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: Data Coordinating Center for the NHLBI Asthma Network (AsthmaNet) (U10)

Announcement Type
New

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

Request For Applications (RFA) Number: RFA-HL-08-011

Catalog of Federal Domestic Assistance Number(s)
93.838

Key Dates
Release Date: June 19, 2008
Letters of Intent Receipt Date: December 30, 2008
Application Receipt Date: January 30, 2009
Peer Review Date(s): May-June 2009
Council Review Date: August 2009
Earliest Anticipated Start Date: September 30, 2009 
Additional Information To Be Available Date (Url Activation Date): Not applicable
Expiration Date: January 31, 2009

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 purpose of this funding opportunity annoucement, issued by NHLBI, NIH, is to invite applications to participate as Data Coordinating Center in the NHLBI Asthma Network (AsthmaNet), a clinical research network that will develop and conduct multiple clinical trials to address the most important asthma management questions and new treatment approaches in pediatric and adult populations.  AsthmaNet is designed to promote cooperation and coordination, facilitate scientific exchange, provide training opportunities, and leverage resources.  AsthmaNet will include multiple Clinical Centers and one Data Coordinating Center.  The protocols will include clinical trials to evaluate and/or compare existing or new therapeutic approaches to asthma management as well as a limited number of proof-of-concept studies to advance the development of novel therapies and studies that investigate the mechanistic basis for interventions examined in AsthmaNet.  This FOA solicits applications for the Data Coordinating Center and runs in parallel with a separate FOA that solicits applications for up to ten Clinical Centers (see RFA-HL-08-010).

Background

Asthma affects more than 22 million persons and it is one of the most common chronic diseases of childhood.  The burden of the disease is high to the individual who has asthma, to his/her family, and to the larger community.  Asthma costs over $14 billion annually, with a majority of expenses related to urgent care, hospitalizations, and lost productivity.  The NHLBI’s National Asthma Education and Prevention Program strives to reduce this burden through the development of clinical practice guidelines and educational programs.  The NHLBI established two asthma clinical research networks (one for adult asthma, originating in 1993, and one for childhood asthma in 1999) to fill the gaps in science identified by the guidelines and to address newly arising areas of clinical concern in the management of asthma.  The results of the networks’ studies have influenced subsequent revisions of the guidelines and identified new approaches for managing asthma.  The most recent guidelines update, NAEPP Expert Panel Report-3: Guidelines for the Diagnosis and Management of Asthma, 2007 (http://www.nhlbi.nih.gov/guidelines/asthma/index.htm), notes that significant strides have been made, but that challenges remain.

The 2007 release of the NHLBI’s strategic plan (http://apps.nhlbi.nih.gov/strategicplan/) and the anticipated end of the current funding period for the Asthma Clinical Research Network and Childhood Asthma Research and Education network prompted the Division of Lung Diseases (DLD) to convene a working group with leaders in pulmonary, sleep and critical care medicine research, clinical trial design, biostatistics and biomedical informatics to obtain advice on a network structure that would sustain success of the asthma networks while meeting future clinical research needs.  The working group strongly endorsed the concept of networks and encouraged the following network objectives: maintain the focus on improving clinical care but allow more flexibility in the type of research questions to advance the development of novel therapies and accelerate translational research, develop mechanisms to facilitate and promote scientific exchange across networks and other clinical research programs, structure networks to maximize programmatic and scientific efficiency, promote shared use of resources and standardization among networks, promote training, and facilitate rapid dissemination of research findings to the medical community (see http://www.nhlbi.nih.gov/meetings/workshops/network-wkgp-exesum.htm).  NHLBI’s plans for promoting the shared use of resources and the promotion of programmatic and scientific efficiency coincide with the expansion of the NIH Roadmap of Medical Research initiative to Re-engineer the Clinical Research Enterprise through the Clinical and Translational Science Award program (www.ctsaweb.org).

The primary aim of AsthmaNet is to address important clinical management questions in asthma, mainly through Phase II and Phase III clinical trials.  The emphasis will be on clinical trials 12-20 months in duration that help identify optimal therapies for a variety of asthma phenotypes, genotypes, and racial and ethnic backgrounds. A limited number of clinical trials of longer duration may be considered. The knowledge gained will inform clinical practice and future updates to the NAEPP clinical practice guidelines.  The secondary aim is to conduct proof-of-concept studies that have an objective of advancing novel asthma therapies and to conduct studies that investigate the mechanistic bases for interventions in AsthmaNet clinical trials.  The knowledge gained will advance the development and application of novel treatment approaches.  The merger of the pediatric and adult networks into one AsthmaNet will enhance scientific exchange and stimulate research that addresses questions on the similarities, differences, and relationships between childhood and adult asthma.  Research approaches, research topics and organizational structure for the AsthmaNet are presented in the FOA for Clinical Centers (RFA-HL-08-010).

Scope of Activities for Data Coordinating Center to Achieve Objectives of the AsthmaNet 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 the Cooperative Agreement (U10) award mechanism(s).
The Project Director/Principal Investigator (PD/PI) will be solely responsible for planning, directing, and executing the proposed project.  

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). 

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." Plans for this cooperative agreement project beyond the current funding opportunity are indefinite. This is a one time solicitation to fund AsthmaNet for 7 years.  It is expected that all protocols will be completed within the 7-year time period.  Plans beyond the current funding period are indefinite.

2. Funds Available

Because the nature and scope of the proposed research will vary from application to application, it is anticipated that the size and duration of each award will also vary. Although the financial plans of the NHLBI provide support for this program, awards pursuant to this 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 NIH Grants Policy Statement will apply to the applications submitted and awards made in response to this FOA.

Section III. Eligibility Information


1. Eligible Applicants

1.A. Eligible Institutions
 
The following organizations/institutions are eligible to apply:

1.B. Eligible Individuals

Any individual with the skills, knowledge, and resources necessary to carry out the proposed research as the PD/PI is invited to work with his/her institution to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support.

Applicant must posses a doctoral degree in a relevant field such as biostatistics, clinical epidemiology, biomedical informatics or other relevant area.  The PI must have clinical trials and statistical expertise. A minimal time commitment of 30% is anticipated.

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

Resubmission of an application in response to this FOA is not permitted. 

Renewal applications are not permitted in response to this FOA. 

Applicant institutions may submit more than one application, provided they are scientifically distinct and from different principal investigators.

Awards for a Clinical Center and a DCC will not be made to the same Principal Investigator to ensure that data analyses and data acquisition are performed independently.

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.

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.

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
Letter of Intent Receipt Date: December 30, 2008
Application Receipt Date: January 30, 2009
Peer Review Date(s): May-June 2009
Council Review Date: August 2009
Earliest Anticipated Start Date: September 30, 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
Division of Extramural Research Activities
National Heart, Lung, and Blood Institute
6701 Rockledge Drive
Room 7214, MSC 7924
Bethesda, MD 20892-7924 (Express zip: 20817)
Telephone: (301) 435-0270
FAX: (301) 480-0730
Email: nhlbichiefreviewbranch@nhlbi.nih.gov


3.B. Sending an Application to the NIH

Applications must be prepared using the 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
Division of Extramural Research Activities
National Heart, Lung, and Blood Institute
6701 Rockledge Drive
Room 7214, MSC 7924
Bethesda, MD 20892-7924 (Express zip: 20817)
Telephone: (301) 435-0270
FAX: (301) 480-0730
Email: nhlbichiefreviewbranch@nhlbi.nih.gov


3.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 or renewal 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 or renewal award.

The incurrence of pre-award costs in anticipation of a competing or non-competing award imposes no obligation on NIH either to make the award or to increase the amount of the approved budget if an award is made for less than the amount anticipated and is inadequate to cover the pre-award costs incurred. NIH expects the grantee to be fully aware that pre-award costs result in borrowing against future support and that such borrowing must not impair the grantee's ability to accomplish the project objectives in the approved time frame or in any way adversely affect the conduct of the project (see NIH Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part6.htm.)

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

6. Other Submission Requirements and Information

Research Plan

In lieu of a research plan, the following items should be addressed satisfactorily by the applicant.

Evidence of Leadership and Performance Experience:  Applicant should demonstrate leadership in concept development and feasibility assessment, research design, data analysis, timely implementation and management of collaborative Phase II-III and Phase III, proof-of-concept and mechanistic research, and provide evidence of successful performance as a DCC for multicenter studies (not necessarily in asthma) within the past three years.  Applicant must demonstrate experience monitoring and evaluating trials including development of Clinical Centers’ performance metrics and description of corrective action for under-performance.  Further, applicants must demonstrate experience with monitoring and evaluating DCC performance (e.g., allocation of resources, leveraging internal and external resources to achieve research objectives with operational efficiency, reduction of duplicative and/or redundant work processes, timely negotiation of clinical agreements with Third Parties and obtaining IND and/or IDE approval from FDA).  Applicant must provide evidence of ability to:

Academic Productivity:  Applicant should provide evidence of scholarship as PI of a DCC in previous or ongoing clinical trials, especially those of a cooperative or multicenter design.  Provide summary of the proposed DCC team’s contributions in preparing manuscripts from previous collaborative or multicenter clinical research.

Capacity and Ability to Manage Data and Communications:  Ability to develop manual of operations, data collection forms, study manuals, data collection systems, electronic technology, and data entry systems must be demonstrated in the application.  The applicant should have experience in developing and maintaining data quality control systems.  Applicants should provide evidence of data management and program support capabilities by describing the processes for data collection, management, analysis, data security, privacy protections, and quality control.  Applicant should propose methods to be employed to facilitate communication between DCC staff and other components of AsthmaNet including plans for support of electronic mail and communication (e.g., tele-/Internet-conferencing) and plans for a website system for participants of the AsthmaNet.  The website should have public and password protected access links available. 

Evidence of Management Capabilities:  Applicants should demonstrate skills as a manager for a DCC.  The applicant must provide evidence of experience and ability to estimate appropriateness and reasonableness of resources required for individual projects and manage those resources efficiently.  Applicant must describe planned modifications in organizational systems to assign and adjust resource allocation during protocol execution, including potential outsourcing to increase efficiency or to address short-term demands.  Experience with meeting deadlines (e.g., NHLBI and FDA reporting requirements, National meetings, Steering Committee meetings, DSMB meetings, PRC meetings) should be delineated in the application.  Experience with subcontracts is required as supplemental expertise/resources may be required to develop and execute AsthmaNet research projects.

Staffing Expertise and Capabilities:  Applicant should propose an operational structure for providing and coordinating all DCC functions for conducting at least three clinical trials simultaneously, including lines of responsibility for professional staff.  The DCC should provide evidence of its management capability to ensure that NHLBI funds are properly and efficiently deployed including:

Evidence of Reporting Capabilities:  Applicant should describe the reports prepared by the proposed DCC team regarding protocol execution, patient safety, data capture/quality, data and performance of Clinical Centers in previous multicenter clinical research (e.g., reports to Steering Committee and DSMB). 

Expertise and Experience in Logistical and other Support Services:  The DCC provides arrangements for logistical support associated with Steering Committee meetings and conference calls, DSMB meetings and conference calls, and other meetings as required by AsthmaNet.  The DCC is responsible for supporting infrastructure for meetings and teleconferences.  Applicant should have experience arranging logistical services for multicenter clinical trials, such as assuring appropriately prepared and labeled supplies of study medications for the Clinical Centers.  Coordinating sample storage and study drug/equipment assignment is required.

Evidence and Experience of On-site and Off-site Monitoring Ability:  Applicant should have experience in organizing and conducting both on-site and off-site monitoring of multicenter clinical research studies.  Identification of data errors and appropriate edits are required.  The DCC must ensure that AsthmaNet Clinical Centers comply with NIH and NHLBI regulatory requirements, including Human Subjects Protections, informed consent, reporting of adverse events and unanticipated problems, and FDA requirements as required by specific studies.

Evidence of Technology Transfer, Data Management and Protocol Training Capabilities:  The DCC should be able to assist Clinical Centers in data management and communication activities.  Training sessions and procedure certifications for AsthmaNet studies (clinical trials, proof-of-concept studies, mechanistic studies), and data entry are facilitated by the DCC.  Training and technical expertise, and experience and resources, should be delineated. 

Capacity and Ability to Manage and Distribute Protocol Funds:  The applicant should demonstrate skills to assist with development of a comprehensive protocol specific budget to include all costs related to protocol development, implementation, and completion of the protocol and the DCC will be responsible for managing the distribution of funds to execute protocol.  This may include (1) developing templates for obtaining costs from Clinical Centers for personnel effort, procedures and laboratory expenses; (2) obtaining costs for core laboratory functions (it is expected that when feasible, the DCC will leverage federally funded resources, e.g., CTSA sites, GCRCs); and (3) developing and executing Clinical Center agreements (e.g., fee-for-service) regarding terms and conditions for protocol cost reimbursement, which should include the milestone payment amounts and payment schedule.  The applicant should demonstrate ability to perform these tasks. 

Departmental and/or Institutional Commitment:  The departmental and/or institutional commitments to participate in research should be clearly documented with letters of support from appropriate individuals.  Support in areas of grants management, personnel management, pharmacy, space allocation, data coordination and confidentiality, information technology, procurement, and equipment, and general support of research, should be described along with evidence of previous research support.

Particular Strengths of PI or Institution:  Applicants are encouraged to describe special or unique strengths that may be relevant to AsthmaNet infrastructure and research.  These can include state-of-the art biomedical informatics systems (e.g., innovative tools, methods and algorithms), which may be shared or may be available to develop and expand scientific productivity of AsthmaNet; and an understanding of methods to develop consistent standards for representing pulmonary research data; special administrative strengths or experience.  Participation by the PI or other proposed DCC staff in administrative aspects of clinical research (e.g., IRB, DSMB, PRC) should be highlighted.  Applications from institutions that have a CTSA or GCRC funded by NIH or other federally funded research centers as resources for conducting the proposed research should provide a letter of agreement that identifies the level of support from the PI or program director of those centers.  Applicants are encouraged to suggest collaboration strategies with CTSA and GCRC sites and how collaboration would enhance performance, productivity and cost-effectiveness of AsthmaNet.

Willingness to Collaborate:  Collaborate across AsthmaNet, and other DCCs and investigators involved in DLD clinical research programs to accelerate translation of study findings to the scientific community and clinical practice as well as stimulate identification of salient research questions from experiences in clinical practice.  Applicants should indicate willingness to work, through the AsthmaNet, with the NHLBI Division of the Application of Research Discoveries (DARD), whose mission is to promote the development and implementation of evidence-based guidelines in partnership with individuals, professional and patient communities, and health care systems and to communicate research advances effectively to the public, and to bridge the gap between research and practice through knowledge networks.  DARD is in the early planning stages of developing a Pulmonary Knowledge Network (PKN) which will serve as a knowledge and communication resource for researchers and clinicians.  Examples of potential PKN-related collaborative opportunities may include, but are not limited to:  (1) use of a Web-based virtual collaborative work environment to exchange information and ideas, such as new research findings, to other researchers and clinicians, communication from practicing clinicians to researchers that inform and shape the research agenda, and interactive discussion groups to stimulate ideas and answer important questions from the research and clinical communities; (2) automated methods for rapidly identifying relevant research findings that can be integrated into the guidelines development process to ensure that guidelines are updated regularly; (3) promotion of standardized methodologies for reporting research findings to facilitate more rapid and efficient translation of research findings into clinical practice; and (4) contribution to data repositories and evidence tables that can be accessed by clinicians and researchers.

Link with NIH resource centers:  Applications from institutions that have a General Clinical Research Center (GCRC) or Clinical and Translational Science Award (CTSA) funded by the NIH National Center for Research Resources should identify the resources that could be available to support the proposed AsthmaNet Data Coordinating Center, commenting particularly on those aspects that will enhance their programmatic and scientific efficiency.  In such a case, a description of the GCRC or CTSA and how the applicant proposes interacting with it should be included, as well as letter of agreement from either the GCRC/CTSA Program Director or PI.

Budget Information:  For budget planning assume (1) that during the first year one clinical trial protocol will be designed and initiated within six months and another designed to be initiated in the second year of the project period; (2) that two clinical trial protocols will be designed and initiated in years 2 through 5 of the project period; (3) one year followup per patient randomized and two years to complete trials due to rolling enrollment; and (4) that three to four proof-of-concept and/or mechanistic studies will be designed, initiated, executed and closed-out throughout the project period.  The budget justification for each year should include a table that assigns direct costs among Core Costs and Research Design and Initiation Costs.  Core Costs include essential personnel, facilities and other services to address the Scope of Activities described in this FOA not involving Research Design and Initiation or Protocol Execution and Close-out (described below).  Research Design and Initiation Costs include costs associated with protocol design and preparations required to initiate, and receive and process data from clinical trials.  The cumulative direct costs for both components should not exceed $995,000 in year 1, which will be a nine-month budget period, and should not exceed $1.62 million per year in years 2 though 4, and should not exceed $1.35 million in year 5, and should not exceed $920,000 in years 6 and 7. 

Core Costs include funds to execute actions described in the Scope of Activities not involving Research Design and Initiation or Protocol Execution and Close-out, including, but not limited to:

Research Design and Initiation Costs include costs associated with protocol design and preparations required to initiate, and receive and process data from clinical trials.  For budget planning, assume that clinical trials will include approximately 210 participants and collect data on 2300 items per participant.  Research Design and Initiation Costs include, but are not limited to:

Protocol Execution and Close-out Costs:  No specific budget requested at time of application, but applicant will be required to provide an example budget of all DCC work contributed to execute and close-out one protocol (DCC capitation cost), including a detailed description of assumptions for budget calculations.  The DCC capitation budget example should reflect specific protocol-related costs to be incurred after start of patient enrollment.  Assumptions should include strategies for increasing or decreasing staff time commitment based on actual protocol needs.  Assumptions proposed by applicant will be used as basis for individualizing cost reimbursement for each protocol.  Adjustment of reimbursement assumptions may be made empirically with protocol execution and close-out experience.  After protocol and budget (clinical center and DCC components) are approved by the Protocol Review Committee and NHLBI, and protocol and informed consent template are approved by the Data Safety Monitoring Board, Protocol Execution and Close-out Costs will be released to DCC before execution of the trial.  For this example, assume a three-arm, randomized, single cross-over design with 70 participants per arm and data collected on 2300 items per participant.  Assume 12-months of enrollment with 12-months of follow-up for rolling randomization.  Protocol Execution and Close-out Costs include, but are not limited to:

Application must include a plan for dissemination of research findings and should include:

Awardee must agree to the Cooperative Agreement Terms and Conditions of Award in Section VI.2.A.

Research Plan Page Limitations

The research plan may not exceed 25-pages.

Appendix Materials

All paper PHS 398 applications must provide appendix material on CD 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 one-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/.

Prepare public-use files for disseminating research resources, such as methods of procedures, study manuals, case-report form templates, patient-centric diary templates and phenotype ascertainment instruments (e.g., National Technical Information Service -- http://www.ntis.gov/index.asp).

All Data Coordinating Center applicants in response to the RFA HL-08-011 should include a plan for sharing research data and submitting Genome-Wide Association Studies data to the NIH-designated GWAS data repository.  All Clinical Center applicants in response to the AsthmaNet Clinical Centers FOA should indicate their willingness to participate in data sharing and submitting Genome-Wide Association Studies (GWAS) data to the NIH-designated GWAS data repository.  The precise content of the data-sharing plan ultimately developed by the Data Coordinating Center will vary, depending on the data being collected and how the investigators in the Steering Committee are planning to share the data.  The reasonableness of the data-sharing plan proposed by the Data Coordinating Center applicants will be assessed by the reviewers.  However, reviewers will not factor the proposed data sharing plan into the determination of scientific merit or the priority score.

It is expected that AsthmaNet research resources such as Manual of Operations, study manuals, case-report forms, phenotype ascertainment instruments will be made available to the public after publication of study findings (e.g., through the National Technical Information Service, see http://www.ntis.gov/index.aspx). The Data Coordinating Center applicants will include a plan for sharing these resources in response to
RFA-HL-08-011.  Clinical Center applicants in response to this FOA should indicate here their willingness to cooperate with this resource sharing.

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 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, weighting them as appropriate for each application. Note that an application does not need to be strong in all categories to be judged likely to have major scientific impact and thus deserve a 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?

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? Does the applicant propose adequate plans to:

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?  Are new approaches proposed that would streamline clinical trial processes, improve communication, collaboration, creativity and performance of the AsthmaNet?

Investigators: Are the investigators 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 investigative team bring complementary and integrated expertise to the project (if applicable)? What is the experience of the proposed DCC team, as a whole, in supporting multi-site clinical studies? Does the PI substantiate ability to:

Environment: Does the scientific environment 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 of experience and accomplishments in design and analysis of large-scale interventional trials and datasets (not necessarily in asthma), and of the availability of an infrastructure to support the appropriate storage, management, and analysis of data generated, including genetic and omics datasets?  How adequate is the organizational and administrative structure, including the capacity to assure quality control of data, data entry, confidentiality of data, distribution of protocol funds to Clinical Centers and proposed plans for day-to-day coordination?  If the DCC is part of a larger institution, is the Institutional commitment adequate to support the DCC proposed program?

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.

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

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 (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/grants/policy/nihgps_2003/NIHGPS_Part4.htm) and Part II Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Grantees, and Activities (http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_part9.htm).

The following Terms and Conditions will be incorporated into the award statement and will be provided to the Principal Investigator as well as to the appropriate institutional official, at the time of award.

2.A. Cooperative Agreement Terms and Conditions of Award

The following special terms of award are in addition to, and not in lieu of, otherwise applicable OMB administrative guidelines, HHS grant administration regulations at 45 CFR Parts 74 and 92 (Part 92 is applicable when State and local Governments are eligible to apply), and other HHS, PHS, and NIH grant administration policies.

The administrative and funding instrument used for this program will be the cooperative agreement an "assistance" mechanism (rather than an "acquisition" mechanism), in which substantial NIH programmatic involvement with the awardees is anticipated during the performance of the activities. Under the cooperative agreement, the NIH purpose is to support and stimulate the recipients' activities by involvement in and otherwise working jointly with the award recipients in a partnership role; it is not to assume direction, prime responsibility, or a dominant role in the activities. Consistent with this concept, the dominant role and prime responsibility resides with the awardees for the project as a whole, although specific tasks and activities may be shared among the awardees and the NIH as defined below.

2. A.1. Principal Investigator Rights and Responsibilities

The Principal Investigator will have the primary responsibility for:  The overall function of the DCC, which is to coordinate, administer, and support all AsthmaNet research activities.  The DCC PI will be responsible for oversight of protocol development, drug acquisition and distribution, data collection, data safety and confidentiality, quality assurance, data analysis, coordination of data distribution, and implementation of all data sharing plans.  The DCC PI will be responsible for the distribution of most of the protocol funds to the Clinical Centers (see “Funds Available” in Section II).  The DCC PI will be responsible for the editorial and meeting coordination for manuscript preparation, coordination of the activities of the Steering Committee, Protocol Review Committee, and Data and Safety Monitoring Board.

The Clinical Center PI will be responsible for all aspects of the AsthmaNet studies, including proposing protocols, participating in their overall development, preparing protocol budgets in collaboration with the DCC, modifying proposals if indicated, recruiting study participants, conducting the research, assuring quality of study participant care and protocol adherence, assuring the accurate and timely transmission of data collected in conjunction with the DCC, analyzing and interpreting data, preparing publications, and working with the DCC and NHLBI to disseminate research findings.  Clinical Center PIs will also be responsible for working with the DCC to develop common definitions and standardization across protocols wherever appropriate.

Support or other involvement of industry or any other third party in the AsthmaNet studies 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.  Awardees must follow NHLBI policy concerning third party agreements.

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

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.

AsthmaNet will have two NIH Project Scientists who will also serve as program directors; they will share participation in overall Steering Committee activities.

The NHLBI Project 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 potential changes in the 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 Project Scientists, 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.

The NHLBI reserves the right to terminate or curtail an AsthmaNet study (or an individual award) in the event of (1) failure to develop or implement mutually agreeable collaborative protocol; (2) substantial shortfall in participant recruitment, follow-up, data reporting, or quality control; (3) major breach of a protocol or substantive changes in the agreed-upon protocol with which NHLBI cannot concur; (4) attaining of a major study endpoint before schedule with persuasive statistical significance, or (5) human subject ethical issues that may dictate a premature termination.

Annual continuation and level of funding for each Clinical Center will be based on NHLBI review of actual recruitment and overall performance, determined as part of the NHLBI review of the annual non-competing continuation grant progress reports submitted by awardees.

2.A.3. Collaborative Responsibilities

Awardees agree to the governance of the study through a Steering Committee (SC).  All principal investigators and a Chairperson, to be appointed by the NHLBI will comprise the SC.  All major scientific decisions will be determined by majority vote of the SC.  Each Clinical Center, the Data Coordinating Center, and the NHLBI Project Office will have one vote; the Chair will have one vote in case of a tie.  Note that although each Clinical Center’s two principal investigators (one with expertise in adult asthma, one with expertise in pediatric asthma) are expected to participate in all SC meetings, each Clinical Center has one vote.  It is anticipated that SC meetings will be held twice a month by conference call and six times a year in person.

An independent Protocol Review Committee (PRC) will provide peer review for each AsthmaNet protocol.  The PRC will be appointed by and be advisory to the NHLBI.  It will consist of a chairperson, and Executive Secretary who is an NHLBI scientist other than the NHLBI Project Scientists, and scientists with expertise in clinical trial design, biostatistics and data coordinating center management, asthma clinical management and research in adults and pediatrics, bioethics, and other areas of expertise as needed.  Because the Board serves as an independent group advisory to the NHLBI, study investigators will not communicate with Board members regarding study issues, except as authorized by PRC Executive Secretary. The PRC will evaluate protocols proposed by the SC based on the significance of the questions to be addressed, scientific merit and innovation of the experimental design and approach, feasibility, appropriateness for the Network and consistency with NHLBI missions and policies.  The PRC will provide a written critique of each proposal and a final recommendation to the NHLBI.  All study protocols performed by the AsthmaNet will be recommended by the PRC and approved by the NHLBI before initiation. 

A Data Safety Monitoring Board (DSMB) will be appointed by the Director, NHLBI to provide overall monitoring of study performance, interim data, and safety issues.  The Steering Committee may nominate members for the DSMB.  DSMB meetings will ordinarily be held in Bethesda.  An NHLBI scientist, other than the NHLBI Project Scientists, shall serve as Executive Secretary to the DSMB.

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:

Robert A. Smith, Ph.D.
Division of Lung Diseases 
National Heart, Lung and Blood Institute 
6701 Rockledge Drive, Room 10148
Bethesda, MD 20892
Telephone: (301) 435-0202
Email: smithra3@nhlbi.nih.gov

Virginia S. Taggart, M.P.H
Division of Lung Diseases
National Heart, Lung and Blood Institute
6701 Rockledge Drive, Room 10150
Bethesda, MD 20892
Telephone: (301) 435-0202
Email: taggartv@nhlbi.nih.gov

2. Peer Review Contacts:

Chief, Review Branch
Division of Extramural Research Activities
National Heart, Lung, and Blood Institute
6701 Rockledge Drive
Room 7214, MSC 7924
Bethesda, MD 20892-7924 (Express zip: 20817)
Telephone: (301) 435-0270
FAX: (301) 480-0730
Email: nhlbichiefreviewbranch@nhlbi.nih.gov


3. Financial or Grants Management Contacts:

Ryan Cherise Lombardi, M.S.M.
Division of Extramural Research Activities
National Heart, Lung, and Blood Institute
Room 7154, MSC 7926
6701 Rockledge Drive
Bethesda, MD 20892-7926
Telephone: (301) 435-0144
FAX: (301) 451-5462
Email: lombardr@nhlbi.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/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 or Health Systems Agency review. Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement. The NIH Grants Policy Statement can be found at http://grants.nih.gov/grants/policy/policy.htm.

The PHS strongly encourages all grant recipients to provide a smoke-free workplace and discourage the use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routine education, library, day care, health care, or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people.

Loan Repayment Programs:
NIH encourages applications for educational loan repayment from qualified health professionals who have made a commitment to pursue a research career involving clinical, pediatric, contraception, infertility, and health disparities related areas. The LRP is an important component of NIH's efforts to recruit and retain the next generation of researchers by providing the means for developing a research career unfettered by the burden of student loan debt. Note that an NIH grant is not required for eligibility and concurrent career award and LRP applications are encouraged. The periods of career award and LRP award may overlap providing the LRP recipient with the required commitment of time and effort, as LRP awardees must commit at least 50% of their time (at least 20 hours per week based on a 40 hour week) for two years to the research. For further information, please see: http://www.lrp.nih.gov.


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