Tuesday, February 24, 2009

The IRB and Expedited Review

Most IRBs have procedures for expedited review for specific types of research involving no more than minimal risk. These include procedures that follow, adapted from the Code of Federal regulations (45 CFR 46).

Prospective collection of:

1. Biological specimens for research purposes by noninvasive means such as: hair and nail clippings in a non-disfiguring manner; deciduous teeth at time of exfoliation; permanent or deciduous teeth if routine patient care indicates a need for extraction; excreta and external secretions (including sweat); uncannulated saliva collected either in an unstimulated manner or stimulated by chewing gum base or wax or by applying a dilute citric acid solution to the tongue; placenta removed at delivery; amniotic fluid obtained at the time of rupture of the membrane prior to or during labor; supra- and subgingival dental placque and calculus, provided the collection procedure is not more invasive than routine prophylactic scaling of the teeth and the process is accomplished in accordance with accepted prophylactic techniques; mucosal and skin cells collected by buccal scraping or swab, skin swab, or mouth washings; sputum collected after saline mist nebulization.

2. Blood samples by finger stick, heel stick, ear stick or venipuncture collected no more than twice weekly from health, nonpregnant adults who weight at least 110 pounds in amounts not to exceed 550ml in an 8-week period, or from other adults and children, considering the age, weight, and health of the subjects, the collection procedure, the amount of blood to be collected, and the frequency with which it will be collected, but the amount drawn may not exceed the lesser of of 50ml or 3ml per kg in an 8-week period.

3. 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).

4. Data obtained through noninvasive procedures (not involving general anesthesia or sedation) routinely employed in clinical practice, excluding procedures involving x-rays or microwaves. Any medical devices must be already approved for marketing and not currently being tested for safety and effectiveness. Examples: physical sensors that are applied to the either 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; weighing or testing sensory acuity; magnetic resonance imaging; electrocardiography, electroencephalography, thermography, detection of naturally occurring radioactivity, electroretinography, ultrasound, diagnostic infrared imaging, Doppler blood flow and echocardiography; moderate exercise, muscular strength testing, body composition assessment, and flexibility testing where appropriate given the age, weight, and health of the individual.

5. Data from voice, video, digital, or image recordings made for research purposes.

6. Data on individual or group characteristics or behavior (such as 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.

Decisions on exemption at Palmer College initially start with consideration by the Human Protections Administrator. If exempt, you are free to conduct your research; if not, the IRB will review the project proposal.

No comments: