14.3 Research on Human Subjects

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In 1962, MIT became one of the first educational and research institutions to recognize and act upon the need for a committee of an investigator's peers to review the use of humans as subjects in research projects. In 1964, the World Medical Association adopted the Declaration of Helsinki, a code of ethics in human experimentation. The National Institutes of Health (NIH) in 1966 made such review mandatory for all projects funded by that agency. By 1971, such review was required for all human experiments, governmentally funded or not, in each institution receiving federal funds for human research. In the same year, the Food and Drug Administration adopted similar review principles for the use of investigational new drugs.

With these considerations in mind, the President of the Institute has charged the Committee on the Use of Humans as Experimental Subjects (COUHES) with the review of every project utilizing humans as research subjects. If diagnosis or treatment of a diseased individual is experimental, approval must be obtained from COUHES, even if such diagnosis or treatment is for the benefit of the subject.

All types of research using humans as experimental subjects fall within the purview of COUHES, including investigation of new drugs and medical, radiological, physical, psychological, sociological, and nutritional studies. This encompasses research performed under the auspices of MIT or any part of MIT, as well as research involving any form of MIT support, such as funding, personnel, facilities, academic credit, or access to experimental subjects. Such research is included wherever it is performed. Collaborative projects with other institutions must be approved by the institutional review boards of each institution. If the use of radioactive materials or other sources of radiation energy is proposed, the project must also have the approval of the Committee on Radiation Exposure to Human Subjects.

Investigators who contemplate the use of humans as research subjects may obtain informational material and application forms from the office of the chair of COUHES. Applications as submitted must be signed by the responsible investigator and by the department head or laboratory director.

The application must describe completely the procedures to be used on humans, including as appropriate: medication, diets, psychological and physical stress, any physical agents such as electrical stimulation, radiation, or radioactive materials. In psychological or sociological experiments, sample questionnaires or examples of proposed interviews must be submitted. Any embarrassment, humiliation, or deception of persons as subjects in experiments must be revealed. Means whereby confidentiality of information and anonymity of subjects are maintained must be described. COUHES gives special consideration to the manner by which informed consent will be obtained and documented. It requires that all risks to the individual be justified on the basis of potential benefits with full protection of the subject's rights and welfare. Justification for deception in the course of an experiment must be explained carefully, and methods described to repair any damage occasioned by such deception.

NIH policy requires the inclusion of minorities and women in study populations so that all persons share the benefits and burdens of research; NIH applications must address this issue.

After reviewing the application, COUHES reports its decision in writing to the responsible investigator; a copy is sent also to the appropriate department head or laboratory director and to all other interested parties. In the event of an unfavorable decision, COUHES endeavors to assist the investigator in modifying the experiment to meet its requirements. Approval of a project must be obtained before any human studies are begun; such approval is valid for one year only. Any changes in the use of human subjects must be approved by COUHES before such changes are effected.

This policy applies to the use of students as experimental subjects. After the investigator has received the approval of COUHES, requests for student subjects should be referred to the Student Employment Office.

The members and chair of COUHES are appointed by the President. The membership typically consists of biologists, nutritionists, physicians, political scientists, psychologists, students, other members of the Institute community, and non-Institute members.