IRB Guidelines - Continuing and Final Review
- Continuing Review
- What occurs if there is a lapse in continuing review?
- Final Report
- Adverse Event (AE) Report for an e-Protocol submission
- IRB Guidelines for Reporting Significant Adverse Events
Researchers are responsible for providing continuing review information to the IRB. This is a monitoring mechanism that assures that continuing safeguards are in place to protect the rights and welfare of study participants. Continuing review of research is required at intervals appropriate to the degree of risk, but not less often than once per year (45 CFR 46.109(e)).
For Projects with Exempt approval
Studies that present little or no risk to the participant and that fall into one of the six designated categories (see Levels of Review) of research that may qualify for exempt status, may be exempt from continuing IRB review. Although the rights and welfare of subjects in those studies still require protection, there is usually no need for a detailed IRB Review. Researchers should note that changes to the study design should be reported to the IRB to be sure that the exempt review level is still appropriate. While continuing review is not necessary, the IRB requests that researchers submit a final report (see below).
For Projects with Expedited Approval
For a study approved under expedited review, the typical continuing review period must occur within one year of the date the IRB Chair, or IRB member(s) designated by the Chair, gives final approval to the protocol. Review of a change in a protocol does not alter the date by which continuing review must occur. This is because continuing review is review of the full protocol, not simply a change to it. The regulations make no provision for any grace period extending the conduct of research beyond the expiration date of the IRB approval. Therefore, continuing review and re-approval of research must occur on or before the date when IRB approval expires.
For Projects with Full Board Approval
Continuing review for research studies that originally had full board review must be approved by the convened IRB. Researchers must submit the continue review form 10 days in advance of the scheduled IRB meeting that will guarantee that the review will be done BEFORE the expiration of the study. Please see the IRB meeting schedule.
Renewal/Continuation for an e-Protocol submission
Investigators must plan ahead to meet required continuing review dates. If an investigator has failed to provide continuing review information to the IRB or the IRB has not reviewed and approved a research study by the continuing review date specified by the IRB, the research must stop, unless the IRB finds that it is in the best interests of individual subjects to continue participating in the research interventions or interactions. Enrollment of new subjects cannot occur after the expiration of IRB approval and the approval expires automatically.
Final reports must be submitted upon completion of the study. Studies would be considered eligible for closure once the following is complete:
- enrollment of subjects is closed, and subjects have completed all research-related interventions, and
- data collection is complete, and
- data are de-identified*, for example data are being maintained in such a way that identifiers are separated from the coding system, or data is in a secure location, and
- there is no additional research beyond the original intent planned for these data.
*For the purposes of submitting the IRB final report, the study will be considered complete if only data analysis using de-identified data remains. If identifiers remain on the data, researchers must request continuing review.
Note that it is the continued responsibility of the research team to maintain the confidentiality of the data. Please complete a final report form and submit it to the HRPO so the study file may be closed.
Final Report for an e-Protocol submission