Requirements for rDNA and SNA Work

The University of Michigan adheres to the NIH Guidelines for Research Involving Recombinant and Synthetic Nucleic Acid Molecules and follows recommendations of the NIH Office of Biotechnology Activities (OBA). 

IBC Registration and Approval

U-M requires that all research involving recombinant DNA (rDNA) or synthetic nucleic acid (SNA) molecules be registered with and approved by the Institutional Biosafety Committee (IBC), regardless of funding source and regardless of whether such use falls into exempt categories of the NIH Guidelines (Section III-F and Appendix C).

Assessment of animal housing containment

IBC review will include an assessment of animal housing containment for laboratory work involving rDNA. The IBC reviews and assigns housing containment for transgenic animals and for animals that have been administered rDNA. 

All work with vertebrate animals must also be approved by U-M's Institutional Animal Care & Use Committee (IACUC) prior to the start of research.

Investigators planning to administer rDNA or other biohazards to animals should refer to the IBC Recommendations to Animal Housing Containment Chart as well as to Appendix G, Appendix M, and Section III-D-4 of the NIH Guidelines for information on biological and physical containment practices. Note that, if your animal rDNA work involves the administration of recombinant virus to animals, the U-M Unit for Laboratory Animal Medicine (ULAM) may ask for proof that each batch of virus used is substantially free of replication competent virus.

Biosafety Standards & Practices

U-M Environment, Health & Safety (EHS) provides operational procedures and guidelines for research conducted at each biosafety level (BSL). U-M expects that:

• At a minimum, lab practices meeting BSL1 requirements will be used for all recombinant DNA work, even when that work is exempt from the NIH Guidelines.
• Laboratories will be inspected by EHS prior to the start of any recombinant DNA research at BSL2.
• Research requiring BSL2 containment may require additional containment and biosafety practices based on the risk assessment for the specific work.
• Researchers will seek all required approvals and perform the work at the biosafety level approved by the IBC, and they will follow EHS standard operating procedures (SOPs) for the work.

See References & Resources below for links to the EHS Biological Safety website, which provides guidelines such as the U-M EHS Biological Safety Designated Standards for U-M Laboratories, Additional BSL2 Practices, and viral vector SOPs.

Select Agent Use:

For investigators planning to work with federally regulated Select Agents and Toxins or with other agents that require BSL3 containment, whether or not the work involves recombinant DNA, see the Introductory Guide for Faculty Planning to Use Select Agents in Their Research.

Life sciences research with Select Agents and Toxins may be considered "dual use research of concern" (DURC) per the definition in the U.S. Government Policy on Institutional Oversight of Life Sciences Dual Use Research of Concern.  See U-M's DURC policy for more information about investigator and institutional requirements regarding DURC.