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Institutional
Bio-Safety Committee (IBC)
LSUHSC-NO’s
Institutional Bio-safety Committee (IBC) acts as the framework for risk
management associated with research-related, bio-safety issues. The
committee works in concert with the LSUHSC-NO Office of Environmental
Health and Safety and the Office of Research Services The
objectives of this risk management program are threefold:
1) To assure that the
Institution is in compliance with all state and federal regulatory agency
bio-safety requirements, e.g. rDNA research as described in the NIH GUIDELINES FOR RESEARCH INVOLVING RECOMBINANT
DNA MOLECULES (NIH GUIDELINES)
2) To review projects for
use of “Select Agents” under the Select Agents Program of DHHS and USDA
and/or “Dual use items” under export control regulations of the
Department of Commerce
3) To protect individuals and
research animals from potential dangers in the use of or exposure to such
things as pathogens, organs or tissues of biological origin, genetic
therapy products, transgenic genes, bacteria, viruses, prions and
chemicals and toxins that may affect health.
Information concerning rDNA research being
conducted at LSUHSC-NO can be obtained by contacting the Office of
Research Services.
IBC
Policies and Procedures
All research projects must be submitted for IBC review
to allow a determination of whether all bio-safety concerns are resolved
or managed, or that the project is exempt from further IBC
oversight. Both IRB and IACUC approval are contingent upon IBC
review and approval. The
Principal Investigator must submit all forms electronically by emailing
the IBCoffice@lsuhsc.edu.
Mail only the signature
page of initial applications (Section F) to the IBC Office at 433 Bolivar
Street, Room 206, New Orleans, LA 70112. Initial applications, amendments
and annual reviews are processed as received.
·
IBC Policies and Procedures Guidebook
·
IBC
Protocol Submittal Form for initial application and amendments
·
IBC Annual
Update Form for
re-approval and adding new personnel
Training and Education
Requirements
Principal
Investigator is responsible for all personnel participating in the
research project and assures that all personnel receive adequate training
to perform all activities safely and proficiently. The following training
courses are available online at KDS Web Based Training.
·
IBC
and rDNA Compliance Training for principal and
key investigators
·
Bloodborne
Pathogen Training for every employee
and medical student
·
Biological
Training for anyone handling biological materials
Other training that may
be required by the LSUHSC-NO Environmental Health and Safety (EH&S)
include General, Laboratory, and Radiation
Safety, Shipping Biological Materials and Laboratory Specific Training.
Governmental Programs Related
to Bio-Safety
As listed and described
at the following websites, there are potential reporting and licensing
requirements for the use of certain pathogens and toxins. You should be
aware of these regulations and must report to the Office of Research
Services (ORS) and the Office of Environmental Health and Safety
(EH&S) the possession and use of such agents/items. The ORS and
EH&S will help you with any regulatory requirements related to such
issues.
“Select Agents” Program:
DHHS (CDC) and USDA (APHIS)
The
National Select Agent Registry Program oversees the activities of
possession of biological agents and toxins that have the potential to
pose a severe threat to public, animal or plant health, or to animal or
plant products. Depending on quantities, there may be reporting
requirements for the possession and use of certain agents.
“Dual Use Items” Program:
Department of Commerce - Export Administration
Regulations (EAR) and Commerce Control List (CCL)
The
CCL contains items that are considered “Dual Use” items, i.e., used for
commerce/research and could be used as a potential bio-terrorist weapon.
Depending on the circumstances there may be limitations on the use and
licensing requirements of such items.
“Dual Use Research of Concern”:
US Government Policy for Oversight of DURC
The
National Science Advisory Board for Biosecurity (NSABB) has defined dual
use research of concern as research that, based on current understanding,
can be reasonably anticipated to provide knowledge, products, or
technologies that could be directly misapplied by others to pose a threat
to public health and safety, agricultural crops and other plants,
animals, the environment or material. NIH has been given oversight of
this program. Although NSABB provides a list of agents of concern, the
issue is more related to the type of research being conducted as opposed
to the agent.
International Traffic in Arms Regulations (ITAR)
This
set of federal (US State Department) regulations limits the export of
military defense articles and services. While it is unlikely that any
activities conducted at the Health Sciences Center will be subject to
these regulations, there are situations where the institution must
certify to that effect, e.g., I-129 visa applications. Be aware that the US Munitions List (ITAR Part 121) has a
section (Category XIV) that includes toxilogical agents, including
chemical agents, biological agents, and associated equipment that might
be used by our investigators. Items on the list that are a) designed,
developed, configured, adapted, or modified for a military application,
and do not have a predominant civil application and do not have
performance equivalent (defined by form, fit and function) to those of an
article or service used for civil applications; or b) are specifically
designed, developed, configured, adapted , or modified for a military or
intelligence applicability such that control under this ITAR is necessary
fall under the ITAR regulations. You must notify the ORS immediately if
any of your work is subject to ITAR and involves any item on the US
Munitions List.
Links
to Other Resources
American Biological Safety
Association (ABSA): http://www.absa.org/
*ABSA Biosafety Links: http://www.absa.org/resbslinks.html#bmbl
*Comprehensive
list of agencies, regulations and guidelines related to all aspects of conducting
research.
National Institutes of Health
(NIH): http://nih.gov/
NIH Office of Biotechnology
Activities (OBA): http://oba.od.nih.gov/oba/index.html
NIH Guidelines to rDNA Research: http://oba.od.nih.gov/rdna/nih_guidelines_oba.html
NIH/OBA Frequently Asked
Questions: http://oba.od.nih.gov/rdna/rdna_faq_list.html
NIH/OBA
IBC Information: http://oba.od.nih.gov/rdna_ibc/ibc.html
NIH/OBA Educational Materials: http://oba.od.nih.gov/rdna_ibc/ibc_training.html
NIH/OBA Dual Research: http://oba.od.nih.gov/biosecurity/biosecurity.html
CDC National Select Agency
Registry: http://www.selectagents.gov/
LSUHSC Division of Animal Care: https://intranet.lsuhsc.edu/animalcare/
USDA – APHI (Animal
Welfare): http://www.aphis.usda.gov/animal_welfare/publications_and_reports.shtml
NIH Office of Laboratory Animal
Welfare (OLAW): http://grants.nih.gov/grants/olaw/olaw.htm
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