Research COI Management

  1. A potential conflict of interest in research is identified via a new annual outside interest disclosure, disclosure upon submission of an internal regulatory document (grant, contract, IRB or IACUC protocol) or other means.
  2. The potential conflict is reviewed by the Medical Center Conflict of Interest Office and either resolved or scheduled for review by the Conflict of Interest in Research 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 Medical Center Conflict of Interest Office takes an active role in facilitating the creation of the draft plan. If the project involves human study participants, the institutional review board (IRB) will be made aware of the conflict
  4. The draft plan is submitted for review and approval by the Conflict of Interest in Research Committee, which can require specific changes to the plan. Upon completion of the changes, the conflicted investigator's department chair signs off on the plan.
  5. The plan is reviewed and approved by the chair of the Conflict of Interest in Research Committeeand 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. If a conflict of interest exists on sub-award for a PHS-funded project, the awardee institution must be notified prior to expenditure of any of the awarded funds.

Developing a Plan:

Unless the Medical Center Conflict of Interest Office provides you with a customized template, the quickest way to draft a plan is by using the template(s) below, which may be revised using Word. The Conflict of Interest Director and/or Specialist should be contacted as a resource and advocate by calling 716-9300.

Annual Review of Plan: 

At least annually, the conflicted investigator will submit a written report describing how the conflict of interest management plan has been implemented and/or revised since the initial approval. The annual report must be approved by the CIRC in order for the project to continue under the existing management plan. 

Quick Reference

Contact Information
Conflict of Interest Office

Main 336-716-9300

Departmental email
coioffice
@wakehealth.edu

Ways to Give
Last Updated: 07-31-2014
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Disclaimer: The information on this website is for general informational purposes only and SHOULD NOT be relied upon as a substitute for sound professional medical advice, evaluation or care from your physician or other qualified health care provider.