Clinical Trials

Human gene transfer and all other research involving recombinant or synthetic nucleic acids in human research participants requires review and approval by the UW Institutional Biosafety Committee (IBC) if it is sponsored by or conducted at the University of Washington. Studies involving deliberate transfer of genes into human research participants (human gene transfer) via either of the following are covered by the NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules Section III-C and require review by the NIH Office of Science Policy Recombinant DNA Advisory Committee (RAC) and the UW IBC:

  1. Recombinant nucleic acid molecules, or DNA or RNA derived from recombinant nucleic acid molecules; or
  2. Synthetic nucleic acid molecules or DNA, or RNA derived from synthetic nucleic acid molecules, that meet any one of the following criteria:
    • Contain more than 100 nucleotides; or
    • Possess biological properties that enable integration into the genome (e.g., cis elements involved in integration); or
    • Have the potential to replicate in a cell; or
    • Can be translated or transcribed.

Clinical Trial BUA application process

Reporting Requirements

More about Clinical Trials