A white hospital hallway

The ‘Nazi Problem’ in Human Subject Research Regulation

As Holocaust Martyrs’ and Heroes’ Remembrance Day draws near, it is heartening to note that our collective horror against Nazis and Nazism is still sufficiently strong as to make them the archetype evil villains in movies, TV, and dystopian literature. The evil doctor conducting fiendish experiments lives on in fiction because we recall the all-too-real horrific acts of torture conducted by Nazi physicians against children held captive and killed in the millions.

(Here are the Personal Statements of people who survived to tell their stories.)

Yet, as important as it is to never forget these crimes, we should resist the temptation of letting these memories lead us to a false story about the origin of human subject research regulation in the United States.

Yes, U.S. doctors and scientists were involved in drafting a code to protect human subjects of research based on the revelations of war crimes. But this code did not lead directly to the adoption of human subject research protection laws in the United States. Indeed, the 30 year delay between the Nuremberg Code and the Common Rule may well be attributable to a belief that it was drafted to protect against Nazi experimentation, not the research studies they were conducting at home.

As Jonathan Moreno and others have carefully detailed, this immediate post-war generation did not see themselves as Nazis and would not or could not see how the work they were doing, while not motivated by hate or with the intent of killing their subjects, was not consistent with the Nuremberg Code’s insistence on informed consent, voluntary participation, and just distribution of risks and benefits. This history is detailed further in the archives of the President’s Commission on Bioethics, as well the foundational report of the Advisory Committee on Human Radiation Experiments.

This false origin story is not just wrong, it is actually counter-productive to the task of ensuring that people involved in studies today are protected by the laws that were eventually passed 30 years later.

The obvious mismatch between the size of the office Congress created to enforce the new laws, now known as the Office for Human Subject Research Protection, and the volume of human subject research funded by or subject to federal regulation meant that the burden of protection fell on the researchers themselves.

In the more than 30 years since the adoption of the Common Rule, there has arisen a substantial body of expertise disseminated through organizations such as PRIM&R on how to protect human subjects of research and a very impressive profession consisting of people expert not just in these methods but also in communicating them to researchers. It is inevitable that there will be friction points between those directly responsible for protection of the humans in their research studies, the researchers, and those charged with making sure that this protection occurs as required by the Common Rule.

But these friction points are substantially exacerbated by a false origin study that suggests that the Common Rule exists to keep research scientists from acting like Nazis. The Common Rule stands for the principle that the rights of the individual research subject are always more important than the needs of the researcher, and almost always more important than the need society may have for the results of the research. For example, a research subject must be allowed to leave a study without having or giving a reason at any time, even if means the failure of the study as a whole or substantial economic harm to the researchers involved. This is hard enough to convey without adding explicit or implicit suggestions that those involved are behaving like Nazis.

So instead of tracing the origins of U.S. human subjects research regulation to Nazi war crimes, we should all follow the much more appropriate and accurate contemporary practice of identifying growing public awareness of the U.S. Public Health Service’s syphilis study at Tuskegee.

Funded by the United States government and conducted by a series of highly respected U.S. scientists with the full cooperation of the academic medical establishment over the course of 50 years, this study prevented African American sharecroppers from getting access to available treatments long after the discovery a fully effective cure for syphilis. It caused unjustifiable harm not just to the men involved, but also to the women and children who contracted the disease from them. We rightly identify it today as the paradigm of a study that violated every principle of informed consent, fairness, and equity for which the Common Rule stands. Yet, it was completely American and did not end until the emergence of the Civil Rights movement made it impossible to ignore its fundamental racism and cruelty.

Rejecting the Nazi origin story of the Common Rule does not lessen the wrongs of the U.S. research studies that sparked its development nor, as Jonathan Moreno explains, does it minimize the importance of the Nuremberg Code. Nor does it require us to absolve researchers of the past because they were applying the standards of their times. Looking ahead, the factors that contribute to failures of human subject research protection, including the scientific zeal for discovery and the inevitable conflicts of interest are still very much with us.

We all hate Nazis and deplore what they do, what they stand for, and what they believe in. But transferring those feelings to research scientists via a false, and perhaps self-serving, origin story that puts the responsibility for human subject abuses on “others” will not increase the protection of the humans enrolled in their studies.


Jennifer Bard is a Petrie-Flom Center Visiting Scholar. 

Jennifer S. Bard

Jennifer S. Bard is a professor of law at the University of Cincinnati College of Law where she also holds an appointment as professor in the Department of Internal Medicine at the University of Cincinnati College of Medicine. Prior to joining the University of Cincinnati, Bard was associate vice provost for academic engagement at Texas Tech University and was the Alvin R. Allison Professor of Law and director of the Health Law and JD/MD program at Texas Tech University School of Law. From 2012 to 2013, she served as associate dean for faculty research and development at Texas Tech Law.

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