HSP Module 1: Introduction/Ethical Overview


The first systematic effort to address the field of research ethics began in the latter half of the 20th century. The field expanded rapidly and received national attention in response to revelations of abuses of human subjects in medical research. Although many investigators recognized a duty to protect the welfare of their research subjects long before there were guidelines and regulations, some investigators grossly abused the rights of patients, prisoners, soldiers, the mentally ill and infirm, orphans, and other vulnerable populations. During World War II, researchers in the Japanese military killed Chinese civilians in germ warfare testing. In Nazi Germany, medical researchers conducted a wide variety of dangerous and often fatal experiments on prisoners of concentration camps involving exposure to high altitudes and extreme temperatures, forced drinking of sea water, and burn and transfusion studies. In the United States, perhaps the most notorious case of research abuse was the U.S. Public Health Service “Study of Untreated Syphilis in the Negro Male,” or what has come to be known as the Tuskegee Study. From 1932 to 1971, PHS investigators monitored the progress of untreated syphilis, long after treatment with penicillin had become widely available and established as the standard treatment for syphilis, in a population of rural African-American men who were told they were receiving treatment for “bad blood.” Abuses also occurred in the social and behavioral sciences. Milgram’s Obedience to Authority study, conducted here at Yale, and Humphrey’s Tearoom Trade study were considered to be designed with ethical flaws that exposed participants to risks of serious social and psychological harm. Additional information on these studies is available at the following link.

In the wake of public outrage over some of these studies, the United States Congress passed the National Research Act (1974), which mandated that institutions conducting research with human subjects establish local review boards, termed Institutional Review Boards or IRBs, that are responsible for protecting the rights and welfare of human subjects. The act also required that investigators obtain “informed consent” from all subjects prior to their enrollment in a research protocol. The National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research (hereafter, National Commission) was also established by this act and was charged with identifying the key components of ethical research involving human subjects. One of their reports, known as the Belmont Report and published in 1979, identified three cardinal principles to guide ethical research with human subjects: respect for persons, beneficence, and justice. These principles, and the guidelines also found in this report, have become the benchmark against which research protocols are evaluated from an ethical perspective. IRBs and investigators use them to distinguish research abuses from acceptable human experimentation, as well as to reconcile the rights of research participants with the need to advance scientific knowledge. These principles also form the basis of our current regulatory system for human subjects protections. Links to these regulations and a summary of the Belmont Report are located in the Additional Resources and Links section of this module. The following paragraphs describe each of the Belmont Report’s ethical principles in some detail. The rest of the modules in this resource describe how these principles can be applied in various research settings.