Upcoming Regulatory Deadlines: NIH Policy on sIRB Review, 21st Century Cures Act and Final Revisions to Common Rule

May 25th, 2017 by Eli Alford, COO

Update: On October 7, 2017, the US Department of Health and Human Services (HHS) submitted a proposal to the White House Office of Management and Budget (OMB) to delay implementation of the final revised Common Rule by 1 year (to January 2019).

 As of October 13, 2017, this proposal is under review with OMB, and it is not known whether the proposal will proceed or be modified. Specific dates or other information discussed below may be affected by the outcome of this proposal. Schulman will continue to monitor the status of this proposal and will provide updates as they become available.

The past 12 months brought the research community some dramatic regulatory changes, including June’s NIH policy on the use of a single IRB for multi-site research, December’s passage of the 21st Century Cures Act, and most recently January’s final revisions to the Common Rule.

With these new policies come compliance dates, and with so many changes coming in such a short amount of time, it can be difficult to keep track of all the deadlines. So we’ve broken it down for you:


Regulation/PolicyPublication DateRequirementsCompliance DateNotes
NIH Single IRB PolicyJune 21, 2016Requires domestic awardees and domestic sites conducting NIH-funded multisite research to be overseen by a single IRB.January 25, 2018Applies to all competing NIH grant applications (new, renewal, revision or resubmission) with receipt dates on or after September 25.
Final Revisions to Common RuleJanuary 19, 2017Requires single IRB review for federally funded multisite research with a few exceptions.January 19, 2018Mandate for single IRB review of multi-site studies delayed until January 20, 2020.
21st Century Cures ActDecember 13, 2016Requires US government to reduce “duplication of effort” in human subject protections, suggesting centralized IRB review as one way to do that. Removes “local” from “institutional review board” references for device studies, aligning device regulations with established drug research regulations.December 13, 2019Compliance date reflects deadline for harmonization of HHS (Common Rule) and FDA regulations to avoid regulatory duplication and unnecessary delays.

I’ve Got the Dates—Now What?

If you haven’t already, it’s now time to meet with your research colleagues to figure out how your organization will meet the new requirements.

If your organization conducts a lot of NIH-funded research, you may be well ahead of other institutions and are already revising SOPs and drafting communication plans. If you’re a device sponsor, you might have started talking with research sites about the central IRB you want them to use for your next study.

If you have the luxury of waiting for the 2020 Common Rule single IRB compliance date, use that time to speak with research colleagues to set a game plan for your institution. Find out what has worked well at other institutions and what you might want to avoid. Evaluate your processes and SOPs to determine what needs to be changed, and start communicating with institutional stakeholders for buy-in and support throughout the process.

Change isn’t always easy, but it often makes things better in the long run. By planning for change now, you set your institution up for the best chance at success in this new regulatory environment.

Want to learn more? Download our white paper to learn how Schulman can serve as a single IRB for multicenter research, or read our blog on the benefits of centralized IRB review.

*10/13/17: This article has been updated to reference the HHS proposal to delay implementation of the final revised Common Rule by 1 year.

*6/22/17: This article has been updated to change the extended effective date of September 25, 2017, to the new extended effective date of January 25, 2018.