Expedited Review Categories
The categories for expedited level of review are listed below. The Department of Health and Human Services (HHS) and Food and Drug Administration (FDA) permit these types of research, which are published in the Federal Register. Research which falls into these categories can be reviewed and approved by the chair and one to three members of the board if: (i) research activities present no more than minimal risk, and/or (ii) the application is for minor changes in research previously approved by the IRB and is submitted during the period in which the approval is granted. If your research does not fall into any of these categories, you may need to complete an application for full review for your research study. These categories are taken from the Federal Register, see 45 CFR 46.110 or 21 CFR 56.110 for reference. Most expedited research at the University of St. Thomas will fall into categories 4-8.
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. (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.
Collection of blood samples by finger stick, heel stick, ear stick, or venipuncture as follows: (a) from healthy, nonpregnant adults who weigh at least 110 pounds. For these subjects, the amounts drawn may not exceed 550 ml in an 8-week period and collection may not occur 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 collection may not occur more frequently than 2 times per week.
Prospective collection of biological specimens for research purposes by noninvasive means. Examples: (a) hair and nail clippings in a nondisfiguring 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 removal at delivery; (g) amniotic fluid obtained at the time of rupture of the membrane before or during labor; (h) supragingival 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; and (j) sputum collected after saline mist nebulization.
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. (Studies intended to evaluate the safety and effectiveness of the medical device are not generally eligible for expedited review, including studies of cleared medical devices for new indications.) 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 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; (e) moderate exercise, muscular strength testing, body composition assessment, and flexibility testing where appropriate given the age, weight, and health of the individual.
Research involving materials (data, documents, records, or specimens) that have been collected, or will be collected, solely for nonresearch purposes (such as medical treatment or diagnosis).
Collection of data from voice, video, digital, or image recordings made for research purposes.
Research on 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.
Continuing review of research previously approved by a convened IRB as follows: (a) where (i) the research is permanently closed to the enrollment of new subjects; (ii) all subjects have completed all research-related interventions; and (iii) the research remains active only for the long term follow-up of subjects; or (b) where no subjects have been enrolled and no additional risks have been identified; or (c) where the remaining research activities are limited to data analysis.
Research Subject and Method
Twenty women are collectively interviewed via a focus group to determine their experiences volunteering with a non-profit organization. The participants are well known and have given their permission to be video recorded and identified in the research.
Why does this qualify for expedited review?
Since the research participants are able to see each other and hear one another’s answers, they are no longer anonymous (to the investigator and other participants). Also, the investigator will record their responses to questions using video recording, but has consent from well-known participants to do so.