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If a study involving prisoners previously authorized by OHRP is amended, does the institution need to recertify?

April 26, 2017authorized institution involving OHRP prisoners recertify study

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If a study involving prisoners previously authorized by OHRP is amended, does the institution need to recertify?

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Usually not. OHRP should be notified only if there is a fundamental change in the research that alters the applicability of the approved category under 45 CFR 46.306.