Conflicts of Interest in Human Subject Research

Financial and non-financial interests can pose conflicts for many health care professionals. Conflicts of interest have the potential to compromise patient care and erode patient-physician trust if not fully disclosed and managed by the health care team. In the area of human subject research, persons involved in research activities also have the potential for similar conflicts of interest. In some situations, these conflicts of interest can carry serious ramifications for research.

Conflict of interest in human subject research remains a topic of much debate. Conflict of interest disclosure is already a requirement of the U.S. Department of Health and Human Service's Food and Drug Administration (FDA) and Public Health Service (PHS). In addition, a mechanism to address conflicts of interest is required as part of the Association for the Accreditation of Human Research Protection Programs, Inc. (AAHRPP) accreditation standards. Aurora's Research Subject Protection Program ("RSPP") is currently pursuing accreditation review by AAHRPP.

In the interest of protecting Aurora's research subjects and the integrity of our research data, and in complying with AAHRPP's accreditation standards, Standard Operating Procedures ("SOPs") are in place to address conflicts of interest in human subject research conducted at Aurora (Aurora IRB SOPs GA104 and FO304). These procedures require all investigators (principal, co-, and sub-investigators), IRB Members, RSPP office staff, and identified administrators involved in research oversight, to report conflicts of interest to the Aurora Research Integrity Committee ("RIC"). RIC members include the Senior Vice President Clinical of Aurora Health Care, the designated Institutional Official, and a non-affiliated bioethicist. The RIC can obtain consultations with third parties as needed. Read the RIC Mission Statement.

The "Investigator Conflict of Interest Statement" (Aurora IRB Form GA104-A) is used to disclose information pertaining to a conflict of interest. If the disclosure indicates that there is a potential or perceived conflict of interest, further information may be requested by the RIC to determine the significance of the conflict of interest. The RIC will recommend to the Aurora Institutional Review Board (IRB) ways to manage identified conflicts of interest that have the potential to adversely affect the safety of research subjects or research data.

Research protections are of the utmost importance at Aurora Health Care. This includes the appropriate management of any potential or perceived conflicts of interest in research conducted at Aurora. Please direct any questions regarding these requirements to Lori Roesch, manager of the RSPP, who may be reached by calling (414) 219-7744.