Approved by: Human Protections Administrator, Director of OPRS, and Executive IRB Chair
AAHRPP REF#: 150
AAHRPP Elements: II.2.D.2, II.2.E.2
- In accordance with federal regulations, UIC policy requires that IRB-approved research be reviewed at intervals appropriate to the degree of risk and at a minimum of once per year for both federally funded and non-federally funded research. Research that is not reviewed at least once a year is deemed to be lapsed in IRB approval and a notice of expiration of IRB approval must be issued.
- Continuing review of research must be substantive and meaningful. The approval criteria at 45 CFR 46.111 (and at subparts B, C, and D of 45 CFR part 46, when applicable) or 21 CFR 56.111 must be satisfied when the IRB conducts continuing review of research either at a convened meeting or under an expedited review procedure. These criteria include determinations by the IRB regarding minimizing risks, risks reasonable in relation to potential benefits, equitable selection of subjects, obtaining and documenting informed consent, monitoring safety, protection of privacy and maintenance of confidentiality, and additional safeguards for subjects likely to be vulnerable to coercion or undue influence
- Continuing review is allowed to stop only when the research is permanently closed to the enrollment of new subjects, all subjects have completed all research-related interventions, research is no longer active for long term follow up and collection and analysis of individually identifiable private information has been completed.
- An investigator may submit a request to OPRS for a protocol exception after a study is deemed lapsed in IRB approval to allow follow up interventions or interactions for some or all subjects when it is in the best interest of the subjects to continue . The investigator requests a protocol exception for the continuation of certain aspects of the research on the UIC OPRS Protocol Exception Form. An investigator must clearly distinguish and explain what research activities from which he or she will refrain as part of the lapse and what research activities require continuation. The investigator must also explain the underlying reasons for which the protocol exception is requested for each activity and each subject where an over-riding safety concern or ethical issue indicates that it is in the best interests of the individual to continue participating. (Refer to UIC HSPP policy Protocol Exceptions).
Version (#, date)
Replaces (#, date)
Summary of changes
Revised policy to include policy statement II, which further refines the explanation of the duration of continuing review.
Revised policy to specify that the approval criteria as specified in 45 CFR 46.111 and 21 CFR 56.111 (if applicable) must be met.