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Registration Procedures
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 DNA 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:
DE - Recombinant DNA registration exempt from formal IBC review as defined in section III-E of the NIH Guidelines DN - Recombinant DNA registration subject to formal IBC review
P - Pathogen registration. All are reviewed by the IBC.
T - Toxin registration. All are reviewed by the IBC.
GT - Gene Therapy or Pathogens in 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.
P - Pathogen registration. All are reviewed by the IBC.
T - Toxin registration. All are reviewed by the IBC.
GT - Gene Therapy or Pathogens in 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.
