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.

 

Full Board Review

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)


Expedited Category of Review

Initial review process for research protocols that involve no more than minimal risk to subjects (45 CFR 46.102(i))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 to previously approved research during the period (of one year or less) for which approval is granted (45 CFR 46 110 (b)). 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.


Exempt Category of Review

Review process to determine if the research protocol qualifies for exemption from further institutional review by meeting one or more of the six exempt categories listed at 45 CFR 46 101 (b).


Continuing Review

Federal regulations (45 CFR 46.109(e)) mandate that ongoing Expedited or Full Board 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.

For each approved study that has been reviewed under expedited or full committee status, the Office of Human Subject Research Protection and IRB assigns a continuing review interval and expiration date. The office sends notification to investigators 4-6 weeks prior to the impending expiration of the study approval. The investigator must complete the accompanying continuing review/study completion form (CRF) and return it at least one week before the designated date. Regardless of whether or not the study has begun, is still open to enrollment, is closed to new enrollment with follow-up and/or ongoing analysis of data or has concluded, the NU IRB Continuing Review/Study Completion Form must be completed for our records. Directions for completing the CRF are on the form.

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


Modification/Addendum Review

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 (b2)). The modification must be approved by the NU IRB before you institute the change.

For specific information about how to submit a modification request, please click here.