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

The NIH published information in the Federal Register on August 16, 2018:
  • NIH Registration will no longer be a requirement prior to final IBC approval
  • Redefined federal RAC (Recombinant Advisory Committee) role; no longer reviewing HGT
  • Changes to NIH Guidelines will be forthcoming

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 - Clinical trials need not report to IBCs per recent FR notice
 NIH GeMCRIS Database search database for NIH Registered Clinical Trials
Page updated 28 November 2018; minor revisions