To the Editor:
Institutional review boards (IRBs) play a vital role in protecting the welfare and rights of human research subjects. The Code of Federal Regulations ensures diverse membership of the IRB, allowing for different points of view. The IRB, composed of at least five members chosen with consideration to race, gender, cultural background, and sensitivity to community attitudes,1 includes community members, physician scientists, nurses, and pharmacists.1,2 Medical students could be an important addition. Whether considered “scientists” or “nonscientists,” students who participate in the review process would benefit by learning research design and developing analytic skills.
Harvard Medical School students interested in clinical research have the opportunity to participate as voting members on a hospital IRB at a time when they are learning basic science and gaining early exposure to translational research and medical ethics. Medical student IRB members review important randomized clinical trials, as well as the use of experimental drugs and medical devices that will impact the future practice of virtually all fields of medicine. Participation fosters an understanding of inherent risks associated with specific populations, including students, employees, children, and pregnant women, as well as vulnerable groups such as the imprisoned and mentally ill. Membership is an opportunity to learn standard-of-care guidelines; rules of ethics; regulations concerning fairness, gender, ethnic and racial equality, informed consent, confidentiality, and potential conflicts of interest; and emerging technologies and breakthroughs in an era of genetic and stem cell research. Medical students have the scientific literacy to offer a unique perspective and fulfill a novel role in IRB proceedings. The experience reinforces core principles learned in the medical school curriculum and underscores the relevance of classroom learning to genetic, environmental, and epidemiologic problems.
In one study,3 medical students worked through ethical issues posed in a hypothetical biomedical vignette designed for an IRB. We believe that actually taking part in the evaluation of ethical soundness in real human research studies has an even more robust effect.
Mark A. Gromski, MD
First-year fellow in gastroenterology and hepatology, Indiana University School of Medicine, Indianapolis, Indiana.
Christopher A. Miller, MD
Third-year resident in anesthesiology, Stanford University Medical Center, Palo Alto, California.
Julian L. Seifter, MD
Associate professor of medicine, Department of Medicine, Brigham and Women’s Hospital and Harvard Medical School, and chair, Continuing Review Committee, Partner’s HealthCare, Boston, Massachusetts; firstname.lastname@example.org.
1. Clinical Research Resources. Regulations and Guidance on Clinical Investigator & IRB Responsibilities. 2003 Philadelphia, Pa Clinical Research Resources
2. Sengupta S, Lo B. The roles and experiences of nonaffiliated and non-scientist members of institutional review boards. Acad Med. 2003;78:212–218
3. Roberts LW, Warner TD, Green Hammond KA, Brody JL, Kaminsky A, Roberts BB. Teaching medical students to discern ethical problems in human clinical research studies. Acad Med. 2005;80:925–930