Ethical Principles in the Conduct of Research with Human Participants

History

Although ethical considerations have influenced researchers on an informal and individual basis throughout history, the first formal recognition of the importance of ethical principles in research occurred in 1947, after the Nuremberg Trials of Nazi war criminals. These trials revealed to the public that during World War II, physicians and scientists had conducted biomedical experiments on involuntary participants drawn from Nazi concentration camps. Some of these experiments were designed to assess human responses to poisons, extreme temperatures, and infections, and they essentially resembled torture. Noting that there was at the time no international law or ethics code to refer to in addressing such egregious treatment of human participants, Leo Alexander, an American physician and consultant to the prosecution during the trials, submitted a report that presented standards for legitimate, ethical research. This report formed the basis of the subsequently developed Nuremberg Code, the first formal code of ethical principles addressing the conduct of research with human participants. The Nuremberg Code emphasized principles such as informed consent, avoidance of harm, the necessity of researchers having appropriate training, and freedom of participants to withdraw at any time.

The Nuremburg Code played a significant role in shaping the content of ethical guidelines published by professional organizations such as the American Psychological Association (APA). The APA first published a general ethics code for psychologists in 1953. In 1966, APA established an ad hoc committee to further examine research ethics. In 1973, the committee published a booklet titled “Ethical Principles in the Conduct of Research With Human Participants.” This booklet, along with APA's general ethical guidelines, has subsequently undergone revision. The most recent APA ethics code, which includes guidelines for research, was published in 2002.

The Nuremberg Code also influenced federal regulations that were set forth by the U.S. Congress in the National Research Act of 1974. This legislation created a National Commission for the Protection of Human Subjects in Biomedical and Behavioral Research and required the formation of an institutional, or internal, review board (IRB) by every university or other organization that receives federal funds for research. The purpose of the IRB is to review proposals for research with the aim of preventing ethically questionable studies from being conducted with human participants. During the mid-1970s, the National Commission held hearings on a series of ethically problematic research efforts, including the Tuskegee Syphilis Study, which examined the degenerative course of syphilis in rural, underprivileged African American males by deliberately withholding treatment of the disease. These hearings led the National Commission to develop specific recommendations for research with human participants, published in “The Belmont Report,” which set the framework for federal regulation of research. The U.S. Department of Health and Human Services issued a set of regulations in 1981, called “Protection of Human Subjects.” This document and its subsequent revisions have continued to emphasize the principles of beneficence, justice, and respect for persons, as outlined in the Belmont Report.

...