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:
12/8/2014
Responsible Party:
Contacts:
None Assigned
Administrative Category:
Applies To:
Faculty, Staff, Students
Material Original Source:

 

HRPP Document:     PRO123
Effective Date:   3/30/07
Revision Date:  2/16/10, 10/29/10, 4/4/14, 12/8/14, 7/15/15
Subject:  Procedure for Identifying and Managing Investigator and Institutional Conflicts of Interest

 

PROCEDURE

Investigator Responsibilities

The Investigator:

  • Discloses directly (or indirectly through the external activities request) (SUP418) to the CIRB all financial interests, as specified under the UAB Enterprise Conflict of Commitment and Conflict of Interest Policy (SUP415) and the UAB Institutional Conflict of Interest Policy (SUP401).
  • Notifies the IRB of a financial conflict of interest as required
    • During initial IRB application process;
    • During continuing review application process;
    • By submitting an amendment or notifying OIRB Director of a previously undisclosed conflict within 30 days of becoming aware of it.

IRB Responsibilities

The IRB or Designee:

  • May review research during a convened IRB meeting following CIRB/ICOI Committee review and issuance of a management plan or a decision that no management plan is required;
  • May approve research with limited modifications pending CIRB/ICOI Committee review, and issue formal approval through the expedited review procedure if CIRB/ICOI Committee identifies no financial interest that requires management or requires divestment of all financial interests;  
  • May, after reviewing CIRB recommendations:
    • Approve an amendment for financial 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, which shall use the UAB CIRB/ICOI management plan for their review;
  • Accepts the recommendations of the CIRB/ICOI Committee or if the IRB requires additional safeguards be added for patient protection due to a financial conflict of interest, submits a request for re-review to the CIRB/ICOI Committee that incorporates the IRBs concerns.  The IRB of record has the final authority to decide whether the interest and the CIRB/ICOI management plan, if any, allows the research to be approved.  The IRB may disapprove any IRB project that it determines has insufficient safeguards related to financial conflicts.  
  • 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 the CIRB/ICOI management plan, if any, allows the research to be approved.  The IRB may disapprove any IRB project that it determines has insufficient safeguards related to financial conflicts.

OIRB Responsibilities

Review Staff:

  • If notified of a financial conflict of interest on initial, continuing review or amendment application, reviews management plan in CIRB;
  • Notifies OCIRB and UCO when a protocol application reveals that the institution has a financial interest in a company that owns or controls products being studied or tested;
  • For initial review, any research in which a financial conflict of interest is identified by the CIRB/ICOI Commitee, protocol is reviewed at the same level of review required by the protocol (convened or expedited review);
  • Assists in arranging review by the convened IRB when protocols with contingent approval are subsequently identified and require an investigator financial conflict of interest management plan by the CIRB;
  • Receives determination made by ICOI Committee and includes these in information sent to the IRB for review;
  • Reviews approved protocols that are identified by the CIRB as requiring increased management plan elements by the expedited review procedure. 
Administrative Staff:
  • Drafts approval letter for protocols pending review by the CIRB clearly acknowleding that the protocol approvals are contingent upon a determination by the CIRB that a financial conflict of interest does not exist or can be managed.  The OIRB shall require that protocol activities not begin until the CIRB renders a final determination.

Institutional Official Responsibilities

Institutional Officials (which include University President; Provost; Vice Presidents; Deans; and other senior administrators, as determined by the University Compliance Officer in consultation with the University President):

  • Report at least annually (SUP418) any financial or fiduciary interests;
  • Report any updates within 20 working days after financial and/or fiduciary interests change.

Institutional Responsibilities

The CIRB:

  • Reviews significant financial interests of investigator(s) performing human subjects research to determine if conflict(s) exist and if so, issues management plans to reduce, mitigate, or eliminate identified conflict(s);
  • 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.

ICOI Committee:

  • Reviews financial interests held by the institution and by institutional officials to determine whether conflicts exist and, for research involving human subjects, issues management plans to reduce, mitigate, or eliminate indentified conflicts.

The OCIRB Staff:

  • Enters personal financial interest information disclosed by investigators and institutional officials and institutional financial information into the Integrated Research Administration Portal (IRAP);
  • Prepares agenda for CIRB;
  • Identifies institutional conflicts of interest with research by comparing institutional financial interests with potential sponsors and technology to be studied to tested;
  • Refers institutional conflicts of interest related to proposed research with human subjects to the University Compliance Office for review by the ICOI Committee;
  • Enters conflict of interest management plans into IRAP and communicates management plans to investigators.

The University Compliance Office Staff:

  • Convenes ICOI Committee as needed to review identified ICOIs;
  • Prepares ICOI Committee recommendations for President and communicates final determinations to OIRB and OCIRB.

Approved on July 15, 2015, by:

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

Teresa D. Bragg
University Compliance Officer

Karen Iles, PhD
Director, OCIRB

Ferdinand Urthaler, MD
IRB Chair

Sheila Deters Moore, CIP
OIRB Director