Some clinical trials require Institutional Biosafety Committee approval before enrollment of study subjects. Clinical trials being 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 blood, fluids, or tissue that will be analyzed or handled in an IU laboratory.
- 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 to the Office for Research Compliance, Research Safety Office at IBC@iu.edu for guidance.
Required Training
IBC training requirements for investigators participating in a clinical trial are the same as any IBC involving biological research.
Clinical trials involving an investigational product that requires IBC coverage that utilize IU Health Services or Groups (e.g., BMT Nurses, Clinical Research Center (CRC), Cellular Therapy Lab (CTL), Investigational Drug Services (IDS), or CTSL) must ensure that all staff members handling the investigational product are appropriately trained. Staff members from these groups/services are not required to take individual trainings (i.e., NIH Recombinant DNA Guidelines Training, Biological Safety Training, Bloodborne Pathogens Training), but should review the Biosafety Considerations for Clinical Studies Involving an Investigational Product, found below.