Virginia Polytechnic Institute and State University
Virginia Tech Recombinant and Synthetic Nucleic Acid and Biohazard Research Policy - No. 13030 - Page 7
including plant or animal experts, a Biological Safety Officer (BSO), or other expertise as appropriate, and must
also include at least two unaffiliated members who can represent the interests of the community surrounding the
registered institution.
IBC Research or Teaching Protocol (Protocol) – Information provided by the Principal Investigator (PI) in
defined submission forms that describes: (i) the use of recombinant DNA or synthetic nucleic acid molecules and
the cells, organisms, and viruses containing such molecules; (ii) the applicable NIH Guidelines; (iii) the training,
experience, and expertise of the PI in handling and use the specified agents under specified containment criteria;
(iv) the training of staff included in the protocol; (v) a description and floorplan of facilities and equipment to
assess whether containment practices are appropriate; (vi) lab Biosafety Manual.
Biohazardous Materials – Infectious biological or synthetic agents, biologically derived materials and toxins that
present a risk or potential risk to the health of humans, animals, or plants either directly through exposure or
infection or indirectly through damage to the environment. Categories of potentially infectious biological materials
may include the following:
• human, animal, and plant pathogens (bacteria, parasites, fungi, viruses, prions)
• toxins of biological origin
• human and non-human primate cells and unfixed tissues
• animal or plant pathogens and products, specifically genetically engineered organisms and veterinary
biologics
• select agents and toxins
• infected animals and animal tissues and infected plants.
Biological Safety Officer (BSO) – This individual is required by the NIH Guidelines, and has the following duties
and responsibilities: to conduct periodic inspections to ensure that laboratory biosafety standards are rigorously
followed; to report to the IBC and the institution any significant problems, violations of the NIH Guidelines, and
any significant research related accidents or illnesses; to develop emergency plans for handling accidental spills
and/or personnel contamination, and for investigating lab accidents involving rDNA research; to provide advice on
laboratory security; to provide technical advice to PIs and the IBC on research safety procedures.
BMBL – The CDC/NIH handbook, “Biosafety in Microbiological and Biomedical Laboratories (BMBL) 5th
Edition”, provides a code of practice for biosafety, addressing the safe handling and containment of infectious
microorganisms and hazardous biological materials. The BSO and the IBC use the BMBL to assess containment
practices and personal protective equipment (PPE) required for activities proposed in a PI’s IBC protocol.
Office of Science Policy (OSP) – The NIH Office of Science Policy promotes science, safety, and ethics
in biotechnology through advancement of knowledge, enhancement of public understanding, and
development of sound public policies. OBA accomplishes its mission through analysis, deliberation, and
communication of scientific, medical, ethical, legal, and social issues. An institution that is
conducting research subject to the NIH Guidelines must have an IBC, and that IBC must be registered
with and approved by OSP, demonstrating that the IBC has knowledge of local institutional
characteristics, e.g., adequate investigator training, laboratory conditions, and operating procedures.
Responsible Official (RO) – The RO is the designated individual at the institution with the authority and
responsibility to act on behalf of the institution to ensure compliance with the requirements of APHIS and HHS