World Report Country Chapter Template 2014
Total Page：16
File Type：pdf, Size：1020Kb
HHr Health and Human Rights Journal Human Subject Research: International and RegionalHHR_final_logo_alone.indd 1 10/19/15 10:53 AM Human Rights Standards andrés constantin Abstract This article will place the discussion of human subject research within the larger context of human rights law, both at the international and regional level, and examine existing normative human rights frameworks that can be used to protect research subjects. The traditional approach has commonly focused on the ethical aspects of human subject research and little has been said about the implications of human experimentation on the enjoyment of basic rights. The difference between ethical principles and human rights is clearly determined by the non-enforceability of ethical norms and the legally binding nature of human rights obligations. A human rights approach to bioethics, and particularly to human subject research, can bring about a defined system and universally accepted set of rules in a field where sociocultural and religious diversity come into play. Andrés Constantin, LLM, is an institute associate at the O’Neill Institute for National and Global Health Law, Georgetown University Law Center, Washington, DC, USA. Please address correspondence to Andrés Constantin. Email: [email protected]. Competing interests: None declared. Copyright © 2018 Constantin. This is an open access article distributed under the terms of the Creative Commons Attribution Non- Commercial License (http://creativecommons.org/licenses/by-nc/3.0/), which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original author and source are credited. DECEMBER 2018 VOLUME 20 NUMBER 2 Health and Human Rights Journal 137 a. constantin / papers, 137-148 Introduction as CRISPR-Cas9, pose serious risks and challeng- es to the protection of peoples’ human rights and During the Second World War and the Holocaust, basic ethical principles in terms of, for instance, Nazi researchers committed mass-scale atrocities human dignity, informed consent, and the rights of against Jews and other prisoners under the name of future generations.7 Some companies have already medical research. The largest German Nazi concen- sought permission from European regulators and tration camp, Auschwitz, witnessed Josef Mengele’s are planning to seek approval from the US Food egregious experiments performed on Gypsy chil- and Drug Administration to begin CRISPR clinical dren, twins, dwarfs, and people with abnormalities. trials in humans for metabolic, autoimmune, and When the research came to an end, they were killed neurogenerative diseases, among others.8 and their organs autopsied and analyzed.1 This article will place the discussion of hu- It took two years after the end of the war for 16 man subject research within the larger context of German physicians to be found guilty of nefarious human rights law, at both the international and crimes against humanity. The Nazi doctors’ trial regional level, and examine existing normative exposed torture, deliberate mutilation, sterilization, human rights frameworks that can be used to pro- and murder.2 Their trial led to the 1947 drafting of tect research subjects. The traditional approach has the Nuremberg Code, a set of guidelines governing commonly focused on the ethical aspects of human research on humans, which included 10 principles subject research and little has been said about the focused on patient consent and autonomy. The implications of human experimentation on the Nuremberg Code, the first of its kind, was created to prevent a recurrence of the horrors committed enjoyment of basic rights. With the Nuremberg in Nazi Germany, and it paved the way for the de- Code, the Helsinki Declaration, the Belmont Re- velopment of medical ethics and greatly influenced port, and the International Ethical Guidelines for the evolution of human rights law.3 The later Dec- Biomedical Research Involving Human Subjects as laration of Helsinki, adopted in 1964, reaffirmed the instruments to be followed, there is a notice- the need for informed consent in all research and able need for legally enforceable norms to protect warned that the “interest of science and society the rights of research participants. The difference should never take precedence over considerations between ethical principles and human rights is related to the wellbeing of the subject.”4 In 1978, the clearly determined by the non-enforceability of Belmont Report framed these issues into “broad- ethical norms and the legally binding nature of hu- er ethical principles [to] provide a basis on which man rights obligations. A human rights approach specific rules may be formulated, criticized, and to bioethics, and particularly to human subject interpreted,” and focused on three main principles: research, can bring about a defined system and respect for persons, beneficence, and justice.5 universally accepted set of rules in a field where so- 9 While experimentation with human subjects ciocultural and religious diversity come into play. is widely practiced, it is often done without due In the era of the Sustainable Development Goals regard to the human rights of participants. For (SDGs), health research is a primary and vital goal. example, recent cases include oxygen experiments Target 3.b supports “the research and development conducted on premature babies without the parents’ of vaccines and medicines for the communicable knowledge, and studies on whether cooling kidneys and non-communicable diseases that primarily af- before a transplant would result in fewer complica- fect developing countries.”10 In this context, human tions, conducted without adequate assessment of subject research is necessary and even desirable to the risks to transplant recipients.6 With the advent achieve Universal Health Coverage (UHC) and the of new technologies, the links between ethical full realization of the right to health.11 The enjoy- principles and human rights in research involving ment of the right to health is recognized in core human participants become particularly relevant. human rights treaties as a fundamental human For instance, new gene editing technologies, such right.12 138 DECEMBER 2018 VOLUME 20 NUMBER 2 Health and Human Rights Journal a. constantin / papers, 137-148 Nonetheless, human research is not exempt a response to the atrocities committed in concen- from restrictions necessary to guarantee respect tration camps during the Second World War.16 The for human rights. States must protect people from UN Human Rights Committee later interpreted potential harms arising from and during scientif- Article 7 as requiring “special protections” and ic research. States have the obligation to protect provided that the prohibition in article 7 relates people from being used or exploited in harmful not only to acts that cause physical pain but also scientific experiments, as well as the obligation to to acts that cause mental suffering to the victim. set safeguards to prevent harm caused by research Moreover, the prohibition extends to corporal pun- or experimentation. ishment, including excessive chastisement ordered This article proceeds as follows. First, I de- as punishment for a crime or as an educative or scribe the international standards for human disciplinary measure.17 subject research in the light of norms enshrined in On the other hand, Article 12 of the ICESCR human rights treaties. Next, I briefly examine the calls states to prevent, treat, and control epidemic, regional standards in the Inter-American System endemic, occupational, and other diseases to achieve of Human Rights, the European System of Human the full realization of the highest attainable stan- Rights, and the African System of Human Rights, dard of physical and mental health.18 This, in turn, with particular references to cases and relevant requires “the promotion of medical research and normative frameworks. Then, I present core issues health education” and “fostering recognition of fac- regarding human subject research and delve into tors favoring positive health results, e.g., research.”19 the crucial question of derogations of human rights However, this obligation is not limitless. The right to obligations in the context of public health emer- health is intimately related to and dependent upon gencies, and the implications for human subject the realization of other human rights, such as the experimentation. I conclude with a brief reflection “right to be free from torture, non-consensual medi- on the potential of using international human cal treatment and experimentation.”20 rights law to protect human research subjects. As will be examined later, the Convention on the Rights of the Child (CRC) requires States par- International standards for human subject ties to ensure that the views of the child are given research “due weight… in all matters affecting the child” and that parents and guardians act in the “best The Universal Declaration of Human Rights interests of the child.”21 Moreover, particularly rel- (UDHR) was adopted in 1948, proclaiming that “All evant when it comes to the selection of vulnerable human beings are born free and equal in dignity groups as research participants, the Convention and rights…endowed with reason and conscience” on the Elimination of all forms of Discrimination and recognizing that “No one shall be subjected to Against Women (CEDAW) establishes the obliga- torture or to cruel, inhuman or degrading treat- tion of States parties to “establish