At JMU, the IBC reviews activities involving recombinant or synthetic nucleic acid molecules, infectious agents, human materials, biological toxins, and other biohazards that may affect human, animal, plant, or environmental health.
Examples include:
- Research involving recombinant or synthetic nucleic acid molecules, including plasmids and viral vectors
- Human or non-human primate cell lines, tissues, blood, body fluids, and other potentially infectious materials
- Human embryonic stem cells, induced pluripotent stem cells, and related derivatives
- Infectious agents that may affect human, animal, or plant health
- Biological toxins and select agents
- Generation of transgenic plants or animals using recombinant DNA technology
- Regulated plant pathogens, pests, arthropods, nematodes, or weeds
If you are unsure whether your work requires IBC registration, contact ORIC for guidance.
Registration also allows the IBC to notify researchers of regulatory changes, new biosafety information, or institutional requirements that may affect their work.
Exempt Registration
Exempt registration is generally appropriate for activities involving recombinant or synthetic nucleic acid molecules that present minimal risk to human health and the environment.
Non-Exempt Registration
Non-exempt registration is required for activities involving infectious agents, biological hazards, or research that presents a greater potential risk to personnel, the public, or the environment.
If you are uncertain which registration type applies to your work, he IBC will assist in determining the appropriate review pathway.
Non-exempt protocols require renewal every three years. Annual progress updates may be requested during the approval period to verify that approved activities remain accurate and current.
When a project ends or a principal investigator leaves the university, the protocol should be formally closed through the protocol termination process
Laboratories may be inspected by institutional oversight committees as well as federal, state, accrediting, sponsoring, or funding agencies. In addition, laboratories operating under non-exempt IBC registrations are subject to periodic biosafety inspections conducted by the IBC.
The purpose of these inspections is to verify compliance with approved protocols and biosafety requirements, identify potential safety concerns, and promote a safe research environment. Inspectors will provide feedback and work collaboratively with researchers to address any identified issues.
Select agents and toxins are biological agents and toxins that the federal government has determined have the potential to pose a severe threat to public health, animal health, plant health, or animal and plant products. Because of their potential risks, the possession, use, and transfer of these materials are subject to strict federal regulations and oversight.
Current information on select agents and toxins, including the official list of regulated agents, is available through the Federal Select Agent Program website.
If your research involves a select agent or toxin, contact ORIC before acquiring, possessing, transferring, or using the material to ensure all regulatory and institutional requirements are met.
BSL-2 laboratories are designed for work involving biological agents that pose a moderate potential hazard to personnel and the environment. BSL-2 requirements typically include specialized laboratory practices, personnel training, appropriate personal protective equipment (PPE), restricted laboratory access, biological safety cabinets for procedures that may generate aerosols or splashes, and specific decontamination and waste disposal procedures.
The IBC will work with researchers to determine the appropriate biosafety level for their activities and identify any facility, equipment, training, or procedural requirements necessary to conduct the work safely and in compliance with applicable regulations.
Detailed guidance on BSL-2 containment practices and laboratory requirements can be found in the Biosafety in Microbiological and Biomedical Laboratories (BMBL) published by the Centers for Disease Control and Prevention (CDC) and the National Institutes of Health (NIH).
Biosafety Levels (BSL) describe the laboratory practices, safety equipment, and facility requirements used to contain those agents.
Although related, Risk Groups and Biosafety Levels are not equivalent. An agent's Risk Group does not automatically determine the Biosafety Level required for a particular activity. The IBC considers the agent, procedures performed, potential exposures, and other risk factors when determining appropriate containment.
Minor changes that do not substantially alter the approved activities may be submitted as modifications. Examples might include personnel changes or other administrative updates.
A new protocol may be required when proposed changes substantially alter the approved work, such as changes in biological agents, risk assessments, or containment requirements. The IBC reserves the right to require a new application when modifications are considered significant.
Researchers are encouraged to attend meetings when their protocols are under review to answer questions and facilitate the review process.
Please contact the Office of Research Integrity & Compliance at (540) 568-7025 or researchintegrity@jmu.edu.
