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Does a quality improvement project that involves research need to be reviewed by an IRB?

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Does a quality improvement project that involves research need to be reviewed by an IRB?

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Yes, in some cases. IRB review is needed if the research involves human subjects, is not exempt, and is conducted or supported by HHS or otherwise covered by an applicable FWA. (See exempt categories at http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm#46.101.

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