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Terms & Definitions
Agent or material which is potentially hazardous to humans, animals, and other forms of life. They include, but are not limited to, bacteria, plasmids, phages, viruses, fungi, mycoplasmas, parasites, cell lines, human or animal fluids, tissues, and remains, and laboratory animals (including insects) which may harbor such infectious agents.
Biosafety Level (BL)
A description of the degree of physical containment being employed to confine organisms containing recombinant DNA molecules and to reduce the potential for exposure of laboratory workers, persons outside of the laboratory, and the environment. In Appendix G of the NIH Guidelines, these are graded from BL-1 (the least stringent) to BL-4 (the most stringent).
Biological Safety Officer (BSO)
An individual appointed by an institution to oversee management of biosafety risks. The NIH Guidelines require that a BSO be appointed when the institution is engaged in large-scale research or production activities, or in research requiring containment at BL-3 or BL-4. The duties of the BSO are described in section IV-B-3 of the NIH Guidelines.
Infectious agent is used broadly to apply to agents that could possibly cause harm to humans, animals, plants, or insects; examples of potential infectious materials are human cells, tissue cultures, organ cultures, other tools used that can be contaminated by infectious agents, etc.
In the context of the NIH Guidelines, an institution is any public or private entity, including federal, state, and local governments.
Institutional Biosafety Committee (IBC)
An institutional committee created under the NIH Guidelines to review research involving recombinant and synthetic nucleic acid molecules. The role of IBCs has evolved over time, and many committees also review other activities, such as teaching laboratory classes, that include biohazardous risk as part of their institutionally assigned responsibilities.
National Institutes of Health (NIH)
One of the world's foremost medical research institutions and the preeminent federal fund of medical research in the U.S. The NIH, comprised of 27 separate Institutes and Centers, is one of eight health agencies within the Public Health Service, which is an agency within the U.S. Department of Health and Human Services. The goal of NIH research is to acquire new knowledge to help prevent, detect, diagnose, and treat disease and disability. The NIH mission is to uncover new knowledge that will lead to better health for everyone.
NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules (NIH Guidelines)
A document created in 1976 that outlines principles for the safe conduct of research employing recombinant DNA technology. The NIH Guidelines detail practices and procedures for the containment of various forms of recombinant DNA research, for the proper conduct of research involving genetically modified plants and animals, and for the safe conduct of human gene transfer research. As a “living” document, it is periodically revised to keep pace with the changing state of science.
Office of Biotechnology Activities (OBA)
The NIH office responsible for developing, implementing, and monitoring NIH policies and procedures for the safe conduct of recombinant DNA activities, including human gene transfer.
Recombinant DNA Advisory Committee (RAC)
An NIH advisory committee whose principal role is to provide advice and recommendations to the NIH Director on (1) the conduct and oversight of research involving recombinant DNA, including the content and implementation of the NIH Guidelines, and (2) other NIH activities pertinent to recombinant DNA technology. A major element of this role is to examine the science, safety, and ethics of clinical trials that involve the transfer of recombinant DNA to humans. More details about RAC membership and responsibilities can be found on the RAC page of the OBA Website, as well as in its Charter.
Recombinant or Synthetic Nucleic Acid Molecules
Under the current NIH Guidelines, these are:
- Molecules that a) are constructed by joining nucleic acid molecules and b) that can replicate in a living cell, i.e., recombinant nucleic acids;
- Nucleic acid molecules that are chemically or by other means synthesized or amplified, including those that are chemically or otherwise modified but can base pair with naturally occurring nucleic acid molecules, i.e., synthetic nucleic acids OR
- Molecules that result from the replication of those described in (1) or (2) above.