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2.3 Expedited Review

1.0 Purpose

The purpose of this policy and procedure is to describe the Organization’s requirements for using expedited review procedures for consideration of: 1) new research proposals, 2) continuing review of previously approved research, 3) minor changes in protocol, 4) minor complaints, and 5) non-serious noncompliance.

2.0 Policy

  • 2.1. It is the policy of the Organization that expedited review will be conducted in accordance with HHS regulations at 45 CFR 46.110; FDA regulations at 21 CFR 56.110; and will satisfy the criteria for IRB approval described in HRPP policy 2.5 (Criteria for Approval).

  • 2.2. Protocols initially reviewed and approved by the expedited method must (1) be no more than minimal risk; (2) involve only activities listed in one or more of the categories specified in the OHRP Expedited Review Categories (63 FR 60364-60367, November 9, 1998); and (3) meet all the criteria specified in HHS regulations 45 CFR 46.111, FDA regulations at 21 CFR 56.111 (as applicable), the HIPAA Privacy Rule (as applicable), and UNMC HRPP policies.

  • 2.3. Following the effective date of the Revised Rule, protocols for which limited IRB review is a condition of exemption under (rev) 45 CFR 46.104(d)(2)(iii), or (d)(3)(i)(C) are eligible for expedited review.

    Note: the Organization does not utilize exempt categories 7 and 8 (rev 45 CFR 46.104(d)(7) or (8)).

  • 2.4. Expedited review will not be used for initial or continuing review of (1) classified research, or (2) research involving prisoners.

  • 2.5. Minor changes in IRB-approved research qualify for expedited review in accordance with HRPP policy 2.4 (IRB Review of Changes in Previously Approved Research).

  • 2.6. Continuing review of research previously approved by a convened IRB where no subjects have been enrolled and no additional risks have been identified may undergo expedited review.

  • 2.7. Continuing review of research which satisfies the requirements of OHRP Expedited Review Categories (1998) category 9 (“research not conducted under an investigational new drug application or investigational device exemption where [expedited] categories 2 through 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”) may undergo expedited review.

  • 2.8. Continuing review of research which has been previously approved by the full IRB prior to the effective date for the Revised Rule, when the research meets the requirements of OHRP Expedited Review Categories (1998) category 8, is eligible for expedited review.

  • 2.9. Complaints which are considered minor, unexpected incidents involving no more than minimal risk to subjects or others, and noncompliance which is not serious is eligible for expedited review in accordance with HRPP policies 8.2 (IRB Review of Study Related Complaints) and 8.4 (IRB Review of Noncompliance Involving the PI and Study Personnel).

  • 2.10. It is the policy of the Organization that expedited review be substantive and meaningful in accordance with OHRP guidance (November 10, 2010); and FDA guidance (1998 FDA Information Sheets), and that the standard requirements for informed consent will be applied to all studies undergoing expedited review.

  • 2.11. The status of studies reviewed by an Expedited Review process are maintained in the Research Administration (RA) database and Research Support Services (RSS) application system.

3.0 Definitions

  • 3.1. Expedited Review is a method of review of research involving human subjects by one or more experienced reviewers designated by the Chair from among members of the IRB in accordance with the requirements set forth in 46 CFR 46.110; 21 CFR 56.110.
  • 3.2. 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 (per 45 CFR 46.102(i) (rev 45 CFR 46.102(j)), and 21 CFR 56.102(i)).

4.0 Expedited Review Categories

  • 4.1. The following categories of research may be eligible for review through the expedited review procedure when the proposed research involves no more than minimal risk to subjects. Following the effective date of the Revised Rule inclusion of research activities on the list is presumed to mean that the activity is minimal risk (FR 82 (12):7206, 2017) unless the reviewer determines and documents the rationale for considering the activity greater than minimal risk.

    • 4.1.1. Category 1: Clinical studies of drugs and medical devices only when condition (a) or (b) is met:

      • 4.1.1.1. 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.

      • 4.1.1.2. Research on medical devices for which:

        • 4.1.1.2.1. An investigational device exemption application (21 CFR Part 812) is not required; or
        • 4.1.1.2.2. The medical device is cleared/approved for marketing and the medical device is being used in accordance with its cleared/approved labeling.

    • 4.1.2. Category 2: Collection of blood samples by finger stick, heel stick, ear stick, or venipuncture as follows:

      • 4.1.2.1. From healthy, non-pregnant 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
      • 4.1.2.2. 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.

    • 4.1.3. Category 3: Prospective collection of biological specimens for research purposes by noninvasive means.

      Note: Examples of such biological specimens include but are not limited to (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 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.

    • 4.1.4. 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.

      Note: Examples of such non-invasive procedures include but are not limited to (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.

    • 4.1.5. 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 subjects. This listing refers only to research that is not exempt.

    • 4.1.6. Category 6: Collection of data from voice, video, digital, or image recordings made for research purposes.

    • 4.1.7. 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 subjects. This listing refers only to research that is not exempt.

    • 4.1.8. Category 8: Continuing review of research previously approved by the convened IRB as follows:

      • 4.1.8.1. 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
      • 4.1.8.2. Where no subjects have been enrolled and no additional risks have been identified; or
      • 4.1.8.3. Where the remaining research activities are limited to data analysis.

    • 4.1.9. 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) above 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

5.0 Procedures

  • 5.1. All IRB applications are submitted to the ORA and processed in accordance with HRPP policy 2.1 (Submission of Items for Review by the IRB).
  • 5.2. The designated Expedited Reviewer will have access to and review all documentation that the full IRB would normally receive for an initial review, Continuing Review, Change Requests, and other actions. Documentation will be available online through RSS (https://net.unmc.edu/rss).
  • 5.3. Appointment of Designated Expedited Reviewers
    • 5.3.1. An IRB member may serve as an expedited reviewer once he/she has been judged by the IRB Executive Chair to be sufficiently qualified and experienced. Specifically, the reviewer must have:
      • 5.3.1.1. An acceptable level of knowledge about the area of research under review.
      • 5.3.1.2. An understanding of the categories of research that qualify for expedited review.
      • 5.3.1.3. The ability to apply the IRB approval criteria and determine conditions required for IRB approval.
      • 5.3.1.4. An absence of a COI in accordance with HRPP policy 1.7 (IRB Member, Consultant, Staff COI Identification & Management) and verified on the IRB Review Checklist: Full and Conditional Approval.
    • 5.3.2. An IRB administrator who is also a voting board member may serve as an expedited reviewer, provided he/she meets the requirements above.
    • 5.3.3. Assignment of an expedited reviewer for a protocol will be made by the Executive Chair or his/her designee. In the absence of a specific designation to the contrary the expedited reviewer will be the IRB Administrator responsible for the protocol, provided he/she meets the requirements above.
  • 5.4. Criteria for Expedited IRB Approval and Other Determinations
    • 5.4.1. Criteria for IRB approval of all human subject are described in HRPP policy 2.5 (Criteria for IRB Approval).
    • 5.4.2. During the review, the IRB reviewer must also determine, as appropriate:
      • 5.4.2.1. The research is no more than minimal risk and represents one or more approvable expedited review categories of research.
      • 5.4.2.2. The research does not include activities where identification of the subjects 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.
      • 5.4.2.3. The research does not involve classified research.
      • 5.4.2.4. Whether the research requires continuing review more often than annually, as required at 45 CFR 46.109E; 21 CFR 56.108(a)(2), as appropriate to the degree of risk. The IRB may consider other factors as well:
        • 5.4.2.4.1. The nature of and any risks posed by the clinical investigation.
        • 5.4.2.4.2. The degree of uncertainty regarding the risks involved.
        • 5.4.2.4.3. The vulnerability of the participants. When research involves vulnerable populations, additional safeguards have been included in the study to protect the rights and welfare of these participants.
        • 5.4.2.4.4. The experience of the clinical investigator in conducting the clinical research.
        • 5.4.2.4.5. The IRBs previous experience with that researcher or sponsor (e.g., compliance history, previous problems with the researcher obtaining informed consent, prior complaints from participants about the researcher).
        • 5.4.2.4.6. The projected rate of enrollment
        • 5.4.2.4.7. Whether the study involves novel therapies.
      • 5.4.2.5. Whether the research need verification from sources other than the PI that no material changes have occurred since the previous IRB review, as required at 45 CRF 46.102(a)(4) (or rev 45 CFR 46.108(a)(3)(ii)), or 21 CFR 56.108(a)(2). The IRB will consider:
        • 5.4.2.5.1. Whether the research should have a third party observe the consent process in accordance with HRPP policy 1.2, Section 2.7 (Authority Granted to the IRB by the Organization).
        • 5.4.2.5.2. Whether the current consent form is still accurate and complete.
        • 5.4.2.5.3. Whether the research requires an audit of research records in accordance with HRPP policies 1.21 (Post Approval Monitoring of Research) and 8.4 (Review of Noncompliance Involving Risk to the Subject or Others).
      • 5.4.2.6. Whether there are any significant new findings that arise from the review process that might relate to a subject’s willingness to continue participation in the study.
      • 5.4.2.7. When the PI is the lead researcher of a multi-site trial, whether the management of information to the protection of human subjects is adequate, such as reporting of unanticipated problems, interim results, and protocol modifications.
    • 5.4.3. The Expedited Reviewer cannot disapprove research. The reviewer retains the right to refer any protocol for review by the full convened IRB. Such protocols are then reviewed in accordance with HRPP policy 2.2 (Full IRB Review). The reviewer must document the rationale for this determination and the rationale for review by the convened IRB.

6.0 Expedited Review Actions

  • 6.1. Final approval and full release; initiation of the research is authorized.
    • 6.1.1. All of the criteria for IRB approval are satisfied and no changes are required.
  • 6.2. Conditional approval; final IRB approval and full release contingent upon IRB Expedited Reviewer/designee review and acceptance of specified modifications and/or submission of additional documents
    • 6.2.1. All of the criteria for IRB approval are satisfied provided the investigator makes the specified changes. The IRB requirements for final approval and release are considered minor and not substantive in nature.
  • 6.3. Refer to full IRB for review
    • 6.3.1. The expedited reviewer is unable to make either of the above two findings.

7.0 Development of IRB Expedited Review and Final Approval Letters

  • 7.1. Expedited review letters, which reflect the deliberations and decisions of the expedited reviewer(s), are developed by the IRB Administrators, in consultation with the IRB Executive Chair and reviewers as applicable.
  • 7.2. IRB review letters must be written in a clear, explanatory, and facilitative fashion in order to assist PIs in understanding the rationale for any IRB concerns, clarifications and mandated changes to the application and ICF(s)/information sheet(s).
  • 7.3. The IRB review letters will clearly document the determinations of the Expedited Reviewer, as referenced above in Sections 5.2 of this policy, including:
    • 7.3.1. The decision to approve, or require modifications.
    • 7.3.2. List any modifications/clarifications required by the Expedited Reviewer.
    • 7.3.3. Signature authority is granted to the Expedited Reviewer in accordance with HRPP policy 1.19 (IRB Signature Authority).

8.0 Deadlines for PI Responses

  • 8.1. The PI is given 45 days from the date of the IRB review letter to respond to the IRB’s review by submitting appropriately revised documents. If no response is received by the end of the 30-day period, the PI and Lead Coordinator (if applicable) are contacted by either phone or email to determine the status of their response.
    • 8.1.1. Extensions will be granted on a case-by-case basis, as determined by the IRB Administrator in consultation (if needed) with the IRB Executive Chair.
  • 8.2. If there has been no response by 45 days (or by the expiration of the extension provided per section 8.1.1 above) the study will be withdrawn or closed.

9.0 Review of PI Responses

  • 9.1. The IRB Administrator serves as the designated reviewer and is authorized to review and determine the acceptability of the PI’s response. The IRB Administrator will consult with the IRB Executive Chair/designee or IRB reviewers as necessary.

    • 9.1.1. If, on consultation with the Executive Chair, the IRB Administrator determines that the investigator’s response to the IRB review is inadequate, incomplete, or contains significant changes not initially reviewed by the IRB, he/she will refer the submission for review by the full convened IRB.

      Note: If the original submitted protocol required modification that were more than minor it would have been referred to the full IRB and reviewed in accordance with HRPP policy 2.2 (Full IRB Review).

10.0 Final IRB Approval Letter

  • 10.1. The IRB final approval letter will document the following determinations:
    • 10.1.1. Pertinent dates:
      • 10.1.1.1. Date of full Board review.
      • 10.1.1.2. Date all conditions set by the IRB were determined to be met and the study was granted final approval and release.
      • 10.1.1.3. Expiration Date (per section 11.0)
    • 10.1.2. Compliance with applicable HHS and FDA regulations
    • 10.1.3. Verification that the research is classified as minimal risk
    • 10.1.4. The applicable expedited review category
    • 10.1.5. Subpart B category for inclusion of pregnant women (as applicable)
    • 10.1.6. Subpart D category for inclusion of children (as applicable)
    • 10.1.7. Waiver or alteration of the requirements for informed consent (as applicable)
    • 10.1.8. Waiver of the requirement for documentation of informed consent. (as applicable)

11.0 IRB Approval Periods

  • 11.1. The approval period for protocols for which continuing review is required is based on the date that the convened IRB gave conditional approval of the research. Studies approved with annual continuing review are valid for 364 days from the date of conditional approval; the approval period expires on the 365th day.

12.0 Documentation of Expedited Review

  • 12.1. The IRB Review Checklist: Full and Conditional Approval must be completed and maintained in the protocol file. This checklist will specify: a) the category of research under which the protocol qualifies, b) the risk level as being no more than minimal risk, and c) the IRB approval criteria are satisfied.
  • 12.2. IRB members and the IO are advised via electronic distribution of the minutes of all actions reviewed and approved by the expedited review procedure.
  • 12.3. The full convened IRB retains the authority to require modification of the protocol and/or ICF(s) of research reviewed and approved under the expedited process, or to suspend the study or halt accrual if warranted.

13.0 Review by Other Organizational Committees

  • 13.1. Before the IRB will grant final approval and release, the Organization has determined the ORA must receive verification of approval or completion of review by the following committees/offices as applicable:
    • 13.1.1. Fred & Pamela Buffett Cancer Center Scientific Review Committee
    • 13.1.2. Conflict of Interest Committee
    • 13.1.3. Sponsored Programs Administration/Contracts Office
    • 13.1.4. Research Billing/Coverage Analysis Office

ADMINISTRATIVE APPROVAL: BRUCE G. GORDON, MD IRB EXECUTIVE CHAIR & ASSISTANT VICE CHANCELLOR FOR REGULATORY AFFAIRS CHRISTOPHER KRATOCHVIL, MD INSTITUTIONAL OFFICIAL

POLICY AMENDED:

 REVISED JUNE 13, 2018

 INITIAL APRIL 11, 2016

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