In addition to IRB approval, some clinical trials require Institutional Biosafety Committee (IBC) approval before enrollment of study subjects. Clinical trials performed by Indiana University employees or receiving Indiana University funding that meet any of the following criteria must be reviewed by the IBC:
- Trials that involve human participant samples including blood, fluids, or tissue that will be analyzed or handled in an IU laboratory.
- If human samples are collected in a clinical setting and sent directly back to the trial sponsor for analysis, and the Investigational Product does not meet the definition of Human Gene Transfer (HGT), no IBC protocol is required.
- Trials that meet the definition of Human Gene Transfer (HGT), as stipulated by the NIH Guidelines:
- The NIH defines HGT as “the deliberate transfer into human research participants of either:
- Recombinant nucleic acid molecules, or DNA or RNA derived from recombinant nucleic acid molecules, or
- Synthetic nucleic acid molecules, or DNA or RNA derived from synthetic nucleic acid molecules, that meet any one of the following criteria:
- Contain more than 100 nucleotides; or
- Possess biological properties that enable integration into the genome (e.g., cis elements involved in integration); or
- Have the potential to replicate in a cell; or
- Can be translated or transcribed.”
- The NIH defines HGT as “the deliberate transfer into human research participants of either:
If you are unsure whether a trial will require IBC approval, please send the Sponsor Protocol and the Investigator Brochure to the Research Safety Compliance Office (RSCO) at IBC@iu.edu for guidance.