Atrocities conducted in the name of research by many prominent doctors and scientists during World War II led to the formulation of the Nuremberg Code and the subsequent WMA’s Declaration of Helsinki many years later. Later modern research ethics began in the wake of the Tuskegee Study with the issuance of the Belmont Report by the U.S. National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research in 1979. The perception was that subjects needed protection and that mandating both informed consent and review by independent local committees (IRBs/RECs) would suffice. Later still, in the wake of the death of Jesse Gelsinger in 1999, another protection was added, the minimization and management of financial conflict of interest. Huge changes have arisen in research since these protections were instituted not the least of which are the emergence of huge collaborative clinical trials, the role of private entities in sponsoring clinical research, the perception of many subjects that they do not need protection when entering research and a growing international footprint in the scope of many studies. Did the ‘traditional protections work? Have they outlived their usefulness? What new ‘protections’ might be needed in the future?
Currently the Drs. William F and Virginia Connolly Mitty Professor and founding head of the Division of Medical Ethics at NYU School of Medicine in New York City. Prior to coming to NYU School of Medicine, Dr. Caplan was the Sidney D. Caplan Professor of Bioethics at the University of Pennsylvania Perelman School of Medicine in Philadelphia, where he created the Center for Bioethics and the Department of Medical Ethics. Caplan has also taught at the University of Minnesota, where he founded the Center for Biomedical Ethics, the University of Pittsburgh, and Columbia University. He received his PhD from Columbia University. Dr. Caplan is the author or editor of thirty-five books and over 725 papers in peer-reviewed journals. His most recent books are The Ethics of Sport, (Oxford University Press, 2016 with Brendan Parent) and Vaccination Ethics and Policy, (MIT Press, 2017 with Jason Schwartz).