When you hear that one impetus behind OHRP’s decision to revise the Common Rule was to minimize regulatory burdens where appropriate, you may be tempted to switch your studies initially reviewed under the old rule to the Revised Common Rule (RCR). You have the chance to do so at your next continuing review. But, before you switch, please keep in mind that before you get to the smooth sailing of the RCR, you may have to climb over a few hurdles first. The CLARA help text that accompanies the question about transitioning to the RCR spells out some of what PIs can expect if they have their study switched.
First, the RCR significantly changed informed consent requirements. If your study has a written consent form, and you are still enrolling subjects, a switch to the RCR will entail fairly extensive consent form revision. For this reason, the IRB is not encouraging studies using written consent forms to switch to the revised rule. If you’ve already completed enrollment, a switch to the RCR is more easily accomplished, but not before then if you’re using a written form in your consent process.
Note that while a switch to the RCR may require document changes, the IRB still cannot review or approve revised documents submitted with a CR form (unless the documents are submitted in response to a specific IRB contingency). So if you transition your study, you will have to submit a separate modification form with revised documents.
Please review our blogs and call the IRB office with any questions about switching previously approved studies to the RCR.