The Belmont Report: Ensuring Ethical Human Subjects Research

By Sheeva Azma

When I was a scientist, every time I started working at a new institution or even a new lab, I was required to complete human subjects training. In my work studying people’s brains using magnetic resonance imaging (MRI), all researchers (including me) were required to complete this training before being able to conduct research. Truth be told, it was pretty boring, and it almost always focused on the same topic: the processes that we use to conduct human subjects research. The training focused on something I, at the time, took for granted, called The Belmont Report.

It’s a document published in 1979 that details the ethical principles involved in human subjects research and discusses the core values driving such research. The Belmont Report protects human subjects participating in research studies (such as clinical trials). While the Belmont Report celebrated its 40th birthday in 2019, and might need an update, it’s still going strong.

The Belmont Report provides ethical guidelines for human subjects research.

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As a researcher, I can’t remember how many times I had to read and study different parts of the Belmont Report (and the whole thing) — many, many times. I remembered the Belmont Report again recently as I was scrolling through Facebook and saw a post about the ethics of COVID-19 vaccine development. I realized that not everyone has heard of the Belmont Report and its origins. Maybe if people understood the murky history of human subjects research — and the fact that this tragic history led directly to the establishment of ethical reserach guidelines — then we’d all be getting our COVID-19 vaccines.

So, is it a good idea to casually mention the Belmont Report in your next discussion with your unvaccinated loved one?

I’m not sure, but one thing missing from the discussion of COVID-19 vaccine development is the ethical guidelines that are established by law to protect human subjects. So, that’s why I am writing this post.

In this blog, I discuss the origins of the Belmont Report in unethical experimentation in the US and Nazi Germany, talk about what’s in the Belmont Report, and mention a few ways the Belmont Report has helped make human subjects research, such as clinical trials, more ethical. Keep reading to learn more about this report, which forms the foundation of human subjects research today.

Unethical Nazi Experimentation and The Nuremberg Code

The Belmont Report is not a complicated document, but its publication arises from a complicated past in human subjects research. Two examples of unethical research stand out which formed the basis for the Belmont Report. These are research conducted by Nazis in World War II and the infamous Tuskegee Study conducted by the United States Public Health Service (USPHS).

From 1933 to 1945, scientists in Nazi Germany conducted unethical human subjects experiments. Research participants often died. These experiments ultimately led to the development of the Nuremberg Code. The Nuremberg Code was published in 1947 as a result of the Nuremberg Trials which tried Nazi war criminals. The Nuremberg Code articulates ten rules to guide research studies involving humans. You can read them all on the United States Holocaust Memorial Museum’s website.

Informed Consent in Human Subjects Research

One of the most important concepts in the Nuremberg Code is the idea of informed consent. Informed consent means that people participating in research studies must be doing so due to their own free will, without being forced, deceived, or otherwise coerced into participating in research. It is the researcher’s responsibility to obtain informed consent from the participants in their studies. Another aspect of the Nuremberg Code is the minimization of risks to participants in human research studies.

The Nuremberg Code was a Blueprint for The Belmont Report

The Nuremberg Code served as the foundation for future ethics guidelines, such as the Declaration of Helsinki, a similar set of guidelines published by the World Medical Association in 1964. Both of these documents contributed to the Belmont Report, which was published in 1976.

The Tuskegee Experiment, an Unethical Study, Led to the Belmont Report

An unethical human research study called the Tuskegee Study coerced and deceived hundreds of Black men into participating in an unethical research program for decades. The Belmont Report was published as a direct result of the Tuskegee Study.

The Tuskegee Study started in 1932. At that time, the United States Public Health Service (USPHS) began the study. The researchers wanted to examine the natural progression of syphilis as it progressed without treatment. They recruited 600 Black men, many of whom were poor and illiterate sharecroppers. The Tuskegee study coerced and deceived the men, luring them to participate with things like free medical care and hot lunches, which were otherwise unavailable to Black men of the time.

When the Nuremberg Code was published in 1947, the now infamous Tuskegee Study was underway, but it continued to progress under the radar. Just a few years earlier, in 1943, penicillin also became known as a cure for syphilis, but the participants of the Tuskegee Study were denied treatment. The study went on until 1972, when the Associated Press finally broke the news. By then, it had gone on for 40 years, causing severe illness and death in the study participants.

In 1997, President Bill Clinton issued an apology for the Tuskegee Study. You can watch the video below or by clicking here.

Both the Nazi experimentation in WWII and the Tuskegee Study eroded public trust in science. Importantly, they also reflected an ethics environment for human subjects research which did not have established guidelines. Sure, the Nazi studies had led to the Nuremberg Code and the Declaration of Helsinki, but there were no formal guidelines for ethical research in the United States. The Belmont Report changed that.

Things changed in 1974. That’s when President Richard Nixon signed the National Research Act into law. This bill established a National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. The purpose of this Commission was to draft formal guidance for ethical research. In 1979, the National Commission published The Belmont Report.

What’s in the Belmont Report?

The Belmont Report outlines the basic ethical principles of research. These overarching principles are respect for persons, beneficence, and justice. Here in the United States, research studies must follow all three core principles: respect for persons, beneficence, and justice. Let’s unpack each of those below.

Respect for persons.

Put simply, “respect for persons” means that people should not be used as a means to an end. Informed consent helps maintain respect for persons. All human research subjects must participate voluntarily, and prospective research participants must be given sufficient information about the research and its goals to make a decision. The idea of autonomy is central to the principle of respect for persons. A person that has autonomy can think about their personal goals and make decisions freely. Not all human beings have a high level of autonomy, such as children. Therefore, these and other vulnerable populations must be protected in research.

Beneficence.

This core principle derives partly from the Hippocratic Oath to “do no harm.” It also seeks to maximize possible benefits of the research while minimizing any harms.

Justice.

This pillar ensures that the costs and benefits of the research are distributed fairly. As Yale University writes, “It would be unjust, for example, if one group in society incurred the risks of research and failed to benefit from the knowledge or application of such research.” Choosing participants fairly (rather than merely as a result of convenience) is one way that research remains just. Additionally, the people involved in the research should also benefit from it. In the Tuskegee Study, the people involved did not benefit, so the study was unjust.

Three aspects of human subjects research derived from the Belmont Report are informed consent, assessment of risk and benefits, and participant selection.

In the US, Institutional Review Boards (IRBs) Oversee Human Subjects Research Ethics

Here in the United States, the federal government mandates that all research institutions that receive federal dollars must maintain what is called an Institutional Review Board or IRB to protect human subjects. Each IRB is made up of five people, including scientists and nonscientists, at the given institution. The IRB serves as a system of checks and balances for human research. The board meets regularly to review research proposals and evaluate their adherence to the principles of the Belmont Report.

Can Understanding Human Research Processes Boost Public Trust in Science?

Human research ethics have always been important. They have become even more crucial in the COVID-19 pandemic. Most people don’t understand the challenges that have beset human subjects researchers over the years, or the troubled past of this field that has led to the Belmont Report.

Maybe that’s why people are hesitant to get a COVID-19 vaccine because they don’t want to be a “guinea pig.”

Could understanding the Belmont Report and its core principles improve public trust in science? In the COVID-19 pandemic, that could translate to greater vaccine uptake, which could help us get back to a new normal. Outside of the COVID-19 pandemic, improved public trust in science could lead to improved engagement with science in the form of science literacy, participation in research studies, and so on.

Having read about the Belmont Report, do you feel more confident in the clinical trials process for the COVID-19 vaccines and/or in the scientific process in general? I’d love to hear from you in the comments.