HHS Issues a NPRM to Further Delay the Revised Common Rule
Madeleine Williams, Jonathan M. Hunter, Rochelle Kane
According to the proposal, the new general compliance date would be January 21, 2019
On April 20, 2018, the U.S. Department of Health and Human Services and 16 other federal departments and agencies published a Notice of Proposed Rulemaking (NPRM) in the Federal Register that proposes to delay the general compliance date for the revisions to the Federal Policy for the Protection of Human Subjects (the “Revised Common Rule”). The proposed compliance date is January 21, 2019.
This proposed delay would extend the delay period approximately one year beyond the original compliance date of January 19, 2018. The general compliance date was previously delayed six months with an interim final rule, to the current date of July 19, 2018. This proposed delay would furnish federal departments and agencies and regulated entities alike with additional time to prepare for implementation of the Revised Common Rule.
According to the NPRM, regulated entities would be required to comply with all current Common Rule provisions (the “Pre-2018 Requirements”) until the new compliance date, which entails that the new effective date would also be January 21, 2019. There is an exception, however, for the allowance of three burden-reducing provisions in the period between July 19, 2018 and January 21, 2019.
The three burden-reducing provisions are:
- Early adoption of the Revised Common Rule definition of “research”
- Elimination of grant application review
- Elimination of Continuing Review for certain non-exempt human research
The NPRM details the rationale for and regulatory text impacted by the provisions above. Regulated entities that would choose to take advantage of these burden-reducing provisions should carefully evaluate the transition provisions attached to them to ensure continued compliance once the full Revised Common Rule were to become effective.
Apart from the burden-reducing provisions above, the NPRM does not generally impact other transition provisions included with the original text of the final rule, with one difference being that “documentation of an institution's transition determination may be performed either by an institution (through officials who have the authority to make such determinations on behalf of the institution) or an IRB” (83 FR 17598). This would have been a requirement for the IRB alone.
Importantly, the decision to publish an NPRM for an additional delay means that there must be a public comment period. Comments must be received no later than 11:59 PM EST on May 21, 2018 in order to be included for consideration. After the comment period closes, the HHS and the other departments and agencies will review the comments and determine whether to move forward with a new Final Rule.
As with the previous delay, institutions engaged in human research will need to thoughtfully consider this proposed delay in relation to any pre-existing plans for implementing the Revised Common Rule and consider whether it makes sense to implement portions of the Revised Common Rule early for research that does not fall under the purview of any Common Rule agency.
How Huron Can Help
Huron’s IRB software product is configured with a Revised Common Rule effective date setting to accommodate the flexibility required during this time of regulatory change.
Huron’s HRPP Toolkit has been updated to provide organizations with revised policies, procedures, and review tools to comply with the Revised Common Rule when it becomes effective. Adopting the Huron HRPP Toolkit is the fastest and most efficient way of ensuring your policies and procedures are in full compliance with federal regulations, guidance, accreditation standards and industry best practices. In combination with our subscription model, organizations will be able to stay on top of the ever-shifting regulatory landscape.
Our HRPP professionals are also available to provide individual assistance and guidance to organizations, as needed. If you would like additional insight into the revised Common Rule, or assistance identifying the most effective ways to help prepare your organization, contact us.Contact Us