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What is the best award mechanism for my clinical research proposal?

NIH uses many mechanisms to fund basic, educational, training, clinical and other research. Information on the OER website describes Types of Grant Programs.

Award mechanisms described here include:

Investigator-Initiated Clinical Research Grants (R01)

These applications are commonly submitted by investigators who have an idea for a research project. Most NHLBI clinical research is investigator-initiated. Depending on the type (observational or interventional), the cost of the study and whether it will be a multi-center study, there may be additional NHLBI requirements.

Investigator-Initiated Epidemiology Studies (R01)

NHLBI’s Guidelines for Investigator Initiated Epidemiology Studies include similar information regarding preparation and submission of applications to conduct epidemiology studies.


Other considerations for investigator-initiated studies

If you anticipate that your project will cost more than $500,000 in direct costs in any year, click here for more details.

Before making an award for an investigator-initiated clinical trial or epidemiology study, NHLBI will consider the desirability of substantial continued staff involvement in programmatic activities of the award. If such involvement is deemed appropriate by the Institute, the award mechanism will be converted to a Cooperative Agreement. The Terms and Conditions of Grant Award will reflect that arrangement.

Demonstration and Education Research (D&E) Grants (R18)

This mechanism is designed to test the effectiveness of interventions that are based on strategies designed to promote healthful behaviors and to prevent or ameliorate disease in defined populations. D&E research is an extension or adaptation of interventions generally accepted as beneficial, to new populations or settings. Examples of such proposals, application preparation and submission details are given in Guidelines for Demonstration and Educational Research Grants.

Exploratory/Developmental Research Grants (R21)

These awards are used to support projects in early stages of development such as the feasibility of a novel intervention or therapy which may eventually lead to a breakthrough in a particular research area. The details for application and submission are discussed on the OER website for R21 grant awards.

Investigator-Initiated Resource-Related Research Projects Applications (R24)

The R24 mechanism is occasionally used based on a decision by the NHLBI Director. It can be used to fund development of infrastructure or resources to support research by NHLBI investigators.

NHLBI Clinical Trials Pilot Studies (R34)

This program is used for planning grants that provide funding for pilot studies to obtain data critical to the successful design of a full-scale clinical trial. Please see the Guidelines for detailed information.

Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) grants (R41, R42, R43, R44)

These mechanisms are used to support small businesses that wish to conduct research on drugs, devices, informatics and other scientific areas. NHLBI provides information on the SBIR/STTR program and current opportunities for small businesses in specific areas. These grants and contracts are currently using electronic submission. Information about receipt dates and Submitting Competing SBIR/STTR Grant Applications can be found on the OER website. The Application Instruction Guide can assist you in your submission.

Program Project Grants (P01).

The purpose of the P01 mechanism is to encourage multidisciplinary approaches to the investigation of complex problems relevant to NHLBI's mission and to facilitate economy of effort, space, and equipment. PPGs are available to a group of several investigators with differing areas of expertise who wish to collaborate in research by pooling their talents and resources. They are designed to achieve results not attainable by investigators working independently. Guidelines for Program Project Grants will provide detailed information on how to prepare an application, submission and review procedures and Institute contacts. Allowable Requested Direct Costs for Program Projects gives additional budgetary information.

Mentored Patient-Oriented Research Career Development Award (K23)

Career development awards support career development of investigators who conduct human subjects research. In addition to salary support, this mechanism provides funds for development and conduct of research that involves direct interaction with study subjects. Mentored Patient-Oriented Research Career Development Award describes these awards in greater detail.

NIH Pathway to Independence Award (K99/R00)

This program features a new opportunity for promising postdoctoral scientists to receive both mentored and independent research support from the same award. OER offers additional information on the Pathway to Independence Award and who is eligible to apply.


Grants Solicited by NHLBI

Besides encouraging investigators to submit research applications by the R01 or P01 mechanisms, NHLBI will issue requests for applications ( RFA ) to fund certain types of clinical (and other) research. RFAs for clinical research usually use one of two mechanisms:

Cooperative Agreements (U01 or U10)

Cooperative Agreements are grant awards that incorporate substantial NHLBI involvement in the project’s scientific and administrative activities. If you are responding to an RFA for a Cooperative Agreement, please read the terms of the RFA carefully for details about who may apply, what to include in the application, review specifics and award policies.

Many Clinical Research Networks are funded by a Cooperative Agreement. Network structure and procedures are described in detail in the RFA. If you want to know more about how a Network functions, you can go to the NHLBI Clinical Research Network Program for more information.

Page Last Updated: February 2011
Content Manager: ClinicalResearchPolicyManager@nhlbi.nih.gov

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