Institutional Device Review Committee
We review investigational devices and approved devices provided by sponsors for use in clinical research studies.
The Investigational Device Review Committee is a committee charged with reviewing devices involving human subjects to protect the rights and welfare of those subjects and to insure that all federal, state and local regulations as well as policies and procedures are followed.
The Investigational Device Review Committee is composed of core members with rotating subject matter experts (i.e., composition of committee would be determined by department proposing to use the device, the department where the device would be stored and or utilized).
The Investigational Device Review Committee has the authority to release or require modifications (to secure approval), for research. The Investigational Device Review Committee also serves as a resource for researchers by providing advice and guidance on identification and regulatory issues related to use of devices in human subject research.
Primary Contact
Contact the individual below with any questions. If you are ready for IDRC review, send an email with the protocol and associated documents.
Grace L. Videtich
IDRC Sr. Compliance Analyst
Send Email
Phone: 402-559-7421
Studies Reviewed by the IDRC
Any study that has a device or equipment that is:
- experimental
- FDA approved/released; but, is being used “off-Label”
- commercially available to the general public for purposes not medically related
- an application that is being used in research in a manner outside the use for which it was designed and or marketed
The IDRC will also review studies that:
- utilize experimental software to facilitate use of a device/equipment or to collect data
- utilizes an In-Vitro device (IVD), even if it is used at a central lab
- receive approved devices or equipment that is not currently stocked or used at NM
- expect to utilize hospital stock as the investigational item
- require the hospital to purchase devices, equipment, and/or supplies to facilitate the research
- result in cost to install or renovate hospital spaces to store or use the device/equipment
- provide devices at no cost for use on a study and does not expect the equipment to be returned (i.e. Patient/Hospital gets to keep the device for use post study)