This SOP describes the process WVU's OHRP and IRB follow when a principal investigator (PI) decides to appeal an IRB determination or decison.
The WVU IRB has the authority to approve research activity, specify modifications required to secure IRB approval of the research activity, or disapprove any research activity overseen and/or conducted by WVU. The IRB has the authority to suspend or terminate approval of research that is not conducted in accordance with IRB policies, and is not in compliance with applicable federal regulations, or that is associated with unexpected serious harm to participants (See SOP 029: Suspension, Administrative Hold, Early Termination).
Research approved by the IRB may be subject to further review by WVU officials as part of the human research protection program, as appropriate. The institutional official (IO) may override the IRB’s decision to approve research; however, they may not approve the research if it has not been approved by the IRB, nor can they overrule other decisions made by the IRB (See SOP 004: IRB Authority, Membership, and Responsibilities).
If the appeal is denied, the investigator’s institution cannot override the IRB decision. Documentation of appeal, including all correspondence relating to the appeal, is retained within the research protocol in the WVU electronic IRB system.
3.1. If a PI disagrees with a revision requested by the IRB, the PI may submit a written appeal to the WVU OHRP staff responsible for issuing the request. The PI should include information supporting any arguments made in the appeal.
3.2. For research reviewed using the expedited review procedure, the appeal is reviewed by the expedited reviewer who requested the revisions. The expedited reviewer may either (a) make a decision on the appeal, or (b) refer the appeal to the convened board. If the PI disputes the decision of the expedited reviewer, the appeal is then referred to the convened board for resolution.
3.3. For research reviewed by the convened IRB, the appeal is reviewed by the convened IRB. The PI may be invited to a convened meeting to provide clarification or additional information to the IRB. The PI may also request to be in attendance at a convened meeting to provide clarification or additional information to the IRB. The PI may not be present for the vote on the appeal.
3.4. The expedited reviewer or convened IRB may accept the appeal, request different revisions, or deny the appeal. The investigator is notified in writing of the decision. If the appeal is accepted the investigator is not required to submit the requested revisions that applied to the appeal process. If different revisions are requested, the investigator must submit the different revisions. If the appeal is denied, the IRB decision is final, and the revisions must be made prior to approval.
4.1. For the purposes of this policy, the term “IRB determination” means a determination of non-compliance, serious non-compliance, continuing non-compliance, or an unanticipated problem involving risks to participants or others.
4.2. If a PI disagrees with an IRB determination, the PI may submit the appeal and any information supporting the appeal in the form of “Notify the IRB” within the WVU electronic IRB system within 60 days of being notified of the determination.
4.3. For IRB determinations made through administrative review (review conducted by an IRB Chair, WVU OHRP Director, or designee), the appeal is reviewed by the individual who made the determination. The administrative reviewer makes a decision on the appeal. If the PI disputes the decision of the administrative reviewer, the appeal is then referred to the convened board for resolution.
4.4. For IRB determinations made by the convened IRB, the appeal is reviewed by the convened IRB. The PI may be invited to a convened meeting to provide clarification or additional information to the convened IRB. The PI may also request to be in attendance at a convened meeting to provide clarification or additional information to the IRB. The PI may not be present for the vote on the appeal.
4.5. The administrative reviewer may accept the appeal or deny the appeal. The PI is notified in writing of the decision. If the appeal is accepted, a new determination is made using the information provided in the “Notify the IRB” report on which the appeal was submitted. If the appeal is denied, the IRB decision is final, and the original determination stands.
5.1. If a PI disagrees with the IRB decision to disapprove or terminate a study, the PI may submit a written appeal of the decision to disapprove or terminate to the IRB Chair and WVU OHRP Director within 60 days of being notified of the decision. The appeal should address the specific concerns of the IRB and the IRB basis for disapproval or termination.
5.2. The appeal is reviewed by the convened IRB. The PI may be invited to the convened meeting to provide clarification or additional information to the IRB. The PI may also request to be in attendance at a convened meeting to provide clarification or additional information to the IRB. The PI may not be present for the vote on the appeal.
5.3. The convened IRB votes to accept or deny appeal. The PI is notified in writing of the decision.
5.3.1. If the appeal to the decision to disapprove a study is accepted, the PI is invited to submit a new study application to the IRB for review and approval, according to the conditions set forth by the IRB in accepting the appeal.
5.3.2. If the appeal to the decision to terminate a study is accepted, the PI may resume research activities after any conditions set forth by the IRB are met. In some cases, the IRB may require the PI to submit a new study application for review and approval prior to resuming research activities.
5.3.3. If the appeal is denied, the IRB decision is final, and the study may not be approved or resume.
WVU Policies:
SOP 004: IRB Authority, Membership, and Responsibilities
SOP 029: Suspension, Administrative Hold, Early Termination
