700-22-Expedited Review

Title:	Expedited Review
Owner:	IRB
Last Update/Revised:	05/01/2024

Policy: Expedited review procedures consist of a review of research involving human subjects by the IRB Chair or qualified designee (see 700-5: Duties of IRB Members for a description of the procedure used to designate expedited reviewers). The IRB Chair or designee may exercise all the authorities of the IRB, except that he/she may not table or disapprove the research. A research proposal may be tabled or disapproved only after review by the convened IRB.

The categories of research that the IRB may review through an expedited review procedure include research activities that:

1. present no more than minimal risk to human subjects (defined as: 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), and

2. involve only procedures listed in one or more of the specific categories listed in the regulations at Federal Register (FR) Volume 63, No 216 (for details about these categories, see below under “Expedited Research Categories”) and

3. the research is not classified.

The criteria for approval using the expedited procedure are the same as those for review by a convened IRB. The IRB is permitted to use expedited review for initial and continuing review of research that involves solely one or more of the activities listed below.

If research did not qualify for expedited review at the time of initial review, it does not qualify for expedited review at the time of continuing review, except as described in category 7, below. The IRB Chair or designee may use the expedited review procedure to review minor modifications to previously approved research during the period for which approval is authorized. A modification is minor if it does not involve greater than minimal risk to the participant and it does not have a significant impact on the (1) risk level of the study, (2) risk-to-benefit ratio of the study, or (3) a participant’s willingness to participate in the study. The following conditions must be met:

the proposed modifications are administrative changes or similar minor changes; or
the research was previously determined to be eligible for expedited review and the proposed modifications do not change the study’s expedited determination; or
the research was previously determined to be exempt and the proposed modifications do not change the study’s exempt status.

Any modification that does not meet the criteria above must be reviewed by the full IRB at a convened meeting.

The IRB Chair or designee may use the expedited review procedure to review amendments proposing changes that have been requested by a convened board. In such cases, changes must be stipulated by the convened board, and no additional changes may be added to the amendment that would require convened board review.

When the expedited review procedure is used, it is recorded on the appropriate form in the USU IRB Google Drive.

Purpose: The purpose of this policy is to describe the process for reviewing expedited research.

Procedures:

Procedures for Expedited Review
1. The IRB Chair or designee conducts an administrative review of the new study, Continuing Review Form, or Amendment Form using the appropriate IRB Reviewer Checklist.
  1. The IRB Chair or designee is assigned as an expedited reviewer. Assigned expedited reviewers perform an in-depth review of pertinent documentation and materials submitted by the Investigator.
  2. For new studies and those requiring continuing review, the assigned expedited reviewer completes the appropriate IRB Reviewer checklist, documenting whether the application meets one or more of the expedited categories and whether the study meets the criteria for IRB approval. The reviewer documents the applicable expedited category.
2. For amendments, the assigned expedited reviewer completes the appropriate IRB Reviewer Checklist, documenting whether the amendment to the previously approved research is eligible for expedited review and the modification involves no more than minimal risk to participants.
3. If the expedited reviewer determines the application does not qualify for an expedited review, or recommends that the study be tabled or disapproved, the IRB Chair will assign the study for the next convened IRB meeting. The IRB Chair or designee will communicate this decision and a timeline to the investigator (and chair of a doctoral student) via email from IRB@usuniversity.edu.
4. If the expedited reviewer determines that the criteria for approval of the application have been met, the reviewer may approve the application. The IRB Chair or designee will communicate this decision and a timeline to the investigator (and chair of a doctoral student) via email from IRB@usuniversity.edu.

<gu-sc>Expedited Research Categories per FR63 pgs. <gu-sc-dial data-dn="6036460367" title="Click to Connect 6036460367"><gu-sc-img></gu-sc-img>60364-60367</gu-sc-dial> Permitted at USU<gu-sc-orig style="display: none;">Expedited Research Categories per FR63 pgs. 60364-60367 Permitted at USU</gu-sc-orig></gu-sc>

Collection of blood samples by finger stick, heel stick, ear stick, or venipuncture as follows:

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
from other adults, considering subjects' age, weight, and health, 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 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) un-cannulated 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.
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; (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 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 subjects. 45 CFR 46.101(b)(4). This listing refers only to research that is not exempt.)
Collection of data from voice, video, digital, or image recordings made for research purposes (NOTE: Research that is not federally funded may be exempt, see 700-21: Exempt Research).
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 subjects. 45 CFR 46.101(b)(2) and (b)(3). Research that is not federally funded may be exempt, see 700-21: Exempt Research). This listing refers only to research that is not exempt.
Continuing review of research previously approved by the convened IRB as follows:

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
where no subjects have been enrolled, and no additional risks have been identified; or
where the remaining research activities are limited to data analysis.

Scope: This policy applies to expedited research proposed at USU.

Documents and Forms:

IRB Reviewer Checklist (available on IRB Google Drive)

Amendment Form