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Focus on Regulation

FDA aims to harmonize its human subject protection regulations with Common Rule

On October 12, FDA published guidance for sponsors, investigators, and IRBs titled “Impact of Certain Provisions of the Revised Common Rule on FDA-Regulated Clinical Investigations.”  The guidance outlines FDA’s expectations for clinical research that is subject to both the FDA’s human subject protection regulations and DHHS’ recently revised Common Rule, which takes effect in January 2019.  FDA’s rules on human subject protection govern clinical investigations regulated by FDA under sections 505(i) and 520(j) of the FDCA, as well as studies used to support applications for research or marketing permits for  products regulated by FDA, while the DHHS Common Rule covers DHHS federally funded research.  FDA’s recent guidance discusses informed consent requirements, expedited review procedures, and IRB continuing review.

Importantly, this guidance makes clear that research subject to FDA rules must continue to abide by those regulations, even when they are more restrictive than the Common Rule.  For instance, FDA maintains the requirement, eliminated in the revised Common Rule, that some low-risk studies undergo an annual check-up known as “continuing review.”  However, IRBs should apply Common Rule measures governing structure and content of informed consent documents, which do not conflict with any FDA regulations.  As one example, the revised Common Rule includes a new requirement that all the key information in informed consent forms be at the top of the form; FDA does not yet require this.

FDA to update rules to match Common Rule provisions

In order to harmonize FDA’s regulations for the Protection of Human Subjects and Institutional Review Boards (IRBs) with the recently revised final HHS Common Rule, FDA plans to issue three more guidances.  The White House’s fall 2018 regulatory agenda, released October 17, indicated FDA plans to go through the formal proposed rulemaking process to finalize these rules, meaning the agency will accept and consider public comments before issuing the guidances in final form.  The three planned FDA guidances are:

  • RIN 0910-AI07, “Part 50 Protection of Human Subjects and Part 56 Institutional Review Boards,” which would add new definitions and conforming language to FDA rules.
  • RIN 0910-AH52, “Institutional Review Board Waiver or Alteration of Informed Consent for Minimal Risk Clinical Investigations,” which would align FDA rules with the Common Rule provision permitting an IRB to waive or alter the informed consent requirements under certain conditions for minimal risk clinical investigations in order to support the development of new products to diagnose or treat disease, or to address unmet medical needs.
  • RIN 0910-AI08, “Institutional Review Boards; Cooperative Research,” which addresses the “single IRB” provision in the Common Rule (the provision that requires each research institution participating in a multi-site study to use the same IRB). This planned guidance is the only one of the three guidances deemed “economically significant” and the only one that was always intended to have a comment period.

Previous OHRP guidances on Common Rule revisions

HHS’ Office for Human Research Protections (OHRP) has also separately issued three draft guidances on the Common Rule revisions on July 20, titled:

  • Draft guidance: Scholarly and Journalistic Activities Deemed Not to be Research: 2018 Requirements
  • Draft guidance: When Continuing Review Is Not Required During the 6-Month Delay Period of July 19, 2018 through January 20, 2019: 2018 Requirements
  • Draft guidance: Elimination of Institutional Review Board (IRB) Review of Research Applications and Proposals: 2018 Requirements

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If you have any questions on the new FDA guidance, please contact one of the authors or the Hogan Lovells lawyer with whom you regularly work.