What Level of Review Do I Need?
Although the category is called "exempt," this type of research does require registration with the Institutional Review Board. The exempt registration process is much less rigorous than an expedited or full-committee review. To qualify, research must fall into at least one (1) of six (6) Federally-defined exempt categories located at 45 CFR 46.101 of the Code of Federal Regulations. These categories present the lowest amount of risk to potential subjects because, generally speaking, they involve either collection of anonymous or publicly-available data, or conduct of the least potentially-harmful research experiments. Some examples of exempt research are:
- anonymous surveys
- taste tests
- analyses of discarded pathological specimens without patient identifiers
To qualify for an expedited review, research must fall into at least one (1) of nine (9) Federally-defined expedited categories. These categories involve collection of samples and data in a manner that is not anonymous and that involves more than minimal risk to subjects. CLINICAL INVESTIGATIONS WHICH MAY BE REVIEWED THROUGH EXPEDITED REVIEW PROCEDURES SET FORTH IN FDA REGULATIONS. Research activities with human subjects involving no more than minimal risk and involving one or more of the following categories (carried out through standard methods), may be reviewed by an IRB through the expedited review procedure authorized by 45 CFR 46:110 and 21 CFR 56.110.
NOTE: BBH-IRB will review Retrospective Chart Reviews under this 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) is not required. (Note: Research on marketed drugs that significantly increase the risks or decrease 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, 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.
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.
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 devices 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) weighting or testing sensory acuity; (c) magnetic resonance imaging; (d) electrocardiography, electroencephalography, thermography, detection of naturally occurring radioactivity, electroretinography, ultrasound, diagnostic 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 nonresearch purposes (such as medical treatment or diagnosis). (Note: Some research in this category may be exempt from the OHRP regulations for the protection of human subjects. 45 CFR 46.101(b)(4). This listing refers only to research that is not exempt.)
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 methodologies. (Note: Some research in this category may be exempt from the OHRP regulations for the protection of human subjects. 45 CFR 46.101(b)(2) and (b)(3). This listing refers only to research that is not exempt.)
8. Continuing review of research previously approved by the 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 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.
9. Continuing review of research, not conducted under 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.
Full Committee Research:
Proposed human subject research which does not fall into either the exempt or expedited review categories must be submitted for full committee review. This is the most rigorous level of review and, accordingly, is reserved for research projects that present more than minimal risks to subjects.