Does This Study Require IBC Review?

By Daniel Eisenman, Executive Director, Biosafety Services

While clinical research professionals are familiar with the role of the IRB to protect research subjects, most are unfamiliar with the added need for an Institutional Biosafety Committee (IBC) to review the risks associated with engineered genetic material in clinical trials. NIH Guidelines require IBC review for any genetic engineering research, including gene therapy research, that receives NIH funding or takes place at sites receiving NIH funding. This means any funding—even $1 of NIH funds for the site or the study means the study must be reviewed by an IBC.