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    Institutional Review Board (IRB)

    Standard Operating Procedure
    Expedited IRB Review


    Purpose  |  Policies  |  Procedures  |  Expedited IRB Review (PDF format)

    Purpose

    This Standard Operating Procedure (SOP) is to document the policies and procedures for conducting expedited review of research projects operating under the approval of the California Pacific Medical Center (CPMC) Institutional Review Board (IRB).
    This SOP is written to comply with applicable federal regulations including the following:

    • U.S.  Department of Health and Human Services (DHHS) 45 CFR 46 (Common Rule);
    • U.S. Food and Drug Administration (FDA) 21 CFR 50 and 56;
    • DHHS rules published on November 9, 1998 titled “Categories of Research That May Be Reviewed by the Institutional Review Board (IRB) through an Expedited Review Procedures;”
    • DHHS Standards for Privacy of Individually Identifiable Health Information 45 CFR 46 160 and 164 (Privacy Rule); and
    • The CPMC Federalwide Assurance (FWA).


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    Policies

    1. The CPMC IRB will make determinations of eligibility for expedited review according to federal regulations and CPMC policies.
    2. The CPMC IRB may establish additional policies and criteria for conducting expedited review as long as the policies and criteria do not conflict with federal regulations.
    3. The CPMC IRB will use federal criteria and any additional written and approved IRB criteria as noted below to determine eligibility for expedited review.
    4. Initial Review
      1. When a study is determined to be minimal risk and all research activities fall within one or more of the eight categories listed below, the study is eligible for expedited review according to federal regulations.
        1. Uses data, documents, records, or specimens that have already been collected, or will be collected, for non-research purposes (e.g., review of medical records, utilization data, etc.);
        2. Evaluates individual or group characteristics, behaviors or opinions where the research data is collected by survey, focus group, program evaluation, quality assurance methodologies, interview, or oral history;
        3. Does NOT involve an investigational drug or biologics or an approved drug being used for a non-approved purpose, population, route, or dosage;
        4. Does NOT involve a significant risk device unless the device is being used according to the approved purpose;
        5. Collects data only from voice, video, digital or image recording made for research purposes;
        6. Collects blood samples by finger stick, heel stick, ear stick or venipuncture, in amounts defined by federal rules;
        7. Collects biological specimens for research purposes by non-invasive means; and
        8. Collects data through non-invasive procedures routinely employed in clinical practice, excluding procedures involving x-ray and microwave radiation.
      2. When a study is not eligible for expedited review it is referred to the convened IRB. The convened IRB must make the final decision to approve, require modification of, or disapprove the study.
      3. If the convened IRB decides to defer action on a study, the Principal Investigator’s (PI) responses(s) must go back to the convened IRB until the IRB makes its final decision.
    5. Continuing Review
      1. Continuing review may be conducted using an expedited review procedure:
        1. When the study was determined to be minimal risk and was eligible for expedited review at the time of initial review and no additional risks have been identified since the initial review; or
        2. When, at CPMC, the study is permanently closed to enrollment of new participants, and when all participants have completed research-related interventions, andwhen the research remains active only for long-term follow-up; or
        3. When no research subjects have been enrolled at the CPMC site since the study received initial IRB approval and no additional risks have been identified; or
        4. When the remaining research activities are limited to data analysis.
    6. Minor Modifications
      1. Minor modifications in previously IRB-approved research may be reviewed using an expedited review procedure. This includes minor modifications to IRB-approved consent forms and other study-related documents.
      2. A minor modification is defined as one that does not have a reasonable anticipated negative impact on the safety, confidentiality, rights, or welfare of study subjects, and does not represent a significant change in the study design or methods. Examples of minor modifications include:
        1. Substitution of assessments (e.g., physical examination, laboratory test, etc.) with alternate assessment that presents minimal risk;
        2. Increase or decrease of enrollment (in some instances, the IRB may require statistical justification);
        3. Narrowing the range of inclusion criteria;
        4. Broadening the range of exclusion criteria;
        5. Decreasing the number or volume of biological sample collections, provided that such a change does not affect the collection of information related to safety evaluations;
        6. Changes to improve clarity of statements or to correct typographical errors, provided that the change does not alter the content of intent of the statement;
        7. Addition or deletion of qualified sub-investigators;
        8. Addition or deletion of study sites;
        9. Addition of or revision to study tools (e.g., survey instruments, questionnaires, member and provider contact letters, recruitment materials);

        NOTE: An expedited review procedure will not be used for reviewing study tools intended for use with a vulnerable population or that ask questions about illegal or sensitive behavior, such as illegal drug use or sexual practices.

        1. Revisions or modifications to consent forms to provide clarification, revised lay language, or inclusion of missing elements; and
        2. Addition of recruitment notices provided there is no change in the risk/benefit determination or evidence of inappropriate inducement.
    7. PI Concurrence with Stipulations on IRB Approvals
      1. When the convened IRB approves a study conditioned upon specific stipulations for which only the PI’s simple concurrence is required, the PI’s written response concurring with the stipulation(s) may be reviewed under an expedited review procedure to verify that the stipulation(s) have been, or will be, met.
      2. If the investigator does not concur with the IRB-required stipulation(s), the convened IRB will review the investigator’s response.
      3. The PI may not begin or continue the study until the IRB has removed all conditions and/or stipulations.
    8. AE, IND Safety and Protocol Violation Reports
      1. Documents containing local adverse events that are serious, at least possibly related to study drug, and unanticipated, IND safety information or reports of protocol violations must be reviewed by the convened IRB or a duly constituted IRB sub-committee and reported to the convened IRB. (For more information, please refer to the SOPs on SAEs and Protocol Violations.)
    9. The CPMC IRB may establish additional criteria to restrict expedited review, for example:
      1. The PI is new to CPMC;
      2. The study requires prior expert review;
      3. The study population is selected on the basis of a specific characteristic, such as a medical condition or an identifiable vulnerability;
      4. The study involves direct contact (such as letter, e-mail, internet, telephone, or in-person) with a vulnerable population; and/or
      5. Other criteria as determined by the CPMC IRB.
    10. The CPMC IRB will approve a new consent form using an expedited review procedure only when the entire study is eligible for expedited review at the time of initial review.
    11. The CPMC IRB Chair has the authority to conduct expedited review on all studies which he/she has no conflicts of interest.
    12. The CPMC IRB Chair may delegate the authority to conduct expedited review to appropriately experienced IRB members. This delegation must be in writing.
    1. The CPMC IRB Administrator is responsible for assuring that studies reviewed by expedited review are eligible for expedited review.
    1. From among the group of IRB members delegated by the Chair, the CPMC IRB Chair or Administrator will determine which IRB member will be asked to conduct an expedited review of a particular study.
      1. The IRB member selected to conduct the expedited review of a study will have the background and experience appropriate to the study.
    1. The expedited reviewer can refer any study being reviewed by expedited review to the convened IRB for any reason.
    2. It is not permissible to disapprove a study using the expedited review procedure. If an expedited reviewer believes a study should not be approved, he/she must refer the study to the convened IRB.
    3. When any study or minor modification is approved by expedited review, the expedited reviewer will make all determinations (e.g., study approval, waiver of informed consent, waiver of privacy authorization) required by federal regulations, including the Common Rule and the Privacy Rule. These determinations will be documented in writing in the IRB study file.
    4. The CPMC IRB will be notified in writing of studies and study-related documents that were approved by expedited review (e.g., a list of titles for those studies/submissions approved using an expedited review procedure).
    5. The CPMC IRB may approve a waiver of privacy authorization or a mechanism for obtaining authorization using an expedited review procedure if the study or study modification is otherwise eligible for expedited review under current federal rules.

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    Procedures

    1. The IRB Administrator, or designee, will screen new research applications, progress reports, final reports, modifications, new study tools, and other items to determine if they are eligible for expedited review.
      1. The CPMC IRB will maintain written documentation of the elements of the study that makes it eligible by federal regulations and CPMC IRB policies.
    2. The expedited reviewer, when conducting a review, will make one of the following decisions:
      1. Approve the research or minor modification;
      2. Stipulate modification(s) inthe research as a condition of approval that requires only simpleconcurrence by the PI;
      3. Defer action and request clarificationfrom the CPMC PI. The expedited reviewer or IRB staff will request furtherinformation from the PI to enable continued expedited review; or
      4. Refer the item for review tothe convened IRB.

    NOTE: Federal regulations do not allow an expedited reviewer to disapprove research. Any item that the reviewer does not approve must be reviewed by the convened IRB.

    1. The IRB will send written notification (e.g., letter or e-mail) informing the PI of the review decision.
      1. A copy of the notification letter will be maintained in the IRB study file.
    2. All IRB members will be notified in writing of items approved by expedited review.

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    Expedited IRB Review (PDF format)

    You can also download SOP Expedited IRB Review in PDF format.



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