Overview

Federal mandate (“The Common Rule,” 45 CFR pt. 46) and longstanding MIT policy require that the Committee on the Use of Humans as Experimental Subjects (COUHES) review and approve ALL research involving human subjects that is performed under the auspices of MIT.

Types of research that must be reviewed by COUHES include investigation of new drugs and medical, radiological, engineering, physiological, behavioral, sociological, and nutritional studies. COUHES’s jurisdiction includes projects involving human tissues, blood, or images, and questionnaires, interviews, and other procedures.

Some categories of research are exempted from review by federal regulation. However, it is COUHES’s responsibility to make a determination on a study’s exempt status, and so ALL projects involving human subjects at MIT must be reviewed and either approved or ruled exempt by COUHES.

COUHES approval must be obtained BEFORE any human subjects studies are begun. For research involving minimal risk, approval is granted for one year and must be renewed annually. For research involving more than minimal risk, renewal frequency will be determined by the Committee upon approval.

Ethical and legal guidelines for conducting studies involving human subjects are explained in a training course. All personnel who participate in any way in studies involving human subjects must complete and pass this course.

Criteria for acceptance of studies, as well as other COUHES policies and procedures, definitions, and resources including an investigator quick guide, are provided at other segments of this website. (These may be accessed via hyperlinks or menus.)

COUHES acts as the M.I.T. Privacy Committee and ensures that any research determined to be subject to HIPAA, the federal health information privacy law, conforms to the requirements of the HIPAA Privacy Rule.

COUHES meets on the third Thursday of each month. (Dates may change without notice.) Applications for review by the Committee are due approximately three weeks prior to the meeting.