14. Continuing Review Procedures

Continuing Review Procedures

Federal regulations (45 CFR 46.109(e)) mandate that Full Board and some Expedited Category research studies be reviewed at intervals appropriate to the degree of risk, but not less than once per year from the previous date of approval. The NU IRB will make the final determination on the need for ongoing Continuing Review for all expedited category studies.

Effective on January 21, 2019, Continuing Review will no longer be required for:

• Most new studies that qualify for the expedited review process.
• Studies that are closed to enrollment with no active or long-term follow-up and activities are limited to final analysis of identifiable data/biospecimens.

Please note that research studies approved via expedited review and governed by the Pre-2018 Rule (prior to January 21, 2019) that are open to enrollment or closed to enrollment with either active or long-term follow-up ongoing still require continuing review.

Projects determined to require continuing review that do not receive written notice of renewed approval from the Office of Human Subject Research Protection may not continue past the expiration date.