IRB Expedited Review Eligibility.pdf

Expedited review requires research presenting minimal risk to human subjects and meeting at least one category below. If none apply, full committee review is mandatory. The IRB determines final eligibility. Categories include: (1) drug/device studies where drugs lack investigational new drug requirements or devices have exemption clearance; (2) blood collection from healthy non-pregnant adults (≥110 lbs) with ≤550 ml in 8 weeks or other subjects with ≤50 ml or 3 ml/kg in 8 weeks; (3) non-invasive biological specimen collection like hair/nail clippings, deciduous teeth, excreta, saliva, placenta, amniotic fluid, dental plaque, mucosal/skin cells, or sputum; (4) non-invasive data collection using routine clinical procedures without x-rays/microwaves, including sensors, sensory tests, MRI, ECG, ultrasound, and exercise testing; (5) research using materials collected solely for non-research purposes; (6) data from voice/video/digital/image recordings; (7) research on behavior, cognition, communication, or social aspects using surveys, interviews, focus groups, or program evaluation. Some research in categories (5) and (7) may be exempt from HHS regulations but this listing applies only to non-exempt studies.