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Human Gene Transfer

DNA, or RNA derived from recombinant DNA into human subjects (human gene transfer) will be considered through a review process involving the University of Utah Institutional Review Board (IRB) and Institutional Biosafety Committee (IBC), as well as the NIH Office of Biotechnology Activities (OBA) and the Recombinant DNA Advisory Committee (RAC). Proposals for germ line alterations will not be entertained, but proposals involving somatic cell gene transfer will be considered. The purpose of somatic cell gene transfer is to treat an individual patient, e.g., by inserting a properly functioning gene into the subject's somatic cells. Germ line alteration involves a specific attempt to introduce genetic changes into the germ (reproductive) cells of an individual, with the aim of changing the set of genes passed on to the individual's offspring.

Submit the following:

  • A cover letter on institutional letterhead, signed by the Principal Investigator(s), that: (1) acknowledges that the documentation submitted complies with the NIH requirements for protocol submission; (2) identifies the IBC, and IRB at the proposed clinical trial site(s) responsible for local review and approval of the protocol; and (3) acknowledges that no research participant will be enrolled until the RAC review process has been completed; IBC approval (from the clinical trial site) has been obtained; IRB approval has been obtained; and all applicable regulatory authorizations have been obtained. Note: "Enrollment" is the process of obtaining informed consent from a potential research participant, or designated legal guardian of the participant, to undergo a test or procedure associated with the gene transfer experiment.
  • The scientific abstract
  • The non-technical abstract
  • The proposed clinical protocol, including tables, figures, and relevant manuscripts
  • Response to Appendices M-II through M-V, Description of the Proposal, Informed Consent, Privacy and Confidentiality, and Special Issues. Responses may be provided either as an appendix to the clinical protocol or incorporated in the clinical protocol. If responses are incorporated in the clinical protocol, each response must refer to the appropriate Appendix (i.e.,M-II through M-V).
  • The proposed informed consent document (Appendix M-III)
  • Curriculum vitae of the principal investigator(s) (no more than two pages in biographical sketch format). Note: A human gene transfer experiment submitted to NIH OBA should not contain confidential commercial information or trade secrets, enabling all aspects of the review to be open to the public.
Investigators shall submit their relevant information on the proposed human gene transfer experiments to the IRB Administrator, IBC Administrator, and NIH/OBA. The documentation must be submitted in printed or electronic form to:

Director
Institutional Review Board
MREB 101
581-3655
587-9138 (fax)

AND

Biosafety Officer
Environmental Health and Safety
Bldg. 605
581-6590
585-7240 (fax)
Jim.Johnston@ehs.utah.edu

AND

Office of Biotechnology Activities, National Institutes of Health
6705 Rockledge Drive, Suite 750, MSC 7985
Bethesda, MD 20892-7985 (20817 for non-UPS mail)
301-496-9838
301-496-9839 (fax)
email: rosenthg@od.nih.gov

The Biosafety Officer and NIH OBA will confirm receipt within three working days after receiving the submission. Investigators should contact the Biosafety Officer and OBA if they do not receive this confirmation.