Expedited Review
Expedited does not mean that a review is less rigorous or happens more quickly than convened IRB review. Instead, it refers to certain types of research considered to involve minimal risk to participants.
Expedited review at Brown is conducted by an experienced IRB member. The IRB member conducting the expedited review may exercise all of the authorities of the IRB, except that the reviewer may not disapprove the research. The reviewer must refer any research protocol that he/she would have disapproved to the Full IRB for review. The reviewer may also refer other research protocols to the Full IRB whenever the reviewer believes that Full IRB review is warranted.
Eligibility
Expedited review is applicable to research activities that involve no more than minimal risk to the human participants and that can be placed in one or more of the nine categories below.
Categories 1 through 7 pertain to both initial and continuing review. Categories 8 and 9 pertain only to continuing review.
Continuing Review (Progress Reports)
Continuing Review will no longer be required for studies eligible for expedited review (minimal risk research) and studies that underwent Full Board review for which ongoing activity is limited to data analysis, including analysis of identifiable data/biospecimens OR involve accessing follow-up clinical data from procedures that subjects would undergo as part of clinical care. Continuing review will still be required for FDA regulated research studies.
Studies released from continuing review requirements will undergo quality assurance monitoring efforts to confirm if the study is still ongoing, remind investigators to continue to submit amendments and Reportable Events related to the research, and to prompt investigators to close the study if human subject research activities are complete.
Applicability
-
Research activities that (1) present no more than minimal risk to human subjects, and (2) involve only procedures listed in one or more of the below categories, may be reviewed by the IRB through the expedited review procedure authorized by 45 CFR 46.110 and 21 CFR 56.110. The activities listed should not be deemed to be of minimal risk simply because they are included on this list. Inclusion on this list merely means that the activity is eligible for review through the expedited review procedure when the specific circumstances of the proposed research involve no more than minimal risk to human subjects.
-
The categories apply regardless of the age of subjects, except as noted.
-
The expedited review procedure may not be used 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.
-
The expedited review procedure may not be used for classified research involving human subjects. Brown does not permit the conduct of classified research.
- The standard requirements for informed consent (or its waiver, alteration, or exception) apply regardless of the type of review--expedited or convened--utilized by the IRB.
Categories of Review
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; or
(b) Research on medical devices for which (i) an investigational device exemption application (21CFR812) 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.
*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
Category 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 participants, 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 participants, the collection procedure, the amount of blood to be collected, and the frequency with which it will be collected. For these participants, 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 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 gum base 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.
*NOTE: 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 non-research purposes (such as medical treatment or diagnosis).
*NOTE: Some research in this category may be exempt from the HHS regulations for the protection of human research participants. 45 CFR 46.101(b)(4). This 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 HHS regulations for the protection of human research participants. 45 CFR 46.101(b)(2) and (b)(3). This listing refers only to research that is not exempt.
Category 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 participants;
(ii) all participants have completed all research-related interventions; and
(iii) the research remains active only for long-term follow-up of participants; or
(b) where no participants 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.