and Human Services (HHS)
EXPIRED
Department of Health and Human Services
Title: Cardiovascular Research
Network (CVRN) in Community-Based Care (U19)
Announcement Type
New
Update: The following update relating to this announcement has been issued:
Catalog of Federal Domestic Assistance Number(s)
93.837, 93.226
Key Dates
Release Date: December 15,
2006
Letters of Intent
Receipt Date(s): January 22, 2007
Application
Receipt Date(s): February 21, 2007
Peer Review
Date(s): June/July 2007
Council Review
Date(s): August 2007
Earliest
Anticipated Start Date(s): September 2007
Expiration Date: February 22, 2007
Due Dates for E.O. 12372
Not Applicable
Additional
Overview Content
Executive Summary
Table of Contents
Part I Overview Information
Part II Full Text of Announcement
Section I. Funding Opportunity Description
1.
Research Objectives
Section II. Award Information
1.
Mechanism(s) of Support
2.
Funds Available
Section III. Eligibility Information
1.
Eligible Applicants
A.
Eligible Institutions
B.
Eligible Individuals
2.Cost
Sharing or Matching
3.
Other - Special Eligibility Criteria
Section IV. Application and Submission Information
1.
Address to Request Application Information
2.
Content and Form of Application Submission
3.
Submission Dates and Times
A.
Receipt and Review and Anticipated Start Dates
1.
Letter of Intent
B.
Sending an Application to the NIH
C.
Application Processing
4.
Intergovernmental Review
5.
Funding Restrictions
6.
Other Submission Requirements
Section V. Application Review Information
1.
Criteria
2.
Review and Selection Process
A.
Additional Review Criteria
B.
Additional Review Considerations
C.
Sharing Research Data
D.
Sharing Research Resources
3.
Anticipated Announcement and Award Dates
Section VI. Award Administration Information
1.
Award Notices
2.
Administrative and National Policy Requirements
A.
Cooperative Agreement Terms and Conditions of Award
1.
Principal Investigator Rights and Responsibilities
2.
NIH Responsibilities
3.
Collaborative Responsibilities
4.
Arbitration Process
3.
Reporting
Section VII. Agency Contact(s)
1.
Scientific/Research Contact(s)
2.
Peer Review Contact(s)
3.
Financial/ Grants Management Contact(s)
Section VIII. Other Information - Required Federal
Citations
Part II
- Full Text of Announcement
Section I. Funding Opportunity Description
1. Research Objectives
Nature of
the Research Opportunity
The National Heart, Lung, and Blood Institute (NHLBI) of the National Institutes of Health (NIH) invites applications for a five-year cooperative agreement to develop and support a Cardiovascular Disease Research Network (CVRN). The CVRN will facilitate and perform collaborative cardiovascular disease (CVD) research among healthcare organizations located in geographically diverse areas with the following characteristics: comprehensive longitudinal care including prevention, diagnosis and treatment of the major CVDs; access to large and diverse patient populations with low turnover rates; and patient- and provider-level information relevant to CVD. Although this research opportunity will support enhancements to existing data systems for research purposes, we envision that healthcare organizations will have already completed substantial work to integrate data systems (e.g., from laboratory, pharmacy, outpatient, hospitalization, and specialty care sources) in order that research can be completed within the timeframe of this award.
Need for the Research
No reliable nationwide data collection system exists to identify incident CVD events or prevalent CVD, to evaluate how preventive strategies and treatments for CVD and risk factors are used in practice or their patient outcomes, nor to respond rapidly to evolving research priorities or emerging public health issues concerning CVD. The National Committee for Quality Assurance estimates that if hypertension were controlled nationwide at levels seen in the best healthcare settings, over 29,000 deaths would be prevented annually. While there is evidence that delivery of evidence-based medicine is suboptimal, existing resources provide limited ability to examine factors associated with delivery of optimal care. In addition, changing patterns of diagnosis and treatment over time may substantially affect interpretation of CVD morbidity and mortality trends.
The ultimate impact of CVD research depends on how well scientific advances reach the population. NHLBI has invested enormous research resources to identify safe, effective CVD preventive, diagnostic, and therapeutic strategies. However, mechanisms are lacking to close the loop from research results to clinical care, i.e., to track actual clinical use of these therapies, to identify factors related to their adoption, and to assess associations of adoption vs. non-adoption with patient outcomes. In addition, mechanisms are lacking to determine incidence, prevalence, and prognosis of CVDs in actual clinical practice settings with typical patient populations. Investment in better data collection and utilization of existing data resources to assess patient characteristics and clinical care delivery in actual practice, as well as evaluation of approaches to improve care delivery, are crucial to the final step in this process, which aims to deliver improved care and achieve improved patient outcomes.
Scientific Goals and Objectives
The goal of the CVRN is to increase scientific knowledge of cardiovascular diseases (CVDs) including their epidemiology, risk and risk factors, prevention, detection and diagnosis, treatment, and prognosis in the context of community-based healthcare delivery, the environment in which most clinical and preventive care is delivered. Research funded by this RFA should be designed to be conducted in healthcare delivery organizations, take advantage of existing integrated data systems, and use complementary resources for collaborative activities relevant to the goal. The proposed healthcare organizations should provide care in diverse patient care settings (e.g., inpatient, outpatient), provide longitudinal care (including prevention, diagnosis, and treatment) of the major CVDs, and have access to large, diverse, and geographically dispersed patient populations with low turnover rates.
The CVRN program will provide targeted infrastructure development to facilitate conduct of CVD research across multiple healthcare organizations, such as creating common data definitions and merging data from various sources; conduct multi-site, collaborative, productive CVD research projects using integrated data systems within the timeframe of this project; and perform short-term investigations of emerging public health issues concerning CVD.
Specific objectives of the CVRN Research Program are as follow:
These research objectives will be accomplished by several cores and individual research projects. The specific cores and research projects will be proposed by the applicant.
The following approaches are anticipated for meeting the objectives: (1) developing and applying innovative methods to efficiently collect and interpret data from existing electronic data systems including electronic health records and web-based medical communication systems; (2) assembling large samples of patient and provider data for patients with CVDs or CVD risk factors; (3) documenting patient demographic and chronic disease risk characteristics, including traditional as well as novel risk factors; (4) obtaining data on hypothesized prognostic factors associated with healthcare delivery as well as with patient outcomes; (5) documenting longitudinal patterns of healthcare delivery, resource utilization, and costs; (6) collecting and integrating complex data from patients, providers, and organizations to examine issues in healthcare delivery from multiple perspectives, and (7) creating de-identified research datasets containing health information from the network’s member organizations for use by both network and outside researchers.
Types of Research Sought
Areas of research sought and examples of questions appropriate for the research to be supported by this RFA include, but are not limited to, the following:
1. Surveillance
2. Clinical Epidemiology, Prevention, and Outcomes Research
3. Evaluation and Methodological Studies related to Clinical Trials
4. Clinical Informatics Studies
Potential analysis approaches include: traditional epidemiologic methods using longitudinal medical records that examine hypothesized factors associated with outcomes (controlling for potential confounders) or case-comparison designs; quasi-experimental designs such as interrupted time series (e.g., to study CVD outcomes and cost-effectiveness); randomized designs for small-scale feasibility intervention studies or pilots; and others as appropriate to the research question and feasibility.
Through the multi-component U19 mechanism, the application must be organized into Research Projects and Cores. Each application must consist of two or more separate but related Research Projects, each of which makes a unique contribution to the research goals of the overall program, and associated cores that support the research projects. In general, a multi-component research program should achieve its overall goals more quickly and more efficiently than would individual projects each working independently.
See Section VIII, Other Information - Required Federal
Citations, for policies related to this announcement.
Section II. Award Information
1. Mechanism(s) of Support
The administrative and
funding opportunity to be used for this program will be a multi-component
Research Program cooperative agreement (U19), an "assistance"
mechanism (rather than an "acquisition" mechanism), in which
substantial NHLBI scientific and/or programmatic involvement with the awardee
is anticipated during performance of the activity. Under the cooperative
agreement, the NHLBI’s purpose is to support and/or stimulate the activity of
recipient(s), to generate a high-quality resource by involvement in and
otherwise working jointly with the award recipient(s) in a partner role, but it
is not to assume direction, prime responsibility, or a dominant role in the
activity. NHLBI staff will also be involved with the coordination of different
groups. Details of the responsibilities, relationships, and governance of the
study to be funded under the cooperative agreement are discussed later in this
document under the section "Terms and Conditions of Award." As an
applicant, you will be solely responsible for planning, directing, and
executing the proposed project.
This FOA uses NIH just-in-time budget concepts. It also uses the non-modular
budget format described in the PHS 398 application instructions (see http://grants.nih.gov/grants/funding/phs398/phs398.html).
A detailed categorical budget for the "Initial Budget Period" and the
"Entire Proposed Period of Support" is to be submitted with the
application.
NIH U19 cooperative agreement award mechanism, the Principal Investigator (PI)
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 PI, as described under the Section VI. 2. Administrative
Requirements, "Cooperative Agreement Terms and Conditions of
Award."
2. Funds Available
NHLBI
expects to provide a total of $7.5 million, over a five-year period, for this
RFA. The anticipated number of awards is one. The total cost for each project
year may not exceed $1.5 million subject to the availability of funds,
including all direct and indirect costs. No escalation beyond the total cost
allocation will be considered. The anticipated start date for this award is September 30, 2007, and the probable period of performance is September 30, 2007 - September 29, 2012.
Applications should contain five budget periods of 12 months each. Applicants should provide adequate written budget justification and include all applicable direct and F&A costs. It is anticipated that approximately 55-65% of the five-year budget will be allocated to the two proposed research projects. It is anticipated that no more than 30% of the budget should be allocated for infrastructure activities, including 5% or less of total costs for evaluation functions of the evaluation core. No more than 10% of the budget should be allocated for emerging research issues. Applications must include estimates for travel costs for in-person Steering Committee meetings. Travel cost estimates should include three in-person meetings the first funding year, two of which will occur in Bethesda, MD. In funding years 2-5, estimates should include two in-person Steering Committee meetings (one in Bethesda, MD, and one at the location of a national meeting).
Although the financial plans of the NHLBI provide support for this program, awards pursuant to this funding opportunity are contingent upon the availability of funds and the receipt of at least one meritorious application. No additional funding is guaranteed.
Facilities and
administrative costs requested by consortium participants are not included in
the direct cost limitation, see NOT-OD-05-004.
Section
III. Eligibility Information
1. Eligible Applicants
1.A. Eligible Institutions
You may submit an
application if your organization has any of the following characteristics:
Applications may be submitted by domestic for-profit and non-profit health care provider organizations (network members) acting jointly as a U.S. research network. A domestic application may not include an international component.
Networks must include a sufficient number of healthcare organizations such that total patient enrollment is stable (i.e., the majority of patients can be followed for a combined retrospective and prospective period of five years) and is at least three million adults (ages 18 and over). Also, network-covered populations should approximate the demographics of the general U.S. population, and must include diverse populations with respect to gender, race/ethnicity and, to the extent that it is practical, rural/urban populations and a range of geographic locations.
Applicants must demonstrate a shared commitment among all participating network members to working together on proposed research studies. Applicants must show evidence of ability to access and organize data collection from all participating network members and to utilize an integrated system across all sites. Applicants should also demonstrate linkage of electronic laboratory, pharmacy, outpatient, and hospitalization data at many network sites. If these capabilities do not currently reside within one or more of the network members, the applicant must include details of plans to develop the necessary linkages and integration in all network members. Applicants must demonstrate previous research productivity using the data resources available to their network. Each network member must have access to a resource unit that supports research data management.
1.B. Eligible Individuals
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 for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support.
The Principal Investigator of the program is expected to possess certain essential qualifications:
(1) capability to lead a strong scientific research team, including those with CVD research, bioinformatics, and data management expertise; (2) scientific leadership experience and a strong academic and scientific background, as exemplified by scientific publication and a record of peer-reviewed scientific support; (3) knowledge of NIH grant and research policies including those concerning data management and data privacy; and (4) knowledge of integrated data systems in health care organizations.
2. Cost Sharing or Matching
There is
no cost sharing requirement for this RFA.
The most current Grants
Policy Statement can be found at: http://grants.nih.gov/grants/policy/nihgps_2003/nihgps_Part2.htm#matching_or_cost_sharing
3. Other-Special Eligibility Criteria
An applicant may submit only
one application under this announcement.
Section
IV. Application and Submission Information
1. Address to Request Application Information
The PHS 398 application
instructions are available at http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive format. Applicants must use the currently approved version of
the PHS 398. For further assistance contact GrantsInfo, Telephone (301) 710-0267, Email: GrantsInfo@nih.gov.
Telecommunications
for the hearing impaired: TTY 301-451-5936.
2. Content and Form of Application Submission
Applications must be
prepared using the most current PHS 398 research grant application instructions
and forms. Applications must have a D&B Data Universal Numbering System
(DUNS) number as the universal identifier when applying for federal grants or
cooperative agreements. The D&B number can be obtained by calling (866) 705-5711 or through the web site at http://www.dnb.com/us/. The D&B
number should be entered on line 11 of the face page of the PHS 398 form.
The title and
number of this funding opportunity must be typed on line 2 of the face page of
the application form, and the YES box must be checked.
The
Research Plan in the application must be organized in the following sections:
A. Background and Significance
B. Overall Aims
C. Governance and Operational Structure
D. Individual Research Projects
E. Research Infrastructure
F. Emerging Research Issues
G. Supplementary Documentation
Sections A-C must not exceed a 15- page limit. Section D is limited to 15 pages per project. Section E must not exceed a 20-page limit. Section F should not exceed 3 pages.
A. Background and Significance. This section should briefly describe the healthcare organizations, including their size, diversity and stability of the patients, demographic composition of the patient population, and diversity of their geographic service areas; the potential significance of the CVRN in these organizations; and relevant research conducted to date in these organizations, including that which demonstrates productivity using available data resources and electronic data systems.
B. Overall Aims. The overall, broad objectives of the CVRN, including a description of what it intends to accomplish in this funding period, should be described in this section. The application must describe the structure of the CVRN, including an overview of the infrastructure, cores and individual research projects. The plans must also address how the proposed CVRN activities complement past or ongoing CVD research in the healthcare organizations, particularly research that has used available data resources and existing electronic data systems.
C. Governance and Operational Structure. This section should describe the proposed administrative structure of the CVRN, e.g., PI, co-Investigators, Steering Committee, other committees, other research support resources, and how these entities would function to support and maintain the cores and research projects of the CVRN. The narrative should also address how communication and collaboration will be established and maintained between the research projects and cores and across participating CVRN healthcare organizations, participating federal agencies (i.e., NHLBI/NIH), and other research collaborators. Costs should include face-to-face Steering Committee meetings and other key administrative functions. Appropriate structures to oversee quality control of the research (e.g., internal or external advisory committees) should be described.
D. Individual Research Projects. This section should provide details about how the CVRN resources will be used to complete at least two research projects. The research should be consistent with the goals identified earlier in this RFA. At least one project should be feasible to conduct within the first three to four years of funding, i.e., can report on preliminary results at the end of the third funding year. Each proposed research project should provide a narrative not to exceed 15 pages. The narrative should provide information on: (1) scientific background and the significance of the research project; (2) research question and specific aims; (3) preliminary results, including methodological investigations and pilot research data from any previous studies that form the basis for the proposed project; (4) research design and methodology; (5) data sources and data collection instrumentation and methods; and (6) statistical issues and analytical methods. In addition, information on the performance sites, budget, key personnel, resources and environment for each research project should be provided.
E. Research Infrastructure. The infrastructure should be described in detail, and organized by cores to perform administrative, data standardization and integration, and evaluation functions. These cores should support more than one research project. In addition, information on the performance sites, budget, key personnel, resources and environment for each core should be provided. Core functions should include:
The narrative for this section should not exceed 20 pages.
F. Emerging Research Issues. This section should describe the ability to perform a limited number of short-term investigations of emerging public health issues concerning CVD. These should be accomplished through the analyses of descriptive data, using available data resources of the network. Section F should not exceed three pages.
G.
Supplementary Documentation. Statements of Institutional Commitment, Letters of
Support, letters of collaborations, and other similar documents, if
appropriate, should be included in this section.
3. Submission Dates and Times
Applications must be
received on or before the receipt date described below (Section IV.3.A). Submission times N/A.
3.A. Receipt, Review and Anticipated
Start Dates
Letters of Intent
Receipt Date(s): January 22, 2007
Application
Receipt Date(s): February 21, 2007
Peer Review
Date(s): June/July 2007
Council Review
Date(s): August 2007
Earliest
Anticipated Start Date(s): September 2007
3.A.1. Letter of Intent
Prospective applicants
are asked to submit a letter of intent that includes the following information:
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 IC 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:
Chief, Review Branch
Division of Extramural Research Activities
National Heart, Lung, and Blood Institute
6701 Rockledge Drive, Room 7214, MSC 7924
Bethesda , MD 20892-7924 (Express Zip: 20817)
Telephone: (301) 435-0270
FAX: (301) 480-0730
Email: nhlbichiefreviewbranch@nhlbi.nih.gov
3.B. Sending an
Application to the NIH
Applications must be
prepared using the research grant applications found in the PHS 398
instructions for preparing a research grant application. 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 (U.S. Postal Service Express or regular mail)
Bethesda, MD
20817 (for express/courier service; non-USPS service)
Personal
deliveries of applications are no longer permitted (see http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-040.html).
At the time of
submission, two additional copies of the application and all copies of the appendix material (a pdf version of the appendix
material is preferred but not required) must be sent to:
Chief, Review Branch
Division of Extramural Research Activities
National Heart, Lung, and Blood Institute
6701 Rockledge Drive, Room 7214, MSC 7924
Bethesda , MD 20892-7924 (Express Zip: 20817)
Telephone: (301) 435-0270
FAX: (301) 480-0730
Email: nhlbichiefreviewbranch@nhlbi.nih.gov
Using the RFA Label: The RFA label available in
the PHS 398 application instructions 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/labels.pdf.
3.C. Application
Processing
Applications must be received on or before the
application receipt date(s) described above (Section IV.3.A.). If an application is
received after that date, it will be returned to the applicant without review.
Upon receipt, applications will be evaluated for completeness by the CSR and
responsiveness by the NHLBI. Incomplete and non-responsive applications will not be
reviewed.
The NIH will not
accept any application in response to this funding opportunity 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 a funding opportunity, it is to
be prepared as a NEW application. That is, the application for the funding
opportunity 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.
Information on
the status of an application should be checked by the Principal Investigator in
the eRA Commons at: https://commons.era.nih.gov/commons/.
4. Intergovernmental Review
This initiative is not
subject to intergovernmental review.
5. Funding Restrictions
All NIH awards are
subject to the terms and conditions, cost principles, and other considerations
described in the NIH Grants Policy Statement. The Grants Policy Statement can
be found at http://grants.nih.gov/grants/policy/policy.htm.
Pre-award costs
are allowable. A grantee may, at its own risk and without NIH prior approval,
incur obligations and expenditures to cover costs up to 90 days before the
beginning date of the initial budget period of a new or competing continuation
award if such costs: are necessary to conduct the project, and would be
allowable under the grant, if awarded, without NIH prior approval. If specific
expenditures would otherwise require prior approval, the grantee must obtain
NIH approval before incurring the cost. NIH prior approval is required for any
costs to be incurred more than 90 days before the beginning date of the initial
budget period of a new or competing continuation award.
The incurrence of
pre-award costs in anticipation of a competing or non-competing award imposes
no obligation on NIH either to make the award or to increase the amount of the
approved budget if an award is made for less than the amount anticipated and is
inadequate to cover the pre-award costs incurred. NIH expects the grantee to be
fully aware that pre-award costs result in borrowing against future support and
that such borrowing must not impair the grantee's ability to accomplish the
project objectives in the approved time frame or in any way adversely affect
the conduct of the project. See NIH Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part6.htm.
6. Other Submission Requirements
Plan for Sharing Research
Data
The precise content of
the data-sharing plan will vary, depending on the data being collected and how
the investigator is planning to share the data. Applicants should describe
briefly the expected schedule for data sharing, the format of the final
dataset, the documentation to be provided, whether or not any analytic tools
also will be provided, whether or not a data-sharing agreement will be required
and, if so, a brief description of such an agreement (including the criteria
for deciding who can receive the data and whether or not any conditions will be
placed on their use), and the mode of data sharing (e.g., under their own
auspices by mailing a disk or posting data on their institutional or personal
website, through a data archive or enclave). Investigators choosing to share
under their own auspices may wish to enter into a data-sharing agreement.
References to data sharing may also be appropriate in other sections of the
application.
All applicants
must include a plan for sharing research data in their application. The data
sharing policy is available at http://grants.nih.gov/grants/policy/data_sharing. All
investigators responding to this funding opportunity should include a
description of how final research data will be shared, or explain why data
sharing is not possible.
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 the
priority score.
Sharing Research
Resources
NIH policy expects that
grant recipients make unique research resources readily available for research
purposes to qualified individuals within the scientific community after
publication (NIH Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps_2003/index.htm and http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part7.htm#_Toc54600131).
Investigators responding to this funding opportunity should include a plan for
sharing research resources addressing how unique research resources will be
shared or explain why sharing is not possible.
The adequacy of
the resources sharing plan and any related data sharing plans will be
considered by Program staff of the funding organization when making
recommendations about funding applications. The effectiveness of the resource
sharing will be evaluated as part of the administrative review of each
non-competing Grant Progress Report (PHS 2590, http://grants.nih.gov/grants/funding/2590/2590.htm).
See Section VI.3. Reporting.
Section V. Application Review Information
1. Criteria
The following will be
considered in making funding decisions:
2. Review and Selection Process
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 NHLBI in
accordance with the review criteria stated below.
As part of the
initial merit review, all applications will:
The goals of NIH supported research are to advance our understanding of biological systems, to improve the control of disease, and to enhance health. In their written critiques, reviewers will be asked to comment on each of the following criteria in order to judge the likelihood that the proposed research will have a substantial impact on the pursuit of these goals. Each of these criteria will be addressed and considered in assigning the overall score, weighting them as appropriate for each application. Note that an 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.
A. Review Criteria for Overall Program
o The demonstrated ability of the PI and Co-Investigators to provide effective scientific and administrative leadership, as demonstrated by selection of individual projects for scientific excellence and thematic relatedness and by promotion of effective interactions and collaborations. Although the scientific merit of the CVRN is based on the overall quality of scored and rated projects and cores, any components Not Recommended for Further Consideration (NRFC) are considered in the peer review evaluation of the investigators leadership and program administration skills.
o The adequacy of the commitment (level of effort) of the PI to the CVRN. There should be a specific commitment to both the scientific and administrative aspects of the network. It is acceptable, but not mandatory, that the PI be a project leader of an individual research project.
o Evidence that the program’s team is multidisciplinary and possesses expertise in CVD research, data management and bioinformatics.
o Evidence of coordination, interrelationships, and synergy between meritorious research projects and core components as related to the common theme of the CVRN.
o The advantages or value added that could be realized by conducting the proposed research as a collaborative network rather than through separate research efforts.
o The presence and quality of mechanisms for regular communication and coordination among investigators and network components
o The mechanisms for quality control of the research (e.g., internal or external advisory committees, such as a Data and Safety Monitoring Board).
o Adequacy of plans to provide opportunities for collaboration or data access by non-network investigators and organizations.
B. Review Criteria for Individual Research Projects
Projects may be Not Recommended for Further Consideration (NRFC) based on seriously flawed research approaches or on inclusion of research hazardous to human subjects.
NOTE: Synergy and thematic relatedness between the projects and cores, and their significance for the program as a whole, are not discussed when rating individual projects. These characteristics are discussed and rated under the Integration review criterion when evaluating the Overall Program.
C. Review Criteria for the Cores
Cores may be Not Recommended for Further Consideration (NRFC) if they have seriously flawed approaches, do not serve more than one research project, or lack sufficient evidence of technical expertise and experienced leadership.
2.A.
Additional Review Criteria:
In addition to the above
criteria, the following items will continue to 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 the Research Plan, Section E on Human Subjects in the PHS Form
398).
Inclusion
of Women, Minorities and Children in Research: The adequacy of plans to
include subjects from both genders, all racial and ethnic groups (and
subgroups), and children as appropriate for the scientific goals of the
research will be assessed. Plans for the recruitment and retention of subjects
will also be evaluated (see the Research Plan, Section E on Human Subjects in
the PHS Form 398).
2.B.
Additional Review Considerations
Budget: The reasonableness of the
proposed budget and the requested period of support in relation to the proposed
research. The priority score should not be affected by the evaluation of the
budget.
2.C. Sharing Research Data
Data Sharing
Plan: 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 the priority score. The presence of a data sharing plan will be part
of the terms and conditions of the award. The funding organization will be
responsible for monitoring the data sharing policy. Program staff will be responsible
for the administrative review of the plan for sharing research data.
2.D. Sharing Research
Resources
NIH policy expects that
grant recipients make unique research resources readily available for research
purposes to qualified individuals within the scientific community after
publication (See the NIH Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps/part_ii_5.htm#availofrr and http://www.ott.nih.gov/policy/rt_guide_final.html). Investigators responding to
this funding opportunity should include a sharing research resources plan
addressing how unique research resources will be shared or explain why sharing
is not possible.
Program staff will
be responsible for the administrative review of the plan for sharing research
resources.
The adequacy of
the resources sharing plan will be considered by Program staff of the funding
organization when making recommendations about funding applications. Program
staff may negotiate modifications of the data and resource sharing plans with
the awardee before recommending funding of an application. The final version of
the data and resource sharing plans negotiated by both will become a condition
of the award of the grant. The effectiveness of the resource sharing will be
evaluated as part of the administrative review of each non-competing Grant
Progress Report (PHS 2590). See Section VI.3. Reporting.
3. Anticipated Announcement and Award Dates
An announcement about an
award from this solicitation will be made by September 30, 2007.
Section
VI. Award Administration Information
1. Award Notices
After the peer review of
the application is completed, the PD/PI will be able to access his or her
Summary Statement (written critique) via the eRA
Commons.
If the
application is under consideration for funding, NIH will request
"just-in-time" information from the applicant. For details,
applicants may refer to the NIH Grants Policy Statement Part II: Terms and
Conditions of NIH Grant Awards, Subpart A: General (http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_part4.htm).
A formal
notification in the form of a Notice of Award (NoA) will be provided to
the applicant organization. The NoA signed by the grants management officer is
the authorizing document. Once all administrative and programmatic issues have
been resolved, the NoA will be generated via email notification from the
awarding component to the grantee business official (designated in item 12 on
the Application Face Page). If a grantee is not email enabled, a hard copy of
the NoA will be mailed to the business official.
Selection of an
application for award is not an authorization to begin performance. Any costs
incurred before receipt of the NoA are at the recipient's applicant’s risk.
These costs may be reimbursed only to the extent considered allowable pre-award
costs. See Also Section IV.5. Funding Restrictions.
2. Administrative and National
Policy Requirements
All NIH grant and
cooperative agreement awards include the NIH Grants Policy Statement as part of
the NoA. For these terms of award, see the NIH Grants Policy Statement Part II:
Terms and Conditions of NIH Grant Awards, Subpart A: General (http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part4.htm)
and Part II Terms and Conditions of NIH Grant Awards, Subpart B: Terms and
Conditions for Specific Types of Grants, Grantees, and Activities (http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_part9.htm).
The following
Terms and Conditions will be incorporated into the award statement and will be
provided to the Principal Investigator as well as to the appropriate
institutional official, at the time of award.
2.A. Cooperative Agreement
Terms and Conditions of Award
The following special
terms of award are in addition to, and not in lieu of, otherwise applicable OMB
administrative guidelines, HHS grant administration regulations at 45 CFR Parts
74 and 92 (Part 92 is applicable when state and local governments are eligible
to apply), and other HHS, PHS, and NIH grant administration policies.
The
administrative and funding instrument used for this program will be the
cooperative agreement U19, an "assistance" mechanism (rather than an
"acquisition" mechanism), in which substantial NIH programmatic
involvement with the awardees is anticipated during the performance of the
activities. Under the cooperative agreement, the NIH purpose is to support and
stimulate the recipients' activities by involvement in and otherwise working
jointly with the award recipients in a partnership role; it is not to assume
direction, prime responsibility, or a dominant role in the activities.
Consistent with this concept, the dominant role and prime responsibility
resides with the awardees for the project as a whole, although specific tasks
and activities may be shared among the awardees and the NIH as defined below.
2.A.1. Principal
Investigator Rights and Responsibilities
The Principal Investigator will have the primary responsibility for the CVRN effort as a whole, including research design and the actual performance of the CVRN effort, and preparation of publications. The PI will attend all CVRN Steering Committee meetings, will annually document progress in written reports to the NHLBI Program Director, and will provide periodic supplementary reports upon request.
To accommodate the changing environment resulting from improved technologies, the PI is expected to make any necessary adjustments in the overall research strategies during the course of the project period. While joint research projects are strongly encouraged under this RFA, research projects are also allowed that are conducted under the supervision of site-specific PIs at individual CVRN member organizations otherwise contributing to meeting the goals and objectives of this RFA. PIs of such single member organization studies will have equivalent status with all other PIs in regard to participation on the CVRN Steering Committee and other CVRN committees.
The awardee will retain custody of and have primary rights to the data developed under this award, subject to Government rights of access consistent with current HHS, PHS, and NIH policies. The awardee and NHLBI will jointly develop appropriate confidentiality procedures for data collection, processing, storage and analysis to ensure the confidentiality of data on individual healthcare organization patients, health care providers and institutions involved in CVRN research projects. No identifying information of individual patients or providers should be available through aggregated CVRN research databases. Encrypted study identification numbers will be used for all aggregated CVRN studies. The NHLBI expects that limited access data will be released under this study. Limited access data refers to study data, with certain deletions and recoding, that are released to requesting institutions and investigators for specific purposes and with certain restrictions and conditions. Limited access data should be made available to the public in accordance with the NHLBI Policy for Distribution of Data (http://www.nhlbi.nih.gov/resources/deca/policy_new.htm) as revised on June 27, 2005. Requests for exceptions to these guidelines will be considered by the NHLBI if adequately justified.
2.A.2. NIH Responsibilities
NIH/NHLBI will assign one
staff member to serve as the coordinator of the project (Project Scientist). The Project Scientist will
have substantial programmatic involvement that is above and beyond the normal
stewardship role in awards, as described below:
An NHLBI program official (Program Director) will be responsible for the normal scientific and programmatic stewardship of the award and will be named in the award notice.
The NHLBI reserves the right to terminate or curtail the CVRN (or an individual component of the award) in the event of inadequate progress, data reporting, insufficient use of this resource, or safety issues.
The NHLBI Program Director will interact with the PI on a regular basis to monitor progress. Monitoring may include: regular communication with the PI and his/her staff, periodic site visits for discussion with the awardee research team, observation of field data collection and management techniques, fiscal reviews, and other relevant stewardship matters.
The NHLBI
Program Director will also identify additional extramural staff from NHLBI and
other participating organizations that have appropriate experience and
expertise to collaborate with CVRN in the development of research concepts,
review of study designs and methods, participation in study analyses, and
review of scientific reports and articles. These additional staff may serve on
various CVRN committees.
2.A.3. Collaborative
Responsibilities
During the course of the
award period, the awardee will be invited to meet with the NHLBI, other PIs,
and/or other uninvolved experts in Bethesda, MD, to review scientific progress.
The CVRN Steering Committee will be the main oversight body for this cooperative agreement. The Steering Committee will coordinate the overall governance of the CVRN and establish and administer specific CVRN-wide policies. Membership of the Steering Committee will consist of the CVRN PI, PIs from each CVRN member organization, project leaders for each CVRN research project, and the Project Scientist from NHLBI. The chair of the Steering Committee will be selected by the Steering Committee members in consultation with the NHLBI. Each full member will have one vote.
The
Steering Committee will periodically review the research agenda and specific
research projects, review the evaluation of the overall operations of the CVRN,
determine directions for future development and improvement, and share
experiences in implementing the CVRN activities. It is expected that decisions
made or actions taken by the Steering Committee will be by consensus, or
majority vote when needed, and all network organizations will be expected to
implement them. Meetings of the Steering Committee will frequently be held by
teleconference calls, with in-person meetings usually held twice each year (see
Section IV.6). Financial support for these meetings should be included in the
CVRN application budget.
2.A.4. Arbitration
Process
Any disagreements
that may arise in scientific or programmatic matters (within the scope of the
award) between award recipients and the NIH may be brought to arbitration. An
Arbitration Panel composed of three members will be convened. It will have
three members: a designee of the Steering Committee chosen without NIH staff
voting, one NIH designee, and a third designee with expertise in the relevant
area who is chosen by the other two; in the case of individual disagreement,
the first member may be chosen by the individual awardee. This special
arbitration procedure in no way affects the awardee's right to appeal an
adverse action that is otherwise appealable in accordance with PHS regulations
42 CFR Part 50, Subpart D and HHS regulations 45 CFR Part 16.
3. Reporting
Awardees will be
required to submit the PHS Non-Competing Grant Progress Report, Form 2590
annually (http://grants.nih.gov/grants/funding/2590/2590.htm)
and financial statements as required in the NIH Grants Policy Statement.
Section
VII. Agency Contacts
We
encourage your inquiries concerning this funding opportunity 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:
1. Scientific/Research Contacts:
Barbara Wells, Ph.D.
Division of Prevention and Population Sciences
National Heart, Lung and Blood Institute
6701 Rockledge Drive, Room 8601, MSC 7936
Bethesda, MD 20892-7936 (Express Zip: 20817)
Telephone:
(301) 435-0417
FAX: (301-480-1863
Email: wellsb@nhlbi.nih.gov
2. Peer Review Contacts:
Chief, Review Branch
Division of Extramural Research Activities
National Heart, Lung, and Blood Institute
6701 Rockledge Drive, Room 7214, MSC 7924
Bethesda , MD 20892-7924 (Express Zip: 20817)
Telephone: (301) 435-0270
FAX: (301) 480-0730
Email: nhlbichiefreviewbranch@nhlbi.nih.gov
3. Financial or Grants Management Contacts:
Craig Bagdon
Office of Grants Management
National
Heart, Lung, and Blood Institute
6701 Rockledge Drive, Room 7129, MSC7921
Bethesda, MD 20892-7921 (Express Zip: 20817)
Telephone: (301) 435-0480
FAX: 301-480-3310
Email: cb422x@nih.gov
Section
VIII. Other Information
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). Monitoring should
be commensurate with risk. The establishment of data and safety monitoring
boards (DSMBs) is required for multi-site clinical trials involving
interventions that entail potential risks to the participants (NIH Policy for
Data and Safety Monitoring, NIH Guide for Grants and Contracts, http://grants.nih.gov/grants/guide/notice-files/not98-084.html).
Sharing
Research Data:
Investigators
submitting an NIH application seeking $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 and 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.
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 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 funding opportunity 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.
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 (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html);
a complete copy of the updated Guidelines is 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: (1) 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 (2)
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 Clinical Research:
The NIH maintains
a policy that children (i.e., individuals under the age of 21) must be included
in all clinical research, conducted or supported by the NIH, unless there are
scientific and ethical reasons not to include them.
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 (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 applications for research involving human subjects
and individuals designated as key personnel. The policy is available at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html.
NIH Public
Access Policy:
NIH-funded
investigators are requested to submit to the NIH manuscript submission (NIHMS)
system (http://www.nihms.nih.gov)
at PubMed Central (PMC) an electronic version of the author's final manuscript
upon acceptance for publication, resulting from research supported in whole or
in part with direct costs from NIH. The author's final manuscript is defined as
the final version accepted for journal publication, and includes all
modifications from the publishing peer review process.
NIH is requesting
that authors submit manuscripts resulting from (1) currently funded NIH
research projects or (2) previously supported NIH research projects if they are
accepted for publication on or after May 2, 2005. The NIH Public Access Policy applies to all research grant and career development award mechanisms,
cooperative agreements, contracts, Institutional and Individual Ruth L.
Kirschstein National Research Service Awards, as well as NIH intramural
research studies. The Policy applies to peer-reviewed, original research
publications that have been supported in whole or in part with direct costs
from NIH, but it does not apply to book chapters, editorials, reviews, or
conference proceedings. Publications resulting from non-NIH-supported research
projects should not be submitted.
For more
information about the Policy or the submission process please visit the NIH
Public Access Policy Web site at http://publicaccess.nih.gov/ and
view the Policy or other Resources and Tools including the Authors' Manual (http://publicaccess.nih.gov/publicaccess_Manual.htm).
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).
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. For publications listed in the appendix and/or Progress report,
internet addresses (URLs) must be used for publicly accessible
on-line journal articles. Unless otherwise specified in this solicitation, Internet addresses (URLs) should not be used to provide
any other information necessary for 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.
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.
Loan Repayment
Programs:
NIH encourages
applications for educational loan repayment from qualified health professionals
who have made a commitment to pursue a research career involving clinical,
pediatric, contraception, infertility, and health disparities related areas.
The LRP is an important component of NIH's efforts to recruit and retain the
next generation of researchers by providing the means for developing a research
career unfettered by the burden of student loan debt. Note that an NIH grant is
not required for eligibility and concurrent career award and LRP applications
are encouraged. The periods of career award and LRP award may overlap providing
the LRP recipient with the required commitment of time and effort, as LRP
awardees must commit at least 50% of their time (at least 20 hours per week
based on a 40 hour week) for two years to the research. For further
information, please see: http://www.lrp.nih.gov.
Weekly TOC for this Announcement
NIH Funding Opportunities and Notices
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