Part I Overview Information


Department of Health and Human Services


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)

Title:   Cardiovascular Research Network (CVRN) in Community-Based Care (U19)

Announcement Type
New

Update: The following update relating to this announcement has been issued:

Request For Applications (RFA) Number: RFA-HL-07-011


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) 435-0714, 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.


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