Section VIII:

Review Types/Process

WPP #: VIII-2

Title 2:

Initial Review - Expedited

Effective Date:

09-24-14

Revision History:

06-20-00; 09-20-01; 06-07-04; 12-06-04; 6-21-06; 02-05-07; 01-15-08; 04-22-14

Policy Statement

All proposed projects that involve human subjects and that satisfy the definition of research must be reviewed prior to the activity beginning. This review is called “initial review.” The types of initial review are exempt, expedited and full. Expedited initial review is described within this WPP.

Identification of research projects that qualify for expedited review will be made by the IRB administrative staff. Expedited research projects will be reviewed by the Chairperson of a VCU IRB Panel or by an experienced member of the IRB designated by the Chairperson.

Description and Procedures

  1. Qualification for Expedited Initial Review:

    Only projects involving no more than minimal risk are considered for expedited review. The reviewer makes the final decision as to whether or not the protocol meets the applicability criteria and qualifies for the category or categories noted (or another one or more of the 7 categories) and can make a decision to refer the review to the full board. Investigators must submit sufficient information to ensure that the IRB criteria for approval are met, including but not limited to the Smartform application, scientific rationale, research protocol, consent form and any other necessary information.

  2. Minimal Risk Determination:

    At initial review, the expedited review type applies to research projects that:

    1. pose no more than minimal risk, AND
    2. involve one or more research activities (see 9 categories below) listed in the federal regulations as qualifying for expedited review.

    NOTE: The activities listed should not be deemed to be of minimal risk simply because they are included in the federal regulations as qualifying for expedited review. 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.

    Minimal risk is defined in 45 CFR 46.102(i) and 21 CFR 56.102(i): “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.”

    The following conditions also apply:

    • The expedited review procedure is not 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 are implemented so that risks related to invasion of privacy and breach of confidentiality are no greater than minimal.
    • The expedited review procedure cannot be used for classified research.
    • For FDA-regulated research: 21CFR56.110 (d) states "The FDA may restrict, suspend, or terminate an institution's or IRB's use of the expedited review procedure when necessary to protect the rights or welfare of subjects." 21 CFR 46.110(d) states that "The department or agency head may restrict, suspend, terminate, or choose not to authorize an institution's or IRB's use of the expedited review procedures."
  3. Expedited Review Categories:

    The following 9 categories include two categories (8 and 9) that specifically pertain to continuing review and NOT initial review. VCU IRB WPP#: VIII-4 addresses Continuing Review. However the 9 categories are quoted here in their entirety as published at 63 FR 60364-60367 and referenced in 45 CFR 46.110(a).

    The following research activities are listed in the federal regulations as qualifying for expedited review:

    Categories For Expedited Review:
    HHS 45 CFR § 46.110
    FDA 21 CFR § 56.110

    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 increases the risks or decreases the acceptability of the risks associated with the use of the product is not eligible for expedited review.) or (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 children2, 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. NOTE: 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.
    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 HHS 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 HHS 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 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.
  4. Reviewer, Approval, and Disapproval Guidelines:

    A Panel Chairperson or experienced IRB member may conduct expedited reviews. The reviewer may (1) approve research submitted for Expedited review (as submitted) or may (2) require modifications prior to approval. An experienced reviewer is one who has served with the IRB for a duration that has allowed for an evaluation of the reviewer's understanding of the regulations and the VCU IRB written policies and procedures as they pertain to expedited review. Expedited research is assigned to a reviewer by the VCU ORSP staff, based upon area of expertise.

    The reviewer may not disapprove projects that have been submitted for expedited review. In cases where the research cannot be approved via expedited review, the reviewer must recommend resubmission for full board approval or forward to the VCU IRB panel for review as full board, with their written comments.

  5. Document Distribution and Reviewer Actions:
    1. If there is any protocol-related information requiring clarification, the expedited reviewer should contact the principal investigator (or student/trainee conducting the activity) directly.
    2. Final review comments by the expedited reviewer must be documented in writing and forwarded to the IRB coordinator for processing. Expedited reviewers will document the following:
      1. Confirmation that the research meets the criteria for review found at 45 CFR 46.111 and 21 CFR 56.111.
      2. Confirmation that the research meets the requirements found at Subparts B, C and D, when applicable.
      3. Confirmation that the research meets the requirements for informed consent, including consent alterations or waivers.
      4. Confirmation that the research poses no more than minimal risk;
      5. Identification of the Expedited Research Category;
      6. Determination of the requirement for continuing review and any other additional requirements;
      7. Review of any recruitment procedures involving advertisements.
    3. Final documentation of approval will be generated by the ORSP staff and communicated in writing to the principal investigator.
    4. Research studies approved via expedited procedure are reported on a monthly basis to the relevant IRB Panel (as part of the meeting agenda).

References

HHS 45 CFR § 46.110
FDA 21 CFR § 56.110
HHS 45 CFR § 46.111
FDA 21 CFR § 56.111