Biosafety Frequently-Asked Questions

Click Registration, IBC Review

• Which biosafety projects require Click registration / IBC review?

  The following must be registered in Click:

  • All recombinant/GE research covered under the NIH Guidelines
    • including the purchase of constructs that are used or tested in plants, animals, cell culture, etc. and
    • including generation of transgenic materials - animals, plants, arthropods, etc.
    • Contact the BSO regarding transgenic animal breeding to determine if covered or exempt
  • All BSL-2 and higher research
    • including work with human materials like blood and tissues that are not fixed

  
  The following do not require Click registration:

  • Animal tissues or blood that does not fall under recombinant, BSL‐2 or BSL‐3 work
  • BSL‐1 organisms (contact the BSO to confirm your research does not cross into potential BSL-2 work)
• How long does Click registration and approval take?
  Click registration and IBC review requires 6-8 weeks.
• Do I need to file a separate Click registration for each proposal that has a different project title/funding source?
  No. One document is appropriate, listing all applicable project titles/funding sources.
• Does IBC approval expire?

  Yes. The IBC approval is not indefinite. All registrations will have a 3-year limit on approval with provision for submission of an annual assurance document regarding your material use.

  Additionally, the approval covers only the recombinant or synthetic nucleic acid molecules activities and biological materials listed on the document.

Recombinant Research, NIH Guidelines

• 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.
• 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)."
  
  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.
• How do I know if my use of recombinant or synthetic nucleic acid is exempt from the NIH Guidelines?
  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.
• My use of recombinant or synthetic nucleic acid molecules 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.
• My funding source is not NIH. Do I still need to register my project with the IBC?
  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.
• 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?
  Click registration should be prepared and submitted to the IBC by your PI on your behalf.