Institutional Biosafety Committee (IBC) and Institutional Review Entity (IRE) for DURC
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 and USG Policy for Institutional Oversight of Life Sciences Dual Use Research of Concern (DURC).
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 and IRE/DURC 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 to the IBC Office at 433 Bolivar Street, Room 206, New Orleans, LA 70112. Initial applications, amendments and annual reviews are processed as received. Applications requiring Full Committee Review are processed must be submitted by the last Monday of the month for the next month’s meeting.
- IBC Policies and Procedures Guidebook
- IRE DURC Policies and Procedures Guidebook
- Request for Exemption from IBC Oversight is a one page form that must be submitted electronically to the IBCoffice@lsuhsc.edu by the Principal Investigator. Approval for exemption will be emailed to the PI. If the exemption is not approved by the IBC Chairperson, the PI will receive an email notification to submit a full application.
(Examples: chart review, web/phone survey or data analysis with no physical human contact or data collection/survey conducted in the presence of the subject but with no physical human contact.)
- IBC Application and Amendment Form is a seven part form that is required for all research activities not exempted from IBC oversight. This application will also be used by the IRE to review any potential research categorized as DURC. The IBC application must submitted electronically to the IBCoffice@lsuhsc.edu by the Principal Investigator. The PI need only submit the first page with original signature to the IBC Office (RCB #206) for the initial application and any amendments. Approvals and any other correspondence will be conducted by email. An IBC application may be renewed up to five annual reviews.
(Note: The application must be electronically submitted in the original WORD format. Parts that are not applicable to the project can be deleted to conserve paper; however, do not delete questions within an applicable part. Provide an answer to all questions or enter “not applicable” where appropriate.)
- IBC Annual Update Form is required annually unless the project was “Exempted from LSUHSC-NO IBC Oversight”. The form will be emailed to the PI the month before the annual review is due. IBC annuals do not always coincide with corresponding IACUC or IRB annual reviews.
- Amendment to Change in Personnel Form Updated 3/01/2016 rRequired to remove or add personnel to projects under IBC, IACUC or IRB oversight. The form outlines training required by the IBC, IACUC and IRB.
Training and EH&S Requirements
The Principal Investigator is responsible for all individualsl participating in the research project and assures that all personnel receive adequate training to perform all activities safely and proficiently. Refer to the web page for Training Required to Participate in Research to determine courses required.
Refer to the LSUHSC EH&S webpage for additional training specific to labortary activities including shipping chemical or biological materials training. Investigators must maintain an inventory of chemicals and biological materials by accessing the on-line EH&S Biological Inventory Control database (LSUHSC intranet log in required).
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.
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 – APHIS (Animal Welfare): http://www.aphis.usda.gov/animal_welfare/pubs_reports.shtml
NIH Office of Laboratory Animal Welfare (OLAW): http://grants.nih.gov/grants/olaw/olaw.htm