Initial Review of a New Protocol:
The following criteria apply to ALL categories:
• The research presents no greater than minimal risks to subjects
• The research includes reasonable and appropriate protections so that risks related to invasion of privacy and breach
of confidentiality are no greater than minimal, if the identification of the participants or their responses will
reasonably place them at risk of criminal or civil liability or be damaging to their financial standing, employability,
insurability, reputation, or be stigmatizing.
• The research is not classified
• The research fits into one (or more) of the following categories
1) Clinical studies of drugs and medical devices only when condition (a) or (b) is met.
(a) Research on drugs for which an investigational new drug application (21 CFR Part 312) is not required. (Note:
Research on marketed drugs that significantly increases the risks or decreases the acceptability of the risks associated
with the use of the product is not eligible for expedited review.)
(b) Research on medical devices for which (i) an investigational device exemption application (21 CFR Part 812) is not
required; or (ii) 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 as follows:
(a) From healthy, non-pregnant adults who weigh at least 110 pounds: For these subjects, the amounts drawn may not
exceed 550 ml in an 8 week period and no more frequently than 2 times per week; or
(b) 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. For these subjects, the amount
drawn may not exceed the lesser of 50 ml or 3 ml per kg in an 8 week period and no more frequently than 2 times per
3) Prospective collection of biological specimens for research purposes by noninvasive means.
Examples: (a) Hair and nail clippings in a non-disfiguring manner; (b) deciduous teeth at time of exfoliation or if
routine patient care indicates a need for extraction; (c) permanent teeth if routine patient care indicates a need for
extraction; (d) excreta and external secretions (including sweat); (e) uncannulated saliva collected either in an
unstimulated fashion or stimulated by chewing gumbase or wax or by applying a dilute citric solution to the tongue; (f)
placenta removed at delivery; (g) amniotic fluid obtained at the time of rupture of the membrane prior to or during
labor; (h) supra- and subgingival dental plaque 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; (i) mucosal and skin cells collected by buccal scraping or swab, skin swab, or mouth washings; (j) sputum
collected after saline mist nebulization.
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.
Examples: (a) 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; (b) weighing or testing
sensory acuity; (c) magnetic resonance imaging; (d) 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) 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).
6) Collection of data from voice, video, digital, or image recordings made for research purposes.
7) 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
Protocols that do meet the criteria will be so reported and documented at the next IRB meeting. Protocols that do
not meet the criteria for an expedited review will be presented before a full convened board.