 |
Chairs
of the Committee
| Harriet
Hardy |
1962-1966 |
| Samuel
Stein |
1966-1970 |
| Warren
Point |
1970-1976 |
| Bernard
S. Gould |
1976-1984 |
| George
Wolf |
1984-1988 |
| H.
Walter Jones, Jr. |
1988- |
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 committee consisted of fifteen members, including a chairperson,
and typically included biologists, 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. Currently (as of 1995), COUHES,
is composed of fifteen members, including at least one non-MIT member,
two student members, three active physicians, and at least one member
whose primary concerns are in non-scientific areas.
Prepared
by the Institute Archives, MIT Libraries
October 1995
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