This document outlines National Heart, Lung, and Blood Institute (NHLBI) policy and procedures for investigator-initiated Research Dissemination and Implementation grant applications (R18). It provides guidelines for the preparation and submission of these applications. This document is intended to provide background information relating to program areas. This is not a solicitation for applications.
These guidelines are designed specifically for applications that will be assigned for review by the NHLBI Office of Scientific Review in an ad hoc Special Emphasis Panel (SEP), for initial merit review. They are not designed for investigator-initiated multi-site clinical trials or multi-site observational studies.
For applications submitted electronically (see Application and Submission section below) this document is intended to complement, and should be used in conjunction with, Funding Opportunity Announcement (FOA) Program Announcement (PA): PAR-10-114 Research Dissemination and Implementation Grants (R18).
Efficacy is the extent to which an intervention can be shown to be beneficial under optimal study conditions.
Effectiveness is the extent to which an intervention can be shown to be beneficial under real world conditions.
Intervention is a method or technique used as part of a program or protocol that introduces a change for individuals, patients, groups, or populations.
Dissemination and Implementation (D&I) research is an integral part of the NHLBI’s systematic approach to the support of research throughout the biomedical spectrum. D&I research involves extension or adaptation of generally accepted and efficacious interventions that have been previously carried out in well-controlled settings to broader populations or settings. In issuing these guidelines, NHLBI intends to provide information to assist members of the scientific community interested in applying for D&I research grants in the cardiovascular, pulmonary, blood, and sleep areas.
For the purpose of these guidelines, we make a distinction between "dissemination" and "implementation."
This distinction needs to be made because interventions developed in the context of efficacy and effectiveness trials are rarely transferable without adaptations to broader and less-controlled settings.
D&I research studies involve extending or adapting generally accepted, efficacious, and/or guideline-based interventions such as behavioral techniques; educational, environmental, or organizational strategies; and the delivery of healthcare services such as pharmacotherapies and more. The aim of extending such interventions is to be able to apply them to broader real-world populations, settings, and conditions such as clinic, community, school, and work environments, and other real-world settings. In other words, the ultimate goal is to determine feasible and effective strategies to translate research findings into practice, to identify determinants of implementation effectiveness at all levels, and to identify ways to accelerate the adoption, integration, and sustainability of evidence into practice and medical decision-making.
Studies of the characteristics that determine whether an effective program will be successfully implemented (including but not limited to patient, provider, demographic, clinic, or system characteristics) are of interest. Studies of intervention or treatment efficacy are not supported by the D&I mechanism but are supported by other mechanisms.
D&I research is a critical step in the medical research discovery process, and provides the bridge linking findings of well controlled trials to community, primary care, and other real-world settings. D&I research is one of many translational phases along the biomedical research spectrum.
This section lists the major areas of research interest at the NHLBI. Topics are based on the research areas identified in the NHLBI Strategic Plan for the program areas of heart, lung, and blood diseases and sleep disorders.
The following topics are intended as examples and are not all-inclusive, exhaustive, or listed in order of priority.
Consultation with NHLBI program staff prior to submission of a D&I research grant application is not a prerequisite for submission of an application; however, it is highly recommended. Investigators are urged to contact program staff early in the process of preparing a grant application.
Applications prepared in response to PAR-10-114 must be submitted using the SF424 Research and Related (R&R) forms and the SF424 R&R Application Guide, through Grants.gov (http://www.grants.gov/). To download a SF424 R&R Application Package for FOA PAR-10-114, click on “Apply for Grant Electronically” on page 1 of the FOA.
All new, resubmission (formerly “revised” or “amended”), and revision (formerly “competing supplement”) applications seeking support from NHLBI for D&I research studies must be submitted electronically. Such applications must be prepared in response to Funding Opportunity Announcement (FOA) Program Announcement (PA) Number: PAR-10-114 Research Dissemination and Implementation Grants (R18).
Standard submission/receipt dates apply. Please see http://grants.nih.gov/grants/funding/submissionschedule.htm.
Applications with Direct Costs Equal To Or Greater Than $500,000 In Any One Year
Any application requesting more than $500,000 in direct costs in any year must be formally approved for acceptance by the NHLBI by following the process described on the NHLBI Internet site, as required by NIH policy.
Inquiries about possible new D&I research grant applications may be directed to the offices listed. Applicants should consult Institute staff early in the planning phases. Consultation about renewal and supplemental grant applications should be sought from the NHLBI staff member who administers the current grant.
Dr. Michael Lauer
Two Rockledge Center, Room 8124
6701 Rockledge Drive, MSC 7940
Bethesda, MD 20892-7940
Dr. James Kiley
Two Rockledge Center, Room 10042
6701 Rockledge Drive, MSC 7952
Bethesda, MD 20892-7952
Dr. W. Keith Hoots
Two Rockledge Center, Room 9136
6701 Rockledge Drive, MSC 7950
Bethesda, MD 20892-7950