As an institution engaged in non-exempt human subjects research conducted or supported with federal funds, MIT is required to submit a written assurance of compliance with the Federal Regulations for the Protection of Human Subjects (45 CFR 46) as amended, approved by the Office for Human Research Protection (OHRP), Health and Human Services.
COUHES’s oversight of human subjects research is also guided by the Ethical Principles and Guidelines for the Protection of Human Subjects, generally known as the Belmont Report.
COUHES is responsible for the review of all research activities that involve human subjects, whether directly or indirectly, that will be conducted by investigators at or from MIT except for research that meet the criteria for exemption. Investigators conducting research that may meet the criteria for exemption must submit an Exempt Evaluation through COUHES connect and follow the Investigator Responsibilities Guidelines for exempt research. COUHES has authority to:
- Approve, require modifications to secure approval of, defer action on or disapprove research protocols involving human subjects
- Require progress reports from investigators
- Oversee the conduct of research
- Suspend or terminate approval of a study
- Place restrictions on a study
- Conduct reviews and inquiries regarding research activities as needed to obtain information necessary for the fulfillment of their responsibilities under the institutional Assurances
COUHES must approve the research protocol and, when applicable, the consent form(s) to be used to obtain informed consent of subjects prior to the initiation of the research and enrollment of subjects. The decision of COUHES to disapprove a research protocol cannot be overruled by any other institutional body or individual(s).
COUHES approval must be obtained before any human subjects studies are conducted.
Ethical and legal guidelines for conducting studies involving human subjects are explained in the Human Subjects Training course(s). All personnel engaged in the research must complete and pass this course.
COUHES meets monthly, generally on the third Thursday of every month. Meeting dates and times can be found on Dates & Deadlines.
Initial and continuing review of research protocols is conducted either at a convened meeting of a quorum of the membership of COUHES or using expedited review procedures as authorized in 45 CFR 46.