Who needs to prepare a registration of their biological materials and research activities?

 Vanderbilt University and Vanderbilt University Medical Center researchers need to register with the Institutional Biosafety Committee (IBC) of their institution if the following criteria are met:

  1. The researcher is a Principal Investigator (PI). A Principal Investigator (PI) is defined as a Vanderbilt University or Medical Center faculty member to whom space is assigned for conducting research. Investigators such as graduate students, research fellows, and research assistant professors, who conduct their research using space assigned to another PI, should register their research as part of that PI’s registration.
  2. The researcher’s lab is working with any of the following materials:
    • Recombinant or synthetic nucleic acids (including transgenic animals)
    • Microorganisms that are infectious to humans, animals or plants
    • Toxins of biological origin that meet one or more of the following:
      1. presents a life-threatening or severe irreversible health effect risk in a single exposure incident scenario;
      2. meets the OSHA definition of a particularly hazardous substance as outlined in the VEHS document “Managing Particularly Hazardous Substances”;
      3. is included on the CDC/APHIS Select Agent List.
    • Human derived materials, including cultured cells and patient samples used in basic research
    • Non-human primate (NHP) derived materials, including cultured cells and tissue samples used in basic research

How do I submit a biological materials registration?

 Contact Robin Trundy, Biosafety Officer, for the current version of the Vanderbilt Biological Materials Registration (VBMR) form. The VBMR form is provided as a Word document. Once it is initially completed, send the first draft of the form as a Word document (with no signatures) to biosafety@vumc.org. A VEHS representative will contact you within three working days to continue the IBC registration process.   

NOTE: This registration form is not intended for human clinical trials involving the use of biological agents. The review process for those studies is now managed as part of the DISCOVER-e registration system.

The IBCs meet on the fourth Tuesday of each month except during December due to the holidays. To be considered for inclusion on an IBC agenda, the first draft of a new VBMR form must be submitted at least 4 weeks before the next available IBC meeting.

Before finalizing your registration for IBC review, a VEHS Biosafety Team member will review your submission and schedule a time to go over your responses and refine the submission content. If your work requires supplemental forms to be prepared (such as for animal protocol-related activities or toxin use), they will work with you on this as well. The VEHS Biosafety Team Member will also visit your lab space and give you guidance on actions needed in order to effectively implement the biosafety practices that will apply to your work.

Once a final registration submission is prepared, and the IBC representing your home department reviews and approves the registration, this approval is valid for 3 years provided that the PI uses the amendment process to notify the IBC of changes in materials, activities, personnel and spaces when appropriate. 

How do I amend a currently approved registration?

Contact Robin Trundy, Biosafety Officer, for the current version of the VBMR Amendment form to capture new activities, agents, personnel and spaces. Submit this as a Word document to biosafety@vumc.org. If the amendment will require a full IBC review (i.e., new RG2 or higher agents, use of RDNA in elevated activity categories), the submission deadline for consideration at the next IBC meeting is the same as described previously for full registrations.

Questions?

For additional assistance, please contact a VEHS Biosafety Team Member at 615-322-2057.