The Revised Common Rule (RCR), slated to take effect Monday, January 21, gives studies open prior to that date the choice of either staying with the current Common Rule regulations or transitioning to the RCR.
The UAMS IRB will allow investigators to request consideration to change to the RCR with their next continuing review. The CR form will include a question at the top asking if you’d like this study to be considered for the switch to the RCR. Note that regardless of your answer, you’ll go on to complete the full CR form. (Yes, everybody will get one more complete CR, even if they do decide to switch their study to the RCR and the switch means they won’t have to submit full CRs in the future.)
If you check “yes” to the “do you want to switch” query, please note that the transition is not automatic. The IRB office will contact you regarding what the transition will entail and see if it is worth pursuing. Depending on where in its life cycle a study is, and/or what kind of study it is, it may be simpler to stay under the old rule.
Some things to keep in mind when deciding whether or not to switch are below. Most of this text will also be included as help text with the CLARA question regarding transitioning. Please review it before deciding which box to check:
The 2019 revisions generally decrease the oversight and regulatory burdens of minimal-risk studies. However, the revised rules/policies do have additional requirements related to informed consent. PI may wish to consider transitioning the following types of studies:
- Those currently reviewed using expedited procedures and that either do not have any written consent documents or that use written consent materials that the study team is willing to revise.
- Current expedited-review-status studies that would qualify for exempt status review under the RCR. In particular, prospective chart reviews and studies involving “benign behavioral interventions” may qualify for exempt status review in the future.
- Full-board review studies NOT subject to FDA oversight that have reached the data analysis or long-term follow-up (collecting only information created through standard clinical care) phase only.
Note: FDA-regulated studies CANNOT be transitioned to the 2019 rule, as they are subject to additional regulations that have not changed.