Institutional Biosafety Committee (IBC)

About the Institutional Biosafety Committee

Institutional Biosafety Committees (IBCs) were established under the NIH Guidelines for Research Involving Recombinant DNA Molecules to provide local review and oversight of nearly all forms of research utilizing recombinant DNA. Over the years, the role of IBCs has expanded to include areas such as research use of human and non-human primate derived materials, infectious agents, select agents, and biological toxins. The goal of the Children's Hospital IBC is to promote occupational and environmental safety in all research on our campus.

Our IBC program is guided and regulated by the NIH Office of Biotechnology Activities, CDC guidelines entitled Biosafety in Microbiological and Biomedical Laboratories (BMBL) and the federal Occupational Health & Safety Administration (OSHA). The IBC is composed of faculty investigators and laboratory staff with expertise in biohazards research, as well as non-scientist community members. It is also a condition for NIH funding of recombinant DNA research that our institution ensures research conducted at our institution, irrespective of the source of funding, complies with the NIH Guidelines.

IBC duties include pre-approval of all proposed research involving biohazards, continuing review, review of laboratory inspection reports, investigation of complaints and concern, and review of training and a medical surveillance programs.

Research Project Registration

In order to maintain safe conditions and regulatory compliance in research areas, work done with any of the following biological materials must be registered with the IBC:

• Recombinant DNA (even work that is exempt from the NIH Guidelines must be registered)
• Infectious agents (any organism, such as a pathogenic virus, parasite, or bacterium that is capable of invading body tissues, multiplying, and causing disease)
• Human or non-human primate materials (e.g., human cell lines; blood or blood products; most bodily fluids; any tissues)
• Biological toxins and select agents
• Transgenic plants

To facilitate proper registration, a set of guidelines for what work must be approved has been created. Please review the guidelines to determine if your work needs approval. A worksheet has also been compiled for determining the risk group and biosafety level of your work.

If you have any questions in determining if your work requires IBC approval, please contact the IBC coordinator or an IBC member in advance of completing an application. We can often save you a great deal of time by helping you determine if you should fill out an application or not. It is worth your effort to discuss your work and gain a better understanding of what is and is not regulated instead of just filling out an application because you think you might be required to.

Review Process

Any given protocol may have a combination of “exempt” and “non-exempt” components. Just as a PI may have more than one active research grant, the PI may have more than one approved IBC protocol.

To expedite the review process, the IBC utilizes three levels of review based on the hazard(s) involved:

• Exempt: Present only minor hazards with very low risk that is reviewed by the IBC chair. They do require continuing annual review via the original chain, unless amendments result in it being classified to expedited or full committee.
• Expedited Review: Present a moderate risk and require review by the IBC chair or at least one member with the appropriate expertise. These protocols require annual review via the original chain, unless amendments result in it being classified as Full Committee. Protocols involving Risk Group-1 or Risk Group-2 (in vitro) agents, human or non-human primate derived materials or toxins with a LD50>100 µg/kg of body weight are handled via expedited review.
• Full Committee: Present significant hazards to humans, animals or the environment. Review will occur at the next scheduled meeting of the entire committee. These protocols require full committee review on an annual basis.
  

Policy & Procedure

All principal investigators, regardless of approved IBC protocols, must submit a Biohazardous Criteria Acknowledgement form semi-annually.

Once a project has received approval from the IBC, the IBC Coordinator will issue an approval letter and a copy of the final registration documents. The project registration will be valid for three years from the date of approval. If work is continuing beyond that time, new project registration forms will need to be submitted.

Any proposed changes in the protocol regarding the use of hazardous agents must be submitted and approved as an amendment prior to the initiation of the work by e-mailing assurances@chnola-research.org. All IBC approved protocol’s will have an annual review form along with the documentation of retraining within the lab (biohazard acknowledgement form) due on the one year anniversary of the approval. Protocols are approved for a period of three years. At that time, a new application will have to be submitted, if work continues with the agent(s).

Forms & Instructions

Before completing an application, please review a set of guidelines for what work must be approved. Much of the recombinant DNA work at our institution is exempt from NIH guidelines and requires only registration with the IBC, not a complete application. Please note that the Protocol Application only needs to be completed once per application and multiple forms for specific work may be attached as needed.

Please choose the appropriate download(s) that correspond to your protocol:

The following annual compliance forms are in Microsoft Word format. Please note that previous versions of registration forms are no longer accepted.

• Annual Protocol Review Form (for approved protocols)
• Annual Training Acknowledgment (for approved protocols)
• Biohazardous Criteria Acknowledgment (to be completed semi-annually by all PIs)

All completed forms should be submitted electronically to assurances@chnola-research.org.

Registration Deadlines

The IBC meets once per quarter during the calendar year. Deadline dates were created to allow adequate time for reviewers to assess submitted research project registrations. In order to ensure review of your research project at the next committee meeting, complete registration information must be submitted by 5:00 p.m. on the dates listed below.

Contacts

Tristane Darensburg
Assurances Coordinator
x2808 / (504) 896-2808

Emily Moran
Research Supervisor
x2750 / (504) 896-2750

Full Text Guidelines & Other Resources

• NIH Guidelines for Research Involving Recombinant DNA Molecules
• CDC Biosafety in Microbiological and Biomedical Laboratories (BMBL), 5th Edition
• Biosafety Material Safety Data Sheets (MSDSs), Public Health Agency of Canada
• DOT Shipment of Infectious Substances and Diagnostic Specimens