Survey Shows Almost 80% of Institutions Plan to Support Revised Common Rule
Frank Conte, Jonathan Hunter
Despite a possible delay, more institutions plan to take action by January 19, 2018.
A proposed delay to the Common Rule was posted on the Office of Management and Budget (OMB) website on October 7. This indicates that the Office of Human Research Protections (OHRP) is proposing a delay with the following title, Federal Policy for the Protection of Human Subjects: Proposed 1-Year Delay of the General Implementation Date While Allowing the Use of Three Burden-Reducing Provisions During the Delay Year. Other than the intriguing title, there were no additional details provided.
Until further notice, however, the effective and compliance date of the revised Common Rule remains January 19, 2018.
The human research protections community anticipated hearing more information from the OHRP representatives at the annual PRIM&R conference in November, but no information came. Because it is unclear when the OMB will move the proposal to delay forward, and because the OHRP cannot comment on draft proposals, there is uncertainty in the community about how to proceed. Until further notice, however, the effective and compliance date of the revised Common Rule remains January 19, 2018.
In Huron's latest Common Rule webinar on November 15, we asked a series of polling questions about the community's preparation plans. We surveyed nearly 300 research compliance and IT leaders. Of that total, the majority of respondents, at 79 percent, said they plan to be prepared for the new requirements of the revised Common Rule, despite the proposed delay announcement. The results for other questions are also below.
Results for: What action does your institution plan on taking as a result of the proposed delay announcement? (In percentages)
Results for: If you have an electronic IRB system, how many collective hours have technical team members spent modifying or upgrading your system? (In percentages)
Results for: Excluding technical team time, how many collective hours has your team spent preparing for the deadline? (In percentages)
Throughout the Huron Common Rule webinar series, we have encouraged attendees to prepare, even with the possibility of a delay, by providing timelines with example milestones and specific recommendations for operationalizing the requirements of the Common Rule. Institutions that are ready by January 19, 2018, will be compliant if there is no delay, while staying ahead of the game in the event of a delay.
Do you know what it takes to achieve compliance for the revised Common Rule? We can help. View our webinar series and contact us to learn more.Contact Us