Biosafety

Mission/Goals

The Biosafety Office assists the Hopkins community in maintaining a safe work environment that is compliant with federal, state and community regulations. Our goal is to serve as a technical knowledgebase and training resource for biological safety issues on campus.

Services

The following services are provided to the Hopkins community through the Biosafety Office:

Recombinant DNA Registration
Infectious Agent/Pathogen Registration
Biological Toxin Registration
Human Tissue Registration
Select Agent Registration
Registration of Clinical Protocols Involving the Introduction of Recombinant DNA, Infectious Agents/Pathogens, and/or Biological Toxins in Human Subjects
Biological Safety Cabinet Certification and Maintenance
Annual Research Laboratory Safety Surveys
Biosafety Training Modules for Laboratory Personnel and Interested Support Staff

Recombinant DNA Registration

All research involving the use or manipulation of recombinant DNA must be registered with the Biosafety Office in order to maintain compliance with institutional and federal regulations.
The Recombinant DNA Registration form is available online at this link.

Once registered, experiments considered "exempt" as defined within the NIH Guidelines may be initiated upon notification from this office. Under normal circumstances the investigator can expect notification within a few days of submission.

All "non-exempt" research must be reviewed by the Institutional Biosafety Committee (IBC). Experiments requiring IBC review may not be initiated until a formal letter of approval is received by the investigator. IBC meetings occur monthly to bi-monthly depending on the volume of submissions under consideration.

Human Subjects Gene Transfer Pathogen Protocol Registration

Studies that involve the use of Recombinant DNA or potentially Pathogenic agents in human subjects must be reviewed and approved by the Institutional Biosafety Committee (IBC).

Investigators who intend to submit a human pathogen or gene transfer protocol to the Johns Hopkins Institutional Review Board (IRB) should contact the Biosafety Officer for IBC submission details.

Human Tissue, Pathogen, and Toxin Registration

Research involving the use of human and human-derived tissue, infectious agents/pathogens, or toxins must be registered with the Biosafety Office in order to maintain compliance with institutional and federal regulations.
The Human Tissue, Pathogen, and Toxin Registration form is available online at this link.

Human tissue includes tissue samples and/or blood from patients, volunteers, or cadavers as well as human-derived cells in tissue culture. Common laboratory cell lines including HEK293 and Hela are not exempt and must be registered.

Infectious agents and pathogens include all bacterial, viral, and fungal agents with potential for vertical or horizontal transmission. "Host-specific" viruses and viral vectors commonly used for gene transfer must also be registered. This includes, but is not limited to, adenovirus, MuLV, and other commercially available or investigator-generated modified lentiviral and retroviral-based vectors.

Select Agent Registration

The United States Department of Health and Human Services (HHS) and the United States Department of Agriculture (USDA) have identified bacteria, viruses, toxins, rickettsia, and fungi that pose a potential threat to public health or welfare. These organisms are considered Select Agents and High Consequence Livestock Pathogens and Toxins.

Laboratories currently in possession of, or intending to obtain select agents must be registered with the Centers for Disease Control and Prevention (CDC) through the Biosafety Office and must adopt security and control measures acceptable to the governing authorities. Contact the Biosafety Officer for more information on the current status of these emergent regulations.

Biological Safety Cabinet Program

Biological Safety Cabinets (BSCs) must be certified on an annual basis at minimum. Certain environmental or laboratory conditions may necessitate more frequent certifications.

The Biosafety Office maintains a professional in-house certification and maintenance team headed by an NSF accredited specialist. Our BSC team operates as a service center for the Hopkins community and, thus, is able to provide rapid response service "at cost" resulting in significantly reduced investigator fees and equipment down-time.

Annual BSC certifications and any required maintenance may be scheduled by contacting the Biosafety Office at the address below. Further information regarding BSCs is available at this link.

The Biosafety Office serves as a resource for the purchase and/or maintenance of your BSC. To ensure system adequacy, all BSC purchases must be vetted through this office. Feel free to contact us with any questions you may have.

Frequently Asked Questions

Training

The Biosafety Office offers training and training materials on a number of topics. Click on an item of interest or contact us directly for more information.

Safe Laboratory Practices for BSL1 and BSL2,
Safe Laboratory Practices for BSL3 Research Programs
Bloodborne Pathogen Training: either taken online or in class
- Online self study
- Instructor lead classroom session
Packaging and Shipment of Biological Materials (DOT/IATA Shipping Course offered by Environmental Health)
Proper Use of Biological Safety Cabinets
Online biosafety policies