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

Adverse Events should be reported to the FDA through MedWatch; the IBC will not be reviewing these incidents

 

Submit New Clinical studies for IBC review through the MyIBC portal

 

Page updated 28 August 2019; removed link to GeMCRIS database; updated AE reporting information- Medwatch site link