It is University policy that all principal investigators (PIs) must comply with the NIH “Guidelines for Research involving Recombinant or Synthetic Nucleic Acid Molecules” (NIH Guidelines) regardless of the project’s funding source, and all research involving recombinant or synthetic nucleic acids (rsNA) must be registered with the Institutional Biosafety Committee (IBC).
While it is impossible to offer a complete summary of the NIH Guidelines, one key part of the document outlines IBC review requirements for different types of rsNA research. These requirements are defined through six rDNA categories (Section III-A through III-F), and four of these groups encompass the majority of rsNA research being done on campus. If your work does not fall clearly into one of the four groups summarized below, it may require review by the NIH Director or Office of Science Policy (OSP); consult the NIH Guidelines or contact firstname.lastname@example.org for project-specific guidance.
Please note that it is ultimately the PI’s responsibility to ensure their work is categorized appropriately and registered with the necessary review bodies.
Experiments Requiring IBC Approval Prior to Initiation
Section III-C covers “Experiments involving the deliberate transfer of rsNA molecules, or DNA or RNA Derived from rsNA, into human research participants.” Most Clinical Trials involving rsNA will undergo review by an external IBC. Please consult the Clinical Trials tab on the Institutional Biosafety Committee page for registration instructions.
Section III-D describes a wide range of experiments. In general, this category covers research that involves:
- Using restricted agents or pathogens (human or animal) classified as risk group 2-4 for a host-vector system (e.g., adenovirus, retroviruses)
- Cloning DNA from restricted agents or pathogens (human or animal) classified as risk group 2-4 into a non-pathogen host-vector system
- Using infectious or defective viruses (DNA or RNA) in the presence of helper virus in tissue culture systems
- Large volume cultures (greater than 10L)
- Experiments involving whole plants or animals
Experiments Requiring IBC Notice Simultaneous with Initiation
Experiments which fall under Section III-E or III-F require UNC-Chapel Hill IBC review but may be initiated prior to receiving final approval. In general, the following experiments must involve constructs or organisms that can be safely handled at biosafety level 1 (BSL-1) containment. Investigators should consult the NIH Guidelines prior to registration for any restrictions on their proposal.
Section III-E describes a wide range of experiments. In general, this category includes (but is not limited to) research that involves:
- rsNA molecules containing no more than 2/3 of the genome of any eukaryotic virus propagated and maintained in cells in tissue culture
- Certain experiments involving whole plants or animals
- The purchase or transfer of transgenic rodents for use BSL-1 containment. This activity is exempt from full committee review and should be registered using a Schedule H form. Please consult the Forms tab on the Institutional Biosafety Committee page for registration instructions.
Section III-F describes experiments which are technically exempt from the NIH Guidelines. University policy still requires all research in this category to be registered and reviewed by the IBC. This group includes (but is not limited to) experiments that:
- Use as host vector systems E. coli K 12, Saccharomyces cerevisiae, Saccharomyces uvarum, or Bacillus subtilis, and their plasmids
- rsNA molecules containing less than one-half of any eukaryotic genome that are propagated and maintained in cells in tissue culture