The NIH Guidelines are available via the Internet at URL: http://oba.od.nih.gov/rdna/nih_guidelines_oba.html
They can also be obtained by writing to the following address:
Office of Biotechnology Activities,
National Institutes of Health
6705 Rockledge Drive, Suite 750,
Bethesda, MD, 20892-7985.
What is "Recombinant DNA"? "Recombinant” DNA (r-DNA) refers to molecules constructed outside living cells by joining natural or synthetic DNA fragments to DNA molecules that can replicate in a living cell, or molecules that result from the replication of such constructed molecules.
What do the Guidelines require? Experiments covered by the Guidelines (i.e., “non-exempt”) require varying degrees of review and approval (see next item) depending on the risk to human or animal health.
What does “review and approval” entailfor “non-exempt” activities? Depending on the risk, IBC approval prior to initiation or committee notification upon initiation is required. Gene therapy protocols, transferring drug resistance to organisms not known to acquire the trait naturally, and the cloning of highly potent toxins also require prior NIH approval.
How are “non-exempt” activities categorized? A summary of this information is incorporated into the registration form. Complete information can be found in section IIIF of the Guidelines or, you can contact EOHSS (Jessica McCormick) at 2-8424.
What is the purpose of this review/approval process? The purpose is to ensure that work practices and other controls appropriate to the hazard level are implemented to minimize the risk of infection. The controls will invariably be those that should already be in place as Standard Operating Procedures for work with infectious materials.
Are the Guidelines applicable to non-NIH funded activities? The Guidelines apply institution-wide if NIH support is provided anywhere at the institution for r-DNA activities. For NIH funded projects: suspension, limitation, or termination of financial assistance for the non-compliant NIH-funded research project and of NIH funds for other r- DNA research at the institution. For non-NIH funded projects: suspension, limitation, or termination of NIH funds for r-DNA research at the institution. For this reason the Guidelines are applicable to all protocols at UMDNJ.
What activities are exempt from the NIH Guidelines? The Guidelines exempt the majority of r-DNA activities including:
E. coli K-12 host-vector systems in the absence of conjugation proficient plasmids or transducing phages, asporogenic Bacillus subtilis, and Saccharmyces host-vector systems except when DNA from Risk Group 3 or 4 organisms is used.
Tissue culture activities containing less than one-half of any eukaryotic viral genome except when DNA from Risk Group 3 or 4 organisms is used.
Activities with molecules consisting exclusively of DNA segments from different species that exchange DNA by a known physiological process.
Purchase or transfer of transgenic rodents for experiments requiring BL-1 containment.
Work with r-DNA molecules that are not in organisms or viruses (e.g., amplification only using PCR). (While the NIH does not require any action on the part of the Principal Investigator for such activities, some granting agencies may require that they be registered with or approved by the IBC.)
UMDNJ Newark Campus Recombinant DNA Protocol Registration Requirements (top)
Please use these guidelines to help determine the appropriate notification status for proposed work using recombinant DNA molecules. Be aware that the Biosafety Level is dictated not only by the recombinant DNA portion of the study but also by other components (e.g., cells to be transfected).
The most recent and complete NIH Guidelines for Recombinant DNA can be found at: http://www4.od.nih.gov/oba/rac/guidelines/guidelines.html
or by writing to the following address:
Office of Biotechnology Activities,
National Institutes of Health
6705 Rockledge Drive, Suite 750,
Bethesda, MD, 20892-7985
A. Experiments requiring NIH and local Institutional Biosafety Committee (IBC) approvals before initiation of experiments:
The deliberate transfer of a drug resistance trait to microorganisms that are not known to acquire the trait naturally, if such transfer could compromise use of the drug to control disease agents.
Formation of recombinant DNA containing genes for the biosynthesis of toxin molecules lethal for vertebrates at an LD50 of less than 100ng/kg body weight (e.g.,botulinum toxin, tetanus toxin, diptheria toxin, & shigella dysenteriae neurotoxin.
The deliberate transfer of recombinant DNA, DNA or RNA derived from recombinant DNA into one or more human subjects.
B. Experiments requiring local IBC approvalsbefore initiation of experiments:
Experiments using Risk Group 2, 3 or higher agents as host-vector systems.
Experiments in which DNA from Risk Group 2, 3 or higher agents is cloned into nonpathogenic prokaryotic or lower eukaryotic host-vector systems.
Experiments involving the use of infectious DNA or RNA viruses or defective DNA or RNA viruses in the presence of helper virus in tissue culture systems including the use of viral vector systems for gene delivery.
Experiments involving transgenic animals or plants and experiments involving viable recombinant DNA-modified microorganisms tested on whole animals or plants.
Experiments involving more than 10 liters of culture.
C. Experiments requiring notification of the local IBC at the time of initiation of experiments.
Experiments involving the formation of recombinant DNA molecules containing no more than 2/3 of the genome of any eukaryotic virus propagated and maintained in cells in tissue culture if the cells lack helper virus for the specific Families of defective virus being used.
D. Exempt experiments not requiring registration. (Note: Although the NIH does not require notification of exempt experiments, some granting agencies require any proposal involving recombinant DNA to be approved by the local IBC.)
Experiments involving transgenic rodents if the experiments require only BL1 containment.
Experiments not involving introduction of DNA sequences into cells, organisms, or viruses including amplification with no cloning (e.g., PCR product)
Cloning of all other DNA in E.coli K12, S. cerevisae, and B. subtilis host-vector.
Introduction into cultured cells of any rDNA containing less than half of a eukaryotic viral genome (excluding BL 3 or higher).
Experiments that consist entirely of DNA segments from the same or closely related species or different species that exchange DNA by known physiological processes
