1. What are the NIH Guidelines for Research Involving Recombinant DNA Molecules (NIH Guidelines)?

The NIH Guidelines detail safety practices and containment procedures for basic and clinical research involving recombinant DNA, including the creation and use of organisms and viruses containing recombinant DNA. The NIH Guidelines are a “living” document that was first drafted in 1976 as an outcome of a meeting of scientists concerned about addressing the potential public health and environmental risks associated with this developing technology.  Since that time, the NIH Guidelines have been frequently amended to reflect evolving scientific understanding of recombinant DNA and its applications.  

2. When must institutions follow the NIH Guidelines?

An institution must follow the NIH Guidelines if it is conducting or sponsoring any recombinant DNA research that is funded by the NIH.  Even if only one project of recombinant DNA research benefits from NIH support, all such projects conducted at or sponsored by that institution must comply with the NIH Guidelines.  
 
Also, adherence to the NIH Guidelines may be a condition of support from other federal agencies, or even private funders of research.  Finally, regardless of NIH funding,  institutions may be subject to local ordinances, federal or state regulations, or agency guidelines that require compliance with the NIH Guidelines.

3. Why must institutions comply with the NIH Guidelines?  

Compliance with the NIH Guidelines is important because it promotes the safe conduct of research involving recombinant DNA.  Also, compliance with the NIH Guidelines is mandatory as a condition of receiving NIH funding.  Institutions that fail to comply risk:

• suspension, limitation, or termination of financial assistance for:
• non-compliant NIH projects; 
• NIH funding for other recombinant DNA research at the institution; 
• having to obtain prior NIH approval for any recombinant DNA projects.

Many institutions that do not receive any  NIH funding for recombinant DNA research nonetheless choose voluntarily to comply.  These institutions recognize that following the NIH Guidelines promotes the safe and responsible practice of this research and gives the public confidence that the institution is attending to important safety matters.  

4. What do I do if my committee or the research project that my committee is reviewing does not comply with the NIH Guidelines?

First and foremost, you should attempt to rectify the problem by conforming to the requirements of the NIH Guidelines.  In addition, when you recognize an occurrence of non-compliance with the NIH Guidelines, you must forward within 30 days a complete report of the incident along with any recommended actions to OBA.  OBA staff will respond with comments on the incident and on the institutional response.  In general, OBA will evaluate the adequacy of that response and make recommendations on any additional measures that should be taken.  

5. How do the NIH Guidelines apply to the containment or release of transgenic plants and animals?  
   
   The NIH Guidelines require physical and biological containment of experiments involving the use of transgenic plants and animals, including insects.  As with other experiments involving recombinant DNA, the appropriate level of containment is graded according to the potential risks of the experiment.  
   
   The NIH Guidelines do not permit experiments involving the deliberate release of transgenics into the environment unless, as provided in Section I-A-1, another Federal agency has jurisdiction over the experiment and approves the proposed release.  As part of overseeing adherence to the NIH Guidelines, IBCs should ensure that institutional policies and procedures prohibit the release of transgenic animals and plants into the environment when not otherwise Federally authorized.  Further, institutions should ensure that investigators are educated about proper containment and disposal, as well as other aspects of the NIH Guidelines. 
   
   
6. Which experiments are exempt from the NIH Guidelines?

Experiments that employ recombinant DNA with the characteristics listed below are generally exempt from the NIH Guidelines and IBC review unless they also involve, for example,: (1) 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; (2) deliberate formation of recombinant DNA containing genes for the biosynthesis of toxin molecules lethal for vertebrates at an LD50 of less than 100 nanograms per kilogram of body weight, or (3) the deliberate transfer of recombinant DNA, or DNA or RNA derived from recombinant DNA into one or more human research subjects.  Otherwise, per Section III F of the NIH Guidelines, experiments are exempt when they involve recombinant DNA that is:

• not in organisms and viruses,
  
  
• entirely DNA segments from a single nonchromosomal or viral DNA source,
  
  
• entirely from a prokaryotic host including its indigenous plasmids or viruses when propagated only in that host or when transferred to another host by well established physiological means, 
  
  
• entirely from a eukaryotic host including its chloroplasts, mitochondria, or plasmids when propagated only in that host or a closely related strain of the same species,
  
  
• entirely segments from different species that exchange DNA by known physiological processes, though one or more may be a synthetic equivalent; see Appendix A of the NIH Guidelines; or
  
  
• not a significant risk to health or the environment as determined by the NIH Director; see Appendix C of the NIH Guidelines for a detailed listing.

Details on certain other experiments that may be exempt, as well as exceptions, may be found in Appendix C of the NIH Guidelines.