Notice of Clarification of NINDS Statement of interest for PAR-18-208 "Bioengineering Research Partnerships (BRP) (U01 Clinical Trial Optional)"

Notice Number: NOT-NS-18-029

Key Dates
Release Date:   December 18, 2017

Related Announcements
PAR-18-208

Issued by
National Institute of Neurological Disorders and Stroke (NINDS)

Purpose

The purpose of this Notice is to revise the NINDS interest statement for PAR-18-208.

The current language reads:

Part 2. Full Text of Announcement

Section I. Funding Opportunity Description

Institute statements of interest:

 
For applications relevant to the mission (http://www.ninds.nih.gov/about_ninds/mission.htm) of the National Institute for Neurological Disorders and Stroke (NINDS) under this FOA:

Applications should be milestone-driven, translational engineering for development and regulatory approval of targeted, diagnostic devices (excluding neuro-imaging).  Specific go/no-go milestones will be negotiated with NINDS Program staff at the time of award for inclusion in the notice of award. 

Applications proposing translational studies designed for pre-clinical and pilot clinical studies for therapeutic devices, specifically, should be submitted to one of the following NINDS CREATE Devices FOAs (http://www.ninds.nih.gov/funding/areas/translational_research/CREATE-Devices.htm). 
Applications for NINDS proposing pre-translational, pre-clinical, investigative research projects on deliberative optimization and development of devices for impacts in neurology and neuroscience should apply through the Bioengineering Research Grants (R01) or Exploratory Bioengineering Research Grants (R21) [refer to 2018 FOAs]. 

NINDS will not accept applications under this announcement that include clinical trials (https://grants.nih.gov/grants/guide/notice-files/NOT-OD-15-015.html). A clinical trial is a prospective biomedical or behavioral research study of human subjects designed to answer specific questions about safety, tolerability, efficacy and/or effectiveness of pharmacologic, behavioral, biologic, surgical, or device (invasive or non-invasive) interventions. Other human subjects research can be submitted and NINDS may decline funding of any application that includes human subjects for programmatic or administrative reasons. Applicants considering projects involving human subjects research are strongly encouraged to contact Scientific/Research staff.  Applications for NINDS proposing a clinical trial must be submitted to one of the following NINDS FOAs specifically designed for clinical trials (http://www.ninds.nih.gov/research/clinical_research/index.htm#tab3-panel)

The language has been modified and now reads:
Part 2. Full Text of Announcement

Section I. Funding Opportunity Description

Institute statements of interest:

NINDS: Within the goals of this FOA, NINDS is particularly interested in bioengineering research that advances technologies with the potential to decrease the burden of neurological disorders and stroke. Examples of areas of interest include the development and validation of invasive and non-invasive devices, diagnostic/monitoring tools, advanced imaging techniques, computational models, tissue engineering, and other innovative methods. Applicants are strongly encouraged to contact NINDS Scientific Program staff prior to submission. Applicants interested in translational activities and clinical studies of therapeutic and diagnostic devices for disorders that affect the nervous or neuromuscular systems may be more appropriate for other NINDS bioengineering opportunities (https://www.ninds.nih.gov/Current-Research/Focus-Research/Focus-Bioengineering-Research).

Inquiries

Please direct all inquiries to:

Nick Langhals, Ph.D.
National Institute of Neurological Disorders and Stroke
Telephone: 301-496-1447
Email: nick.langhals@nih.gov