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Office of Research and Development at Wake Forest University School of Medicine


Managing Conflicts

Process in Brief:

1.     A potential conflict of interest is identified via a new disclosure, the submission of an internal regulatory document (grant, contract, IRB or ACUC protocol) or other means.

2.     The potential conflict is reviewed by the Conflict of Interest Administrator and either resolved or set for review by the Conflict of Interest Review Committee.

3.     Some conflicts require a Conflict of Interest Management Plan.  The plan is drafted by the conflicted investigator and his/her department chair.  The Conflict of Interest Administrator often takes an active role in facilitating the creation of the draft plan. If the project involves human study participants, the institutional review board must be made aware of the conflict.

4.     The draft plan is submitted for review and approval by the Conflict of Interest Review Committee, which can require specific changes to the plan.  Upon approval, the chair of the conflict of interest review committee signs off on the plan.

5.     The committee-approved plan is reviewed and approved by the conflicted investigator’s department chair and the Dean of the School of Medicine, or designee.

6.     Work on the project may begin as described in the plan, pending approval of any other regulatory bodies such as the IRB.

 

Developing a plan: Often the fastest way to draft a plan is with the template(s) below, which can be revised in MS Word. The Conflict of Interest Administrator should be used as a resource and advocate.

Annual review of plan:  At least annually, the conflicted investigator will submit a written report describing how the conflict of interest management plan has served its purpose.

Disclosure Language for Publications, Etc.