9.2 Completing the rDNA Registration Document

Each PI involved with rDNA research is required to complete an rDNA Registration Document prior to initiating any experiments and submit the completed document to EHS’s Biosafety Office.  The IBC will review for compliance with the NIH Guidelines all rDNA research at the University and approve those projects in conformity with the NIH Guidelines.  The IBC will communicate its approval to the PI.  Under the Guidelines, the IBC is also responsible for assessing the facilities, procedures, practices and training and expertise of the personnel involved in the rDNA research.

A description of the project on the rDNA registration document is required, including:

  • A brief description of the overall project and its goals.
  • A list of all hosts, vectors, and inserts used in the proposal.  Describe any host specificity of the vector and the molecular basis of any vectors which are replication defective.  Please list and differentiate hosts for transformation and transfection.
  • Identification of any antibiotic resistance gene(s) that will be expressed in bacteria or cell culture followed by an indication of whether or not this trait will affect clinical treatment of humans or animals infected by this modified organism.  Commonly used selection antibiotics, such as ampicillin, neomycin and kanamycin, should be included.
  • A list of any proteins and regulatory RNAs that will be expressed from the inserted genes and the function of each.
  • If appropriate, include human and/or animal subjects involved in the proposal; list the IRB or ACURF approval number; describe the rDNA or recombinant organisms that will be administered to the subjects and how it will be administered.
  • If appropriate, include any species involved in transgenic work; list the ACURF approval number; describe the genetic alterations that will be done to the animal.
  • If appropriate, list any other labs/core facilities that will be involved with this rDNA work (e.g. vector construction, propagation, transgenics, etc.); describe the work that will be carried out by this lab/facility.
  • If the research involves more than one host, vector, or insert, please complete the Insert/Vector/Host/BSL Table.

During rDNA registration with the IBC, the PI will be asked to classify the research experiments.  The NIH Guidelines list 6 Classifications, III-A through III-F.  It is the responsibility of the PI to read the Guidelines in order to determine which class is applicable to the work being conducted.

The NIH Guidelines also call for the use of good microbiological techniques and for physical and biological barriers to prevent the dissemination of potentially hazardous biological agents.  In all studies, the physical and biological level of containment must match or exceed the estimated potential hazard for each of the different classes of rDNA.  It is the responsibility of the PI to determine a comprehensive risk assessment of the agent(s) being manipulated.  Several factors to consider include: assigned risk group of the agent(s), virulence, pathogenicity, communicability, environmental stability, quantity, toxicity and type of manipulations proposed (e.g. animal inoculation or transmission experiments).  The appropriate containment levels for experimentation are then based on the final risk assessment.  The IBC will review the containment levels set by the PI for rDNA experiments during review of the rDNA registration document and modify, if necessary.

If employee health will be monitored, a description of the surveillance program is required.