Rethinking the Belmont Report?


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Tag(s): Legacy post
Topic(s): Clinical Trials & Studies Human Subjects Research & IRBs Research Ethics

Some bioethicists link the beginnings of our field to the Nazi Medical experiments and the Nuremberg Trial (Annas). Whether this is the beginning of bioethics is debatable, but without a doubt, research ethics has been a central topic in the field. In fact, the very first federal bioethics commission laid out the principles of research ethics in the Belmont Report. Later, the President’s Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research recommended to the President and Congress that a uniform framework and set of regulations should govern human subjects research. This effort reached fruition under The Federal Policy for the Protection of Human Subjects or the “Common Rule” that was issued in 1991. Since then, there have been no major changes to the regulations – until now. After a five-year process and thousands of comments, the new “final rule” was released on January 19th, 2017. The July 2017 issue of the American Journal of Bioethics addresses these changes. In addition to our usual open peer commentaries, we are posting a number of blog posts written in response to the AJOB target article.

by Ibrahim Garba, MA, JD, LLM, Elizabeth Hall-Lipsy, JD, MPH, Leila Barraza JD, MPH

Norms supporting ethical research have been part of international human rights law from the start. The Doctors Trial in 1947 convicting 23 Nazi physicians and officials accused of euthanasia and unethical medical experiments produced the Nuremburg Code. The Code became a blueprint for subsequent human subject protection frameworks, most notably the World Medical Association’s Ethical Principles for Medical Research Involving Human Subjects (i.e., the Declaration of Helsinki) (1964).

The Nuremburg Code preceded the adoption of the Universal Declaration of Human Rights (UDHR) (1948) by a year. The UDHR is the foundation of the current human rights system, providing the normative basis for a system of laws, bodies and processes for protecting human dignity globally. Among protections afforded by the system are safeguards for research subjects. A notable example is Article 7 of the International Covenant on Civil and Political Rights (1966), which requires “free consent to medical or scientific experimentation.”

However, and as Friesen and colleagues note regarding the Belmont Report, the human rights system has been criticized for its “ethical individualism”—the view that the individual human person should be the prime, if not sole, focus of moral concern and analysis. Prominent and consistent among these critiques have been those of indigenous peoples and other collectives, who integrate communal considerations into their practices of ethical deliberation.

In response to this normative gap, efforts have been made to complement the human rights system’s individualist approach with a collective one. African governments acting through the Organization of African Unity (now the African Union) have adopted the African Charter on Human and Peoples Rights (1981). The treaty includes individual rights but also features collective rights through the concept of “peoples’ rights,” which protects African ethnic groups (e.g., Xhosa, Kikuyu, Tuareg, Fula) as collectives, not just as aggregates of individuals. Similarly, indigenous peoples (e.g., Inupiat, Maori, Aboriginal Australians, Navajo) advocated successfully for the adoption of the United Nations Declaration on the Rights of Indigenous Peoples (UNDRIP) (2007). Although not yet a legally binding treaty like the African Charter, UNDRIP establishes a broadly endorsed framework for protecting the rights of indigenous peoples as collectives.

Friesen and colleagues propose that the risk of harm to communities would be reduced if a notion of community harm were explicitly recognized in the Belmont Report. The authors suggest creating a new principle or expanding on the principle of respect for persons, while noting the challenge of defining what a “community” is. The African Charter and UNDRIP offer lessons in recognizing and protecting communities within an existing structure of individual recognition and protection. Given their interconnected history, the field of research ethics could benefit from engaging the field of human rights on the question of community recognition.

Emphasis on protectionism

Friesen and colleagues observe that the Belmont Report’s protectionist stance is out of step with today’s move towards more collaborative research models. As the authors suggest, the shift from “subjects” to “partners” means a shift from subjects passively enrolling in research to participants actively “shap[ing] research goals and protocols.” In other words, easing the Belmont Report’s protective stance should increase the number of subjects previously excluded from research on account of vulnerability, while enriching the quality of subjects’ engagement with and in the research process.

This partnership model is analogous to developments in international law relating to indigenous peoples. The developments are captured in the evolution of two related principles expressed in UNDRIP: self-determination and the collective right to participation. Self-determination is the ability of an indigenous people to direct the course of their development on their own terms (i.e., without unsolicited outside influence). The collective right to participation refers to indigenous peoples’ capacities to shape decisions on matters affecting their members.

A distinction has been recognized between internal and external aspects of participation. Internal participation refers to the right of indigenous peoples to decide on matters concerning their collective welfare through their own institutions and processes, whether such mechanisms be traditional governance systems or administrative structures set up by outside authorities (e.g., American Indian/Alaska Native tribal governments under US federal law). External participation refers to the right of indigenous peoples to influence extrinsic decision-making processes affecting their communities (e.g., the Secretary’s Tribal Advisory Council at the US Department of Health and Human Services). The complementary aspects of participation work together to ensure a meaningful exercise of self-determination.

The principle of self-determination realized through the collective right to participation offers useful insights for addressing the protectionism of the Belmont Report. Applied to research, external participation sets an expectation that community engagement with indigenous peoples should be approached as an opportunity for mutual benefit and influence rather than as an administrative hurdle or merely an exercise in risk prevention. External participation also helps steer researchers clear of adopting a deficit model, the view that indigenous peoples lack capacity within their communities to solve their health problems. A deficit model presents a seemingly sensible response to overwhelmingly poor health indicators among indigenous populations, but the model only reinforces protectionism in research.

Fully realized internal participation sets an expectation that researchers should acknowledge, respect and work with an indigenous community’s internal institutions and processes. In engaging mechanisms of self-determination, researchers will aid in an effective transition of indigenous communities from “subjects” to “partners” – a positive development, as noted by Friesen and colleagues.


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