INSTRUCTIONS FOR EXPERIMENTAL PROTOCOLS INVOVING RECOMBINANT DNA
RWJMS -CAMDEN

INDEX

• General Instructions
• Frequently Asked Questions
• DNA Protocol Registration Requirements
• RWJMS - Camden  Recombinant DNA Registration Form in rich text format (RTF).  Type directly into the form, save it, and print out a copy.

General Instructions (top)

The Institutional Biosafety Committee (IBC) for Robert Wood Johnson Medical School  - Camden is responsible for ensuring compliance with NIH Guidelines for Research Involving Recombinant DNA Molecules. The Institutional Biosafety Committee (IBC) for Robert Wood Johnson Medical School - Camden is responsible for ensuring compliance with NIH Guidelines for Research Involving Recombinant DNA Molecules. Submit completed Recombinant DNA forms to:

Tonya Smith, RWJMS-C Office of Research Administration,
E&R Bldg, Suite 150
401 Haddon Avenue
Camden, NJ 08103
Phone: (856) 757-2572 / Fax: (856) 757-2569
Email: smithtm@umdnj.edu

An original and four (4) copies are to be submitted.

a.  The references are all to the latest version of the "Guidelines for Research Involving Recombinant DNA Molecules," and are often referred to as the "NIH Guidelines." The April 2002 version is available on the internet at: http://oba.od.nih.gov/rdna/nih_guidelines_oba.html.

The Guidelines can also be obtained by writing the Office of Biotechnology Activities, 6000 Executive Boulevard, Suite 302, Bethesda, MD, 20892-7010. 

Frequently Asked Questions (top)

1.  What is "Recombinant DNA?" (r-DNA) refers to (i) molecules constructed outside living cells by joining natural or synthetic DNA fragments to DNA molecules that can replicate in a living cell, or (ii) molecules that result from the replication of those described in (i) above. 

2.  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.  

3. What does “review and approval” entail for “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. 

4. How are "non-exempt" activities categorized? A summary of this information is incorporated into the registration form. Complete information can be found at: section IIIF of the Guidelines. You may also contact the Tom Boyle , EOHSS Campus Safety Officer, boyletp@umdnj.edu or ( (856) 566-6189 or 6-6189 for more information.

5.  What is the purpose of this review/approval process?  The purpose of this process is to ensure that comprehensive risk assessment and physical containment are appropriate to the hazard level in order 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.  

6.  Are the Guidelines applicable to non-NIH funded activities? YES, the guidelines are applicable to non-NIH funded activities if NIH support is provided anywhere at the institution for r-DNA activities. If a funded or non NIH-funded activity does not comply with the NIH guidelines suspension, limitation, or termination of financial assistance may result for all funded projects at the institution.

7.  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 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 PI for such activities, some granting agencies may require that they be registered with or approved by the IBC.) 

UMDNJ/RWJMS-Camden
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., human, animal, plant and insect cells to be transfected).  For assistance, please contact the Thomas Boyle, Campus Safety Officer at (856) 566-6189 or email boyletp@umdnj.edu. The April 2002 version of the NIH Guidelines for Recombinant DNA can be found at:   http://oba.od.nih.gov/rdna/nih_guidelines_oba.html  or may be obtained by writing to the NIH Office of Biotechnology Activities, 6000 Executive Boulevard, Suite 302, Bethesda, MD, 20892-7010. 

A.  Experiments requiring NIH and local Institutional Biosafety Committee (IBC) approvals before initiation of experiments:

1. 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.
2. 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.
3. The deliberate transfer of recombinant DNA, DNA or RNA derived from recombinant DNA into one or more human subjects.

B.  Experiments requiring local IBC approvals before initiation of experiments:

1. Experiments using Risk Group 2, 3 or higher agents as host-vector systems.
2. Experiments in which DNA from Risk Group 2, 3 or higher agents is cloned into nonpathogenic prokaryotic or lower eukaryotic host-vector systems.
3. 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.
4. Experiments involving transgenic animals or plants and experiments involving viable recombinant DNA-modified microorganisms tested on whole animals or plants.
5. Experiments involving more than 10 liters of culture.

C.  Experiments requiring notification of the local IBC at the time of initiation of experiments.

1. 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.
2. Experiments involving transgenic rodents if the experiments require only BL1 containment.

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.)

1. Experiments not involving introduction of DNA sequences into cells, organisms, or viruses including amplification with no cloning (e.g., PCR product)
2. Cloning of all other DNA in E.coli K12, S. cerevisae, and B. subtilis host-vector.
3. Introduction into cultured cells of any rDNA containing less than half of a eukaryotic viral genome (excluding BL 3 or higher).
4.  Experiments that consist entirely of DNA segments from the same or closely related species or different species that exchange DNA by known physiological processes

E. Experiments that require IBC notice simultaneous with initiation of experiments.

Experiments involving the formation of recombinant DNA molecules containing no more than 2/3 of the genome of any eukaryotic virus may be propagated and maintained in cells in tissue culture using BL1 containment if the cells lack helper virus for the specific Families of defective virus being used.
Experiments involving whole plants involving r-DNA- modified organisms associated either whole plants that do not fall under Sections III-A, III-B, III-D and III-F.
Experiments involving the generation of transgenic rodents if the experiments require only BL1 containment.

F. Exempt are exempt from NIH Guidelines, IBC registration required

1. Those that are not in organisms or viruses.
2. Those that consist entirely of DNA segments from a single nonchromosomal or viral DNA source, though one or more of the segments may be a synthetic equivalent.
3. Those that consist entirely of DNA from a prokaryotic host including its indigenous plasmids or viruses when propagated only in that host (or a closely related strain of the same species), or when transferred to another host by well established physiological means.
4. Those that consist entirely of DNA from a eukaryotic host including its chloroplasts, mitochondria, or plasmids (excluding viruses) when propagated only in that host (or a closely related strain of the same species).
5. Those that consist entirely of DNA segments from exchange DNA by known physiological processes, though one or more of the segments may be a synthetic equivalent. A list of such exchangers will be prepared and periodically revised by the NIH see appendices A-I, A-II, A-III, A-IV, A-V and A-VI.
6. Those that do not present a significant risk to health or the environment as determined by the NIH Director. See appendix C.

RWJMS - Camden  Recombinant DNA Registration Form in rich text format (RTF)   (top)