Responsible Conduct of Research Track
2019 AER Conference
E16 - IRBs and Conflict of Interest (COI) Oversight—Mind the Gaps
John R. Baumann, PhD
Associate Vice President for Research, Indiana University
Scott J. Lipkin, DPM, CIP
Managing Director, Health Solutions, Ankura Consulting, Ankura Consulting
Shelby Moench, BA
HRPP/IRB Director, Intermountain Healthcare
Speaker(s)
This session will present three areas highlighting shared goals of IRB and COI oversight, including: (1) the point of intersection between COI and IRB review with a focus on where these processes overlap and where they diverge, and how this combination of overlap and divergence may introduce gaps in the review and management of said conflict; (2) the need for and set up of the foundations of a strong research COI program, with a case study discussion on how a national multi-centered research group convened a national COIs Advisory Council, as well as the goals for the Council; (3) while there are federal COI regulations, designed to promote objectivity in research and mandate disclosure, management, and reporting of COIs related to research, there are no controls related to COI disclosure requirements to scientific journals. Moreover, journals do not fact-check or enforce COI disclosure requirements and those who fail to disclose financial relationships to journals create circumstances that call into question the objectivity and validity of their research, leading to institutional vulnerability. During this session, speakers and attendees will:
Learning Objectives:
- Review the regulatory requirements and ethical principles as related to research COI and the foundations of a strong research COI program
- Identify points of overlap and divergence in the COI and IRB processes
- Discuss best practices for COI and IRB review of outside financial interests related to human subjects research
- Share challenges that the IRB faces in assessing conflicts of interest, and approaches to minimize them
- Explore the pros and cons of monitoring faculty/staff journal disclosures and provide examples of sample monitoring programs