Procedure for Identifying and Managing Investigator and Institutional Conflicts of Interest - IRB PRO123

Procedure for Identifying and Managing Investigator and Institutional Conflicts of Interest - IRB PRO123

Abstract:
This procedure outlines the responsibilities of the Investigator, IRB, and OIRB for handling Investigator and Institutional Conflicts of Interest.
Effective Date:
10/29/2010
Responsible Party:
Contacts:
None Assigned
Administrative Category:
Applies To:
Faculty, Staff, Students
Material Original Source:
UAB Human Research Protection Program

HRPP Document:     PRO123
Effective Date:   3/30/07
Revision Date:  2/16/10. 10/29/10
Subject:  Procedure for Identifying and Managing Investigator and Institutional Conflicts of Interest

PROCEDURE

Investigator Responsibilities

An investigator:

  • Discloses to the CIRB all financial conflicts of interest required under the CIRB reporting process and, if known, any potential institutional conflict of interest with the research as defined by UAB's Institutional Conflict of Interest Policy (see SUP401). 
  • Notifies the IRB of a conflict of interest as defined by the CIRB (see GUI321 FAQ on Disclosure of Financial Interests);
    • During initial IRB application process;
    • During continuing review application process;
    • By submitting an amendment or notifying OIRB Director of a previously undisclosed conflict within 10 days of becoming aware of it.

IRB Responsibilities

The IRB:

  • May review research during a convened IRB meeting following CIRB review and completion of a conflict management plan;
  • May approve research with limited modifications pending CIRB review, and issue formal approval through the expedited review procedure if CIRB identifies no financial interest that requires disclosure or requires divestment of all financial interests that require disclosure;
  • Schedules for convened review using the amendment process any subsequent conflict of interest that arises after IRB approval of a protocol;
  • May, after reviewing CIRB recommendations:
    • Approve an amendment for conflict of interest and complete IRB review through the expedited review procedure;
    • Place the protocol on administrative hold until the CIRB management plan is reviewed; or
    • Refer to an independent IRB for review.
  • Accepts or rejects the recommendations of the CIRB. If the IRB does not accept all the recommendations or requires additional safeguards for patient protection due to a conflict of interest, it will provide reason(s) for its actions in writing to the Principal Investigator and the CIRB.
  • Receives reports of Institutional Conflict of Interest (COI) from the CIRB through the OIRB and reviews the determination made by the ICOI Committee for Research and the President. The IRB of record has the final authority to decide whether the interest and its management, if any, allows the research to be approved.

OIRB Responsibilities

OIRB Director/Senior/Office Administrative/Staff:

  • Refer notifications and disclosures, if any, of conflict of interest on initial, continuing review or amendment applications to the CIRB and documents in the IRB records.
  • Upon finalizing the agenda, send a report to the CIRB at least 1 week prior to the meeting listing the following information:
    • Principal Investigator's name
    • Title of Protocol
    • Sponsor
    • OGCA link and/or tracking number, if available
    • IRB protocol number
    • Other research personnel (including other investigators, informed consent process)
  • Draft approval letters for protocols involved with review by the CIRB clearly acknowledging that the protocol approvals are contingent upon a determination by the CIRB that a significant conflict of interest does not exist, and protocol activities may not begin until the CIRB renders a final determination. If a significant conflict of interest is identified by the CIRB, the protocol returns to the IRB for convened review.
  • Assist in arranging review by the convened IRB when protocols with contingent approval are subsequently identified to require a conflict of interest management plan by the CIRB.
  • Draft and forward letters to the CIRB and PI when any of the CIRB recommendations are not accepted or additional safeguards added.
  • Receives determination of ICOI and includes determination in information sent to the IRB for review. 

Institutional Official Responsibilities

Institutional Officials (which include University President; University Provost and Vice/Associate/Assistant Provosts; University Vice Presidents; Deans; and other senior administrators, as determined by the University):

  • Reports at least annually (see attached disclosure form) any financial or fiduciary interests;
  • Reports any updates within 10 working days after financial and/or fiduciary interests change.

Institutional Responsibilities

The CIRB:

  • Reviews conflicts of interest of investigator(s) including study staff performing human subjects research protocol to determine significance of any conflicts and develops conflict management plans to reduce mitigate, or eliminate any conflicts.
  • Provides written determinations on management of conflict of interest or notification that no conflicts of interest exist related to the protocol under consideration by the IRB. Information must be in sufficient detail for the IRB to assess the importance of the conflict of interest and its proposed management to protect the subjects rights and welfare;
  • Queries UAB Departments and affailiated entities on a quarterly basis for information on institutional financial interests as defined in ICOI policy and confirms reporting of those interests to the ICOI Committee for Research;
  • Receives listings at least bi-weekly of all new protocols submitted for review to the OIRB/IRB to examine for any known or potential ICOI;
  • Reports findings or determinations of known or potential ICOI to the OIRB/IRB.

Approved on October 29, 2010, by:

Richard B. Marchase, PhD
Vice President for Research and Economic Development

Teresa D. Bragg
University Compliance Officer

Ferdinand Urthaler, MD
IRB Chair

Sheila Deters Moore, CIP
OIRB Director