Critical information for researchers submitting new, initial IRB applications now through January 21, 2019
On Jan. 21, 2019, the Revised Federal Policy for the Protection of Human Subjects, also known as the Revised Common Rule or New Rule, becomes effective at WVU. This is also the compliance date, meaning the rule cannot be implemented before Jan. 21. There is no federal grace period to become compliant with the new regulations.
- Any protocol approved on or before Jan. 20, 2019, must comply with the previous rule.
- Any protocol approved on or after Jan. 21, 2019, must comply with the New Rule.
Therefore, initial submissions received before Jan. 21, 2019 but not approved before that date must be resubmitted to the IRB using the new templates.
While some institutions are implementing a freeze on all new submissions during this time, WVU IRB will continue to accept new submissions.
Impact on Research Reviews and Approvals
- Research approved before Jan. 21, 2019, will continue through completion, based on the current regulations.
- Research approved on and after Jan. 21, 2019, must comply with the New Rule. The New Rule regulatory changes will be reflected in WVU+kc on Jan. 21, 2019.
- During the transition, WVU IRB will work with researchers on a case-by-case basis to manage submissions with special circumstances (e.g. funding award deadlines).
- WVU IRB will strive to complete reviews on protocols submitted prior to the deadline. Those approved before Jan. 21, 2019, will be grandfathered in under the Current Common Rule.
Timetable for Submissions
Efforts to minimize impact of transition timeline.
WVU IRB is working to lessen the impact of the transition for researchers wishing to create and begin work on new IRB applications during this time. To mitigate risk, changes to WVU+kc will be limited to those necessary under the revised regulations.
Advice for Researchers
Submit new, initial submissions for review no later than the suggested timelines:
- New full board protocols: Before Dec. 12, 2019
- Exempt or Expedited Protocols: Before Jan. 1, 2019
While WVU IRB cannot guarantee all reviews will be completed and approvals granted by Jan. 21, there is a higher likelihood of meeting the cutoff date.
As a precaution, WVU IRB strongly recommends you keep a full copy of your submission outside of WVU+kc until the transition period is complete and your study has been approved.
Research Impact During Transition
Studies Most Impacted
- New, initial full board protocols submitted after Dec. 12, as these won’t make the cutoff for the IRB meeting on Dec. 19.
- All expedited or exempt submissions submitted after Jan. 1, 2019.
Studies Not Impacted
- Studies that have already received initial approval won’t be affected during this transition. Any study that has already received initial approval and falls under the Common Rule will be grandfathered in under the current Common Rule. No changes will be required for the life of the study.
- Continuing reviews, amendments, event reporting, and CIRB submissions will continue as normal. There is no requirement to transition to the New Rule unless warranted at a future date, or unless the Investigator chooses to transition the study under the new regulations.
- Studies that fall under FDA regulations that do not fall under the Common Rule.
- Studies that are currently overseen by a Central IRB, unless that IRB has contacted you directly regarding process changes.
- Non-federally funded, minimal-risk studies that qualify for the Flex Model submission. (We strongly advise you to use this application in lieu of the Exempt or Expedited application, whenever possible.)
- Not Human Subject Research (NHSR)