The revised Common Rule requires existing research (approved or determined exempt prior to January 21, 2019) to remain compliant with the pre-2018 regulations. Therefore, for existing studies, researchers do not need to take any action at this time beyond maintaining active IRB approval. Maintaining IRB approval includes submitting for continuing review (unless previously granted exemption).
Existing research can be transitioned to operate under the revised Common rule only after being reviewed and determined to comply with the revised Common Rule. To be brought into compliance with the revised regulations, existing studies may require substantial revisions.
To assess whether to transition existing research to operate under the revised Common Rule, RCS will work with researchers in advance of a study’s existing expiration and/or when an amendment is submitted. In some cases, it may be best for a project to remain under the pre-2018 regulations. In other cases, it may be best to transition an existing project to operate under the revised Common Rule.
Process for Transitioning
The revised Common Rule offers flexibility to allow existing studies to remain under the pre-2018 Common Rule, existing studies are not required to comply with the revised Common Rule. Studies cannot pick and choose between the two sets of regulations. In order to transition to the revised Common Rule, a study must be determined to satisfy ALL criteria under one set of regulations or the other.
Therefore, to transition an existing study from oversight under the pre-2018 Common Rule to the 2018 revised Common Rule, the IRB must determine that all criteria in the 2018 revised Common Rule are or can be satisfied.
Existing studies will be automatically assessed for transition readiness upon submission of an amendment or continuing review. Transition assessment will be based on a number of considerations (see next section below).
If a researcher wishes to be assessed for transition outside of this cycle, RCS is offering special topic workshops as well as separate dedicated office hours to work with research teams to determine if transitioning existing research to the 2018 revised Common Rule makes sense. See the Education and Outreach webpage for more information.
Preliminary Considerations for Transition
To determine if a study is a good fit for transition to the 2018 revised Common Rule, the IRB will consider the study’s progress, study activities, additional regulatory oversight requirements, and the extent of revisions required to achieve compliance.
Key considerations include:
- Timing and study status
- Estimated end date
- Conclusion for active data collection
- Approaching expiration and extent of changes needed to achieve compliance
- Whether there are multiple IRB reviews
- Impact of transition on other sites
- Collaborating site requirements and/or policies
- Whether the funding agency requires different or additional regulatory compliance
- Complexity of Study
- Number of studies, sub studies, subject populations, consent documents, research tasks
- History/age of protocol
- Quality and completeness of submission
- Researcher responsiveness/willingness to transition
- Assess current/future protocol activity if possible
- Whether future phases/design changes are anticipated
- Previous compliance or other challenges that would or would not make the protocol a good candidate for transition.