On Wednesday, April 1, 2015, nearly 800 Guatemalan plaintiffs filed a $1 billion lawsuit against Johns Hopkins University for allegedly participating in a medical experiment in Guatemala where Hopkins scientists and physicians infected human beings with syphilis, gonorrhea and other sexually transmitted diseases (Laughland, Reference Laughland2015), in violation of the ethical standards governing human experimentation (Laughland, Reference Laughland2015). Similar reports have surfaced of human experimentation.Footnote 1 In addition,Footnote 2 the Egyptian Center for Right to Access Medicine reported that experimental tests on new drugs were being conducted in the Center for Cancer Treatment in Egypt where 100 files of sick patients were missing under the label of “Scientific Research.” Those files included street children, prisoners and patients with cancer and mental deficiencies.Footnote 3 Also documented are at least 100 cooperative research projects that are worth $100 million a year. Those projects are collaborations between pharmaceutical companies and the Ministry of Health in Egypt and some involve human experiments.Footnote 4
It has been observed that, “Many factors make the Middle East attractive for clinical research, including the diversity of its patients, good medical facilities, cost advantages, and favorable infrastructure—especially in the Persian Gulf countries.” (Alahmad, Al-Jumah, and Dierickx Reference Alahmad, Al-Jumah and Dierickx2012)
It has been noted that “with countries in the Middle East operating under considerably fewer strict ethical guidelines, than their European and North American counterparts, drugs companies are increasingly moving trials of new and untested drugs to Arab countries.” (Alahmad et al. Reference Alahmad, Al-Jumah and Dierickx2012)
The purpose of this paper is: (a) to inquire into the ethical rules, principles and norms that apply to human experimentation; and (b) to address the issue of when does human experimentation become a form of human trafficking, giving rise to criminal liability of medical doctors. A case of medical experimentation, in addition to being in violation of ethical standards, may also give rise to the crime of human trafficking. Richardson notes that “criminal punishment in appropriate instances would send a clear, expressive message that doctors are not privileged to treat human subjects in a manner inconsistent with their inherent value as human beings.” (Richardson Reference Richardson2008) The three basic elements of a case of human trafficking are: (a) did the victim of human experimentation give informed consent; (b) did the medical doctor or the medical facility take advantage of the victim’s vulnerability; and (c) did the human experimentation amount to exploitation? In attempting to answer those questions, the article will focus on the main ethical rules, principles and norms that may apply to human experiments. They may be more properly interpreted by using the three elements of consent, vulnerability and exploitation. Establishing the three elements, in a case of human experimentation, may amount to a crime of human trafficking, although establishing liability of a medical doctor for human trafficking may require proof of a direct link between his/her act and the act of trafficking itself.
The paper is divided into two parts. Part I addresses whether the concept of human trafficking may incorporate human experimentation, while part II will focus on the three elements of a human trafficking case: consent, vulnerability and exploitation.Footnote 5
HUMAN EXPERIMENTATION AS A FORM OF HUMAN TRAFFICKING
Medical Liability for Failure to Comply with International and National Standards of Practice in the Medical Profession
Medical liability may arise for illegal adoption,Footnote 6 trafficking in human organs,Footnote 7 forced pregnancyFootnote 8 or other illicit practices.
According to the Law of Qatar No. 2 of 1983, as amended by the Law of Qatar No. 16 of 1994, regarding practice of the medical profession, a medical doctor may be held liable, “if the cause for injuring the patient is conducting scientific experiments and research which are not authorized.”Footnote 9 The rule of medical liability, expressed by Qatar courts, is that a doctor is under an obligation to exercise best efforts for curing his/her patient. In performing their duties, doctors must follow the established traditions and scientific norms. A “medical fault” may be established if the doctor fails to comply with these traditions and norms and this causes injury to his/her patient.Footnote 10
According to settled international ethics, it is the duty of a doctor to protect the health of a patient, provide complete medical care with “respect for human dignity”Footnote 11 and “in full professional and moral independence.”Footnote 12 It is also the duty of a doctor to report illegal or unethical acts.Footnote 13 In addition, a doctor should not “allow his/her judgment to be influenced by personal profit or unfair discrimination.”Footnote 14 These ethical rules should be applicable when the doctor is a “researcher” as discussed below.
The hospital itself, that is, the medical facility or establishment, may be liable for illegal human experimentation. This liability, including criminal liability, may also be established regarding pharmaceutical companies (Mattar Reference Mattar2012).
Research proposals must obtain approval of a research ethics committee in Morocco, as a part of the Ministry of Health; in Saudi Arabia, the National Committee of Medical and Bioethics; in Kuwait, the Committee for Medical and Health Related Research Revenue; in Bahrain, the relevant authority in the Ministry of Health; and in Oman, the Research and Clinical Studies Committee.
Principles, Norms and Guidelines on Ethics of Human Experimentation
In 1947, the Nuremberg Code was issued providing for basic guidelines on ethics of human experimentation. In 1964, the World Medical Association (WMA) adopted the Declaration of Helsinki, which has been adapted several times with the latest version appearing in 2013. Later, a number of the guiding principles were adopted – including the Guidelines for Biomedical Research Involving Human Subject of 1982 that was revised in 2002 – which were prepared by the Council for International Organizations of Medical Science (CIOMS) and the World Health Organization (WHO). Other ethical documents included the Guidelines for Good Clinical Practice that was drafted in 1995 and revised in 2004 by the International Conference of Harmonization. Whereas those rules, principles and guidelines are not binding, they may constitute norms of customary international law,Footnote 15 whether in the medical field or other professions such as teaching,Footnote 16 engineering,Footnote 17 nursing,Footnote 18 communications,Footnote 19 sociologyFootnote 20 or social work.Footnote 21
Laws on Human Experimentation in the Arab World
In the Arab world, there are a number of laws on the ethics of the medical profession, including the Law of Medical Ethics of 1994, as amended in 2012, in the Law of Lebanon. Article 30 of the Lebanese Law covers human experiments and clinical research. It prohibits any experiment on patients unless comprehensive scientific studies and research are properly conducted in a specialized university medical center under the supervision of the College of Medicine after obtaining the approval of the ethics committee.
In Morocco, article 15 of a draft code of conduct for medical doctors involved in biomedical research states that:
Medical doctors can participate in biomedical research involving human subjects according to the national law.
They have the duty to check and confirm the relevance of the research as well as the objectivity of its hypothesis and conclusions.
The physician who takes part in biomedical research as an investigator must take all necessary caution to make sure that the proposed research will neither deteriorate the relationship of mutual trust which binds him/her to the patient, nor affect the continuity of the care due to the patient.
The medical test is registered in the Ministry of Health and that the minister provides his/her written consent, before conducting the test, and the test is conducted free without consideration.Footnote 22
In Qatar, the ethical conduct of research involving human subjects, issued by the Supreme Council of Health in Qatar, is addressed by the Policies, Regulation and Guidelines for Research Involving Human Subjects (2009).
The Expansive Concept of Human Trafficking: Does It Incorporate Human Experimentation?
The United Nations (UN) protocol to prevent, suppress and punish trafficking in persons – especially women and children – defines trafficking in persons as “the recruitment, transportation, transfer, harboring or receipt of persons, by means of the threat or use of force or other forms of coercion, of abduction, of fraud, of deception, of the abuse of power or of a position of vulnerability or of the giving or receiving of payments or benefits, to achieve the consent of a person having control over another person, for the purpose of exploitation. Exploitation shall include, at a minimum, the exploitation of the prostitution of others or other forms of sexual exploitation, forced labor or services, slavery or practices similar to slavery, servitude or the removal of organs.”Footnote 23
Most Arab anti-trafficking laws follow the UN Protocol in adopting “definition by category” as opposed to “conceptual definition.” Few anti-trafficking laws define the crime by focusing on the essence of the act of trafficking that constitutes a “transaction in person” such as the Israeli LawFootnote 24 and the Egyptian Law.Footnote 25
Sudan’s Law, Combating of Human Trafficking of 2014, provides that “there shall be deemed to have committed the offence of human trafficking whoever kidnaps, transfers, abducts, transports, harbors, receivers, detains or equips a natural person with intent to exploit, or use the same in unlawful business or any acts as may by nature degrade his dignity or achieve unlawful aims.”Footnote 26
Syria’s Legislative Decree No. 3 of 2010, regarding the crimes of trafficking in persons, defines trafficking in persons as an act that “employs them in legal acts or objectives in consideration for a return ....”Footnote 27
Only two anti-trafficking laws in the Arab legislation explicitly refer to medical experimentation as a form of human trafficking. Iraq’s Law No. 28 of 2012 defines human trafficking to include “Trafficking in their human organs or for the purpose of medical experiments.”Footnote 28 The Law of Saudi Arabia of 2008 defines human trafficking in article 2 to include “removal of organs or conducting medical experiments ....”Footnote 29
Regional Definition of Human Experimentation as a Form of Trafficking
International standards on medical or scientific experimentation are embodied in article 7 of the International Covenant on Civil and Political Rights (ICCPR). It states that “No one shall be subjected without his free consent to medical or scientific experimentation.” (United Nations 1966:175)
In adopting those international standards, the Arab Charter on Human Rights sets the conditions for conducting such experimentation. Article 9 thereof provides that “No one shall be subjected to medical or scientific experimentation ... without his free consent and full awareness of the consequence and provided that ethical humanitarian and professional rules are followed and medical procedures are observed to ensure his personal safety pursuant to the relevant domestic laws in force in each state party ....” (Al-Midani, Cabinettes, and Akram Reference Al-Midani, Cabinettes and Akram2006:152)
Article 10 of the Arab Charter on Human Rights prohibits all forms of human trafficking. The first paragraph of article 10 provides that “Slavery and slave trade in all their forms shall be prohibited and punishable by law. No one shall, under any circumstances, be held in slavery or in servitude.” The second paragraph states that “forced labor, human trafficking for prostitution or sexual exploitation, the exploitation of others for prostitution and any other form of exploitation” are prohibited. Exploiting a victim in conducting a medical or scientific experiment shall be considered a form of trafficking in human beings and thus be prohibited under article 10 (Al-Midani et al. Reference Al-Midani, Cabinettes and Akram2006:153).
Article 5 of the Cooperation Council for the Arab States of the Gulf (GCC) Human Rights Declaration states that “No medical or scientific experiment may be conducted on any human being, nor may his organs be exploited without his consent and without being fully aware of the subsequent complications that may result.” (Cooperation Council for the Arab States of the Gulf 2015:4)
Article 3 of the GCC Declaration provides that “human trafficking shall be prohibited in all [its] forms, particularly those involving women and children.” (Cooperation Council for the Arab States of the Gulf 2015:4)Footnote 30
When can a medical or scientific experiment become a form of human trafficking and thus prohibited by law? (Article 5: Cooperation Council for the Arab States of the Gulf 2015:4)
The UN trafficking protocol may be interpreted to include experimentation that involves human subjects as a form of human trafficking in two ways. As stated by the UN Office on Drugs and Crime (UNODC), “the list of exploitative purpose set out in the protocol is not exhaustive and may be expanded provided the integrity of the protocol is retained.” One may also interpret the UN protocol to include human experimentation as a practice similar to slavery (UNODC 2015). In such a case, the physician treats the vulnerable person – whether a woman, a child, an elderly person, a person with disability, or foreign workers and so forth – as a property and exercises the right of ownership upon this person. This action treats the vulnerable person as a slave.
To consider human experimentation as a form of trafficking, three elements must exist: (a) absence of consent; (b) abuse of a position of vulnerability; and (c) exploitation.
Addressing those elements requires answers to three main questions: (a) Is consent relevant when illegal means are used, such as taking advantage of a vulnerable person? (b) Who is vulnerable? (c) What amounts to exploitation? The question must be asked of how consent, vulnerability and exploitation are defined in the context of medical experiments on humans and when can a medical doctor be held criminally liable for human trafficking for the purpose of medical experimentation?
CONSENT, VULNERABILITY AND EXPLOITATION: THE THREE ELEMENTS OF THE CRIME OF TRAFFICKING FOR THE PURPOSE OF HUMAN EXPERIMENTATION
The rule, as stated by the ICCPR, is that “No one shall be subjected without his free consent to medical or scientific experimentation.”Footnote 31
Voluntary, Free and Informed Consent
What do we mean by “free consent” and is a victim of human trafficking capable of giving free consent?
Previously, the first principle of the Nuremberg Code of 1947 clearly stated, “The voluntary consent of the human subject is absolutely essential.”Footnote 32 The code explains that this consent “means that the person involved should have legal capacity to give consent, should be so situated as to be able to exercise free power of choice, without the intervention of any element of force, fraud, indecent duress, or other ulterior form of constraint or concern and should have sufficient knowledge and comprehension of the intent of the subject matter involved as to enable him to make an understanding and enlightened decision.”
The principle of voluntary consent was again emphasized by the Declaration of Helsinki stating in principle 25 that “participation by individuals capable of giving informed consent as subjects in medical research must be voluntary.”Footnote 33
Applying the principle of “voluntary and free consent” in the case of medical or scientific experimentation on a human subject requires informing the participant of all aspects of the experimentation. That includes the aims, methods, sources of funding, any possible conflict of interest, institutional affiliation of the researcher, the anticipated benefits and potential risks of the study, the discomfort it may entail, post-study provision and any other relevant aspects of the study.Footnote 34
As stated in guideline 4 of the International Ethical Guidelines for Biomedical Research Involving Human Subjects, the investigator must obtain the voluntary informed consent of the prospective subject for all biomedical research involving humans.Footnote 35
If the prospective subject for research is not capable of providing such informed consent then the “physician must seek informed consent from the legal authorized representative.”Footnote 36 This informed consent must be obtained in writing as described in the Declaration of Helsinki: “If the consent cannot be expressed in writing, the non-written consent must be formally documented and witnessed.”Footnote 37 The subject of research must have “the right to refuse to participate in the study or to withdraw his consent at any stage of such study without reprisal.”Footnote 38 The Qatar policies adopted the principle of voluntary and informed consent including the right to refusal and the right to withdraw without penalty or loss of benefits.Footnote 39
The Qatar policies also prohibit waiver of any of the subject’s rights as stated: “No informed consent whether oral or written may include any exculpatory language through which the subject or the representative is made to waive or appear to release the investigator the sponsor, the institute or its agent from liability for negligence.”Footnote 40
The Qatar policies also require that the information given to the subject or the representative shall be in language untestable to the subject or the representative.Footnote 41
Only in the absence of consent may a physician be liable in accordance with the rules of criminal law.Footnote 42 The Criminal Code of Qatar provides the following: “Nothing is an offence which is done in good faith, in exercising the right justified by the law or Islamic Shari’a and within the limits thereof including practicing medicine according to acknowledged scientific principles in the licensed medical professions with the consent of the patient or his representatives expressly or implicit or if the medical procedure is an emergency or the patient is not in a condition to express his will or it is difficult to obtain the consent of the representative in a timely manner.”Footnote 43
Thus, the question becomes, is the victim of trafficking for the purpose of medical or scientist experimentation capable of giving such voluntary and free consent?
The UN Protocol to Prevent, Suppress, and Punish Trafficking in Persons, Especially Women and Children, adopts the following rule, as stated in article 3(b) of the protocol. “The consent of a victim of trafficking in persons to the intended exploitation set forth in subparagraph (a) of this article shall be irrelevant where any of the means set forth in subparagraph (a) have been used, these illegal means include the threat or use of force or other forms of coercion of abduction, of fraud, of deception, of the abuse of power, or of a position of vulnerability.”Footnote 44
The argument may be made that a “vulnerable person” who has been recruited to participate in a medical or scientific experiment is incapable of giving voluntary and free consent.”Footnote 45 So how can we define the vulnerable person?
Vulnerability: Should the Vulnerable Victim of Trafficking Be Involved in Human Experimentation?
When a vulnerable person is involved in research, special justification is required and special protection must be guaranteed.Footnote 46
Whereas many ethics principles refer to the concepts of vulnerability, principles most often rely on what is called “definition by category.” The commentary to guideline 13 of the International Ethics Guidelines for Biomedical Research Involving Human Subjects states that “vulnerable persons are those who are relatively or absolutely incapable of protecting their own interest.”Footnote 47
The Declaration of Helsinki adds that these vulnerable persons “may have an increased likelihood of being wronged or of incurring additional harm.”Footnote 48
The traveaux preparatoire to the UN Trafficking Protocol explains that the “person involved has no real and acceptable alternative but to submit to the abuse involved.”Footnote 49 Commenting on this definition, the UNODC expands it by stating that vulnerable people are defined as those who, due to reason of age, gender, physical or mental state, or due to social, economic, ethics, or cultural circumstances find it especially difficult to fully exercise their rights before the justice system as recognized to them by law.Footnote 50
The Arab model law on combating human trafficking combines all these elements in defining abuse of position of vulnerability to mean “exploitation of physical, mental or psychological disability or a given legal status, or any particular situation that may affect the will or behavior of the person when she/he has no real and acceptable alternative but to submit to the abuse involved.”Footnote 51
The Belmont Report defines vulnerable persons as “persons with diminished autonomy.” (United States Department of Health and Human Services 1979) The report was drafted by the National Commission for the Protection of Human Subjects, and it embodied the ethical principles that govern research study in the United States and that must be followed by the Institutional Review Board system.
Vulnerable persons may be defined by “categories.” The UN Principles and Guidelines on Access to Legal Aid in Criminal Justice Systems of 2013 states: “Special measures should be taken to ensure meaningful access to legal aid for women, children and groups with special needs, including, but not limited to, the elderly, minorities, persons with disabilities, persons with mental illnesses, persons living with HIV and other serious contagious diseases, drug users, indigenous and aboriginal people, stateless persons, asylum seekers, foreign citizens, migrants and migrant workers, refugees and internally displaced persons.”Footnote 52
Arab constitutions address the vulnerable populations and provide them with special protections. Article 21 of the constitution of Qatar states that “the Law shall organize means of protecting the family, supporting its principles, bolstering its ties, preserving ideals of matrimony, childhood and the elderly.” In article 22, the constitution also provides that the “state shall extend care to the young generation and protect them from influences of corruption, from exploitation, from physical, mental and spiritual negligence, and provide adequate circumstances for developing its creativity in different fields with improved education.”
Islamic law divides the vulnerable into different groups depending on whether such vulnerability is due to natural or non-natural causes. In the first category, it lists the child, the juvenile, the orphan, women and the elderly. The second category involves the poor, the hostage, the patient, minorities of non-Muslims in Islamic territories, domestic workers, migrants and migrant workers.Footnote 53
An expanded list is being produced in the context of ethical principles in medical research. The International Ethics Guidelines for Biomedical Research Involving Human Subjects adds to the elderly, children, women, and other groups or classes that may also be considered vulnerable.
They include: (a) residents of nursing homes; (b) people receiving welfare benefits or social assistance and other poor people and the unemployed patients in emergency rooms; (c) some ethnic and racial minority groups; (d) homeless persons; (e) nomads; (f) refugees or displaced persons; (g) prisoners; (h) patients with incurable diseases; (i) individuals who are politically powerless; and (j) members of communities unfamiliar with modern medical concepts.Footnote 54
Should any of these vulnerable persons be subject to medical or scientific tests or clinical trials?
The Qatar policies provide us with the principle of “equitable selection of human subjects,” stating that, in selecting the subject of research, one should take into consideration the “purpose of the research and the setting in which the research will be conducted and should be particularly cognizant of the special problems of research involving vulnerable populations, such as children, prisoners, pregnant women, mentally disabled persons, or economically or educationally disadvantaged persons.”Footnote 55 The Belmont Report, in adopting the equitable selection of subjects of research, explains that it can be considered a matter of social justice that there is an order of preference in the selection of classes of subjects (e.g., adults before children) and that some classes of potential subjects (e.g., the institutionalized mentally infirm or prisoners) may be involved as research subjects, if at all, only under certain conditions (United States Department of Health and Human Services 1979). In addition, they should be protected against the danger of being involved in research solely for administrative convenience, or because they are easy to manipulate because of their illness or social economic condition (United States Department of Health and Human Services 1979). This equitable selection also requires that the inclusion of any subject in research experimentation should not be made without regard to race, ethnicity, economic status or gender.Footnote 56 Neither should such population be categorically excluded or discouraged from research protocols.Footnote 57
This selection must therefore be justified. “Special justification requires a showing that the research is responsive to the health needs or priorities of these groups,”Footnote 58 that the research cannot be covered but in non-vulnerable groupsFootnote 59 and that this group should stand to benefit from the knowledge, practices or interventions that result from the research.Footnote 60 It must be proven that the research is intended to obtain knowledge that will lead to improved diagnosis, prevention or treatment of diseases or other health problems characteristics of or unique to the vulnerable classes.Footnote 61 Some of these vulnerable classes will be discussed further.
Are women considered part of a vulnerable group that deserves special protection?
Arab legislation on combating human trafficking disagrees as to whether a female victim of trafficking may give rise to an aggravated circumstance that enhances the penalty. It has been argued elsewhere that “one may consider enhancing the penalty in trafficking cases that involve a female as an example of positive discrimination that is allowed under the Arab Charter for Human Rights.”Footnote 62 The UK Guidelines in the Practice of Ethics Committees in Medical Research with Human Participants acknowledge that “in some cultures women are vulnerable to neglect or harm in research because of their social conditioning to submit to authority to ask no question and to tolerate pain and suffering.”Footnote 63
Whereas the status of women may not necessarily place them in the category of a vulnerable class, certain conditions may contribute to their need of special protection. Article 9 of the Inter-American Convention on the Prevention, Punishment and Eradication of Violence against Women states that, “with respect to the measures in this chapter the state parties shall take special account of the vulnerability of women to violence by reason of, among others, their race or ethnic background or their status as migrants, refugees or displaced persons. Similar consideration shall be given to women subject to violence while pregnant or who are disabled, of minor age, elderly, socioeconomically disadvantaged, affected by armed conflict or deprived of their freedom.”Footnote 64
If the research involved children, the International Ethics Guidelines for Biomedical Research Involving Human Subjects requires an investigator to ensure: (a) that the research might not equally well be carried out with adultsFootnote 65 ; (b) that the purpose of the research is to obtain knowledge relevant to the health needs of childrenFootnote 66 ; (c) that the investigator has obtained the approval or permission of the parent or the legal representative of each child to conduct the research;Footnote 67 (d) that to the extent possible, the consent of each child is also obtained;Footnote 68 and (e) that he or she was given the option to refuse to participate or continue his or her participation.Footnote 69
The UN Convention on the Rights of Persons with DisabilitiesFootnote 70 allows conducting such experiments on persons with disabilities as long as their consent is obtained. Article 15 of the convention states that no one shall be subjected without his or her free consent to medical or scientific experimentation.
The convention does not state whether the experimentation may be concluded for the interest of the persons with disabilities or for the purpose of scientific advancement. The text of the convention is unclear and therefore requires illumination (Hammad Reference Hammad2014). On the basis of the general ethical principles meant to apply to the vulnerable groups, it must be proven, before involving a person with disability in medical or scientific research, that the purpose of the research is to benefit directly his or her health, or at least the medical or scientific research must have a reasonable chance of generally benefiting persons with disabilities.
The UN Committee on the Rights of Persons with Disabilities raised concerns “about the lack of information including whether or not persons with disabilities, particularly persons with intellectual and/or psychosocial disabilities can be subject to medical interventions ....” The committee recommended that “no medical treatment … is administered without the full and informed consent of the person concerned ….” (paragraphs 33–34)Footnote 71
More recently, the UN Commission on Crime Prevention and Criminal Justice passed a resolution on the UN Standard Minimum Rules for the treatment of prisoners – or what is called “The Mandela Rules.”Footnote 72 This resolution adopts a balancing test in involving a human subject in research and in deciding his or her inclusion or exclusion. The Mandela Rules provide for an absolute prohibition on engaging, actively or passively, in acts that may constitute torture or other cruel inhuman or degrading treatment, punishment, including medical or scientific experimentation that may be detrimental to a person’s health such as the removal of a person’s cells, body tissues or organs.Footnote 73 The Mandela Rules also state that without prejudice to …. this rule, “prisoners may be allowed upon their free and informed consent and in accordance with the applicable law, to participate in clinical trials and other health research accessible in the community if these are expected to produce a direct and significant benefit to their health.”Footnote 74
Exploitation: What Constitutes Exploitation of a Victim of Trafficking in Human Experimentation?
The third element of a case of a medical or scientific experimentation that may amount to human trafficking is exploitation. The UN Trafficking Protocol does not define exploitation. One may rely on the general meaning of the term “taking unfair advantage of another person, their vulnerability or their situation.”Footnote 75
This “unfairness” may be interpreted by analogy to the concept of “gross disparity” of the International Institute for the Unification of Private Law (UNIDROIT) Principles of International Commercial Contracts that provides that a “party may avoid the contract or an individual term of it if at the time of the conclusion of the contract, the contract or term unjustifiably gave the other party an excessive advantage.”Footnote 76
A reading of the ethical principles developed in the context of human experimentation reveals a number of elements that help to define exploitation. The primary purpose of medical research involving human subjects is to understand the causes, development and effects of diseases and to improve preventive, diagnostic and therapeutic interventions (methods, procedures and treatments).Footnote 77
Before performing a medical test or experiment, a risk assessment must be conducted that involves a careful assessment of predictable risks and burdens to the individuals and groups involved in the research in comparison with foreseeable benefits to them and to other individuals or groups affected by the condition under investigation.Footnote 78 The research may only be conducted if the importance of the objective outweighs the risk and burdens to the research subjects.Footnote 79 In other words, “the degree of risk to be taken should never exceed that determined by the humanitarian importance of the problem to be solved by the experiment.”Footnote 80 The Qatar policies, adopting this balancing test, state: “Risks to subjects are reasonable in selection to anticipated benefits, if any, to subjects and the importance of the knowledge that may reasonably be expected to result.”Footnote 81 In defining “reasonableness” of the risk, the Qatar policies require that the research “involves no more than minimal risks to the subject.”Footnote 82
In performing the experiment, it must be noted that the experiment should be conducted only by scientifically qualified personsFootnote 83 using the highest degree of care. As explained by the Declaration of Helsinki, “Medical research involving human subjects must confirm to generally accepted scientific principles, be based on a thorough knowledge of the scientific literature, other relevant sources of information, and adequate laboratory and, as appropriate, animal experiment.”Footnote 84 These standards of care include “Ethical standards that promote and ensure respect for all Human subjects and protect their health and rights.”Footnote 85
The experiment should not cause harm to the human subject and it should be so concluded as to “avoid all necessary physical and mental suffering and injury.”Footnote 86
Any harm caused to the victim, of improper research experimentation, requires appropriate medical treatment,Footnote 87 a principle that is clearly stated in anti-trafficking legislation. Article 5 of the Law of Qatar on Combating Human Trafficking provides that “the competent authorities shall guarantee the protection and physical and mental safely of the victims and shall provide them with health, educational and social care and shall ensure the appropriate circumstances for their rehabilitation and integration in society in a manner that takes into account their needs and human dignity.”Footnote 88
A victim of human trafficking is entitled to legal and medical aid. The UN Trafficking Protocol states, in article 6, that each state party shall consider implementing measures to provide for the physical, psychological and social recovery of victims of trafficking in persons and, in particular, the provision of medical, psychological and mutual assistance.Footnote 89
The UN Principles and Guidelines on Access to Legal Aid in Criminal Justice Systems link such medical aid with legal aid. Guideline 7 states that “mechanism and procedures are established to ensure close cooperation and appropriate referral systems between legal aid providers and other professionals (namely, health, social and child welfare providers) to obtain a comprehensive understanding of the victim as well as an assessment of his or her legal, psychological, social, emotional, physical and cognitive situation and needs.”Footnote 90
Such harm may constitute an aggravated circumstance that enhances the penalty in cases that involve (a) the death of the victimFootnote 91 or his/her permanent disabilityFootnote 92 or (b) if the victim suffers an incurable diseaseFootnote 93 or an illness that threatens his or her life.Footnote 94 It also may entitle the victim to the right to an “appropriate compensation”Footnote 95 that should include punitive damages in the legal systems that recognize this type of compensation.Footnote 96
CONCLUSION
Human experimentation, whether for medical or scientific purposes, is covered by well-established rules and principles of ethics including: (a) the Nuremberg Code of 1947 providing the 10 guiding principles in human experimentation; (b) the Declaration of Helsinki Ethical Principles of 1964 as amended in 2013; (c) the International Ethics Guidelines for Biomedical Research Involving Human Subjects that were prepared by the Council for International Organizations of Medical Sciences in collaboration with the WHO and the World Medical Organization; and (d) the World Medical Association International Code of Medical Ethics of 2006.
These ethical documents may be properly interpreted and fully understood in accordance with the three main elements of the crime of human trafficking, namely: (a) consent; (b) vulnerability; and (c) exploitation. If a person is recruited, to be the subject of a medical or scientific experiment and the medical doctor fails to obtain his/her free, voluntary and informed consent, thereby taking advantage of the person’s vulnerability because of his/her status as a woman, a child, a person with disabilities, an elderly person or other status and exploiting him/her in conducting the experiment, then the medical doctor may be held liable, not only for breach of contract or tort, but also for the crime of human trafficking. Establishing liability in such a case requires proof of causation between the act of the medical doctor and the offense of human trafficking. This may be the case, if the medical doctor is the “actor” who recruited, transported, transferred, harbored or received a victim of trafficking for the purpose of exploitation in human experimentation or human subject research. This may also be the case if the medical doctor, although not committing the act of trafficking him/herself, knew or should have reasonably known that the subject of experimentation or research has been trafficked for the purpose of exploitation. In other words, the medical doctor should be either the principal actor in a trafficking scheme or complicit in participating in the act of trafficking.
The Council of Europe Convention on Action Against Trafficking in Human Beings states that, “each party, shall consider adopting such legislative and other measures as may be necessary to establish as criminal offenses under its internal law, the use of services which are the object of exploitation … with the knowledge that the person is a victim of trafficking in human beings.”Footnote 97 With such knowledge, whether actual or constructive, a medical doctor may be held liable for human trafficking provided that its main elements are established; namely absence of consent, taking advantage of a position of vulnerability and proof of abuse and exploitation.
Mohamed Y. Mattar is an expert in comparative and international law. He is recognized as an international expert on anti-trafficking legislation. He has worked for over 15 years in more than 75 countries, including countries in the Middle East, to promote state compliance with international human rights standards and to advise governments on drafting and enforcing human rights laws. He has testified in the United States on the status of human trafficking around the world at various Congressional Hearings. He also testified before the Russian Duma, the Mexican Senate, the Inter-American Human Rights Commission and the Egyptian Parliament. He teaches courses on: International Trafficking in Persons; Corporate Social Responsibility; International Contract Law; Investment and Trade Laws of the Middle East; Islamic Law; Introduction to the American Legal System; International Business and Human Rights; and Legal Ethics. He co-taught the International Human Rights Clinic at The Johns Hopkins University School of Advanced International Studies, which he founded. He is also the founder and editor-in-chief of The Protection Project Journal of Human Rights and Civil Society. He received his Doctorate of Juridical Sciences (S.J.D.) and Master of Laws (LL.M) from Tulane University, his Master of Comparative Law (M.C.L.) from the University of Miami, and his License en Droit (LL.B.) from Alexandria University where he still serves as a non-resident distinguished professor of law.
