The Belmont Report and Modern Clinical Trialsby Paul Ballas, D.O. Health Professional
In my last entry, I discussed some of the many ethical problems with the design and implementation of the Tuskegee Syphilis Study and how it came to an end when these issues were brought to national attention in the late 1970's. This was a historic study in that it led to a re-examination and revision in the rules regarding ethical treatment of participants involved in biomedical research. In this entry, I'd like to discuss some of the changes that came about in part because of the outrage over this study. Some specific changes that were implemented were published under the name "The Belmont Report".
The Belmont Report was created by the organization then known as the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research under the name "Ethical Principles and Guidelines for the Protection of Human Subjects of Research". The name, the Belmont Report, came from the conference center (the Belmont Conference Center) where the first drafting took place. The report identified three ethical principles that govern research involving human participants: respect for persons, beneficence, and justice. To this day, these are key pillars that underlie ethical research conducted in this country and remain guiding principles behind regulations on research created by the Department of Health and Human Services. The principle of justice refers to using procedures in research that are well considered, reasonable, and do not exploit the humans subjects involved. Beneficence in research refers to taking reasonable efforts to minimize the risks involved in using human participants while still attempting to maximize the benefits of doing research. Respect for persons means treating participants with courtesy, offering informed consent, and protecting their autonomy (which includes the ability of a person to make decisions on their own without aid from others).
Today, the Belmont Report stands as a historically significant document about doing ethical human research, and adhering to the ethical principles of the report is still considered by many researchers as a key aspect of going good research. During the time the Belmont report was issued, modern institutional review boards were created with the aim of monitoring clinical trials to ensure the safety and welfare of participants. These boards also usually review the protocols involved in the research and monitor for any adverse events that may occur throughout the studies. Institutional review boards (IRBs) were created to make sure that people who agree to become involved in clinical research are treated with respect, are kept as safe as possible, and are treated ethically.
Unfortunately, the Tuskegee study is not ancient history, as some of the research and the transgressions that occurred happened within the last 40 years. It is understandable why many people are still wary of entering into clinical research, but the truth is that since the Tuskegee Syphilis study and the publication of the Belmont Report, there are several new levels of oversight that have been developed in order to protect the rights and autonomy of participants in research. There is, of course a great deal more to discuss about the ethics of research and the history of IRBs, and several other historical works that have significant influence on how research is done today, most notably the Nuremberg Code of 1947, the Declaration of Helsinki of 1964, and the Advisory Committee on Human Radiation Experiments of 1996. I would be happy to further explore the impact of these works, and as always, I welcome any questions about this topic.
Running an ethical trial 60 years after the Nuremberg Code, The Lancet Oncology
Jonathan R Markmana and Dr Maurie Markman MDb,
Volume 8, Issue 12, December 2007, Pages 1139-1146