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Dartmouth Compliance Matrix

Complex organizations such as Dartmouth comply with a multitude of policies, laws, and regulations.  Risk and Internal Controls has developed a compliance matrix to guide the Dartmouth community in identifying key compliance areas, the Dartmouth staff responsible for various aspects of compliance oversight, and where to go to learn more about each compliance area.
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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.
IBC SOP #300.2: Recombinant or Synthetic Nucleic Acid Incident Spill Response and Reporting SOP (updated 2015)
Working with viral vectors? Go to the Working With Viral Vectors webpage for relevant registration, training, and policies.
Working with transgenic or genetically altered organisms?  Go to the Working with Transgenic Organisms webpage for IBC-approved standard operating procedures (SOPs), registration info, etc.


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.

Summary of Experiments Falling Under NIH Guidelines:

Compliance with the NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid 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.
Section III-A: Experiments Requiring IBC Approval, Recombinant DNA Advisory Committee (RAC) Review, and NIH Director Approval Before Initiation
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


Section III-B: Experiments Requiring IBC and NIH/OBA Approval Before Initiation
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
Section III-C: Experiments Requiring IBC and IRB Approval and RAC Review Before Initiation
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.   
Sections III-D, III-E, and III-F: Experiments Requiring IBC Approval Before Initiation
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.

Helpful Links:

FAQ's regarding NIH Guidelines on rDNA or synthetic DNA experiments
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: 10/29/15