|
The Institutional Biosafety Committee (IBC) evaluates human gene transfer investigations focusing on public protection (i.e., research personnel, care givers, general public, etc.).
This review compliments the Institutional Review Board review (University of Washington Human Subject Division);
both are necessary prior to subject enrollment.
NIH's Office of Biotechnology Activities (OBA) administratively supports the Recombinant DNA Advisory Committee (RAC) and the NIH guidelines authorize the institution to establish a local IBC.
A brief description of IBC roles and responsibilities can be found at http://www4.od.nih.gov/oba/IBC/IBCRole.htm.
The clinical investigator's application packet for IBC review should contain copies of:
Clinical Investigators should be familiar with the NIH Guidelines pertaining to NIH and local IBC Human Gene Transfer review and reporting obligations.
UW-affiliated clinical investigators must have IRB and IBC approval before enrolling subjects for human gene transfer, regardless of the funding source or the molecular nature of the gene transfer reagent (plasmid or viral vector, vaccines).
-
If you are the first site to conduct the clinical trial (NIH Appendix M-1-C-1):
- Submit the protocol for RAC review
- Obtain both IRB and IBC approval
- Register with OBA no later than 20 working days after enrollment of the first research participant
- If your site is added after the initial site has initiated the RAC review process (NIH Appendix M-1-C-2):
- Obtain both IRB and IBC approval
- Register with NIH OBA before enrollment
For additional information contact the Institutional Biosafety Committee by email: rbso@u.washington.edu.
|
