Which Studies and When
Summary
The revised Common Rule is implemented on January 21, 2019. It applies only to studies whose initial IRB application has been approved on or after January 21, 2019, or to studies where the IRB and the researcher have mutually agreed (after January 21, 2019) to “switch over” to the revised Common Rule.
HSD and the UW IRB generally apply the Common Rule to all UW research except when doing so directly conflicts with other human subjects regulations or when the study qualifies for the UW Flexibility Policy.
The Details
Initial IRB application was approved prior to January 21, 2019
Studies that were approved under the original Common Rule continue to be governed by the original Common Rule after January 21st.
- At the time of the next continuing review for these studies, the IRB and the researcher will have the option to switch over to the revised Common Rule if they choose to do so. Switching over to the revised regulations is not mandatory. However, it may be advantageous for many studies.
Initial IRB application was submitted on or after January 21, 2019
These studies (and their IRB review are governed by the revised Common Rule). This is mandatory; there are no other options.
The “In Between” applications
Initial IRB application was submitted before January 21, 2019 but not yet approved on that date
The version of the Common Rule that applies to these studies (and their IRB review) depends upon the IRB application status on January 21, 2019.
| Application Status | Version of the Common Rule |
|---|---|
| Pre-Review | Revised |
| Clarifications Requested (Pre-Review) | Revised |
| Committee Review | Revised |
| Non-Committee Review | Revised |
| Deferred | Revised |
| Modifications Required* | Original |
| Post-Review | Original |
| Approved | Original |
| Human Research, Not Engaged | Original |
| Not Human Research | Original |
| Not Research | Original |
*Sometimes also called conditional approval
Where to find the submission status
Open up the study in Zipline. The application status is in the purple box on the left side of the screen, to the left of the study number and short title.
