Disclose—reporting the specific nature, amount, and relationships of financial interests as defined by UAB’s conflicts of interest policy and guidelines.
Notify—reporting the existence of a conflict or potential conflict of interest as defined by UAB’s conflicts of interest policy without additional identifying information.
Conflict of Interest—a set of circumstances that creates a risk that professional judgment or actions regarding a primary interest will be unduly influenced by a secondary interest.
UAB policy and guidelines on conflict of interest include specific requirements applicable to conflict of interest associated with the conduct of human subjects’ research protocols. Under its Conflict of Interest Policy UAB maintains a Conflict of Interest Review Board (CIRB). The UAB IRB and OIRB will collaborate with the UAB CIRB to ensure that financial conflict of interest are identified and managed before the UAB IRB completes its review of any protocol. The UAB IRB and OIRB have established procedures to implement this collaborative arrangement. (See also:PRO123 Procedure for Identifying and Managing Investigator Conflict of Interest; SUP415 UAB CONFLICT OF INTEREST POLICY; SUP416 Conflict of Interest Review Board (CIRB) Manual; GUI321 FAQs on Disclosure of Financial Interests; and DHHS Financial Relationships and Interests in Research Involving Human Subjects: Guidance for Human Subject Protection 69 FR 26393 (May 12, 2004); FDA Financial Disclosure by Clinical Investigators, Board of Trustees of the University of Alabama Rule 106.
The IRB will determine (1) whether the methods used for management of individual or institutional financial interests adequately protect the rights and welfare of human subjects; (2) whether other actions are necessary to minimize risks to subjects; and (3) the kind, amount, and level of detail of information that must be disclosed to research participants regarding: (1) the financial interests of the institution, (2) the interest of individuals involved in performing the research and (3) any conflict management arrangements applied. Should circumstances arise where the IRB determines that the review of research creates a conflict of interest on the part of the IRB as a committee, the IRB will communicate this determination and the reasons for this decision in writing to the Institutional Official, who will make arrangements for outside independent IRB review of the research.
In instances where a conflict of interest review is under negotiation by the CIRB, the IRB will not give final approval to a protocol until the CIRB review and conflict management plan is finalized. The IRB may not change the terms of the CIRB conflict management plan. Whenever a conflict of interest arises or is identified after IRB approval of research, the investigator will promptly disclose the conflict to the CIRB and notify the IRB. The CIRB will formulate a plan to manage the conflict of interest with respect to the human subjects research activity and inform the investigator and the IRB of its recommendations. The investigator will submit promptly an amendment for the research protocol to the IRB. The convened IRB will review the management plan and may choose to accept or reject the terms of the conflict management plan. If the IRB rejects all or part of the CIRB management plan, it will provide reasons for its decision to both the Principal Investigator and the CIRB. The IRB will consider financial conflict of interest at the time of initial and continuing review.
Investigators and research team members with financial conflicts of interest will disclose these to the CIRB and notify the IRB if such conflicts exist. Investigators with conflicts of interest will consider (1) the potential effects that a financial relationship might have on the research or interaction with research subjects; (2) whether information about the conflict should be included in the informed consent document; and (3) whether special measures to modify the informed consent process are indicated, such as involving an individual without a conflict of interest as an observer of the informed consent process or using an independent monitor of the research.
Approved on March 1, 2010, by:
Richard B. Marchase, PhD
Vice President for Research and Economic Development
Ferdinand Urthaler, MD
Sheila Deters Moore, CIP