Remember that asterisk in our blog items that talked about the final* Revised Common Rule? Well, it’s still there.
Most of the Revised Common Rule was, and still is as of this writing, slated to take effect in January 2018. However, even its authors agree that the revised rule introduces a lot of changes to human subject protections procedures and practices; these changes will require a lot of resources to implement; guidance about some of the changes will be needed and has not yet been issued; and that the 12 months between the announcement of the Final Rule and its ultimate implementation is not a lot of time to make all the systems, policy, and process changes required.
Translation of the above: Many research institutions, including academic medical centers, have had their fingers crossed about a possible delay in the Final* Final Rule’s implementation date. Now there is ray of hope in that regard, thanks to SACHRP (an advisory committee that works with OHRP) and OHRP. From the desk of IRB Director Jennifer Holland:
On May 26, 2017 SACHRP made recommendations to the Secretary of HHS that the effective date of the revised regulations be delayed for one year. This followed SACHRP asking OHRP a large number of unanswered questions about the new rules (see link below). Then on October 7, 2017, OHRP requested a “1-year delay of the general implementation date while allowing the use of three burden-reducing provisions during the delay year” from the Office of Management and Budget (OMB). OHRP has not said what the three burden-reducing provisions are. OMB has not yet responded to the request. The final outcome is unknown but the following are possibilities:
- The delay will be denied and the revised regulations will go into effect on January 19, 2018.
- The implementation will be delayed 60 days while OMB reviews them.
- The implementation will be delayed one year and will take effect on January 19, 2019.- with or without allowing the implementation of the three burden-reducing provisions.
- The revisions to the regulations will be scrapped completely, and the current regulations will remain in effect.
Note that we still, as of this writing, don’t know if any delay will be approved, so we have to proceed with the thought that big changes are still afoot and will take effect in January 2018. As soon as we learn something here at IRB Blog Central, we’ll let you know.
And as an aside — SACHRP has issued a lot of guidance regarding all sorts of things related to regulatory oversight of human subject research. Its work provides a little insight into OHRP’s inner workings. Please take a look at the link above when you get a chance to find out more about SACHRP (it’s pronounced Sack-Harp), its expert members, and what it does.