Impact of Revised Common Rule on FDA-Regulated Clinical Investigations
This guidance clarifies the impact of certain provisions of the revised Common Rule on FDA-regulated clinical investigations, addressing the differences between FDA's human subject regulations and HHS' human subject regulations. It aims to reduce confusion and burden for stakeholders who need to comply with both sets of regulations during FDA's harmonization process.
Recommended Actions
- Continue following FDA’s current requirements for IRB continuing review
- Implement the new informed consent provisions as they are not inconsistent with FDA’s current policies
- Use the 1998 list for expedited review procedures in FDA-regulated clinical investigations
- For dual-regulated studies (HHS and FDA), follow the regulations that offer greater human subject protection
- Monitor FDA’s upcoming rulemaking process for harmonization with the revised Common Rule
- Review and update informed consent forms to incorporate the new organization and presentation requirements
- Submit questions or comments to FDA’s public docket for further clarification if needed
Key Considerations
Clinical testing
- IRBs must continue to conduct continuing review of research at intervals appropriate to the degree of risk, but not less than once per year
- For studies subject to both HHS and FDA regulations, the regulations offering greater protection to human subjects should be followed
Other considerations
- Informed consent requirements:
- New provisions for content, organization, and presentation of information
- Must begin with concise and focused presentation of key information
- Must provide information a reasonable person would want for decision-making
- New basic and additional elements regarding biospecimens and identifiable information
- Expedited review procedures:
- Informed Consent in Clinical Investigations: Requirements, Documentation, and Procedures
- Continuing Review of Clinical Investigations by Institutional Review Boards (IRBs)
- Categories of Research Eligible for Expedited IRB Review
Related references and norms
- 21 CFR part 50: Protection of Human Subjects
- 21 CFR part 56: Institutional Review Boards
- 45 CFR part 46, Subpart A: Federal Policy for Protection of Human Research Subjects (Common Rule)
Original guidance
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