Process for Appealing Adverse IRB Dispositions

The intent of the appeal process is to provide an avenue for a principal investigator to seek reconsideration of an adverse IRB disposition of his/her Application for IRB Review.  If the investigator believes a disposition by the Board to approve pending revision or to deny approval of the application has resulted from a misapplication of IRB regulations, a misunderstanding of the proposed research protocol, or other reasons, he/she may appeal the disposition by submitting an Appeal of Adverse IRB Disposition Form to the IRB chair.

Adhering to the instructions on the appeal form, the investigator must provide detailed justification for approval of the research protocol as submitted and attach any documents he/she deems are supportive of the presented justification.  The appeal submission must include seven copies of the appeal form and supportive documents for distribution to members of the Executive Committee.

Submitted appeals will be reviewed by the Executive Committee at its next available meeting. At the IRB chair’s discretion, the principal investigator may be invited to the convened meeting to provide additional clarification.  Furthermore, when issues raised in an appeal are deemed by the committee members to be beyond their areas of expertise, the IRB chair may solicit external input from individuals with specialized knowledge relevant to such issues. In either case, however, neither the investigator nor the external expert may be present for the committee’s final deliberations on the appeal.

Normally, within three days of the Executive Committee meeting, a designated committee member must notify the principal investigator by email of the appeal’s disposition including, when applicable, the committee’s reasons for denying the appeal.  Denial of an appeal by the Executive Committee is final.

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