Guidelines for PROGRAM PROJECT GRANTS
National Heart, Lung, and Blood Institute
National Institutes of Health
Revised: June 2007
Beginning January 1, 2007, the
following new NIH-wide receipt dates for New,
Renewal (competing continuation), and Resubmission (revised)
Program Project (P01) applications will be in effect:
New Receipt Date |
January 25 |
May 25 |
September 25 |
Additional information about changes in P01 and other mechanism
receipt dates can be found in the NIH Guide Notice NOT-OD-07-001
(http://grants.nih.gov/grants/guide/notice-files/NOT-OD-07-001.html)
|
Beginning with the September 25, 2007 receipt date, a letter of intent must be submitted no later than six weeks prior to the intended receipt date. (See Chapter 1, Presubmission Section and Chapter 4 Section A.)
Beginning with the September 25, 2007 receipt date, applicants submitting a new application with direct costs of $500,000 or more in any year must meet with NHLBI staff no later than 10 weeks prior to the intended receipt date. (See Chapter 1, Presubmission Section and Chapter 4, Section A) |
Applications for NHLBI Program Project Grants
with direct costs of $500,000 or more in any
year must also comply with the NHLBI
Guidelines for Applications with Direct Costs
of $500,000 or More in Any One Year. |
|
CHAPTER 1
INTRODUCTION
The National Heart, Lung, and Blood Institute (NHLBI) Program Project
Grant (P01) supports research related to fundamental processes and
diseases of the heart, blood vessels, lungs, and blood as well as
transfusion medicine, blood resources, and sleep disorders. A P01 grant requires a minimum of three interrelated research projects
that focus a number of scientific disciplines on investigations of
a complex biomedical theme or research question. The projects may
be supported by core units to facilitate economy of effort, space,
and equipment. The NHLBI provides support for program project grants
in the belief that a collaborative research effort can accelerate
the acquisition of knowledge more effectively than a simple aggregate
of research projects that have no interaction or thematic integration.
The Institute is particularly interested in encouraging new scientific
directions in program project grants. The P01 mechanism is viewed
as an opportunity to attract scientists who have not traditionally
been supported by the NHLBI. However, all projects must be interrelated
and have objectives that address a central theme within the mission
of the Institute.
PRESUBMISSION
ANYONE planning to submit a P01 application (new
competing [Type 1], competing renewal [Type 2], supplemental [Type
3], or amended [A1]) must send a letter of intent at least six weeks prior to submission. Details regarding the letter of intent and additional requirements for new P01s are in Chapter 4, Section A of this document.
- For a NEW P01 application:
- Applicants are strongly encouraged to contact NHLBI staff 18 weeks or more prior to the intended application receipt date. NHLBI staff will
engage in detailed discussions with the proposed principal
investigator, offer advice and suggestions, and review a draft application. However,
staff will not comment on the merit of the science
proposed. The applicant must also participate in a pre-submission meeting with NHLBI staff to be held no later than 10 weeks prior to the intended receipt date. Additional information is in Chapter 4, Section A in this document
- Applications with direct costs greater than or equal to $500,000 in any one year must comply with all aspects of the Guidelines for
Applications with Direct Costs of $500,000 or More in Any One Year. Additional information is in Chapter 4, Section A in this document
- New applications submitted without prior consultation with NHLBI
staff will be returned without review.
Anyone planning to submit a COMPETING CONTINUATION OR AMENDED
application must send a letter of intent at least six weeks prior
to the intended receipt date but do not need prior approval to submit an application.
Applications that do not follow this presubmission guidance, are
not prepared according to the instructions, or do not meet the
criteria for a program project grant will be RETURNED TO THE APPLICANT
WITHOUT PEER REVIEW.
CHARACTERISTICS OF A PROGRAM PROJECT
A program project grant application is responsive to NHLBI Guidelines
if it has the following:
- A. A clearly defined, unifying, central theme
to which each component project relates and to which each
research investigator contributes.
- In keeping with the tradition of investigator initiated
research, the NHLBI expects the applicants to define
the integrating theme and to develop multidisciplinary
approaches used to accomplish the objectives of the
proposed research.
- The central theme must be clearly developed in the
introduction and must be accompanied by a compelling
scientific rationale for using the program project
mechanism to conduct the proposed multi-disciplinary
research, as opposed to a group of separate individual
research project grants.
- The central theme of the research program may bridge
the programmatic responsibilities of two or more NHLBI
Divisions. The theme of the scientific research, not
the organizational structure of the NHLBI, should
define its boundaries.
- The target goals anticipated on completion of the
5-year program should be outlined carefully in the
introduction with special reference to contributions
expected from the multidisciplinary team.
- Examples should be presented of previous collaborations
that may have led to the goals and hypotheses of the
program.
B. Component research projects that are interrelated
and contribute scientifically to the central theme of
the program.
- The relationship of hypotheses and goals of each
component project to the central theme should be described.
- Each component project requires a well described
hypothesis or plan for discovery research, preliminary
data, and a timetable for conducting the proposed
investigations.
- Component projects may be basic research, clinical
research, or a combination of basic and clinical research.
Population-based research is acceptable as one of
several projects in the program if the objectives
of the project can be completed in a 5-year project
period. A program project grant may not be used to
support Phase III clinical trials. The usual NIH policies
concerning research on human subjects apply. Instructions
for Form PHS 398 should be followed for addressing
use of human subjects. Some additional details are
available in Chapter 2, Section D.4.e. of this document.
- If core facilities are included, the scientific and
fiscal relationship of each component project to each
core should be described and fully justified.
- A program project requires a minimum of three interrelated
component projects, each of which is funded for 5
years.
- In general, each individual project in a program project
grant should have a different project leader. Although
individual investigators are not precluded from leading
more than one project in a program project grant,
strong justification must be provided for all such
instances. In no case may one individual serve as
project leader on more than two projects and each
funded program project grant must have a minimum of
three individual project leaders.
- In general, no more than half of the projects included
in a funded program project grant application may
overlap significantly in time and objectives with
currently funded individual research project grants,
i.e., be individual research project grants that would
have to be relinquished if the program project grant
application is funded. However, an amended program
project grant application may include any overlapping
individual research project grants that were
- included in the original program project grant application
and
- submitted as new individual research project grant applications
simultaneously with the original program project grant application
(note that such simultaneous submissions are permitted as provided
by the instructions for the PHS form 398).
- Individual components of a program project
grant application can be submitted from organizations other than
the applicant organization. However, all program project grant applications
must provide a compelling justification for how the proposed program
structure will encourage and enable extensive interactions among
investigators and accelerate the acquisition of knowledge.
C. A principal investigator who is a research
scientist of recognized stature in his/her scientific
discipline and has the demonstrated ability to ensure
quality control and to administer and integrate all components
of the program.
- A principal investigator must devote a minimum of
25 percent time commitment to the grant.
- A principal investigator must also be the project
leader of one of the component projects submitted
and ultimately funded. If the project submitted by
the principal investigator is judged by peer review
to be of low scientific merit, this will markedly
reduce the overall scientific merit ranking assigned
to the entire application by the review committee.
If the project submitted by the principal investigator
does not receive a fundable score, the program project
grant application will not be funded.
- A principal investigator must be fully established
at the applicant institution at the time of submission
of a program project grant application.
D. Project leaders who provide expertise
from several disciplines.
- Project leaders must be individuals whose scientific
publications demonstrate their potential to contribute
to the overall theme of the program project.
- Project leaders must agree to commit at least 20 percent
effort to the project for which they are responsible.
- Investigators with excellent research training, who
have not yet achieved established investigator status,
may participate; however, most of the project leaders
should be investigators with significant research
experience.
- Project Leaders must be fully established at their
institutions at the time of submission of a program
project grant application.
E. Core leaders who have appropriate expertise
- Core leaders must be qualified for their role(s) in
the core unit.
- Core leaders should dedicate time and effort commensurate
with the complexity of the core unit's function.
F. A plan to ensure extensive interaction
among all participants and the communication of ideas
and results.
- A compelling justification must be presented for how
the proposed program structure will encourage and
enable extensive interactions among investigators
and accelerate the acquisition of knowledge.
- Both internal and external advisory committees should
be established to evaluate progress and the effectiveness
of interaction among participants. See Chapter 2,
section C.3. for additional guidance on creating advisory
committees and naming members in the application.
G. A section titled "Synergy and Interactions
Among Projects and Project Leaders." The section
must address:
- Collaborative aspects, inter-relatedness of research,
and the contribution of each project to both the central
theme of the application and the other projects included
in the application.
- Multi-authored publications that demonstrate recent
collaboration among investigators included in the
application and among the project leaders in particular.
- A description of inter-project use of resources and
research findings.
- A proposed schedule of seminar series, monthly group
meetings, semi-annual retreats, or other features
that will stimulate collaboration and interaction
among investigators included in the application.
- The role of external and internal advisory committees,
their interactions with each other and with the project
leaders.
CHAPTER 2
GUIDELINES FOR THE PREPARATION
OF A PROGRAM PROJECT GRANT APPLICATION
A. Introduction
This chapter supplements instructions in
PHS Form 398 that are enclosed with NIH grant application kits
available at grantee institutions (and from the NIH Web site at http://grants2.nih.gov/grants/funding/phs398/phs398.html).
Because Form 398 is used primarily for applications for individual
research project grants (R01), sections must be modified and expanded
to provide the additional information needed for a program project
grant application.
The exceptions and additions noted below are the only changes from
the general requirements provided in the instructions for PHS
Form 398. Page limitations specified for R01 grant applications
in PHS Form 398 apply to each project and core unit of a P01 application.
B. Specific Instructions
- Face Page (page 1 of application): Type "Program Project"
on line 2. The title of the grant application must not exceed 81 characters.
Complete all items on the face page of the application. This is page
1 of the application; all succeeding pages should be numbered consecutively.
- Description, Performance Sites, and Key Personnel (see PHS Form 398
Instructions)
- State concisely the overall goals of the entire P01 and the contribution
of each component to the overall goals.
- In the block requesting key personnel, add the position title
and department for each individual.
- Table of Contents
- Provide a detailed table of contents that will enable readers
to find specific information readily. List each project, the budget
for each project, each core unit, and the budget for each core unit,
and supply the page number for each item. Identify each project
by title, assign each project a number that reflects the order in
which the projects are presented in the application, and provide
the name of the project leader or responsible investigator. (In
the case of competing continuation applications, identify each project
with the same number used for it in the previous application, or,
if projects have been dropped or added, arrange the numbers in sequence
and identify projects being proposed for continuation with their
former numbers.)
- Detailed Budget for Initial Budget Period
- All Program Project Grant Applications
- Provide a detailed categorical budget for EACH PROJECT AND
EACH CORE UNIT in their respective sections of the application.
In addition, provide and identify a complete budget for each
consortium project
- Incorporate a detailed budget for all requested support for
the first year ( Sample Table 1). For each category, such as
"Personnel," "Equipment," "Supplies,"
"Travel," and "Other Expenses," give the
amount requested for EACH PROJECT AND CORE UNIT with subtotals.
If contractual arrangements or "purchased services"
involving other institutions or organizations are anticipated
(as in project 5 in Sample Table 1), include total (direct and
facilities and administrative) costs associated with each third
party participation in the " Consortium/Contractual Costs"
category.
- New Program Project Grant Applications
- New applications may request direct costs in the first year
up to the maximum allowable direct costs for the fiscal year
(FY) in which funding is proposed to begin (The
most recent maximum allowable direct costs are posted on the
NHLBI Web site (at http://www.nhlbi.nih.gov/funding/policies/grantcaps.htm).
The allowable rate
of increase in the direct costs for subsequent years is also
posted on the NHLBI Web site (at http://www.nhlbi.nih.gov/funding/policies/grantcaps.htm).
Requests for expensive items of equipment that cause an application
to exceed the posted limits may be permitted on a case-by-case
basis, following staff consultation. However, applicants should
make every attempt to include all equipment in the ceiling amount.
Applicants must discuss equipment requests with NHLBI staff
early in the planning phase and must receive permission from
the Institute to include equipment costs in their budget request.
All requests for equipment that may cause an application to
exceed the posted NHLBI limits require in-depth justification.
Final decisions depend on the nature of the justification and
the Institute's fiscal situation.
- Competing Continuation Program Project Grant Applications
- Budget for Entire Proposed Period of Support.
- Prepare a detailed categorical budget that provides totals for
each year of requested support. Requests for any increases in succeeding
years must be clearly stated and any changes in percent effort and
funds must be justified in the individual project and core unit
budgets.
- Biographical Sketch (see PHS Form 398 Instructions)
- Other Support
- Do not include Other Support as a separate section. Although
information on Research Support is important in evaluating the qualifications
of proposed staff for their roles and for assessing the degree of
commitment that is feasible, a description of other support should
be included as part of the Biographical Sketch (Research Support)
and should not exceed two pages.
- Resources (see below under Research Plan)
- Research Plan
- FOLLOW THE FORMAT OF THE PHS FORM 398 for each project, providing
supplementary information when necessary for each section as indicated
below. Describe each research project and each core unit in the
same detail that is required for an individual research project
grant application, so that the scientific merit can be judged on
the basis of the written proposal. Keep in mind that the application
will be reviewed by experts who can judge, collectively, all areas
represented in the application but who may not be familiar individually
with each area of research proposed. Therefore, the description
of a project should be concise yet explicit enough to enable experts
in related areas to understand the main thrust of each project and
how it relates to the overall program project grant.
- Page limitations specified for R01 applications in PHS Form 398
apply to each project and core unit section. Applications
exceeding the page limitation will be returned without peer review.
Additional information concerning collaboration and integration
between projects and cores and the contribution of each component
to the program's specific goals should be succinct. Unnecessarily
long, wordy, or confusing presentations are usually perceived as
indicative of premature or poorly planned research. The bibliography
is not counted toward the 25 page limitation per project.
- Full-sized glossy photographs of materials such as electron micrographs
or gels may be sent to the Scientific Review Administrator for distribution
to the reviewers so long as a photocopy (which could be reduced
in size from the glossy photograph in the appendix) is included
within the 25-page limit of sections a-d of the Research Plan. All
other graphs, diagrams, tables, and charts must be included within
the 25-page limit of sections a-d in the Research Plan. The appendix
may not be used to circumvent the page limitations in the Research
Plan. Applications that do not conform to these restrictions
will be returned without peer review. An appendix will
not be duplicated with the rest of an application. Therefore, material
in an appendix should be sent directly to the Scientific Review
Administrator (SRA). (The SRA will instruct the applicant as to
when to send extra materials.)
C. Additional Format Instructions - The
following sections must precede the portion of the application
that contains the details of the individual projects.
- Program Introduction and Statement of Objectives
- A program project grant should be viewed as a group
of interrelated research projects, each of which is
not only individually meritorious scientifically but
also complementary to and interrelated with the other
projects in the research program and contributes to
the integrating theme. The theme of a proposed program
project grant should be established in the first few
sentences of the general introduction.
- Describe the rationale for the proposed total research
program. Explain the strategy for achieving the objectives
of the overall program and how each research project
and core unit relates to that strategy and to each
other.
- The general introduction of the overall program description
is the appropriate place to indicate any prior collaborative
arrangements between investigators in the group, to
explain the genesis of the current application, to
predict the anticipated unique advantages that would
be gained by the research within the proposed program
project grant, to describe how the projects are synergistic
and mutually interrelated, and to explain how the
proposed program project grant would enable the stated
objectives of the proposed research to be addressed
more efficiently and effectively than a group of individual
research project grants. (See also Chapter
1, Sections F and G above).
- Institutional Environment and Resources
- Briefly describe the features of the institutional
environment that are relevant to the effective implementation
of the overall program. As appropriate, describe available
resources such as clinical and laboratory facilities,
participating and affiliated units, patient populations,
geographic distribution of space and personnel, and
consultative resources. The information requested
here supplants the "Resources" page in the
PHS Form 398 grant application, which is NOT to be
used.
- Organizational and Administrative Structure of the Program
Project Grant
- CHAIN OF RESPONSIBILITY. Describe in detail, and by
diagram if appropriate, the chain of responsibility
for decision making and administration, beginning
with the principal investigator and including the
leaders of the research projects and core units. Indicate
where, in the chain of responsibility, advisory groups
(internal and external consultants) would be used,
and describe their function in ensuring quality control
in the research efforts.
- EXTERNAL AND INTERNAL ADVISORY BOARDS. Every program
project grant should have plans for both an external
advisory board and an internal advisory board. The
external advisory board should normally consist of
two or three named advisers committed to the evaluation
of the program by written documentation. Two or three
additional advisers may be added once the progress
of the program and its needs are clearer. New program
project grant applications should not constitute their
external advisory board prior to or during the review
of their application because individuals identified
in an application cannot participate in its peer review.
The internal advisory board should consist of three
to five members outside of the program but within
the applicant institution (or within neighboring institutions)
who are able to assist in frequent, ongoing reviews.
- SPECIFIC MANAGERIAL RESPONSIBILITIES: Indicate who
would be responsible for assisting the principal investigator
with day-to-day administrative details, program coordination,
and planning and evaluation of the program.
- RELATION OF THE PROGRAM PROJECT GRANT ORGANIZATION
TO THE ADMINISTRATION OF THE APPLICANT INSTITUTION:
Describe the relation between the proposed program
project grant and other existing research, academic,
and administrative units of the applicant institution
such as schools, centers, institutions, departments,
and central administration.
- CONSORTIUM ARRANGEMENTS: Applications that include
research activities involving institutions other than
the applicant institution are considered consortia.
Consortia applications must be prepared so that the
programmatic, fiscal, and administrative considerations
are explained fully. The published policy governing
consortia is available in the business offices of
institutions that are eligible to receive Federal
grants-in-aid. Consult the latest published policy
governing consortia before preparing an application.
If clarification of the policy is needed, contact
the Director, Office of Grants Management, Division
of Extramural Research Activities, NHLBI, at 301-435-0144.
- DESIGNATION OF REPLACEMENT FOR PRINCIPAL INVESTIGATOR:
Describe the procedure for selecting a proposed replacement
for the Principal Investigator, should the need arise.
The NHLBI must approve any request to replace the
Principal Investigator.
- Summary Report of Progress
Competing continuation applications must include a progress
report that highlights achievements under the program project
grant since the last competitive review. A progress report
is required for each research project and core unit in other
sections of the application. The composite summary/progress
report must include:
- A brief summary of major accomplishments that can
be attributed to the program project grant and a brief
explanation of how they relate to the stated objectives
of the program.
- A list of all publications and completed (not "in
preparation") manuscripts that have resulted
from the program project grant.
- A list of changes, if any, in the professional staffing
since the last competitive review.
- A list of research projects and core units, in tabular
form, that have been discontinued, modified, or completed
since the last competitive review, identified by number
and title, with a brief explanation of the actions
taken.
- A list of research projects and core units in the
current program project grant, with the amount of
current funding for each and the requested funding
for the first budget period of each project and core
unit that would be continued in the program project
grant. Identify each as a "new" or "continuing"
component.
D. Individual Projects
- Title and number each research project so that it can be readily
distinguished from any other project in the program. An individual
description should be prepared for each project in the program
project grant application as would be required for an R01
application. The title must NOT exceed 81 typewriter characters/spaces.
DO NOT provide a face page (i.e., PHS Form 398 face page)
for individual projects. Provide the name and academic title
of the project leader and each participating investigator.
This request is being made pursuant to the basic authority
of the NHLBI to award research project grants (see Title 42,
United States Code, Section 241).
- Present the budget for each research project according to
the instructions for PHS Form 398. A detailed categorical
budget is required for the first and all subsequent years.
Include budget requests and explicit detailed budget justifications
for all years.
- Describe in detail the facilities to be used by each project.
This is to be accomplished by completing the "Resource
and Environment" page included in the PHS Form 398 grant
application packet.
- Research Plan: State the overall objective for each proposed
research project and explain how it relates to the central
theme of the program project grant and how it interrelates
with and complements and/or supplements, the other research
projects and core units of the program project grant. In addition,
describe the overall expected biomedical significance of the
proposed research.
- Specific Aims
- List the specific aims of the research project
for the total period of requested support.
Indicate the general priority of each aim
in the overall research plan.
- Background and Significance
- Review the most significant previous work
and describe the current status of research
in this field: document with complete references.
- Preliminary Studies/Progress Report
- Refer to PHS form 398 Instructions for Preliminary
Studies.
- See under Summary Report of Progress Studies.
- Research Design and Methods
- Give details of the research plan, including
a description of the experiment(s) or other
work proposed; present the methods and techniques
to be used; note the limitations, if any,
of the procedures proposed. In so far as possible,
describe the experiments in the sequence in
which they would be conducted. (It is important
to convey to the reader that the proposed
effort would require the time requested for
the project period.)
- Discuss the kinds of results expected from
the experimental procedures described in the
"Methods of Procedure" section,
and explain how the data would be analyzed
and interpreted. Discuss the extent to which
anticipated results would relate to the original
hypothesis and how they would be important
for planning the next steps in the research
plan.
- Human Subjects
- The usual NIH policies concerning research
on human subjects apply. Form 398 should be
followed for human subjects information.
- NIH policy requires applicants for NIH clinical
research grants and cooperative agreements
to include minorities, women, and children
in study populations so that research findings
can benefit all persons at risk for the disease,
disorder, or condition under study. Special
emphasis should be placed on the need for
inclusion of minorities, women, and children
in studies of diseases, disorders, and conditions
that disproportionately affect them. If women
or minorities are excluded or inadequately
represented in clinical research, particularly
in proposed population-based studies, a clear
and compelling rationale must be provided.
Refer to chapter 1, B. for the appropriate
types of research in a program project grant.
- The composition of the proposed study population
must be described in terms of gender and racial/ethnic
group. In addition, gender and racial/ethnic
issues should be addressed in developing a
research design and sample size appropriate
for the scientific objectives of the study.
This information should be included on PHS
Form 398 in Sections a-e of the Research Plan
AND summarized in Section e, Human Subjects.
Applicants are urged to assess carefully the
feasibility of including the broadest possible
representation of minority groups. However,
the NIH recognizes that it may not be feasible
or appropriate in all research projects to
include representation of the full array of
U.S. racial/ethnic minority populations (i.e.,
Native Americans including American Indians
or Alaska Natives, Asian Americans, Hawaiians
and other Pacific Islanders, Blacks, Hispanics).
The rationale for studies on single minority
population groups should be provided.
- For foreign studies and domestic studies with
a foreign component, the NIH policy on inclusion
of women, children, and minority groups in
research is the same as that for research
conducted in the U.S.
- If the required information is not contained
within the application, the application will
be returned without review.
- Vertebrate Animals (see PHS Form 398 Instructions.)
- If animals are involved, indicate what kinds
are to be used and whether nonhuman primates
are to be used, listing the special justifications
for their use, and describe in detail their
care, use, and treatment and the method to
be followed for euthanasia.
- Literature Cited
- Include a complete citation for each reference
in the text. TITLES OF REFERENCE PUBLICATIONS
SHOULD BE INCLUDED.
- Consortium/Contractual Arrangements and/or Collaborative
Arrangements (See PHS Form 398 Instructions)
- Describe the collaboration of investigators
within the program project grant. Describe
in detail any other collaborative arrangements
anticipated, either within the applicant institution,
between it and other institutions, or among
other institutions.
- Consultants (See PHS Form 398 Instructions)
- Appendix
- Appendix materials should NOT be included as part
of a grant application. They may be submitted as additional
material at the same time that reprints are provided
in response to a request from the SRA.
E. Individual Core Units
A core unit is defined as a resource for the program project grant
that provides centralized services to more than one of the research
projects.
- Title and assign a LETTER designation to each core unit so
that it can be readily distinguished from any other core unit.
Do NOT exceed 81 typewriter characters/spaces for each title.
- Provide the name and academic title of the core unit leader
and each participating investigator.
- Describe the function of the core unit as a resource to the
program project grant. This section must present clearly the
facilities, techniques, and professional skills that the core
unit would provide to the program and explain why its inclusion
is essential to two or more of the individual research projects
and to the overall research program.
- Describe in detail the facilities to be used by EACH core
unit. This is to be accomplished by completing the "Resource
and Environment" page included in the PHS Form 398 grant
application packet.
- Present the budget for each core unit in the format and according
to the instructions for Form 398. A budget for the entire
proposed project period is required for all subsequent years
of support (direct costs only). Include explicit and detailed
categorical budget justifications for all years and fully
describe how the costs interrelate with those of the projects
serviced by the core unit.
- Relation of the Core Units to the Research Projects: Provide
in tabular form information concerning the research projects
that each core unit would serve and the proportion of the
cost of the core unit associated with each research project
involved (Sample Table 2).
( Sample Table 2 ).
CHAPTER 3
ADDITIONAL GUIDELINES FOR THE PREPARATION OF A SUPPLEMENTAL PROGRAM
PROJECT GRANT APPLICATION
Supplemental program project grant applications may only be submitted
to the NHLBI for continuation of funding of component projects
originally recommended for a period shorter than the project period
for the program project grant. In such cases, after NHLBI staff
has been apprised of the applicant's intent, a supplemental application
may be submitted to bring the component project's funding into
synchrony with the rest of the program project grant.
Strong justification must be provided for the proposed supplement.
The project must be described in sufficient detail to ensure adequate
evaluation solely on the basis of the written proposal.
A. Program Abstract
On page 2 of the application, in the space provided, give a brief
description of the entire program in addition to a summary of
the supplemental request.
B. Budget
Use the instructions from PHS Form 398, "Detailed Budget for
Initial Budget Period," to present a composite budget for
the first continuing year (or portion thereof) of the supplemental
request. For each category, give the amount requested for each
research project and core unit and the total for the category.
Use a format such as that suggested in the presentation of a composite
budget for the first year budget section of new and competing
continuation applications (Sample Table 1 in
the Appendix).
Use the instructions for "Budget for Entire Proposed Period
of Support," of PHS Form 398 to prepare a budget, by category,
for all years of supplemental request. The first year of the supplement
may be no more than 3 percent greater than the last funded (or
committed) year. The budget is subject to a maximum increase of
no more than 3 percent in each succeeding year.
Submit a detailed budget for the "Personnel" category
for the first year of supplemental request.
Show the funding relation between the parent grant and the supplemental
request by a summary table.
Use the column title "Prior Year Budget" to indicate
the funding allocation for the year preceding the year for which
funds are being sought in the supplemental grant application.
In the column titled "Current Grant" indicate the current
funding for the supplemental projects or core units for the first
year for which supplemental funding is being sought.
C. Budgetary Information Related to the Parent Grant
Include the following tables:
- The budget remaining for the parent grant. Provide a table
for each year of the parent grant that coincides with the
requested budget period(s) of the supplemental application.
- Any changes, with brief explanations, in the budgets of research
projects and core units since the last competitive review.
In particular, note and explain any rebudgeting of funds between
projects and core units.
D. Summary Report of Progress
A comprehensive progress report covering the period since the beginning
of the project period to the present is required for all supplemental
applications. This summarizing progress report, which is to be
prepared by the principal investigator, must include:
- A brief summary of major accomplishments that can be attributed
to the program project grant and a brief explanation of how
they have contributed to furthering the stated goals of the
program.
- A list of all publications and completed (not "in preparation")
manuscripts that have resulted from the program project.
- A list of research projects and core units, in tabular form,
that have been discontinued, modified, or completed since
the last competitive review, identified by title and number,
with a brief explanation of the actions taken.
- A list of changes, if any, in the professional staffing since
the last competitive review.
E. Research Plan and Content
- Follow instructions for the Research Plan and project/core
content as described in these guidelines and in PHS Form 398
for the format of Component Research Project and Component
Core Unit.
CHAPTER 4
SUBMISSION AND REVIEW OF APPLICATIONS
The NHLBI will only accept program project applications
(whether new, competing continuation, amended, or supplemental) on
the three regular receipt dates: January 25, May 25, and September 25.
Peer review consists of initial review by a committee tailored for
each application, evaluation by the NHLBI Program Project Review Committee
(HLBP), and secondary review by the National Heart, Lung, and Blood
Advisory Council (NHLBAC). Applicants are strongly advised to make
their applications as complete as possible, as neither site visits
nor reverse site visits will be used in the review process.
Please note that only one amendment of a program project
grant application will be accepted for review.
The timing of each step in the process and the corresponding earliest
start date for each receipt date are indicated below.
1. The Application Review Cycles by Application Receipt Date
Receipt by the NHLBI |
Tailored Review |
Review by Program
Project Committee |
Review
by NHLBAC |
Earliest Possible
Start Date |
January 25 |
April-May |
June |
October |
Dec. 1 |
May 25 |
Sept.-Oct. |
December |
February |
April 1 |
September 25 |
Jan.-Feb. |
March |
May |
July 1 |
APPLICATION AND REVIEW PROCESS
The following phases will normally comprise the process of submission
and review of a program project grant application:
A. Presubmission
- ALL Program Project Grant Applications
- For ALL program project grant applications (new, competing
continuation, supplemental, and amended), investigators are
encouraged to discuss their intent to submit an application
with NHLBI staff 18 weeks or more prior to the intended receipt date.
- To enable the NHLBI to plan its review schedule, the
Institute requires that at least six weeks before the intended receipt date
of the application, a letter of intent be sent to:
Scientific Review Administrator
Program Project Review
National Heart, Lung, and Blood Institute
Two Rockledge Centre, Room 7208
6701 Rockledge Drive
Bethesda, Maryland 20892-7924
Bethesda, Maryland 20817 (for express/courier
service)
301-435-0303
- The letter should contain the following information:
- Names of the Principal Investigator and the subproject leaders
- Applicant and sub-project Institutions
- Overall program title
- Title of each subproject and each core
- Specific Aims for each subproject and core
- To enable the Institute staff to advise whether the
application meets the scientific and programmatic
requirements for a program project grant and is prepared
according to the technical guidelines, it is recommended
that a draft application be sent to the appropriate
Division Director and to the SRA, early in its preparation.
- Questions concerning budgets and/or grants policy
should be addressed to the Director, Office of Grants Management of the NHLBI.
- New Program Project Grant Applications -- Presubmission Meeting
- To ensure that each application meets the policies
and guidelines for P01 grants and to encourage
more complete and well-prepared documents, the NHLBI
requires a pre-submission meeting of new program project grant applicants with staff, no later than 10 weeks prior to the intended receipt date.
- New Program Project Grants applications -- $500,000 Policy
- New P01 applications with direct costs of $500,000 or more in any year must comply with the NHLBI Guidelines for Applications with Direct Costs of $500,000 or More in Any One Year . A letter requesting permission to submit the application must be sent to the NHLBI at least six weeks prior to the intended receipt date. One letter can be used to request permission to submit an application with direct costs of $500,000 or more and as the P01 letter of intent. (See the $500,000 guidelines for additional items to include in the letter). The letter should be sent to two addresses: the address listed above (Chapter 4; Section A) and to the appropriate addressee listed in the $500,000 guidelines. The letter from the NHLBI approving submission of the application must accompany the submitted application. The requirement is based on NIH policy. (NIH Guide to Grants and Contracts, October 16, 2001 )
- Competing Continuation and Amended New Program Project Grant
Applications
- A letter of intent is required no later than six weeks prior to the intended receipt date
- The NHLBI exempts competing continuation and amended
program project grant applications from the requirement
for prior acceptance of applications with direct costs
of $500,000 or more.
B. Submission
At the same time that the original and three copies of the grant
applications are submitted to the Center for Scientific Review,
National Institutes of Health, Suite 1040, 6701 Rockledge Drive
MSC 7710, Bethesda MD 20892-7710 (20817 for express/courier service),
TWO ADDITIONAL COPIES OF THE GRANT APPLICATION ARE REQUESTED TO
BE SUBMITTED TO THE PROGRAM PROJECT REVIEW OFFICE (ROOM 7208,
MAIL STOP 7924) BY A SEPARATE MAILING. A copy of the letter indicating
the willingness of the NHLBI to accept the application must accompany
any new program project grant application.
C. Streamlined Review
The HLBP, with the possible addition of temporary members, has
the option to determine, prior to the tailored review, whether
an application meets the criteria for a program project grant
application and is of significant and substantial merit to warrant
further review. Any application found by the HLBP not to meet
these criteria, will not be scored and will not be considered
further.
D. Tailored Review Committee
New, competing continuation, and amended program project grant
applications are normally reviewed by a tailored review committee
composed of scientific peers convened to review a group of program
project grant applications with similar content.
Competing supplemental applications are normally evaluated by mail
review and/or conference call review.
Amended applications in which the majority of projects (three or
more) received outstanding priority scores but no more than two
projects received less than outstanding scores during the initial
review may also be reviewed by mail review and/or conference call
in order to reevaluate those particular projects.
- In preparation for the meeting of the Tailored Review Committee,
the SRA will:
- Transmit questions from reviewers to the applicant
in preparation for the review, if the SRA believes
they are critical to the review.
- Allow submission of relevant new data acquired since
the submission of the application, up to thirty days
prior to the tailored committee review.
The Tailored Review Committee will:
- Assign a priority score to each project based on its
intrinsic stand-alone scientific merit. This scoring
process is to be comparable to that for R01 applications.
- Describe in the critique of each project its importance
and contribution to the overall recommended program.
- Provide written comments on the overall program, as
well as the synergy of the projects and how they are
interrelated, one to another.
- Rate each core unit as "Recommended" or
"Not Recommended" based on whether it is
essential for the proposed research and has the capability
to fulfill the proposed function. Reviewers will evaluate
the number of projects serviced by the core unit (the
core unit must service two or more projects); strengths
and weaknesses of the proposed approaches, resources,
and interactions; whether the investigators are qualified
for their role(s) in the core unit and have dedicated
appropriate time and effort commensurate with the
complexity of its functions; and whether the proposed
budget for the core unit is appropriate.
E. Heart, Lung, and Blood Program Project Review Committee Evaluation
The HLBP considers the review reports, makes recommendations, and
assigns an overall scientific merit rating to each application.
It may not change an individual project score assigned by the
Tailored Review Committee, but it is asked to provide written
comments to be included in its overall report if it has any disagreement
with a project score.
F. National Heart, Lung, and Blood Advisory Council Review
The NHLBAC assesses the recommendations of the HLBP, taking into
account the level of merit of the individual projects as well
as the overall merit assigned by reviewers, overall programmatic
considerations relevant to each application, and the total recommended
budget.
G. Funding
- The NHLBI and the NHLBAC are committed to the program project
grant as an important support mechanism to accomplish various
research goals and opportunities.
- The NIH Plan for Managing the Costs of Biomedical Research
has placed an increased emphasis on the total cost of an application
as a factor in the funding decision. This affects program
project grant applications and other research grant applications
with a high total cost.
- To stabilize the base funding of program project grants, the
NHLBI has set aside a percentage of its Research Project Grant
budget for P01s.
- The priority scores assigned to the component projects are
used as one factor in making funding decisions for program
project grant components.
H. Post Award Issues
- If the Principal Investigator of a P01 moves to another institution,
a request to transfer the P01 to that institution will be
considered by the NHLBI only if all of the following conditions
are met:
- The institution from which the P01 would be transferred
agrees to permit the transfer of the grant.
- If the institution from which the P01 would
be transferred refuses to permit the transfer,
the grant will remain at that institution
if a replacement Principal Investigator is
proposed who is acceptable to the NHLBI. Otherwise,
the grant will be terminated.
- The institution to which the P01 would be transferred
agrees to accept the grant.
- If the institution to which the P01 would
be transferred declines to accept the transfer,
the grant will remain at the original institution
if a replacement Principal Investigator is
proposed who is acceptable to the NHLBI. Otherwise,
the grant will be terminated.
- The facilities and environment at the institution
to which the P01 would be transferred are comparable
or superior to those at the institution from which
it would be transferred.
- The Principal Investigator of the P01 demonstrates
conclusively to the NHLBI that the grant can be effectively
administered at the new institution and that interaction
between all of the components of the project will
not be impaired in any way.
- If the NHLBI has any doubts about a request
to transfer a P01, even if the transfer is
acceptable to both institutions, the Principal
Investigator must submit an application for
competitive review as described in this chapter.
- If the leader of an individual component of a P01
moves to another institution and the Principal Investigator
of the P01 wishes to allow the component to relocate
to the new institution along with the component leader,
the Principal Investigator of the P01 must demonstrate
conclusively to the NHLBI that the interaction between
all of the components of the project will not be impaired
in any way and request that the NHLBI approve the
change.
- The NHLBI will reinstate into a program project grant
a project initially deleted from a P01 application
by the Institute if all of the following conditions
are met.
- The project was submitted as an unsolicited
R01 application, i.e., not in response to
an RFA.
- Reinstatement of the project is requested
by the Principal Investigator of the P01,
the Principal Investigator of the R01 application,
and their respective Institution(s).
- The Principal Investigator of the R01 application
is the same individual proposed for the project
in the P01 application.
- The P01 is in the first or second year of
its project period.
- The scientific objectives of the R01 application
remain consistent with the major theme of
the P01.
- The funds requested and approved for the R01
application do not exceed those initially
requested for the project in the P01 application,
including associated core costs.
- The percentile assigned to the R01 application
is equal to or better than that used for the
R01 official pay line for one or more of the
Council meetings at which it would be considered.
If all of these conditions are met, the NHLBI will
reinstate the project (and associated core costs)
for funding for the same period of time that remains
in the parent P01 grant. A reinstated project may
be included in the P01 base funding level when determining
the allowable direct cost for a competing continuation
application.
INSTITUTE CONTACTS
Director, Division of Cardiovascular Diseases
Two Rockledge, Room 9158
6701 Rockledge Drive
Bethesda, Maryland 20892-7940
301-435-0477
Director, Division of Lung Diseases
Two Rockledge Centre, Suite 10042
6701 Rockledge Drive
Bethesda, Maryland 20892-7952
301-435-0233
Director, Division of Blood Diseases and Resources
Two Rockledge Centre, Room 10160
6701 Rockledge Drive
Bethesda, Maryland 20893-7950
301-435-0080
Director, Division of Prevention and Population Sciences
Two Rockledge Centre, Room 8100
6701 Rockledge Drive
Bethesda, Maryland 20892-7938
301-435-0422
Scientific Review Administrator, Program Project Review
Two Rockledge Centre, Room 7208
6701 Rockledge Drive
Bethesda, Maryland 20892-7924
301-435-0303
Deputy Director, Office of Grants Management
Two Rockledge Centre, Room 7130
6701 Rockledge Drive
Bethesda, Maryland 20892-7926
301-435-0149
APPENDIX
TABLE 1
Detailed Budget for the First 12-Month Period
Direct Costs only Personnel (Applicant organization only)
Time/Effort
Name |
Title of Position |
% Hours / week |
Salary |
Fringe Benefits |
Totals |
|
Principal Invest. |
|
|
|
|
Project 1 |
. |
. |
$30,000 |
$3,000 |
$ 33,000 |
Project 2 |
. |
. |
20,000 |
2,000 |
22,000 |
Project 3 |
. |
. |
25,000 |
2,500 |
27,500 |
Project 4 |
. |
. |
15,000 |
1,500 |
16,500 |
Core Unit A |
. |
. |
22,000 |
2,200 |
24,200 |
Core Unit B |
. |
. |
10,000 |
1,000 |
11,000 |
|
|
|
|
|
|
Subtotals |
. |
. |
122,000 |
12,200 |
$134,200 |
Consultant Costs (See instructions) Project
2 ($1,000), Core Unit A ($2,000)
$ 3,000
Equipment (Itemize) Project 1 ($4,000), Project
2 ($2,000), Project 3 ($3,000) Project 4 ($5,000),
Core Unit A ($16,500), Core Unit B ($2,000)
$32,500
Supplies (Itemize by Category) Project 1 ($14,200),
Project 2 ($2,000), Project 3 ($11,500), Project
4 ($8,900), Core Unit A (16,400), Core Unit B ($18,200)
$79,900
Travel
Domestic
$ 3,000
Foreign
$ 1,000
Patient Care Costs
Inpatient -- Project 4
$20,000
Alterations and Renovations (Itemize by Category)
Core Unit A ($50,000)
$ 0
Consortium/Contractual Costs (see instructions)
Project 5 - Cooperating Institution X ($45,200, including $10,000
IDC)
$55,200
Other Expenses (Itemize by category) Project
1 $1,000), Project 2 ($1,500), Project 3 ($1,900)
Project 4 ($1,100), Core Unit A ($1,500), Core Unit B ($2,200)
$ 9,200
Total Direct Costs (Also enter on Page 1, item 7) $338,000
TABLE 2
Relation
of Core Units to Research Projects
Projects |
Core Unit A |
Core Unit B |
Project 1 |
$ 3,000 |
$ 6,900 |
Project 2 |
13,100 |
6,000 |
Project 3 |
14,500 |
10,000 |
Project 4 |
10,000 |
6,000 |
Project 5 |
20,000 |
4,500 |
TOTAL |
$60,600 |
$33,400 |
|