The use of recombinant DNA technology (rDNA), including synthetic DNA, in the laboratory is highly regulated by the National Institutes of Health (NIH). Strict adherence to the NIH Guidelines For Research Involving Recombinant Or Synthetic Nucleic Acid Molecules is essential to maintain the proper regulatory oversight of rDNA at Dartmouth College. All recombinant or synthetic DNA research is required to have the approval of the Dartmouth Institutional Biosafety Committee (IBC), PRIOR to commencement of research. Click here to learn about the IBC approval process.
In the context of the NIH Guidelines (Section I-B), recombinant and synthetic nucleic acids are defined as:
(i) molecules that a) are constructed by joining nucleic acid molecules and b) that can replicate in a living cell, i.e., recombinant nucleic acids;
(ii) nucleic acid molecules that are chemically or by other means synthesized or amplified, including those that are chemically or otherwise modified but can base pair with naturally occurring nucleic acid molecules, i.e., synthetic nucleic acids, or
(iii) molecules that result from the replication of those described in (i) or (ii) above.
Compliance with the NIH Guidelines for Research Involving Recombinant DNA Molecules is mandatory for every institution that receives NIH funding for research involving recombinant DNA (rDNA). It is the responsibility of the Principal Investigator (PI) to make sure that his/her laboratory is in compliance. The following is a summary of experiments covered by the NIH Guidelines and is intended to assist you in determining which category/categories apply to your experiments.
III-A-1-a. This category is limited to studies that involve the deliberate transfer of a drug resistance trait to microorganisms that are not known to acquire the trait naturally if such acquisition could compromise the use of the drug to control disease agents in humans, veterinary medicine, or agriculture (antibiotic resistance markers used for selecting and propagating plasmids in E. coli are not included).
Examples: Cloning a gene for rifampin resistance into Mycobacterium tuberculosis, cloning a gene for tetracycline resistance into Chlamydia trachomatis
III-B-1. This category is limited to experiments involving the cloning of toxin molecules with LD50 of < 100 ng/kg body weight
Examples: Botulinum toxins, tetanus toxin, diphtheria toxin, Shigella dysenteriae neurotoxin
III-C-1. This category pertains to experiments involving the deliberate transfer of rDNA, or DNA or RNA derived from rDNA, into one or more human research participants (human gene therapy). All requirements of Appendix M apply to human gene therapy studies.
The majority of the rDNA research at Dartmouth College falls into one of these sections. The information regarding the various applications in these categories is presented in this Quick Reference to the NIH Sections III-D, -E, -F.
Note - Dartmouth College Viral Vector Policy and SOPs are coming soon. Please contact the Biological Safety Officer if you have any questions regarding the use of viral vectors, including viral vector use in animals.
FAQ's regarding NIH Guidelines on rDNA or synthetic DNA experiments
FAQ's regarding transgenic animals or the use of rDNA in animals
FAQ's regarding cloning of toxin molecules
NIH oversight and approval requirements for experiments involving the transfer of drug resistant traits
FAQ's regarding EXEMPT rDNA experiments according NIH Guidelines. Note - Dartmouth College IBC requires review of exempt experiments.
Last Updated: 8/14/14