Common Rule

Background

In the early 1970s, a number of high-profile cases of clearly unethical research made headlines and resulted in calls for congressional hearings. A few of the most striking examples include the following:

• The Tuskegee Syphilis Study (1932–1972). Begun in 1932 to test syphilis treatments, the federal Public Health Service enrolled hundreds of African American men to participate. Deception was a key feature of the research from the start, but it was taken to new levels in the 1940s, after penicillin was proven an effective cure for syphilis. The researchers prevented their subjects from obtaining beneficial medical treatment and maintained their deception until 1972, when details of the study first came out in the Press. The study directly caused 28 deaths, 100 cases of disability, and 19 cases of congenital syphilis and was in direct violation of several elements of the Nuremberg Code (1945), developed after World War II in response to Dr. loseph Mengele's infamous experiments on Nazi concentration camp victims.
• Milgram's Experiments on Obedience to Authority. In attempting to determine the extent to which typical Americans might be willing to harm others simply because an authority figure told them to, psychologist Stanley Milgram designed an experiment in the early 1960s in which the subjects believed that they were delivering ever-stronger electrical shocks to a “learner” who was actually part of the research team. A large majority of subjects continued to comply even after they believed they were causing severe pain, unconsciousness, and even, potentially, death. Very early on, subjects showed clear signs of severe psychological stress, but Milgram continued his experiments to the end, even adding an especially cruel treatment condition in which the subject had to physically hold the “victim's” hand in place. (The ethics of Milgram's work has been debated for years, but many believe that it served a very positive role in showing the power and danger of authoritarianism and also served as an important warning to the scientific community for the need to make more formal and stringent ethical procedures for all social research.)
• Zimbardo's Prison Experiment. As part of a research study, and after randomly assigning student volunteers to be either “prisoners” or “guards” in the early 1970s, psychologist Philip Zimbardo found that members of both groups were taking to their roles to a much greater extent than he had anticipated. Despite clear indications within 36 hours that some of the students were deeply stressed by participating in the study, the experiment was continued for 6 fall days.

The Milgram and Zimbardo experiments, in particular, served as wake-up calls to social science researchers who, until that point, had generally considered research ethics a topic of interest to medical research but not to the social sciences. In both cases the unethical behavior occurred not so much with regard to the research designs but rather with regard to the choices the researchers made after their studies went in unanticipated harmful directions. The principal investigators decided to continue their experiments long after they were aware of the harm they were causing their research subjects, a fact that made comparisons to the Tuskegee Experiment both inevitable and appropriate. Indeed, by failing to balance the anticipated benefits of the research with the risks to their subjects, they were in violation of a key provision of the Nuremberg Code.

...