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.
What You Need to Know? 👇
What is the impact of the Revised Common Rule on FDA-regulated clinical investigations?
The Revised Common Rule creates differences between FDA and HHS regulations. FDA issued guidance to reduce confusion during their rulemaking process, clarifying that certain provisions like informed consent requirements are compatible with FDA policies.
Can we use the same informed consent form for both HHS and FDA-regulated studies?
Yes, the 2018 Requirements’ informed consent provisions regarding content, organization, and presentation are not inconsistent with FDA’s current policies. This may eliminate the need for separate consent forms for dual-regulated studies.
Which expedited review list should IRBs use for FDA-regulated clinical investigations?
IRBs must continue using FDA’s 1998 expedited review list for FDA-regulated clinical investigations, even if the study is also subject to HHS regulations. The newer HHS list doesn’t apply to FDA-regulated studies.
Are continuing review requirements different under the Revised Common Rule for FDA studies?
Yes, FDA has not revised its regulations, so IRBs must continue conducting continuing review at least annually for FDA-regulated studies, even when HHS regulations may not require continuing review for certain research.
What new informed consent elements are required under the 2018 Requirements?
New requirements include a concise presentation of key information first, statements about future use of identifiable information/biospecimens, disclosure of commercial profit potential, clinical results disclosure policies, and whole genome sequencing notifications.
How should conflicts between FDA and HHS regulations be resolved?
When regulations differ, follow the regulations that offer greater protection to human subjects. FDA guidance recommends this approach for studies subject to both regulatory frameworks during the harmonization process.
What You Need to Do 👇
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:
- Must continue using the 1998 list for FDA-regulated clinical investigations
- IRBs must comply with FDA’s regulation at 21 CFR 56.110(b)
Relevant Guidances 🔗
- 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)