UAB maintains a project review panel for protocols involving gene therapy. The panel documents its review on the Report of the Project Review Panel form, which serves as the Protocol Oversight Review Form for these studies. The list below includes all panel members as of this revision of the guidebook. Members of the UAB Gene Therapy
Protocols involving gene therapy require quarterly, not annual, continuing review and approval (see "Approval Periods" in General Information).
For continuing review, the IRB does not require a face-to-face or teleconference meeting of the investigator and panel unless there are significant changes to the protocol or "unanticipated problems involving risks to subjects or others" have occurred during the current approval period (see Reporting Research-Related Problems).
To apply for continuing review when review by the panel is necessary, investigators obtain an updated review from the same three-member Project Review Panel that reviewed the protocol initially. They should have each panel member review the protocol and make a determination on the following criteria:
The investigator should then obtain each panel member's signature on a memorandum that, at a minimum, describes the panel's determinations on the items above. If the panel finds or recommends changes, the memorandum should explain the panel members' reasons for each change.