Registrations arrive in the Biosafety Office by campus mail, US mail, FAX, or hand delivery. Incoming Registrations are screened by the Biosafety Office to determine:
- Has the registration been completed correctly?
- Is the registration signed?
- Does the registration indicate the use of agents that have not been registered by the PI? For example, propagation of adenoviral vectors is frequently done with HEK293 cells, a human cell line. Thus, any investigator that registers adenoviral vectors is checked for human tissue registration. If none is noted, the investigator is queried as to whether human cells will, indeed, be utilized. Likewise, Recombinant or Synthetic Nucleic Acid Molecules Registrations that indicate transduction of cells are cross-checked for registered viral vectors and the investigator queried if none are found.
Once a registration is determined to be complete, the registration is coded for entry into the database and a letter is sent to the investigator indicating the status of the registration. The following code letters precede the registration numbers transmitted to investigators:
as defined in section III-E of the NIH Guidelines
P - Infectious Agent/Pathogen registration. All are reviewed by the IBC.
T - Toxin registration. All are reviewed by the IBC.
GT- Clinical Research involving Gene Therapy, the introduction of Recombinant or Synthetic Nucleic
Acid Molecules, potential Infectious Agents/Pathogens, or Biological Toxins into human
subjects. All are reviewed by the IBC.
BC - Human tissue registration for clinical studies. Reviewed by the Biosafety Office.
B - Human tissue registration for laboratory-based studies. Reviewed by the Biosafety Office.