Gene Therapy Project Review Panel

Gene Therapy Project Review Panel

Institutional Review Board (IRB) Guidebook Gene Therapy Project Review Panel

Gene Therapy Project Review Panel

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

Project Panel
Ronald Alvarez, M.D.
Markus Bredel, M.D.
William Carroll, M.D.
Charles Elson, M.D.
Harry Erba, M.D.
Yancey Gillespie, Ph.D.
Kevin Harris, M.D.
Warner K Huh, M.D.
John Kappes, Ph.D.
James Markert, M.D.
John Mountz, M.D.
Kristen Riley, M.D.
Mansoor Saleh, M.D.
Eric Sorscher, M.D.
John Anthony Thompson, Ph.D.
Tim Townes, Ph.D.
Richard Whitley, M.D.

Initial Review of Gene Therapy Protocols

Most protocols involving gene therapy or gene transfer are reviewed by the UAB IRB, even if they are industry-sponsored. Please contact the OIRB on a protocol-by-protocol basis for guidance. To apply for initial review of such protocols, investigators complete the following process before applying for IRB review:
  • Obtain review and approval from the UAB Institutional Biosafety Committee (IBC) and Research Advisory Committee (RAC).
  • Select three members from the list above who are willing to serve as the Project Review Panel for the protocol.
  • Arrange and attend a meeting (face-to-face or teleconference) of all three members to discuss the protocol.
  • Document the panel's review by having them complete and sign the Report of the Project Review Panel.
  • Include that report with the application for IRB review.

Continuing Review of Gene Therapy Protocols

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:

  • Whether the risk-benefit ratio has changed,
  • Whether the protocol or consent form should be revised, and
  • For studies involving minors, whether the CRL should stay the same or be changed.

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. ‚Äč