The Study That Set the Stage for Protecting Human Research Subjects

On July 26, 1964, Dr. Henry Beecher, an anesthesiologist at the Massachusetts General Hospital in Boston, gave a presentation at a medical conference in Dallas that would reverberate around the world. The presentation, “Ethics and Clinical Research,” would become one of the most famous and most often-cited articles in the history of biomedical ethics. In it, Dr. Beecher detailed 22 studies that he said had “Flagrant ethical violations.” These studies, conducted between 1932 and 1962, were not anomalous; they were indicative of a general pattern of unethical research that had been going on for decades, mostly in the United States but also in other countries. In many cases, the subjects of these studies were not only not informed of the risks they were taking, but were actively misled about the nature of the research. In some cases, subjects were not even given the option of saying no; they were simply enrolled in the study without their knowledge or consent. Dr. Beecher’s presentation was a bombshell. It helped to galvanize the medical community and the general public around the need for better protection of human research subjects. In the years since,

• The Public Health Service Tuskegee Study of Untreated Syphilis in the Negro Male

 The study that set the stage for protecting human research subjects.

It is hard to imagine a time when human subjects were not protected in research. Yet, there was a time not long ago when the well-being of research participants was not always a priority for scientists. The Tuskegee Syphilis Study is one example of an unethical clinical trial in which human subjects were deliberately harmed. The study, which ran from 1932 to 1972, enrolled poor, African American men with syphilis who were not told of their diagnosis or treated for the disease. The men were simply observed as the disease progressed. The Tuskegee Syphilis Study is now considered one of the most unethical studies in history. It led to the development of regulations to protect human subjects in research. The study also showed the need for informed consent, which is the process of getting permission from a research participant before involving them in a study. Informed consent forms must now be used in all research studies. The Tuskegee Syphilis Study is a reminder of the importance of ethical research. Scientists must always put the welfare of their subjects first. Only through ethical research can we hope to make progress in our understanding of the world and improve the lives of those around us.

 The Tuskegee Syphilis study and the rise of medical ethics.

When the United States Public Health Service (USPHS) launched the Tuskegee Syphilis study in 1932, they could not have anticipated the uproar it would cause. The study, which followed 600 black men with syphilis for 40 years, was designed to observe the natural progression of the disease. However, the men were not told they had syphilis, and they were not given any treatment for the disease, even when penicillin became available as a cure in the 1940s. The Tuskegee Syphilis study caused a great deal of public outrage when it was finally exposed in the early 1970s. This outrage led to the development of new regulations and guidelines to protect human research subjects. The Tuskegee Syphilis study is now widely considered to be one of the most unethical medical studies ever conducted.

 The Belmont report and the three basic ethical principles.

When the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research was created in 1974, its goal was to address the ethical issues raised by the Tuskegee syphilis study and others like it. One of the first things the Commission did was to commission the Belmont Report, which set out the three basic ethical principles that should guide all human research: respect for persons, beneficence, and justice. Respect for persons includes understanding the intrinsic value of all human beings as well as respecting their autonomy to make decisions about their own lives. beneficence requires that researchers do no harm and strive to maximize the benefits of the research for participants. And finally, justice requires that research be conducted equitably, with a fair distribution of risks and benefits. The Belmont Report was groundbreaking in its recognition of the need to consider ethics in research. However, it was also controversial, and some criticized it for being too vague. Nonetheless, it remains an important document in the history of human research ethics.

 The history of the IRB and theCommon Rule.

In the United States, the system for protecting human research subjects has its roots in the work of the Nuremberg Doctors Trial in 1947. After World War II, it became clear that Nazi doctors had conducted horrifying medical experiments on concentration camp prisoners without their consent. In response to this, the United States government convened the Nuremberg Code, which established principles for the ethical conduct of human research. The Nuremberg Code was a set of voluntary guidelines, but it did not have the force of law. In 1974, Congress passed the National Research Act, which created the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. The National Commission was tasked with developing regulations for the protection of human research subjects. The National Commission’s work led to the development of the Belmont Report, which outlined the ethical principles of respect for persons, beneficence, and justice. These principles form the basis of the Common Rule, which is the set of regulations that govern human research in the United States. The Common Rule requires that all research involving human subjects must be reviewed and approved by an institutional review board (IRB) before it can proceed. The IRB is responsible for ensuring that the research proposal meets ethical standards and protecting the rights of research subjects. The IRB system is not perfect, but it is an important safeguard for human research subjects. The history of the IRB and the Common Rule is a history of the effort to protect vulnerable populations from exploitation.

 The future of protecting human research subjects.

There is no question that the Tuskegee Syphilis Study was one of the most unethical clinical trials in history. The study subjected hundreds of poor, black men to deliberately withheld treatment for a deadly disease, in the name of science. As a result of the Tuskegee Study and other unethical research trials, the United States government passed the National Research Act in 1974. This act established the Belmont Report, which set forth the ethical principles of respect for persons, beneficence, and justice. These principles continue to guide researchers today in their efforts to protect human research subjects. Despite the establishment of these ethical guidelines, there have been numerous instances of unethical research trials in the years since the Tuskegee Study. In the late 1990s, for example, it was revealed that patients with AIDS were purposely infected with the HIV virus at the U.S. government-funded research center in Guatemala. More recently, it was revealed that children in New York City were deliberately exposed to lead paint as part of a research study. These and other unethical research trials have led to calls for greater oversight of clinical trials. There is currently no federal agency that is responsible for overseeing all clinical trials in the United States. The FDA does not have the authority to review the ethical aspects of clinical trials, and the National Institutes of Health (NIH) does not have the resources to do so. As a result, it is up to individual Institutional Review Boards (IRBs) to review and approve clinical trials. However, IRBs are often understaffed and lack the resources to thoroughly review all aspects of a trial. One way to address this problem is to create a federal agency that would be responsible for overseeing all clinical trials in the United States. This agency would be responsible for reviewing and approving all clinical trials, as well as investigating any allegations of unethical research. Another way to address the problem is to provide more funding and resources to IRBs, so that they can more thoroughly review clinical trials. whichever solution is adopted, it is clear that more needs to be done to protect human research subjects. The Tuskegee Study and other unethical research trials have shown that the current system is not adequate. In order to protect human research subjects, we need to do better.

As the world population continues to grow and technology advances, the need for research on human subjects increases. The Nuremberg Code and the Declaration of Helsinki are two ethical frameworks that guide this type of research and protect human research subjects. Although the guidelines set forth in these documents are not binding, they provide an important foundation for the ethical conduct of human research.