UTDPP1016
Biosafety Committee

Policy Statement

The Institutional Biosafety and Chemical Safety Committee (IBCC) is a University-Wide, Standing Committee appointed by the President not reporting to the Academic Senate of The University of Texas at Dallas.

The Committee operates in accordance with The Committee operates in accordance with NIH Guidelines. for research involving recombinant or synthetic nuclei acid molecules (rDNA). The Committee implements policies that provide for the safe conduct of research and has oversight all research or teaching laboratory projects involving rDNA and/or other hazardous biological materials that may pose safety, health, or environmental risks. The Committee is charged to perform the following duties:

1. Advise the University on policies regarding rDNA research.
2. Review research proposals and conduct independent assessments of containment level requirements for rDNA and potentially biohazardous agents in compliance with the CDC's Biological Safety in Microbiological and Biomedical Laboratories (BMBL) guidelines.
3. Assess facilities and safe handling practices, procedures, and the training and expertise of the personnel involved in rDNA research.
4. Report violations of the NIH Guidelines and significant research-related accidents or illnesses unless the Principal Investigator has reported such matters.
5. Perform all responsibilities required of an Institutional Biosafety Committee (IBC) under the NIH Guidelines as may be amended from time to time. Should the Biosafety Committee's duties under the NIH Guidelines conflict with any duties outlined in this policy, then, the Guidelines will control.

Under the NIH Guidelines Section IV- B- 2, an institution's "responsibilities need not be restricted to recombinant or synthetic nucleic acid molecule research." Accordingly, the Committee also operates as the institutional chemical safety committee to develop policies for the acquisition, safe handling and storage of hazardous chemical materials that require oversight under local, State and Federal guidelines.

Taking both concerns together, researchers at UT Dallas using any of the following materials are requested to register their project with the IBCC.

• Recombinant (rDNA) or synthetic DNA and related materials
• Pathogenic organisms or other potentially infectious materials
• Human and non-human primate cells, tissue, blood, or body fluids
• Research with animals and animal tissues known to be potential reservoirs of zoonotic disease
• Biological Toxins or Select Agents
• Particularly hazardous chemicals

Procedures for the secure storing, working with, transport of and disposal of these materials and agents will be approved by the Committee. The Committee will work with the Office of Institutional Risk and Safety Programs to maintain biological and chemical safety manuals.

Members of the Committee must be sufficiently qualified through their experience, expertise, and diversity to ensure respect for its advice and counsel. Members must have expertise in rDNA technology associated with biological research, animal research, or plant research and the capacity to assess the safety of rDNA research experiments and any potential risk to public health or the environment. Members must also have knowledge of chemical agents and any potential risk to public health or the environment.

The Committee shall be composed of at least seven members appointed by the President who may seek the advice of the Chair of the University Safety and Security Council and the Dean, School of Natural Sciences and Mathematics. At least two members (and not less than 20% of the membership of the Committee) shall not be affiliated with the University (apart from their membership on the IBCC) and shall represent the interest of the surrounding community with respect to health and protection of the environment. The Vice President for Research and Innovation or designee, the Office of Risk and Safety Sr. Director or designee, and the Biosafety Officer serve as ex officio non-voting members. The term of office of the Committee members shall be for three years and members may be reappointed by the President for additional terms. The Chair and Vice Chair of the Committee shall be appointed by the President for a two- year term in that office and shall be a member of the University Safety and Security Council. If for any reason a Committee member resigns, the President shall appoint another qualified individual to serve the remainder of the unexpired term. The Responsible University Official (RUO) for the Committee is the Vice President for Research and Innovation.

If needed, additional consultants, competent in the corresponding research area and familiar with Federal, State and Local regulations, may be called in by the Chair.

Principal Investigators whose research activities fall under the requirements listed under Section III of the NIH Guidelines for rDNA research, in the most current version of the NIH Guidelines, are required to register their research with the IBCC and ensure full compliance with the NIH and UTD policies. The Principal Investigator ensures any significant violation of the NIH Guidelines is reported to the Biosafety Officer, IBCC, and NIH within 30 days. To provide for any non-sponsored research, a request will be sent annually to the appropriate Department Heads requesting they certify that they are not (or are) aware of any non-sponsored research in their program that involves recombinant DNA and potential chemical or biohazards.

Upon request of a Committee member, the RUO, and/or the Chair of the University Safety and Security Council, the Committee Chair will convene the Committee with the Principal Investigator to further discuss a research proposal. If the Principal Investigator is also a committee member, they will not function as a member in the Committee's deliberations. If the opinion of the Committee is equally divided, the Committee shall continue to meet until it gets a majority viewpoint. In the case of a disagreement of the Committee about the evaluation of the risk level, the minority opinion shall be forwarded to the President to be included in the letter to NIH.

The Committee will produce and submit an annual report to the University Academic Senate and the Safety and Security Council.