Biosafety Page

Procedure for Biosafety Approval for Work with rDNA

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All research conducted at Idaho State University involving recombinant DNA molecules must meet with current NIH Guidelines. (Please see below for the definition of recombinant DNA molecules*.) These Guidelines describe five categories of experiments involving recombinant DNA; four of the categories require Institutional Biosafety Committee (IBC) approval, and the fifth category is exempt from the NIH Guidelines. The Idaho State University IBC is the local committee that reviews experiments identified by a DNA Registration Document. If you conduct research using rDNA, you must follow this procedure.

For each separate experiment you are conducting, please submit a copy of your research protocol and a completed DNA Registration form in Microsoft Word format . You must answer all questions and indicate whether you feel your project is exempt or not exempt. Many experiments involving recombinant DNA molecules are classified as exempt. Such experiments are defined in Section III-E and Appendices A and C of the Guidelines. Please review these to decide if your project is exempt. If you feel your research is exempt, also submit a letter explaining your reasoning.

The NIH Guidelines are complex and somewhat difficult to interpret. If you have difficulty determining the status of your experiments, please don't hesitate to contact the committee's chair, Malcolm Shields, x5719, for assistance.

Please email the completed DNA Registration Document, your protocol, and letter of explanation of exemption (if needed) to Malcolm Shields at shiemalc@isu.edu. After you have submitted the completed document via email, send a signed original hardcopy of the DNA Registration Document to:

Malcolm Shields
Idaho State University Biosafety Committee
Box 8007


The ISU Biosafety Committee will review this information and notify you of its decision concerning your project's status.

*Definition of Recombinant DNA Molecules (taken from NIH Guidelines Section I-B.) In the context of the NIH Guidelines, recombinant DNA molecules are defined as either: (i) molecules that are constructed outside living cells by joining natural or synthetic DNA segments to DNA molecules that can replicate in a living cell, or (ii) molecules that result from the replication of those described in (i) above.

Synthetic DNA segments which are likely to yield a potentially harmful polynucleotide (e.g., a toxin or pharmacologically active agent) are considered as equivalent to their natural DNA counterpart. If the synthetic DNA segment is not expressed in vivo as a biologically active polynucleotide or polypeptide product, it is exempt from the NIH Guidelines.

Genomic DNA of plants and bacteria that have acquired a transposable element, even if the latter was donated from a recombinant vector no longer present, are not subject to the NIH Guidelines unless the transposon itself contains recombinant DNA.

 

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Last Modified: 02/03/09 at 03:37:01 PM