What if I hold the IND for an investigational drug or an IDE for an investigational device?
Research involving investigational drugs, biologics, or devices where the investigator holds the IND or IDE is subject to additional regulatory oversight in addition to that within the IRB’s purview. For investigator-initiated research involving investigational drugs or biologics, follow FDA requirements in 21 CFR Part 312, Subpart B for obtaining Investigational New Drug (IND) clearance/approval. For investigator-initiated research involving investigational devices, follow FDA requirements in 21 CFR Part 812, Subpart B for obtaining Investigational Device Exemption (IDE) approval. Please refer to Appendix A-2, Additional Requirements for USFDA Regulated Research.
The institution has resources available to investigators who wish to conduct such research. Please see the following webpage for more information: https://www.nucats.northwestern.edu/research-resources/clinical-research-infrastructure/index.html.