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: NHLBI Centers for Cardiovascular Outcomes Research (U01)

Announcement Type
New

Request For Applications (RFA) Number:  RFA-HL-10-008

Catalog of Federal Domestic Assistance Number(s)
93.837

Key Dates
Release Date:  October 19, 2009
Letters of Intent Receipt Date: December 21, 2009
Application Receipt Date: January 21, 2010
Peer Review Date(s): June/July 2010
Council Review Date: August 2010
Earliest Anticipated Start Date: October 1, 2010 
Additional Information To Be Available at: http://www.nhlbi.nih.gov/funding/inits/faq-hl-10-008andhl-10-018.htm
Expiration Date: January 22, 2010

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, Review and Anticipated Start Dates
         1. Letter of Intent
    B. Sending an Application to the NIH
    C. Application Processing
    D. Application Assignment
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. Resource Sharing Plan(s)
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

Purpose

This FOA solicits four-year cooperative agreement (U01) applications to institutions/organizations to establish three Centers for Cardiovascular Outcomes Research (CCOR) to complement and collaborate with other existing centers in cardiovascular outcomes research. This Funding Opportunity Announcement (FOA) runs parallel with a separate FOA that solicits the applications for a Research Coordinating Unit (See RFA-HL-10-018). This FOA will fund centers to conduct cardiovascular outcomes and comparative effectiveness research – natural experiments, quasi-experimental research, and practice-based randomized trials - that focuses on patient and clinician-relevant outcomes of healthcare and the determinants of these outcomes. The goal is to directly inform public policy and/or clinical practice. Proposed research should engage multidisciplinary teams such as clinician researchers, health services researchers, biostatisticians, and/or health economists to undertake novel projects focused on measuring, evaluating, and improving patient-centered outcomes of cardiovascular care delivery across the care continuum. Outcomes relevant for this FOA include cardiovascular mortality, clinical events, cost-effectiveness, or patient health-related quality of life.

This FOA supports both methodological and applied research focused on patient outcomes. Aims could include assessing, monitoring, and enhancing the quality of cardiovascular care at patient, clinician, and system levels; translating research findings into practical care delivery strategies for decision-makers (i.e., patients, providers, payers, regulators, and policymakers); evaluating innovative programs or interventions designed to improve the effectiveness and efficiency of delivering evidence-based cardiovascular care; enhancing the state of the science of comparative effectiveness and outcomes measurement; and developing innovative study designs and statistical methods for experimental designs and to address confounding and selection biases for quasi-experimental research on cardiovascular care.

Each Center will include several components: a designated Center director, one or two novel research projects with an integration of these studies within the Center, and a faculty development component. Each Center will be linked to the other NHLBI Centers and other cardiovascular outcomes research groups by interactions and meetings to facilitate the exchange of ideas, encourage the sharing of mutually beneficial knowledge and methods, and create networking and learning opportunities for Early Stage Investigator faculty and trainees.

Background

The 2004 NHLBI working group report on outcomes research in cardiovascular disease defines "Outcomes Research" as applied clinical research that generates knowledge to improve clinical decision-making and health care delivery to optimize patient outcomes. It is the component of health services research that studies the delivery and consequences of health care, and the comparative effectiveness of testing or treatment options on outcomes, from the perspective of patients, clinicians, and the health care system. Two central tenets of outcomes research are the focus on patient-centered outcomes and the direct and immediate relationship to health care delivery.  Outcomes research generates evidence that informs quality of care, cost-effective and clinically appropriate choices for patients in allocation of health care resources (comparative effectiveness), incorporation of best practice models into clinical practice, and promotion of clinically effective therapeutic interventions. Outcomes research investigates overall and differential patterns of care and consequences for general and disparate cardiovascular health outcomes.  It is particularly well suited to generate hypotheses and investigate strategies to address gaps in scientific knowledge relevant to clinical practice. 

Outcomes Research is not defined by a specific methodology, but rather employs natural experiment designs, quasi-experimental approaches, or experimental approaches such as randomized trials at the group level (e.g., randomizing clinics to evaluate interventions). Multiple fields contribute to outcomes research including clinical epidemiology, biostatistics, health services research, decision science, implementation science, health informatics, political science, public policy, and economics among others. The goal of outcomes research is to report the results of care delivered to patients, providers, health care systems, payers, and policymakers and to provide supporting data for the development of evidence-based strategies across the care continuum.

Despite the rapid pace of discovery in clinical research, technological advances in health care, and increasing knowledge about therapeutic efficacy, clinicians and policymakers often lack necessary information about clinical effectiveness, or rather how best to translate research findings into clinical practice and ultimately improved cardiovascular health. Outcomes research serves to bridge this gap in the following three ways: (1) providing information about contemporary patterns of care to identify strategies that work to improve health and health care; (2) developing and testing an array of valid tools to quantify and improve clinical performance, highlighting best approaches to translate evidence into clinical practice with a goal of universally high quality of care; and (3) determining the comparative effectiveness of different clinical strategies in actual practice as well as the barriers to achieving the full potential of these interventions. In focusing on patient outcomes from health care practices and interventions, outcomes research provides fundamental information on the impact of clinical and policy strategies on a broad range of patient outcomes, particularly those that patients experience and care about, such as mortality, clinical events, costs, and quality of life. By linking the care people receive to the outcomes they experience, outcomes research has become the key to enhancing methods to monitor and improve quality of care and to inform practice and policy decision-making.

Outcomes research provides mechanisms to understand how to translate research into practice, how to improve the quality and efficiency of care, how to achieve equitable and appropriate delivery of care, while maximizing and complementing the NHLBI investment in lab to bedside research. The Institute of Medicine in its landmark report Crossing the Quality Chasm emphasized six goals of a health care system: safe, effective, patient-centered, timely, efficient and equitable health care. Outcomes research is aligned with these aims and can link basic and efficacy research with quality patient and value-centered health care delivery.

Objectives and Scope

The purpose of this FOA is to fund up to three Centers for Cardiovascular Outcomes Research (CCOR). Projects should focus on the outcomes of cardiovascular mortality, clinical events, cost-effectiveness and/or quality of life. This funding opportunity provides support for the conduct of cardiovascular outcomes and comparative effectiveness research--natural experiments, quasi-experimental research, and practice-based randomized trials--that focuses on the patient and clinician-relevant outcomes of healthcare and the determinants of these outcomes. The goal is to directly inform public policy and/or clinical practice. For the purposes of this RFA, practice-based randomized trials exclude those that randomize at the patient-level, but rather focus on cluster, clinic, or institution-level randomization within the budgetary constraints of the RFA. Multidisciplinary project teams in each CCOR are appropriate and desired representing disciplines such as medicine, clinical epidemiology, biostatistics, health services research, sociology and behavior, health communications and marketing, anthropology, economics and management sciences. Populations of interest for these projects include patients at high risk for or with established cardiovascular disease. Proposed research may include clinical, health services, geographical, environmental, or socioeconomic data. The linkage of data across varying sources is encouraged and may be necessary to address pertinent questions. This program is interested in applications that take advantage of existing large scale registries or utilizes traditional large cohort studies for outcomes research. Broadly, the types of studies that would be considered responsive to this FOA focus on outcomes of mortality, clinical events, cost-effectiveness, and quality of life and could include the following: (1) studies of comparative effectiveness of therapy; (2) methodological work advancing the measurements of health outcomes and the methodology of outcomes and comparative effectiveness research; (3) studies of cost effectiveness, quality assessment, quality improvement, and comparative effectiveness; and (4) studies that relate access to care, informed medical decision-making, patient adherence, or efforts to promote the health of individuals and populations to patient outcomes.

Centers

Each CCOR will support one to two outcomes research projects of four years duration focusing on measuring, evaluating, and improving patient-centered outcomes of cardiovascular care delivery across the care continuum – at the patient, provider, health care organization or health care systems level. Multidisciplinary teams are encouraged and innovative study designs can be used to address important deficiencies in knowledge and implementation and/or statistical methods to augment the methodology of outcomes and comparative effectiveness research.

A Center Director will coordinate activities of the Center, providing administrative and scientific leadership, and will be responsible for the organization and operation of the Center and for communication with an Observational Study Monitoring Board (OSMB) or Data and Safety Monitoring Board (DSMB), as appropriate. Each Center will be linked to the other NHLBI Centers and existing cardiovascular outcomes research groups by interactions and meetings facilitated by the RCU (funded under a different FOA) to enhance exchange of ideas, encourage sharing of mutually beneficial knowledge and methods, and create networking opportunities for Early Stage Investigator faculty and trainees.

Faculty Development and Training

Centers will also have a focus on developing the cardiovascular outcomes research pipeline. Specifically, at least one project from each Center should have an identified Early Stage Investigator (NIH Early Stage Investigator; see http://grants.nih.gov/grants/new_investigators/ for definition). The application should describe a plan for mentoring and career development as well as demonstrate institutional commitment for developing and retaining this individual as an outcomes researcher. The program also can include the training and mentoring of fellows during the period of the award, but funds may not be used for training stipends or training not required to conduct the research. Centers should have a plan for monitoring the progress of the Early Stage Investigator (ESI) and any proposed fellows, for involving ESI faculty and fellows in annual Center meetings, for identifying opportunities for fellows to work with established outcomes investigators at other collaborating institutions, for tracking ESI faculty and trainees, and for allowing conferences and meeting participation for ESI faculty and trainees.

Selected Research Examples

The following are intended only as examples of the types of research relevant to this FOA, and should not be regarded as a call to pursue any specific line of investigation. Study outcomes relevant for this FOA and the examples below include cardiovascular mortality, clinical events, cost-effectiveness, or patient health-related quality of life.

Program Organization and Coordination

The Centers supported by this FOA will not use a common study protocol.  However, after awards are made, investigators will share knowledge, collaborate on developing and reporting standardized measures of key common variables, link datasets, or work on other collaborative activities. For example, investigators may collaborate on development of assessment measures, methodological techniques, or protocols. When appropriate, the use of common study variables, criteria, and protocols is highly encouraged to facilitate future analyses of the studies when possible. These collaborations will be facilitated by the RCU and the NHLBI Project Office.  

Investigators should indicate in their application their willingness to collaborate broadly as described above with NHLBI and NIH scientists, as well as with other awardees, in all aspects of the study.  The cooperative agreement mechanism will be used and a Steering Committee formed to facilitate collaboration (see Section VI.2.A, Cooperative Agreement Terms and Condition of Award).

Each awardee is responsible for refining and finalizing his/her research protocols, coordinating and funding the Center’s independent protocol review committee, and conducting the research.  Awardees should oversee implementation of the protocols and assure appropriate quality control procedures are in place.  Each awardee will be responsible for training and certifying his/her personnel.

The NHLBI will be substantially involved with the awardees in a partnership role.  The NHLBI Program Scientist will collaborate on project development, monitor study progress, ensure disclosure of conflicts of interest, and assure adherence to NHLBI policies.  NHLBI will appoint an Observational Study Monitoring Board (OSMB) or Data and Safety Monitoring Board (DSMB), as appropriate, and appoint a chairperson of the Steering Committee.

A Steering Committee will be the governing body for this project.  The Steering Committee will be composed of the Principal Investigators of each CCOR and the RCU and the NHLBI Program Scientist, each of whom will have one vote.  It is anticipated that the Steering Committee will meet in-person three times in the first year and two times each year thereafter throughout the course of the project. The Committee will meet by teleconference on at least a monthly basis.

An OSMB or DSMB will be established to monitor data and oversee participant safety in all of the studies supported by this initiative. An OSMB or DSMB will be responsible for monitoring the funded projects and will report to the Director of the NHLBI.  Therefore, applicants should not identify OSMB or DSMB members in their applications, or even inquire about the interest of possible OSMB or DSMB members, because anyone so contacted would not be eligible to serve as a member of the peer review committee that will evaluate the applications for scientific merit. 

The OSMB or DSMB will review the awardees protocols before the start of each project.  Subsequently, the OSMB or DSMB will monitor and review recruitment, adverse events, quality control, data analysis and publications, and overall awardee performance and scientific directions.  The Board has the responsibility to monitor study progress, review interim and final data, and to make recommendations regarding appropriate protocol and operational changes which may have substantial effects upon the ultimate interpretation of the study or affect the study’s funding. Thus, its ethical responsibilities to the participants, as well as to the integrity of the study, are of paramount importance to the NHLBI.  The OSMB or DSMB will meet at least twice each year and more frequently if needed.  At least one of the meetings each year will be in person.

In addition to the OSMB or DSMB meetings, each awardee will be required to attend Steering Committee meetings, and subcommittee meetings as appropriate, in which study plans, findings, and issues of common interests and concerns will be shared and discussed.  Each applicant must include in his/her budgets funds for attending these meetings.  For budgeting purposes, applicants should assume OSMB or DSMB meetings for one day, twice per year held in the Washington, D.C. metro area. The Steering Committee will convene three times during the first funding year and twice a year for each funding year thereafter.  Steering Committee meetings will be for two days held in the Washington, D.C. metro area. Applicants should budget for the attendance of at least the Principal Investigator. Investigator and trainee meetings will be held yearly around one of the Steering Committee meetings. Applicants should budget for one additional day in the Washington, D. C. metro area yearly for this meeting. 

Research Coordinating Unit

To facilitate coordination of research activities and communications between and among awardees and the NHLBI, a separate FOA under this program will support a Research Coordinating Unit (RCU). Please see the RFA-HL-10-018 for RCU functions and information about applying as a RCU. Applicant institutions are strongly encouraged to apply for both the research Center and RCU components of this program. The PD/PI for the Center must not be the same PD/PI for the Research Coordinating Unit, but can be from the same institution. Applicants proposing to perform the Research Coordinating Unit function should describe how these activities will be performed in a separate application responsive to RFA-HL-10-018

Please Note: The evaluation of the RCU will be separate from the overall review of the scientific merit of the Center application (see Section IV. 2.B). Institutions may apply for a Center award, RCU, or both.

See Section VIII, Other Information - Required Federal Citations, for policies related to this announcement.

Facilities and Environment

All applicants must provide evidence that the institution or institutions in which the research will take place have the infrastructure, resources and institutional support needed to facilitate interdisciplinary, collaborative research across clinical and applied research boundaries. Applicants must demonstrate the availability of adequate laboratory, clinical, office and other facilities needed to carry out the objectives of the proposed Centers for Cardiovascular Outcomes Research program. To the extent possible it is desirable for CCORs to have a commitment for sufficient contiguous space so that the Center has a high degree of cohesion and visibility. Internet access to scientific literature and other information must be readily available. Relevant support services, including for example adequate data management and analytic support, must also be readily accessible and documented in the proposal.

Successful applicants will provide evidence that the research teams assembled as part of the CCOR span multiple disciplines in areas relevant to the topic of investigation, including the social and behavioral sciences (e.g., psychology, sociology, anthropology), medical fields of study (e.g., cardiovascular medicine, general internal medicine, pharmacology, nutrition science), and related fields such as economics, business (marketing), health policy, environmental redesign, urban planning, engineering, informatics, communication sciences, humanities, exercise sciences, and other disciplines.  

Applicants must show they have access to the appropriate data and populations in which the studies will be conducted.  Applicants should outline the community and clinical engagement activities to be conducted to ensure that the proposed studies can be developed with appropriate community, health care system, public health, or health policy involvement. 

Applicants from institutions housing transdisciplinary, translational programs (such as Clinical and Translational Science Awards [CTSAs], NIH Roadmap Interdisciplinary Research Center Awards, Individual IC Transdisciplinary Centers and similar programs) are encouraged to apply, although applicants need not be from these programs and institutions to be successful. 

The NHLBI Clinical Research Guide at http://www.nhlbi.nih.gov/crg/index.php provides helpful information for preparation of clinical study applications.

Areas of research that will not be considered responsive to the FOA include:

See Section VIII, Other Information - Required Federal Citations, for policies related to this announcement.

Section II. Award Information


1. Mechanism of Support

This funding opportunity will use a cooperative agreement award mechanism. In the cooperative agreement mechanism, the Project Director/Principal Investigator (PD/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 Principal Investigator, as described under the Section VI. 2. Administrative Requirements, "Cooperative Agreement Terms and Conditions of Award."

This FOA uses “Just-in-Time” information concepts. It also uses non-modular budget formats described in the PHS 398 application instructions (see http://grants.nih.gov/grants/funding/phs398/phs398.html). 

At this time it is not known if this FOA will be reissued.

2. Funds Available

The NHLBI intends to commit up to $4.1 million in total costs to support 3 research centers awarded as a result of this announcement for fiscal year 2010.

NHLBI expects to commit up to $16.8 million in total costs over fiscal years 2010 through 2013 for the 3 research centers.  Each Center applicant may request a project period of four years and a budget for direct costs of up to $3,700,000 over the four-year period, with a limit of $920,000 in direct costs for any single year.

Applicant institutions are strongly encouraged to apply for both the research Center and RCU components of this program.

Funds for attending three face-to-face Steering Committee meetings in the first year and two meetings per year thereafter in the Washington, D. C. metro area must be included in the application. Funds for attending two face-to-face OSMB or DSMB meetings per year must be included in the application. Funds for attending an annual investigator meeting around a Steering Committee meeting must be included in the application. These funds should include travel for Early Stage Investigator faculty and Center fellows to participate in the annual investigator meetings in the Washington, D. C. metro area.

Because the nature and scope of the proposed research will vary from application to application, it is anticipated that the size and duration of each award will also vary. Although the financial plans of the IC(s) provide support for this program, awards pursuant to this funding opportunity are contingent upon the availability of funds and the receipt of a sufficient number of meritorious applications.

Facilities and administrative costs requested by consortium participants are not included in the direct cost limitation, see NOT-OD-05-004.

NIH grants policies as described in the http://era.nih.gov/ElectronicReceipt/preparing.htm for instructions).

The decision of whether to apply for a grant with a single PD/PI or multiple PDs/PIs is the responsibility of the investigators and applicant organizations, and should be determined by the scientific goals of the project. Applications for grants with multiple PDs/PIs will require additional information, as outlined in the instructions below. When considering multiple PDs/PIs, please be aware that the structure and governance of the PD/PI leadership team as well as the knowledge, skills and experience of the individual PDs/PIs will be factored into the assessment of the overall scientific merit of the application.  Multiple PDs/PIs on a project share the authority and responsibility for leading and directing the project, intellectually and logistically. Each PD/PI is responsible and accountable to the grantee organization, or, as appropriate, to a collaborating organization, for the proper conduct of the project or program, including the submission of required reports. For further information on multiple PDs/PIs, please see http://grants.nih.gov/grants/multi_pi.

The PD/PI must have the necessary expertise to lead this effort. He or she must be an experienced investigator in outcomes research, be able to lead a collaborative effort and must establish and/or nurture existing and ongoing partnerships.

The PD/PI for the Center must not be the same PD/PI for the Research Coordinating Unit. However, the PD/PI for the Center can be from the same institution as the PD/PI for the Research Coordinating Unit.

2. Cost Sharing or Matching

This program does not require cost sharing as defined in the current NIH Grants Policy Statement. However, third party in-kind matching contributions could be proposed to promote participation of Early Stage Investigator faculty or a diverse group of multidisciplinary teams and to encourage partnerships with agencies. Applicants who propose matching or in-kind financial contributions will be held to the requirement financially and must provide evidence (e.g., letter of support) of such contribution.  Please see 2 CFR 215.23 “Cost sharing or matching” http://www.whitehouse.gov/omb/assets/omb/circulars/a110/2cfr215-0.pdf

3. Other-Special Eligibility Criteria

Number of Applications. Applicants may submit more than one application, provided they are scientifically distinct.

Awards for the Research and Coordination Unit will not be made to the same Principal Investigator to ensure that, when appropriate, pooled data analyses are performed independently and that Center investigators are not diverted from their research by coordination activities.

An institution is strongly encouraged to submit an application for both an RCU and a Center, but each must have a different PD/PI.

Resubmissions.  Resubmission applications are not permitted in response to this FOA. 

Renewals.  Renewal applications are not permitted in response to this FOA.  

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 in item (box) 2 only of the face page of the application form, and the YES box must be checked.

SPECIAL INSTRUCTIONS

Applications with Multiple PDs/PIs 

When multiple PD/PIs are proposed, use the Face Page-Continued page to provide items 3a – 3h for all PD/PIs. NIH requires one PD/PI be designated as the “contact PD/PI” for all communications between the PD/PIs and the agency. The contact PD/PI must meet all eligibility requirements for PD/PI status in the same way as other PD/PIs, but has no special roles or responsibilities within the project team beyond those mentioned above. The contact PD/PI may be changed during the project period. The contact PD/PI should be listed in block 3 of Form Page 1 (the Face Page), with all additional PD/PIs listed on Form Page 1-Continued. When inserting the name of the PD/PI in the header of each application page, use the name of the “Contact PD/PI, et. al.” The contact PD/PI must be from the applicant organization if PD/PIs are from more than one institution.

All individuals designated as PD/PI must be registered in the eRA Commons and must be assigned the PD/PI role in that system (other roles such as SO or IAR will not give the PD/PI the appropriate access to the application records). Each PD/PI must include their respective eRA Commons ID in the eRA Commons User Name field.

All projects proposing Multiple PDs/PIs will be required to include a new section describing the leadership plan approach for the proposed project.

Multiple PD/PI Leadership Plan: For applications designating multiple PDs/PIs, a new section of the research plan, entitled “Multiple PD/PI Leadership Plan,” must be included. A rationale for choosing a multiple PD/PI approach should be described. The governance and organizational structure of the leadership team and the research project should be described, and should include communication plans, process for making decisions on scientific direction, and procedures for resolving conflicts. The roles and administrative, technical, and scientific responsibilities for the project or program should be delineated for the PDs/PIs and other collaborators. 

If budget allocation is planned, the distribution of resources to specific components of the project or the individual PDs/PIs should be delineated in the Leadership Plan. In the event of an award, the requested allocations may be reflected in a footnote on the Notice of Award.

Additional information is available in the PHS 398 grant application instructions.

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: December 21, 2009
Application Receipt Date: January 21, 2010
Peer Review Date(s): June/July 2010
Council Review Date: August 2010
Earliest Anticipated Start Date: October 1, 2010

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 in Section IV.3.A.

The letter of intent should be sent to:

Director, Office of Scientific Review
Division of Extramural Research Activities
National Heart, Lung, and Blood Institute
6701 Rockledge Drive, Room 7214
Bethesda, MD 20892-7924
Bethesda, MD 20817 (express/courier service)
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 forms 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 must be sent to:

Director, Office of Scientific Review
Division of Extramural Research Activities
National Heart, Lung, and Blood Institute
6701 Rockledge Drive, Room 7214
Bethesda, MD 20892-7924
Bethesda, MD 20817 (express/courier service)
Telephone: (301) 435-0270
Fax: (301) 480-0730
Email: nhlbichiefreviewbranch@nhlbi.nih.gov

3.C. Application Processing

Applications must be received on or before the application receipt date described above (Section IV.3.A.). If an application is received after that date, the application may be delayed in the review process or not reviewed.  Upon receipt, applications will be evaluated for completeness by the CSR and for responsiveness by the reviewing Institute Incomplete and/or 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 NIH Grants Policy Statement.

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 award if such costs: (1) are necessary to conduct the project, and (2) 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 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/archive/grants/policy/nihgps_2003/index.htm.)

6. Other Submission Requirements

Additional information or answers to questions on submission requirements are at: http://www.nhlbi.nih.gov/funding/inits/faq-hl-10-008andhl-10-018.htm.

Awardees must agree to the "Cooperative Agreement Terms and Conditions of Award" in Section VI.2.A "Award Administration Information."

Research Plan Page Limitations

25 pages

Appendix Materials

All paper PHS 398 applications submitted must provide appendix material on CDs only. Include five identical CDs in the same package with the application. See http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-031.html.

Do not use the Appendix to circumvent the page limitations of the Research Plan component. An application that does not observe the required page limitations may be delayed in the review process.

Resource Sharing Plan(s)

NIH considers the sharing of unique research resources developed through NIH-sponsored research an important means to enhance the value of, and advance research. When resources have been developed with NIH funds and the associated research findings published or provided to NIH, it is important that they be made readily available for research purposes to qualified individuals within the scientific community. If the final data/resources are not amenable to sharing, this must be explained in Resource Sharing section of the application. See http://grants.nih.gov/grants/policy/data_sharing/data_sharing_faqs.htm.

(a) Data Sharing Plan: Regardless of the amount requested, investigators are expected to include a brief 1-paragraph description of how final research data will be shared, or explain why data-sharing is not possible. Applicants are encouraged to discuss data-sharing plans with their NIH program contact. See Data-Sharing Policy or http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-032.html.

(b) Sharing Model Organisms: Regardless of the amount requested, all applications where the development of model organisms is anticipated are expected to include a description of a specific plan for sharing and distributing unique model organisms and related resources, or state appropriate reasons why such sharing is restricted or not possible. See Sharing Model Organisms Policy, and NIH Guide NOT-OD-04-042.

(c) Genome-Wide Association Studies (GWAS): Regardless of the amount requested, applicants seeking funding for a genome-wide association study are expected to provide a plan for submission of GWAS data to the NIH-designated GWAS data repository, or provide an appropriate explanation why submission to the repository is not possible.  A genome-wide association study is defined as any study of genetic variation across the entire genome that is designed to identify genetic associations with observable traits (such as blood pressure or weight) or the presence or absence of a disease or condition.  For further information see Policy for Sharing of Data Obtained in NIH Supported or Conducted Genome-Wide Association Studies, NIH Guide NOT-OD-07-088, and http://grants.nih.gov/grants/gwas/.

Section V. Application Review Information


1. Criteria

Only the review criteria described below will be considered in the review process.

2. Review and Selection Process

Review Process

Applications that are complete and responsive to the FOA will be evaluated for scientific and technical merit by an appropriate peer review group convened by the National Heart, Lung, and Blood Institute and in accordance with NIH peer review procedures (http://grants1.nih.gov/grants/peer/), using the review criteria stated below.

As part of the scientific peer review, all applications will:

The mission of the NIH is to support science in pursuit of knowledge about the biology and behavior of living systems and to apply that knowledge to extend healthy life and reduce the burdens of illness and disability.  As part of this mission, applications submitted to the NIH for grants or cooperative agreements to support biomedical and behavioral research are evaluated for scientific and technical merit through the NIH peer review system. 

Overall Impact. Reviewers will provide an overall impact/priority score to reflect their assessment of the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following five core review criteria, and additional review criteria (as applicable for the project proposed). 

Core Review Criteria.  Reviewers will consider each of the five review criteria below in the determination of scientific and technical merit, and give a separate score for each.  An application does not need to be strong in all categories to be judged likely to have major scientific impact.  For example, a project that by its nature is not innovative may be essential to advance a field.

Significance.  Does the project address an important problem or a critical barrier to progress in the field?  If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved?  How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field? How will the proposed research directly affect patient care, health-care delivery, health care systems, public health and/or health policy?

Investigator(s).  Are the PD/PIs, collaborators, and other researchers well suited to the project?  If Early Stage Investigators or New Investigators, do they have appropriate experience and training?  If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)?  If the project is collaborative or multi-PD/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project? Does the PD/PI devote enough time for the research effort? Faculty Development Component - Is there a detailed plan for career development, mentoring, and evaluation of a named Early Stage Investigator in outcomes research? Is this individual listed as the PD/PI on one of the projects? Are there adequate-described qualifications and characteristics of this Early Stage Investigator faculty member? Is there a well-demonstrated commitment of institutional support to the development and retention of this Early Stage Investigator faculty member as an outcomes researcher?

Innovation.  Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions?  Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense?  Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed?

Approach.  Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project?  Are potential problems, alternative strategies, and benchmarks for success presented?   If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed?
If the project involves clinical research, are the plans for (1) protection of human subjects from research risks, and (2) inclusion of minorities and members of both sexes/genders, as well as the inclusion of children, justified in terms of the scientific goals and research strategy proposed? Do the projects complement other aspects of the proposed Center and demonstrate potential for collaboration or synergy? Is there evidence of synergy among the projects and the faculty development and training components of the Center? Are the data management plans and total project coordination adequately specified and addressed? Do the projects differ significantly from other funded work of similar topic or methodology?

Environment.  Will the scientific environment in which the work will be done contribute to the probability of success?  Are the institutional support, equipment and other physical resources available to the investigators adequate for the project proposed?  Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements? 

In addition to the above review criteria, the following criteria will be applied to applications in the determination of scientific merit and the impact/priority score.

Collaboration: Have the investigators stated their willingness to collaborate with NHLBI and NIH scientists and staff and with Investigators and staff from other Centers supported by this initiative? Is there evidence that the applicant is willing to collaborate on the development and use of key common measures and measurement protocols and share/link data among Centers when relevant and applicable? Is there evidence that the applicant is willing to collaborate, where applicable, on identification of eligibility criteria, assessment methods, data analysis, and to provide information and data for Steering Committee and OSMB or DSMB reports?

Additional Review Criteria

As applicable for the project proposed, reviewers will consider the following additional items in the determination of scientific and technical merit, but will not give separate scores for these items.

Protections for Human Subjects.  For research that involves human subjects but does not involve one of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate the justification for involvement of human subjects and the proposed protections from research risk relating to their participation according to the following five review criteria: (1) risk to subjects, (2) adequacy of protection against risks, (3) potential benefits to the subjects and others, (4) importance of the knowledge to be gained, and (5) data and safety monitoring for clinical trials.

For research that involves human subjects  and meets the criteria for one or more of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: (1) the justification for the exemption, (2) human subjects involvement and characteristics, and 3) sources of materials.

Inclusion of Women, Minorities, and Children.  When the proposed project involves clinical research, the committee will evaluate the proposed plans for inclusion of minorities and members of both genders, as well as the inclusion of children.

Vertebrate Animals.  The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following five points: (1) proposed use of the animals, and species, strains, ages, sex, and numbers to be used; (2) justifications for the use of animals and for the appropriateness of the species and numbers proposed; (3) adequacy of veterinary care; (4) procedures for limiting discomfort, distress, pain and injury to that which is unavoidable in the conduct of scientifically sound research including the use of analgesic, anesthetic, and tranquilizing drugs and/or comfortable restraining devices; and (5) methods of euthanasia and reason for selection if not consistent with the AVMA Guidelines on Euthanasia.

Biohazards.  Reviewers will assess whether materials or procedures proposed are potentially hazardous to research personnel and/or the environment, and if needed, determine whether adequate protection is proposed.

Additional Review Considerations

As applicable for the project proposed, reviewers will address each of the following items, but will not give scores for these items and should not consider them in providing an overall impact/priority score.

Budget and Period Support.  Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.

Select Agents Research. Reviewers will assess the information provided in this section of the application, including (1) the Select Agent(s) to be used in the proposed research, (2) the registration status of all entities where Select Agent(s) will be used, (3) the procedures that will be used to monitor possession use and transfer of Select Agent(s), and (4) plans for appropriate biosafety, biocontainment, and security of the Select Agent(s).

Resource Sharing Plans.  Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable: (1) Data Sharing Plan (http://grants.nih/gov/grants/policy/data_sharing/data_sharing_guidance.htm), (2) Sharing Model Organisms (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-04-042.html), and (3) Genome Wide Association Studies (GWAS) (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-07-088.html).

Selection Process

The following will be considered in making funding decisions:

3. Anticipated Announcement and Award Dates

Not Applicable

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.

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.

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 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 Notice of Award. 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/archive/grants/policy/nihgps_2003/index.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/archive/grants/policy/nihgps_2003/index.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 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: all aspects of the study, including any modification of study design, conduct of the study, quality control, data analysis and interpretation, preparation of publications, and collaboration with other investigators, unless otherwise provided for in these terms or by action of the Steering Committee.

Study investigators are encouraged to publish and to release publicly and disseminate results and other products of the study, in accordance with study protocols and governance. Within three years of the end of the period of NHLBI support for the project, data not previously released and other study materials or products not previously distributed are to be made available to individuals who are not study investigators, provided such release is consistent with the study protocol and governance and with 2.A.2, paragraph 2.  In addition, study investigators must establish a plan for making data sets and materials available to the scientific community and to the NHLBI immediately upon completion of the three year period following the end of the period of NHLBI support.

Awardees will retain custody of and have primary rights to the data and software developed under these awards, subject to Government rights of access consistent with current HHS, PHS, and NIH policies.

2. A.2. NIH Responsibilities

The NHLBI Project Scientist (and other NHLBI scientists) may work with awardees on issues coming before the Steering Committee and, as appropriate, other committees, e.g., data selection and management, follow-up, quality control, adherence to protocol, assessment of problems affecting the study and possible changes in protocol, study monitoring, final data analysis and interpretation, preparation of publications, and development of solutions to major problems.

The NHLBI reserves the right to phase out or curtail the study (or an individual award) in the event of (a) failure to develop or implement a mutually agreeable collaborative protocol; (b) substantial shortfall in study or data management, follow-up, data reporting, or quality control; (c) major breach of the protocol or substantive changes in the agreed-upon protocol with which NHLBI cannot concur; (d) attainment of a major study endpoint before schedule with persuasive statistical significance; or (e) human subject ethical issues that may dictate a premature termination.

Support or other involvement of industry or any other third party in the study -- e.g., participation by the third party; involvement of study resources or citing the name of the study or NHLBI support; or special access to study results, data, findings or resources -- may be advantageous and appropriate. However, except for licensing of patents or copyrights, support or involvement of any third party will occur only following notification of and concurrence by NHLBI.

Additionally, an agency program official or IC program director will be responsible for the normal scientific and programmatic stewardship of the award and will be named in the award notice.

The assigned program director may also serve as an NIH Project Scientist.

2.A.3. Collaborative Responsibilities

Awardee(s) agree to the governance of the study through a Steering Committee. Steering Committee voting membership shall consist of the principal investigators (i.e., cooperative agreement awardees), the NIH Project Scientist, and the Chairperson. Meetings of the Steering Committee will ordinarily be held by telephone conference call or in the metropolitan Washington, D.C. area.

An Observational Study Monitoring Board or Data and Safety Monitoring Board will be appointed by the Director, NIH to provide overall monitoring of interim data and safety issues; the Steering Committee will nominate members for this Board. Meetings of the OSMB or DSMB will ordinarily be held in Washington, D.C. metro area.  An NIH scientist other than the NIH Project Scientist shall serve as Executive Secretary to the Board. Because the Board serves as an independent group advisory to the NIH, study investigators will not communicate with Board members regarding study issues, except as authorized by the Board’s Executive Secretary.

The collaborative protocol and governance policies will call for the continued submission of measures or datasets that are common or linked to the coordinating unit for a collaborative database; the submittal of copies of the collaborative datasets to each principal investigator upon completion of the study; procedures for data analysis, reporting and publication; and procedures to protect and ensure the privacy of medical and genetic data and records of individuals. The NIH Project Scientist, on behalf of the NIH, will have the same access, privileges and responsibilities regarding the collaborative data as the other members of the Steering Committee.

Each full member will have one vote. Awardee members of the Steering Committee will be required to accept and implement policies approved by the Steering Committee.

2.A.4. Dispute Resolution

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. A Dispute Resolution 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 dispute resolution procedure does not alter 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 Non-Competing Continuation Grant Progress Report (PHS 2590) annually and financial statements as required in the NIH Grants Policy Statement.

A final progress report, invention statement, and Financial Status Report are required when an award is relinquished when a recipient changes institutions or when an award is phased out.

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:

Nakela L. Cook, M.D., M.P.H.
Division of Prevention and Population Sciences
National Heart, Lung, and Blood Institute
6701 Rockledge Drive, Suite 10018, MSC 7936
Bethesda, MD 20892
Telephone: (301) 435-0383
Fax:  (301) 480-1773
Email: cookn2@nhlbi.nih.gov

2. Peer Review Contacts:

Director, Office of Scientific Review
National Heart, Lung, and Blood Institute
National Institutes of Health
6701 Rockledge Drive, Room 7214
Bethesda, MD 20892-7924
Bethesda, MD 20817 (express/courier service)
Telephone: (301) 435-0270
Fax: (301) 480-0730
Email: nhlbichiefreviewbranch@nhlbi.nih.gov

3. Financial or Grants Management Contacts:

Kimberly Stanton, Senior Grants Management Specialist
Division of Extramural Research Activities
National Heart, Lung, and Blood Institute
6701 Rockledge Building, Suite 700
Bethesda, MD 20892-7926
Telephone: (301) 435-0166
Fax:  (301) 435-0159
Email: kimberly.stanton@nih.gov
 

Section VIII. Other Information


Required Federal Citations

Use of Animals in Research:
Recipients of PHS support for activities involving live, vertebrate animals must comply with PHS Policy on Humane Care and Use of Laboratory Animals (http://grants.nih.gov/grants/olaw/references/PHSPolicyLabAnimals.pdf) as mandated by the Health Research Extension Act of 1985 (http://grants.nih.gov/grants/olaw/references/hrea1985.htm), and the USDA Animal Welfare Regulations (http://www.nal.usda.gov/awic/legislat/usdaleg1.htm) as applicable.

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.

Policy for Genome-Wide Association Studies (GWAS):
NIH is interested in advancing genome-wide association studies (GWAS) to identify common genetic factors that influence health and disease through a centralized GWAS data repository. For the purposes of this policy, a genome-wide association study is defined as any study of genetic variation across the entire human genome that is designed to identify genetic associations with observable traits (such as blood pressure or weight), or the presence or absence of a disease or condition. All applications, regardless of the amount requested, proposing a genome-wide association study are expected to provide a plan for submission of GWAS data to the NIH-designated GWAS data repository, or provide an appropriate explanation why submission to the repository is not possible. Data repository management (submission and access) is governed by the Policy for Sharing of Data Obtained in NIH Supported or Conducted Genome-Wide Association Studies, NIH Guide NOT-OD-07-088. For additional information, see http://grants.nih.gov/grants/gwas/.

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.

Sharing of Model Organisms:
NIH is committed to support efforts that encourage sharing of important research resources including the sharing of model organisms for biomedical research (see http://grants.nih.gov/grants/policy/model_organism/index.htm). At the same time the NIH recognizes the rights of grantees and contractors to elect and retain title to subject inventions developed with Federal funding pursuant to the Bayh Dole Act (see the NIH Grants Policy Statement http://grants.nih.gov/archive/archive/grants/policy/nihgps_2003/index.htm). All investigators submitting an NIH application or contract proposal, beginning with the October 1, 2004, receipt date, are expected to include in the application/proposal a description of a specific plan for sharing and distributing unique model organism research resources generated using NIH funding or state why such sharing is restricted or not possible. This will permit other researchers to benefit from the resources developed with public funding. The inclusion of a model organism sharing plan is not subject to a cost threshold in any year and is expected to be included in all applications where the development of model organisms is anticipated.

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: (a) all applications or proposals and/or protocols must provide a description of plans to conduct analyses, as appropriate, to address differences by sex/gender and/or racial/ethnic groups, including subgroups if applicable; and (b) investigators must report annual accrual and progress in conducting analyses, as appropriate, by sex/gender and/or racial/ethnic group differences.

Inclusion of Children as Participants in 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.

Human Embryonic Stem Cells (hESC):
Criteria for federal funding of research on hESCs can be found at http://stemcells.nih.gov/index.asp and at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-09-116.html . Only research using hESC lines that are registered in the NIH Human Embryonic Stem Cell Registry will be eligible for Federal funding (http://escr.nih.gov). It is the responsibility of the applicant to provide in the project description and elsewhere in the application as appropriate, the official NIH identifier(s) for the hESC line(s) to be used in the proposed research.

NIH Public Access Policy Requirement:
In accordance with the NIH Public Access Policy (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-033.html) investigators must submit or have submitted for them their final, peer-reviewed manuscripts that arise from NIH funds and are accepted for publication as of April 7, 2008 to PubMed Central (http://www.pubmedcentral.nih.gov/), to be made publicly available no later than 12 months after publication. As of May 27, 2008, investigators must include the PubMed Central reference number when citing an article in NIH applications, proposals, and progress reports that fall under the policy, and was authored or co-authored by the investigator or arose from the investigator’s NIH award.  For more information, see the Public Access webpage at http://publicaccess.nih.gov/.

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 FOA 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. 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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