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EHS > Biological Safety > Programs & Guidelines >

Recombinant Research Frequently-Asked Questions

 

What are "recombinant or synthetic nucleic acid molecules"?
Recombinant or synthetic nucleic acid molecules (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.

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Who regulates recombinant or synthetic nucleic acid molecule use in research?
The National Institutes of Health (NIH) regulates recombinant or synthetic nucleic acid molecules use in research. The regulatory document that applies is entitled "NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules (NIH Guidelines)". This document can be accessed through the resources link of this website.

Included in the NIH Guidelines is a requirement for the institution to establish an Institutional Biosafety Committee (IBC) with authority to approve or disapprove proposed recombinant or synthetic nucleic acid molecules research using the NIH Guidelines as a minimum standard. The MSU Institutional Biosafety Committee was established for this purpose and fulfills these requirements by holding monthly meetings to review proposed registration documents, receive reports from the Biosafety Officer regarding inspections and facility issues, and address other IBC-related issues including policy development.

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I've heard that some recombinant or synthetic nucleic acid molecules use is exempt from the NIH Guidelines. How do I know if my use is exempt or not?
Your answer can be found by reviewing Section III of the NIH Guidelines. Exempt experiments are covered under Section III-F. If your use does not fall within the exempt experiments, you should review the Section III in whole to determine where your research falls for registration purposes. To view Section III of NIH Guidelines, click here.

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If my recombinant or synthetic nucleic acid molecules use falls into the exempt category, do I still need to register the project with the IBC?
Currently, the IBC requires registration of exempt projects. Registration is a benefit for the PI because funding sources will often ask for documentation of IBC review regardless of the exempt status of the use. In some cases, the funding source will not release funds without this documentation.

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My funding source is not NIH. Do I still need to register my project?
YES. MSU has received some funds for research involving the use of recombinant or synthetic nucleic acid molecules. Therefore, under the NIH Guidelines, all MSU research involving the use of recombinant or synthetic nucleic acid molecules must be conducted in accordance with the NIH Guidelines. This includes the provision for registration on the part of the PI and review and surveillance on the part of the IBC.

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I am using recombinant or synthetic nucleic acid molecules in research but am not a Principal Investigator. How do the NIH Guidelines apply to me?
If your recombinant or synthetic use is not included as part of a currently approved IBC registration document filed under your PI's name, a registration document should be prepared and submitted to the IBC by your PI on your behalf.
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I received IBC approval in the past for my recombinant or synthetic nucleic acid molecules use. Does this approval expire?
YES. The approval of an IBC registration documents covers only the recombinant or synthetic nucleic acid molecules activities and biological materials listed on the document. The IBC approval is not indefinite. In fact, beginning with registrations approved after July 1st, 2002, all registrations will have a 3-year limit on approval with provision for submission of an annual assurance document regarding your material use.

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Do I need to file a separate IBC registration document for each proposal that involves the same recombinant or synthetic nucleic acid molecules use but has a different project title and funding source?
NO. One document is appropriate but when preparing the document, list all applicable project titles/funding sources. If additional proposals are prepared after the IBC registration document has been reviewed and by the IBC, you can add these proposals to the registration by simply preparing a memo and submitting it to the Biosafety Officer, Jamie Willard-Smith, cherryme@msu.edu. The memo should include the IBC registration number of the approved registration document, the name of the PI that the document is registered under, the additional project titles and funding sources.

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I will be submitting an IBC registration document for committee review and approval. How long does the IBC review process take?
Registration documents requiring IBC review and approval will require between 6 and 8 weeks for the review process.

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