The National Institutes of Health Guidelines for Research Involving Recombinant DNA Molecules, developed by the NIH Office of Biotechnology Activities (OBA), govern the construction and handling of all research involving recombinant deoxyribonucleic acid (rDNA), whether the research is supported by the NIH or some other funding source. The NIH Guidelines specify practices for constructing and handling rDNA molecules and organisms and viruses containing rDNA molecules, outlining procedures involving use of rDNA and describing roles, responsibilities, and relationships in relation to the principal investigator, the Institutional Biosafety Committee (IBC), and the NIH Office of Biotechnology Activities (OBA). University of Iowa investigators pursuing research involving rDNA must also complete an rDNA Registration Document and comply with the University of Iowa Review Procedures for Research Involving Recombinant DNA Molecules, following the guidelines available through the UI Environmental Health & Safety Office.
The NIH Guidelines define rDNA molecules as either (i) molecules that are constructed outside living cells by joining natural or synthetic DNA segments to DNA molecules that can replicate in a living cell; or (ii) molecules that result from the replication of those described in (i) above.
Principal Investigators involved in rDNA research are responsible for reviewing the NIH Guidelines and for submitting an rDNA Registration Document to the University of Iowa Institutional Biosafety Committee for review and approval prior to the project's initiation.
Note that projects involving rDNA testing in humans must be reviewed by the NIH/OBA Recombinant DNA Advisory Committee, and then by the UI Institutional Biosafety Committee and Institutional Review Board.
More information on the rDNA registration process and guidelines is available on the UI Environmental Health & Safety website by phoning the EHS at 335-8501.