Notice of Intent to Publish a Funding Opportunity Announcement for NINR Clinical Trial Planning Grant (R34- Clinical Trial Optional)

Notice Number: NOT-NR-18-015

Key Dates

Release Date: July 23, 2018
Estimated Publication Date of Funding Opportunity Announcement:November 15, 2018
First Estimated Application Due Date: February 16, 2019
Earliest Estimated Award Date: October 01, 2019
Earliest Estimated Start Date: November 01, 2019

Related Announcements
PAR-19-060

Issued by
National Institute of Nursing Research (NINR)

Purpose

The National Institute of Nursing Research (NINR) intends to promote a new initiative by publishing a Funding Opportunity Announcement (FOA) to solicit applications that propose development of the essential elements of a clinical trial.

The FOA will utilize the R34 activity code, which provides support for the initial development of a clinical trial including the establishment of the research team; the development of tools for data management and oversight of the research; the development of a trial design and other essential elements of the study or project, such as the protocol, recruitment strategies, procedure manuals, and collection of feasibility data.

The NINR is interested in applications that will address relevant questions relevant to the NINR mission and align with the Institute’s Strategic Plan. Investigators are encouraged to visit the NINR website for additional information about the research mission and high-priority research areas of the NINR https://www.ninr.nih.gov/aboutninr/ninr-mission-and-strategic-plan.

The R34 is not a prerequisite for a clinical trial implementation award.

This Notice is being provided to allow potential applicants sufficient time to develop meaningful collaborations and responsive projects. 

The FOA is expected to be published in Fall 2018 with an expected application due date in Winter 2019.

Details of the planned FOA are provided below.

Research Initiative Details

Clinical research and clinical trials are among several research strategies NINR utilizes to achieve its mission. As NINR’s research investments have expanded, the issues facing nursing science have evolved and become more complex, and the need for achieving definitive research outcomes has never been greater. Over 50% of NINR-supported R01 grant awards are clinical trials, and meritorious applications require well-designed trials supported by feasibility data.

To facilitate achievement of meritorious applications, the R34 Clinical Trial Planning grant provides a low risk, low cost entry point for Early Stage or New Investigators to develop the skills and resources to plan high quality clinical trials. The R34 is also intended for established investigators, including established investigators who intend to shift their research into clinical trials.

The proposed clinical trial should be hypothesis-driven, related to the research mission of the NINR and considered a high priority by the Institute.  

The R34-funded study should collect the preliminary data that would enhance the probability of reaching more definitive outcomes in a subsequent larger trial. Applications that propose solely to write a protocol or manual of operations or to develop infrastructure for a clinical trial will not be considered appropriate. 

Only one clinical trial planning project may be proposed in each NINR Clinical Trial Planning Grant (R34) application.

Funding Information

Estimated Total Funding TBD
Expected Number of Awards TBD
Estimated Award Ceiling Direct costs limited to $150,000 over the 2-year project period
Primary CFDA Numbers 93.361

Anticipated Eligible Organizations

Public/State Controlled Institution of Higher Education
Private Institution of Higher Education
Nonprofit with 501(c)(3) IRS Status (Other than Institution of Higher Education)
Nonprofit without 501(c)(3) IRS Status (Other than Institution of Higher Education)
Small Business
For-Profit Organization (Other than Small Business)
State Government
Indian/Native American Tribal Government (Federally Recognized)
County governments
City or township governments
Special district governments
Independent school districts
Public housing authorities/Indian housing authorities
Indian/Native American Tribally Designated Organization (Native American tribal organizations (other than Federally recognized tribal governments)
U.S. Territory or Possession
Indian/Native American Tribal Government (Other than Federally Recognized)
Non-domestic (non-U.S.) Entity (Foreign Organization)
Regional Organization

Applications are not being solicited at this time.

Inquiries

Please direct all inquiries to:

Karen Huss, PhD

National Institute of Nursing Research
301-594-5970
hussk@mail.nih.gov