Revised NIH Guidelines effective March 5, 2013
The National Institutes of Health (NIH) Office of Biotechnology Activities (OBA) has revised the NIH Guidelines for Research Involving Recombinant DNA Molecules. These revised guidelines are called “NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules” and are effective March 5, 2013. The guidelines were revised primarily to address biosafety considerations for research with synthetic nucleic acids.
In the context of the NIH Guidelines, 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.
How do the revised guidelines affect Cornell researchers and the IBC?
By March 5, 2013, all ongoing and newly proposed experiments that are subject to the revised NIH Guidelines must be registered by the Principal Investigator (PI) to the Cornell Institutional Biosafety Office (IBC). Failure to do so could jeopardize current and future NIH funding for research involving r/sNA materials at Cornell. Contact Debra Dwyer at 255-7219.
Please see below for the next steps that apply to you:
- If the use of synthetic nucleic acids contained in cells, organisms, or viruses is already described in your current approved MUA with the IBC, no action is required on your part. Please review your current MUA to make sure that the work with synthetic nucleic acids is adequately described.
- If the use of synthetic nucleic acids contained in cells, organisms, or viruses is not described in your current approved MUA, you must submit an amendment to your current approved MUA by March 5, 2013.
- If you do not have a current approved MUA (application) with the IBC, you must submit a new MUA to the IBC by March 5, 2013.
- For more information regarding the revised guidelines, refer to:
Log into: e-MUA
Start/Submit/Open an Existing Memorandum of Understanding and Agreement (MUA)
Biosafety Level -3 application
e-MUA Help line – 607-255-7219 or contact the IBC Administrator, Debra Dwyer at firstname.lastname@example.org
The Cornell IBC is the institutional body responsible for oversight of activities involving biohazardous materials as required by the National Institutes of Health Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules (NIH Guidelines) and the Centers for Disease Control and Prevention (CDC) Biosafety in Microbiological and Biomedical Laboratories (BMBL).
All RESEACHERS must secure IBC approval for their activities with recombinant or synthetic mucleic acid molecules (r/sNA) or biohazardous materials by submitting a Memorandum of Understanding and Agreement (MUA) with the IBC. The MUA is filed through an electronic submission site (e-MUA) and covers r/sNA or biohazardous materials. Research at Biosafety Level -3 requires a separate application.
Uses of r/sNA or Biohazardous materials (list is not inclusive):
- transgenic plants or animals
- infectious organisms (bacteria, fungi, parasites, prions, rickettsias, viruses, yeasts, etc.) which can cause disease in humans and animals
- human or non-human-primate materials (body fluids, tissues, cell lines, etc.)
- select agents
- investigational live, recombinant, synthetic or attenuated virus strains
- plant pathogens
- mammalian cell culture
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