Clinical Trials Administrative Start-Up Handbook

SECTION 7

HUMAN GENE TRANSFER REVIEW

The National and Local Review Process

Clinical trial protocols involving gene transfer or recombinant-DNA-based vaccines need to be reviewed at two levels:

1. nationally, by the NIH Recombinant DNA Advisory Committee and/or by the FDA (note that the national review by NIH/FDA is necessary even if the trial is not proposed for funding through the NIH)
2. locally, by the Institutional Biosafety Committee (IBC) of the institution where the investigational agent will be administered.

About National Review

For sponsor-initiated gene transfer or recombinant-DNA-based vaccine trials, the NIH/FDA application will normally be handled by the sponsor. For investigator-initiated gene transfer or recombinant-DNA-based vaccine trials, the NIH/FDA application will need to be prepared by the investigator. The UW Biosafety Officer can advise you about the NIH/FDA application process.

For complete and detailed information about the NIH/FDA review process and about the procedures for submission of human gene transfer protocols, call NIH's Office of Biotechnology Activities (OBA) at 301-496-9838 or read the "Points to Consider…" at OBA's website.

About Local Review

Investigators conducting trials that involve gene transfer or recombinant-DNA-based vaccines need to complete the Research Project Hazard Assessment (RPHA) form. Then, depending on your specific protocol, you may need to provide some additional information. Call the Biosafety Officer at 206-543-7278 to determine what additional information is needed. Send the completed package to the Biosafety Officer in the Environmental Health and Safety Department (EHS) at Box 357165.

When your protocol has been reviewed and approved, you'll receive an approval letter and a protocol reference number.

If the hazards associated with your trial change during the approval period, call the Biosafety Officer at 206-543-7278 to discuss what action you need to take. It's likely that you will need to submit changes for IBC review, but call the Biosafety Officer to be sure.

Best Practices for Expediting the Institutional Biosafety Committee Review

• Be sure to time carefully your submissions to the various national and local oversight committees. If the protocol for your trial was written by an industry sponsor, timing for your submissions will be determined by your classification either as (1) a first investigative site or as (2) an additional site. Ask the sponsor into which category you fall. If you are a first investigative site, your protocol will need to be reviewed by the NIH/FDA before local review can begin. (You and the sponsor will be partners in this national review process). If you are an additional site, you can proceed with local IBC/IRB review right away, then "register" with the national oversight committees by sending them the required local approvals. If you (not the industry sponsor) have written the protocol, call the Biosafety Officer for advice.
• Before you submit your completed UW RPHA form to the Institutional Biosafety Committee, call the Biosafety Officer to determine whether additional information will need to be attached to your application. The required attachments will vary by situation and may not be obvious from the other application materials.

Administrative Start-Up Checklist
Institutional Biosafety Committee

Click to Download Checklist in Word

Key Contact

Bruce Whitney
Biosafety Officer
Box 357165
Phone: 206-221-7770
Fax: 206-221-3068

Glenn McLean
Biosafety Officer
Box 357165
Phone: 206-221-7770
Fax: 206-221-3068

Timeline

UW IBC meetings are held as needed. Applications are screened and assigned continuously for review. Depending on the complexity of the protocol and the nature of the investigative reagent, turn-around time is similar to the UW Human Subjects Committees.