How should we handle financial conflicts of interest in FDA-regulated clinical trials?

Question:

May the inventor of a new therapy using gene editing technology also be the principal investigator of the study and owner of the clinical trial site conducting the clinical trials? It seems that there could be an ethical issue if the principal investigator has a proprietary or equity interest in new therapy.
- Clinical trial site

Answer:

In answering this question, we are assuming that there is no federal funding such as an NIH grant involved.  Under the FDA regulations, certain conflicts of interest will need to be reported to FDA in accordance with 21 CFR 54.  The FDA, through guidance, encourages sponsors with certain conflicts of interest to work with the FDA prior to the start of the study to “minimize any potential bias.”

In addition, most IRBs will ask about conflict of interest as part of their submission requirements.  An IRB is likely to find that this type of financial conflict would need to either be controlled or eliminated, but that will depend on many factors such as the level of risk to the human subjects and the potential for bias allowed by the study design. 

About the Author

David Forster, JD, MA, CIP | Chief Compliance Officer

Mr. Forster joined Western IRB (WIRB) in 1996 and is currently the Chief Compliance Officer for the WIRB-Copernicus Group (WCG). A strong advocate for human subject protections, Mr. Forster co-chairs the Secretary’s Advisory Committee on Human Research Protections (SACHRP) Sub-Committee on Harmonization. He previously served a four-year term as a member of SACHRP, and was previously a member of the SACHRP Sub-Committee on Inclusion of Individuals with Impaired Decision-Making in Research. Mr. Forster also served on the Certified IRB Professional (CIP) Council. Mr. Forster has a law degree and a Masters in Medical Ethics from the University of Washington.

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