Recombinant and Synthetic Nucleic Acid Research

The NIH Guidelines for Research Involving Recombinant or synthetic Nucleic Acid Molecules contain procedures for the containment of Recombinant or synthetic Nucleic Acid Molecules. Synthetic nucleic acids are defined as molecules that a) are constructed by joining nucleic acid molecules and b) that can replicate nucleic acids. Nucleic acids include those that are chemically or otherwise modified or amplified but that can base pair with naturally occurring nucleic acid molecules. Or molecules that result from the replication of those described under this definition. The Guidelines apply to all institutions that receive NIH funding for rDNA.  Consequences of noncompliance include suspension, limitation, or termination of NIH funds for rDNA research at the institution, or a requirement for prior NIH approval of rDNA projects at the institution. The purpose of the guidelines is to specify safe handling practices and containment levels for rDNA molecules, organisms and viruses containing rDNA molecules, and transgenic animals. A complete description of the University’s responsibilities can be found in Section IV-B of the NIH Guidelines.

The institution assures that all NIH-funded projects involving recombinant DNA techniques shall comply with the NIH Guidelines. The institution expects all investigators to comply with the standards and procedures set forth in NIH guidelines for any rDNA research conducted at the institution irrespective of the source of funding.

Protocols or proposals for non-exempt rDNA work are submitted to the Institutional Biological Safety Committee (IBSC) for review prior to initiation. The Committee is responsible for review of rDNA experiments for compliance and for assessing the containment level, facilities, procedures, practices, and expertise and training of research personnel. UBSC results are communicated to the PI describing the containment level and any additional precautions. The UBSC will also periodically review rDNA research at the University to ensure that the University is in compliance with the NIH Guidelines.                                

The PI is ultimately responsible for compliance with the NIH Guidelines and for the safe conduct of rDNA experiments. The PI must perform an initial risk assessment for rDNA work and identify an appropriate containment level for the experiment. In addition, the PI must ensure that all personnel involved in the experiment are trained in safe working procedures. (A complete list of PI responsibilities can be found in Section IV-B-7 of the NIH Guidelines). Experiments that require UBSC approval may not be initiated or modified until approval has been obtained from Committee.

For more information on rDNA research go to Biosafety on the Office of Research & Innovation website.