Client Alert: Final Rule Revising The Federal Policy For the Protection of Human Subjects
The U.S. Department of Health and Human Services and 15 other federal agencies have issued a final rule to update the "Common Rule" regulations that safeguard individuals who participate in research.
This update to the Common Rule follows the September 2015 publication of the Notice of Proposed Rulemaking (NPRM). In response to concerns raised during the public comment period and extensive subsequent review processes, the final rule contains a number of significant changes from the originally-proposed rule.
Key changes to existing Common Rule regulations include:
- Required additional content in informed consent documents.
- Required use of a single IRB for most multi-institution research studies.
- New options for the use of “broad consent” documents for research involving identifiable data or identifiable biospecimens.
- New categories of “exempt” human research.
- Elimination of continuing review requirements for certain human research studies.
- Required posting of consent documents for certain federally-funded trials to a public website.
- Elimination of grant congruency review by the IRB.
- New criteria for limited IRB review required for certain exempt categories.
The following proposed changes in the NPRM were NOT included in the revised Common Rule:
- The definition of human subject to include non-identifiable biospecimens, as well as most of the proposed changes to biospecimen research requirements, were not made.
- The use of federally-developed templates for “broad consent” forms, and decision tools for making exemption determinations, will not be implemented.
- The proposal that non-federally-funded clinical trials be subject to the revised Common Rule was not adopted.
- The “excluded” categories of research were not adopted.
- The requirement for standardized privacy safeguards for identifiable private information and identifiable biospecimens has been excluded from the revised Common Rule.
These new regulations are scheduled to take effect on January 19,2018, except for the single IRB review requirement which is effective January 20, 2020.
Download the complete final rule here.
The future of these regulations is currently uncertain due to the possibility that Congress may overturn this and other new regulations passed in recent months. The research community should monitor this situation closely in the coming weeks for additional clarity on the future viability of the revised Common Rule. Huron will provide further client updates on these Common Rule revisions in the coming weeks, and recommends that no immediate action be taken by human research protection program leaders at this point except to begin familiarizing yourselves with these new regulations.
If you would like additional insight into the revised Common Rule, or assistance identifying the most effective ways to help prepare your organization, please contact us.