Expedited Review

Understanding IRB's Decisions

Expedited Review

At its discretion, the IRB may conduct an Expedited Review of research that poses no more than minimal risk or involves minor changes in previously approved research during the period for which the original approval had been authorized. The decision to conduct an Expedited Review is not based upon the schedule of the investigator. Rather, to be eligible for Expedited review, the research must fall into one of the following categories, as per the Office for Human Research Protections (OHRP):

• Collection of data from voice, video, digital, or image recordings made for research purposes;
• Non-exempt research on individual or group characteristics or behavior (including, but not limited to, research on perception, cognition, motivation, identity, language, communication, cultural beliefs or practices, and social behavior) or research employing survey, interview, oral history, focus group, program evaluation, human factors evaluation, or quality assurance methodologies;
• Non-exempt research involving materials (data, documents, records, or specimens) that have been collected, or will be collected solely for non-research purposes (such as medical treatment or diagnosis);
• Prospective collection of biological specimens for research purposes by noninvasive means;
• Collection of data through noninvasive procedures (not involving general anesthesia or sedation) routinely employed in clinical practice, excluding procedures involving x-rays or microwaves.

Expedited review will be carried out by one of the two IRB chairpersons and a PR and SR selected by the IRB Administrator from among the IRB membership. Following the Federal Regulations (45 CFR §46.110), the reviewers may exercise all of the authorities of the IRB except that the reviewers may not disapprove the research. A research activity may be disapproved only by the full IRB.

The IRB Administrator will apprise all members of the IRB of research proposals that have been approved under the procedure in writing at least once per semester.

The Federal authorities may restrict, suspend, terminate, or choose not to authorize the use of the expedited review procedure at any time (45 CFR §46.110).