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Office of Research Integrity

HRPP 1.6 Communicating Conflict of Interest (COI) among IRB, ORSP and University COI Committees

Policy Name: Communicating Conflict of Interest (COI) among IRB, ORSP and University Research COI Committees
Approved:
Effective Date: 01/27/2012Page 1 of 2Section: HRPP 1.6
Replaced Policy: Effective 09/10/2009

I.  POLICY

 Disclosures of individual and institutional Conflicts of Interest (COI) are received through a variety of avenues. These may be received through the Annual COI Disclosures, the Institutional Review Board (IRB), the Office of Research and Sponsored Programs (ORSP), and/or by a variety of MUSC Officers and administrators who request a review for potential or real conflicts and are initially reviewed by the MUSC/MUHA COI Triage Group as part of the MUSC/MUHA Conflict of Interest Operations. Disclosures related to research are forwarded for review through the University Research COI Review Committee, which includes membership from the staff of the ORSP and the IRB.

It is this Committee's responsibility to review the requests in a timely manner, to maintain confidentiality, and to communicate their recommendations, findings and actions to the requesting unit and/or impacted unit in either detailed or summary form as appropriate, and to copy the written committee deliberations to the responsible University Officer.

The IRB manager is notified of any disclosure involving human subjects received by the University Research COI Review Committee or ORSP.

II. PROCEDURE

A. Upon disclosure of a conflict of interest in the IRB initial protocol application (Human Research Conflict of Interest Disclosure Form) an electronic notice is sent to the Office of Research and Sponsored Programs (ORSP). The ORSP Administrative Assistant coordinates the necessary documents between the researchers and the Research COI Review Committee Chair and when Financial Interests are involved, the researcher will complete the Financial Interest Disclosure Form and submit this form to the Research COI Review Committee. The IRB will also receive the Financial Interest Disclosure Form, which includes an initial proposal for managing the conflict of interest.

B. The chair of the University Research COI Review Committee determines whether an administrative review is appropriate or if full committee review is warranted and notifies the IRB Manager by written communication.

C. The IRB will receive the conflict resolution as submitted by the researcher on the Financial Disclosure Form. If the Research COI Review Committee requires a Conflict Management Plan beyond what the researcher proposed, the IRB and ORSP will be notified that a specific management plan is under development. If and when a Committee reviewed and approved COI Management Plan has been approved, the Management Plan must be reviewed by the IRB prior to full IRB approval of the protocol.

D. All management plans developed by the University Research COI Committee are provided to ORSP and those Plans involving human subjects will also be provided to the IRB Manager. The Office of Conflict of Interest is responsible for recording and monitoring COI management plans with relevant outcomes reported to various parties including the IRB and ORSP.

E. The IRB has the final authority to decide whether the approved management plan for any disclosed conflict of interest allows research protocols involving human subjects to be approved.