The Research Compliance department has interpreted the revised Common Rule and updated policies and business processes to accommodate the changes. Handouts and training will be provided to prepare the KPNW research community for the new regulations by January 21, 2019.
Quick Reference Guide
In general, the new regulations do not impact studies approved prior to January 21, 2019 (grandfathered in). However, some minimal risk research will become exempt from further review under the new regulations. The IRB will make these exempt determinations at the study’s next continuing review and will notify study teams accordingly.
Additionally, some minimal risk studies may benefit from being re-reviewed according to the new regulations (> 2018) because continuing review would no longer be required. However, these studies would also have to comply with all document and procedural changes, which could entail more work for the study team.
We recommend the following studies transition to the new regulations (> 2018):
- Ongoing expedited studies that have a waiver of consent for the entire study and are not FDA-regulated will have the option to transition at the next continuing review. (Further continuing reviews would not be required.) The studies must meet the added criterion for waiver of consent that states the research would not be practicable with de-identified data or specimens.
- Ongoing expedited studies that involve any sort of consent process and are not FDA-regulated AND will have future contact with ALL participants (either with initial enrollment or an opportunity to reconsent) will have the option to transition at the next continuing review OR with a modification. The study must meet all additional consent requirements.
Considerations for transitioning an existing study:
- 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, 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.
If the PI would like to convert any other type of grandfathered study, it is recommended to meet with the IRB staff on a case-by-case basis to see if there are reasons why the study should remain under the old rule (< 2018).