University of Alabama

Application for Recombinant DNA  - Biological Safety Program

Investigator  ________________________________________________________________

Building(s)  ________________________________         Room(s)  ____________________ 

Dept  ____________________________________           Date  _______________________

All research conducted at the University of Alabama involving R-DNA must meet current NIH guidelines. See Federal Register of April 2002 (or most recent) at http://www.niehs.nih.gov/odhsb/ .

Under all circumstances, whether or not your cloning research is exempt, you must fill out the Application for Recombinant DNA.

These guidelines group protocols into six classes based on their perceived risk.  Five of these classes require review by a local committee.  High-risk experiments require review by national committees. The Institutional Biological Safety Committee (IBSC) is the local committee that reviews experiments identified by the R-DNA Registration Document. You, as the PI, are responsible for determining the status of your experiments and completing and submitting this R-DNA Registration Document.

Many experiments considered safe are exempt from filing and review, i.e., cloning a non-toxic gene from a non-pathogenic organism in a suitable phage or plasmid propagated in E.coli K-12 employing standard microbiological techniques. Such experiments are defined as “exempt” in Section III-F and Appendices A & C of the Guidelines. If the experiments are in this class (III-F), we ask that the researcher/teacher submit a R-DNA Registration Form to obtain IBSC documentation of exempt status, since some granting agencies now require this documentation. Please be aware, however, that there are factors – large-scale culture, releasing organisms containing recombinant DNA from the lab – which shift an exempt procedure to the non-exempt class.

Where is this project carried out?        ______________________________________________________

NIH: National Institutes of Health       OBA:  Office of Biotechnology Activities   

RAC: Recombinant DNA Advisory Comm.

Recombinant DNA experiment and/or project details   (use additional sheets if necessary)

Attach a short, clear summary of your proposed recombinant experiments that will explain their essential features. Avoid jargon and excess technical detail. Include the following and any other data that you feel has important bearing upon the decision-making process.  Explain the significance of the experiments and exactly why you are performing operations that make the experiments non-exempt. If appropriate, explain and justify the use of pathogenic organisms not named in Appendix B of the NIH Guidelines, or of the Biological Containment Host-Vector System if it is important for the safety of the experiment and not named in Appendix E. Describe any special precautions required for containment and personal safety.

Additional Comments/Information

I hereby apply for approval of my plans for experiments involving recombinant DNA molecules.  I am familiar with, and agree to abide by, the provisions of the current NIH Guidelines (April 2002 Federal Register (or later) and appendices), and any other specific NIH or University of Utah instructions pertaining to the proposed project. I agree to provide the IBC prompt written notification of any significant changes in these protocols or of any major accidents involving recombinant DNA molecules. I agree to comply with NIH requirements pertaining to shipment and transfer of recombinant DNA materials. I certify that all herein provided information is accurate and complete.

I accept responsibility for the safe conduct of work with this material as indicated on any page of this form. I will ensure that all personnel receive appropriate training in regard to proper safety practices and personal protective equipment needed for this work and that all building occupants are educated when warranted. I certify that all herein provided information is accurate and complete.

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