Revised Common Rule Compliance Now in Full Effect—and What That Means

After multiple delays, exceptions, and oh-so-many training sessions, on January 20, 2020, we reached the last remaining compliance milestone for the final revisions to the Federal Policy for the Protection of Human Subjects (“revised Common Rule”).

The Final Rule published in the Federal Register on January 19, 2017 (82 FR 7149), finalized the regulatory revisions, which seek to “modernize, simplify, and make more effective the current system of oversight” for clinical trials. Wondering what this all means for your research? Advarra’s got you covered with a variety of resources:

• How does the revised Common Rule affect me and my research?
  • In a nutshell, it depends on the source of research funding. For details, read our blog Do I Need to Comply With the Revised Common Rule?
• Where can I get a quick summary of the revised Common Rule changes?
  • Download Advarra’s Revised Common Rule Quick Reference for key changes, common questions, and a simple decision tree to help you understand when the revised Common Rule does and does not apply.
• How have the new regulations changed informed consent requirements?
  • Many of the revised Common Rule’s changes were aimed at making informed consent more meaningful. For an overview of these updates, read our blog Informed Consent Changes in the Revised Common Rule.
• What does the sIRB mandate mean?
  • The final compliance requirement for single IRB (sIRB) review of multisite cooperative research went into effect January 20, 2020. To find out whether your research must comply with this mandate, read our news item Revised Common Rule Single IRB Mandate Now Effective.
• How does the revised Common Rule affect FDA-regulated research?
  • Since FDA has not yet revised its regulations to harmonize with the revised Common Rule, FDA released a guidance in October 2018 to help “reduce confusion and burden” for those working under both sets of regulations. Find out more in our news item FDA Guidance Addresses Impact of Revised Common Rule on FDA-Regulated Clinical Trials.
• Have I done everything I need to do to comply with the revised Common Rule?
  • Advarra Director of Regulatory Affairs Judith Carrithers, JD, and Chief Compliance Officer and Institutional Official Michele Russell-Einhorn, JD, discuss a checklist of action items to consider in the webinar Making a List, Checking It Twice… The Revised Common Rule Is Coming to Town!
• How has the research community been handling the revised Common Rule transition?
  • So far, it seems, so good. We discuss some common questions, issues, and hot topics in the blog After the Compliance Date: Revised Common Rule FAQs (Or: Why We Cancelled Our February Webinar).
• Is Advarra in compliance with the revised Common Rule?
  • Yes, Advarra has updated its policies and processes to be fully compliant with the revised Common Rule. For more information, read our news item Advarra Is Ready for the Revised Common Rule.
• What other revised Common Rule resources does Advarra provide?
  • New informed consent form (ICF) and short form consent templates are available, as are new guidance documents to help you understand the ICF changes and updated exemption categories. Get the details in these and other resources in our news item Advarra Resources for Revised Common Rule Now Available.

Still not sure what to do about the revised Common Rule? Advarra’s dedicated revised Common Rule experts have years of experience helping the research community understand and implement these changes to the way we conduct and oversee research. Contact us for customized support.

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