Research with human subjects has a long and often troubled history in the U.S. and throughout the world. Chances are you have already heard of some of the most egregious—and famous—examples of unethical research in the biomedical sciences, such as the experiments conducted by Nazi doctors and scientists on concentration camp prisoners during World War II and the Tuskegee Study of Untreated Syphilis in the Negro Male, conducted by the U.S. Public Health Service. These abuses led to the creation of codes of research ethics in Europe and the U.S. In the wake of the Second World War, the Subsequent Nuremberg Trials on war crimes produced the Nuremberg Code, which outlined ten points for conducting ethical research with human subjects. Nearly two decades later, the World Medical Association developed a code of research ethics, known as the Declaration of Helsinki, published in 1964 and subsequently revised. This document built on both the Nuremberg Code and physicians' code of ethics known as the Declaration of Geneva by adapting the existing guidelines to address the growing field of clinical research.
In the U.S., news that researchers deceived and withheld treatment from subjects in the Tuskegee Study, led to the creation of the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. The National Commission was charged with the establishing a code of research ethics for U.S. research with human subjects. In 1979, the Commission issued the Belmont Report, the foundational document of the current system of U.S. human subjects protections. The Belmont Report outlines three key ethical principles for conducting research with human subjects: respect for persons, beneficence, and justice. The Belmont Report, in turn, informed the U.S. Department of Health and Human Services' (HHS) Code of Federal Regulations (45 CFR 46), created in 1974 and later revised. In 1991, Subpart A of these regulations (Basic HHS Policy for the Protection of Human Research Subjects) was adopted by 15 federal agencies and became known as "the Common Rule."
Landmark social sciences studies such as Milgram's Obedience to Authority Study, Zimbardo's Stanford Prison Experiment, and Humphreys's Tearoom Trade Study, made it clear that social and behavioral research may carry risks of harm related to psychological wellbeing, violations of autonomy and privacy, and reputational damage. Despite good intentions and best efforts, researchers are not always able to anticipate risks of harm. This module aims to bring human subjects protections into focus for investigators in the social and behavioral sciences, education, and the humanities by examining the complex issues raised by research with human subjects and how these issues may be addressed using the ethical principles outlined in the Belmont Report.
Excerpts of the Belmont Report appear below in italics. The full report (approximately seven pages long) provides the conceptual foundation for the federal regulations and the conduct of research with human subjects and is recommended reading