On January 18, 2017, the Common Rule (45 CFR 46, Subpart A), which sets forth requirements for the protection of human subjects involved in research conducted or supported by HHS, was updated for the first time since being issued. The main goals of the updates are to lessen an Institutional Review Board’s (IRBs) administrative burden and enhance human subject protections in the modern environment of clinical research.
FDA’s regulations on human subject protection (21 CFR part 50) and IRBs (21 CFR part 56) help ensure that the rights, safety, and welfare of human subjects participating in FDA-regulated clinical investigations are protected. These regulations generally conform to the Common Rule.
FDA recently published a Guidance for Sponsors, Investigators, and IRBs regarding the Impact of Certain Provisions of the Revised Common Rule on FDA-Regulated Clinical Investigations.
The guidance is intended to address questions regarding the impact of certain provisions of the revised Common Rule on FDA-regulated clinical investigations. Guidance on the updated Common Rule provisions include:
- INFORMED CONSENT
- FDA states that providing a “concise and focused presentation of key information” up front and the new required consent elements concerning data and biospecimen collection and use are not inconsistent with FDA’s current policies and guidances.
- EXPEDITED REVIEW and CONTINUING REVIEW PROCEDURES
- Because FDA has not revised its regulations, IRBs must continue to comply with FDA’s regulations at 21 CFR 56.110(b) and 21 CFR 56.109(f). This also includes those studies that are subject to both HHS and FDA regulations.
In short, FDA has concluded that, as regulations at 21 CFR 56 have not changed, IRBs must continue to comply with FDA’s regulations. Additionally, because the proposed changes to informed consent are not inconsistent with FDA’s current policies and guidances, these elements may be implemented if study personnel choose to do so.
Look for news and announcements from Pearl IRB. Pearl IRB delivers quick, quality expedited and full board reviews without compromising the thorough analysis required by regulations. We are one of only 19 AAHRPP accredited institutional review boards in the United States and are committed to supporting high quality research by strengthening human subject protection programs. To learn more about our IRB services click here.