HHS Delays Compliance Date for Revised Common Rule
On January 19, 2017, The U.S. Department of Health and Human Services and 15 other Federal Departments and Agencies’ published revisions to the Federal Policy for the Protection of Human Subjects (the Common Rule) in the Federal Register. Huron issued a previous client alert discussing this revision.
The same agencies released a change to the implementation timeline of the Revised Common Rule on January 17, 2018, specifically updating the Effective and Compliance Date to July 19, 2018. The compliance date for §_.114(b) (cooperative research) of the Revised Common Rule remains January 20, 2020.
Institutions engaged in human research will need to thoughtfully consider the delay in relation to any pre-existing plans for implementing the revised Common Rule and consider if it makes sense to implement portions of the revised Rule early for research that doesn’t fall under the purview of any Common Rule agency.
How Huron Can Help
Huron’s IRB software product has been configured with a 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 HRPP 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.
Join our webinar on Friday, January 26 to discuss this delay, its impact IRBs around the country and ways to leverage revised policies and procedures prior to the July effective and compliance date. To register, click here.
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