Institutional Biosafety Committee

Background

The Biosafety Office and IBC are not involved in patient care or clinical pathways of diagnostic specimen handling and processing. When patients present to the hospital for a blood draw or biopsy or COVID-19 test, that material is handled through established pathways for how clinical diagnostic work is conducted, without the need for Biosafety Office or IBC registration.

Once the work enters the research realm, even if the work is research initiated by a clinical diagnostic group such as Clinical Pathology, for example, then material registrations and IBC approval must be obtained.

Lab Inspections: As part of the approval process, the IBC requires inspections of all labs submitting SARS-CoV-2 registrations. Labs that do not meet requirements (which include a biosafety cabinet located in a separate room or in a well secluded area) will not be approved for research. Lab inspections are prompted by biosafety registrations.

Investigators must maintain their own portfolio of registrations. Registration is not conferred to multiple PIs on a study. Each investigator who may handle or possess the material, or have staff under their direction who may handle or possess the material, including material in freezers and such, must register.

 

Required Biosafety Registrations

Studies, whether clinical or lab research, require the following, if applicable:

• HUMAN-DERIVED MATERIALS REGISTRATION
  Study PIs need to hold, or submit, a registration for human-derived materials that will be used in the study. Many PIs already hold this registration. Registration numbers start with a BC (for clinical research studies) or a B (for lab research only) and the registration covers all use of human materials while the PI is at JHU. Once a PI has a human-derived materials registration, a new one is not required each project. However, BC and B registrations do not confer—PIs who already have a BC registration and who want to conduct bench studies must also have a B registration; PIs who already have a B registration and who want to do clinical research studies must have a BC registration.

Human Derived Materials Registration Form

**Instructions: Question 7: If the registration is for clinical research studies, check the box and skip the rest of the form. If the registration is for laboratory research, complete the entire form, including the narrative.

 

Additional Research Registrations Are Most Likely Required

• INFECTIOUS AGENT/PATHOGEN REGISTRATION
  

• • Not Required When:  The study is not targeting a particular disease. For example, an assessment of the prevalence of SARS-CoV-2 seroconversion of 100 random individuals in Baltimore does not require a pathogen registration for SARS-CoV-2, because although the virus may be present in the patient or samples, the investigator is not specifically targeting SARS-CoV-2 positive people. Rather, the investigator is looking at a population that may or may not be ill, and standard precautions apply.

• • Required When:
    • The investigator is specifically looking for disease in a population, such as testing samples for COVID-19, and the activity is expressly for research and not for clinical diagnosis—the investigator must file a pathogen registration for SARS-CoV-2.
    • The investigator will send samples to clinical labs for diagnosis, but will obtain or retain some of the sample for their own research.
    • The investigator will send samples to clinical labs for diagnosis as part of a research project, and is using research staff to handle, package, and/or deliver the materials to the lab. An infectious agent/pathogen registration is required from the investigator as the party legally responsible for the safety of their research staff.
    • The investigator is conducting a clinical trial and will use human-derived materials that are not FDA approved for that particular usage. In most cases this material needs to be registered as a potential pathogen.

Infectious Agent/Pathogen/Biological Toxin Form

• RECOMBINANT/SYNTHETIC NUCLEIC ACID MOLECULE REGISTRATION 
  Required when recombinant or synthetic DNA, RNA, or other nucleic acid molecules will be involved in the research. Like the human-derived material registration, investigators need only one recombinant/synthetic nucleic acid registration. A new registration is required only if the material will be introduced into human subjects.

Recombinant/Synthetic Nucleic Acid Molecule Form

• BIOLOGICAL TOXIN REGISTRATION
  Required when the study involves the use of a biological toxin.

Infectious Agent/Pathogen/Biological Toxin Form