General Guidelines for Submitting a Human Subjects Proposal for Review

The U.S. Department of Health and Human Services has mandated that research which involves human subjects must be approved by an Institutional Review Board (IRB) to ensure the safety and the appropriate use of humans as subjects in research studies. All protocols involving human subjects must be submitted to the Protection of Human Subjects Committee at the College of William and Mary for approval or exemption. Please review the related information regarding exemption from the review process, expedited or full review, and informed consent procedures located under the Grants Office web site/Institutional Compliance Committees/Committee for the Protection of Human Subjects.

In some cases the investigator will submit the protocol to a department review board prior to submitting to the College Committee. Once the proposal has cleared the department board, if one exists, it is then submitted to the Chair of the College Committee with the Ethics Proposal For Research With Human Participants cover sheet which may be downloaded from the above web site. Based upon guidelines provided by the Department of Health and Human Services, the Protection of Human Subjects Committee will either exempt the protocol from formal review or require that it undergo either 1) expedited review by the Chair, and typically, selected member(s) of the committee, or 2) review by the full committee during a convened meeting.

A properly completed protocol will include a brief rationale for the study, the full procedures, a description of the participants, a copy of all tests, questionnaires, all interview questions, a copy of the informed consent form, and other pertinent information. You must use the Protocol and Compliance Management system found on the Self Service tab within myWM to submit your project proposal. Normal review times are one to two weeks for an expedited review and one month for a full review if all the above information has been included. **Please allow sufficient time for review**

05/11/06