Research Using Drugs or Devices
Drugs: Any research involving a drug or device, whether FDA approved or not, requires IRB approval.
Drugs, drug combinations, or biological agents which have not been approved by the FDA for that use may require an IND (Investigational New Drug) number from the FDA. Please see here for a Decision Chart that will help you determine whether an IND application needs to be submitted to the FDA, or whether you should request an IND Exemption determination from the FDA or the BMC/BU Medical Campus IRB. The decision chart provides guidance on evaluating whether use of a drug or biologic is exempt from the IND requirements; and also provides links to FDA Guidance documents and contact instructions for requesting an IND exemption determination from the FDA.
Devices: Devices which are not approved by the FDA or which are being studied for “off-label uses” require an IDE (Investigational Device Exemption) from the FDA, an IRB deemed IDE under 21 CFR 812.2 as a non-significant risk (NSR) device determination, or documentation from the FDA stating that the device is a NSR device.
More information about drug and device requirements may be found by contacting us or at the following links: