That sound you hear is a giant sigh of relief from a whole lot of institutions subject to OHRP oversight.
Late this afternoon, we received word of the planned Federal Register Publication of an interim Final Rule, delaying the effective and compliance date of the Revised Common Rule until July 19, 2018, which is 6 months later than its original planned effective and compliance date of Jan. 19, 2018. Part of the rationale for the delay is to give the affected federal agencies more time to request a possible further delay after the July date.
In a nutshell, the move means that we will continue operating under the current Common Rule through at least July 19. While there had been some talk of implementing certain burden-reducing aspects of the revised rule even if overall implementation was delayed, OHRP has clarified that the current rule will remain in effect as is.
A bit of background — the Revised Common Rule is the first major revision of the regulation governing human subject research since its initial publication years ago. OHRP spent years drafting this revised Common Rule, and kept us guessing until the very last minute whether it was going to publish a final version. The revised rule finally dropped Jan. 19, 2017, and sent everybody scrambling to try to figure out what needed to be done to comply with it by its original compliance date.
Well, a whole lot needed to be done, it turned out. Electronic systems needed revision, office processes needed changing, and OHRP needed to issue some guidance (as it indicated it would when issuing the revised final rule) to guide some of those systems and process changes. We’re still waiting for the guidance, and institutions all over the country were wondering how many resources to invest in changes that may or may not turn out to be appropriate once all the expected guidance is released. Requests for delays in the effective and compliance date came in from all over. Once again, OHRP waited until close to the very last minute to let us know the answer, but our collective wishes for a delay appear to have been granted.
Please click on the two links above for more information about this delay.