Section VII:

General Operations

WPP #: VII-5

Title 5:

Appeal of IRB Decisions

Effective Date:

07-22-14

Revision History:

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

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 panel 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 university policies and procedures. In so doing, an IRB panel 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 IRB panels to pursue common goals of adherence to policy and regulations and ethical principles of research conduct.

  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 ORSP, ORIE, or the ILEC Chair 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. 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 panel Chair or investigator can offer to meet together with the ILEC Chair, Directors of the ORSP or ORIE for further discussion and determination of a resolution. The ILEC Chair may bring the disputed IRB determination to an ILEC meeting for informal discussion.
    4. If the investigator and Panel cannot reach an agreement that is satisfactory to the investigator, as a last resort, the investigator may contact the ILEC Chair and request an appeal (see below). An appeal proceeding is initiated at the discretion of the ILEC Chair.
  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 different 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 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 14 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 will complete a VCU IRB Appeals Form. The form and material is submitted as per the form instructions to the ILEC Chair 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 Chair of the IRB Panel whose determination is being appealed and constitute the Appeals Committee.
      1. Those eligible to be voting members on the Appeals Committee are IRB members drawn from the following individuals who state their ability to engage in objective deliberation about the issue(s) under appeal:
        1. Chairs/Vice Chairs from the uninvolved Panels,
        2. a non affiliate member from one of the IRB panels not involved with the review under appeal,
        3. the Director of the ORSP, and
        4. a member to be selected by the investigator. This member will be chosen from current IRB members and, unless a non-affiliated member of a VCU IRB panel, he/she must be a VCU employee.
      2. A minimum of 5 voting individuals must be present at the meeting. The voting member selected by the investigator must be present at the meeting.
    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 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 committee Chair.
      1. Presentation of the issue(s) under appeal:
        • The investigator (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.
        Voting members and Chair remain to deliberate and vote. The ILEC Chair may be present at all or part of the meeting as observers and may provide information relevant to the appeal, but are not voting members.
    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, terms of agreement, federal regulations, or institutional policies; the determination of the IRB Panel of record is upheld. If the IRB Panel’s decision involved disapproval of an entire protocol at initial review, the investigator may re-submit a new protocol with major revisions aimed at resolving the human subjects’ issue(s). If the IRB Panel’s determination involves only a portion of the protocol (for example, recruitment), or a modification to a previously approved protocol, the Appeals Committee will refer the protocol back to the IRB Panel of record for review of the investigator’s modifications to address the Panel’s concerns. If the IRB Panel’s determination involved a finding related to a study event or study conduct, 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 another IRB Panel for full review of the protocol including the issue under appeal. The determinations of the new IRB Panel regarding the protocol disposition and other issues under appeal are final.
      • Transfer or stay in Panel. If the committee is in agreement with the IRB Panel determination AND the appellant has requested transfer of the protocol to another Panel, the Appeals Committee will vote on the transfer and specify the appropriate IRB Panel to be assigned for subsequent reviews. Considerations for transfer include history of the protocol, suitability of the new Panel placement, and input from the Chair of the prior Panel. The Appeals Committee has the final decision regarding transfer of the protocol to a new Panel.
    6. The findings of the Appeals Committee will be provided in writing to the investigator, the initial IRB Panel Chair, as well as the receiving IRB Chair, if being transferred. The IO and appellant’s Chairperson will be copied on the written communication. The minutes are retained by the Appeals Committee Chair. The letter will become part of the IRB protocol record.
    7. Decisions by the Appeals Committee are final and cannot be appealed. The IO cannot reverse the findings of the Appeals Panel. However, the IO may ultimately disapprove the study.
  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 ILEC.

References

45 CFR 46.109(d)
21 CFR 56.109(e)
ICH 3.1.2 and 3.3.9)
VCU IRB Appeals Form