Indiana University Institutional Biosafety Committee's
GUIDE To The GUIDELINES

If you use recombinant DNA (rDNA), you will need to file with the Institutional Biosafety Committee.  The Committee operates under the scope of the NIH Guidelines.  The NIH Guidelines for Research Involving Recombinant DNA Molecules, including those for human gene therapy submissions, is available on the World Wide Web at:  http://www4.od.nih.gov/oba/rac/guidelines/guidelines.html.   This Guide to the Guidelines is meant as an orientation and does not replace the federal NIH Guidelines and should be used only as a first step.   This Guide to the Guidelines is a highly condensed version of Section III of the NIH Guidelines.    Section III is divided into subsections, and one (or possibly more) will cover your experiments.  The Section III information will also help you identify which appendix (A, B or C) describes the type of rDNA you use and the appropriate subsection of Appendix G (Biosafety Practices) to be used in your laboratory.   Studies involving large animals, plants or large scale production should refer to Appendices Q, P, or K respectively.  Refer to the Submission flowchart for help in determining the appropriate application form to submit to the Committee.  

Experiments which must be reviewed and approved prior to initiation (BL2):
	-Introduction of rDNA into Class 2,3,4 or 5 microbial agents:  bacterial, parasitic, viral 

	-Introduction of Class 2,3,4 or 5 microbial DNA into nonpathogenic prokaryotic or lower eukaryotic Host-Vector systems

	-Transfer of greater than 2/3's of a eukaryotic viral genome to any (in)vertebrate organism

	-Use of infectious Class 2 animal or plant DNA/RNA viruses or defective animal or plant DNA/RNA viruses in the presence of helper virus in tissue culture systems, animals or plants

	-Introduction into animals or plants of rDNA encoding sequences of potent vertebrate toxins 
	(LD50< 100 ng/kg body wt) - require NIH and IBC approval

	-Testing of viable rDNA-modified microorganisms on whole animals
	
	-Experiments involving more than 10 liters of culture

-Introduction of exotic rDNA (DNA of species not indigenous to the USA) into plants, propagation of plants containing exotic rDNA or use of plants with genetically engineered insects or microorganism containing exotic rDNA

Experiments that require IBC notice simultaneous with initiation (BL1):
	-Transfer of rDNA encoding less than 2/3's of a eukaryotic viral genome to any (in)vertebrate organism

	-Propagation and maintenance of rDNA containing less than 2/3's of the genome of any eukaryotic virus in 	tissue culture 

	-Use of rDNA containing plants and plant-associated microorganisms not described under BL2

Experiments that may be registered as exempt (Exempt):
	-Cloning of all non-Class 3,4 or 5 DNA in E.coli K12, S. cerevisiae and B. subtilis host-vector systems
	(ie. cloning/subcloning of non-toxic vertebrate cDNAs and genomic fragments into plasmid vectors)

	-Those that are not in organisms or viruses

	-Introduction of rDNA containing less than 1/2 of a eukaryotic viral genome (except Class 3, 4 or 5 agents) 	into tissue culture cells 							Revised 8/05