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Policy for human radiation research outlined in manual

MIT's "red book" manual for faculty and staff members, "Policies and Procedures," describes the history and procedures in the section, "5.13 Research on Human Subjects."

"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 guide says.

"In 1964, the World Medical Association adopted the Declaration of Helsinki, a code of ethics in human experimentation. The National Institutes of Health 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 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 the Committee, 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 this Committee, including investigation of new drugs and medical, radiological, physical, psychological, sociological, and nutritional studies. 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.

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....

"The Committee 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. (Editor's note: This applies only to sociological studies, such as situations involving prejudices and perceptions. No deception is allowed in medical studies).

After reviewing the application, the Committee 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.

"Approval of a project must be obtained before any human studies are begun; such approval is valid for one year only," the MIT policy says.

A version of this article appeared in the January 5, 1994 issue of MIT Tech Talk (Volume 38, Number 18).

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