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.