All research involving the use or manipulation of recombinant or synthetic nucleic acid molecules must be registered with the Biosafety Office in order to maintain compliance with institutional and federal regulations.
The Recombinant or Synthetic Nucleic Acid Molecules Registration form is available online.

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.

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.

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.

The Human Tissues and Body Fluids Registration form is available online.

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.

The Infectious Agents/Pathogens and Biological Toxins Registration form is available online.

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 and toxins are considered Select Agents.

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.

Visit the IRE site

Studies that involve the use of Recombinant or Synthetic Nulcleic Acid Molecules, potentially Infectious or Pathogenic agents, Biological toxins 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.

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 staffed with four technicians, three of which are NSF-accredited for field-certification. 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.

• Annual Research Laboratory Safety Surveys
• Biosafety Training Modules for Laboratory Personnel and Interested Support Staff