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 protect individuals, research animals, facilities and the community from potential dangers in the use of or exposure to such things as pathogens, tissues or fluids of biological origin, genetic therapy products, transgenic genes, bacteria, viruses, prions and chemicals and toxins that may affect health.
2) 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).
3) 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).
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 registered with the Office of Research Services via the IRB, IACUC and/or IBC. The IBC reviews Research Registration Forms and IBC applications to determine whether all bio-safety concerns are resolved or managed, or that the project is exempt from further IBC oversight. Where applicable, IRB and IACUC approvals are contingent upon IBC review and approval. IBC applications listing materials categorized as Select Agents or Dual Use Research of Concern (DURC) also require review by the DURC committee. Guidance to policy and procedures for both committees are detailed in the following guidebooks.
To request IBC review, the Principal Investigator must submit all forms electronically by emailing the IBCoffice@lsuhsc.edu. Approvals and any other correspondence will be conducted by email. To facility processing, follow the instructions on each form.
Registrations, applications, amendments and annual update forms are processed as received. Applications requiring Full Committee Review must be submitted by the last Monday of the month for the next month’s meeting.
- Research Registration Form Update 3/09/2018 If you must file an IRB or IACUC application/form, DO NOT use this form. Use this form only to register a project that does not require institutional oversight by the IRB, IACUC or IBC. In most instances, research personnel do not conduct any laboratory work or collect, process, test, store or ship any research materials whether biological, pathological, diagnostic specimens, radiological, vertebrate or invertebrate animals, recombinant or synthetic molecules. Acceptance of the registration will be emailed to the PI. Annual reviews are not required. If the registration is not approved for exemption from oversight, the PI will receive an email notification to submit a full application.
- IBC - Clinical Studies Application NEW 3/09/2018 Use this application for human clinical studies where human biological samples will be collected, processed or shipped for clinical testing by LSUHSC study personnel. If samples will be manipulated with other biohazards or involve the use of rDNA, DO NOT use this application. A renewal application must be submitted after the fifth annual review. Use this form to submit an amendment prior to initiating any changes to an approved IBC application.
- IBC Application and Amendment Form Use this application for all research projects that cannot use the Registration Form, IBC-Clinical Studies Application or meets a specific criteria on the IRB Section II.D table for IBC exemption. A renewal application must be submitted after the fifth annual review. Use this form to submit an amendment prior to initiating any changes to an approved IBC application.
- IBC Annual Update Form Update 2/02/2018 This form will be emailed to the PI one month prior to the annual due date unless the project was “Exempted from LSUHSC-NO IBC Oversight”. IBC annuals may not always coincide with corresponding IACUC or IRB annual reviews.
- Change in Personnel Form (CIP) is required to remove or add personnel to projects under IBC oversight when there is not an associated IRB or IACUC oversight. The form outlines training required to conduct research.
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 Biosafety): http://osp.od.nih.gov/office-biotechnology-activities/biosafety
NIH Office of Biotechnology Activities (OBA): http://osp.od.nih.gov/office-biotechnology-activities/rdna/nih_guidelines_oba.html
NIH Guidelines to rDNA Research: http://osp.od.nih.gov/office-biotechnology-activities/biosafety/nih-guidelines
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