and Human Services (HHS)
EXPIRED
PARTNERSHIP PROGRAMS TO REDUCE CARDIOVASCULAR DISPARITIES
RELEASE DATE: September 15, 2003
RFA Number: RFA-HL-04-002
Department of Health and Human Services (DHHS)
PARTICIPATING ORGANIZATIONS:
National Institutes of Health (NIH)
(http://www.nih.gov/)
COMPONENTS OF PARTICIPATING ORGANIZATIONS:
National Heart, Lung and Blood Institute (NHLBI)
(http://www.nhlbi.nih.gov/)
CATALOG OF FEDERAL DOMESTIC ASSISTANCE NUMBER: 93.837
LETTER OF INTENT RECEIPT DATE: January 22, 2004
APPLICATION RECEIPT DATE: February 19, 2004
THIS RFA CONTAINS THE FOLLOWING INFORMATION
o Purpose of this RFA
o Research Objectives
o Mechanism of Support
o Funds Available
o Eligible Institutions
o Individuals Eligible to Become Principal Investigators
o Special Requirements
o Where to Send Inquiries
o Letter of Intent
o Submitting an Application
o Peer Review Process
o Review Criteria
o Receipt and Review Schedule
o Award Criteria
o Required Federal Citations
PURPOSE OF THIS RFA
The purpose of this initiative is to promote and expedite research that improves
cardiovascular disease (CVD) outcomes in racial and ethnic minorities. This
objective will be accomplished by funding up to seven collaborative partnerships
(i.e., Partnerships Program to Reduce Cardiovascular Health Disparities) between
research-intensive medical centers (RIMCs) that have a track record of NIH-
supported research and patient care; and minority healthcare serving systems
(MSSs) that lack a strong research program. Each Partnership Program will: a)
design and carry out multiple interdisciplinary research projects that
investigate complex biological, behavioral and societal factors that contribute
to CVD health disparities and facilitate clinical research within the MSS to
improve CVD outcomes and reduce health disparities, and b) provide reciprocal
educational and skills development programs to develop investigators able to
conduct research aimed to reduce cardiovascular disparities and thereby enhance
research opportunities, enrich cultural sensitivity and cardiovascular research
capabilities at both institutions.
For the purpose of this solicitation, minority serving systems (MSSs) may
include graduate or medical schools with more than 50% enrollment of minority
students (African American, Hispanic, Native Americans, Alaskan Natives, Native
Hawaiians, Pacific Islanders) or non-academic medical centers, community
hospitals, community health centers or private practices serving minority
communities and which lack a robust research program. Research-intensive
medical centers (RIMCs) are universities, medical schools or medical centers
with documented accomplishments in research. Research intensive medical
institutions that serve a significant number of minorities are considered RIMCs,
not MSSs for the purpose of this solicitation.
Applicants must indicate whether they are applying as an RIMC or MSS and provide
documentation of their strengths in support of their eligibility claim. Because
this program seeks to establish new partners, a single institution should not
apply as both the RIMC and MSS for a Partnership Program unless there are
special circumstances, such as a large umbrella health system that includes
multiple facilities that operate independently.
RESEARCH OBJECTIVES
Nature of the Research Problem
While there has been great progress in reducing CVD morbidity and mortality in
the U.S. over the past 40 years, some minority groups have not shared fully in
this progress and continue to have lower life expectancy and higher CVD
morbidity. On average, minorities have less access to medical care, receive
less aggressive care and fewer diagnostic and therapeutic cardiac procedures,
and adhere poorly to prescribed medical regimens. Thus, research to reduce
health disparities by improving CVD outcomes in minorities offers potential for
a substantial positive public heath impact. Academic medical centers and
institutions capable of carrying out such research, however, often lack access
to and the trust of minority patients. Minority patients often receive
fragmented care because they lack access to regular medical care, present to
emergency departments rather than primary care physicians for complications of
an advanced chronic CVD condition, and are less likely to follow medical
regimens. Minority communities often harbor distrust of clinical research.
Minority patients report greater satisfaction when receiving care from minority
providers and are reluctant to receive treatment outside their MSS.
Background
In general, minorities have high rates of hypertension, elevated cholesterol,
cigarette smoking, obesity, metabolic syndrome, and diabetes, as well as other
behavioral, environmental, and occupational risk factors for cardiovascular
diseases, such as sleep problems - all elements that contribute to excess CVD
morbidity and mortality. The causes of minority health disparities are complex
and incompletely understood. Although evidence of genetic, biologic, and
environmental factors is well documented, poor outcomes are also attributed to
under-treatment. Such under-treatment may be due to limited access to health
care or, in some cases, break-down of the medical system, or failure of the
physician and/or patient to allow for optimal health care, even when access is
not impaired. The complex interactions of behavior, socio-economic status
(SES), culture, and ethnicity are important predictors of health outcomes and
sources of health disparities. Despite efforts to elucidate genetic and
environmental risk factors and to promote cardiovascular health in high-risk
populations, trends in CVD outcomes suggest that CVD health disparities continue
to widen.
Scientific Knowledge to be Achieved through Research Supported by the Program
This program is intended to promote a coordinated, comprehensive,
interdisciplinary, and focused research effort to improve cardiovascular health
outcomes in minority populations. The program will accomplish this goal by
establishing meaningful partnerships between a RIMC (which will provide research
experience and expertise) and a MSS (which will provide access to patients and
established close community interactions). The MSS and RIMC must be full
partners who together will provide a fertile environment for studying how to
optimize prevention, diagnosis and treatment of CVD in minority populations and
individuals. Each partnership will minimize medical access barriers through
community participation and fostering of collaboration between researchers and
community health providers to develop effective strategies to overcome
impediments to the prevention and treatment of CVD. It is expected that
patients eligible for clinical studies in the partnerships program will be
recruited, treated and followed in the MSS with minimal disruption of
established practice relationships. The RIMC would insure rigorous standards of
scientific investigation, analysis and dissemination of findings.
Scope of Research and Educational Objectives
This RFA is designed to stimulate MSSs and RIMCs to generate partnerships to: 1)
conduct collaborative research on the causes and resolution of disproportionate
burden of cardiovascular disease in U.S. minority populations, and 2) provide
culturally sensitive, reciprocal educational and skills development programs
that will serve to enhance and enrich the research potential and cardiovascular
disease management capabilities at the collaborating organizations.
Each Partnership Program will design and carry out an integrated research
program to improve a cardiovascular health outcome relevant to the MSS and its
community. Multiple projects may address gaps in our understanding of how CVD
outcome is influenced by clinical presentation and manifestations; differences
in behavior, education, cultural and economic environment; and differing
responses to treatment. Measurements selected to monitor CVD outcome of
interest must be meaningful to the local, health care practice, and research
communities in terms of demonstrating improvement over the period of the
program.
Partnerships are expected to encourage recruitment of new investigators with
interests in reducing health disparities. Interdisciplinary teams may include
behavioral and social scientists in addition to basic and clinical
investigators.
Types of Research and Experimental Approaches
The two applications, one from the MSS and one from the RIMC, that form a
Partnership Program should include an identical "Research Plan" that covers in
no more than 40 pages (Section A through D) four aims and two educational aims.
(See "Special Requirements"). A wide range of research areas (e.g.
pathophysiologic mechanisms, pharmacology, clinical trials, complementary
medicine, and patient and health care provider education) would be responsive to
this RFA directed at understanding and reducing cardiovascular disparities. It
is expected that each project will include or derive methods to reduce
cardiovascular disparities. A few topics illustrative of these areas are
provided below. These are only examples and applicants are encouraged to
propose others.
A. Examples of Research Topics
o Intervention projects that will prevent, decrease, or eliminate cardiovascular
disparities.
o Intervention projects that will improve cardiovascular outcomes in minorities.
o Investigations to elucidate pathophysiologic mechanisms that result in
differing clinical symptoms, response to diagnostic evaluation, and/or
intervention.
o Investigations to elucidate the contributions, roles, and mechanisms of risk
factors in cardiovascular disparities.
o Investigations to provide new strategies to enhance delivery of medical care,
such as improving patient, physician, or medical system adherence.
o Investigations to elucidate and resolve the effect of various factors of
health care seeking behavior on cardiovascular health disparities.
o Studies which focus on community environment as a resource to eliminate
disparities.
o Studies to identify and validate suitable measures of outcomes to monitor
improvement in health care that are practical and compelling to community,
practice and research communities.
B. Education and Skills Development
A second goal of this RFA is to educate and promote career development of new
investigators capable of conducting research to reduce cardiovascular health
disparities. The proposed program should encourage reciprocal educational
programs between the MSS and the RIMC to enhance research capabilities and
enrich the sensitivity to minority cardiovascular research projects and
interventions at both institutions. The educational activities within a
Partnership Program should include educational programs in cardiovascular care
in high risk populations as well as the conduct of research.
The educational project must represent a true collaboration between partner
organizations. For example, proposed training or skills development might
provide graduate students in the MSS with the opportunity to fulfill research
requirements in the RIMC with mentoring by RIMC investigators. Clinical
research training and skills development proposed for RIMC students could
include rotations at the MSS that focus on dealing with cross-cultural factors
and reducing cardiovascular health disparities.
Successful activities should lead to more extensive educational projects that
may ultimately lead to competitive applications for NIH training grants. The
educational aim(s) in each application should include the following elements:
o Designation of key personnel who will lead the educational activities at each
institution in the Partnership Program and description of the organizational
structure and management to insure collaboration.
o Plans for a training core to accomplish the cross-institution training
objectives of the RFA that is comprised of courses, seminars, mentoring projects
or other training methods.
o Plans for training students, investigators and other personnel on issues and
problems associated with cardiovascular disparities in minority populations.
o Plans by the MSS to stimulate research programs in the RIMC that focus on
reducing cardiovascular disparities and provide education for the Partnership
Program researchers and staff in cultural sensitivity and methods to promote
community participation in research.
o Plans by the RIMC to help the MSS build its resources, research capacity, and
skills to conduct clinical research. This should include seminars or mentoring
for administrative personnel as well as researchers and include issues related
to research grant development and administration with grant awarding agencies
such as NIH.
o Plans to sustain the partnership and help investigators at the MSS and the
RIMC generate collaborative investigator-initiated research proposals and
continue reciprocal training opportunities.
o Plans of the partnership to foster career development programs that expand the
scientific cadre of investigators dedicated to research on cardiovascular health
and disease in minority populations.
Program Organization
Partnership programs must include established academic investigators and primary
care and cardiovascular medicine health providers that will work as a team to
develop an integrated research program focused on a significant contributory
factor(s) to poor cardiovascular health outcomes in one or more minority
populations. Projects may address multiple areas such as pathophysiology,
pharmacology, genetics or genomics, behavioral or social science, patient
education, and alternative methods to focus on reducing or eliminating health
disparities. Each component partner is required to include an education and
skills development aim to expand the number of investigators dedicated to
research aimed at improving CVD outcomes in high risk minority populations.
Partnerships are permitted to request support for a core or shared resources
including administrative staff.
A successful Partnership Program will recognize the separate but, complementary
strengths of each component partner. It is anticipated that the goal of
reducing health disparities is facilitated by the effective collaboration of the
MSS and RIMC and resulting Partnership Program organization, management and
operation. Each Partnership Program will include two or more projects that
relate to a clearly defined, unified central theme. Each partner institution
will be responsible for at least two research aims and one educational aim
within the research projects. Because the factors contributing to health
disparities are complex, proposed programs may include multiple requisite
disciplines. The central theme should be clearly developed in the introduction
and indicate the rationale of how the multidisciplinary projects are related and
will uniquely meet the goals of the five year program. The relationship of each
project to the central theme must be described and each project should have
clearly defined hypotheses and aims. Projects should be patient-oriented and
include at least one intervention project to reduce cardiovascular health
disparities which can be completed in a five-year project period. Each
Partnership Program may request core facilities for administration, community
participation, and education.
An important element of the Partnership Program is the community involvement.
Community participation is expected to improve awareness, understanding and
knowledge of specific projects and to promote acceptance of the overall goals of
the Partnership Program by the target population. It is also expected that an
open dialogue with representative community leaders will facilitate
identification and resolution of obstacles to conducting clinical
investigation(s). Ultimately research objectives and methods should be mutually
understood and accepted by the research team and the target population.
Community acceptance will enhance subject recruitment and interest in the
successful completion and results of the Partnership Program. Description of
community involvement and how it will enhance the Partnership Program should be
fully developed.
Example of a Partnership Program
One example of a partnership would be the collaboration of an urban research
hospital center with MEDICAID-supported managed care facilities. In such a
partnership, investigators might develop a program around the theme of excess
morbidity and mortality in African-Americans with coronary artery disease.
Separate interventions to improve outcomes following acute myocardial infarction
might include 1) aggressive revascularization versus usual care, or 2) protocol-
guided aspirin, beta-blocker, ACE inhibition versus usual community care in-
hospital and with follow-up. Outcome measures might include the proportion of
patients that reach target treatment goals. Studies that address 1) adherence
to medical regimens in patients with multiple risk factors, 2) impaired
endothelial function in African-Americans and 3) patient recognition of acute
myocardial infarction symptoms, are examples of related projects. Examples of
other possible topics that would benefit from this coordinated approach include:
a) obesity-related cardiovascular diseases in Hispanics; or b) hypertension-
related end-organ disease in African Americans.
Minimum Requirements for Partnership Program Application
Each partnership should include the following:
o Minority healthcare serving system
o Research-intensive medical center in close proximity to the minority
healthcare serving system.
o Interdisciplinary investigation of the complex biological, behavioral and
societal factors contributing to higher CVD morbidity and mortality in
minorities.
o Collaborative research conducted in each of the partnership components (RIMC
and MSS).
o Community participation for improving community understanding and interest in
the successful completion of program and for recruiting and retaining minority
patients.
o Education and skills development of new investigators focusing on reduction of
CVD health disparities.
o Identification and development of objective endpoints to gauge the
effectiveness of each interventional project conducted.
MECHANISM OF SUPPORT
This RFA will use NIH U01 award mechanism(s). The NIH (U01) is a cooperative
agreement award mechanism in which the Principal Investigator retains the
primary responsibility and dominant role for planning, directing, and executing
the proposed project, with NIH staff being substantially involved as a partner
with the Principal Investigator, as described under the section "Cooperative
Agreement Terms and Conditions of Award". This RFA is a one-time solicitation.
Future unsolicited, competing-continuation applications based on this project
will compete with all investigator-initiated applications and will be reviewed
according to the customary peer review procedures. The anticipated award date
is September 30, 2004.
This RFA uses just-in-time concepts. It also uses the modular as well as the
non-modular budgeting formats (see
http://grants.nih.gov/grants/funding/modular/modular.htm).
Specifically, if you are submitting an application with direct costs in each
year of $250,000 or less, use the modular format. Otherwise follow the
instructions for non-modular research grant applications. This program does not
require cost sharing as defined in the current NIH Grants Policy Statement at
http://grants.nih.gov/grants/policy/nihgps_2001/part_i_1.htm
The total project period for an application submitted in response to this RFA
may not exceed 5 years. Applications from each collaborating organization that
form a partnership should clearly identify the institutions constituting the
Partnership Program and the investigators in each institution who will serve
respectively as the Principal Investigator and Co-principal Investigator(s) of
each grant. The two applications, one from the MSS and the other from the RIMC,
will be treated as a single program for review purposes and receive a single
score based on the strengths and weaknesses of the two component applications.
Although they will receive separate grant awards, if successful, they will be
treated as a single entity (i.e., a Partnership Program for Reducing
Cardiovascular Disparities) in post award monitoring, for submission of progress
reports and other RFA-related activities.
FUNDS AVAILABLE
The NHLBI intends to commit approximately $6.0 million in FY 2004 to fund 5 to 7
new partnership programs in response to this RFA. An applicant (one component
of the Partnership Program) may request a project period of up to 5 years and a
budget of up to $600,000 total costs per year. A maximum of $75,000 may be
budgeted for educational and career development activities in each application.
Travel funds for a roundtrip to Bethesda for at least two individuals from each
partner institution should be included for program-related travel for each year
of the grant period. Funds for core facilities and expenses for administration,
community participation and training may also be requested. Because the nature
and scope of the proposed research will vary from application to application, it
is anticipated that the size and duration of each award will also vary.
Although the financial plans of the NHLBI provide support for this program,
awards pursuant to this RFA are contingent upon the availability of funds and
the receipt of a sufficient number of meritorious applications. At this time,
it is not known if this RFA will be reissued.
ELIGIBLE INSTITUTIONS
You may submit (an) application(s) if your organization is a domestic
institution and has any of the following characteristics:
o For-profit or non-profit organizations
o Public or private institutions, such as universities, colleges, hospitals, and
laboratories
o Units of State and local governments
o Eligible agencies of the Federal government
o Faith-based or community-based organizations
INDIVIDUALS ELIGIBLE TO BECOME PRINCIPAL INVESTIGATORS
Any individual with the skills, knowledge, and resources necessary to carry out
the proposed research is invited to work with their institution to develop an
application. Individuals from underrepresented racial and ethnic groups as well
as individuals with disabilities are encouraged to apply.
SPECIAL REQUIREMENTS
(Please see SUPPLEMENTARY INSTRUCTIONS too)
Applications may be submitted by institutions that meet the definitions for MSSs
and RIMCs provided in the RFA. Applications will be accepted only from MSSs and
RIMCs that enter into bilateral agreements and establish themselves as a
Partnership Program for Reducing Cardiovascular Health Disparities. Separate
applications are to be submitted by each partner in the Partnership Program, but
the applications will provide the same Research Plan (i.e., identical parts A to
D of Form PHS 398-Rev. 5/01). The common Research Plan, which has 40 page
limit, must have at least six specific aims (four research-specific aims plus
two training-specific aims), with each institution serving as the lead
performance site for at least two research-specific aims and one training-
specific aim. It is expected that the research and training program at one
component of the Partnership Program will complement the program at the other,
be performed as a collaborative effort and that the Principal Investigator from
one component of the Partnership Program will name investigators from the second
component as collaborating investigators. Each of the two applications should
identify the component institutions of the Partnership program, delineate the
research and educational activities to be performed at each of the components,
and explain how these activities complement each other. Although the Research/
Education Plan section of the applications from each institution will be
identical, the applications will have different Face Pages, Budgets,
Biographical Sketches, and Other Support and Resource pages. Because of the
expected complementary and interrelated nature of this common research effort,
the separate applications from each Partnership Program for Reducing
Cardiovascular Disparities will be considered and reviewed as a single program,
and assigned the same priority score by the Scientific Review Group. However,
a successful Partnership Program will receive two separate awards, one to the
MSS and the one to the RIMC.
COOPERATIVE AGREEMENT TERMS AND CONDITIONS OF AWARD
The following terms and conditions will be incorporated into the award statement
and provided to the Principal Investigator as well as the institutional official
at the time of the award. These special Terms of Award are in addition to and
not in lieu of otherwise applicable OMB administrative guidelines, HHS Grant
Administrative Regulations at 45 CFR Parts 74 and 92, and other HHS, PHS and
NIH Grant administration policy statements.
1. Awardee Rights and Responsibilities
Awardees have primary authorities and responsibilities to define objectives and
approaches, to plan and conduct the research activities, and to analyze and
publish results, interpretations and conclusions of their studies.
Awardees will retain custody of and have primary rights to the data developed
under these awards, subject to Government rights of access consistent with
current HHS, PHS, and NIH policies.
Awardees, two from the MSS and two from the RIMC, should attend an annual
meeting at Bethesda, Maryland for the purpose of discussing progress and
exchanging ideas.
2. NHLBI Staff Responsibilities
The dominant role and prime responsibility for the Center activities reside with
the awardees for the project as a whole, although specific tasks and activities
in carrying out the programs will be shared among the awardees and the NHLBI
Project Scientist. The Program Administrator may serve as the NHLBI Project
Scientist.
The Program Administrator will be an Extramural official with responsibility for
normal program stewardship and administration of the award. The NHLBI reserves
the right to terminate or curtail the study (or an individual award) for lack of
scientific progress, failure to adhere to policies of the NHLBI under the U01
mechanism, or failure of the partnerships to evolve within the intent and
purpose of this initiative. The NHLBI Project Scientist's scientific-
programmatic involvement during the conduct of this activity is expected to be
above and beyond that normally exercised in the administration of a traditional
R01 research grant. The expanded programmatic involvement will provide
technical assistance, support, coordination, and momentum to help accomplish the
goal of creating effective research partnerships and will include:
o working with individual investigators and partners to facilitate
collaborations, including coordinating regularly scheduled conference calls with
principal investigators to discuss progress and approaches to address any
problems;
o assisting the partnership efforts by facilitating access to fiscal and
intellectual resources provided by NHLBI, NIH, and federal funding agencies;
o providing assistance in reviewing and commenting on all major transitional
changes of an individual partner's activities prior to implementation to assure
consistency with the goals of the RFA;
o coordinating activities with other ongoing studies supported by NHLBI to avoid
duplication of efforts and encourage sharing and collaboration in the
development of new interventions to reduce cardiovascular health disparities;
o linking the approaches developed from these partnerships to other Partnership
Programs funded by the RFA to ensure that information is shared and utilized on
the widest basis possible;
o helping re-direct program efforts within the peer reviewed scope of work,
including modifying projects/programs when they are not making sufficient or
timely progress; and
o organizing an annual meeting of the RFA participants.
3. Arbitration
Any disagreement that may arise on scientific/programmatic matters (within the
scope of the award); between award recipients and the NHLBI may be brought to
arbitration. An arbitration panel will be composed of four members: one
selected by each of the individual awardees in the Partnership Program, a third
member selected by NHLBI, and the fourth member to be selected by the three
previously selected members. This special arbitration procedure in no way
affects the awardee's right to appeal an adverse action that is otherwise
appealable in accordance with the PHS regulations at 42 CFR Part 50, Subpart D
and HHS regulation at 45 CFR Part 16.
WHERE TO SEND INQUIRIES
We encourage inquiries concerning this RFA and welcome the opportunity to answer
questions from potential applicants. Inquiries may fall into three areas:
scientific/research, peer review, and financial or grants management issues:
o Direct your questions about scientific/research issues to:
Patrice Desvigne-Nickens, M.D.
Division of Heart and Vascular Diseases
National Heart, Lung, and Blood Institute
6701 Rockledge Drive
Suite 9044, MSC 7956
Bethesda, MD 20892-7940
Bethesda, MD 20817 (for express/courier service)
Telephone: (301) 435-0515
Fax: (301) 480-1336
Email: [email protected]
o Direct your questions about peer review issues to:
Anne Clark, Ph.D.
Chief, Review Branch
Division of Extramural Affairs
National Heart, Lung, and Blood Institute
6701 Rockledge Drive
Room 7214, MSC 7924
Bethesda, MD 20892-7924
Bethesda, MD 20817 (for express/courier service)
Telephone: (301) 435-0270
FAX: (301) 480-0730
Email: [email protected]
o Direct your questions about financial or grants management matters to:
David Reiter
Grants Management
Division of Extramural Affairs
National Heart, Lung, and Blood Institute
6701 Rockledge Drive
Room 7156, MSC 7926
Bethesda, MD 20892-7926
Bethesda, MD 20817 (for express/courier service)
Telephone: (301) 435-0166
FAX: (301) 480-3310
Email: [email protected]
LETTER OF INTENT
Prospective applicants from each partnership programmed are asked to submit a
joint letter of intent that includes the following information:
o Descriptive title of the proposed research
o Name, address, and telephone number of the Principal Investigator from each
partner institution
o Names of other key personnel
o Participating institutions
o Number and title of this RFA
Although a letter of intent is not required, is not binding, and does not enter
into the review of a subsequent application, the information that it contains
allows NHLBI staff to estimate the potential review workload and plan the review.
The letter of intent is to be sent by the date listed at the beginning of this
document. The letter of intent should be sent to Dr. Anne Clark at the address
listed under WHERE TO SEND INQUIRIES.
SUBMITTING AN APPLICATION
Applications must be prepared using the PHS 398 research grant application
instructions and forms (rev. 5/2001). Applications must have a DUN and
Bradstreet (D&B) Data Universal Numbering System (DUNS) number as the Universal
Identifier when applying for Federal grants or cooperative agreements. The DUNS
number can be obtained by calling (866) 705-5711 or through the web site at
http://www.dunandbradstreet.com/. The DUNS number should be
entered on line 11 of the face page of the PHS 398 form. The PHS 398 document is
available at http://grants.nih.gov/grants/funding/phs398/phs398.html
in an interactive format. For further assistance contact GrantsInfo,
Telephone (301) 710-0267, Email: [email protected].
SUPPLEMENTARY INSTRUCTIONS: Each component institution within a proposed
Partnership Program for Reducing Cardiovascular Health Disparities should submit
a separate application with a cover letter that clearly delineates the proposed
partnership and includes a letter of commitment to the Partnership Program that
describes the bilateral agreement (See "Special Requirements").
Although each component submits a separate application, each application will
provide the same "Research Plan" (identical parts A to D of the PHS 398 form).
The "Research Plan" will cover both the research and educational aims (see
"Special Requirements") and must be limited to 40 pages. The research section
of the plan should include, for each of the 4 proposed research aims, a specific
description of the research approach proposed to address the aim, including the
goals, background and significance, preliminary studies, and research design and
methods. The "Research Plan" should also include an explanation of how the four
aims relate to and complement each other, and a timeline that describes how the
four aims will be addressed over the five year grant period. The educational
section of the plan should include the elements described in the "Education and
Skills Development" section of this RFA.
Description of community participation in the Partnership Program is required.
Community awareness, understanding, and commitment to the goals of the program
are likely to favorably influence participant recruitment and retention.
Outreach activities may include but are not limited to: establishing
relationships with traditional or non-traditional (regarding health) community
leaders, employing established or new methods to identify and trouble shoot
community concerns and obstacles to conducting the Partnership Program,
inclusion of community representatives in the Partnership Program, and
disseminating educational and informational materials. Evidence or plans for
establishing ties with the target community during planning, performance and
dissemination of program should be detailed under discussion of the environment.
Since the application must include an intervention project, plans for data
safety monitoring, including establishment of and independent data and safety
monitoring board must be included. Applicants should describe the
organizational structures and procedures they will employ to ensure the safety
of participants and the validity and integrity of the data; for a statement of
issues and concerns, see "NIH Policy for Data and Safety Monitoring," NIH guide
to Grants and Contracts, Release Date: June 10, 1998,
http://grants.nih.gov/grants/guide/notice-files/not98-084.html.
At the time of the award, applicants should be prepared to make adjustments to
their procedures based upon NHLBI policy.
Travel funds for a two-day meeting each year, most likely to be held in
Bethesda, Maryland, must be included in the budget calculation. The Principal
Investigators at the MSSs and RIMCs must include a statement indicating their
willingness to participate in these meetings. Applicants are encouraged to
contact the program officials listed under INQUIRIES for further information.
USING THE RFA LABEL: The RFA label available in the PHS 398 (rev. 5/2001)
application form must be affixed to the bottom of the face page of the
application. Type the RFA number on the label. Failure to use this label could
result in delayed processing of the application such that it may not reach the
review committee in time for review. In addition, the RFA title and number must
be typed on line 2 of the face page of the application form and the YES box must
be marked. The RFA label is also available at:
http://grants.nih.gov/grants/funding/phs398/label-bk.pdf.
SENDING AN APPLICATION TO THE NIH: Submit a signed, typewritten original of the
application, including the Checklist, and three signed, photocopies, in one
package to:
Center For Scientific Review
National Institutes of Health
6701 Rockledge Drive, Room 1040, MSC 7710
Bethesda, MD 20892-7710
Bethesda, MD 20817 (for express/courier service)
At the time of submission, two additional copies of the application plus all
five collated sets of appendix material must be sent to
Dr. Anne Clark at the address listed under WHERE TO SEND INQUIRIES.
APPLICATION PROCESSING: Applications must be received on or before the
application receipt date listed in the heading of this RFA. If an application
is received after that date, it will be returned to the applicant without
review.
Although there is no immediate acknowledgement of the receipt of an application,
applicants are generally notified of the review and funding assignment within 8
weeks.
The Center for Scientific Review (CSR) will not accept any application in
response to this RFA that is essentially the same as one currently pending
initial review, unless the applicant withdraws the pending application.
However, when a previously unfunded application, originally submitted as an
investigator-initiated application, is to be submitted in response to an RFA, it
is to be prepared as a NEW application. That is, the application for the RFA
must not include an Introduction describing the changes and improvements made,
and the text must not be marked to indicate the changes from the previous
unfunded version of the application.
PEER REVIEW PROCESS
Upon receipt, applications will be reviewed for completeness by the CSR and
responsiveness by the NHLBI. Incomplete applications will not be reviewed.
Applications that are complete and responsive to the RFA will be evaluated for
scientific and technical merit by an appropriate peer review group convened by
the NHLBI in accordance with the review criteria stated below. Because of their
interrelatedness, the applications from each component institution comprising a
Partnership Program will be reviewed as a single program and assigned the same
priority score. As part of the initial merit review, all applications will:
o Undergo a process in which only those applications deemed to have the highest
scientific merit, generally the top half of the applications under review, will
be discussed and assigned a priority score
o Receive a written critique
o Receive a second level review by the National Heart Lung and Blood Advisory
Council or Board.
REVIEW CRITERIA
The goals of NIH-supported research are to advance our understanding of
biological systems, improve the control of disease, and enhance health. In the
written comments, reviewers will be asked to evaluate the following aspects of
the application in order to judge the likelihood that the proposed research will
have a substantial impact on the pursuit of these goals. The scientific review
group will address and consider each of these criteria in assigning the
application's overall score, weighting them as appropriate for each application.
o Research plans
o Educational plans
o Collaboration
o Innovation
o Investigators
o Environment and institutional commitment including community participation
The application does not need to be strong in all categories to be judged likely
to have major scientific impact and thus deserve a high priority score. For
example, an investigator may propose to carry out important work that by its
nature is not innovative but is essential to move a field forward.
RESEARCH PLANS: Do the proposed research projects address important problems? If
the aims of the application are achieved, would care and clinical outcomes of
minority patients be improved? Are the conceptual framework, design, methods,
and analyses adequately developed, well-integrated, and appropriate to the aims
of the project? Do preliminary data support feasibility and proposed endpoints
and sample sizes? Do the applicants acknowledge potential problem areas and
consider alternative tactics?
EDUCATIONAL PLANS: Is the organizational structure of training activities well
planned? Are the content and breadth of proposed courses, seminars, and
mentorships appropriate for career development of the investigators/staff? Are
the educational aims of each partner complementary to one another such that the
research potential and cardiovascular disease management skills of the trainees
at both institutions will be enriched to reduce health disparities?
COLLABORATION: What is the quality of the collaborations envisioned within each
member institution and between the two partnering institutions? Are the aims at
the two partnering institutions complementary? Is there evidence that MSS and
RIMC have jointly planned projects? Is there evidence of community involvement
and acceptance of the proposed research?
INNOVATION: Does the project employ novel concepts, approaches or methods? Are
the research and educational aims original and innovative? Does the project
challenge existing paradigms or develop new methodologies or technologies?
INVESTIGATORS: Are the investigators from both members of the partnership
appropriately trained and well suited to carry out this work? Are the levels of
effort of the investigators sufficient for successful functioning of the
Partnership Program?
ENVIRONMENT: Do the scientific environments in which the work will be done
contribute to the probability of success? Do the proposed studies take
advantage of available resources? Does the Partnership Program have access to
minority populations willing to participate in clinical research projects? Is
there evidence of institutional support? Is the proposed community
participation appropriate for recruiting and retaining study participants?
ADDITIONAL REVIEW CRITERIA: In addition to the above criteria, the following
items will be considered in the determination of scientific merit and the
priority score:
PROTECTION OF HUMAN SUBJECTS FROM RESEARCH RISK: The involvement of human
subjects and protections from research risk relating to their participation in
the proposed research will be assessed. (See criteria included in the section on
Federal Citations, below).
INCLUSION OF WOMEN, MINORITIES AND CHILDREN IN RESEARCH: The adequacy of plans
to include subjects from genders, all racial and ethnic groups (and subgroups),
and children as appropriate for the scientific goals of the research. Plans for
the recruitment and retention of subjects will also be evaluated. (See Inclusion
Criteria in the sections on Federal Citations, below).
CARE AND USE OF VERTEBRATE ANIMALS IN RESEARCH: If vertebrate animals are to be
used in the project, the five items described under Section f of the PHS 398
research grant application instructions (rev. 5/2001) will be assessed.
SHARING RESEARCH DATA: Applicants requesting more than $500,000 in direct costs
in any year of the proposed research must include a data sharing plan in their
application. The reasonableness of the data sharing plan or the rationale for
not sharing research data will be assessed by the reviewers. However, reviewers
will not factor the proposed data sharing plan into the determination of
scientific merit or priority score. See
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-032.html
for guidance.
BUDGET: The reasonableness of the proposed budget and the requested period of
support in relation
RECEIPT AND REVIEW SCHEDULE
Letter of Intent Receipt Date: January 22, 2004
Application Receipt Date: February 19, 2004
Peer Review Date: June/July, 2004
Council Review: September 2-3, 2004
Earliest Anticipated Start Date: September 30, 2004
AWARD CRITERIA
Award criteria that will be used to make award decisions include:
o Scientific merit (as determined by peer review)
o Availability of funds
o Programmatic priorities.
REQUIRED FEDERAL CITATIONS
HUMAN SUBJECTS PROTECTION: Federal regulations (45CFR46) require that
applications and proposals involving human subjects must be evaluated with
reference to the risks to the subjects, the adequacy of protection against these
risks, the potential benefits of the research to the subjects and others, and
the importance of the knowledge gained or to be gained.
http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm
DATA AND SAFETY MONITORING PLAN: Data and safety monitoring is required for all
types of clinical trials, including physiologic, toxicity, and dose-finding
studies (phase I); efficacy studies (phase II); efficacy, effectiveness and
comparative trials (phase III). The establishment of data and safety monitoring
boards (DSMBs) is required for multi-site clinical trials involving
interventions that entail potential risk to the participants. (NIH Policy for
Data and Safety Monitoring, NIH Guide for Grants and Contracts, June 12, 1998:
http://grants.nih.gov/grants/guide/notice-files/not98-084.html).
SHARING RESEARCH DATA: Starting with the October 1, 2003 receipt date,
investigators submitting an NIH application seeking more than $500,000 or more
in direct costs in any single year are expected to include a plan for data
sharing or state why this is not possible.
http://grants.nih.gov/grants/policy/data_sharing
Investigators should seek guidance from their institutions, on issues related to
institutional policies, local IRB rules, as well as local, state and Federal
laws and regulations, including the Privacy Rule. Reviewers will consider the
data sharing plan but will not factor the plan into the determination of the
scientific merit or the priority score.
INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH: It is the policy of the
NIH that women and members of minority groups and their sub-populations must be
included in all NIH-supported clinical research projects unless a clear and
compelling justification is provided indicating that inclusion is inappropriate
with respect to the health of the subjects or the purpose of the research. This
policy results from the NIH Revitalization Act of 1993 (Section 492B of Public
Law 103-43).
All investigators proposing clinical research should read the "NIH Guidelines
for Inclusion of Women and Minorities as Subjects in Clinical Research -
Amended, October, 2001," published in the NIH Guide for Grants and Contracts on
October 9, 2001
(http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html);
a complete copy of the updated Guidelines are available at
http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm.
The amended policy incorporates: the use of an NIH definition of clinical
research; updated racial and ethnic categories in compliance with the new OMB
standards; clarification of language governing NIH-defined Phase III clinical
trials consistent with the new PHS Form 398; and updated roles and
responsibilities of NIH staff and the extramural community. The policy
continues to require for all NIH-defined Phase III clinical trials that: a) all
applications or proposals and/or protocols must provide a description of plans
to conduct analyses, as appropriate, to address differences by sex/gender and/or
racial/ethnic groups, including subgroups if applicable; and b) investigators
must report annual accrual and progress in conducting analyses, as appropriate,
by sex/gender and/or racial/ethnic group differences.
INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS: The
NIH maintains a policy that children (i.e., individuals under the age of 21)
must be included in all human subjects research, conducted or supported by the
NIH, unless there are scientific and ethical reasons not to include them. This
policy applies to all initial (Type 1) applications submitted for receipt dates
after October 1, 1998.
All investigators proposing research involving human subjects should read the
"NIH Policy and Guidelines" on the inclusion of children as participants in
research involving human subjects that is available at
http://grants.nih.gov/grants/funding/children/children.htm
REQUIRED EDUCATION ON THE PROTECTION OF HUMAN SUBJECT PARTICIPANTS: NIH policy
requires education on the protection of human subject participants for all
investigators submitting NIH proposals for research involving human subjects.
You will find this policy announcement in the NIH Guide for Grants and Contracts
Announcement, dated June 5, 2000, at
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html.
PUBLIC ACCESS TO RESEARCH DATA THROUGH THE FREEDOM OF INFORMATION ACT: The
Office of Management and Budget (OMB) Circular A-110 has been revised to provide
public access to research data through the Freedom of Information Act (FOIA)
under some circumstances. Data that are (1) first produced in a project that is
supported in whole or in part with Federal funds and (2) cited publicly and
officially by a Federal agency in support of an action that has the force and
effect of law (i.e., a regulation) may be accessed through FOIA. It is
important for applicants to understand the basic scope of this amendment. NIH
has provided guidance at
http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm.
Applicants may wish to place data collected under this PA in a public archive,
which can provide protections for the data and manage the distribution for an
indefinite period of time. If so, the application should include a description
of the archiving plan in the study design and include information about this in
the budget justification section of the application. In addition, applicants
should think about how to structure informed consent statements and other human
subjects procedures given the potential for wider use of data collected under
this award.
STANDARDS FOR PRIVACY OF INDIVIDUALLY IDENTIFIABLE HEALTH INFORMATION: The
Department of Health and Human Services (DHHS) issued final modification to the
"Standards for Privacy of Individually Identifiable Health Information", the
"Privacy Rule," on August 14, 2002. The Privacy Rule is a federal regulation
under the Health Insurance Portability and Accountability Act (HIPAA) of 1996
that governs the protection of individually identifiable health information, and
is administered and enforced by the DHHS Office for Civil Rights (OCR). Those
who must comply with the Privacy Rule (classified under the Rule as "covered
entities") must do so by April 14, 2003 (with the exception of small health
plans which have an extra year to comply).
Decisions about applicability and implementation of the Privacy Rule reside with
the researcher and his/her institution. The OCR website
(http://www.hhs.gov/ocr/) provides information on the
Privacy Rule, including a complete Regulation Text and a set of decision tools
on "Am I a covered entity?" Information on the impact of the HIPAA Privacy Rule
on NIH processes involving the review, funding, and progress monitoring of
grants, cooperative agreements, and research contracts can be found at
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-025.html.
URLs IN NIH GRANT APPLICATIONS OR APPENDICES: All applications and proposals for
NIH funding must be self-contained within specified page limitations. Unless
otherwise specified in an NIH solicitation, Internet addresses (URLs) should not
be used to provide information necessary to the review because reviewers are
under no obligation to view the Internet sites. Furthermore, we caution
reviewers that their anonymity may be compromised when they directly access an
Internet site.
HEALTHY PEOPLE 2010: The Public Health Service (PHS) is committed to achieving
the health promotion and disease prevention objectives of "Healthy People 2010,"
a PHS-led national activity for setting priority areas. This RFA is related to
one or more of the priority areas. Potential applicants may obtain a copy of
"Healthy People 2010" at http://www.health.gov/healthypeople.
It is also supportive of the President's new Healthier US Initiative and the
DHHS Secretary's Prevention Initiative, Steps to a Healthier US which can be
accessed at http://www.healthierus.gov/steps/.
AUTHORITY AND REGULATIONS: This program is described in the Catalog of Federal
Domestic Assistance at http://www.cfda.gov/ and is not subject
to the intergovernmental review requirements of Executive Order 12372 or Health
Systems Agency review. Awards are made under the authorization of Sections 301
and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and
under Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92). All awards are
subject to the terms and conditions, cost principles, and other considerations
described in the NIH Grants Policy Statement. The NIH Grants Policy Statement
can be found at http://grants.nih.gov/grants/policy/policy.htm
The PHS strongly encourages all grant recipients to provide a smoke-free
workplace and discourage the use of all tobacco products. In addition, Public
Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain
facilities (or in some cases, any portion of a facility) in which regular or
routine education, library, day care, health care, or early childhood
development services are provided to children. This is consistent with the PHS
mission to protect and advance the physical and mental health of the American
people.
Weekly TOC for this Announcement
NIH Funding Opportunities and Notices
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