Due to changes in the federal regulations for the protection of humans in research, starting January 21, 2019, all new research receiving federal funding must comply with the New Rule.
Before that, starting August 31, 2018, the Northwestern University IRB is adopting one of the burden reducing provisions for research that complies with the New Rule:
- For most new non-exempt, minimal risk, and non-FDA regulated research projects, there will no longer be an expiration date and therefore, no requirement for annual continuing review.
What this means:
- If research project documents are in compliance with the New Common Rule and the project qualifies for expedited review and is not subject to FDA regulations, the IRB has the option to approve the project without an expiration date. (See HRP-033 3.4 for reasons the IRB might maintain the expiration date on your project.)
- Research projects that are greater than minimal risk, FDA regulated, or which are minimal risk and require full board review will continue to have an expiration date and an annual continuing review.
Phased roll out of "No Continuing Review":
- Starting August 31, all new expedited, non-FDA regulated research will be considered for no continuing review.
- If that goes well, on September 28, as standard continuing reviews are submitted for existing expedited, non-FDA regulated projects, the projects will be considered for no continuing review.
- Starting October 26, all modification to existing expedited, non-FDA regulated research will be considered for no continuing review.
- Any modifications to research must still be submitted to the IRB and approved prior to implementation.
- Reports of new information (RNIs) should still be submitted within five business days.
- All research approved under the "no CR" requirement will receive a system generated annual reminder from eIRB+ to keep the study record up to date with modifications, RNIs and to close the study when research activities are completed.