Notice of Intent to Publish a Funding Opportunity Announcement for NHLBI Clinical Ancillary Studies (R01)

Notice Number: NOT-HL-17-545

Key Dates
Release Date:   September 25, 2017
 
Estimated Publication Date of Announcement:  January 2018
First Estimated Application Due Date:  May 2018
Earliest Estimated Award Date:  
December 2018
Earliest Estimated Start Date:  
December 2018

Related Announcements
NOT-HL-16-451

Issued by
National Heart, Lung, and Blood Institute (NHLBI

Purpose

The purpose of this Notice is to inform potential applicants that the NHLBI intends to publish a new Funding Opportunity Announcement (FOA) that will support time-sensitive ancillary studies related to heart, lung, and blood diseases and sleep disorders (HBLS), to leverage resources and infrastructures of ongoing clinical trials, observational studies, and/or registries supported by NIH or non-NIH entities. The purpose of this Notice is to provide applicants time to develop necessary collaborations and appropriate applications.

The FOA is expected to be published in January 2018 with the first application due date in May 2018.

This FOA will utilize the R01 activity code and will be a PAR. Details of the planned FOA are provided below.

Research Initiative Details
The intended FOA will solicit applications to conduct time sensitive ancillary studies to ongoing clinical research studies, including clinical trials, prospective observational studies, and registries. Applications submitted in response to this FOA must propose to collect new data and/or biological samples from participants of the ongoing parent study to address new research questions within the scientific mission of the NHLBI that are not being addressed by the parent study. The ancillary study cannot be used to extend the duration of the parent study or to provide funds solely for parent study enrollment, capitation, or study performance.   

Applications received in response to this FOA are expected to undergo an accelerated review/award process to facilitate the conduct of time-sensitive ancillary studies that are operating within a limited timeframe. The program is intended for ancillary studies that require data collection during the active phase of the parent study and would need to be begin recruiting subjects as close as possible to the start of the parent study, and/or that would require time-sensitive data collection at a specific phase of the parent study.

Special Requirements of this FOA
All ancillary study applications MUST include a letter or statement documenting that it is feasible for the proposed ancillary study investigator(s) to collect new samples, data, and/or materials from the parent study and that the proposed ancillary study has the approval of the parent study's organization/leadership. This letter must also provide documentation of a resource and data sharing agreement between the parent and proposed ancillary study. Applications not containing such documentation will be considered incomplete to this FOA and will not proceed to review.

All ancillary study applications MUST provide justification for the time-sensitive nature of the proposed ancillary study. Investigators who would be able to complete the same work using the regular R01 submission cycles should not apply to this FOA.

All ancillary study applications MUST include a timeline for the parent study to demonstrate that there is sufficient time remaining in the parent study to complete the ancillary study.

APPLICATIONS ARE NOT BEING SOLICITED AT THIS TIME.

Inquiries

Please direct all inquiries to:

Jue Chen, PhD
National Heart, Lung, and Blood Institute (NHLBI)
Telephone: 301-435-0550
Email: jue.chen@nih.gov