In 1945-1946, after the conclusion of the Second World War, several Nazi German leaders and doctors stood trial for crimes against humanity, war crimes, and other atrocious crimes.  One of the trials, the so-called Doctor’s Trial (U.S.A. v. Karl Brandt et al.), helped shape how we view and perform clinical research today. One of the major defenses in the Doctor’s Trial was a lack of international law or agreement against the horrible activities the Nazis were doing. To remedy this, the trial ruling (in which seven defendants were sentenced to death) gave an outline of “Permissible Medical Experiments.” This was called the Nuremberg Code and was later expanded by the World Medical Association into the Declaration of Helsinki.

The Declaration of Helsinki, originally released in 1964, is the cornerstone of modern clinical research. The medical atrocities during the Holocaust showed that the unsaid rules of medicine needed to be said, printed, and widely distributed. The World Medical Association’s original Declaration of Helsinki has been revised seven times and has since grown by 300%. It concerns the ethical treatment of human participants in medical research.

The foundational notions of the Declaration of Helsinki rest on the following two ideas: “The health of my patient will be my first consideration” and “A physician shall act in the patient’s best interest when providing medical care.” The fact that these were up for debate is wild to me, but thanks to the Declaration of Helsinki these are now universal statements. The rest of the Declaration of Helsinki has similar “this should be obvious” content but has been critical for ensuring the safe and ethical treatment of people in research.

The document first states that human medicine must be tried in humans at some point. There are also stipulations about what must happen before a study can begin. A protocol must be written that outlines the entire study. An independent review board (IRB) must approve the protocol and any changes. Funding and results should be transparent and public. The document also outlines in broad terms how to do this with respect, beneficence, and justice.

Respect comes from the assertion that individual people matter more than new knowledge. This is how we get concepts like informed consent – that all trial participants must have full knowledge of what they are getting into before signing up. Respect also states that patients must voluntarily sign up and be able to discontinue at any time. Further, special protections must be in place for vulnerable populations – like children, prisoners, and people with mentally disabilities.

Beneficence is the concept of weighing benefits against risks. In medical research, the benefits must always outweigh the risks. Benefits must help the individual person, a population, or society. Risks must be minimized wherever possible. This is one reason you often see a long list of things that can exclude a person (like being pregnant) from a study: to minimize risks. Beneficence also mandates that studies must be stopped if the risks become too high – if an unintended side effect emerges, for instance.

Justice is the concept that research should be for the benefit of everyone. Medications that would target a specific population should be researched in that population. If left-handed people made up 90% of smokers, for instance, then smoking cessation studies should aim to enroll mostly left-handed people. Justice also means groups should be fairly selected and that studies should help people who live where the studies take place. You shouldn’t test a pants-lengthening drug on people in Bermuda (for their Bermuda shorts) and refuse to sell it to them.

Altogether, these seem like common-sense rules to have in place, but they need to be written. The Nazis claimed the ends justify the means – even though their end goals were abhorrent. In this world, however, there are no ends – only means.

Staff Writer / Editor Benton Lowey-Ball, BS, BFA

References:

Bošnjak, S. (2001). The declaration of Helsinki: The cornerstone of research ethics. Archive of Oncology, 9(3), 179-184.

Nuremberg Trials Project (n.d.). NMT case 1. Harvard Law School. https://nuremberg.law.harvard.edu/nmt_1_intro

Shrestha, B., & Dunn, L. (2019). The Declaration of Helsinki on medical research involving human subjects: a review of seventh revision. https://elibrary.nhrc.gov.np/handle/20.500.14356/1367 

Taylor, T. (1955). Nuremberg Trials, The. Colum. L. Rev., 55, 488. https://www.jstor.org/stable/1119814?read-now=1&seq=38

United States Holocaust Memorial Museum, Washington, DC. (n.d.). The Nuremberg code. Holocaust Encyclopedia. Accessed 5/13/2024. https://encyclopedia.ushmm.org/content/en/article/the-nuremberg-code 

World Medical Association. (2013). World Medical Association Declaration of Helsinki: ethical principles for medical research involving human subjects. Jama, 310(20), 2191-2194. https://jamanetwork.com/journals/jama/fullarticle/1760318/