Clinical Trial Research Submissions

University of Pittsburgh IBC review and approval is required prior to IRB review for clinical trials.

The NIH Guidelines require that research involving recombinant or synthetic nucleic acid molecules administered to human participants must be reviewed by the IBC. The deliberate transfer of recombinant or synthetic nucleic acids into one human research participant, conducted under a Food and Drug Administration (FDA) regulated individual patient expanded access Investigational New Drug (IND) or protocol, including for emergency use, is not research subject to the NIH Guidelines and thus does NOT need to be submitted to an IBC for review and approval.

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.

What is required for Human Gene Transfer (HGT) review?