Section VII:

General Operations

WPP #: VII-5

Title 5:

Appeal of IRB Decisions

Effective Date:

09-12-18

Revision History:

06-20-00; 09-20-01; 06-07-04; 04-30-06; 06-21-06,09-1-09, 07-22-14

Policy Statement

The VCU Human Research Protection Program ascribes to an investigator’s ability to appeal an IRB determination – related to protocol approval or study conduct - that cannot be resolved through negotiated discussion. However, the expectation is that the investigator(s) and the IRB reviewer or panel first make every effort to work toward an acceptable resolution of a disputed IRB determination. As a last step for addressing an irreconcilable disagreement about an IRB determination, the Appeals proceeding is a confidential, non-adversarial, collegial process. The outcome of the Appeals proceeding is final.

Description

It is the IRB’s primary charge to protect human subjects while adhering to federal and state regulations and institutional policies and procedures. In so doing, the IRB may make two general types of determinations: 1) protocol-related findings (i.e. disapproval, modifications required to approve an initial or amendment submission) and 2) findings regarding study conduct and/or study events, such as determinations of noncompliance, unanticipated problems involving risk to subjects or others, and study suspension or termination. If the investigator disagrees with either type of IRB determination, this WPP describes a stepwise method of resolution that allows PIs and the IRB to pursue common goals of adherence to policy and regulations and ethical principles of research conduct.

Procedures

  1. Process to address disagreement with an IRB determination:
    1. Upon receipt of a disputed IRB determination, the investigator should contact the reviewer and/or IRB Chair to discuss the disagreement and work toward a resolution. The Directors of the Office of Research Subjects Protection (ORSP) or Office of Research Integrity and Ethics (ORIE) can be consulted at any time by the reviewers, IRB Chair, or investigator.
    2. If resolution is unsuccessful, the disputed issue is referred to the convened Panel. The investigator will present the issue of concern to the convened Panel [45 CFR 46.109(d) and 21 CFR 56.109(e)]. The investigator may be accompanied by a subject matter consultant of his or her choosing and at his or her expense (if any). The investigator and consultant, if applicable, are excused during the Panel discussion and voting process, but will be invited to receive the verbal report of the Panel’s determination, with formal written follow up.
    3. If the disputed issue persists, the IRB Chair or investigator can offer to meet together with the Directors of the ORSP or ORIE for further discussion and determination of a resolution. .
    4. If the investigator and Panel cannot reach an agreement that is satisfactory to the investigator, then as a last resort, the investigator may contact the Senior Associate Vice President for Research Administration and Compliance and request an appeal (see below).
  2. Appeal Procedures and Process:

    After previously described steps have been taken by the investigator, an Appeals proceeding affords a formal consideration of the purview and validity of an IRB determination. Because the Appeals Committee is not, and does not function as, a duly constituted IRB panel, it does not make IRB determinations. Investigators appealing an IRB decision must understand that an IRB Appeal does not overrule an initial IRB determination. Rather a disputed protocol may be assigned to a differently constituted panel of the IRB for review of the study and may require changes or clarifications. The Appeals process affords high regard for the confidentiality of the appellant, the convened Panel that issued the determination under appeal and the Appeals Committee members.

    1. Timeframe of the appeal:
      1. Appeals regarding determination of noncompliance, unanticipated problems, suspension, termination, or other findings must be made within 15 business days of the receipt of the finding.
      2. Appeals of decisions regarding disapproval of a protocol or elements of a protocol or amendment must be made within 30 business days of the convened panel’s decision.
    2. Appeal Request Form: The investigator (appellant) will complete a VCU IRB Appeals Form. The form and supporting material is submitted as per the form instructions, and, if determined eligible for appeal, referred to the IRB Appeal Process. For confidentiality purposes, the form and supporting documents should not be placed into RAMS-IRB.
    3. Composition of ad hoc Appeals Committee: The Director of the ORIE will serve as Chair of the Appeals Committee and is a non-voting member unless needed for tie breaking. The Appeals Chair will notify the IRB Chair and constitute the Appeals Committee.
      1. Those eligible to be voting members on the Appeals Committee are IRB members who did not participate in the original review/determination and who state their ability to engage in objective deliberation about the issue(s) under appeal:
        1. Chairs/Vice Chairs,
        2. A non-affiliate member of the IRB Panel,
        3. The Director of the ORSP, and
        4. A member to be selected by the appellant. This member, if possible, will be chosen from current or past IRB members, and unless they are a non-affiliated member of a VCU IRB panel, they must be a VCU employee.
      2. A minimum of 5 voting individuals must be present at the meeting. The voting member selected by the appellant must be present at the meeting. The Institutional Official (IO) may be present at the meeting as an observer and may provide information relevant to the appeal, but is not a voting member.
    4. Appeals Committee meeting:

      The Chair for the Appeals Committee arranges a suitable meeting time and location. Documents made available by the appellant and Chair, as context and background, are provided to the voting members. The meeting’s focus is on the unresolved issue(s) under appeal. Audio recording may be utilized. The Appeals Chair presides over the meeting and will enforce an atmosphere of respect for all participants.The meeting consists of two portions: a) presentation of the issue(s) under appeal by the appellant and Panel representative(s) followed by questions and comments, and b) closed meeting of the voting members and Appeals committee Chair.

      1. Presentation of the issue(s) under appeal:
        • The appellant will present the issue(s) under appeal, including his or her actions undertaken to resolve the disagreement prior to filing an appeal.
        • One or more VCU faculty consultants (as approved by the Chair of the Appeals Committee) may be invited by the appellant to present relevant information, background, or precedent in regard to the issue(s). The consultant(s) may be associated with the research. Because this is a collegial process and not a legal proceeding, a consultant may not be an attorney representing the appellant.
        • The Panel Chair/Vice Chair and/or Panel reviewers will present relevant information from the Panel’s prior discussions and decisions.
      2. Closed meeting of Voting members and Chair.
        The Appeals Committee will deliberate and reach a final decision by majority vote to either agree or disagree with the IRB determination.
    5. Decision by blinded majority vote.

      The following decisions may be rendered by the Appeals Committee.

      • Agree with the determination of the IRB Panel.

        Agreement means that based on the evidence reviewed by the committee, the determination was within the Panel’s purview and is reasonably supported by IRB WPP’s, conditions of approval, federal regulations, or institutional policies; the determination of the IRB is upheld. For example, if the IRB’s decision involved disapproval of an entire protocol at initial review, then the appellant may re-submit a new protocol with major revisions aimed at resolving the human subjects’ issue(s). If the IRB’s determination involves only a portion of the protocol (for example, recruitment) or a modification to a previously approved protocol, then the Appeals Committee will refer the protocol back to the IRB for review of the appellant’s modifications to address the Panel’s concerns. If the IRB’s determination involved a finding related to a study event or study conduct, then any associated corrective action plan remains in place, and the finding is final.

      • Disagree with the determination of the IRB Panel.

        The protocol will be transferred to a differently constituted meeting of the IRB Panel for full review of the protocol, including the issue under appeal. The determinations of the second IRB Panel review regarding the protocol disposition and other issues under appeal are final.

    6. Post-Meeting Actions:.

      The findings of the Appeals Committee will be provided in writing to the appellant and the IRB Panel Chair. The Institutional Official (IO) and appellant’s Chairperson will be copied on the written communication. The minutes are retained by the Appeals Committee Chair. The letter will be uploaded into RAMS-IRB and will become part of the IRB protocol record. Decisions by the Appeals Committee are final and cannot be appealed. The IO cannot reverse the findings of the Appeals Panel. However, the IO has the authority to institutionally disapprove, suspend, or terminate the project on behalf of the institution, as outlined in WPP II-1.

  3. Evaluation of the Appeals Process
    After the conclusion of an Appeals proceeding, the Appeals Committee members are asked to evaluate the process. Any resultant recommendations for changes in practice or WPPs will be presented to the ORSP Director.

References

45 CFR 46.109(d)
21 CFR 56.109(e)
ICH E6 Good Clinical Practice (GCP) Guidelines 3.1.2 and 3.3.9
VCU IRB WPP II-1 HRPP Overview
VCU IRB Forms and Templates