For Assistance with:
Recombinant DNA Consultation and Registration -
Wendie Dockstader, 353-5678
Haley Sinn, 335-9553
Grant Administration – Sponsored Programs
The National Institutes of Health Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules (NIH Guidelines) govern the construction and handling of recombinant DNA (rDNA) molecules and the organisms/viruses that contain them. 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 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.
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 at eIBC rDNA Protocol Management System.
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 for researchers.
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 Experiments
Additional requirements have been established for rDNA research involving human research participants. The PI is responsible for submitting all documentation as required by Appendix M of the NIH Guidelines. Additional requirements include:
- Submitting a research protocol to NIH’s Recombinant DNA Advisory Committee (RAC).
- The NIH has made available Guidance on Informed Consent for Gene Transfer Research that may be helpful for those involved in this area of research.
- Forwarding correspondence from RAC, responses to RAC recommendations (if applicable), and submitting an electronic rDNA Registration Document for IBC review, as outlined above.
- 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.
The IBC will review all correspondence between the PI and RAC, in addition to the rDNA 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.
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 Haley Sinn, EHS, 100 EHS.
In response to NIH recommendations, a training course was designed to familiarize researchers with the NIH Guidelines and provide information regarding the roles and responsibilities of various personnel involved with rDNA research at the University of Iowa. This course is available online through ICON, accessed through the Employee Self Service site, with instructions provided through EHS.