Does a physician, in private practice, conducting research with an FDA regulated product, need to obtain IRB approval?

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Yes. The FDA regulations require IRB review and approval of regulated clinical investigations, whether or not the study involves institutionalized subjects. FDA has included non-institutionalized subjects because it is inappropriate to apply a double standard for the protection of research subjects based on whether or not they are institutionalized.

An investigator should be able to obtain IRB review by submitting the research proposal to a community hospital,a university/medical school, an independent IRB, a local or state government health agency or other organizations.

About the Author
Proxima CRO Team
Stephanie Mull
Director of Project Management

Stephanie has over 20 years of clinical research experience working from the site, CRO and sponsor perspectives. She graduated Summa Cum Laude from Concordia University in St. Paul, MN, with a degree in Natural Science - biology and math.

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