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. NHLBI has prepared
a document on Guidelines
for Investigator Initiated Clinical Trials. This
document covers application format, human subjects 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 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)
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.
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).
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. They must have a minimum of three interrelated
research projects that focus on a unifying, central scientific
theme. Clinical projects can and have been included
in P01 applications and are a good way to support collaborations
of basic and clinical research investigators. NHLBI Guidelines
for Program Project Grants offer assistance with preparing
an application, submission and review, as well as a sample
budget. 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. In addition, there
are model
K23 grant applications on the NHLBI public web site.
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.
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.
|
