Recombinant and Synthetic Nucleic Acid Molecules

The National Institutes of Health Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules (NIH Guidelines) govern the construction and handling of recombinant and synthetic nucleic acid molecules, as well as cells, organisms, and viruses containing such molecules. The NIH Guidelines define recombinant and synthetic nucleic acids as: (i) molecules that a) are constructed by joining nucleic acid molecules and b) that can replicate in a living cell, i.e., recombinant nucleic acids; (ii) 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, or (iii) molecules that result from the replication of those described in (i) or (ii) above.

The University of Iowa is responsible for ensuring that all recombinant DNA (rDNA) research conducted at or sponsored by the University complies with the NIH Guidelines. Compliance authority on campus is placed with the Institutional Biosafety Committee (IBC). The IBC reviews rDNA research governed by the NIH Guidelines and approves those projects in conformity with the NIH Guidelines. The IBC is appointed by and advises the Assistant Vice President for Research for Regulatory Affairs. Please see the IBC Charter for additional responsibilities appointed to the IBC.

The NIH Guidelines apply to all rDNA research within the United States and its territories that is conducted at, or sponsored by, an institution that receives support for rDNA research from the NIH. Researchers at the University of Iowa must be in compliance with the NIH Guidelines, irrespective of the source of funding.

Contact information and areas of expertise can be found on the Contact Us page.

Program Elements 

Principal investigators (PIs) involved in rDNA research are responsible for:

  • Reviewing the NIH Guidelines.
  • Submitting an electronic rDNA protocol; rDNA protocols are completed and submitted through the eIBC rDNA Registration Document Management System. More information is accessible below under "Resources".

The University of Iowa follows the procedures and policies as outlined in the NIH Guidelines. These policies and procedures, as well as the University of Iowa’s specific review procedures, are summarized in the UI rDNA Procedures. As addressed by the NIH Guidelines, particular research with E. coli K-12 derivatives is exempt from the requirements of the NIH Guidelines; a listing of the K-12 derivatives and applicable references is available under “Resources”.

The IBC will review for compliance all submitted rDNA protocols and an approval/disapproval letter will be emailed to the PI via the management system. The approved rDNA Registration Document (rDNARD), electronically signed by the IBC Chairperson, will be available through the eIBC. The IBC will prohibit the initiation of experiments not explicitly covered by the NIH Guidelines until NIH establishes the containment required for these experiments.

Human Gene Transfer Research

Human gene transfer (HGT) research must be reviewed and approved by the IBC to assess biosafety considerations at the clinical trial site. PIs are responsible for completing an rDNARD for each HGT protocol. After review, an approval/disapproval letter will be emailed to the PI through the management system.  The approved rDNARD, electronically signed by the IBC Chairperson, will be available through the eIBC.

Additionally, PIs are responsible for completing a new human subject’s application for review by the IRB using HawkIRB, an electronic submissions tool. Contact the Human Subjects Office for more information.

rDNA Documentation

The PI may be required to forward a copy of the approved rDNARD to the granting agency.

Additional documentation must be completed for research involving human gene transfer experiments, including:

  • Specific documentation following the initiation of the clinical investigation as required by NIH’s Office of Biotechnology Activities (OBA), see Appendix M of the NIH Guidelines.
  • Annual data report forms sent by NIH OBA, a copy of these forms should be forwarded to Nyree Mortensen, EHS, 100 EHS.

eIBC rDNA Registration Document Management System Information 

Biosafety Staff in Environmental Health and Safety are providing training sessions in the use of the eIBC system and have also developed the documents listed below under “Resources” to assist staff with registering their covered research. Please contact Biosafety Staff at ehs-rdna@uiowa.edu to schedule training and/or with any questions regarding use of the system.

Documents 

Recombinant DNA Procedural Manual

Training 

  • Recombinant DNA (rDNA) Research, NIH Guidelines - W137BO
    • This course is required initially for the indicated audience.
    • Audience: All staff (Principal Investigators, research assistants and students) involved in research utilizing recombinant DNA or recombinant organisms.

For further training and registration information go to EHS Safety Training.

Resources 

External Links