|
|
| |
Institutional Biosafety Committee Services
Unique in the nation, our affiliates send representation to an independent biosafety committee to review recombinant DNA/gene transfer research. Our core committee is composed of chairs and biosafety officers from academic centers. With this mechanism and without sacrificing scrupulous oversight safety, a trial involving recombinant DNA/gene transfer may be started much more expeditiously than in the past.
IBC Services provided by BRANY include:
- Formation of IBC where needed
- Core board of gene transfer and biosafety experts from academic centers
- Network of non-affiliated community members
- Biosafety officers for site inspection
- Facilitation of all administrative requirements, including IBC registration and required reporting
- Expert review and consideration, including:
- Safety Considerations
- Risk Assessment
- Containment levels
- Assessment of the facilities, procedures, practices, and training an expertise of personnel involved
- Appendix M
- RAC Review (if applicable)
- Surveillance, data reporting, and adverse event reporting requirements set forth in the NIH Guidelines
- Ongoing oversight by IBC (continuing review)
- Personalized and responsive service with assigned project coordinator, including:
- Selection of appropriate IBC members
- Registration of IBC with OBA/NIH
- Review of IBC applications for completeness
- Scheduling IBC meetings for initial and continuing review
- Preparation of meeting agenda and distribution of materials for review
- Correspondence between site, sponsor, IBC, and NIH
- Maintenance of appropriate project records and minutes of IBC meetings
- Scheduling site visits as needed
- Meetings scheduled on request
- Very competitive and transparent pricing (fees available upon request)
|
| |
How to contact the IBC:
|
Raffaella Hart, CIP, IRB Director
Phone Number: (516) 470-6909
FAX: (516) 470-6926
rhart@brany.com
|
Urvashi Arora, MA, Project Coordinator
Phone Number: (516) 470-6931
FAX: (516) 470-6926
uarora@brany.com
|
|
| |
BRANY IBC Core Members
Links:
NIH Guidelines.
http://www4.od.nih.gov/oba/rac/guidelines/guidelines.html
OBA: Office of Biotechnology Activities (NIH) email oba@od.nih.gov
http://www4.od.nih.gov/oba/
Centers for Disease Control
http://www.cdc.gov/
Biosafety in Biomedical and Microbiological Laboratories
http://www.cdc.gov/od/ohs/biosfty/bmbl5/bmbl5toc.htm |
|
|
|