Institutional Biosafety Committee

IBC - Glossary

• Biohazardous Materials
  
  Infectious/pathogenic agents classified as Class 2, 3, and 4 bacterial, fungal, parasitic, viral, rickettsial or chlamydial agents, as well as other agents that have the potential for causing disease in healthy individuals, animals or plants ( including infectious agents, regulated pathogens & pests, cell cultures, tissues, human-derived materials, biological toxins, recombinant DNA molecules)
• Biological Safety Officer
  
  Individual responsible for developing and implementing biological hazard monitoring and controlling programs in the workplace. Serves as liaison with state and federal regulatory agencies, campus health services, public safety and provides assistance and emergency response for incidents involving biological and chemical hazardous materials and regulated medical waste.
• BMBL
  
  Biosafety in Biomedical Laboratories , 5th Editions, http://www.cdc.gov/od/ohs/biosfty/bmbl5/bmbl5toc.htm. Manual prepared by the CDC providing guidance for laboratories that work with biohazardous agents.
• CDC (Department of Health and Human Services (DHHS): Centers for Disease Control and Prevention)
  
  Centers for Disease Control and Prevention, Part of the Department of Health and Human Services (DHHS). The CDC provides guidance to the public and the federal community regarding Biosafety in Biomedical Laboratories (BMBL) for work with biohazardous materials, shipping of etiologic agents, bloodborne pathogen standards, and the select agent program. http://www.cdc.gov/od/ohs/biosfty/biosfty.htm
• Institution
  
  any public or private entity (including federal, state and local government agencies).
  NIH (Department of Health and Human Services: National Institutes of Health)
• Institutional Animal Care and Use Committee (IACUC)
  
  Institutional committee that provides guidance, oversees the animal care and use program, ensures compliance with applicable laws, regulations, and policies.
• Institutional Biosafety Committee (IBC)
  
  a committee that: (1) meets the requirements for membership specified in Secion IV-B-2 of the NIH Guidelines, and (2) reviews, approves, and oversees projects in accordance with the responsibilities defined in Section IV-B-2 of the NIH Guidelines
• Institutional Review Board (IRB)
  
  Institutional committee that functions to promote the ethical and responsible treatment of human participants in research. The IRB provides guidance,
• MUA (Memoramdum of Understanding and Agreements)
  
  Applications for the NIH and Institutional Biosafety Committee for research involving rDNA as defined by the NIH Guidelines.
• NIH Guidelines
  
  The NIH Guidelines for Research Involving Recombinant DNA Molecules (NIH Guidelines) set forth the principles for NIH and institutional oversight of recombinant DNA research, including human gene transfer trials. The NIH Guidelines were first published in 1976 as an outcome of a public process by which scientists developed standards to address the risks associated with recombinant DNA research. http://www4.od.nih.gov/oba/rac/guidelines_02/NIH_Guidelines_Apr_02.htm
• NIH - OBA (National Institutes of Health: Office of Biotechnology Activities)
  
  http://www4.od.nih.gov/oba/ The office within the NIH that is responsible for (1) reviewing and coordinating all activities relating to the NIH Guidelines and (2) performing other duties as defined in Section IV-C-3 of the NIH Guidelines
• NIH - RAC (National Institutes of Health: Recombinant DNA Advisory Committee)
  
  the public advisory committee that advises the Department of Health and Human Services Secretary, Assistant Secretary for Health, and the NIH Director concerning recombinant DNA research.
• ORIA
  
  Office of Research Integrity and Assurance has responsibility for managing, supporting, monitoring, and assessing Cornell’s research compliance programs. See http://www.oria.cornell.edu.
• OSHA (Occupational Safety and Health Administration)
  
  Occupational Safety and Health Administration, of the U. S. Department of Labor. Purpose is to assure safe and healthful working conditions for working men and women; authorize enforcement of the standards developed under the Act; assist and encourage States in their efforts to assure safe and healthful working conditions; provide for research, information, education, and training in the field of occupational safety and health. 2http://www.osha.gov/
• Principal Investigator (PI)
  
  This title identifies the individual responsible for the conduct of the project. This responsibility includes the intellectual conduct of the project, fiscal accountability, administrative aspects, and the project's adherence to relevant policies and regulations.
• Recombinant DNA Molecules
  
  http://www4.od.nih.gov/oba/ molecules that are constructed outside living cells by joining natural or synthetic DNA segments to DNA molecules that can replicate in a living cell or molecules that result from the replication of those previously described
• Research
  
  A systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge. Activities which meet this definition constitute research for purposes of this policy, whether or not they are conducted or supported under a program which is considered research for other purposes. For example, some demonstration and service programs may include research activities and they would be included in this definition of Research.
• Risk Groups
  
  Human etiologic agents are classified into four risk groups according to their relative pathogenicity for healthy humans by the following criteria:

  • Risk Group 1: agents not associated with disease in healthy adult humans.
  • Risk Group 2: agents are associated with human disease which is rarely serious and for which preventive or therapeutic interventions are often available
  • Risk Group 3: agents are associated with serious or lethal human disease for which preventive or therapeutic interventions may be available
  • Risk Group 4: agents are likely to cause serious or lethal human disease for which preventive or therapeutic interventions are not usually available
• Select Agents
  
  The Centers for Disease Control and Prevention (CDC) regulates the possession, use, and transfer of select agents and toxins that have the potential to pose a severe threat to public health and safety. The CDC Select Agent Program oversees these activities and registers all laboratories and other entities in the United States of America that possess, use, or transfer a select agent or toxin. USDA/APHIS also provides a list of select agents.
• USDA/APHIS
  
  United States Department of Agriculture, Animal and Plant Health Inspection Service, a multi-faceted Agency with a broad mission area that includes protecting and promoting U.S. agricultural health, regulating genetically engineered organisms, administering the Animal Welfare Act and carrying out wildlife damage management activities. http://www.aphis.usda.gov