Clinical Trial Research Submissions

University of Pittsburgh IBC review and approval is required prior to Human Research Protection Office (HRPO) review for clinical trials.

The NIH Guidelines require that research involving recombinant or synthetic nucleic acid molecules administered to human subjects must be reviewed by the IBC. Vaccine studies involving recombinant or syntheic nucleic acid molecules are not excepted from IBC review.  Vaccine Exemption Information

 IBC review no longer requires NIH Registration for HGT

  • NIH Registration will no longer be a requirement prior to final IBC approval
  • Redefined federal review does not include HGT (formerly the Recombinant Advisory Committee) 
  • Changes have been published as of April 25, 2019 - NIH Guidelines

Submit New Clinical studies for IBC review through the MyIBC portal

Other Clinical Study Information
 No longer accepting paper annual renewal application forms - must be completed in online review system
 Adverse Event Reporting - HGT trials need not report to IBCs per April 2019 version of the NIH Guidelines
 NIH GeMCRIS Database search database for NIH Registered Clinical Trials
Page updated 25 April 2019; Updates to NIH Guidelines are in effect