The expedited review category is used for certain types of research involving no more than minimal risk and minor changes to research previously approved by the full committee, during the period for which approval has been authorized. Research eligible for expedited review is reviewed by a subcommittee of the IRB. Expedited review of continuing reviews where the protocol is unchanged from the previous year or minimal risk amendments/modifications may be conducted by a single designated reviewer. Agreement of all reviewers is needed for approval. Reviewers may refer the proposal to the full committee. The principal investigator will be informed in writing whether the proposed research has been approved or referred for full committee review. The IRB will be notified of all research activities that have been approved by expedited review.
The following types of research may qualify for expedited review:
1. Clinical studies of drugs when an IND is not required, or; clinical studies of medical devices when an IDE is not required, or the medical device is cleared/approved for marketing and the medical device is being used in accordance with its cleared/approved labeling.
2. Collection of blood samples by finger stick, heel stick, ear stick, or venipuncture from healthy, non-pregnant adults who weight >110 pounds where the amount drawn is <500 ml/8 week period and collection occurs at most 2 times/week, or; collection of blood samples by finger stick, heel stick, ear stick, or venipuncture from adults and children, considering the age, weight, and health of the subjects, the collection procedure, the amount of blood to be collected (at most 50 ml or 3 ml/kg/8 week period), and the frequency with which it will be collected (at most 2 times/week.)
3. Prospective collection of biological specimens for research purposes by noninvasive means.
4. Collection of data through noninvasive procedures (not involving general anesthesia or sedation) routinely employed in clinical practice, excluding procedures involving x-rays or microwaves. Where medical devices are employed, they must be cleared/approved for marketing.
5. Research involving materials (data, documents, records, or specimens) that have been, or will be collected solely for nonresearch purposes (such as medical treatment or diagnosis).
(Note: some research in this category may be exempt from the HHS regulations for the protection of human subjects 45 CFR 46.101(b)(4). This listing refers only to research that is not exempt)
6. Collection of data from voice, video, digital, or image recordings made for research purposes.
7. Research on individual or group characteristics or behavior or research employing survey, interview, oral history, focus group, program evaluation, human factors evaluation, or quality assurance methodologies.
8. Continuing review of research previously approved by the convened IRB where:
i. the research is permanently closed to the enrollment of new subjects;
ii. all subjects have completed all research-related interventions; and
iii. the research remains active only for long-term follow-up of subjects, or;
Continuing review of research previously approved by the convened IRB where no subjects have ever been enrolled at a particular site and neither the investigator nor the IRB at a particular site has identified any additional risks from any site or any other relevant source, or;
Continuing review of research previously approved by the convened IRB where the remaining research activities are limited to data analysis. (For a multi-center protocol, and expedited review procedure may be used by the IRB at a particular site whenever these conditions are satisfied for that site.)
9. Continuing review of research, not included under an investigational new drug application or investigational device exemption where categories (2) through (8) do not apply but the IRB has determined and documented at a convened meeting that the research involves no greater than Minimal Risk and no additional risks have been identified.
Policy: Expedited Reviews