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VCU office simplifies IRB appeal process
It's completed in five steps
The Vice President's Office for Research at Virginia Commonwealth University in Richmond, VA, has developed a formal process for investigators who wish to appeal an IRB determination.
The VCU's website includes the appeal process policies and procedures and describes the simple process in this way:
Exempt study: Determined not to qualify for exemption by reviewer. First consider ways to modify if practicable. If no resolution, can be discussed with Panel Chair. Moved to Expedited Review.
Expedited: If needed, initial discussions between reviewer and Chair can be informally referred to panel or IRB Leadership and Enhancement Committee for general discussion of issues. If no agreement, referred to Full Board.
Full Board: Discussions by investigators, reviewers, panel members and informed discussions with Directors of ORSP or ORCE, the Senior Chair, consultants, and can be informally discussed with the IRB Leadership and Enhancement Committee. Full IRB Panel will make formal determination. The investigator may formally appeal to the IRB Leadership and Enhancement Committee.
IRB Leadership and Enhancement Committee: The Senior Chair or Director of ORCE will receive the appeal and documents. The IRB Appeals Committee will be assembled and a meeting scheduled.
IRB Appeals Committee: At the meeting the committee will focus on the unresolved issue but will review in the context of the entire project. The investigator may present the protocol and issue(s) at hand. Consultants (approved by the Chair of the Appeal Committee) may be invited to present relevant information, background, or precedent in regard to the issue. The Chair/Vice Chair and reviewers will present relevant information from the panel's discussions and decisions. After hearing the information and reviewing the documents, the investigator(s), consultants and Panel members are excused for the discussion and voting of the Appeals Committee. Committee will reach a final decision by majority vote to either agree or disagree with the panel's decision regarding the procedure, wording, or plan as outlined by the investigator. The investigator, IO, investigator's Chairperson and IRB panel(s) are informed of the decision in writing.