RFA-NS-19-018 HEAL Initiative: Clinical Devices to Treat Pain (UH3 Clinical Trial Optional)
The purpose of this Funding Opportunity Announcement (FOA) is to encourage investigators to pursue a small clinical trial to obtain critical information necessary to advance recording and/or stimulating devices to treat pain with innovative, targeted, and non-addictive diagnostic and/or therapeutic devices that improve patient outcomes and decrease or eliminate the need to prescribe opioids. Clinical studies supported may consist of acute or short-term procedures that are deemed Non-Significant Risk (NSR) by an Institutional Review Board (IRB), or Significant Risk (SR) studies that require an Investigational Device Exemption (IDE) from the FDA, such as chronic implants. The clinical trial should provide data to answer key questions about the function or final design of a device and is expected to provide information that cannot be practically obtained through additional non-clinical assessments (e.g., bench top or animal studies) due to the novelty of the device or its intended use. This is a milestone-driven cooperative agreement program and will involve participation of NIH program staff in the development of the project plan and monitoring of research progress.
This FOA will leverage Public-Private Partnership Programs (PPP) initiated under the NIH BRAIN Initiative, the Office of Strategic Coordination – The Common Fund’s Stimulating Peripheral Activity to Relieve Conditions (SPARC) Program, and the HEAL Initiative. These programs include agreements (Memoranda of Understanding, MOU) with a number of device manufacturers willing to make such devices available, including devices and capabilities not yet market approved but appropriate for clinical research. In general, it is expected that the devices' existing safety and utility data will be sufficient to enable new IRB NSR or FDA IDE approval without the need for significant additional non-clinical data.
For more information see https://braininitiative.nih.gov/resources/brain_ppp/index.htm, https://commonfund.nih.gov/sparc/newmarkets, and https://www.nih.gov/research-training/medical-research-initiatives/heal-initiative/public-private-partnership. Individuals, institutions, or businesses developing their own devices or that already have established collaborations with device manufacturers are welcome to apply directly to this FOA or any of the companion opportunities.
Application Due Dates: October 21, 2019, February 21, 2020, June 22, 2020, October 21, 2020, February 21, 2021 , by 5:00 PM local time of applicant organization.
Expiration Date: February 23, 2021