Recombinant DNA -- Molecules that are constructed outside living cells by joining a natural or synthetic DNA segment to DNA molecules that can replicate a living cell, or molecules that result from the replication of those described above.
Infectious agents -- any agent that can be infectious to humans, plants/environment, or animals.
Human blood, tissue or fluids and other potentially infectious materials -- Blood includes human blood, human blood components, and products made from human blood. Other potentially infectious materials (OPIM) is defined as the following human body fluids: saliva, semen, vaginal secretions, cerebrospinal, synovial, pleural, pericardial, peritoneal, and amniotic fluids; body fluids visibly contaminated with blood; along with all body fluids in situations where it is difficult or impossible to differentiate between body fluids; unfixed human tissues or organs (other than intact skin); HIV-containing cell or tissue cultures, organ cultures, and HIV- or HBV-containing culture media or other solutions; and blood, organs, or other tissues from experimental animals infected with HIV or HBV. (modified from OSHA's Bloodborne Standard 1901.1030.)
What Projects Must Be Submitted for IBC Review?
All research and teaching projects conducted at NDSU by an NDSU representative or affiliated member that involves recombinant or synthetic DNA, any infectious agents, or human blood, bodily fluids, or tissue must be submitted to the NDSU IBC for review and approval.
NDSU Policy 347 - Institutional Biosafety Committee
Committee Procedures -
- Scope and Regulatory Authority
- Research Categories Requiring IBC Approval
- Protocol Review Procedures
- Adverse Event and Protocol Deviation Reporting
- Investigating Potential Noncompliance
- Biohazard Waste, Containment and Shipping
- Training Requirements
- Committee Membership
- Conflict of Interest - Members
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.