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103.11 Organization Policy on Committee on Outside Interests (COI) and the JHM IRB

April 2016

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 personal and institutional conflicts of interest associated with research projects. All disclosures of outside interests to the OPC occur through the eDisclose electronic system. OHSR staff members have access to eDisclose 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, management recommendations are finalized, and any required conflict of interest language has been included in the consent form. An OHSR Compliance Team member attends JHM IRB meetings and presents the COI management terms to the IRB. The JHM IRBs may not approve a study with a level of conflict of management that is less than that recommended by the COI, but may impose additional terms or restrictions.  The JHM IRBs have final authority to determine whether the management of a disclosed interest is sufficient to permit the approval of associated research.

As described in OPC policies, all investigators must disclose outside activities using eDisclose. The term “Investigators” includes principal investigators, co-investigators, and all study team members on eIRB applications. In addition, the financial interests and fiduciary relationships of a spouse, domestic partner, or minor dependent, must be disclosed of they relate to the Investigator’s institutional responsibilities. All outside activities and financial interests must be disclosed; there is no threshold for disclosure.