All research activities must be reviewed by the Office of Human Subject Research Protection even when categorized as “exempt” status.
In addition, please note that “expedited” does not mean “faster” review. It only refers to the federal categories of research that do not require full board review.
Final determination of exempt, expedited and full committee status is made by the institutional review board.
Review process for research protocols that do not fall under the “exempt” or “expedited” categories, include vulnerable populations, and/or are determined by the NU IRB to involve greater than minimal risk to subjects (45 CFR 46 111).
For those protocols that are reviewed by the full Institutional Review Board, the Principal Investigator and/or co-Investigator are required to be present at the convened IRB committee meeting to discuss their protocol and answer questions posed by the Board. (NU IRB Meeting Schedule)
Initial review process for research protocols that involve no more than minimal risk to subjects (45 CFR 46.110) and include activities listed in one or more of nine categories published by the U.S. Department of Health and Human Services.
Expedited review also includes review of:
Minor changes in previously approved research during the period for which approval is authorized; or
Research for which limited IRB review is a condition of exemption under §46.104(d)(2)(iii), (d)(3)(i)(C)
Any proposed modification to previously approved research resulting in greater than minimal risk or having a negative impact on the balance between the risks and benefits of the research will be referred to the full IRB for review.
Review process to determine if the research protocol qualifies for exemption from further institutional review by meeting one or more of the exempt categories 1 through 6 listed at 45 CFR 46.104. NU will not implement Exemptions #7 and #8 at this time.
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.
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.
The NU IRB will make the final determination on the need for ongoing Continuing Review for all expedited category studies.
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.
After receiving the written approval from the NU IRB to begin a research project, investigators must follow the protocol procedures and use only the versions of the recruitment materials, consent and assent forms and study instruments as approved and on file at the Office of Human Subject Research Protection. However, if you need to make changes to the study, you may do so by requesting a modification in writing to the Office of Human Subject Research Protection (45 CFR 46.110(b)(1)(ii)). The modification must be approved by the NU IRB before you institute the change.
Specific information about how to submit a modification request is also available.