This month marks the 70th anniversary of the writing of the Nuremberg Code, a set of medical research ethics principles laid down by American judges during the 1947 Doctors’ Trial, in which 16 Nazi physicians were found guilty for crimes against humanity. The Code has since informed modern ethical thinking around human research and regulation in the United States. It has also provided guidelines for how patients can both voluntarily consent to and withdraw from research studies. But it set another precedent that, seven decades on, has proven unhelpful to patients: In its quest to protect patients, it has limited their rights.
The bulk of the Nuremberg Code doesn’t discuss patients directly, but rather lays out the responsibilities of physicians in conducting ethical research. On the face of it, this isn’t a bad thing. But in doing so, the Code doesn’t merely define responsibilities — it codifies the absolute authority of the physician-researcher.
[See: 10 Lessons From Empowered Patients.]
Here’s the (well-intentioned) reason why: The Nuremberg prosecutors, seeking to minimize future harm to research patients, took the Hippocratic ethics of traditional medical care — the sacred physician-patient relationship and the dictum “nil nocere” to “do no harm” — and applied them to the world of medical research. Their goal was to humanize research subjects. However, a core tenet of traditional Hippocratic ethics is that the opinions of patients are, by definition, subordinated to those of expert physicians. Disputed today, this made historical sense, given the physician’s expertise and the high barriers to medical knowledge.
In medical research, where the explicit goal is to test a medical hypothesis, rather than to treat, and where there is less of a true physician-patient relationship, the effect is that patients once again become objects of study rather than partners in the research process. If patients today feel that medical research isn’t being conducted in their best interest, they are extraordinarily limited in their ability to correct it. They merely have the right to decline to participate or withdraw.
[See: What Medical Screenings Should You Have in 2017?]
Modern day patients are in a better position than ever to take a more active, informed role in research. They have access to devices and data that can help them virtually compare their experiences with others, and monitor if a current treatment is helping or harming them. Emerging technologies, including advanced digital sensors and multi-omics research, are beginning to reveal more of what was previously unknown. Those same technologies are also revealing stark limits to the Code.
A recent study of people living with lupus identified that patients with specific genetic variants were at risk for certain clinical manifestations such as renal disease, and suggested that genetic profiling could be useful to predict them. But the patients in the study never saw that information. Our current standards, built on the foundation laid by the Code, restricted researchers from telling them.
Informed consent must more broadly acknowledge that unintended or unexpected insights are now possible, and that patient rights must evolve, too. Patients have the right to know information that could affect them directly but, equally, the right to choose to not know.
[See: On a Scale of 1 to 10: Most Painful Medical Conditions.]
The Nuremberg Code made the landmark achievement of formally establishing the basic rights of research patients in the wake of global tragedy. But after 70 years, it reminds us that we must do more than merely implore physicians to act in the best interest of patients. Patients must become true partners in research for us to truly do no harm.
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Nuremberg Code at 70: Are the Ethics Principles That Protected Patients Failing Them? originally appeared on usnews.com
