INSTITUTIONAL BIOSAFETY COMMITTEE SERVICES (IBCS)
A Division of Western Institutional Review Board (WIRB)
PMB 2436, 2103 Harrison Avenue NW, Olympia, WA 98502-2607
(360) 252-2850 FAX (360) 252-2820
General Information
IBC Services Forms
Links
IBC Services Fees
Contact IBC Services
The Institutional Biosafety Committee Services division of WIRB
provides administrative services for biological safety review of recombinant DNA
used in gene transfer research.
An Institutional Biosafety Committee (IBC) is a review body appointed by an institution
to review and approve research involving the transfer of recombinant DNA or RNA
derived from recombinant DNA, into human research participants. If a trial is sponsored
by or conducted by an institution that receives NIH funding for recombinant DNA
research, the institution or clinical trial site must be reviewed and approved by
an IBC before initiation of the research. Voluntary compliance by other institutions
or sponsors is encouraged by NIH because it promotes safe conduct in recombinant
DNA research and gives the public confidence that important safety matters are being
addressed. Regardless of NIH funding, institutions or sponsors may be subject to
local ordinances, federal or state regulations, or agency guidelines that require
compliance with the NIH Guidelines. Vaccine trials exempt from Recombinant DNA Advisory
Committee (RAC) review under Appendix M-I of the NIH Guidelines still require IBC
review.
The IBC Services of WIRB establishes local IBCs that meet the requirements set forth
in the NIH Guidelines for Research Involving Recombinant DNA Molecules (NIH Guidelines).
The core membership has experience and expertise in biological safety issues and
recombinant DNA research. The local membership required to complete the committee
comprises a representative from the site, and two unaffiliated community members.
The two unaffiliated community members represent the concerns and attitudes of their
community. One member will have the expertise to inspect the physical site for biological
safety issues. Most of the IBCs administered by WIRB's IBCS have 6-9 committee members;
depending on the type of research being performed. Each site-specific IBC will provide
prompt, expert reviews of recombinant DNA research to include:
- Protocols, revisions and/or amendments
- Continuing review
- Long-term follow-up
- Serious adverse events
- Research-related accidents and/or illness
- Assessments of the facility and staff
- Biological safety practices
- Biological safety containment levels
The staff of IBC Services of WIRB provides the following services for each site-specific
IBC:
- Ensure that appropriate committee members are selected
- Obtain confidentiality agreements and conflict of interest statements from committee
members
- Ensure IBC members receive appropriate training (including training on Committee
SOPs)
- Provide compensation (honoraria) to unaffiliated committee members
- Facilitate the roster submission to the NIH and required updates
- Schedule all IBC meetings
- Distribute review materials to committee members
- Scribe minutes and distribute final minutes to the Investigator, Institution, and
Sponsor
- Ensure the IBC reviews all amendments, revisions, research location changes, etc.
- Ensure the IBC reviews all Serious Adverse Events as required by the NIH Guidelines
- Ensure that quarterly continuing review reports are obtained
- Schedule IBC annual reviews to include re-inspection of the site
- Coordinate IBC assistance in the event of a research related accident or incident
- Maintain records and files for the life of the study
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Links
NIH Guidelines.
http://www4.od.nih.gov/oba/rac/guidelines/guidelines.html
Centers for Disease Control
http://www.cdc.gov/
Biosafety in Biomedical and Microbiological Laboratories
http://www.cdc.gov/od/ohs/biosfty/bmbl5/bmbl5toc.htm
Office of Biotechnology Activities (NIH) email oba@od.nih.gov
http://www4.od.nih.gov/oba/
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IBC Services Fees
A copy of the IBCS current fee schedule is available upon request.
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Contact IBC Services
Institutional Biosafety Committee Services (IBCS)
[New]
PMB 2436
2103 Harrison Avenue NW
Olympia, WA 98502-2607
Phone: (360) 252-2850 or (800) 562-4789 Ext. 2850
Fax: (360) 252-2820
Email: ibcs@wirb.com
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