Clinical Trials

Any research involving the administration of infectious agents or recombinant or synthetic nucleic acids to 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. Infectious agents are biological organisms capable of causing disease in humans, generally Risk Group 2 or higher. More information about the UW IBC’s definition of a biohazard is on the Biological Research Approval webpage.

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 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

More about Clinical Trials