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Research Committee Approvals


Biosafety/Select Agents (IBC Committee)

 

The Institutional Biosafety Committee (IBC) is responsible for enforcing policies and guidelines related to the use of all potentially hazardous biological agents including but not limited to infectious agents, human and non human primate materials (including established cell lines), known regulated carcinogens, select agents, recombinant DNA and studies involving human gene transfer. The Committee is responsible for ensuring that research involving these agents is conducted in a manner that does not endanger the researcher, laboratory worker, human research subjects, the public or the environment.


The IBC is responsible for:

  • Formulating and implementing policies related to the safe use of biological materials and known chemical carcinogens;
  • Reviewing all research protocols involving biological materials and known chemical carcinogens;
  • Approving or disapproving such projects based on their potential hazard and proposed containment procedures;
  • Establishing, approving and monitoring proper laboratory conditions and procedures required for such projects;
  • Reviewing the qualifications and training of investigators and laboratory personnel engaged in such research to ensure appropriate laboratory safety techniques are used (for a more detailed explanation of education and training programs administered by the Department of Career and Protective Services on the proper use of potentially hazardous biological agents, please review Laboratory Safety Training Requirements);
  • Ensuring that proper disposal and decontamination procedures are adopted;
  • Adopting emergency plans covering accidental spills and personnel contamination resulting from research;
  • Ensuring that any significant problems with or violations of the NIH and/or CDC Guidelines are investigated and reported as specified in the NIH Guidelines for Research Involving Recombinant DNA Molecules and the "Biosafety in Microbiological and Biomedical Laboratories" respectively.
The Committee follows the NIH Guidelines for Research Involving Recombinant DNA Molecules on the use of recombinant DNA and human gene transfer and the CDC/NIH guidelines, "Biosafety in Microbiological and Biomedical Laboratories", in addition to implementing more restrictive guidelines, as needed.

The IBC meets at least once per month, and is comprised of at least 12 voting members. Committee members are selected from a pool of faculty with expertise in the properties and safe use of human and non-human primate materials, infectious agents, carcinogens, select agents, recombinant DNA and human gene transfer trials, including representatives from the Institute for Genetic Medicine with expertise in Recombinant DNA Technology, the Department of Molecular Biology, the Director of the Animal Resources, Laboratory Technical Staff, outside community members and the Biological Safety Officer. Ad-hoc Committee members will be used for various situations as they arise.
 

Special Requirements Regarding Select Agents


The United States Department of Health and Human Services (HHS) and the United States Department of Agriculture (USDA) have identified bacteria, viruses, toxins, rickettsia, and fungi that pose a potential threat to public health or welfare. These organisms, called “Select Agents and High Consequence Livestock Pathogens and Toxins,” are strictly regulated.

  • Authorization to Use Select Agents

Approval must be obtained from the IBC prior to receiving or using any Select Agent in isolated form above exempt quantities. The IBC approval process for Select Agents includes registration with the Centers for Disease Control and Prevention (CDC) and/or the Animal and Plant Health Inspection Service (APHIS).

All individuals with access to Select Agents are required to obtain a security clearance from the Department of Justice. Laboratory Safety submits names and fingerprints of all individuals listed on the IBC protocol form as working with Select Agents to the Department of Justice.

Every person who enters a laboratory containing Select Agents must either have a security clearance or must be accompanied and monitored by such a person. This includes visitors and employees performing routine cleaning, maintenance, and repairs.

Principal investigators submitting an IBC protocol form for approval to use Select Agents must include a security plan that addresses the following elements:

  • Physical security;
  • Cyber security;
  • Inventory;
  • Material transfers;
  • Training;
  • Suspicious persons and activity reporting;
  • Provisions for cleaning and maintenance;
  • Physical security requirements are addressed through a risked-based analysis performed by Laboratory Safety for each laboratory proposing to use Select Agents
  • Thefts or Loss of Select Agents.

Thefts or loss of select agents must be immediately reported to campus police, and Laboratory Safety who in turn will report to CDC and/or APHIS.

 
   
   
       
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