Glossary, CRG, NHLBI, NIH

NIH

National Institutes of Health (NIH)
the United State's medical research agency, a federal government agency composed of diverse Institutes and Centers that conduct and support biomedical and behavioral research. NIH Homepage.

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

Grant
financial assistance mechanism providing money, property, or both to an eligible entity to carry out an approved project or activity. A grant is used whenever the NIH Institute or Center anticipates no substantial programmatic involvement with the recipient during performance of the financially assisted activities.

Programs.

Award

Award
provision of funds by NIH, based on an approved application and budget or progress report, to an organizational entity or an individual to carry out a project or activity.

mechanisms described here include:

Investigator-Initiated Clinical Research

Clinical Research
patient-oriented research (human subjects, tissues, specimens, and cognitive phenomena), including epidemiologic and behavioral studies, outcomes research, and health services research in which a researcher directly interacts with human subjects.

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

National Heart, Lung, Blood Institute (NHLBI)
a NIH Institute that provides leadership for a national program in diseases of the heart, lung, and blood as well as blood resources, sleep disorders and the Woman's Health Initiative. NHLBI Homepage.

requirements. NHLBI has prepared a document on Guidelines for Investigator Initiated Clinical Trials. This document covers application format, human subjects

Human Subject
Legally defined term for living persons about whom an investigator obtains specimens or data through direct interaction

Interaction
any communication or other interpersonal contact between an investigator and a human subject. For more information, go to definitions in 45 CFR 46.102 and full 45 CFR 46.

or intervention or through identifiable, private information. Regulations include but are not limited to human organs, tissues, body fluids, and recorded information. Term is defined differently by FDA.

information, women, children and ethnic participation, data and safety monitoring and a general overview of NHLBI review criteria for these types of applications.

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

Direct Costs
costs in a grant or contract identified with a project or program which may include salaries, travel, supplies, patient care costs, consultant services and others.

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

Office of Extramural Research (OER)
a NIH office that supports extramural research by providing policy and guidance to the NIH ICs that award grants and assisting investigators through the process of attaining grants funding and helping them understand and navigate through federal policies and procedures. OER Homepage

website for R21 grant awards.

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

This mechanism is used to support research projects that enhance the conduct of biomedical research through the development of infrastructure or resources. Please see the Guidelines for detailed information on deadlines and advanced permissions.

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

R01
grant mechanism used by NIH to provide support for health-related research which can be investigator-initiated or in response to a program announcement or request for application.

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

Requests for Applications (RFA)
initiatives sponsored by one or more NIH institutes or centers that stimulate research by requesting grant applications in a well-defined scientific area.

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.

Specialized Center of Clinically Oriented Research (P50).

SCCORs are programs that foster communication and research in a multi-disciplinary environment in a specific scientific area outlined in the RFA. If you are responding to an RFA for a SCCOR, the RFA will guide you through the requirements and process, and will refer you to relevant NHLBI policies, such as the Program Description for Specialized Centers of Clinically Oriented Research, Special Instructions for SCCOR Grant Applications, and for some solicitations, Frequently Asked Questions.

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

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Home » Clinical Research Guide» Applicatiojn» What is the best award mechanism for my clinical research proposal?
CRG Home Contracts Overview What is clinical research? What is the role of NIH and NHLBI in clinical research? What are the Project Officer's responsibilities in clinical research? What is the role of the Principal Investigator/Institution in clinical research? Application How can I find funding opportunities (RFAs, RFPs and PAsG)? What do I need to know before submitting a clinical research application? Am I a new investigator and what if this is my first NIH application? Which NHLBI staff can help me? Is my study considered clinical research? Is my study observational or interventional? What is the best award mechanism for my clinical research proposal? What if my project exceeds $500,000 in direct costs in any given year? Where can I get help with writing the application? What must I include in "Protection of Human Subjects"? How and when do I submit my application? Review What happens to my grant after submission? Who will review my application and when? Did the reviewers like my application? What is a summary statement and what does it mean? What if I don't agree with the review? Funding How do I know if I am funded? Who needs human subjects protection training? Who approves my data monitoring plan? What is a Certificate of Confidentiality and do I need one? How do I develop consent forms and who reviews them? Are there ethical concerns and conflicts of interest I must consider? Do I need IRB, IEC or REB approval? What other approvals are needed? How do I track recruitment of research participants? My study involves Medicare or third party support. My study involves foreign grants and contracts. How do I register my study? When can I begin enrolling participants? Management How do I comply with Good Clinical Practices (GCP)? How do I manage changes to my grant? How do I report amendments, suspensions and terminations? Must I obtain continuing review from the IRB? Who should monitor subject recruitment/retention? How do I report adverse events? How is data quality monitored? What if I wish to add extra sites or studies to my project? How do I manage my budget and when are reports expected? What is HIPAA and how do I abide by the requirements ? Study Closure Tools & Training Glossary	What is the best award mechanism for my clinical research proposal? NIH National Institutes of Health (NIH) the United State's medical research agency, a federal government agency composed of diverse Institutes and Centers that conduct and support biomedical and behavioral research. NIH Homepage. uses many mechanisms to fund basic, educational, training, clinical and other research. Information on the OER website describes Types of Grant Grant financial assistance mechanism providing money, property, or both to an eligible entity to carry out an approved project or activity. A grant is used whenever the NIH Institute or Center anticipates no substantial programmatic involvement with the recipient during performance of the financially assisted activities. Programs. Award Award provision of funds by NIH, based on an approved application and budget or progress report, to an organizational entity or an individual to carry out a project or activity. mechanisms described here include: R01 R18 R21 R24 R34 R 41,42,43,44 P01 K23 K99/R00 U01 or U10 P50 Investigator-Initiated Clinical Research Clinical Research patient-oriented research (human subjects, tissues, specimens, and cognitive phenomena), including epidemiologic and behavioral studies, outcomes research, and health services research in which a researcher directly interacts with human subjects. 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 National Heart, Lung, Blood Institute (NHLBI) a NIH Institute that provides leadership for a national program in diseases of the heart, lung, and blood as well as blood resources, sleep disorders and the Woman's Health Initiative. NHLBI Homepage. requirements. NHLBI has prepared a document on Guidelines for Investigator Initiated Clinical Trials. This document covers application format, human subjects Human Subject Legally defined term for living persons about whom an investigator obtains specimens or data through direct interaction Interaction any communication or other interpersonal contact between an investigator and a human subject. For more information, go to definitions in 45 CFR 46.102 and full 45 CFR 46. or intervention or through identifiable, private information. Regulations include but are not limited to human organs, tissues, body fluids, and recorded information. Term is defined differently by FDA. information, women, children and ethnic participation, data and safety monitoring and a general overview of NHLBI review criteria for these types of applications. 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 Direct Costs costs in a grant or contract identified with a project or program which may include salaries, travel, supplies, patient care costs, consultant services and others. 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 Office of Extramural Research (OER) a NIH office that supports extramural research by providing policy and guidance to the NIH ICs that award grants and assisting investigators through the process of attaining grants funding and helping them understand and navigate through federal policies and procedures. OER Homepage website for R21 grant awards. Investigator-Initiated Resource-Related Research Projects Applications (R24) This mechanism is used to support research projects that enhance the conduct of biomedical research through the development of infrastructure or resources. Please see the Guidelines for detailed information on deadlines and advanced permissions. 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 R01 grant mechanism used by NIH to provide support for health-related research which can be investigator-initiated or in response to a program announcement or request for application. 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 Requests for Applications (RFA) initiatives sponsored by one or more NIH institutes or centers that stimulate research by requesting grant applications in a well-defined scientific area. 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. Specialized Center of Clinically Oriented Research (P50). SCCORs are programs that foster communication and research in a multi-disciplinary environment in a specific scientific area outlined in the RFA. If you are responding to an RFA for a SCCOR, the RFA will guide you through the requirements and process, and will refer you to relevant NHLBI policies, such as the Program Description for Specialized Centers of Clinically Oriented Research, Special Instructions for SCCOR Grant Applications, and for some solicitations, Frequently Asked Questions. Page Last Updated: February 2011 Content Manager: ClinicalResearchPolicyManager@nhlbi.nih.gov
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What is the best award mechanism for my clinical research proposal?