Research Using Drugs or Devices
Drugs: Any research involving a drug or device, whether FDA approved or not, requires IRB approval.
Does my research require an IND?
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 or at the bottom of this page 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.
How do I use an investigational drug to treat an individual patient?
Under special circumstances, FDA regulations permit an investigational drug to be used for the treatment of an individual patient by a licensed physician. This requires the physician to submit an IND for this use. There are two regulatory pathways depending on the urgency of the use. If drug administration must occur as soon as possible and it is not possible for the BMC/BUMC IRB to approve the request before use, then this is considered an emergency use. Otherwise, this is considered an individual patient IND use.
Please see here or at the bottom of this page for a Guidance document that will give you step by step instructions for obtaining an investigational drug to treat an individual patient. Instructions are provided for both emergent and non-emergent use.
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 an NSR device.
Please see here or at the bottom of this page for guidance on when and how to use an unapproved or “off-label” device in a research study.
More information about drug and device requirements may be found by contacting us or at the following links: