July 2007 The Organization policy on Conflict of Interest includes specific management requirements applicable to conflict of interest associated with conduct of human subjects research protocols. The OHSR will work with the Office of Policy Coordination (OPC) to ensure that conflicts associated with research protocols are identified and reviewed by the Committee on Outside Interests (COI) before JHM IRB review is completed. The OPC staffs the COI, which is the Committee charged with review of conflict of interest associated with research projects. Effective June 2007, all disclosures of outside interests to the OPC occur through the electronic system known as eOPC. OHSR staff members have access to eOPC for purposes of obtaining management plans and the COI meeting schedule. When feasible, a member of the OHSR Compliance Team attends meetings of the COI to facilitate communications between the two offices. The JHM IRBs may not take final action on new applications until COI review is complete and management recommendations are finalized. An OHSR staff member attends JHM IRB meetings and presents the COI management terms to the IRB. The JHM IRB may accept COI management terms or may impose additional restrictions. The JHM IRB may not approve a study with a level of conflict of management that is less than that recommended by the COI. |
