Clinical Research Conflict of Interest Review
This page explains the management of real or apparent conflicts of interest for investigators conducting NIH Intramural clinical research, and/or when the NIH IRB is the Reviewing IRB.
This page explains the management of real or apparent conflicts of interest for investigators conducting NIH Intramural clinical research, and/or when the NIH IRB is the Reviewing IRB.
Background
The Federal Government aims to eliminate or minimize actual or perceived conflicts of interest (COI) in clinical research to promote objectivity and maintain public trust.
Financial and other COI can result in incentives that are not aligned with the best interests of research participants. Such conflicts have the potential to compromise the rights, welfare and safety of human subjects participating in research and/or bias the analysis of study data.
The existence of real or perceived conflicts of interest can undermine public trust in research. Hence, the review and management of conflicts of interest are designed to minimize any potential impact of the conflict and provide assurance that NIH conducted research comports with the highest ethical standards.
Types of COI
In general, federal law and NIH policies do not permit any investigator to work on a protocol in which they have a disqualifying financial or other interest.
At the NIH, there are 2 types of financial COI (fCOI) that are managed:
- NIH investigators may have disqualifying financial or other interests that must be managed when they work on Covered Research Protocols.
- NIH investigators may have intellectual property rights that may lead to payment of government royalties related to the research under review. While not legally considered an fCOI, this situation may in some circumstances result in the appearance of a conflict of interest.
NIH Requirements
All investigators, whether NIH or non-NIH employees, who are conducting research on behalf of the NIH Intramural Research Program (IRP), must follow the applicable federal laws and NIH policies that govern financial and other COI.
Deputy Ethics Counselor (DEC) Review
NIH Institute/Center (IC) DECs review disqualifying financial interests for NIH investigators. The NIH requires that the potential for actual or apparent conflict of interest be considered for all investigators and certain individuals who are working on a Covered Research Protocol. For more detailed information and instructions, see:
Protocol Royalty Analysis Review
The Protocol Royalty Analysis Committee (PRAC) reviews research conducted by NIH inventors who have or may receive royalties when they are investigators on clinical studies of their own inventions.
For more detailed information and instructions related to PRAC review see:
IRB Review
Guidance issued by the Office of Human Research Protections (OHRP) advises that Institutional Review Boards (IRBs) consider whether investigators have financial or other interests that may impact the rights and welfare of research participants. In addition to DEC and PRAC reviews, the NIH IRB may impose additional management strategies consistent with Policy 102.
When the NIH IRB is the reviewing IRB for non-NIH investigators, it will review COI management plans provided by relying institutions. Lastly, there are some important details NIH investigators should be aware of when the research is being reviewed by and external IRB. See additional details below.
The NIH IRB serves as the reviewing IRB for other institutions, including non-governmental institutions. These institutions have COI policies that differ from NIH, and non-NIH investigators may have COI that are not permitted under NIH policy. Such conflicts require management plans to ensure the safety of human subjects and the integrity of the data. The determination of whether there is a financial or other COI generally lies with the investigator’s home institution. However, when the NIH IRB is the reviewing IRB, it also has certain obligations that must be met. Therefore:
- A summary of the management plan from the home institution HRPP must be provided to the NIH IRB for review.
NIH investigators are not permitted to disclose financial details or the existence of a fCOI or related determinations outside of the NIH, including to an external reviewing IRB. This includes:
- The contents of their confidential financial disclosure to NIH (e.g, OGE 450 filings)
- Outcome of NIH DEC reviews, or
- If an NIH investigator is entitled to royalties for intellectual property being evaluated in the study
Instead, the NIH sIRB team will disclose how this is managed to the reviewing IRB via the NIH Institutional Review Memo. No other financial details or disclosures will be provided to the external reviewing IRB.
Related Resources
The What, When and Why of Investigator Financial Conflict of Interest Review
Presented by Tonia Smith Awoniyi, Heather Bridge and Jonathan Green