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

  NIH Guidelines: IBC review and NIH REGISTRATION for HGT

Summary of changes to review of NEW Human Gene Transfer studies:
  • NIH Registration requirement prior to final IBC approval
  • Redefined criteria for public NIH review
  • Changes to Appendix M

Submit New Clinical studies for IBC review through the MyIBC portal

Other Clinical Study Information
 Annual Reporting form - only for use with Existing Legacy studies at this time
 Adverse Event Reporting
 NIH GeMCRIS Database search database for NIH Registered Clinical Trials
Page updated 13 June 2017; edits to correct non-working links and update information