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General Information on Institutional Biosafety

Overview

William & Mary recognizes the importance of conducting a broad spectrum of investigative research as well as classroom and laboratory educational activities that require the use of recombinant DNA technology and etiologic agents. Protocols must also be submitted using the compliance system, SPARCS.

Cognizant that these activities may be accompanied by some risks, the university requires that the following activities be reviewed and approved by an Institutional Biosafety Committee (IBC) to ensure that they are conducted in a safe and appropriate manner:

• Recombinant DNA technology, which is subject to the NIH Guidelines for Research Involving Recombinant DNA Molecules;
  • NIH Guidelines for Research Involving Recombinant DNA Molecules,
  • CDC/NIH Biosafety in Microbiological and Biomedical Laboratories
  • University's Bloodborne Pathogens Exposure Control Plan
• Agents infectious to humans and other animals;
• Use of human tissues, fluids, or cell lines or primate tissues, fluids or cell lines;
• Lab or field work on animals for which a documented and reasonable potential for transmission of zoonotic agents exists, e.g., wild-trapped rodents, birds, amphibians
• Lab or field work with the intent to isolate or culture pathogens;
• Research on biological agents that produce harmful toxins, where there is significant potential for human exposure.

William & Mary IBC is not limited to the narrow regulations on recombinant DNA technology set forth by the NIH. Most universities have mandates to oversee broader biosafety issues, particularly projects pertaining to zoonotic and infectious disease agents, but also those dealing with other biohazardous agents such as algal toxins. In fact, the scope of many IBCs is to oversee any biological agents that can potentially harm humans, the environment, or agriculture.

William & Mary IBC takes the stance that any research involving potentially harmful agents must be registered and approved by the university's IBC.

Definitions

• Recombinant DNA molecules are defined as either:
  • (I) molecules that are constructed outside living cells by joining natural or synthetic DNA segments to DNA molecules that can replicate inside a living cell, or
  • (ii) DNA molecules that result from the replication of those described in (I).
  • Synthetic DNA segments likely to yield a potentially harmful polynucleotide or polypeptide (e.g. a toxin or pharmacologically active agent) shall be considered as equivalent to their natural DNA counterpart. If the synthetic DNA segment is not expressed in vivo as a biologically active polynucleotide of polypeptide product, it is exempt from this policy.
• Etiologic agents are defined as those biological agents, both pathogenic and non-pathogenic, known to cause disease in humans as well as selected animal agents that may pose potential risks if transmitted to humans.
• Zoonotic diseases are diseases of animals that can be transmitted to humans. The IBC recognizes that there can be an inherent and probabilistically low risk of transmission of many diseases to humans from field-based studies. Further, many vertebrates possess pathogens of varying risk, with some more likely to be encountered than others, and some more pathogenic than others. Therefore, certain field studies should include safety protocols to limit exposure to potential agents, particularly when working with vertebrates and invertebrates that are known to harbor zoonoses or serve as vectors for disease agents. There may be cases where the risk of infection is extremely small, or where the risks of handling wild-trapped animals have changed (e.g., bird flu, Hanta virus). In these cases, the institutional biosafety officer can determine if registration is required. However, IBC registration is required for any field-based studies where tissues, including blood or hemolymph, are sampled for the isolation and culture of viral or bacterial agents. For additional guidelines for field-based studies, see the Field Study Guidelines page..

"Biotechnology in an Age of Terrorism"

IBC members are instructed to take special care in identifying any protocols involving experiments of concern identified by the National Academies of Science report "Biotechnology in an Age of Terrorism" Adherence to this policy shall not exempt investigators employing recombinant DNA molecules or etiologic agents in their research from compliance with other applicable laws, regulations or policies (e.g. research with human subjects, vertebrate animals, or radioactive materials).

Applicability

This policy is applicable to all research, teaching, and outreach activities involving recombinant DNA or etiologic agents that are conducted at or sponsored by (or under the aegis of) William & Mary. No activity involving the construction or handling of recombinant DNA molecules or the use of etiologic agents shall be initiated without the review and approval of the appropriate registration documents by William & Mary Institutional Biosafety Committee.