The ever-timely (ahem) Office for Human Research Protections (OHRP) has released a draft guidance about transitioning studies approved prior to the Jan. 21, 2019, Revised Common Rule implementation and compliance date.
While this is only a draft and subject to revision, it supports what we’ve been hearing about how to handle studies initiated before Jan. 21, 2019, at conferences and places like that. Key takeaways include:
–Studies approved before that date can remain subject to the original requirements they were approved under (aka the pre-2018 rule), OR they can transition to the RCR.
–Studies that transition must comply with ALL aspects of the RCR, and once they transition, they cannot revert later to the pre-2018 rule.
–IRBs and institutions have the option of applying RCR requirements to studies approved prior to Jan. 21, 2019, as long as those requirements don’t conflict with the pre-2018 rule. For example, the RCR has some new requirements related to informed consent. If the IRB feels those would be helpful to subjects during the consent process, in accordance with the criteria for approval, it can require those changes even if the study does not transition.
Public Responsibility in Medicine and Research, a professional organization, also provides some helpful commentary regarding the draft guidance. And for a refresher on how, and whether, to transition studies overseen by the UAMS IRB, please see this previous blog post.