Remembering the clinical trial that transformed US ethical laws for protecting vulnerable humans. Or did it?
Two of the most crucial turning points in the development of global ideas on the ethics of human experimenting were the Nazi human experimentations and the Tuskegee study. These happened in different parts of the world. However, their context remains the same, that is: dismissive attitudes towards the fundamental worth of research subjects as humans and exploiting individuals from the weaker sections and lower socioeconomic statuses in society by running grossly unethical experiments on them.
Officially known as “the Tuskegee Study of Untreated Syphilis in the Negro Male,” the Tuskegee study was initiated in 1932 in the Tuskegee Institute and sponsored by the US Public Health Services. As part of the study, 600 African American men – 399 men with Syphilis and 201 without Syphilis were recruited. As part of the study, 600 African American men – 300 men with Syphilis and 201 men without Syphilis were recruited. The administrators of this study used vague jargon to educate participants about this trial. For example, some were told that they were getting treated for “bad blood,” which could mean any ailment. Also, some of the participants were not informed that they had Syphilis. The participants were manipulated into believing that the study will do them good, and they must “volunteer.”
The study, which started with an intention to justify treatment programs for African American males, gradually evolved into a project to study the progression of Syphilis in the human body. A study that was supposed to last for six months got prolonged to forty years!
In the 1940s, Penicillin became a widely accepted treatment for Syphilis. But, the participants of the Tuskegee study were neither informed nor provided with access to the treatment. In some cases, they were denied treatment, and their participation was incentivized with free medical exams, free hot meals, and burial insurance. Also, as a “treatment” for Syphilis, many participants underwent invasive procedures such as lumbar punctures, which sometimes led to paralysis. The later investigations also revealed that although some participants were verbally informed, they did not comprehend that they had a highly contagious sexually transmitted disease. As a result, many women contracted Syphilis and transferred it to their offsprings.
United States’ regulations on protecting research participants came into effect after the Tuskegee study. The fierce public outcry following this study eventually led to the formation of the Institutional Review Board (IRB) and the drafting of the Belmont Report. The Belmont Report summarizes ethical principles and guidelines for research involving human subjects, and it has become the guiding principle for informed consent for clinical trials. The IRB is an independent research committee regulated by the United States Health and Human Services (HHS). Its members periodically review and approve proposals for research on human subjects. The IRB requires a signed consent form by all the participants of a research study.
The Tuskegee Study and Its Relevance Today
More recently, despite IRB’s existence, there have been studies that ask research subjects to participate in trials when they do not have other treatment alternatives. Some studies offer desperate humans money to take health risks. Although such studies are officially approved, they are as grossly unethical as the Tuskegee study. While informed consent intends to eliminate power dynamics between the influential and the vulnerable, the mere existence of codes and guidelines does not automatically protect people. Nor do they prevent the IRB’s approval for potentially coercive and exploitative studies.
Understanding the context and the history of informed consent is all the more relevant during the COVID-19 pandemic. Like Syphilis in the early 1930s, there is still so much we don’t know about COVID-19. Researchers around the world are trying to comprehend this virus’ behavior in various conditions. And its severity is causing a sense of helplessness and desperation among people. The fluidity in information about COVID-19, medications, and disease progression has created uncertainty and panic among researchers, policymakers, the pharmaceutical sector, and the general public.
When an approved drug is used as an unapproved treatment for COVID-19, it is “experimental” and is called “off-label” use. Off-label drugs are deregulated and left to the physician to administer and monitor. In addition to the use of off-label drugs, pharmaceutical companies are competing with each other to develop new medicines and vaccines for COVID-19. The rush to discover a treatment, deregulation of many potentially harmful drugs, and loopholes in IRB and informed consent guidelines have left room for bypassing consent protocols and exploiting research participants.
Human clinical trials are integral to drug and vaccine development. In addition to the current wave of trials for COVID-19 drugs, more and more human trials are getting registered every year. So it is essential to educate ourselves and each other about developments in diseases and drugs, and also spread awareness about the side effects of off-label and new medical procedures. We should learn from some of the most horrific human experiments in the history of humanity and make sure that this history does not repeat itself.
This article was first published on Medium.com on Jun 18, 2020.