In the context of the NIH Guidelines for Research Involving Recombinant Recombinant or Synthetic Nucleic Acid Molecules (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 or polypeptide (e.g., a toxin or a 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.
If your research involves the use of recombinant DNA molecules as defined above, you should review the applicable links and documents below. These will assist you in planning your research and initiating a registration with the Vanderbilt Institutional Biosafety Committee (IBC) if your work is not exempt from the NIH Guidelines.
Recombinant or Synthetic Nucleic Acid Molecule Use Registration & Review
This document is designed to aid researchers in determining what category their work is classified as under the NIH Guidelines. It also summarizes the responsibilities of the Principal Investigator under the NIH Guidelines.
What do the NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules (NIH Guidelines) mean to me? A guide for Graduate Students, Postdoctoral Fellows, and Laboratory Workers.
The NIH Guidelines contain details about the training and information lab workers should receive before beginning new experiments in the lab and this document summarizes that information.
Vanderbilt IBC Best Practices for Research Laboratories: Responding to Personnel Exposures and Spills Involving Biological Materials
The Vanderbilt Institutional Biosafety Committee developed this best practices document to aid in training laboratory personnel in proper biohazardous spill response and spill reporting.
Vanderbilt IBC Guidance Document: Applicability of NIH Guidelines to RNA Interference (RNAi) Experiments
All recombinant DNA experiments are regulated by the NIH Guidelines but not all RNAi constructs meet the definition of recombinant DNA. This document outlines the most common methods used for RNAi and how they would be classified under the NIH Guidelines based on the Vanderbilt Institutional Biosafety Committee's interpretation of these requirements.
Working with Adenoviral Vectors
Researchers wishing to work with viral vectors as DNA delivery systems must be familiar with the unique regulations and safety concerns of each family of virus. This document focuses on the adenovirus and the adenoviral vectors made from them.
Biosafety Considerations for Research with Lentiviral Vectors
In response to the rising use of HIV-based lentiviral vectors, the NIH Recombinant DNA Advisory Committee (RAC ) issued this guidance document describing how to conduct a risk assessment for their use. It details the risks of using lentiviral vectors, the common methods of attenuating those risks, and what questions to consider when developing safety protocols.
Animal Experiments Covered Under the NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules
This table summarizes the various recombinant DNA molecule activities that may be carried out in conjunction with animals. This is a valuable planning tool that references which section of the NIH Guidelines applies to the work and provides a basic biosafety level recommendation.
Any lab or animal protocol use of microbiological agents that are infectious to humans requires registration with and approval by the Vanderbilt Institutional Biosafety Committee (IBC). In addition to the use of infectious agents, the IBC must review and approve all use of non-exempt recombinant DNA molecules. When planning animal studies, it is important to remember that your protocol cannot be approved if IBC approval is applicable and outstanding. This document outlines what activities constitute recombinant DNA molecule use in animals and how the process works for getting these activities approved by the IBC.