Advarra Is Ready for the Revised Common Rule

Advarra has revised its policies and processes to be fully compliant with the Revised Federal Policy for the Protection of Human Subjects in Research (“revised Common Rule”) applicable to agencies that have codified the Common Rule, effective January 21, 2019. The Advarra Center for IRB Intelligence (CIRBI) Platform has also been updated to support the new requirements during the IRB submission process.

Advarra applies:

  • The FDA regulations to FDA-regulated research.
  • The revised Common Rule to federally funded research approved on or after the January 21 compliance date (with the exception of the Department of Justice) and exemption requests submitted after the compliance date.
  • The old Common Rule (in effect before January 21, 2019) to federally funded research approved prior to the compliance date, non-federally funded research that is not FDA-regulated, and research funded by the Department of Justice.

HHS issued revisions to the Common Rule, which were originally published in the Federal Register on January 19, 2017 (82 FR 7149). Changes to the Common Rule are intended to modernize, simplify, and enhance oversight for human subjects research. These changes include revised informed consent requirements, revised and new exemptions, and elimination of continuing review for minimal risk studies. While the initial effective date for most provisions of the Final Rule has been delayed twice, the final effective date is January 21, 2019.

Advarra is committed to working with clients to make this transition as straightforward as possible.  To assist with in this effort, several new and updated client resources are available in the Reference Materials section of the Advarra CIRBI Platform. Click here to learn more about these materials.

For more information on the revised Common Rule, refer to OHRP’s revised Common Rule resources. For assistance in implementing these requirements for a new study submission, contact Business Development.

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