Research Using Recombiant-DNA, Biohazards and Bloodborne Pathogens

The ODU Biosafety Manual provides the necessary policies and procedures for working safely with these types of biological materials on campus. This manual applies to all university research and teaching, all university employees and students, and all those using university facilities.

Guidelines for Disposal of Regulated Medical Waste: Below are the guidelines (pdf) for disposal of Regulated Medical Waste at approved locations:

• BSSF Medical Waste Guidelines
• Chemisty Medical Waste Guidelines
• IRP / CBE Medical Waste Guidelines (No autoclave)

The Institutional Biosafety Committee (IBC) has at least five university members and at least two nonaffiliated members having experience or expertise in recombinant DNA (rDNA) technology, in addition to the knowledge and capability to assess the safety of activities involving the use of other biological materials used across campus as described below.

All research and teaching conducted by ODU employees or students, involving any of the agents or materials listed below, must be approved by the ODU IBC prior to initiation by way of the IBC Registration Form.

• Microorganisms - bacteria (including rickettsia, chlamydia, and mycoplasma), viruses, fungi, parasites
• Prions and other infectious agents
• Recombinant and synthetic nucleic acid molecules, including all methodologies that involve the isolation, amplification, hybridization, and any other uses of DNA or RNA from any organism
• Animals infected with human pathogens (including human and non-human primate cells/tissues, recombinant or synthetic nucleic acid molecules) and animals as sources of zoonotic diseases
• Plants involving work with infectious agents and/or recombinant or synthetic nucleic acid molecules in plants)
• Bloodborne pathogens or other potentially infectious material (human blood, fluids, tissues, blood products, or cell lines; including non-human primate derived materials and established cell lines)
• Any exempt select agent or toxin below the permissible toxin amount.

Note: ODU is not currently authorized to possess, use, or transfer select agents or toxins, as defined by the select agent regulations, 7 CFR 331 (agriculture), 9 CFR 121 (animals and animal products), and 42 CFR 73 (public health). See the sections on Select Agents and Toxins and Dual Use Research of Concern below for more information on restricted research.

All principal investigators who conduct research with biological materials, as described above, must submit an IBC Registration Form to the IBC. This application documents that the researcher has implemented all necessary work practices, procedures, and engineering controls into their protocol to adequately protect themselves, others in the laboratory, others at the university, and the community from exposure to potentially hazardous agents. The IBC must review and approve all applications before any work with the described biological materials may be initiated. In addition, all personnel listed on the applications must complete the required training before initiating a project or class using these materials. Information on how to conduct an initial risk assessment of the work to be submitted, and for reinforcement of proper biosafety practices and principles, can be found in the ODU Biosafety Manual and Biosafety in Microbiological and Biomedical Laboratories (BMBL).

Applications for working with biological materials may be approved for a total of five years, but must be renewed annually using the IBC Annual Review/Renewal Form for continuation of the project for each subsequent year following the initial approval. If there are any changes to the protocol, including a change in personnel or procedure, an addition of biological material, a change in location, or any other change to the approved protocol, an amendment must be submitted and approved by IBC using the IBC Amendment Form, BEFORE the change can be initiated. After five years, if the project is to be continued, the researcher must submit a new application to the IBC for approval.

Applicable training must be documented on the IBC Training Record for all individuals listed on an IBC application.

CITI Training

• Instructions on how to complete the online CITI Biosafety training requirements

Mandatory EH&S Training: ODU Laboratory Safety

• Laboratory Safety training is mandatory for Faculty, Staff and GA's/TA's who work in laboratories that use or store chemicals.
• To schedule training, send an email to ehsdept@odu.edu

All submissions to the IBC (new protocols, amendments, annual reports, close-out reports, etc.) must be submitted no later than two weeks prior to the next scheduled meeting date if they are to be reviewed at that month's meeting. The IBC will hold a convened meeting to review applicable submissions on the last Tuesday of every month. If a meeting needs to be rescheduled for any reason (e.g., holidays), updated meeting times will be posted to this website within one week of the meeting.

• All meetings take place on their designated date and time.
• For questions, please email IBC@odu.edu

Select agents are specific biological agents, as defined by federal regulations 7 CFR 331, 9 CFR 121, and 42 CFR 73, which have been determined to possess the potential to cause harm to public health and safety, including animal health, animal products, and/or plant health or plant products. These agents and toxins are regulated by the Centers for Disease Control and Prevention (CDC) and the Animal and Plant Health Inspection Service (APHIS). The federal regulations require an entity with intent to possess, use, or transfer any of the agents on the select agent list to register with the Federal Select Agent Program (FSAP). At the present time, ODU is not registered with the FSAP and cannot possess, use, or transfer any select agent or toxin.

The FSAP does not regulate a select agent or toxin if:

• it is an attenuated strain of a select agent or an inactive form of a select toxin;
• a non-viable select agent or nonfunctional toxin, or;
• if it is in its naturally occurring environment (provided it has not been intentionally introduced, cultivated, collected, or otherwise extracted from its natural source).

Any select agent or toxin on the exclusion list or the permissible toxin amount list must be registered with the ODU IBC and approval must be granted before the work is initiated.

Dual Use Research of Concern (DURC) is defined in the United States Government (USG) Policy for Institutional DURC Oversight (released September 24, 2015) as research that can be reasonably anticipated to provide knowledge, information, products, or technologies that could be directly misapplied to pose a significant threat with broad potential consequences to public health and safety, agricultural crops and other plants, animals, the environment, materiel, or national security. This policy, which establishes review procedures and oversight requirements for potential DURC research at institutions receiving Federal funds for life science research, becomes effective on September 24, 2015. Alongside the March 2012 DURC Policy, these two USG policies provide oversight of DURC when the research is funded by the USG or when the research is taking place at institutions receiving funding from the USG. These two policies work to engage the research community and Federal departments and agencies funding such research. For more information, please go to the NIH Office of Biotechnology Activities DURC website.

At the present time, Old Dominion University is not authorized with the Federal Select Agent Program to possess, use, or transfer any of the agents or toxins listed in the USG Policies, and therefore, research as described in these policies cannot currently be conducted at this institution. The Application for the Use of Biological Materials contains a set of specific DURC identifying questions, which is part of the consistent effort to ensure that all local, state, university, and federal regulations and guidelines are abided by at all times.

• ODU Regulated Medical Waste Guidelines
• BMBL - Biosafety in Microbiological and Biomedical Laboratories (CDC/NIH)
• NIH Guidelines - NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules
• Dual Use Research - US Government Dual Use Policy & Dual Use Research of Concern
• CITI - Collaborative Institutional Training Initiative (REQUIRED online training for all investigators
  • Detailed instructions on how to complete the online training requirements can be found under the "Forms and Templates" section of IRBNet