PROCEDURE

Investigator Responsibilities

Discloses to the Conflict of Interest Review Board (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 (COI) 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

OIRB Responsibilities

Reviewing Staff:

Refer notifications and disclosures, if any, of conflict of interest on initial, continuing review or amendment applications to the Conflict of Interest Review Board and documents in the IRB records
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 the IRB requires additional safeguards added for participant protection due to a conflict of interest.
Receives determination of Institutional Conflict of Interest (ICOI) and includes determination in information sent to the IRB for review.

IRB Responsibilities

May review research during a convened IRB meeting when notified of a potential conflict through information provided by the investigator or following CIRB review and completion of a conflict management plan
May request additional information for research 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 may require additional safeguards for patient protection due to a conflict of interest and will provide reason(s) for its actions in writing to the Principal Investigator and the CIRB
Receives reports of ICOI 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.

Institutional Responsibilities

Institutional Official:

Reports at least annually (LINK TO COI mechanism to report) any financial or fiduciary interests.
Reports any updates within 10 working days after financial and/or fiduciary interests change.

CIRB:

Reviews conflicts of interest of investigator(s) 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 related to the human subjects research 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 affiliated entities for information on institutional financial interests as defined in ICOI policy and confirms reporting of those interests to the ICOI Committee for Research;
Reports findings or determinations of known or potential ICOI to the OIRB/IRB.