1. Any research project that requires the participation of human subjects, observes human behavior, or utilizes existing data sources (including, but not limited to medical records, laboratory and/or pathology specimens, administrative/billing data, archived data sets) must be approved by the Human Subjects Subcommittee of the OU-COM Research and Scholarly Affairs Committee before being submitted to the Ohio University Institutional Review Board. At the time of application for approval, investigators will complete the OU-COM Human Subjects Subcommittee and the OU Institutional Review Board Applications and submit them to the Office of Research.

2. To gain approval, investigators will submit all research proposals to the OU-COM Office of Research and Grants located in Grosvenor Hall 236. Level of review will be in accordance with Title 45, Part 46 of the Code of Federal Regulations, Protection of Human Subjects (45CFR46). 45CFR46 ensures that study protocols provide adequate protection of human rights and confidentiality.

3. In cases requesting "exempt" or "expedited" approval based on 45CFR46 criteria, the Assistant Dean for Clinical Research and the Director for Clinical Research Development will review the proposals. If the study meets the criteria of review for the stated exemption, they will be approved, and forwarded to the OU Institutional Review Board for its approval process. The proposal will be kept on file in the Office of Research and Grants for future reference.

In cases where a proposal does not meet the criteria for approval, one of two actions will be taken: 1) If approval can be made with clarifications from the investigator, a written request will be made. The investigator will have ten days in which to respond. If clarifications and changes are adequate, the protocol will be approved. If the investigator does not respond during the ten day period, the protocol will be denied approval, in which case a new application must be made. 2) If the protocol does not meet the 45CFR46 "exempt" or "expedited" criteria, the proposal will be forwarded on to the full Human Subjects Subcommittee, and the investigator will be notified of this action. Submitting a protocol as "exempt" or "expedited" which must then be forwarded on for full committee review may result in delays in processing.

4. Upon approval of studies by the Human Subjects Subcommittee, the OU-COM Human Subjects Committee will forward the study to the OU Institutional Review Board for review and approval.

5. The Human Subjects Subcommittee members for 2002-2003 are Bonita Biegalke, Ph.D., Allison Batchelor, M.D., Robert Gotfried, D.O., Jay Shubrook, D.O., Christopher Simpson, D.O.