Since its recognition in the early 1980s, the global HIV/AIDS pandemic has continued to grow relentlessly. Early efforts in HIV prevention sought to influence behavior by providing information about the dangers of AIDS along with recommendations for safe behavior. This approach helped to alert people about AIDS, but was insufficient to promote or sustain behavioral change.

The second approach attempted to promote individual behavioral change by designing AIDS programs that would deliver a mix of information, materials, and services. This program-based approach emerged within communities, was gradually adopted by some countries, and was subsequently articulated by the World Health Organization as the first Global AIDS Strategy. The emphasis during this period was to ensure that each community and country developed its own comprehensive program by adapting a global model to local and national circumstances.

The revised Common Rule adopts the reasonable person standard to guide research disclosure. Some members of the research community contend that the standard is confusing and ill-suited to the research oversight system. Yet the revised rule is not as radical as it might seem. During the 1970s, judges started using the standard to evaluate negligence claims brought by injured patients who said doctors had failed to obtain informed consent to the harmful procedures. In its influential Belmont Report, the National Commission recommended application of a “reasonable volunteer standard” to guide IRBs evaluating research disclosures. Evidence also suggests that IRBs often invoke the reasonable person standard in deliberations about consent forms. But past application of the standard has been informal and uneven. Robust application of the reasonable person standard will require researchers and IRBs to learn more about what ordinary people want and need to know about the studies they are invited to join. Input from people with personal experience as study participants could be particularly useful to this effort.

In the U.S., there is no requirement for research sponsors to compensate human research subjects who experience injuries as a result of their participation. In this article, we review the moral justifications that compel the establishment of a better research-related injury compensation system. We explore how other countries and certain institutions within the U.S. have adopted various systems of compensation. The existence of these systems demonstrates both that the U.S. lags behind other nations in its protection of human research subjects and that the establishment of a compensation system is both practical and feasible. We then examine factors which have prevented the U.S. from establishing its own compensation system. We consider possible alternatives for the U.S. by examining the advantages and disadvantages of both established and proposed systems. We offer a new proposal that addresses the justice concerns which compel the establishment of a national compensation system, distributes the burdens of such a system on multiple stakeholders that benefit from research, and has the additional advantage of minimizing the administrative and logistical challenges associated with initiating such a system.

The individual right of access to one’s own data is a crucial privacy protection long recognized in U.S. federal privacy laws. Mobile health devices and research software used in citizen science often fall outside the HIPAA Privacy Rule, leaving participants without HIPAA’s right of access to one’s own data. Absent state laws requiring access, the law of contract, as reflected in end-user agreements and terms of service, governs individuals’ ability to find out how much data is being stored and how it might be shared with third parties. Efforts to address this problem by establishing norms of individual access to data from mobile health research unfortunately can run afoul of the FDA’s investigational device exemption requirements.

Health justice is both a community-led movement for power building and transformational change and a community-oriented framework for health law scholarship. Health justice is distinguished by a distinctively social ethic of care that reframes the relationship between health care, public health, and the social determinants of health, and names subordination as the root cause of health inequities.

The death of William Schroeder in Louisville, Kentucky, on August 6, 1986, brought to a close a remarkable chapter in public human experimentation. Artificial heart implants represent the most public experiments in the history of the world. The manner in which they are conducted is a matter of utmost public and professional concern, since it graphically portrays the seriousness with which we take our laws and ethical rules regarding the protection of the rights and welfare of human subjects. Unfortunately, the brief history of artificial heart implants is neither a happy nor a proud one. Begun with high hopes and therapeutic intentions with the Barney Clark implant, the permanent procedures rapidly became little more than publicity stunts used to advertise Humana, Inc., a for-profit hospital chain. Indeed, on the night Mr. Schroeder died, Humana Hospital Audubon sent its public relations director to justify the experiment to a national television audience on Nightline, apparently because no physician at the hospital was willing or able to publicly defend the experiment.

It is important to re-engage public health professionals, after an absence of almost a half a century, in the issues of land development and community design. Resources should be devoted to processes that directly engaged diverse communities in defining their idea of good public health. In Michigan, within demographic communities, the idea or definition is slightly different, but an agreement was reached that activities should be developed around four basic environmental areas: food, air, water, and land use. Resource teams were developed around each of these areas, and an attempt was made to describe the current status of environmental conditions and identify major health problems. The community was engaged in a dialogue and a strategy for improvements was developed. The Michigan Land Use Resource Team identified land trends, described water and air quality, and even mapped automobile injuries, including pedestrian injuries and deaths.

With developed country governments and high resource institutions engaging in research in low- and middle-income countries (LMIC), we argue that these entities have a moral obligation to help build and strengthen research infrastructure and capacity so local scientists and institutions can adequately conduct studies to understand and resolve the health burdens in low and middle income countries. We explore the moral justifications and motivations behind engaging in research capacity strengthening in the health sector in LMIC at multiple levels. In highlighting these issues, this paper aims to initiate a global discourse around why capacity development in LMIC has a moral basis at the individual, institutional and system levels.

On February 21-22, 1991, the Centers for Disease Control convened an Open Meeting on the Risk for Transmission of Bloodborne Pathogens to Patients During Invasive procedures in Atlanta, Georgia. Over 80 organizations testified at that meeting.

Almost without fail, every organization testified against the use of mandatory HIV testing to screen out HIV-infected surgeons and dentists from practice. Various groups and individuals, however, advocated that HIV-infected professionals should voluntarily restrict themselves from selected procedures and/or should voluntarily disclose their HIV status to their patients.

Larry Gostin, the Executive Director of the American Society of Law and Medicine, argued that HIV-infected health care workers should voluntarily self-defer from selected invasive procedures. I believe that the approach of voluntary self-deferral has legal and practical flaws and is not the appropriate public policy for the CDC to adopt.

Most of us, I think, supposed that the debate over euthanasia (doing something to end a life that could otherwise continue) had been pretty well settled. For a long time a minority favored it and a majority opposed it—at least in principle, although not always in practice. Recent court decisions, however, have thrown the whole question open again, while public opinion polls reflect a marked increase in tolerance, if not positive approval. What follows is a lay discussion of the issue—not legally or medically professional but still, it is hoped, acceptable intellectually.

My own role in the ethical defense of euthanasia goes back a long way. I began to expound it in the early 1930s. The British organized a euthanasia society in 1935. The Euthanasia Society of America came three years later. It started out with a petition by 1,776 physicians addressed to the New York State Assembly, which promptly rejected it.

Given the pain, incapacity, and death that afflict persons with AIDS, it is not surprising that those exposed to HIV or those who have developed AIDS may sometimes feel themselves wronged and entitled to legal damages. There are two main areas of potential AIDS-related litigation: liability related to medical malpractice and liability related to transmission, whether via contaminated blood or blood products, needle-sharing, childbirth, or sexual intercourse.

This article will examine the precedents, arguments, and possible defenses in these areas and in relationship to a variety of potential defendants.

A cause of action for medical malpractice in AIDS-related diagnosis may arise in several ways: failure to diagnose, failure to inform a patient of a diagnosis, failure to provide proper counseling and treatment when patients test positive for HIV antibodies, and failure to report AIDS diagnoses to health authorities or at-risk sexual partners.

I propose in this essay to briefly describe some of the main current stakeholders who issue guidance on the ethics of human subjects research. This will be preceded by a very brief historical introduction.

Prior to World War II, as far as I have been able to ascertain, there were no international efforts to regulate human experimentation. National activities were few and far between. One exception was a Directive on Human Experimentation issued in December 1900 by the then Prussian Minister of Religious, Educational and Medical Mairs. This was followed by a Circular on innovative therapy and scientific experimentation promulgated by the then Reich Minister of the Interior in February 1931. Just over five years later, in April 1936, the Bureau of the Medico-Scientific Council of the People’s Commissariat for Health of the Russian Socialist Federated Soviet Republic (RSFSR), the main constituent Republic of the then Union of Soviet Socialist Republics, issued an Advisory Resolution on the procedures for testing new medicinal substances and methods which may present a hazard for the health and life of patients.

Translational science attempts to accelerate and increase the significance of research progressing from bench to bedside. Support from the NIH through its institutional grant program has increased the prominence and importance of translational science. The inclusion of a broadly based bioethics component to translational science presents an opportunity for bioethics scholars to address fundamental social issues, including the effects of translational science on public health, health equity, and human flourishing. Large-scale bioethical inquiries could examine research priorities, unintended consequences of research, and access to and uptake of research discoveries.

In this article, we consider the possible application of the European General Data Protection Regulation (GDPR) to “citizen scientist”-led health research with mobile devices. We argue that the GDPR likely does cover this activity, depending on the specific context and the territorial scope. Remaining open questions that result from our analysis lead us to call for lex specialis that would provide greater clarity and certainty regarding the processing of health data by for research purposes, including these non-traditional researchers.

Practice guidelines are an increasingly relevant feature of health insurance. One hundred and seventy-eight million people in the United States have some form of private health insurance coverage; coverage for 150 million of them is employment-related. Traditionally, this coverage was provided by employers purchasing a group contract under which an insurance carrier provided indemnity coverage for employees—that is, the insurance company paid all usual, customary, and reasonable charges incurred by an employee for medical care, subject in some cases to an annual deductible and to a percentage of covered expenses, co-paid by the employee, for each service. In recent years, however, employers in greater numbers have switched to so-called self-insurance plans in which employees’ health care claims are paid directly by the employer (although an insurance company or other third party may be retained to administer the claim payment process).

Biomedical advances of the past 20 years have stimulated a renewed interest in medical ethics. Transplantation of multiple human organs, implantation of artificial devices, advances in genetics, and stem cell research are a few of the medical procedures and discoveries that have awakened in both professionals and the public an awareness that medical discoveries often raise important ethical and societal issues. Today, members of the medical profession face issues that did not seem so pressing to their predecessors, and physician conduct in response to many of these issues involves decision-making based on ethical principles. Issues of informed consent, gifts from pharmaceutical companies, and patient rights to privacy were not of great concern to most physicians a generation ago. However, these and other topics that involve a physician's ethical conduct have become increasingly pertinent to the practice of medicine.

A renewed emphasis on ethics has been voiced by leaders in the field of medicine.

Motorcycle helmet laws are perceived to infringe upon individual rights even though they reduce mortality and health care costs. We describe proposed helmet legislation that protects individual rights and provides incentives for helmet use through a differential motorcycle registration fee that requires higher fees for those who wish to ride without a helmet.

Most babies born each year in the U.S. undergo mandatory newborn screening to detect serious medical conditions that can cause devastating effects if treatment is not initiated prior to the onset of symptoms. Not all of the blood collected from newborns is used during routine newborn screening, and many states retain the residual dried blood samples (DBS). DBS have a broad range of potential uses, from program evaluation to public health and biomedical research unrelated to newborn screening. State laws vary regarding whether parental consent is required to use DBS for secondary research, but federal now requires parental consent for the use of DBS in federally funded research.