regulatory or policy area give rise, the less policymakers are inclined to act because of the perceived lack of policy options. This might also explain why the challenges around fostering research activity on rare diseases are predominantly framed as a regulatory policy problem rather than a distributive or redistributive one. Interestingly, the perceived lack of policy options and responses corresponds with a flourishing of solidaristic practices below the level of public policy that span borders and countries at the EU level. For example, there seems to be an emerging recognition of ‘similarity in a relevant respect’ among EU countries in the sense that the issue characteristics of rare diseases are such that no country can stem the challenge of protecting vulnerable patients suffering from rare diseases on its own. Here, Tier 2 solidarity does not just apply to the level of interaction and collaboration among patient groups, but also to the level of cooperation between nation states. The similarity is the recognition that all countries face the same challenge in finding adequate research and treatments on rare diseases – the policy problem – and that countries are similar in their failure to find policy solutions. This can lead to the fostering of solidaristic practices such as the EC’s advocacy for a European Platform on Rare Diseases Registration that would bring together patient registries and databases to encourage and simplify clinical research in the area.

An unresolved question in the application of a solidarity-based approach to the field of HRR is the role of industry, especially in fostering or hindering solidaristic practices. It is frequently argued that pharmaceutical manufacturers do not invest enough resources into the research and development of rare diseases and orphan drugs because the small patient numbers lead to a low return on investment (RoI).¹⁶ The response of EU member states has been to create incentives through policy instruments such as fee waivers for regulatory procedures or a 10-year market exclusivity for authorised products.¹⁷ The introduction of such measures in the Regulation (EC) 141/2000 on orphan medical products has increased the number of orphan drugs being authorised. But is it also a sign that pharmaceutical industries are engaging in solidaristic practices to benefit some of the most vulnerable patients?

We argue that it is not. We must assume that pharmaceutical companies are motivated by the incentives offered through this regulation rather than a recognition of similarity with entities that seek to promote public benefit, or with people suffering from illness. The perception that some people, as taxpayers or patients, are expected to contribute to supporting others who suffer from rare diseases, while some corporate actors do the bare minimum required by law, may have a significant negative effect on the people of other actors to contribute. This may be exacerbated by the payment by corporations of hefty dividends to their shareholders. Institutionalised solidarity requires some level of reciprocity – the understanding that each actor makes a contribution adequate to their nature and ability. As a result, if large multinational companies are seen to get away with ‘picking the raisins’ this is a serious impediment to solidarity.

In a field that is still very dependent on the investment of pharmaceutical companies into drug research, resolving this challenge of asymmetry is not easy to rectify in the short term. Its solution would require legislation that forces companies to cut their profits and support rare disease patients in more significant ways than they are doing at present. A for-profit company cannot reasonably be expected to be motivated by the desire to help people; it is to be expected, and justified, that they put profits first. This is why it is the role and responsibility of legislators to ensure that companies are contributing their fair share. This is not only a necessity for moral and ethical reasons, but also to avoid the hollowing out of solidaristic practices among people who may, as argued above, be deterred by the expectation to accept costs to help others, while others are making huge profits.

The concept of solidarity can and should be used to reframe the regulation of research on orphan drugs from a market failure problem that requires financial incentives, to a societal problem that requires more than market measures. This will require a reframing of the issue as a redistributive policy problem rather than a purely regulatory one, in the hope that this will instigate political debates, as well as patient and public participation that would help bring the challenges of research on rare diseases and orphan diseases more to the centre of the policy process. Using the concept of solidarity to help reframe the policy issue has the potential to draw it out of the comparatively confined policy spaces it currently occupies. This helps to illuminate its political and public salience. The joined-up working of patient groups for rare diseases and the mutual efforts of EU member states – also as regulators that impose rules of fair play on pharmaceutical companies – are needed to facilitate – and where they already exist, stabilise – solidaristic practices. To make these practices more powerful and meaningful, priority-setting mechanisms for the prioritisation of research funding need to be developed,¹⁸ and more public money should be invested, especially into basic research, in an effort to decrease the dependence on the pharmaceutical industry.

5.6 Conclusion

In this chapter, we have used research on rare diseases and orphan drugs to highlight the application of solidarity to HRR. It is an example of a space where solidaristic practices are already taking place, but also illustrates that there is room for improvement. Solidarity is an integral part of health research, and it is enacted every time a person takes part in a clinical trial or other research because they want to support the creation of public benefits. Regulation is important to ensure that research is carried out in an ethical manner, but, equally, it is important that decision-makers who define the regulatory spaces for HRR recognise the need to support solidaristic practices rather than undermine them through overly cumbersome bureaucratic hurdles to enrol in research.

6 The Public Interest

Annie Sorbie

6.1 Introduction

This chapter provides an introduction to the concept of ‘the public interest’ in health research regulation (HRR). It considers two key ways that the public interest is constructed in HRR: namely as a legal device and through empirical evidence of the views of publics. To appreciate the scope of this concept, the public interest is set in its broader context, i.e. beyond HRR, highlighting that, historically, it has been a contested concept that is difficult to define in the abstract. Next, the public interest is situated within HRR, paying attention first to how it features in the HRR legal landscape and then how this is constructed through the views of publics (with specific reference to the use of identifiable health data for research). Both conceptualisations are analysed with reference to the key challenges and opportunities that they present before a holistic concept of the public interest in HRR is proposed and consideration given to how this may be operationalised in practice.

6.2 The Public Interest: A Contested Concept

Although the public interest is fully embedded in HRR, it is by no means exclusive to this context. The following brief consideration of wider perspectives on this contested concept point to persistent debates not only on what the public interest ‘is’, but also to tensions as to how this concept should be understood. Appeals have been made variously to the values it invokes, the process it requires, and/or the views of (some or all) of ‘society’ at large that it reflects.¹

Political and social scientists, philosophers and lawyers, among other disciplines, have contemplated this elusive concept without reaching consensus on its meaning or usefulness. During a period of scholarly interest in the public interest in post-World War II America, it was both lauded as ‘a central concept of a civilised polity’² and dismissed as a concept so vague and ambiguous that it is no more than a rhetorical device.³ This ambivalence can be seen in Sorauf’s work in which, despite his scepticism, he initially concedes a ‘modest conception’ of the public interest that is rooted in ‘our interest in the democratic method and its settlement of conflict by orderly rules and procedures’.⁴ He recognises too the potential function of the public interest as a ‘hair shirt’ that serves as ‘an uncomfortable and persistent reminder of the unorganized and unrepresented (or underrepresented) interests of politics’.⁵ Over time, however, his position hardens and becomes more negative. He later posits that the public interest promotes ‘oversimplification’, as it purports to “solve” the dilemmas of … pluralism’.⁶ Turning to the regulatory role of the public interest, Feintuck also points to a continued reluctance to define the public interest beyond what ‘will vary according to time, place and the specific values held by a particular society’.⁷ He characterises the public interest as an ‘empty vessel’ and argues for an account that looks ‘to the fundamental value laden, democratic imperatives that underlie society: human dignity, parity of esteem, and the ability to participate actively in society’.⁸

Whether the public interest is best understood modestly as a procedural mechanism, ambitiously as protecting fundamental values in society including those that may otherwise be overlooked, or in utilitarian terms as the views of the majority, there is little doubt that this is a contested concept that is ‘much used but ill defined’.⁹ This chapter proposes that while there is need for further conceptual clarity here, there is also value to be found in such contestation and flexibility.

6.3 Appeals to the Public Interest in HRR

In HRR, the concept of the public interest is embedded in law and in policy, often as a counterpoint to individual interests. In medical research involving human subjects – including research on identifiable human tissue and data – consideration of the relationship between individual and public interests can be traced back to the original Declaration of Helsinki.¹⁰ More recently, the legal mandate of the Health Research Authority (HRA) in the United Kingdom, as set out in the Care Act 2014, prescribes twin objectives to protect and promote the interests of both individual participants (and potential participants) and the interests of wider publics in safe and ethical health and social care research.¹¹

However, reflecting the broader literature on public interest, Taylor notes in his consideration of genetic data and the law, that the public interest remains a ‘notoriously uncertain idea’.¹² This chapter proceeds with an account of two key ways in which the concept of the public interest appears in HRR (with a focus on the use of identifiable health data for research), as constructed in law and through publics’ views. It considers the key challenges and opportunities presented by the public interest in each framing. Having identified the benefits and shortcomings of each, a holistic concept of the public interest is proposed, the relationship between the public interest as constructed within and beyond the law is examined, and consideration is given to how, in a more concrete way, public interest might be operationalised in HRR practice.

6.4 The Public Interest as Legal Device

When health research is conducted on identifiable personal data, the public interest is a striking feature of the legal landscape. For example, in the realm of data protection, the public interest forms one of the routes to the lawful processing of personal data in health and social care research. Thus, the General Data Protection Regulation¹³ (GDPR) provides a lawful basis to process personal data where this is a ‘task in the public interest’.¹⁴ Health Research Authority (HRA) guidance confirms that, for the purposes of the GDPR, this is the appropriate legal basis that should be used by public authorities, such as NHS bodies or universities, in order to process data for health and social care research.¹⁵ In UK law, the Data Protection Act 2018¹⁶ (DPA 2018) purports to add further detail to the interpretation of ‘a task in the public interest’, although concerns have been raised that the drafting of this legislation does little to add clarity to how this concept should be understood in practice.¹⁷ A late addition to the Explanatory Note to the Act indicates, by way of an example, that ‘a university undertaking processing of personal data necessary for medical research purposes in the public interest should be able to rely on [a task in the public interest]’¹⁸, thus providing some guidance on the context, if not the content, of the public interest in these circumstances.

Two other prominent features of the health data legal landscape are: (i) the common law duty of confidentiality and (ii) the legislative regime which established the predecessor body to the HRA’s Confidentiality Advisory Group (CAG). The common law duty of confidentiality provides that where confidential information is imparted to another person, in circumstances giving rise to an obligation of confidentiality, this must not be disclosed without consent or justification.¹⁹ One such justification is where disclosure is ‘in the public interest’. This duty, and its exceptions, apply not only in the context of the traditional doctor/patient relationship, but also where it is proposed that the information in question may be used for purposes beyond direct care, such as for health or social care research. The interpretation of this duty of confidentiality (and, importantly for this chapter, the meaning of the public interest) has emerged as a result of decisions made on the facts of cases that have come before the courts. These judgements indicate, for example, that there is not only a personal interest in an individual’s confidentiality being maintained, but also a wider public interest in doing so in order that patients (in general) are not discouraged from consulting with healthcare practitioners.²⁰ Case law, in relation to whether disclosure of deceased patients’ records to a public inquiry was in the public interest,²¹ recognises that the public interest (which was distinguished from ‘what the public found interesting’)²² is multifaceted and can encompass both individual and collective interests. These include interests in: disclosure, maintaining the patient’s confidentiality and maintaining confidence in the institutions under investigation.²³

As with the legislation, there is no fixed definition of the public interest in case law; where this lies must be decided on the individual facts of each scenario. This perception of a lack of certainty led to concerns from some clinicians that routine activities, such as providing information to registries that collect and analyse data on specific diseases, might be vulnerable to challenge in the absence of specific consent.²⁴ These worries about the legality of such practices, among other matters, led to the enactment of legislation in England and Wales in 2001 that forms another key feature of the data sharing landscape, namely the establishment of the predecessor to the CAG. In summary, this legislation allows the Secretary of State for Health to make regulations to explicitly ‘set aside’ the common law duty of confidentiality for defined medical purposes, including medical research, where this is ‘in the interests of improving patient care, or in the public interest’. These powers are now found in Section 251 of the NHS Act 2006 (as enabled by the Health Service (Control of Patient Information) Regulations 2002) and referred to colloquially as ‘s251 support’. In sum: where seeking consent is neither possible nor practical, researchers can obtain s251 support to use confidential patient information for medical research by make an application to the HRA’s CAG. The effect of such an application is that, if granted, the researcher need not be concerned whether (in the admittedly unlikely event of litigation) a court would agree that their use of identifiable patient information without consent was indeed in the public interest.

In common with the broader literature on the public interest, the preceding whistle-stop tour of the public interest in law reveals anxieties around how this concept is interpreted in practice. It also speaks to the strengths and limitations of a narrow legal construction of the public interest decided on a case-by-case basis, but for which precedents can be established over time. These are explored further in the passages that follow.

We return first to Taylor’s description of the public interest as a ‘notoriously uncertain idea’.²⁵ It is of note that Parliamentary debate on the DPA 2018²⁶ on this topic resurrected many of the concerns around the public interest that had arisen some fifteen years previously, at the time of the promulgation of the CAG regime. These included the potential for the public interest to be interpreted widely to deliver ‘sweeping powers’.²⁷ Nonetheless the CAG regime, which was first proposed as a temporary solution as the NHS geared up to apply a ‘consent or anonymise’ binary to its use of health data, has become an example of good governance and established itself as part of the data sharing landscape.²⁸ This can be attributed, in part, to a growing recognition from stakeholders in HRR – including researchers and publics – that consent is not necessarily the ‘magic bullet’ to legitimise HRR governance that it might once have been presumed to be. For example, Wellcome’s research, as commissioned from Ipsos MORI, on public attitudes to commercial access to health data for research purposes found that, when considering data uses, ‘a strong case for public benefit is the most important factor for many people: without it, data use by any organisation is rarely acceptable’.²⁹ This tends to suggest that while concerns about the uncertainty of the application of the public interest in HRR persist, it is a concept that also, in some ways, benefits from its inherent flexibility and its ability to adapt to changing interests over time.

A further critique that arises from this legal construction of the public interest is that this looks inwards to derive its legitimacy from its institutional origins and is disconnected from actual publics’ views. For example, in the case of legislation – such as the DPA 2018 and the legislation underpinning the CAG regime – legitimacy comes from Parliament. Notwithstanding, the public interest in (legal) text tells us little about its context. Even when amplified by its Explanatory Note, the DPA 2018 does not elaborate on the legitimate content of the public interest in HRR.

Turning to case law, the public interest is conceptualised by the courts on the facts of each case, following precedents in previous decisions. This inward-looking legal construction of the public interest is consistent with the long established ‘intellectual tradition’³⁰ within the law of invoking fictional persons to provide a barometer of what ‘reasonable’ members of the public would expect in any given situation. The paradigm is the fictional ‘man on the Clapham Omnibus’,³¹ who in English law is deployed to represent the reasonable person. Elsewhere in the law, other fictional reference points include the ‘right-thinking member of society’ (in defamation law) or even the ‘officious bystander’ (in contract law).³² It has thus been confirmed by the Supreme Court that: ‘The spokesman of the fair and reasonable man, who represents after all no more than the anthropomorphic conception of justice, is and must be the court itself’.³³ This underlines why the law historically has not been centrally concerned with empirical evidence of the views of actual members of the public when it deploys the legal notion of the public interest in civil law cases.

However, this legal self-referential conception of the public interest in HRR is increasingly under pressure, as exemplified by the high-profile failure of care.data. As described more fully in this volume by Burgess (Chapter 25), this was an NHS England initiative that sought to make patient data available for specified purposes, including audit and research, in a format that was stripped of identifiable information. However, following widespread concerns about the scheme – including around its transparency and oversight – the programme closed in 2016.³⁴ Here, a legal framework was in place to facilitate data sharing but, as argued by Carter et al.,³⁵ the social licence to do so was not. This failure underlines the message that ‘legal authority does not necessarily command social legitimacy’.³⁶ It follows that where the law alone is unable to fully legitimise and animate the public interest, something else must fill this void. The following section suggests that a richer relationship between this legal concept and the views of publics could be a worthy candidate.

6.5 The Public Interest as the Views of Actual Publics

The potential benefits of responsible access to health data by researchers, as well as the perils of getting this wrong, have led to a renewed focus on the public acceptability of data sharing initiatives and a growing body of literature that explores public attitudes towards sharing health data for research purposes.³⁷ Aitken et al. note the desire of stakeholders in HRR to optimise the use of existing data in health research and: ‘the recognition of the importance of ensuring that data uses align with public interests or preferences’.³⁸ This commitment to using patient data responsibly is shared by funders, as exemplified by Wellcome’s ‘Understanding Patient Data’ initiative, which works to champion responsible uses of data and improve stakeholder engagement around how and why data is used for care and research.³⁹

Consider too the call in HRR for more and better public and patient involvement (PPI). The National Institute for Health Research (NIHR) recently issued ‘Standards for Public Involvement in Research’, which provide ‘a framework for reflecting on and improving the purpose, quality and consistency of public involvement in research’.⁴⁰ In particular, Standard 6 on Governance states that ‘[w]e involve the public in our governance and leadership so that our decisions promote and protect the public interest’. Here, the role of publics is positioned not only as shaping and supporting research, but also as a means of legitimising HRR and grounding the broader public interest.

This approach has the benefit of being anchored to actual publics’ views, something that is lacking from the narrow legal account set out above. In this way, it has the potential to provide at least some of the social legitimacy that was lacking in care.data. However, public engagement activities also attract criticisms of exclusivity and tokenism,⁴¹ raising ‘questions of representativeness, articulation, impacts and outcomes’.⁴² Thus, to simply equate these outputs with ‘the public interest’ more broadly also runs the risk of reinforcing underlying inequalities in the delivery of a majoritarian account of the concept. Reports of instances of ‘personal lobbying by volunteers for pet causes’⁴³ point to the dangers of ‘assuming that the perspectives of a small number of involved patients necessarily reflect the perspectives of a larger patient community’.⁴⁴ Indeed, McCoy et al.’s analysis of the recent NIHR ‘Standards for Public Involvement’ suggests that ‘it is simplistic to assume that including public representatives on governance and leadership bodies will necessarily promote the public interest’.⁴⁵ They highlight the likelihood that the interests of differing ‘publics’ will, in any event, diverge, and call for more attention to be paid to who is being asked to contribute, at what stage in a research project, and for what purpose.

This is not, of course, to discount the important contributions that can be made to shaping and delivering responsible HRR through the thoughtful involvement of patients and wider publics.⁴⁶ However, whereas it is advanced above that the law alone is not enough to legitimise the public interest, this analysis also suggests that an additive approach to publics’ views in HRR is also insufficient to provide a lasting and justifiable account of this concept. Something more is required.

6.6 The Public Interest: A Holistic Concept

Taken together, the preceding examples illustrate the prevalence of the public interest in HRR and how this concept may be constructed both through the law and through the views of publics. On the one hand, the tendency of the law to approach the public interest as a legal test draws the criticism that this narrow notion of what purports to be in the public interest is wholly disconnected from the views of publics and can lack social legitimacy. On the other, to claim that the public interest can simply be extrapolated from the outputs of public involvement work is equally problematic. Nonetheless, despite this disjuncture, common themes emerge and, in this section, two further contributions to the debate on the role of the public interest are offered. The first is a proposal for a holistic concept of the public interest that is able to account for a plurality of interests and views. The second is that, despite the apparent impasse, legal and empirical notions of the public interest are not mutually exclusive. It is argued that these do bear upon one another and that if the public interest is to be effectively deployed in HRR, this relationship should be both acknowledged and made more overt.

The first proposal is to recognise that both the legal and empirical constructions of the public interest call for a conception of the public interest that is able to account for a range of diverse interests. In law, the potential for this approach is evident in an arc of case law that emphasises that the public interest is a multifaceted and flexible concept that is able to account for both individual and collective interests, including wider publics and institutional stakeholders. Similarly, the analysis above suggests that the value of public involvement is optimised when attention is paid to the multiple interests of differing patients and publics, including who is being asked to contribute, when, and for what purpose. This also tracks a move in HRR literature away from a narrow account of the public interest that pits individual interests against collective benefits. For example, Rid describes this ‘pluralistic conception of public interest’ as an account that is capable of recognising that multiple interests are in play.⁴⁷ Taylor’s work also proposes that individual and public interests need not be balanced against one another, but rather that the need for legitimacy requires that each should account for each other.⁴⁸ Together, this forms the basis for a holistic concept of the public interest in HRR that is able to account for multiple interests and views. This approach does not, in the words of Sorauf, aim to ‘solve’ pluralism. Quite the opposite: it embraces the messy realities and subjectivities, both of the law, as broadly conceived, and of outputs from public involvement activities.⁴⁹

The second contribution is to suggest that, despite the messiness, these accounts are not mutually exclusive and do, in fact, bear upon one another (though this relationship is far from clear). For example, I suggested earlier that shifting public views on health data sharing (and a move away from a ‘consent or anonymise’ binary) have contributed to the longevity of the CAG, which was originally proposed only as a temporary measure. Similarly, I have referred to how lobbying from the HRR community during the promulgation of the DPA 2018 led to an amendment of the Explanatory Note to clarify that ‘a task in the public interest’ is an appropriate route for public authorities such as universities to use when processing health data for research purposes. Lessons from care.data exemplify the importance of ‘social licence’ to the success of otherwise legal data sharing initiatives. In turn, there is an on-going need for deeper understanding of public acceptability to realise the potential of new and novel uses of health data.⁵⁰ Given the impetus to deliver clear and transparent governance of health data, it is proposed that this this relationship ought to be both acknowledged and made more overt, in order that it may be exposed to debate in HRR. Three concrete suggestions are made in this regard. The first is that the public interest, along with other concepts that operate at the intersection of public involvement and governance in HRR, should be examined to identify their potential to bridge the divide between the outputs from public engagement and the implementation of these in practice. The second is that initiatives such as CAG, where there is ‘evidence’ of the public interest being given effect to facilitate responsible HRR, should be further mobilised. The third is that instances where appeals to the public interest are made in HRR should be captured and articulated publicly, in order to promote transparency and accountability around how and why these have (or indeed have not) been justified.

6.7 Concluding Remarks

This chapter advocates for a holistic conception of the public interest, where interests are accounted for, rather than polarised. HRR governance has moved on from a ‘consent or anonymise’ binary and now needs novel and bold mechanisms that do not seek to over-play the role of legal mechanisms, nor suggest that public views alone can deliver good governance solutions. While the concept of the public interest remains contested and highly contextual, there is an increasing drive towards maximising the potential of this embedded concept in order to deliver a step-change in HRR.

7 Privacy

David Townend

7.1 Introduction: The Modern Difficulty¹

Privacy is a well-established element of the governance and narrative of modern society. In research, it is a mainstay of good and best practice; major research initiatives all speak of safeguarding participants’ rights and ensuring ‘privacy protecting’ processing of personal data. However, while privacy protection is pervasive in modern society and is at the conceptual heart of human rights, it remains nebulous in character. For researchers who engage with people in their studies, the need to respect privacy is obvious, yet how to do so is less so. This chapter offers first an explanation of why privacy is a difficult concept to express, how the law approaches the concept and how it might be explored as a broader normative concept that can be operationalised by researchers. In that wider scheme, I show how individuals respond to the same privacy situation in different ways – that we have a range of privacy sensitivities. I think about four privacy elements in the law: human rights, privacy in legal theory, personal data protection and consent. Finally, I consider how law participates in the broader normative understanding of property as the private life lived in society.

7.2 Privacy as a Normative Difficulty

A good starting point is to ask: what do we mean when we talk about ‘privacy’? It would be difficult for a modern research project to suggest that it was not ‘privacy respecting’ or ‘privacy preserving’. However, the concept is somewhat ill-defined, and that claim to be privacy respecting or preserving might, in reality, add little to the protection of individuals. In part, this problem stems from the colloquial, cultural aspect of the concept: we each have our own idea of what constitutes our privacy – our private space.

Imagine setting up a new data sharing project. You hypothesise that linking data that different institutions already gather could address a modern health problem – say, the growth of obesity and type 2 diabetes. Such data, current and historical, could be used by machine learning to create and continuously revise algorithms to help identify and ‘nudge’ those at risk of developing the condition or disease. The already-gathered data could be from general practitioners and hospitals, supermarkets and banks, gym memberships, and health and lifestyle apps on smart phones, watches and other ‘wearables’. But how would individuals’ privacy be protected within such a project? Many will be uneasy about such data being stored in the first place, let alone retaining it and linking it for this purpose. Many will see that there might be a benefit, but would want to be convinced of technical safeguards before opting into such a project. Many will be happy, having ‘nothing to hide’ and seeing the benefits for their health through such an app. Some would see this initiative as socially desirable, as part, perhaps, of one’s general duty and the basis of personalised medicine, so that such processing would be a compulsory part of registration for healthcare; an in-kind payment to the healthcare system alongside financial payments, necessary for the continued development of modern healthcare that is a general societal and personal good.

Our difficulty is that each one of the people taking these different positions would see their response as a ‘privacy preserving’ stance.² As explored elsewhere in this volume, this observation underlines the diversity of ‘publics’ and their views (see Aitken and Cunningham Burley, Chapter 11, and Burgess, Chapter 25, in this volume). Under the label ‘privacy’ there is a wide spectrum of conceptualisations, from the enthusiastic adopter and compulsion for all, through allowing people to opt-out, generally leaving participation to opting in, to wanting nothing to do with such projects. How then can a researcher frame a ‘privacy’ policy for their research? Are we creating the problem by using the term ‘privacy’ informally and colloquially? Does the law provide a definition of the term that avoids or militates against the problem?

7.3 Privacy as a Human Right

A logical starting point might be human rights law. Privacy and the right to respect for private life is enshrined in human rights law. Unfortunately, it does not give much assistance in the definition of those rights. Two examples show the common problem clearly.³ Article 12 of the Universal Declaration of Human Rights states:

No one shall be subjected to arbitrary interference with his privacy, family, home or correspondence, nor to attacks upon his honour and reputation. Everyone has the right to the protection of the law against such interference or attacks.⁴

Article 8 of the European Convention on Human Rights creates the right in this way:

1. 1. Everyone has the right to respect for his private and family life, his home and his correspondence.

2. 2. There shall be no interference by a public authority with the exercise of this right except such as is in accordance with the law and is necessary in a democratic society in the interests of national security, public safety or the economic well-being of the country, for the prevention of disorder or crime, for the protection of health or morals, or for the protection of the rights and freedoms of others.⁵

Two observations can be made about these ‘privacy’ rights: (1) privacy is not an absolute right, i.e. there are always exceptions and (2) ‘privacy’ and ‘respect for private life’ require a great deal of further definition to make them operational. As to the first observation, the rights are held in relation to the competing rights of others: a right against ‘arbitrary interference’ and ‘no interference … except such’. The concepts of privacy in human rights legislation acknowledge that the rights are held in balance between members of society; privacy is not absolute, because on occasion one has to give way to the needs of others.

As to the content of privacy – and reflecting the broad conceptualisations in the research project example above – we see that what is available from the human right to privacy is international recognition of a space where an individual can exist, free from the demands of others; there is a normative standard that recognises that people must be respected as individuals.

The European Court of Human Rights has ruled extensively on the human right to respect for private life, and a line of caselaw has been created. This produces a canon of decisions where particular disputes have been settled where the particular parties have been unable to resolve their conflict between themselves. However, does that line of cases produce a normative definition of privacy, i.e. one that sits with and accommodates the range of sensitivities expressed above? I think not. A courtroom determination arguably defines a point on the range of sensitivities as ‘privacy’, pragmatically for the parties. Our problem comes when we try to use caselaw as indicative of more than how judges resolve conflicts between intractable parties when a privacy right is engaged. Does this mean the law adds little to the broader normative question about how we, as researchers, should respect the privacy of those with whom we engage in our work?

Two North American contributions could help to understand this. The first expression of the legal right to privacy is usually recognised as Warren and Brandeis’ 1890 idea that we can agree that individuals have the right to be left alone.⁶ Reading their paper today, it resonates with current concerns: technological developments and the increasing press prurience required a right to be ‘left alone’. In the modern context of genetics, Allen proposes a broader typology of privacy: ‘physical privacy’, ‘proprietary privacy’, ‘informational privacy’, and ‘decisional privacy’.⁷ The first two, which seem strange ‘privacies’ today, are where Warren and Brandeis clearly see the Common Law as having reached in 1890. Law protects individuals’ physical privacy through consent; private property law is equally well established. Warren and Brandeis identified ‘informational privacy’ and what might be described as ‘reputational privacy’ as the area where the law needed to develop in 1890. Allen pointed to the vast and compelling literature around the woman’s right to choose in discussing the right to ‘decisional privacy’. Legal theory, in part, responds to current privacy issues. Today, two major privacy issues in research are the protection of personal data protection and informed consent.

7.4 Privacy in Specific Legal Responses: Personal Data Protection and Informed Consent

The development of the automated processing of personal data has focussed privacy, at least in part, around ‘informational privacy’.⁸ The Organization for Economic Co-operation and Development OECD Guidelines on the Protection of Privacy and Transborder Flows of Personal Data set an international standard in 1980 that remains at the core of data protection law.⁹ The guidelines are transposed into regional and national laws.¹⁰

Data protection, as an expression of an area of privacy, seeks to balance a variety of interests in the processing of personal data within the non-absolute nature of privacy; the object of data protection is to create the legal conditions under which it is possible and appropriate to process personal data. Taking the European Union General Data Protection Regulation 2016/679 (GDPR) as an example, there are four elements in data protection law: data protection principles;¹¹ legal bases for processing personal data;¹² information that must be given to the data subject;¹³ and, rights of the data subject.¹⁴ Each element contains a balance of interests.

For stand-alone research with human participants directly contacted by the researcher, the route through the GDPR is clear. Security and data minimisation standards (i.e. only gathering, analysing and keeping data for such a time necessary for the purpose of the project) are clear; data subjects can be informed about the project fully, and data subjects rights can be respected. More complex data-sharing methodologies – perhaps the project envisaged in Section 7.2 above – are more difficult to negotiate through the GDPR. Are original consents valid for the new processing? Was the consent too broad for the new GDPR requirements? Might the processing be compatible with the original purpose for which the data were gathered? Could the new processing be in the public interest? How should data subjects be informed about the proposed new project? Each of these questions is open to debate in the GDPR. And the problem is how can the lack of definitional clarity in the rights be resolved in such a way that it accommodates all the positions on the spectrum of interests indicated in Section 7.2 above? One could say, law must produce a working definition and in a democracy, all differences cannot be accommodated, so some will be disappointed. However, the sensitivity of the data in the example above shows that there is a danger that those who are not within the working definition of privacy will be alienated from participating in key areas of social life, perhaps even avoiding interaction with, say, health research or medical services to their detriment.

If one of the current legal discussions is around informational privacy, the other is around decisional privacy. Informed consent is a legal mechanism to protect decisional privacy, not just in research, but across consumer society. The right of individual adults to make their own choices is largely unchallenged.¹⁵ The choices must be free and informed. The question is, how informed must a choice be to qualify as a valid choice from an individual? This, in many modern biomedical research methodologies, is contested. A biobank, where data are gathered for the purpose of providing datasets for future, as yet undefined, research projects, depends on creating the biobank at the outset through a ‘broad’ consent. How though can an individual be said to give ‘informed consent’ if the purposes for which the consent is asked cannot be explained in detail? How can a consent that is ‘for research’ be specific enough to be an adequate safeguard of privacy interests? (See, for example, Kaye and Prictor, Chapter 10, in this volume for a specific discussion of consent in this context.)

The privacy issue is: what constitutes sufficient information upon which a participant can base her choice? Two conditions have to be satisfied: the quality of the information that will be made available; and (who determines) the amount of information that is necessary to underpin a decision. A non-specialist participant is not necessarily in a position to judge the first of these conditions. That is the role of independent review boards, standing as a proxy for the participant to assess the quality and trustworthiness of the scientific and methodological information that will be offered to the participant. For the second condition, what is sufficient information upon which to make a decision and who determines that decision, is a matter for the individual participant, and should not be seen as part of the role of the ethics committee, researcher or other body. The purpose of informed consent is to protect the individual participant from, essentially, paternalism – the usurping of the participant’s free choice of whether or not to participate (unless the decision is palpably to the detriment of an individual who is not deemed competent to make a choice). Therefore, in the general case, it is inappropriate to remove the determination of what is sufficient information to inform the particular person from that person, or to determine for them what are appropriate or inappropriate considerations to bring to the decision-making process. This would seem to be crucial in ensuring an individual’s decisional privacy – the extent of the right to make decisions for oneself.

7.5 Realising Privacy in Modern Research Governance

So far I have made two claims about privacy. First, individuals hold a range of sensitivities about their privacy (and we could add that this is a dynamic balance depending also upon the relationships between individuals and the emotional setting or moment of the relationship.¹⁶ Second, the law produces a mechanism for resolving conflicts that fall within its definition of privacy, but it does not provide a complete normative definition of privacy that meets all the social functions required of the concept (that will confront researchers negotiating privacy relationships with their participants). Two observations might help with locating our thinking at this point. First, there is not a complete, normative definition of privacy in any discipline that satisfactorily meets the dynamic nature of privacy. There are many different definitions and conceptualisations, but there is no granular agreement on the normative question – what ought I to understand as ‘my permitted private life’.¹⁷ Second, the presentation so far might appear to suggest that privacy is a matter of individual autonomy, in opposition to society. This, in the remainder of the chapter, I will argue is not the case, by exploring how privacy might be operationalised, in our case, in research. The question is: what tools can we use to understand our relationships as individuals in society?

To do this, I suggest that there are three areas that can usefully be considered by both researchers (and participants) in the particular circumstances of a research project and by society in trying to understand the conceptualisation of privacy in modern society: the public interest, confidentiality and discourse.

The public interest, the common good, as a measure of solidarity is very attractive. It addresses directly the range of sentiments problem to which I refer to throughout the chapter (see Kieslich and Prainsack, Chapter 5, and Sorbie, Chapter 6, in this section, and Taylor and Whitton, Chapter 24, later in this volume). Appealing to the public interest is a practical mechanism that answers the individual’s privacy sensitivities with the following: whatever you believe to be your privacy, these are the supervening arguments why, for example, you should let me stand on your land or use your personal data (your privacy has to accommodate these broader needs of others). The difficulty with the public interest is that it seems itself to have no definition or internal rules. Appeals to the public interest seem to be constructed loosely through a utilitarian calculus: the greatest utility for the greatest number. Mill himself identifies the problem: the tyranny of the majority. The problem has two elements. The claim to ‘supervening utility’ could seem itself to be a subjective claim, so those in the minority, suffering the consequences of a loss of amenity (in this case the breach of their privacy), are not immediately convinced of the substance of the argument. The construction does not balance the magnitude of the loss to the individual with the benefit (or avoided loss) of another individual; rather, the one stands against the many. This is not particularly satisfactory, especially when one links this back to the fundamental breach and the sense of the loss of privacy cutting to the personhood of the individual. Adopting the arguments of Arendt, we might phrase this more strongly. Arendt identifies the individual as constituted in two parts: the physical and the legal. In her studies of totalitarianism, she finds that tyrannies occur where the two parts of the individual are separated by bureaucracies and the legal individual is forgotten. Left with only the physical individual, the human is reduced to an expendable commodity.¹⁸ Simple appeals to the public interest could be in danger of overlooking the whole individual and producing an alienation of those whose rights are removed in the public interest or common good.

Another way of constructing the appeal to the public interest can be through deontological rather than ontological theories, particularly those of Kant and Rawls. Taking Kant,¹⁹ a first step would be to consider the losses to individuals – the person who stands to lose their privacy rights, and a person who would suffer a loss if that privacy was not breached. A second step would be to require each of those individuals to consider their claim to their privacy through the lens of the second formulation of the Categorical Imperative – that one should treat others as ends in themselves, not merely as means to one’s own ends.²⁰ Because privacy is not an absolute right, when making such a claim, we must each ask: do I merely instrumentalise the other person in the balance by making this privacy claim? This is a matter of fact: which of us will suffer most? The third element is to acknowledge that the law can require me to adopt that choice if I fail to make it for myself, as it is the choice I should have made unprompted (I can argue that the calculation on the facts is incorrect, but not that the calculation ought not to be made). Rawls might construct it slightly differently: whereas I might prefer a particular action preserving my privacy, I must accept the breach of my privacy as reasonable in the circumstances. Using his ‘veil of ignorance’, when I do not know my potential status in society, I must adopt this measure to protect the least-well-off member of society when the decision is made.²¹

In the example raised in Section 7.2, using this public interest consideration helps to reconcile the range of sensitivities problem. As a researcher trying to design privacy safeguards, I can use the calculations to evaluate the risks and benefits identifiable in the research, and then present the evaluation to participants and regulators. The public interest creates a discourse that steps outside self-interest. However, this sets off a klaxon that the public interest is not antithetical to privacy, as presented here; public interest is part of privacy. And I agree. Here, I am suggesting that using public interest arguments is a mechanism for defining the relationship of the individual to others (that is, to other individuals). The result is not saying that the public interest ‘breaches’ the privacy of the participant, but that it helps to define the individual’s privacy in relation to others (for the individual and for other people and institutions). It brings to the subjectivity of the dynamic range of sentiments (that I identified as an issue at the outset) the solidarity and community that is also part of one’s privacy.²² This holistic understanding of privacy as a private life lived in community not reducible to a simply autonomy-based claim is best explored by Laurie’s ‘spatial’, psychological privacy.²³

Confidentiality is a second legal tool to ensure participants’ rights are safeguarded. Arguably, it is a more practical tool or concept for researchers than privacy. Confidentiality earths abstract privacy concepts in actionable relationships and duties. Taking Common Law confidentiality as an example, it is constructed either expressly, as a contractual term, or it is implied into the conduct of a contract or through equity into the relationship between individuals.²⁴ Confidentiality depends on concrete, known parameters of the relationship, or parameters that one ought, in good conscience, to have known. Like data protection, it does not prohibit behaviour; rather confidentiality creates an environment in which particular behaviours can occur. This is important in the context of health research regulation because many potential research participants will be recruited through the professional relationships they enjoy with healthcare professionals; it is a tool that can be extended into other researcher–participant relationships. Confidentiality and the trust-based nature of that relationship can both help with recruitment and provide a welcome degree of reassurance about privacy protection.

Finally, and implicit throughout the operationalisation of privacy, privacy is a negotiated space that requires public engagement through discourse. Discourse ethics has a modern iteration, but a long history. The virtue ethics of Aristotle and Ancient Greek philosophy is dependent on the identification of the extent and nature of the virtues and their application in human life; Shaftesbury’s early enlightenment ‘politeness’²⁵ and the salons of the Age of Reason again ground the discussion of the questions, ‘who are we, and how ought we to behave?’ in public, albeit intellectual, discourse; today, Habermas et al. advocate this inclusion as a part of a participative democracy, perhaps reiterating the central arguments of the early Frankfurt School against the false consciousness of the Culture Industry.²⁶ The thrust of this whole chapter is that privacy must be debated and understood in the lives of individuals; universities, professional bodies, and ethics committees must facilitate conversations that empower individuals to realise their decisional privacy in making choices about the nature of their participation in society.²⁷

7.6 Conclusion

This chapter has focused on different aspects of a conceptual problem raised in relation to a modern research dilemma: how do we negotiate privacy-protecting research where individuals hold a dynamic range of sensitivities about their relationships to others in society? We have seen that whereas human rights law does not present granular definitions of privacy and courts use privacy concepts to resolve disputes in the area, attempts in legal theory and specific areas of law (personal data protection and informed consent) do not fill the conceptual gaps. The argument I advance is that using the public interest, confidentiality and public engagement discourse in constructing research protocols will go some way to address those gaps. It will also strengthen the relationship between researchers and the public they seek to engage and to serve, and could facilitate a greater understanding of the methods and objectives of science.

8 Trustworthy Institutions in Global Health Research Collaborations

Angeliki Kerasidou

8.1 Introduction

Trust is often cited as being fundamental in biomedical research and in research collaborations. However, despite its prominence, its specific meaning and role remain vague. What does trust mean, and is it the same whether directed towards individuals and research institutions? What is it about trust that makes it important in global health research, and how can we effectively promote it? This chapter analyses the meaning of trust and discusses its importance and relevance in the context of global health research collaborations.

In recent decades, biomedical research has moved away from a one-researcher-one-project model to adopt a more collaborative way of working that brings together researchers from different disciplines, institutions and countries. Global health research, a field that has emerged as a distinct area of biomedical research, exemplifies this trend towards collaborative partnerships. Global health, as ‘collaborative trans-national research …’,¹ often relies on collaborations between researchers and institutions from high-income countries (HIC) and low-and-middle income countries (LMIC). LMICs still carry the highest burden of disease globally and have a high prevalence of many illnesses that pose global threats (e.g. infectious diseases). This has motivated a number of national and international funders to support global health research. The redirection of funds towards global health has resulted in increased interest among HIC researchers in working on diseases such as malaria, tuberculosis, HIV–AIDS and conditions such as malnutrition, and also a new impetus in forming partnerships with colleagues from LMICs.

Global health research is seen as a natural field for collaborative work for two reasons. First, by definition, the problems that global health research is trying to answer are complex, multifaceted and transcend borders and boundaries; tackling such problems requires collaborations between disciplines, countries and institutions. Second, most of the issues global health is concerned with affect less affluent parts of the world. Building health research capacity in these countries, and strengthening their public health systems, is seen as the most effective and sustainable way to ensure the successful progress and implementation of global health research, and to meet global health priorities. The importance of trust and the role of institutions in establishing and promoting trust relationships are often noted in discussions regarding global health research collaborations. Trust is often presented as a foundational element of research participation,² data sharing³ and sharing of samples and other resources.⁴

Here, I give an account of what it means for an institution to be trusted and be trustworthy in the context of global health research. I employ the example of data sharing to illustrate the importance and value of trustworthiness as an institutional moral characteristic. I use the term ‘institution’ to refer to groups or collectives that actively undertake research, such as universities and research centres. I conclude that trust is important in global health research collaboration because of the power imbalance between partners that often characterises such collaborations. In order to promote trust, institutions need to focus on being trustworthy by developing a behaviour that corresponds to the aims, principles and values they profess to uphold, and by demonstrating that they have incorporated into their functions, rules and regulations the particular needs of their partners and collaborators.

8.2 What Is a Collaboration?

We use the term ‘collaboration’ in our everyday language to signify many different types of partnerships. Yet, not all ways of working together are collaborations. The term denotes a particular type of partnership where two or more partners come together to achieve a common aim or goal.⁵ Collaborations are non-hierarchical structures, based on the sharing of decision-making and responsibility that rely more on capacity and expertise, rather than on functions or titles.⁶ Consider, for example, a collaboration between a statistics unit and an epidemiology unit working together on a population health project investigating lung cancer. The two groups are committed to the aim of the project and share equal responsibility for its successful completion. They bring different expertise into the project, participate equally in decisions regarding its running and direction and share ownership for its outputs (e.g. authorship on academic publications). Collaborations are characterised by transparency, openness in communication, synergy and honest appreciation of each other’s positions. Transparency facilitates a collective awareness of the project, its structure, strengths and weaknesses, and promotes collective ownership. Open communication allows for the free flow of information and exchange of ideas, but also for the expression of concerns. The easier it is for people to talk to each other and share their thoughts and viewpoints, the easier it is for a project to stay on track and reach its goals. Understanding each other’s positions and particular circumstances is also important, as it helps with setting expectations at the right level, anticipating problems and foreseeing areas where conflict may arise. Finally, synergy, which describes the drive and desire to achieve the common goal and recognition of the partners’ interdependence in fulfilling it, is what drives such partnerships.⁷

Other types of partnerships or co-working include cooperation – which brings partners together who do not share the same goal, but who need each other’s skills and expertise to reach their individual aims – and hiring or commissioning someone to do a specific job. For example, someone can be brought into a project to complete a very specific task, such as to conduct a systematic literature review, collect samples or develop informed consent forms for a clinical trial. Once the task is completed, the person’s involvement in the project is ended. None of these types of partnerships can be described as collaborations as they lack the fundamental characteristics of non-hierarchical and synergistic co-labouring.

8.3 Trust and Trustworthiness

Alongside synergy and horizontal organisation, trust is regularly cited as a fundamental characteristic of collaborations.⁸ D’Amour notes that ‘the term collaboration conveys the idea of sharing … in a spirit of harmony and trust’.⁹ One empirical study that investigated what underpins successful collaborations in global health research from the perspective of scientists and other research actors, identified trust between partners as one of the major contributing factors.¹⁰ But why is trust so crucial for collaborations? Trust is yet another term that is often used in our everyday language but not always to describe the same thing. A short analysis would help to better define this term and see how it applies to the context of global health research.

Trust is an attitude towards a person whom we hope, and have good reasons to believe, will behave in a way that confirms our trust. This attitude can take different forms. People can trust others wholeheartedly and perfectly (A trusts B), for example their mother or spouse. But most commonly, trust is perceived as a three-part relationship (A trusts B to x). There are three main attributes of a trust relationship: vulnerability, assumption of good will from the trustee towards the trustor and voluntariness.¹¹ Vulnerability stems from the fact that when trusting, the trustor becomes vulnerable to the trustee as they acknowledge and accept that the trustee can decisively affect the outcome of the entrusted action.¹² This is what justifies feelings of gratitude or of betrayal when trust is confirmed or broken.¹³ Vulnerability is not, however, a personal characteristic of the trustor. Rather, it is a relational property that emerges from the act of trusting. Consider the following example: a researcher shares some potentially significant pre-publication findings with a colleague who also works in a similar area. She has previously worked with this colleague and trusts him. In her correspondence she stresses the importance of these findings and asks the colleague to keep them confidential. If the colleague confirms her trust, and keeps the findings confidential, she will feel her trust is confirmed; if, however, the colleague ignores her trust and publishes the findings or shares them with others (e.g. at a conference), she will justifiably feel betrayed. The feeling of betrayal is predicated on the fact that she has no assurances, other than her trust, to protect her from the colleague’s decision and behaviour, and this is what makes her vulnerable towards her trustor. Seeking assurances, by trying to constrain someone’s behaviours as a way of limiting one’s vulnerability would indicate that the trustor mistrusts, or lacks trust for that person. This is why trusting requires some level of optimism about the trustee or a normative attitude that the trustee ought to do what the trustor wills them to do.¹⁴

The second characteristic of trust is the belief that the trustee has good will towards the trustor.¹⁵ It is this belief that counterbalances vulnerability and provides a reasonable justification for trusting someone. To return to the previous example, the researcher reveals the pre-publication findings to her colleague because she has good reasons to believe that he has good will towards her and will not intentionally harm or hurt her. If she did not have good reasons to believe this, then choosing to reveal her findings and make herself vulnerable towards him, all things being equal, would be unjustified. Some challenge the importance of good will in trust, by suggesting that trust may be warranted when we believe that those we trust (trustees) will conform to social constraints and norms, or that they will act in the ways we expect out of self-interest.¹⁶ Yet, while social constrains and self-interest could increase people’s reliability, it is questionable whether such motives can underpin trust. A belief in the good will of the trustee signifies that the trustor has good reason to assume that the trustee cares about her and/or about the things about which she also cares. Although this could be problematic in situations where one does not have insight into the ‘psychology of the one-trusted’,¹⁷ one could still justify trust on the belief in the other’s good will by adopting a wide notion of good will, which includes commitment to benevolence and conscientious moral attitude.¹⁸

The third characteristic is that trust is voluntary, insofar as it cannot be forced or demanded. As Baier notes: ‘“Trust me!” is for most of us an invitation which we cannot accept at will – either we do already trust the one who says it, in which case it serves at best as reassurance, or it is properly responded to with, “Why should and how can I, until I have cause to?”’¹⁹ Trust takes time to establish, and requires an expectation that people will behave not only in the way we assume they will, but rather in the way we assume they should.²⁰ A consistent demonstration of good will, as well as capacity to perform the entrusted action, can provide a good reason for trust. And those who want to be trusted can help generate such relationships by fostering and increasing their trustworthiness.

Trustworthiness is a moral characteristic of the trustee and signifies that they have an attitude of good will towards the trustor by being responsive to the trustor’s dependency upon them.²¹ The motivation for behaving trustworthily also matters. Trustworthiness signifies something more than just the mere observation of rules and regulations out of self-interest or duty. It is not just a tactic to avoid punishment or penalties, or to fulfil one’s sense of duty. Potter describes trustworthiness as a virtue. ‘In evaluating someone’s trustworthiness’, she argues ‘we need to know that she can be counted on, as a matter of the sort of person she is, to take care of those things with which we are considering entrusting her’ (emphasis added).²² However, it is important to note that expectation for one to behave in a certain manner does not compel the trustee to behave in the expected way. The fact that one is being counted on forms an important consideration to be taken into account but does not force one to act in a certain way – otherwise one would be forced to act in a ‘trustworthy’ way even when the trust placed on one is unjustified or misguided.

So far, I have argued that trust is a relational mode predicated on a reasonable belief in the trustee’s skill to perform the entrusted action and also good will towards the trustor. Trust cannot be forced or demanded, and by trusting, one makes oneself vulnerable toward the person they choose to trust. Trustworthiness is a moral characteristic that indicates that someone can be counted on. It is not necessary that a trustworthy person is automatically trusted, but trustworthy behaviour can illicit trust. In the context of these definitions we can explore this chapter’s main questions: what is the role of trust in global health research collaborations and can institutions be trusted? If trust is commonly perceived as a characteristic of interpersonal relationships and trustworthiness as a personal quality or virtue, is it possible to talk meaningfully about trusting institutions, or to ascribe moral characteristics such as trustworthiness to collectives?

8.4 Trust in Global Health Research

In 2013, the Council on Health Research for Development (COHRED) published a report on fair collaborations in global health.²³ It noted that relying on HIC collaborators’ good will has not been sufficient to ensure fair and just collaborations between partners. What was needed instead, the report recommended, was to build LMIC institutions’ capacity in contract negotiations. The implication seems to be here, that instead of just trusting people to behave fairly and justly and thus opening oneself up to having their trust betrayed, one needs to ensure that people will behave this way. This could be achieved by putting in place contracts that direct and set the parameters of right behaviour. One way of understanding this contractual relationship is as relationship of reliance. Relationships of reliance are based on proven capacity and clear systems of accountability. In such relationships, the expectation is that the partners will act based on self-interest. Collaborators can ensure successful partnerships by aligning their interests and by putting in place rules to secure against defection. What makes relationships of reliance preferable to relationships of trust is that the former do not require an assumption of good will, nor do they require the trustor to become vulnerable to the trustee.²⁴

One important condition, however, must apply for relationships of reliance to work. Reliance requires power parity between partners.²⁵ This is because in relationships that operate on self-interest, it is far easier for the stronger partners to shift the balance to their favour. This is particularly relevant for global health research collaborations, which often bring together institutions from HICs and LMICs. Giving LMIC researchers and institutions the tools to defend and promote their own interests is one way of promoting reliable – rather than trusting – partnerships and addressing relationships of dependency, and COHRED’s efforts are a valuable step towards this. However, there are a number of reasons why building trust relationships and promoting trustworthiness remains important in this context. First, in situations where power parity between partners is lacking, trust can be an essential foundation on which to build a good and fair collaboration. For example, attitudes of good will – a crucial feature of trust – can counterbalance self-interested motivations. Second, trust could facilitate good collaborative partnerships, by creating a safe environment in which partners can focus on achieving the common goal rather than on protecting their own interests. Finally, it is common sense that everyone, given the option, would prefer to work with partners they trust and not only with those they can reliably predict their behaviour.

If we accept that trust remains relevant in global health research, what we need to consider next is how it could be promoted. One of the reasons that could justify and encourage a trust relationship is trustworthiness. Although trustworthiness cannot always and de facto guarantee trust, moral agents who want to be trusted by their partners and collaborators could do worse than to try to cultivate and demonstrate their trustworthiness. However, while trustworthiness can be attributed to individual persons, collaborations in global health research however, are not just between individuals, but also between institutions. It is important, therefore, to examine whether it is reasonable to talk about ‘trustworthy’ institutions.

8.5 Trustworthy Institutions

Prior to ascertaining whether institutions (e.g. universities, research centres) can be trustworthy, we must establish whether it is reasonable to talk about groups and collectives possessing such moral characteristics as trustworthiness.²⁶ In other words, can institutions involved in global health research collaborations be moral agents? There are two main reasons, which, I believe, give support to the view that collectives are entities that could be treated as moral agents: first, such a position chimes with the way we think about the role of collectives in public life and also the way we treat them in practical terms. For example, we expect universities to adhere to ethical principles when conducting research and we hold them responsible when they fail to do so.²⁷ In law, collectives are treated as bearers of rights and responsibilities and can be penalised for wrongdoing and for failing to meet their duties and obligations. Second, the view that institutions are moral agents reflects a growing realisation that many issues require the action of collectives in order to be resolved. Actions such as conducting large-scale research aimed at halting pandemics or reversing climate change are unavailable to individuals but possible to groups and institutions. If we accept that these actions reflect duties that ought to be met, then these duties will have to be ascribed to actors that can meet them.²⁸

Being trustworthy means that a given individual (or institution) acts not only as they are expected to, but in a way that demonstrates that they have taken into account the fact that someone is counting on them.²⁹ Trustworthiness is a characteristic or moral attitude that is revealed through one’s actions and also in one’s ‘values, commitments and loyalties’.³⁰ When it comes to institutions, their trustworthy character is revealed in their professed goals and aims, at their institutional structures, internal rules and regulations as indicators for their moral motivations,³¹ and in their reputation and track record as indicator for their skill and commitment to right action.³² Researchers and groups in global health who are looking for collaborations would perceive institutions that declare to care about things they also care as more trustworthy, rather than institutions that do not profess such interests. An institution’s track record and proven capacity in their ability to reach these shared goals would add to its trustworthiness. Importantly, being trustworthy is not about following rules but acquiring a disposition of trustworthiness. Behaving in a certain way only for fear of penalty demonstrates a self-interested orientation, rather than concern for others or about what others value. Therefore, institutions would need to demonstrate that their commitment to trustworthy behaviour is principled and corresponds with their aims and purpose, rather than motivated by a desire to avoid sanctions and penalties, including loss of future collaborations. For institutions participating in global health research, this will mean demonstrating that they have incorporated into their structures, rules and regulations central aims of global health such as addressing health inequalities, improving health through rigorous research and promoting research capacity in countries that lack it. Using the example of data sharing and open access may help to illustrate this point.

8.6 Trustworthiness in Data Sharing Collaborations

Data sharing is often presented as foundational to global health research.³³ Health and health-related data (e.g. genomic, phenotypic or clinical data) are an inexhaustible resource that could be used repeatedly to address multiple research questions, provide answers to a plethora of global health issues and thereby help reduce the global burden of disease. For example, data sharing between countries and institutions is essential in the attempt to understand and respond to epidemics and pandemics, as the cases of the H5N1 avian flu in 2007 and the outbreaks of Ebola in 2014 and ZIKA in 2015 have demonstrated.³⁴ Recognition that health data offer valuable resources with multiple applications has led to a position where data sharing is seen as both a scientific and moral imperative in biomedical research,³⁵ while failure to share has been variously described as being unscientific, contrary to research integrity, wasteful and unjust.³⁶ In recent years, a lot of effort has been put into facilitating and promoting the open sharing of data.³⁷ Progress in data sharing tools, methods and policies is seen as the ‘innovation with the farthest-reaching impacts among the global medical community’.³⁸ This has led to the wide endorsement of data sharing and open access policies by many international research bodies, funding organisations, academic publishers and policymakers.³⁹ It seems that adopting and promoting open access of data and the implementation of a robust open data sharing policy would signal an institution’s moral character as being one dedicated to open, transparent and robust science, and to maximising research benefits for all. But would this mean that such an institution is trustworthy?

In the context of global health research, data sharing can be ethically and practically complex. Despite its potential benefits, there are significant ethical and societal barriers to the wide implementation of open data sharing policies and practices.⁴⁰ Leaving aside confidentiality and consent, a significant issue in global health stems from the uneven ability of institutions in different parts of the world to utilise data.⁴¹ As Serwadda and others note, advancements in technology that make data collection, storage and sharing easier, and the shift in the social and scientific norms to support openness and sharing, is undermining equitable collaborations between HIC and LMIC.⁴² This has led to ‘a landscape, often characterised by limited capacity and deep mistrust, for acceptance and implementation of open data policies’.⁴³ Furthermore, despite claims that open data sharing could lead to advancements that would be beneficial to all, including to the communities of origin, this is not always the case. Often, the new therapeutics developed are either too expensive for LMICs to purchase, or these countries lack adequate public health structures to make use of any new actionable knowledge. For example, in 2007, Indonesia refused to share its H5N1 avian flu data and samples unless their country was guaranteed affordable access to vaccines – and researchers from other LMIC seem to think that this was a fair response to an unfair situation.⁴⁴ Although data sharing could accelerate the production of new and useful knowledge, it can also contribute to the perpetuation of global injustices and undercut the stated goals of global health research.

Adopting an open access policy to data sharing could make an institution reliable, in the sense that its partners would know what to expect and would be able to predict its behaviour and actions with a certain degree of accuracy. Would recognising this institution’s reliability in this domain, however, amount to it been perceived as being trustworthy by its partners?⁴⁵ Although adopting certain (moral) rules and acting consistently is an indication of a certain (moral) character, trustworthiness requires more than that; it requires an attitude of good will and responsiveness to the other’s needs. Hence, a trustworthy institution in global health research would not blankly endorse an open data sharing policy, but would retain a flexible stance, leaving room for adapting its policies with the specificities of its collaborators in mind. Such adaptations might include time-specific embargoes on data release to give partners a fair head start on using their data, restrictions of use to protect the stated research aims of such partners and embedding contextually meaningful capacity building activities into their collaboration.⁴⁶ Although an open data sharing policy could ensure that maximum value and utility is extracted from data, allowing for the negotiation of a managed access policy would signal an institution with good will towards its collaborators and ‘a direct responsiveness to the fact that the other is counting on [it]’.⁴⁷

8.7 Conclusion

Trust is and will remain important in global health research collaborations, at least until the power imbalance between LMIC- and HIC-based researchers and their institutions is addressed. Institutions committed to advancing the aims of global health, including helping build research capacity in LMIC, should aim to promote fair and trusting collaborations. The best way of achieving this is by cultivating and demonstrating their trustworthiness as a way of eliciting justified trust. Being trustworthy requires more than just the observation of rules or the incorporation of moral principles in policies and structures. Although such moral attitudes would likely increase an institution’s reliability, trustworthiness also demands attention to the relational aspect of trust. Trustworthiness requires that the institution is concerned with its partners and what its partners value, acknowledges its partners’ vulnerability and demonstrates ‘a direct responsiveness to the fact that the other is counting on [it]’.⁴⁸ The practice of data sharing provides a useful case to examine what being a trustworthy institution might look like in practice. Moving forward, more research will be required to fully examine the relationship between rules, regulations and policies and the moral character of institutions in global health.

9 Vulnerabilities and Power The Political Side of Health Research

Iain Brassington

9.1 Introduction

In this chapter, I will argue that there is a political dimension to research, and that accounts of health research regulation that ignore political relations between stakeholders are therefore incomplete. The concept of vulnerability – particularly vulnerability to exploitation – provides the grit around which the claims are built. This is because vulnerability is an inescapable part of human life; because research participation may magnify vulnerability, even while health research itself promises to mitigate certain vulnerabilities (most directly vulnerability to illness, but indirectly vulnerability to economic hardships that may follow therefrom); and because vulnerability is manifested in, exacerbated by, or mitigated through, inherently political relationships with others, the groups and communities of which we are a part, and in the context of which all research takes place. I shall not be making any normative claims about research regulation here, save for the suggestion that decision-makers ought to take account of latent political aspects in their deliberations. For the most part, I shall simply attempt to sketch out some of those political aspects.

9.2 Setting the Scene

Certain key terms ought to be defined at the offset.

• By vulnerability, I understand a susceptibility to harm or wrong arising from a physical or social contingency above and beyond that found in a recognisably decent human life.

• By the vulnerable, I understand those who are at an elevated risk of harm or wrong arising from such contingencies.

• By power, I understand the capacity to act, or to resist being acted upon.¹

• By power relations, I understand the interplay of agents’ relative power.

• By the political, I understand the domain in which power relations are manifested.²

• By exploitation, I understand the use of some thing or person to serve one’s ends.

Some elaboration is in order. At its most basic, vulnerability is any susceptibility to harms or wrongs; but such an understanding is generally unhelpful, because (per Rogers) ‘it obscures rather than enables the identification of the context-specific needs of particular groups’³ – plausibly, one may read this as ‘individuals and groups’ – and because (per Wrigley and Dawson) ‘if everyone is vulnerable, then no one is’.⁴ A more nuanced and useful conceptualisation of vulnerability would relate it to a susceptibility to harms or wrongs greater than is normally found in a recognisably decent human life. Correspondingly, in stating that ‘[s]ome groups and individuals are particularly vulnerable and may have an increased likelihood of being wronged or of incurring additional harm’,⁵ the Declaration of Helsinki is plainly referring to the ways in which persons may be further vulnerable above a universal baseline. That said, I will indicate below that, and how, the more basic understanding is not without utility.

Wendy Rogers provides an account of some of the difficulties of conceptualising vulnerability in this volume (see Chapter 1) and taxonomies of different kinds of vulnerability have been offered elsewhere.⁶ I will neither rehearse nor assess those accounts here, save to highlight the idea of pathogenic vulnerability, the sources of which include morally dysfunctional or abusive interpersonal and social relationships, and sociopolitical oppression or injustice,⁷ and which thereby illustrates plainly one of the political aspects of vulnerability. However, we conceptualise or parse it, though, vulnerability invites politically-informed responses. Wrigley and Dawson assert that vulnerability ‘implies an ethical duty to safeguard [the vulnerable person’s or group’s] well-being because the person or group is unable to do so adequately themselves’.⁸ For his part, ten Have claims that ‘[w]hat makes vulnerability problematic is the possibility of abuse and exploitation’; for him, vulnerability need not be eliminated, so long as it can be ‘compensated, diminished, and transformed’.⁹ Putative duties to safeguard the vulnerable, or to militate against abuse, could be discharged by individuals in some cases, and by the state in others. Venturing claims one way or the other implies a political position, because it speaks to decisions about how and by whom power may be exerted over, and on behalf of, another.

Exploitation, as defined above, implies the exercise of power over another: the exploiter is in this context more powerful than the exploited. As a manifestation of the power relations between agents, it is therefore a political phenomenon; and if exploitation violates a right of the exploited, it may be wrongful. Insofar as that vulnerability is susceptibility to certain harms or wrongs, it includes susceptibility to wrongful exploitation; and since exploitation is a political phenomenon, vulnerability to wrongful exploitation will therefore also be political. The relevance of this will become clear as we proceed.

9.3 Individuals’ Vulnerability in Research

It is in the nature of research that outcomes are uncertain; this means that healthy volunteers in medical trials might be susceptible to unexpected harms. If research concerns a treatment’s effectiveness, it will often be necessary to recruit patients into a trial; but such a cohort will, by definition, be of people with medical needs, some of which may be otherwise unmet. The prospect of a health benefit, especially if there are few other extant or affordable treatment options, may mean that this somatic vulnerability is accompanied by vulnerability to exploitation: the patient may allow herself to be enrolled into a trial into which she would not have allowed herself to be enrolled otherwise. Moreover, participants’ ability to control their exposure to risk may be limited: even without perfect knowledge, researchers are likely to have greater insight into the risks, and are able to control information in a way that participants, who rely on researchers for information, are not. This is a form of epistemic power held by researchers. Indeed, researchers may be perceived as having control over information even when they do not; and this perception may give them a ‘credibility excess’¹⁰ that is itself a source of epistemic power, insofar as that it can influence the decisions that participants make, perhaps to the extent of inhibiting their making them at all. How researchers and research managers handle the power disparity between them and participants is a political problem writ small.

Even putting the political aspect of this relationship to one side, it would be reasonable to expect that researchers address questions about the broader political context of their programme and protocol. After all, if someone enrols as a research subject because it is the only way they can access treatment, or because it is the only way they can afford it or other necessities, this tells us something about the characteristics of the state in which they live – notably, how just it is. Correspondingly, acknowledged political injustice may alter the likelihood that a person would act as a participant, how they behave as a participant, and whether their participation is voluntary. The political questions are clear. Does the political environment in which a person lives provide adequate protection against exploitation? What should be done if it does not?

At times, it may be that political circumstances make ethically acceptable research impossible. In extremis, this might be because certain people are forced to participate by an overweening government: prisoners, say, may be particularly vulnerable to this kind of pressure in some regimes. But participatory voluntariness may also be eroded by the lure of medical treatment that participants would not otherwise have, perhaps because it is not normally within the state’s abilities to provide it. On the other hand, refusing to carry out research because the context in which it is proposed creates vulnerabilities or militates against their mitigation, may simply mean that would-be participants are deprived of benefits that they might have had – Ganguli-Mitra and Hunt touch on this problem when they consider the use of experimental interventions during the 2013–2016 Ebola outbreak in Chapter 32 of this volume – and that scientific opportunities are lost as well. A further problem is that some illnesses are illnesses of poverty; it may not be possible to carry out research on those illnesses without recruiting people who are socioeconomically vulnerable, because less socioeconomically vulnerable people would be less susceptible to the illness in question. (That said, one may wonder whether prioritising poverty alleviation would dilute any imperative to research the illnesses that it causes.)¹¹

There is unlikely to be an easy way to determine whether a given political situation is conducive to ethically sound research. Possibly the best that could be said is that good research practice may require an awareness of, and sensitivity to, the prevailing political dispensation as it applies to certain individuals.

9.4 Individuals and Groups

How well do these considerations translate to groups?

For the moment, I shall assume that groups are aggregates of individuals, and that groups’ vulnerabilities are aggregates of individuals’ vulnerabilities. Admittedly, this is a simplification: something might be good or bad for the group as a whole without being good or bad for each and every member thereof; a group’s integrity, say, may be vulnerable in a way irreducible to its members’ vulnerabilities. But, for the time being, and given space constraints, I think that the simplification is not gross.

Granted that groups are aggregates of individuals, discriminatory or otherwise unjust political arrangements may exacerbate or even generate vulnerabilities in those individuals qua group-members. Most obviously, individuals may be at increased susceptibility to harm or wrong if they lack legal or political representation, education, and so on, because of their membership of a particular group. This kind of powerlessness to resist injustice is a political product generating a pathogenic vulnerability – and a state in which injustice is not addressed is itself unjust, or vicious in some other way.¹² Further, the legacy of historic injustices may linger even if the unjust policies were ditched long ago.

But even having been identified as a member of a group at all may generate vulnerabilities in individuals, irrespective of the political circumstances. To give a simple example, a public health research programme may require population-level data-gathering. Any given individual may feature in such research by dint of having been identified as belonging to a target group – but they might not be aware that the research is taking place. Already, then, we will be confronted with the possible wrong of individuals not being treated as ends in themselves. This wrong has a political dimension in that the power of research subjects is a consideration: one is powerless to withdraw from a study in which one does not know that one is a subject.¹³ We might say that researchers who think their work is worth the effort ought to approach those persons who may be captured by it – something that is in principle in their power to do – to give them a chance to opt out, and that research without this opt-out would be impermissible. This would restore to individuals some power. Yet giving people the chance to opt out of a large cohort study would be very difficult in practice, and – perhaps more importantly – would risk undermining the study’s scientific integrity, which is itself a criterion of its moral permissibility. There is no clear solution to this sort of problem, though awareness of it is an important precursor to formulating best practice.

Even if that problem is solved, others present themselves. A group might be characterised by an elevated occurrence of certain characteristics. Imagine that members of group A typically have an unusually high susceptibility to a given disease, and that members of B typically have an elevated inherited resistance to it. Facts like this would generate legitimate questions that would be worth investigating: by learning about how it is that some human bodies are more resilient or susceptible to an illness than others, we could glean insight that would help us prevent it or treat it when it occurs. Yet both groups would also be vulnerable to injustice and exploitation. Thinking about the distribution of the eventual benefits of the research will help show how.

Clearly, medical research contributes to the development of new treatments, at least some of which provide profits for the manufacturers; and the profit motive may drive socially-desirable research. However, the line between just profit and profiteering, which is by definition unjust, is crossed if the benefits of the research are not fairly distributed between researchers – and their backers – and participants. Thus, for example, if any drugs arising from research dependent on the participation of members of A are profitmaking, and those participants derive no benefit – perhaps because socioeconomic deprivation makes the drugs unaffordable – that would be a paradigmatic example of injustice. Even if A is a reasonably well-represented and educated group, it or its members might be exploited in other ways, perhaps by being targeted specifically for expensive medical interventions. B would be less vulnerable on these fronts, since its members’ need for any drugs is, by stipulation, reduced. However, again, if members of B received no benefit at all from research into which their contribution was crucial, they might still have been exploited. After all, exploitation does not always imply harm – but to have contributed to something that benefits others is to have been exploited; and if this was without recompense, or at least without the opportunity to waive recompense, it is arguably to have been treated wholly as a means to their end, and therefore to have been wronged.

That groups can be exploited or treated unjustly – such as in the ways illustrated by A and B – is sufficient to show that there is a power differential in play; and because the political domain is that in which power relations are manifested, it is also straightforward to point out that this has a political dimension. As such, a full assessment of the ethics of a given piece of research, and a convincing regulatory policy, would take into account the political situation, both locally and globally.

On the local scale, it would be important to keep in mind questions such as whether the group’s vulnerability to exploitation is exacerbated by things like systemic discrimination or economic disadvantage, which may make it difficult for members of a community to assert moral rights that themselves may not be fully reflected in law. The better protected a group is in law, the better able it and its members will be to avoid or resist exploitation in other contexts.

Globally, if research is carried out on people from low-income countries, and the benefits of that research flow overwhelmingly towards high-income countries, what we see is, in effect, a transfer of benefits from the least-wealthy to the most. In this context, the Swiss NGO Public Eye estimates that

[a]lthough most clinical trials are conducted in the United States and Europe, over the last 20 years there has been a strong tendency towards offshoring to developing and emergent countries. The proportion of testing in emerging markets increased from 10 percent to 40 percent. This continued to increase between 2006 and 2010, while the proportion of clinical trials conducted in Western Europe and the United States fell from 55 percent to 38 percent.¹⁴

Such a transfer is facilitated and guaranteed by a system of domestic and international laws through the framing of which power becomes visible; and keeping those laws in place, or altering them to reduce the chance of exploitation, is correspondingly a matter of the political will of the powerful. And though individual researchers are powerless to do much about laws that facilitate unjust exploitation derived from research, they are able to do something about the design of individual research programmes, and whether or not they go ahead to begin with.

Yet this is not the most difficult problem in the way of handling group vulnerabilities in health research: that concerns how researchers and regulators should respond when the interests, wishes, and vulnerabilities of different members of a group are in tension. It is this problem to which I turn my attention now.

9.5 Group Membership and Group Vulnerabilities

Return to groups A and B from the example above. Suppose that researchers are particularly interested in a gene that is common in A but not in B; they hypothesise that this gene is relevant to understanding the medical condition they are studying. This presents a problem for consent: because genes are not confined to one member of the group, any individual’s participation in the programme automatically recruits other members as what we might call ‘indirect participants’. It might therefore be argued that every member of the group is vulnerable to having been wronged, even if the ‘direct participant’ – the person, say, whose blood is drawn – has given full consent. How might we take account of this vulnerability in other members of the group?

It is a commonplace that full, informed consent is at least a part of protecting the rights of research participants; from that we can infer that it would be part of mitigating their vulnerability. But obtaining the consent of each member of the group before beginning the research would be wildly impractical for any but the smallest groups in the most confined geographical areas. More, we would have to decide whether assent to participation must be unanimous: whether, that is, the permission of a person who would presumably not be a direct participant in the research should be a requirement to secure the participation of those who would be. Inasmuch as that this is a question about the relationship of individuals to each other, it is political.

Another layer of complication is added if we deny that a group’s vulnerabilities are reducible to those of the aggregate of its members – and it seems as though this may sometimes be the case. Plausibly, there will be situations in which the vulnerabilities of individuals and of groups do not map onto each other particularly closely, if at all: groups can be vulnerable in their own right. For example, the size of a tribe of hunter-gatherers may fall as its members urbanise; we might therefore want to say that the group is increasingly vulnerable even as individual members, thanks to better access to things like health care and education, become less so. But if this is correct, then even addressing every individual’s vulnerability may not address wholly the vulnerabilities of the group in the abstract, and so even unanimous consent may be insufficient to prevent impersonal harms or wrongs. Yet it does not seem plausible to say that a research programme should not go ahead because it is impossible to guarantee that the vulnerabilities of the group as a whole will not be exploited. Partly, this is because it seems to sacrifice the (probably admirable) willingness to participate of identifiable members of the community on the altar of concerns about everyone and no one in particular. And partly it is because, though the vulnerabilities of identifiable other members of the community and of the community itself may be important, they are not likely to be the only relevant moral consideration. After all: everyone who stands to benefit – directly or indirectly, tangibly or intangibly – from the research has an interest in its going ahead. These are political problems: to echo Bernard Crick, ‘conflicts of interest, when public, create political activity’.¹⁵

Having a representative or representative body that can speak on behalf of the group broadly understood may be suggested as a way forward. For example, Charles Weijer argues that, although some groups and communities ‘do not possess a legitimate political authority empowered to make binding decisions on behalf of members’, which means that ‘it would be both impossible and inappropriate to seek community consent for research participation’, they ‘may nonetheless have representative groups, and researchers ought to engage these groups in a dialogue concerning study design, conduct, and research results’.¹⁶ Yet we may still wonder how we determine who represents the community and in what way, and what we should do if and when the views of members of the group or community broadly understood diverge from the views of its notional representatives. We should not forget the possibility that would-be research participants may be vulnerable to peer pressure, either to participate or not to, from the group of which they are a part. In this light, it is not obvious what should happen if one member of group A or B from the example above is willing to volunteer as a research participant when those representatives are opposed, or vice versa. Again: since these problems concern how individuals and groups interact, they are plainly political.

Neither should we forget that individuals may be members of several communities or groups simultaneously. As such, referring to membership of a community is likely to mask other problems. Accordingly, when, in the context of genetic research, Jones et al. state that, ‘depending on the research focus’,

a community may include a group sharing a common geographic location, ethnicity, disease, occupation, etc. as well as virtual communities linked regionally, nationally or internationally¹⁷

they leave open questions about whether one must specify just one of these, and which – if any – takes priority over the other. At some point, someone would have to stipulate that the ‘kind’ of community in question is this or that; but such stipulations would appear to be always disputable, and likely politicised to boot.

When considering research involving vulnerable groups then, the relative power of the researcher (and the researcher’s backers) and the participant is not the only consideration. Researchers’ power relative to that of the group as a whole would also be important to keep in mind; at the same time, so would the power of the group as a whole in relation to the individual participant. Finally, even if we think that the interests of the community are significant, there is a lingering question of where the boundaries of the community should be drawn: sufficiently cosmopolitan politics may deny that the boundaries of this or that group are significant.¹⁸ These questions are inescapably political given the understanding of the political as that domain in which power is manifested, but also political in a more everyday sense, because they speak to problems of how individuals relate to the groups and communities of which they are a part, and how we define group or community membership.

9.6 Politics and Protection

I noted earlier in this chapter Wrigley and Dawson’s claim that there is an imperative to mitigate vulnerability. Allowing that there is such an imperative, it speaks to the obligations individuals have to each other, but also to the responsibilities of the community, as expressed through the state. Either way, there is a political dimension to it. More, it is reasonable to suppose that health research is one of the things that might be enlisted as a means of mitigating universally-shared human vulnerabilities, and it is likely that a functioning state of some sort is necessary to facilitate such research. Indeed, the idea that political existence is in one way or another crucial to human flourishing has been a touchstone of western philosophy since Aristotle.¹⁹

It should also be remembered that, as well as facilitating research, protecting research subjects from harms and wrongs more generally – notably, through regulation – falls within the state’s demesne. It is in this light that we might consider moves such as the reforms to the Mexican General Health Law approved in 2008, which made ‘the sampling of genetic material and its transport outside of Mexico without prior approval […] illegal’.²⁰ The Genomic Sovereignty amendment states that Mexican-derived human genome data are the property of Mexico’s government, and prohibits and penalises their collection and use in research without prior government approval.²¹ This may be seen as an attempt by the Mexican state to protect vulnerable groups within it from the depredations of large and wealthy biotech companies. Such moves may be seen as particularly called-for when, for example, the results of genetic research might be patentable. In such circumstances, a national government can shield minority groups that might not be able to resist unjust exploitation on their own, and can work to give them authority over what happens to data derived from their members.

This is not the only way to see things, though. Cooperation with commercial research institutions could provide vulnerable groups – think again of groups A and B above – with a way to capitalise on their own genetic resources, by entering into benefit-sharing agreements that guarantee them a portion of any proceeds. Such cooperation may also provide a way for research attention to be paid to conditions that may be more prevalent in that community than elsewhere. On this basis, legislative moves such as Mexico’s may be seen as an appropriation, however well-meaning, of the rights of some of its people(s) to decide for themselves how to handle data derived from their genes. Alternatively, it may be national governments that are best able to persuade biotech companies to research certain conditions at all; and the state may be able to use its power not to prevent a group exploiting its genetic resources, or to coopt them, but to ensure that the group in question it is able to exploit them effectively, since only national governments have the heft to ensure that the exploitation is not of the objectionable sort.

9.7 Conclusion

Research promises us a way to address human vulnerabilities, but it may exacerbate others in the process. Ensuring informed consent from participants may be a means of mitigating some of these, but not others. Those that it might mitigate often have a political genesis; but the relationship between researcher and participant can only really be understood when its own inherent political dynamic is acknowledged, too. More, the complications of the political aspects of research are magnified when we are dealing with vulnerable groups and communities, and with their members.

It has not been the aim of this chapter to offer any normative suggestions; nevertheless, fully to account for individuals’ vulnerability, and reliably to avoid exacerbating or exploiting it unjustly, researchers should probably take account not just of the familiar ethical norms of health research, such as informed consent, but also of the political context in which such norms are applied.