Committee on the Use of Humans as Experimental Subjects (COUHES)
Chairs of the Committee
|Bernard S. Gould||1976-1984|
|H. Walter Jones, Jr.||1988-1998|
The Massachusetts Institute of Technology Committee on the Use of Humans as Experimental Subjects (COUHES) is responsible for reviewing research projects that utilize humans as research subjects and for devising procedures to ensure that subjects are protected against risk, and that their rights, privileges, and privacy are protected. COUHES policies and procedures are mandated by the president of the Institute in order to comply with the Federal Policy for the Protection of Human Subjects, but the creation of COUHES preceded both United States and international codes regarding ethics in human experimentation.
In 1962 MIT became one of the first educational and research institutions to recognize and act upon the need for a committee of the investigator’s peers to review the use of humans as subjects in research projects. The committee was established under the auspices of the president’s office. The creation of such a body was initially advocated by Harriet Hardy in the mid-1950s in response to experiments involving radiation exposure. In the early 1960s both Hardy and Hans-Lukas Teuber expressed concern about psychological experiments involving the use of hallucinogenic drugs. They recognized the need for an authoritative body to review the protocols of research projects and to ensure that human safety and ethics were not overlooked. They separately brought the matter to the attention of their colleagues and the president’s office. Hardy, who was assistant director of the Medical Department, was asked by the director, Albert Seeler, to set up a mechanism for reviewing potential hazards to MIT students. She created COUHES, a three-member standing committee composed of faculty members. The first committee consisted of Hardy as chair, Benson Snyder, and Martin Lubin. Initially COUHES reviewed primarily medical, science, and engineering projects that used MIT students as subjects.
The policies and procedures of COUHES were devised in meetings with Vice President Malcolm Kispert. Kispert issued a memorandum to department heads on 29 January 1962 stating that all projects involving the use of human subjects needed prior formal approval. The committee met at least once a month on an ad hoc basis. Twice yearly, the committee distributed a description of the project criteria needed to obtain permission to use human subjects. The committee attempted to review and decide on applications within 72 hours of their receipt and the formal permission was written and signed by the director of the Medical Department.
In 1966 Samuel Stein assumed the chairmanship of the committee. In that year the committee expanded to five members who were appointed by the medical director. Three of the members were chosen from the Medical Department including one representative each from the Psychiatric Service, the Department of Psychology, and either the Department of Biology or the Department of Nutrition and Food Science. Subject to the approval of the medical director, the committee made recommendations on each application. All approvals were limited to one year.
Throughout the 1960s COUHES developed a body of precedents and broadened its responsibilities to encompass any MIT experimental research that involved the use of human subjects. The committee concerned itself with such matters as suggesting alternative methods of experimentation; invasion of privacy and breach of confidentiality; informed consent; and establishing a system for evaluating the protocols of the project proposals.
In 1964 the World Medical Association (WMA) adopted the Declaration of Helsinki, a code of ethics in human experimentation. The National Institutes of Health adopted the WMA standard in 1966 and made review mandatory for all projects funded by that agency. By 1971, such review was required for all human experimentation, regardless of funding sources, in institutions receiving federal funds for human research. The same year, the Food and Drug Administration adopted similar review principles for the investigation of new and experimental drugs.
In 1967 COUHES review procedures were formalized in order to meet the necessary standards of the Department of Health, Education, and Welfare and the National Institutes of Health. The committee was expanded to include administrators and students in August of 1970. An official mandate was proposed 19 November, and approved by President Jerome Wiesner on 23 March 1971. As a result of the mandate, COUHES was also responsible for reviewing psychological and behavioral science experiments involving human subjects, but diagnosis and treatment of individuals for their own benefit, however experimental, did not fall under the purview of the committee.
By 1975 COUHES members were appointed directly by the president of MIT. The membership typically consists of biologists, nutritionists, physicians, political scientists, psychologists, students, other members of the Institute community, and non-Institute members. After 1979, COUHES was also charged with reviewing the experimental diagnosis or treatment of human subjects, whether or not such diagnosis or treatment was for the benefit of the individual.
Prepared by the Institute Archives, MIT Libraries
October 1995; updated October 2010