The Human Investigation Committee (HIC) is introducing new policies concerning Financial Conflict of Interest on research protocols submitted for HIC review and approval. Wayne State University (WSU) is committed to the promotion of the highest level of integrity and ethics in all research endeavors in the institution and the HIC is enhancing its ability to identify and manage when appropriate Financial Conflict of Interest (FCOI). In accordance with federal and state regulations and guidance from the Office of the Human Research Protections (OHRP) and other federal agencies, a policy has been developed to assist faculty, staff and Institutional Review Board (IRB) members in identifying the potential for FCOI within research situations.

Individual and Institutional Financial Conflict of Interest refer to situations in which financial considerations may compromise or have the appearance of compromising, an investigator’s professional judgment in conducting or reporting research. The bias such conflict may conceivably impart not only affects collection, analysis, and interpretation of data, but also the hiring of staff, procurement of materials, sharing of results, choice of protocol, involvement of human participants, and the use of statistical methods. Examples of potential financial considerations include salary; equity; stock options; stock warranties; consulting fees; royalty interest; income from seminars, lectures or teaching engagements; income from service on advisory committees or review panels; legal partnerships; gifts to their institutions; and other forms of payments to the investigators, key personnel, their spouses, domestic partners and dependent children.

Individual Financial Conflict of Interest and Institutional Financial Conflict of Interest are addressed in the WSU Financial Conflict of Interest and Commitment Policy
(http://www.research.wayne.edu/coi/). The Human Investigation Committee (HIC) Policy & Standard Operating Procedure compliments the University’s Policy and specifically addresses communication between the University’s Financial Conflict of Interest Committee and the IRBs, the role the HIC plays in providing additional oversight in conflict of interest issues, as well as when the HIC may want to inform the research participant about real or perceived FCOI. Together, these measures are designed to ensure that no real or perceived conflict of interest will adversely affect the objectivity in the conduct of research that involves human participants.

As part of the newly revised Medical/Behavioral Protocol Summary Form, each individual involved in the research project must address the potential for FCOI. If a potential for FCOI exists, that individual must complete the Financial Conflict of Interest Detailed Disclosure Form that is covered under the University’s FCOI research policy. This University’s disclosure form must be completed annually or when changes occur. If disclosures have not been made prior to the submission of the research protocol to the IRB, investigators and key personnel will be required to report these relationships to the FCOI Committee before the protocol can be approved by the IRB. Review by the University’s FCOI Committee and the HIC can occur as parallel processes with the final approval by the HIC occurring after the FCOI Committee has completed their review and approval.

Disclosures to the FCOI Committee are confidential and all employees of WSU who have been provided information from the FCOI database must maintain a high level of confidentiality. Under normal procedures, the HIC administrative personnel and the members of the individual IRBs will not have access to the actual disclosures of other employees or their families. However, select HIC administrative personnel will have administrative access to the summary report that indicates whether of not a potential FCOI might exist and the level of potential FCOI that has been assigned by the FCOI Committee.

The FCOI Committee will have primary responsibilities to review relationships between investigators, key personnel, and individuals who may have an institutional FCOI. Based upon their review, they may require the implementation of a FCOI Management Plan to reduce and/or eliminate the potential FCOI. When a management plan has been established, the IRB will have the authority to review and add additional requirements to the FCOI Management Plan that pertain to the protection of human participants in the proposed research protocol. The IRB will not have the authority to remove a condition in the Management Plan that was approved by the FCOI Committee. However, if appropriate, the IRB may request that the FCOI Committee remove a condition that they have previously incorporated into the Management Plan.

When the IRB is reviewing a research protocol in which a FCOI has identified, the IRB may require that a statement be added to the research informed consent and assent documents about the financial holdings of investigators and key personnel. As part of the IRB review, the IRB will determine if parts of the management plan should be disclosed to the research participants in the research consent and assent documents.

If you have further questions about the HIC policies and procedures regarding FCOI, you can contact the HIC Education Coordinator, Patti Webber, RN at (313) 577-9534 or email her at pwebber@wayne.edu.