Federal regulations provide that certain kinds of research may receive expedited review. Section 46.110 of the OHRP regulations lists the categories of research appropriate for expedited review. The IRB may use an expedited procedure to conduct initial review of research provided that research activities do not fall under any of the general restrictions, present “no more than minimal risk” to participants, and fits in one of the federally designated expedited review categories. In such cases, the Chair and one other member of the IRB need evaluate the proposal which includes the IRB Research Compliance Officer.
Expedited review requires 14 to 20 business days for initial IRB review. The IRB highly recommends the application be submitted at least 1 month before the proposed start date of the study.
Summary of Expedited Categories:
- Clinical studies of drugs and medical devices only when certain conditions are met
- Collection of blood samples by finger stick, heel stick, ear stick, or venipuncture in certain populations and within certain amounts
- 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.
- Research involving materials (data, documents, records, or specimens) that have been collected, or will be collected solely for non-research purposes
- Collection of data from voice, video, digital, or image recordings made for research purposes
- 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
Examples of Expedited Research:
- Studies involving collection of hair, saliva or dental plaque samples
- Studies of blood samples from healthy volunteers
- Analyses of voice and/or video recordings
- Physical sensors that are applied either to the surface of the body or at a distance and do not involve input of significant amounts of energy into the subject or an invasion of the subject’s privacy
- Moderate exercise, muscular strength testing, body composition assessment, and flexibility testing where appropriate given the age, weight, and health of the individual.