Part I Overview Information


Department of Health and Human Services

Participating Organizations
National Institutes of Health (NIH), (http://www.nih.gov)
Canadian Institutes of Health Research (CIHR), (http://www.cihr-irsc.gc.ca)

Components of Participating Organizations
National Heart, Lung, and Blood Institute (NHLBI), (http://www.nhlbi.nih.gov)
Institute of Circulatory and Respiratory Health (ICRH), (http://www.cihr-irsc.gc.ca/e/8653.html)

Title: NHLBI Pediatric Cardiac Genomics Consortium (U01)

Announcement Type
New

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

Request For Applications (RFA) Number: RFA-HL-09-003

Catalog of Federal Domestic Assistance Number(s)
93.837

Key Dates
Release Date: October 14, 2008
Letters of Intent Receipt Date: January 6, 2009
Application Receipt Date: February 6, 2009
Peer Review Date(s): June - July, 2009
Council Review Date: August 2009
Earliest Anticipated Start Date: September 1, 2009
Additional Information To Be Available Date (Url Activation Date): http://www.nhlbi.nih.gov/funding/inits/faq-ptc.htm
Expiration Date: February 7, 2009
One or more pre-submission web conferences will be held.  Details will be posted on the FOA FAQ site, http://www.nhlbi.nih.gov/funding/inits/faq-ptc.htm

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 and Information

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

The NHLBI Strategic Plan (http://apps.nhlbi.nih.gov/strategicplan/) includes, as part of its goals and challenges, recognition of a need to accelerate the translation of basic research findings into clinical studies and trials and to promote the translation of clinical research findings back to the laboratory.  It also recognizes the importance of identifying key genetic variants that are associated with specific diseases and delineating the molecular mechanisms that account for susceptibility or resistance to disease.  This initiative aims to harness the many new genetic technologies and resources to move toward a comprehensive understanding of the genetics and genomics of congenital heart disease in the human population.  The ultimate goal is identification of preventive strategies, therapeutic targets, or risk stratification schemes, but it is recognized that these may not be achieved in the time frame of this initiative.  The immediate approach is to establish a consortium of collaborative clinical research teams, the Pediatric Cardiac Genomic Consortium (PCGC), supported by appropriate cores and research infrastructure to identify genetic and epigenetic causes of human congenital heart disease, and to relate genetic variants present in the congenital heart disease patient population to clinical outcomes. 

The Institute of Circulatory and Respiratory Health (ICRH) mandate amplifies the need for a growing number of clinician scientists and clinicians to contribute to the global health enterprise.  The opportunity exists to engage a wide range of genomic researchers in the key problems of child health and the early antecedents of adult disease. Canada has a special opportunity in this area, based on the amazing combined genomic expertise across the country and the very special opportunities provided by ready access to patient material across Canada.

The Pediatric Cardiac Genomic Consortium also aligns with key priorities within ICRH’s strategic plan.  In 2001, the ICRH of the Canadian Institutes of Health Research (CIHR) identified clinical research as a key strategic priority and was an enabling force in developing the Canadian Institutes of Health Research - Clinical Research Initiative.  Working together with many partners, CIHR aims to transform Canada's capacity for clinical research by:  developing and sustaining the next generation of clinician-researchers, improving the infrastructure for clinical research, and increasing operating funds for clinical research.  This Network complements CIHR’s focus on development of clinical research teams, platforms, networks and centers.  

The influence of genetics on congenital heart disease is well established in animal models of cardiovascular malformations.  Several genes known to be important in the regulation of cardiovascular development have also been implicated as causative genes in human congenital heart disease.  However, studies of the genomics of congenital heart disease are complicated by the large number of distinct cardiovascular malformations, the likely large number of causative genes, and the low frequency of causative variants.  Though heart defects are the most common group of birth defects, estimated to occur at an incidence of 35,000-40,000 newborns per year, the incidence of any specific defect is low.  As with all rare diseases, acquiring sufficient sample sizes for genomic analysis is a significant limiting factor for the study of the genetics of congenital heart disease.  The PCGC will overcome this problem by coordinating recruitment at multiple Research Centers, each of which will propose and implement one or more genetic or genomic studies of a specific cardiovascular malformation or syndrome, but benefit from the recruitment opportunities provided by a consortium of multiple sites. 

Conducting genetic and genomic research in a consortium also affords the opportunity to collaborate on a number of clinical research activities, including recruitment into common patient registries, developing common tools and approaches to assess family and personal medical history, adopting common nomenclature for congenital defects, and developing other shared case report forms. 

Selected research examples include, but are not limited to:

Although the focus of this FOA is  pediatric cardiovascular conditions, applications that propose studies that will include adults as well as children with congenital heart disease will be considered responsive.  This FOA is intended to support only human studies.  Applications that include animal studies will not be considered responsive.  Applications that propose patient registries without concomitant genetic or genomic scientific aims will not be considered responsive.

Program Structure

The consortium is a cooperative research endeavor consisting of up to six Research Centers, an Administrative Coordinating Center, NHLBI, and the ICRH.  NHLBI will oversee the organization of the Network and will be substantially involved with the awardees in a partnership relationship.  The NHLBI Pediatric Cardiac Genomics Consortium (PCGC) will interact collaboratively with the new NHLBI Cardiac Development Consortium (http://grants.nih.gov/grants/guide/rfa-files/RFA-HL-09-002.html) to facilitate mutual translation of findings.  The PCGC will also interact with the NHLBI’s Pediatric Heart Network (PHN) (http://www.pediatricheartnetwork.org/) through the PHN Data Coordinating Center, on areas of mutual scientific interest.  Key functions of both Consortia will be supported by the Administrative Coordinating Center (http://grants.nih.gov/grants/guide/rfa-files/RFA-HL-09-011.html).  The first year of the grant period will be a planning year to permit the Research Centers to conduct the necessary activities, individually and as a Consortium, to be able to begin recruiting patients on or before the start of Year 2. 

Research Centers (RC):  A Research Center can be a single institution or group of institutions with the capability of recruiting sufficient numbers of individuals with congenital heart disease to ensure robust genetic or genomic studies.  RCs will comprise multidisciplinary teams that may include pediatric cardiologists, pediatric cardiovascular surgeons, adult cardiologists, geneticists, statistical geneticists, nurse coordinators, and others.  RCs may use the multiple principal investigator (PI) option (http://grants.nih.gov/grants/multi_pi); investigators can be either from the same institution or different institutions.  Each RC will perform unique genetic or genomic studies, but will participate in a cooperative and interactive manner with all other RCs and the Steering Committee.  Each RC will be expected to recruit participants for genetic or genomic studies performed by Consortium members, and to collaborate through the Steering Committee to develop common recruitment and phenotyping procedures. 

Administrative Coordinating Center (ACC):  The ACC will be shared with the Cardiac Development Consortium (http://grants.nih.gov/grants/guide/rfa-files/RFA-HL-09-002.html), and will be selected through the companion FOA, (http://grants.nih.gov/grants/guide/rfa-files/RFA-HL-09-011.html).  The ACC will serve a range of functions common to both Consortia such as organizing meetings and calls of the Steering Committees, Coordinating Committee, External Advisory Panel, and Consortia joint annual meeting; designing and maintaining written materials and websites to support both Consortia; and awarding subcontracts for Cores. 

Cores:  Cores, such as an echocardiography core, may be required to support the science proposed, and to provide resources and services to multiple Research Centers.  Each RC application should include a description of any Cores required to complete the proposed work, and an estimated total budget for the proposed Cores.  Once the PCGC is established, requirements for Cores across the Consortium will be evaluated.  Whenever possible, Cores will serve multiple RCs and may be required to maximize cost savings.  NHLBI, with input from the Steering Committee and the External Advisory Committee, will determine the Core configuration.  The ACC and NHLBI will oversee the process of Core selection, and the ACC will administer the budget for the Cores.  Cores may be phased in and out based on scientific need during the course of this FOA. 

Steering Committee:  The Steering Committee will have responsibility for overall scientific direction of the Consortium, for evaluating new research directions and opportunities, and for devising plans for including new investigators in Consortium activities.  The Research Center PIs, the ACC PI, and the NHLBI Project Scientist will serve on a Steering Committee for the PCGC.  The Steering Committee will be chaired by an investigator selected by the NHLBI in consultation with ICRH.  Each Research Center will have one vote, as will the Chair, the ACC PI, and the NHLBI Project Scientist.  The Steering Committee will meet by conference call quarterly, in person for an implementation meeting at the start of the project period, and up to twice a year throughout the project period.

Coordinating Committee:  Research Center PIs, the ACC PI, the NHLBI Project Scientist, and an ICRH staff member will also serve on a joint Coordinating Committee with their counterparts from the NHLBI Cardiac Development Consortium (http://grants.nih.gov/grants/guide/rfa-files/RFA-HL-09-002.html).  The role of the Coordinating Committee will be to foster communication and possible collaboration between the two consortia, and to ensure that the science in both consortia is optimally focused on pediatric cardiovascular public health priorities.  The Coordinating Committee will meet once a year during the project period and may have additional conference calls as needed.

External Advisory Committee (EAC): The External Advisory Committee will oversee the PCGC, the Cardiac Development Consortium, and the ACC.  This Committee will consist of non-Consortium affiliated scientists and other experts appointed by the NHLBI, in consultation with the ICRH, to provide annual reviews of progress, and input on key functions such as Cores.  The EAC will meet in person once a year, and by conference call as needed.

Data Coordinating Center (DCC):  DCC functions will be provided to the PCGC by the Pediatric Heart Network DCC, through the PHN FOA and budget.  DCC functions will include facilitating all aspects of recruitment including harmonization of protocol formats across sites, consent form templates, development and programming of case report forms, preparation of materials for submission to local IRBs, manuals of operation, oversight of protocol amendments, web-based data entry, coordinator training, common phenotyping elements, and clinical database management.  The DCC also oversees the Pediatric Heart Network biorepository core lab.

Planning Phase:  The project period for the PCGC will be six years, with the first year serving as a planning phase.  The Steering Committee will meet at the start of the project period, will assess the needs of the consortium, and will develop a plan for Cores, data handling, and collaborations.  The collaborative plan will be reviewed by the External Advisory Committee, which will make recommendations to the NHLBI.

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 the Research Project Cooperative Agreement (U01) award mechanism(s). 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 is a one-time solicitation to fund the Pediatric Cardiac Genomics Consortium for 6 years.  It is expected that at the end of the 6 years. NHLBI will evaluate progress and make a determination whether to renew this solicitation.   

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). 

2. Funds Available

The estimated amount of funds available from the NIH for support of up to 6 projects awarded as a result of this announcement is $1,440,000 for fiscal year 2009Future year amounts are expected to be commensurate with the commencement of recruitment into clinical protocols, but will depend on annual appropriations.

The ICRH intends to commit a maximum of approximately $1 million (CAD) over a five year period toward meritorious grants from Canadian institutions.   ICRH funds will be allocated toward direct costs of Regional Clinical Center(s) located in Canada.  CIHR funds will be directed to Canadian researchers (please see the following link for complete description of eligibility requirements: http://www.cihr-irsc.gc.ca/e/22630.html#F1).

Canadian applicants need to consider that CIHR's contribution to the amount available for this initiative is subject to availability of funds voted annually to CIHR by parliamentary appropriations, and the conditions that may be attached to them. ICRH’s contribution to this funding opportunity will follow the General Guidelines for Grant Programs. Applicants should review the Use of Grant Funds section of the Tri-Agency (CIHR, NSERC and SSHRC) Financial Administration Guide for a complete listing and description of allowable costs and activities.

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. The NIH review criteria for approach, investigators, and environment have been modified to accommodate applications involving either a single PD/PI or multiple PDs/PIs. 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.

2. Cost Sharing or Matching

This program does not require cost sharing as defined in the current NIH Grants Policy Statement.

3. Other-Special Eligibility Criteria

Applicants are not permitted to submit a resubmission application in response to this FOA.

Renewal applications are not permitted in response to this FOA.

Applicants may submit more than one application, provided each application is scientifically distinct.

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.

Foreign Organizations (Canadian Entities Only)

NIH policies concerning grants to foreign (non-U.S.) organizations can be found in the NIH Grants Policy Statement at: http://grants.nih.gov/archive/grants/policy/nihgps_2003/index.htm#_Toc54600260.

Applications from foreign organizations must:

In addition, for applications from foreign organizations:

Proposed research should provide special opportunities for furthering research programs through the use of unusual talent, resources, populations, or environmental conditions in other countries that are not readily available in the United States or that augment existing U.S. resources.

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 V.3.A). Submission times N/A.

3.A. Receipt, Review and Anticipated Start Dates
Letter of Intent Receipt Date: January 6, 2009
Application Receipt Date: February 6, 2009
Peer Review Date(s): June - July 2009
Council Review Date: August 2009.
Earliest Anticipated Start Date: September 1, 2009

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:

Chief, Review Branch
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.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:

Chief, Review Branch
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.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 and Information

Awards will also be made under the Cooperative Agreement Terms and Conditions of Award noted in Section VI. 2. A.

Qualifications and Experience.  Applicants should describe qualifications and experience in the appropriate narrative sections of the application.  Participation in the PCGC will be a complex and time-consuming undertaking.  Applicants should have an established research program in cardiovascular genetics or genomics.  Research Center PIs will be required to declare a minimum effort of 2.4 calendar months, and will be required to participate on the Steering and Coordinating Committees as described in Section VI. 2. A.  Applications proposing Multiple PDs/PIs must have a minimum combined PI effort of 2.4 months.

Collaboration.  Applicants should state their general support of collaborative research and their willingness to participate in a collaborative and interactive manner with other Research Centers, the Administrative Coordinating Center, NHLBI, and the companion Cardiac Development Consortium. 

The applicant should provide a clear and concise description of the interrelationships among the members of the team, their relevant experience and expertise, and the contribution of each to fulfillment of the objectives of this FOA.  In addition, the applicant should provide a plan to ensure the maintenance of close cooperation and effective communication among members of the applicant’s team and evidence of the capability of the applicant organization to participate and interact effectively in cooperative multi-center research.

Applicants must agree, if awarded, to accept the “Cooperative Agreement Terms and Conditions of Award” in Section VI. 2. A.

Study Population.  Applicants should demonstrate access to a sufficient number of patients to accomplish their portion of the proposed protocol(s).  The application should include a description of the pool of potential study participants, including the age range, ethnic/racial and gender distributions, and recruitment sources.  In addition to recruitment across the Consortium sites, patient access may be accomplished by establishing links with other groups, such as other health care providers in the community or foundations.  If links with other groups are planned, the application should include a plan with appropriate letters of support that describes how the applicant Research Center will link to and operate with the other group(s), and how the Research Center will monitor the quality of the other group’s performance, if applicable (e.g., recruitment, patient visits, data collection).

Links with NIH Resources.  Research Center applicants at sites that have a Clinical and Translational Science Award (CTSA) or a General Clinical Research Center (GCRC) funded by the NIH National Center for Research Resources should identify the resources that could be available to support the proposed PCGC Research Center, commenting particularly on those aspects that will enhance their programmatic and scientific efficiency.  In such cases, a description of how the applicant proposes interacting with CTSA or GCRC resources should be included, as well as a letter of agreement from the Program Director or PI. 

Research Plan (30 pages)

Multiple PD/PI Leadership Plan.  If the Multiple PD/PI approach is chosen, a new section of the Research Plan, entitled “Multiple PI Leadership Plan” must be included (see Section IV for details).  When this is the case, the Research Plan can be extended to 32 pages.   

Introduction.  In the Introduction to the Research Plan, applicants should present their views of the important questions facing the field of congenital heart disease and explain how their proposed research addresses one or more of these questions. 

Research Plan.  The Research Plan should propose a project or group of related projects, consistent with the objectives of the FOA, that can be completed by the Research Center within the context of the Consortium in 5 years (after an initial planning year).       

The description of the planning year should include activities required to ensure that research activities can start at the beginning of Year 2, such as finalizing protocols, obtaining pilot data if needed, obtaining IRB approval, establishing cores, completing investigator and coordinator protocol training, and ordering necessary supplies. 

The research plan for years 2-6 should focus on a clinical protocol, or group of related clinical protocols, designed to advance understanding of genetic and genomic influences on congenital cardiovascular conditions and their outcomes.  The protocol proposal should generally follow the instructions in the PHS 398 application form (revised 11/2007; http;//grants.nih.gov/grants/forms.htm) and should include a rationale, research aims, study design and timetable, a description of the study population with sample size calculations, and a description of the statistical analysis plan.  The applicant should indicate how many study participants are available in the applicant’s center, and comment on approaches that will be implemented if recruitment is not as robust as expected locally.   The research plan should also propose specific milestones that could be used to evaluate success of the project throughout the duration of funding. 

All applications should include a data sharing plan, and genome-wide association studies will comply with the NIH GWAS policy (http://grants.nih.gov/grants/gwas/).  Novel genetic variants identified should also be shared (e.g., through dbSNP -- http://www.ncbi.nlm.nih.gov/projects/SNP/). 

Additional submission requirements for the preparation of the Detailed Budget

Research Centers.  The budget for the first year, which is a planning year, should include a minimum of 2.4 calendar months effort for the applicant PI or a minimum of 2.4 calendar months combined effort for all PIs if the multiple PI strategy is used, a 0.5 FTE clinical study coordinator, travel funds for two 2-day Steering Committee meetings in Bethesda, MD, for the PI and coordinator, travel funds for the PI(s) to attend one Coordinating Committee meeting in Bethesda, MD, and travel funds for 2-3 days of study coordinator protocol training in Boston, and additional items as needed.  Direct costs in Year 1 cannot exceed $160,000.  

For Years 02-06, the budget must include support for a 0.75 FTE clinical study coordinator; a minimum of 2.4 calendar months effort for the applicant PI or a minimum of 2.4 calendar months combined effort for all PIs if the multiple PI strategy is used, and other investigators and staff as required.  Travel costs for 2 Steering Committee meetings per year in Bethesda should be included for 2-3 members of the Research Center, including at least one PI and the coordinator.  Travel funds for the PI(s) to attend one Coordinating Committee meeting per year in Bethesda, MD should also be included.  If CTSA resources are to be used, and a fee is charged, please note this in the budget.   

A budget for the protocol(s) should be presented, using a budget table or spreadsheet rather than the PHS 398 budget page forms; the budget pages are not included in the page limit.  The budget should indicate the total direct costs of implementing the proposal across all Research Centers, not just at the applicant’s Center.  Present the budget in direct costs only; do not include any administrative cost.  The protocol budget should include all costs associated with the conduct of the protocol, such as identification, screening, and recruitment of subjects and, if indicated, controls; the costs of obtaining, processing, and storage of biological specimens; and the costs associated with the analyses required for the genetic or genomic aims of the research.  Direct costs in Years 2-6 for Research Center infrastructure and protocol expenses cannot exceed $535,000.    

Cores.  If one or more cores are required, the budget must include the costs associated with that core lab for all patients to be recruited, not just the number of patients that are expected from the applicant site.  Costs may include those associated with shipping specimens, images, or other material to the core lab; core lab staff time to develop operational and training manuals, analyze specimens or images and report the results; any storage capability required at the core lab; travel for one Steering Committee meeting per year in Bethesda, MD; and other components as required.  These budgets, which should be on separate budget pages, are for planning purposes only; the NHLBI, with input from the External Advisory Committee, will determine the Core configuration, and the ACC will allocate funds accordingly.  Cores may be phased in and out based on scientific need during the course of this FOA.  

Data Coordinating Center.  Services provided by the Data Coordinating Center, such as harmonization of protocols and consent forms across the Consortium, development and programming of web-based case-report forms, training of Research Center staff in the conduct of all Consortium protocols, maintaining clinical research data, and conducting quality control activities, will not be funded through this FOA.  The Data Coordinating Center is funded through the Pediatric Heart Network budget. 

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 (Update: Enhanced review criteria have been issued for the evaluation of research applications received for potential FY2010 funding and thereafter - see NOT-OD-09-025).

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

2. Review and Selection 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 NHLBI 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 following will be considered in making funding decisions:

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, and weighted 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 meritorious 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.

Significance: Does this study address an important problem? If the aims of the application are achieved, how will scientific knowledge or clinical practice be advanced? What will be the effect of these studies on the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?  Is the rationale of the proposed studies well developed and feasible?  If implemented, is it likely that the proposed studies will advance the field of congenital heart disease genetics? 

Approach: Are the conceptual or clinical framework, design, methods, and analyses adequately developed, well integrated, well reasoned, and appropriate to the aims of the project? Does the applicant acknowledge potential problem areas and consider alternative tactics? For applications designating multiple PDs/PIs, is the leadership approach, including the designated roles and responsibilities, governance, and organizational structure, consistent with and justified by the aims of the project and the expertise of each of the PDs/PIs? Are there adequate and feasible plans for managing the proposed studies and for recruitment and retention of study participants?  Does the applicant adequately address potential obstacles, limitations and problem-solving strategies with respect to these activities?  Are the milestones proposed appropriate? 

Innovation:  Is the project original and innovative? For example: Does the project challenge existing paradigms or clinical practice; address an innovative hypothesis or critical barrier to progress in the field? Does the project develop or employ novel concepts, approaches, methodologies, tools, or technologies for this area?  

Investigators: Are the PD/PI(s) and other key personnel appropriately trained and well suited to carry out this work? Is the work proposed appropriate to the experience level of the principal investigator and other researchers? Does the PD/PI(s) and investigative team bring complementary and integrated expertise to the project (if applicable)? Does the Principal Investigator(s) have adequate expertise in and a documented history of contributions to the field of human congenital cardiovascular genetics or genomics?  Does the Principal Investigator have prior experience with collaborative research?   

Environment:  Do(es) the scientific environment(s) in which the work will be done contribute to the probability of success? Do the proposed studies benefit from unique features of the scientific environment, or subject populations, or employ useful collaborative arrangements? Is there evidence of institutional support?  Is there evidence that the institution has a track record in supporting collaborative clinical investigations?    

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

Potential for Collaboration:  Would the project proposed benefit from collaborative interactions with the consortium?  Will the proposal allow flexibility in collaboration with the consortium as the project progresses?  Will the investigators bring valuable areas of expertise to the consortium that will maximize flexibility for the program?  Does the application describe prior successful collaborative research? 

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 rating:

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 on Human Subjects in the PHS 398 instructions).

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 on Human Subjects in the PHS 398 instructions).

Care and Use of Vertebrate Animals in Research: If vertebrate animals are to be used in the project, the five points described in the Vertebrate Animals section of the Research Plan will be assessed.

Biohazards: If materials or procedures are proposed that are potentially hazardous to research personnel and/or the environment, determine if the proposed protection is adequate.

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.

Applications from Foreign Organizations: Whether the project presents special opportunities for furthering research programs through the use of unusual talent, resources, populations, or environmental conditions in other countries that are not readily available in the United States or that augment existing U.S. resources will be assessed.  

2.C. Resource Sharing Plan(s)   

When relevant, reviewers will be instructed to comment on the reasonableness of the following Resource Sharing Plans, or the rationale for not sharing the following types of resources. However, reviewers will not factor the proposed resource sharing plan(s) into the determination of scientific merit or priority score, unless noted otherwise in the FOA. Program staff within the IC will be responsible for monitoring the resource sharing.

3. Anticipated Announcement and Award Dates
 N/A

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 (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 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/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 award instrument establishing an "assistance" relationship (rather than an "acquisition" relationship) between NHLBI and a recipient, in which substantial NHLBI scientific and/or programmatic involvement with the recipient is anticipated during the performance of the activities. The NHLBI purpose is to support and/or stimulate the recipient’s activity by involvement in and otherwise facilitating the activity in a “partner” role, but avoiding a dominant role, direction, or prime responsibility.  The terms and conditions below, elaborate on these actions and responsibilities, and the awardee agrees to these collaborative actions with the NHLBI Project Scientist toward achieving the project objectives.  It is anticipated that these terms and conditions will enhance the relationship between the NHLBI staff and the principal investigator(s), and will facilitate the successful conduct and completion of the study.  These agreements will be in addition to, and not in lieu of, the relevant NIH procedures for grants administration.  The terms will be as follows:

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. 

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 NHLBI Project Scientist, the Chairperson, and the ACC PI.  Meetings of the Steering Committee will ordinarily be held by telephone conference call or in the metropolitan Washington Area.

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.  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.                

Upon completion of the project, awardees are expected to put their intervention materials and procedure manuals into the public domain and/or make them available to other investigators, according to the approved plan for making data and materials available to the scientific community and the NHLBI, for the conduct of research at no charge other than the costs of reproduction and distribution.

Awardees will retain custody of and have primary rights to their data developed under these awards, subject to Government rights of access consistent with current HHS, PHS, and NIH policies. The collaborative protocol and governance policies will call for the continued submission of data centrally to the coordinating center 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 NHLBI Project Scientist, on behalf of the NHLBI, will have the same access, privileges and responsibilities regarding the collaborative data as the other members of the Steering Committee.

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. NHLBI Responsibilities

The NHLBI Project Scientist will have substantial programmatic involvement that is above and beyond the normal stewardship role in awards, as described below.

The NHLBI Project Scientist will serve on the Steering Committee; he/she or other NHLBI scientists may serve on other study committees, when appropriate. 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., recruitment, intervention, follow-up, quality control, adherence to protocol, assessment of problems affecting the study and possible changes in protocol, interim data and safety monitoring, final data analysis and interpretation, preparation of publications, and development of solutions to major problems such as insufficient participant enrollment.

The NHLBI reserves the right to withhold funding 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 participant recruitment, 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) attaining of a major study endpoint before schedule with persuasive statistical significance; or (e) human subject ethical issues that may dictate a premature end of the award. 

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 NIH 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 

Awardees agree to the governance of the Consortium through the Steering Committee.  Membership will include, at a minimum, the Consortium PIs, the PI of the Administrative Coordinating Center, and the NHLBI Project Scientist.  A representative from the Pediatric Heart Network Data Coordinating Center will be an ex officio member.  The Steering Committee Chair will be appointed by NHLBI.  Additional members may be added by majority vote of the Steering Committee.

Awardee members of the Steering Committee will be required to accept and implement policies approved by the Steering Committee. 

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 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 terminated.

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:

Gail D. Pearson, MD, ScD
Division of Cardiovascular Diseases
NHLBI
6701 Rockledge Drive, Room 8104
Bethesda, MD 20892
Telephone: (301) 435-0510
Email:   pearsong@mail.nih.gov

ICRH

Christine Lavictoire
A/Assistant Director, ICRH
Institute of Circulatory and Respiratory Health
Canadian Institutes of Health Research
160 Elgin Street, 9th Floor
Address Locator 4809A
Ottawa, Ontario, Canada
K1A 0W9
Telephone: 613-954-0544
Email: christine.lavictoire@cihr-irsc.gc.ca

2. Peer Review Contacts:

Chief, Review Branch
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:

Anthony Agresti
NHLBI/Office of Grants Management
Rockledge II
6701 Rockledge Drive, Room 7158
Bethesda, MD 20892
Phone: 301-435-0166
Fax:     301-451-5462
Email: agrestia@mail.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. Reviewers will consider the data sharing plan but will not factor the plan into the determination of the scientific merit or the priority score.

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-02-005.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. Applications that do not provide this information will be returned without review.

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 percent 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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