NDSU IBC Guidelines
The NIH Guidelines are available online along with Frequently Asked Questions (FAQs).
The Office of Biotechnology Activities (OBA) has also posted additional biosafety recommendations.
The NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules apply to all activities involving:
- recombinant nucleic acid modules,
- synthetic nucleic acid molecules, including those that are chemically or otherwise modified but can base pair with naturally occurring nucleic acid molecules, and
- cells, organisms, and viruses containing such molecules.
The NIH Guidelines define Recombinant and Synthetic Nucleic Acids as:
- molecules that a) are constructed by joining nucleic acid molecules and b) that can replicate in a living cell, i.e., recombinant nucleic acids.
- 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,
- molecules that results from the replication of those described in 1. or 2 above.
Projects involving Recombinant or Synthetic Nucleic Acids are subject to different review and approval processes, depending on the exact procedures utilized in the project. Compliance with the NIH Guidelines is critical, regardless of funding source. Non-compliance in any study can result in loss of NIH funding, not just for the non-compliant project, but for all research utilizing recombinant or synthetic nucleic acids at NDSU.
NIH Guidelines Resource - IBC protocols may be determined Exempt or Non-Exempt under the NIH Guidelines. The following are an educational resources providing:
- Non-exempt study descriptions, their associated Guidelines, and required approvals,
- Exempt study descriptions,
- Guidelines that apply to transgenic rodents.
No work with RG4 or restricted agents (smallpox, alastrim, whitepox, or Federal Select Agents) is currently permitted at NDSU.