Revised Common Rule Single IRB Mandate Now Effective

Compliance with the single IRB mandate for cooperative research, as outlined in the revised Federal Policy for the Protection of Human Subjects (“the Common Rule”), is required as of January 20, 2020.

The revised Common Rule requires that US institutions engaged in cooperative research must rely on a single IRB, or sIRB, to oversee the portion of the research conducted at US sites. The revised Common Rule applies to all research initially approved by an IRB on or after January 21, 2019.

OHRP will permit certain exceptions to this rule, however. To reduce duplication of effort and other administrative burdens, OHRP has determined that the following HHS-conducted or supported research is excepted from the sIRB mandate:

• Cooperative research conducted or supported by HHS agencies other than the NIH, if an IRB approved the research before January 20, 2020.
• Cooperative research conducted or supported by NIH if either:
  • The NIH single IRB policy does not apply, and the research was initially approved by an IRB before January 20, 2020, or
  • NIH excepted the research from its single IRB policy before January 20, 2020.

According to 45 CFR 46.114, “cooperative research projects are those projects covered by this policy that involve more than one institution.”

Advarra is prepared to provide sIRB review support for cooperative research and is experienced in overseeing federally funded research.

For more information on exceptions to sIRB requirements for cooperative research, review the OHRP resource Determination of Exception for Certain HHS-Conducted or -Supported Cooperative Research Activities Subject to the 2018 Requirements.

To find out whether your research must comply with the revised Common Rule, download Advarra’s Revised Common Rule Quick Reference, or contact Business Development to discuss study specifics.

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