The Ever Increasing Importance of Financial Conflict of Interest

It has been eleven years since the NIH last updated their federal regulations on financial conflict of interest (42 CFR 50, Subpart F). But, during that time, and especially over the past four years, a lot has been discussed about conflict of interest (COI).

What started out as concerns over the loss of intellectual property has now morphed into overall requirements for research security, with conflict of interest as the lynchpin. Specific concerns arose over four years ago that researchers may not be entirely forthcoming in their disclosures about international activities. Since that time, NIH has instituted multiple new requirements, including the provision of agreements that faculty may have with international entities for outside activities.

COI offices across the United States have had to respond with updated policies and training, and revised “disclosure forms” that now prompt researchers to appropriately disclose international activities. This will culminate soon in the adoption of “common forms” to be used by NIH, the National Science Foundation (NSF), and other federal granting agencies to ensure that senior and key personnel on grants are disclosing their outside research activities to funders as well as the required “Research Security Program” for institutions receiving more than $50 million in annual research funding from the federal government. Both requirements stem from the adoption of the National Security Presidential Memorandum-33 issued in January, 2020.

This means that academic COI offices will need to continue to up their game by improving processes and requirements, all the while supporting the research enterprise. That is a tall order, but COI professionals are dedicated to ensuring that research is conducted in the most ethical manner, which means requiring disclosures of activities and financial interests to institutions, and being transparent about relationships to research participants in the informed consent process and publishers when reporting on research results in the scientific literature.

The 2022 PRIM&R Annual Conference will feature several sessions focused on the ethical need for transparency and compliance. These sessions will no doubt help COI professionals, and others, navigate the complex and moving landscape of conflict of interest as we know it today.

Stacy Pritt, DVM, MS, MBA, CPIA, CHRC, EXCS, EXoP(EAR), DACAW, is the Associate Vice President for Research Support and Regulatory Management at the University of Texas Southwestern Medical Center. She also holds a faculty appointment as Assistant Professor of Psychiatry (Ethics Division).

Dr. Pritt is a recognized authority on animal program regulatory compliance. She regularly speaks to research audiences and has authored more than 25 publications on management and regulatory compliance. A recipient of numerous awards, Dr. Pritt serves on the Board of Directors for the American Society of Laboratory Animal Practitioners (ASLAP) and Americans for Medical Progress (AMP).  She is a past-president of the American College of Animal Welfare (ACAW) and Laboratory Animal Welfare Training Exchange (LAWTE).