An expedited review is conducted by the IRB chair or a designee. Only research that meets the specific criteria outlined in “Research Activities Which May Be Reviewed Through Expedited Review Procedures” (63 FR 60353-60356 and 63 FR 60364-60367) AND involves no greater than minimal risk will be reviewed by an expedited review process. Minimal risk means that the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests. Most behavioral work involving human participants that is eligible for expedited review falls under Category 7.
Categories of research eligible for expedited review
According to 63 FR 60364-60367, November 9, 1998 and 63 FR 60353-60356, November 9, 1998 www.hhs.gov/ohrp/humansubjects/guidance the following 9 categories of research are permitted to receive expedited review. Most behavioral research falls under Category 7. Category 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 www.hhs.gov/ohrp/humansubjects/guidance 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 www.hhs.gov/ohrp/humansubjects/guidance] 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.
Category 2: 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.
Category 3: 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 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.
Category 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. (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 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; (e) moderate exercise, muscular strength testing, body composition assessment, and flexibility testing where appropriate given the age, weight, and health of the individual.
Category 5: 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. (NOTE: Some research in this category may be exempt from the DHHS regulations for the protection of human subjects--see Exempt Research and 45 CFR 46 101(b)(4)-- www.hhs.gov/ohrp/humansubjects/guidancethis listing refers only to research that is not exempt).
Category 6: Collection of data from voice, video, digital, or image recordings made for research purposes.
Category 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 methodologies. (NOTE: Some research in this category may be exempt from the DHHS regulations for the protection of human subjects--see Exempt Research and 45 CFR 46.101(b)(2) and (b)(3) www.hhs.gov/ohrp/humansubjects/guidance -this listing refers only to research that is not exempt).
Category 8: Continuing review of research that is greater than minimal risk and has been initially reviewed and approved by the convened full-board 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 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.
Category 9: Continuing review of research, not conducted under an investigational new drug application or investigational device exemption where categories two (2) through eight (8) do not apply but the IRB has determined and documented at a convened meeting that the research involves no greater than minimal risk and no additional risks have been identified.
The following cannot be reviewed through the Expedited process.
1. Research where identification of the subjects and/or their responses would reasonably place them at risk of criminal or civil liability or be damaging to the subjects financial standing, employability, insurability, reputation, or be stigmatizing, unless reasonable and appropriate protections will be implemented so that risks related to invasion of privacy and breach of confidentiality are no greater than minimal.
2.Classified research involving human subjects.
3.Research that involves more than minimal risk to human subjects (i.e. the probability and magnitude of harm or discomfort anticipated in the research are greater than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests).
4. Research with prisoners is not eligible for expedited review.