Will we, or won’t we, have to comply with the revised Common Rule in a few short weeks? That’s the big question to which there’s still no solid answer as of this writing.
January 19, 2018, has a big, red circle around it on our calendar. That’s the date the revised Common Rule is slated to take effect. We are still in the process of figuring out how to incorporate the revised rule’s requirements into the IRB’s processes and policies. The revised rule will likely lead to changes in everything from IRB policies to programming changes in CLARA. Other research institutions subject to the rule are also looking at significant changes throughout their Human Research Protection and IRB programs. The implementation date is one short year to the day after the revised rule’s roll out, which is not a lot of time when considering the massive amount of time and resources required to make changes to meet new requirements. In addition, some important aspects of the revised rule refer to guidance to be issued by OHRP about how to meet those requirements. To date, OHRP has not issued word one of such guidance, and institutions are left wondering how to comply with regulations without that guidance. A summation of some of the biggest worries many institutions have was put together by the Association of American Medical Colleges (AAMC), and can be found here.
We, like a lot of other research institutions, are still clinging to a (admittedly fading somewhat) hope that the implementation date will be delayed. See this previous blog item for more details. On the one hand, if the date is delayed, one would think they would have told us by now. On the other hand, we had almost given up on getting a revised rule at all last year, when the rule dropped on the last possible day it could have dropped before the presidential administration changed. So we’ll see. And we’ll be sure to keep you posted.
UPDATE: Per the AAMC, we’re another step closer to a delayed implementation date. We are not quite sure of the entire bureaucratic process to get the delay approved, other than we know that nothing ever happens until it actually happens. We’ll keep an eye out and let you know as soon as we know something.