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International Protection of Persons Undergoing Medical Experimentation: Protecting the Right of Informed Consent

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Abstract

This Article focuses on the right of informed consent to medical experimentation, the "process by which an individual voluntarily expresses his or her willingness to participate in a particular trial, after having been informed of all aspects of the trial that are relevant to the decision to participate." There are many barriers to the comprehension of risk and rational decision-making necessary for informed consent. These barriers are particularly acute in developing nations. The "short course" AZT trials in Africa are a modern example of this problem. In this paradigmatic case, science's quest for a cure has led to the erosion of principles of in-formed consent and the denigration of individual rights. Part II of this Article explains the short course AZT trials conducted on HIV-positive African subjects by U.S. physicians. In particular, Part II outlines violations of the research subject's right of informed consent. Part III describes the experiments of Nazi physicians during World War II, the trial of these physicians at Nuremberg, and the Nuremberg Tribunal's development of the Nuremberg Code, the foundation of modern international regulation of human experimentation. Part IV details the development of international regulation of human experimentation following the Nuremberg Code. Part V highlights the weaknesses of these international regulations insofar as they permitted involuntary medical experimentation with HIV-positive subjects in Africa to continue unabated. Part VI recommends the development of an international solution to guarantee the right of meaningful informed consent to each subject of medical experimentation and proposes the creation of an international convention for the protection of informed consent.
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... Restricting experiments to vulnerable populations without a rational link to the condition under investigation may violate the principle of justice, as these populations are often powerless, impoverished, and politically underrepresented, limiting their ability to question the methods or procedures or to challenge the project (Constantin 2018). Where there was strong criticism of the injustices of early research on HIV treatments in Sub-Saharan Africa (Meier 2002), there is a risk that experimentation for a prospective COVID-19 vaccine may similarly seek out trial sites in the Global South. ...
... From a human rights perspective, a lessening of human rights protections in research involving human subjects may be permissible in the context of an emerging pandemic. The human rights analysis is often framed in terms of balancing the right to public health for all individuals against the right of a single individual participant to informed consent and other human subject protections (Meier 2002). Human rights law offers insights as to how to proceed in these cases under the notion of "derogation under state emergency. ...
... Others pointed to the hypocrisy of applying a standard of care in the host country that was inconsistent with the standard of care in the sponsoring country (Lurie and Wolfe 1997). These concerns were heightened by the particular vulnerability of HIV-positive persons in LMICs to non-consensual experimentation, due to a lack of political power, lack of education, extreme poverty, and lack of familiarity with medical interventions (Meier 2002). It remained unclear to the research community how ethics requirements could or should be interpreted in conditions of prevailing resource scarcity, where research on an affordable option (even one that falls short of the best methods worldwide) still may provide a community's best hope of addressing its health needs (Wendler, Emanuel, and Lie 2004). ...
... Others pointed to the hypocrisy of applying a standard of care in the host country that was inconsistent with the standard of care in the sponsoring country (Lurie and Wolfe 1997). These concerns were heightened by the particular vulnerability of HIV-positive persons in LMICs to non-consensual experimentation, due to a lack of political power, lack of education, extreme poverty, and lack of familiarity with medical interventions (Meier 2002). It remained unclear to the research community how ethics requirements could or should be interpreted in conditions of prevailing resource scarcity, where research on an affordable option (even one that falls short of the best methods worldwide) still may provide a community's best hope of addressing its health needs (Wendler, Emanuel, and Lie 2004). ...
... Restricting experiments to vulnerable populations without a rational link to the condition under investigation may violate the principle of justice, as these populations are often powerless, impoverished, and politically underrepresented, limiting their ability to question the methods or procedures or to challenge the project (Constantin 2018). Where there was strong criticism of the injustices of early research on HIV treatments in Sub-Saharan Africa (Meier 2002), there is a risk that experimentation for a prospective COVID-19 vaccine may similarly seek out trial sites in the Global South. ...
... From a human rights perspective, a lessening of human rights protections in research involving human subjects may be permissible in the context of an emerging pandemic. The human rights analysis is often framed in terms of balancing the right to public health for all individuals against the right of a single individual participant to informed consent and other human subject protections (Meier 2002). Human rights law offers insights as to how to proceed in these cases under the notion of "derogation under state emergency. ...
Chapter
The clinical trials enterprise has expanded globally, involving research developed and owned by research institutions in wealthy countries but conducted with participants in low- and middle-income countries (LMICs). These LMICs commonly provide ready access to large pools of subjects who have never received a particular drug and have—at least historically—a more permissive regulatory environment, raising important questions about the rights of vulnerable participants. The unequal power dynamic and imbalances between researchers and human subjects require specific norms and procedures to respect and protect the human rights of trial participants. Complementing bioethics norms, human rights law offers a lens for understanding participant and public health interests, recognizing the unequal dynamic between the researcher and the individual subject, and furthering the participants’ autonomy and decision-making power. Framing these issues in human rights obligations additionally offers new forms of governance and accountability mechanisms, raising new opportunities for legally enforceable claims.
... The notion of cultural relativism was also invoked by the supporters of the trial who argued that the concept of right to informed consent was a Western construct which could not be applied to Africa due to its unique communitarian social system. (Mason Meier, 2003) Pointing out that vaccine testing is related to the politics and economics of the drug market which has no relevance to African culture, Mason Meier has argued that the notion of cultural relativism was being used as a façade for what he has termed 'cultural rationalization', wherein the concept of cultural relativism has been invoked inappropriately by westerners to justify and validate their own economic and political ends. He also argues that there is no credibility in the assertion that most African social norms are communitarian to the extent that individuals would forsake their right to informed consent. ...
... The notion of cultural relativism was also invoked by the supporters of the trial who argued that the concept of right to informed consent was a Western construct which could not be applied to Africa due to its unique communitarian social system. (Mason Meier, 2003) Pointing out that vaccine testing is related to the politics and economics of the drug market which has no relevance to African culture, Mason Meier has argued that the notion of cultural relativism was being used as a façade for what he has termed 'cultural rationalization', wherein the concept of cultural relativism has been invoked inappropriately by westerners to justify and validate their own economic and political ends. He also argues that there is no credibility in the assertion that most African social norms are communitarian to the extent that individuals would forsake their right to informed consent. ...
Thesis
http://deepblue.lib.umich.edu/bitstream/2027.42/120617/1/sackd.pdf
Article
Objective: Introduction: There is a large number of patents registered in the field of medical practice in Ukraine. Despite this, the peculiarities of the legal protection of inventions within medical practice have not been researched in the modern legal doctrine of intellectual property. The aim of this article is theoretical and practical study of the legal protection of medical inventions in Ukraine based on the analysis of Ukrainian patent law, issued patents for inventions applied within medical practice, as well as data from the State Expert Center of the Ministry of Health of Ukraine. Patients and methods: Materials and methods: The authors of the article have used methods of analysis and synthesis, as well as comparative and legal method. The analysis and further use of data from the State Expert Center of the Ministry of Health of Ukraine contributed to the definition of the problems of this publication, as well as the formulation of the authors' vision of the features of inventions within medical practice. Results: Review: Inventions within medical practice are the result of human intellectual activity in the field of medicine. The authors have offered to refer inventions within medical practice to a group of inventions with a possible risk. The risks of inventions within medical practice are divided into those that have a risk for people undergoing clinical trials and manufacturers who try to use these inventions. Conclusion: Conclusions: The authors have grounded the expediency of supplementing the patent procedure with regard to inventions that can be applied within medical practice, with the rule of obligatory provision of documents on conducting clinical trials to the materials of the application for a patent on the invention, in cases of restrictions of the rights of a patent holder of medical and pharmaceutical inventions, by the provisions that would define the concepts and types of biotechnological inventions.
Chapter
At present, considerable numbers of research projects are conducted on a multinational basis. Teams of researchers based in different States may participate in a single project. Furthermore, internationally-based organizations may be able to choose the country in which a particular research project that they are conducting or funding is carried out. This has led to concerns being expressed about the possibility of fundamentally different standards of protection for participants being applied in different countries. The issue of double standards has increasingly become part of regulatory frameworks in biomedical research. This paper reviews and compares the 2008 version of the WMA Declaration of Helsinki with existing guidelines and rules on research in developing countries adopted by intergovernmental (UNESCO, WHO, Council of Europe, EU) and non-governmental (CIOMS, WMA) organisations. The paper concludes with some reflections on the issues which need to be addressed in the future to achieve solidarity, in line with the EU Charter of Fundamental Rights which proclaims in its preamble that: The Union is founded on the indivisible and universal values of human dignity, freedom, equality and solidarity. (EU Charter of Fundamental Rights 2009) Therefore, research activities involving human subjects cannot exclusively be assimilated to an economic activity subject to market rules. On the contrary, in the context of solidarity, regarding health as a public good rather than a commodity, it needs to be regulated according to fundamental principles.
Article
When lethal injection was first legalized in the late 1970s, many people viewed it as safe, reliable, and humane. Today, however, lethal injection does not always perform as promised. Due to difficulties with sourcing lethal injection drugs, states are utilizing untested lethal injection protocols, with little knowledge or experience to guide them. This article argues that lethal injection reform requires regulation similar to that for human subject research, and that the practice of utilizing untested lethal injection methods comes very close to falling under the federal statutory definition of “human subject research“ formulated in the Common Rule. This article argues further that even if one decides that it does not, the practice of lethal injection today is the type of conduct that the human subject research regulations were designed to correct. Moreover, society has an interest in ensuring that executions are conducted in a way that reduces pain and suffering to the lowest extent possible. As such, lethal injection ought to receive further review and oversight to ensure that it comports with reasonable notions of humanity. © 2015 John Jay College of Criminal Justice of The City University of New York
Article
The question for us international lawyers is how, and how much of, public sentiment for human rights has been transformed into binding international law.
Article
The first Declaration of Helsinki adopted by the World Medical Association in 1964 was one of the first attempts to transform reactions to the atrocities committed in the name of biomedical research during the Nazi period into preventive measures with a full global perspective. The second version, released in 1975, was rewritten from an observation point closer to active clinical science. The resulting impact on biomedical science was obvious within a few years. The requirement to establish research ethics committees made research ethics visible, not only among scientists but also in society at large.
Article
Beginning with the proposition that the western medical tradition of emphasizing patient autonomy undermines a patient's ability to limit his or her role in medical decision-making, the author of this student note proposes a model of informed waiver to counterbalance the perceived legal bias towards informed consent. Part I explains the western notion of patient autonomy in two distinct ways: first, autonomy is rooted in western ideals of self-governance and political freedom; second, the article discusses how this idea has been developed in American courts. In Part II, the author draws on anecdotal and empirical evidence to demonstrate that autonomy is not an appropriate standard for the experience of all patients. Finally, the article concludes by proposing a framework whereby culture might be incorporated into a definition of autonomy in legal and medical practice. In particular, the author offers a notion of informed waiver as a compromise for patients who choose to forego the western-defined approach to decision-making.
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supra note 18. at 1659 (citing Lopez-Rey, Crime and Human Rights
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As a result of its widespread acceptance, peer review was incorporated into the CIOMS Guidelines. See supra note 79 and accompanying text. 188. Bassiouni et al., supra note 18
  • P M Mcneill
Peer review was developed in the United States in the 1960's and soon thereafter was adopted by several other developed countries. P.M. McNEILL, THE ETHICS ANO PoLrrTcs OF HUMAN EXPERIMENTATION 37-50 (1993). As a result of its widespread acceptance, peer review was incorporated into the CIOMS Guidelines. See supra note 79 and accompanying text. 188. Bassiouni et al., supra note 18, at 1651. 189. Supra notes 11-15 and accompanying text.