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: Effectiveness Research on Smoking Cessation in Hospitalized Patients Research Coordinating Unit (U01)

Announcement Type
New

Request For Applications (RFA) Number: RFA-HL-10-025

Catalog of Federal Domestic Assistance Number(s)
93.837, 93.838

Key Dates
Release/Posted Date: November 16, 2009
Letters of Intent Receipt Date: December 18, 2009
Application Due Date: January 19, 2010
Peer Review Date: June 2010
Council Review Date: August 2010
Earliest Anticipated Start Date: January 2011
Additional Information To Be Available Date (Activation Date): Not Applicable
Expiration Date: January 20, 2010

Due Dates for E.O. 12372

Not Applicable

Additional Overview Content

Executive Summary

• Purpose. The National Heart, Lung and Blood Institute (NHLBI) of the National Institutes of Health (NIH) solicits four-year cooperative agreement (U01) grant applications from institutions/organizations to serve as the Research Coordinating Unit (RCU) for the grantees of the Effectiveness Research on Smoking Cessation in Hospitalized Patients (see RFA-HL-10-020), referred to as primary research sites (PRSs). The purpose of the PRS FOA (RFA-HL-10-020) is to encourage research to evaluate the translation of efficacious smoking cessation strategies initiated during hospitalization and continued post-discharge into effective programs that can be widely implemented in routine clinical practice, and assess the cost effectiveness of these interventions. NHLBI, NIDA, and NCI expect to award $21.1 million over four years to fund five to six awards under the companion announcement (RFA-HL-10-020) The RCU solicited by this FOA (RFA HL-10-025) will facilitate coordination of research activities of the PRSs awarded under the parallel FOA. The PRSs will be responsible for planning, directing, and executing their own studies and conducting their own data management and statistical analyses. The RCU awardee will be responsible for: (a) planning, arranging, and supporting meetings of the Steering Committee and its subcommittee to facilitate the use of common measures, methods, and data management procedures of the PRSs; (b) supporting and coordinating the semi-annual meetings of the DSMB appointed by NHLBI; and (c) providing the infrastructure for data aggregation and data sharing across PRSs.
• Mechanism of Support. This FOA will utilize the Cooperative Agreement grant mechanism (U01). A companion FOA (RFA HL-10-020) solicits U01 applications for Primary Research Sites (PRSs) to plan, direct, and execute studies on smoking cessation in hospitalized patients.
• Funds Available and Anticipated Number of Awards. NHLBI expects to award $600,000 in total costs over four years to fund one Research Coordinating Unit (RCU) through this announcement. Awards issued under this FOA are contingent upon the availability of funds and the submission of a sufficient number of meritorious applications.
• Budget and Project Period. Budgets for direct costs up to $100,000 per year may be requested for a maximum of $400,000 direct costs over the four-year period.
• Application Research Plan Component Length: The U01 application Research Plan component of the PHS398 may not exceed 6 pages, including tables, graphs, figures, diagrams, and charts.
• Eligible Institutions/Organizations. Institutions/organizations listed in Section III, 1.A. are eligible to apply.
• Eligible Project Directors/Principal Investigators (PDs/PIs). Individuals with the skills, knowledge, and resources necessary to carry out the proposed research are invited to work with their institution/organization 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.
• Number of PDs/PIs. More than one PD/PI (i.e., multiple PDs/PIs) may be designated on the application.
• Number of Applications. Applicants may submit only one application for this FOA. Applicants with interest and expertise as a Primary Research Site (PRS) are encouraged also to submit an application to the companion PRS FOA (HL-10-020). Applications for the RCU and PRS can be submitted from the same institution, but must have different PD/PIs.
• Resubmissions. Resubmission applications are not permitted in response to this FOA.
• Renewals. Renewal applications are not permitted in response to this FOA.
• Special Date(s). This FOA uses non-standard due dates. See Receipt, Review and Anticipated Start Dates.
• Application Materials. See Section IV.1 for application materials.
• Hearing Impaired. Telecommunications for the hearing impaired are available at: TTY: (301) 451-5936

Table of Contents

Part I Overview Information

Part II Full Text of Announcement

Section I. Funding Opportunity Description
1. Research Objectives

Section II. Award Information
1. Mechanism(s) of Support
2. Funds Available

Section III. Eligibility Information
1. Eligible Applicants
    A. Eligible Institutions
    B. Eligible Individuals
2. Cost Sharing or Matching
3. Other - Special Eligibility Criteria

Section IV. Application and Submission Information
1. Address to Request Application Information
2. Content and Form of Application Submission
3. Submission Dates and Times
    A. Receipt, Review and Anticipated Start Dates
       1. Letter of Intent
    B. Sending an Application to the NIH
    C. Application Processing
D. Application Assignment
4. Intergovernmental Review
5. Funding Restrictions
6. Other Submission Requirements

Section V. Application Review Information
1. Criteria
2. Review and Selection Process
    A. Additional Review Criteria
    B. Additional Review Considerations
    C. Resource Sharing Plan(s)
3. Anticipated Announcement and Award Dates

Section VI. Award Administration Information
1. Award Notices
2. Administrative and National Policy Requirements
     A. Cooperative Agreement Terms and Conditions of Award
       1. Principal Investigator Rights and Responsibilities
       2. NIH Responsibilities
       3. Collaborative Responsibilities
       4. Arbitration Process
3. Reporting

Section VII. Agency Contact(s)
1. Scientific/Research Contact(s)
2. Peer Review Contact(s)
3. Financial/ Grants Management Contact(s)

Section VIII. Other Information - Required Federal Citations

Part II - Full Text of Announcement

Section I. Funding Opportunity Description

1. Research Objectives

Purpose

The National Heart, Lung and Blood Institute (NHLBI) of the National Institutes of Health (NIH) solicits four-year cooperative agreement (U01) grant applications from institutions/organizations to serve as the Research Coordinating Unit (RCU) for the Effectiveness Research on Smoking Cessation in Hospitalized Patients Primary Research Sites (PRSs). This Funding Opportunity Announcement (FOA) runs parallel with a separate FOA that solicits the applications for the Primary Research Sites (PRSs; see RFA-HL-10-020). The PRSs will conduct research that (a) determines how to translate efficacious smoking cessation programs into effective programs for hospitalized smokers that can be widely implemented in routine clinical practice, and (b) assesses the cost-effectiveness of these interventions. The PRS projects are independent, and are responsible for planning, directing, and executing their own studies and conducting their own data management and statistical analyses. However, development of common measures, methods, and data management procedures across sites, whenever feasible, will provide the opportunity for data aggregation and multisite analyses. The RCU solicited by this FOA (RFA HL-10-025) will facilitate communication and coordination of research activities of the PRSs awarded under the parallel FOA. The RCU will be responsible for planning, arranging, and supporting meetings of the Steering Committee and its subcommittee to facilitate the use of common measures, methods, and data management procedures of the PRSs. The RCU will also support and coordinate the meetings of the DSMB appointed by NHLBI. The RCU will provide the infrastructure for aggregating data across sites, facilitating data sharing, and contributing to collaborative manuscripts, but the PRSs will retain primary responsibility for statistical analyses of the aggregated data.

Background

Despite considerable advances in tobacco control, smoking remains the leading preventable cause of premature death in the United States. Nearly one-third of all cancer deaths are caused by smoking, including 87% of lung cancer deaths and most cancers of the larynx, oral cavity and pharynx, esophagus and bladder. Smoking greatly accelerates lung function decline, significantly increases the risk of coronary artery disease, accelerates the development of atherosclerotic vascular diseases, and increases the risk of acute coronary events, including sudden cardiac death. Smoking increases the risk of acute myocardial infarction (MI) threefold across all age groups, and fivefold in those under 50 years of age. Fortunately, smoking cessation, even in patients already diagnosed with smoking-attributable illnesses, reduces the risk of medical complications and premature death. Cancer survivors who smoke may have more progressive disease, increased morbidity and treatment complications, and lower treatment survival rates. Among smokers with coronary heart disease, those who quit smoking reduce their relative risk of mortality by over a third, and reduce their risk of sudden cardiac death to the risk of those who never smoke. Patients with mild to moderate lung function impairment who quit smoking for five years reduce the decline in lung function comparable to those who never smoked.

Hospitalization provides unique cessation opportunities for patients who smoke. Smoking-related illnesses often contribute to the reason for hospitalization, providing a salient motivation to quit. Hospitalization also provides a trial of abstinence removed from most environmental smoking cues, and the availability of a healthcare team that can assist in cessation efforts. In part because of the opportunity that hospitalization provides for smoking cessation efforts, the Joint Commission on Accreditation of Healthcare Organizations (JCAHO) and the Centers for Medicare and Medicaid (CMS) now require reporting on the proportion of current or past year smokers who receive counseling or medications for smoking cessation during a hospitalization for acute myocardial infarction (MI), congestive heart failure (CHF), or pneumonia. A recent Cochrane review showed that smoking cessation counseling during hospitalization that includes supportive contacts for at least one month post-discharge increases the odds of quitting by 65% compared to hospitalization alone. This review also illustrated the wide range of patients and cessation interventions studied (type, intensity, provider) which may contribute to a lack of clarity on how best to implement effective cessation programs for hospitalized smokers.

This FOA provides coordination and communication support to the PRSs solicited under a parallel FOA (RFA-HL-10-020) that encourages research that (a) determines how to translate efficacious smoking cessation programs into effective programs for hospitalized smokers that can be widely implemented in routine clinical practice, and (b) assesses the cost-effectiveness of these interventions. It is anticipated that the results of these projects will provide hospital administrators, health policy makers, and healthcare providers with the scientific basis to implement effective smoking cessation programs initiated during hospitalization. This scientific basis includes the identification and comparative effectiveness of interventions to optimize long-term cessation rates among hospitalized smokers, the efficacy of dissemination and implementation strategies that encourage wide adoption while maintaining treatment fidelity, and the generation of cost-effectiveness data to determine the financial value of these cessation interventions to the patient, healthcare system, and society.

PRS awardees under the parallel FOA (RFA-HL-10-020) are expected to plan, direct, and execute their own studies and conduct their own data management and statistical analyses, but should indicate their willingness to collaborate with the other awardees on the development and use of standardized measures, methods, and data management whenever feasible.

Program Organization and Coordination

The PRSs to be coordinated under this FOA will not use a common study protocol, and are expected to plan, direct, and execute their own data management and statistical analyses. After awards are made, however, investigators are expected to collaborate with other awardees on the development and use of standardized measures, methods, and data management whenever feasible to facilitate data aggregation and collaborative activities between sites. For example, investigators may be encouraged to adopt common measures for nicotine dependence or the biochemical validation of smoking abstinence. Core variables and algorithms used for cost effectiveness data also could be standardized across PRS sites. The variable naming and data coding conventions for PRS databases may be shared to develop common coding and naming conventions across sites to facilitate data aggregation. The timing of follow-up assessments also may be harmonized across studies as appropriate. The use of common study variables, criteria, and protocols is strongly encouraged to facilitate future analyses of the data aggregated across studies. These collaborations will be facilitated by the RCU and the NIH Project Scientists.

A Steering Committee will be the governing body for this project.  The Steering Committee will be composed of the Principal Investigators of each PRS, the RCU Principal Investigator, and the NIH Program Scientists, each of whom will have one vote.  The NIH Program Scientists will constitute no more than one third of the total voting membership of the Steering Committee. The Steering Committee is expected to meet in-person early in the first year of the project, and annually throughout the project period. Steering Committee teleconferences are expected to occur on at least a quarterly basis throughout the project period. In consultation with other NIH program scientists, NHLBI Program Scientist will appoint the chair of the Steering Committee.

NHLBI will be substantially involved with the RCU awardees in a partnership role.  The NIH Program Scientists will collaborate on developing common measures, procedures and data management protocols, monitor study progress, insure disclosure of conflicts of interest and adherence to NHLBI and NIH policies, and participate in data analysis and manuscript preparation as appropriate.  

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

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

Research Coordinating Unit

The primary goal of the RCU is to facilitate coordination of research activities and communications between and among awardees and the NIH. In consultation with the awardees and with NIH, the RCU will be responsible for conducting a number of tasks, including, but not limited to the following:

Facilitation of the Adoption of Common Measures/Procedures and Data Aggregation/Sharing

• Facilitate data aggregation across studies by assessing the potential for and assisting in the selection of standardized variable definitions and common measures and methods. For example, where appropriate, compile a list of proposed standardized variable definitions and common measures or methods, review relevant literature, assess the advantages and disadvantages for common measures and standardized definitions, and facilitate the testing of standard study forms if needed.
• Provide data aggregation infrastructure where appropriate.
• Establish and maintain a computer system to receive and store any datasets that are common or linked across studies.
• Facilitate data transfer and linkage from two or more projects for greater statistical power and analyses, particularly for assessing possible moderator effects.
• Store aggregated data for data sharing requests from outside investigators if appropriate.
• Provide supplemental support to the PRSs as needed for data analysis or manuscript preparation of aggregated datasets.
• Have appropriate measurement, data management, programmatic, statistical, and scientific expertise to achieve the above goals.

Meetings

• Compile individual study protocols and other documents, and provide relevant reports to NHLBI and the DSMB.
• Plan, arrange, and support meetings of the Steering Committee (SC) and its subcommittees, and the DSMB. 
• Prepare minutes of SC meetings, distribute to members, and post on the program website. 
• Prepare minutes of open sessions of the DSMB meetings and teleconferences and submit to NHLBI. 
• Arrange regular (at least quarterly) conference calls of the SC and subcommittees.
• Plan, arrange, and support (including agendas and logistics) an annual in- person steering committee meeting in the Washington, DC area. For budgeting purposes, RCU applicants should anticipate that these SC meetings will be two-day meetings each year, and that PRSs are responsible in their own budgets for the travel-related costs of the PI and one additional investigator to these annual in-person SC meetings.
• Plan, arrange, and support (including agendas and logistics), the semi-annual meetings of the DMSB members, of which at least one meeting per year is in-person. For budgeting purposes, RCU applicants should anticipate that the in-person DSMB meetings each year will be one day in duration, and that the RCU is responsible for all travel-related costs and honoraria of the DSMB members.

Communications and Dissemination

• Develop and maintain a web site and email system for network communication and for distribution of study documents, forms and information.
• Facilitate development of subcommittees as needed and provide the logistics for teleconference meetings of these subcommittees.
• Facilitate sharing of data and the development of collaborative manuscripts among PRSs.
• Facilitate information exchange among and between the PRSs and the NIH.
• Participate in the scientific discussions and implementation of the studies as needed.
• Facilitate the dissemination of study results, including the preparation of limited access aggregated data files for public use.
• Collaborate with NHLBI and other participating NIH institutes, professional associations, and other agencies to promote the dissemination and implementation of successful research outcomes into clinical practice.

Evaluation

• In collaboration with the SC, develop metrics for evaluating program progress and success.

Interested applicant institutions are strongly encouraged to apply for both the PRS and RCU components of this program. The PD/PI for the RCU must not be the same PD/PI for the PRS application, but can be from the same institution. Applicants proposing to perform the research functions of a PRS should apply separately to RFA HL-10-020. 

Please Note: The review of the PRS applications will be separate from the review of the RCU applications (see Section IV. 2.B). Institutions may apply for a PRS award, RCU award, or both.  

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

Facilities and Environment

All applicants to the RCU FOA must provide evidence that the institution or institutions in which the coordination will take place have the infrastructure, resources and institutional support needed to achieve the goals outlined above. Applicants must include the personnel, facilities, and other resources available to the applicant with which to initiate and maintain the functions of the RCU. Relevant support services, including for example adequate data management and analytic support, must also be readily accessible and documented in the proposal.

Research Plan

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

Evidence of Leadership and Performance Experience:

The PD/PI should demonstrate leadership and experience in conducting the following coordinating functions for research studies, including research, demonstration, and information dissemination activities in which the applicant is currently engaged, the sources of funding for these activities, and the relevance of these activities to the proposed RCU. Demonstration of leadership and experience in this role could include:

• Promoting collaboration across studies and among investigators.
• Providing expert assistance in supporting the development of common measures and in the linkage of datasets or analyses of aggregated data.
• Harnessing the skills of staff with varied expertise and working collaboratively in building teams across research sites.
• Coordinating meetings and other forms of communication to facilitate collaboration across study sites.
• Monitoring and evaluating the success of multisite projects.
• Providing evidence of commitment to RCU functions by budgeting at least 15% effort as the PD/PI of the RCU.

Academic and Management Capabilities: 

• Proposed research, training, demonstration, and information dissemination activities
• Evidence of scholarship as PI of a coordinating unit or similar network/collaborative, or evidence of scholarship in outcomes or cost effectiveness research, especially in cooperative agreements.
• Demonstrated skills as a manager of an RCU or comparable research coordination entity.  
• Evidence of scholarship in tobacco research.

Capacity and Ability to Manage Data and Communications: 

• Applicants must indicate in their application their capability to utilize electronic technology to meet the goal for coordination of the PRSs. 
• Applicants should have experience in developing and maintaining data management systems. 
• Applicants should provide evidence of data management and program support capabilities by describing the processes for potential data linkages, pooled/linked data analyses, data security, privacy protections, and quality control. 
• Applicants should propose methods to be employed to facilitate communication between RCU staff and investigators as well as with external partners (e.g., professional associations, hospital systems).

Evidence of Meeting Coordination Capabilities: 

• The RCU is responsible for supporting meetings and teleconferences.  Applicants should have experience arranging logistical services for multiple studies, such as assuring meetings (e.g., DSMB, SC meetings) are held and minutes are recorded and communicated to investigators and NIH in a timely manner.

Staffing Expertise and Organizational Structure: 

• Applicants must propose an operational structure for coordinating functions at the RCU, including lines of responsibility for professional staff at the RCU, and a proposed organizational structure of the relationship of the RCU to the PRSs.
• Applicants should propose staff capable of conducting the various roles of the RCU, and provide the names and qualifications of the RCU PI and key staff members.

Departmental and/or Institutional Commitment: 

• Applicants must demonstrate departmental and/or institutional commitment to participate in research and must provide letters of support from appropriate individuals.  Support in areas of secure transfer of data, information technology, equipment, and general support of research, should be described along with evidence of previous research support.
• Applicants are encouraged to describe special or unique strengths that may be relevant to the outcomes research infrastructure and research described in RFA HL-10-020. Examples include participation by the PI or other staff in administrative aspects of clinical research (e.g., IRB, DSMB), in outcomes research, hospital-based recruitment, tobacco cessation, cost effectiveness analyses, or other facets of the project.

Other Functions

• Applicants must propose methods for monitoring or evaluating individual activities and overall network activities.
• Applicants must provide support for potential linkage of datasets, assist in collaborative analyses across sites, and take appropriate leadership in preparation of scientific reports and manuscripts from linked datasets.
• Applicants must include a plan to prepare public-use files for archiving and sharing results that include common data according to NIH and NHLBI policies (e.g., NHLBI Limited Access Dataset Program (http://www.nhlbi.nih.gov/resources/deca/default.htm).
• Applicants must include a plan for dissemination of research findings including coordination with similar efforts by other public and private organizations, development of message content to be delivered to a wide audience, metrics for successful dissemination, appropriate personnel for developing and implementing dissemination activities, willingness to participate in NHLBI Division of Application of Research Discoveries (DARD s) dissemination and education programs, and a commitment that the Principal Investigator agrees to collaborate with the Steering Committee and NIH program scientists in any dissemination strategy. Applicants are encouraged to suggest collaborative dissemination strategies with hospital systems and health care delivery systems, as well as JCAHO, CMS, AHRQ and other agencies that influence the healthcare quality.
• Awardees must agree to the Cooperative Agreement Terms and Conditions of Award in Section VI.2.A.

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 NIH U01 cooperative agreement 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 (see SF424 (R&R) Application Guide). It also uses the modular as well as the non-modular budget formats (see http://grants.nih.gov/grants/funding/modular/modular.htm). Specifically, a U.S. organization submitting an application with direct costs in each year of $250,000 or less (excluding consortium Facilities and Administrative [F&A] costs) must use the PHS398 Modular Budget component.

U.S. applicants requesting more than $250,000 in annual direct costs must complete and submit budget requests using the Research & Related Budget component.

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."

2. Funds Available

The NHLBI expects to award $600,000 in total costs over four years to support one RCU. Budgets for direct costs up to $100,000 each year may be requested for a maximum of $400,000 direct costs over the four-year period.

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 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:

• Public/State Controlled Institutions of Higher Education
• Private Institutions of Higher Education
• Hispanic-serving Institutions
• Historically Black Colleges and Universities (HBCUs)
• Tribally Controlled Colleges and Universities (TCCUs)
• Alaska Native and Native Hawaiian Serving Institutions
• Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Higher Education)
• Nonprofits without 501(c)(3) IRS Status (Other than Institutions of Higher Education)
• Small Businesses
• For-Profit Organizations (Other than Small Businesses)
• State Governments
• Indian/Native American Tribal Governments (Federally Recognized)
• Indian/Native American Tribally Designated Organizations
• County Governments
• City or Township Governments
• Special District Governments
• Independent School Districts
• Public Housing Authorities/Indian Housing Authorities
• U.S. Territory or Possession
• Indian/Native American Tribal Governments (Other than Federally Recognized)
• Regional Organizations
• Other(s):
  • Eligible Agencies of the Federal Government
  • Faith-based or Community-based Organizations

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.

More than one PD/PI, or multiple PDs/PIs, may be designated on the application for projects that require a team science approach and therefore clearly do not fit the single-PD/PI model. Additional information on the implementation plans, policies and procedures to formally allow more than one PD/PI on individual research projects is available at http://grants.nih.gov/grants/multi_pi. All PDs/PIs must be registered in the NIH eRA Commons prior to the submission of the application (see http://era.nih.gov/ElectronicReceipt/preparing.htm for instructions).

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

The PD/PI for the RCU must not be the same PD/PI for a PRS application. However, the PD/PI for the RCU can be from the same institution as the PD/PI for a PRS.

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

Number of Applications. Applicants may submit only one application as the RCU. An institution is encouraged to submit an application for both an RCU and a PRS, but each must have a different PI/PD.

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

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

Section IV. Application and Submission Information

1. Address to Request Application Information

The PHS 398 application instructions are available at http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive format. Applicants must use the currently approved version of the PHS 398. For further assistance contact GrantsInfo, Telephone (301) 710-0267, Email: [email protected].

Telecommunications for the hearing impaired: TTY 301-451-5936.

2. Content and Form of Application Submission

Applications must be prepared using the most current PHS 398 research grant application instructions and forms. Applications must have a D&B Data Universal Numbering System (DUNS) number as the universal identifier when applying for Federal grants or cooperative agreements. The D&B number can be obtained by calling (866) 705-5711 or through the web site at http://www.dnb.com/us/. The D&B number should be entered on line 11 of the face page of the PHS 398 form.

The title and number of this funding opportunity must be typed in item (box) 2 only of the face page of the application form, and the YES box must be checked.

SPECIAL INSTRUCTIONS

Applications with Multiple PDs/PIs

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

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

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

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

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

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

3. Submission Dates and Times

See Section IV.3.A. for details.

3.A. Submission, Review and Anticipated Start Dates

Letters of Intent Receipt Date: December 18, 2009
Application Due Date: January 19, 2010
Peer Review Date: June 2010
Council Review Date: August 2010
Earliest Anticipated Start Date: January 2011

3.A.1. Letter of Intent

Prospective applicants are asked to submit a letter of intent that includes the following information:

• Descriptive title of proposed research
• Name, address, and telephone number of the Principal Investigator
• Names of other key personnel
• Participating institutions
• Number and title of this funding opportunity

Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows IC staff to estimate the potential review workload and plan the review.

The letter of intent is to be sent by the date listed in Section IV.3.A.

The letter of intent should be sent to:

Director, Office of Scientific Review
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: [email protected]

3.B. Sending an Application to the NIH

Applications must be prepared using the forms found in the PHS 398 instructions for preparing a research grant application. Submit a signed, typewritten original of the application, including the checklist, and three signed photocopies in one package to:

Center for Scientific Review
National Institutes of Health
6701 Rockledge Drive, Room 1040, MSC 7710
Bethesda, MD 20892-7710 (U.S. Postal Service Express or regular mail)
Bethesda, MD 20817 (for express/courier service; non-USPS service)

Personal deliveries of applications are no longer permitted (see http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-040.html).

At the time of submission, two additional copies of the application and all copies of the appendix material must be sent to:

Director, Office of Scientific Review
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: [email protected]

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/grants/policy/nihgps_2003/NIHGPS_Part6.htm.)

6. Other Submission Requirements

For coordination among investigators, applicants are required to participate in Steering Committee and DSMB meetings. The Research Coordinating Unit Principal Investigator, the Principal Investigators from each primary research site, and the NHLBI staff will comprise the Steering Committee. Steering Committee meetings will be held in-person once per year and by teleconference at least quarterly. The RCU staff is required to participate in steering committee conference calls and meetings and should include their time for this effort in their budget. DSMB meetings will be held twice a year to review study progress. In person DSMB meetings will be held at least annually in the Washington, D.C. metro area. For budgeting purposes, applicants should assume two days for in-person Steering Committee meetings and one day for in-person DSMB meetings. Applicants should budget for at least the RCU Principal Investigator and at least one other staff member to travel to all meetings, funds for the DSMB members to attend the DSMB meeting, and the costs associated with the meetings.

• The total time commitment for this FOA for multiple PDs/PIs must not be less than 15% effort per year (reported as 2.4 calendar months in the PHS 398).
• For applicants proposing to serve as a Primary Research Site, please see RFA HL-10-020 for application guidance.

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

Research Plan Page Limitations

The U01 application Research Plan component of the PHS398 may not exceed 6 pages, including tables, graphs, figures, diagrams, and charts.

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/.

The data sharing plan noted above is expected to include a description of how research data will be shared among those awarded grants under this FOA to optimize the potential for data aggregation efforts. Investigators awarded under this FOA are expected to meet early in the first year of the project to coordinate measurement, data collection, and data management efforts to facilitate data aggregation and sharing.

Section V. Application Review Information

1. Criteria

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

2. Review and Selection Process

Review Process

Applications that are complete and responsive to the FOA will be evaluated for scientific and technical merit by an appropriate peer review group convened by the 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:

• Undergo a selection process in which only those applications deemed to have the highest scientific and technical merit, generally the top half of applications under review, will be discussed and assigned an impact/priority score.
• Receive a written critique.
• Receive a second level of review by the NHLBI Advisory Council.

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

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

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

Significance.  Does the project address an important problem or a critical barrier to progress in the field?  If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved?  How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field? Does the applicant address the importance of performing coordinating functions in order to enhance the value of the research programs as indicated in the FOA under Program Organization and Coordination?

Investigator(s).  Are the PD/PIs, collaborators, and other researchers well suited to the project?  If Early Stage Investigators or New Investigators, do they have appropriate experience and training?  If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)?  If the project is collaborative or multi-PD/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project? Does the PD/PI devote sufficient time (at least 15% effort) for the RCU functions and responsibilities? Does the applicant have prior experience in performing coordinating functions and/or expertise in outcomes research? Is there adequate demonstration of prior successful efforts as a coordinating unit? Does the applicant indicate willingness to collaborate with other awardees on common measures and data sharing?

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

Approach.  Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project?  Are potential problems, alternative strategies, and benchmarks for success presented?   If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed? If the project involves clinical research, are the plans for (1) protection of human subjects from research risks, and (2) inclusion of minorities and members of both sexes/genders, as well as the inclusion of children, justified in terms of the scientific goals and research strategy proposed? Are the proposed approaches appropriate for facilitating coordination among smoking cessation research projects and serving as a resource among Primary Research Sites?  Are the proposed coordination strategies adequate? Does the applicant propose adequate plans to facilitate the development of common measures and/or linkage and analysis of common data across the studies? Does the applicant propose plans for developing partnerships with agencies to leverage resources and disseminate findings? Does the applicant provide plans to evaluate progress of the program as a whole?

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

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

NIH considers the following in evaluating Center grant applications:

• The scientific and technical merit of the proposed program. (Use the 5 criteria above.)
• The qualifications and experience of the center director and other key personnel.
• The statutory and program purposes to be accomplished.
• The extent to which the various components of the proposed program would be coordinated into one multi-disciplinary effort within the center.
• The extent to which the center's activities would be coordinated with similar efforts by other organizations.
• The administrative and managerial capability of the applicant.
• Other factors which the awarding IC considers appropriate in light of its particular statutory mission.

Additional Review Criteria

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

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

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

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

Additional Review Considerations

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

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

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

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

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

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

Selection Process

Applications submitted in response to this FOA will compete for available funds with all other recommended applications submitted in response to this FOA. The following will be considered in making funding decisions:

• Scientific merit of the proposed project as determined by peer review.
• Availability of funds.
• Relevance of the proposed project to program priorities.

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.

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: all aspects of the RCU, including any coordination of research activities, communications, meetings, facilitation of common measures and data sharing, evaluation, and collaboration with investigators, NHLBI, and other researchers and agencies, unless otherwise provided for in these terms or by action of the Steering Committee.

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

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

2. A.2. NIH Responsibilities

NIH Project Scientists will serve on the Steering Committee, and may serve on other study committees as appropriate. NIH Project Scientists (and other NIH scientists involved with the project) may work with awardees on issues coming before the Steering Committee, and other committees as appropriate including recruitment, intervention, follow-up, quality control, adherence to protocol, assessment of problems encountered during study implementation, interim data and safety monitoring, final data analysis and interpretation, and preparation of publications.

The NIH reserves the right to phase out curtail or end the study (or an individual award) in the event of: (a) failure to develop and implement a mutually agreeable collaborative protocol; (b) substantial shortfall in participant recruitment, follow-up, data reporting, or quality control; (c) major breach of protocol or substantive changes in the agreed-upon protocol with which NIH did not concur; or (d) human subject ethical issues that may dictate premature termination.

Support or other involvement of industry or any other third party in the study 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 NIH.

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

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

2.A.3. Collaborative Responsibilities

Awardees 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 RCU Principal Investigator awarded under the complementary FOA (HL-10-025) if not one of the principal investigators awarded under this FOA, and specified NIH Project Scientists who will not exceed one third of the total voting membership. The NHLBI Project Scientist will appoint the chair of the steering committee. Meetings of the Steering Committee will typically be held by teleconference or in-person meetings in the Washington, DC area.

A Data and Safety Monitoring Board (DSMB) will be appointed by the NHLBI Director to provide overall monitoring of interim data and safety issues. The Steering Committee will nominate members of this board. Meetings of the DSMB will typically be held by teleconference or in-person meetings in the Washington, DC area. An NIH scientist other than the NIH Project Scientists shall serve as the Executive Secretary to the DMSB. Because the DSMB serves as an independent group advisory to the NIH, study investigators will not communicate with Board members regarding specific study issues except as authorized by the Board’s Executive Secretary.

The collaborative protocol and governance policies will call for the regular sharing of data collected to the RCU for data aggregation, the submittal of copies of the final aggregated datasets to each PI upon completion of the study, procedures for data analysis, reporting and publication, and procedures to insure the privacy of the medical and genetic data and records of the individuals. The NIH Project Scientists, on behalf of NIH, will have the same access, privileges, and responsibilities regarding the aggregated or collaborative data as the other members of the Steering Committee.

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

2.A.4. Dispute Resolution

Any disagreements that may arise in scientific or programmatic matters (within the scope of the award) between award recipients and the NIH may be brought to arbitration. A Dispute Resolution Panel composed of three members will be convened. It will have three members: a designee of the Steering Committee chosen without NIH staff voting, one NIH designee, and a third designee with expertise in the relevant area who is chosen by the other two; in the case of individual disagreement, the first member may be chosen by the individual awardee. This special dispute resolution procedure does not alter the awardee's right to appeal an adverse action that is otherwise appealable in accordance with PHS regulations 42 CFR Part 50, Subpart D and HHS regulations 45 CFR Part 16.

3. Reporting

Awardees will be required to submit the Non-Competing Continuation Grant Progress Report (PHS 2590) annually and financial statements as required in the NIH Grants Policy Statement.

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

Section VII. Agency Contacts

We encourage your inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants. Inquiries may fall into three areas: scientific/research, peer review, and financial or grants management issues:

1. Scientific/Research Contacts:

William T. Riley, Ph.D.
Division of Prevention and Population Sciences
National Heart, Lung, and Blood Institute
6701 Rockledge Drive, Suite 10224, MSC 7936
Bethesda, MD 20892
Telephone: (301) 435-0407
FAX: (301) 480-1455
Email: [email protected]

2. Peer Review Contacts:

Director, Office of Scientific Review
National Heart, Lung, and Blood Institute
National Institutes of Health
6701 Rockledge Drive, Room 7214
Bethesda, MD 20892-7924
Bethesda, MD 20817 (express/courier service)
Telephone: 301-435-0270
FAX: 301-480-0730
Email: [email protected]

3. Financial or Grants Management Contacts:

Ms. Tawana McKeither
National Heart, Lung, and Blood Institute
Division of Extramural Research Administration
Office of Grants Mangement
6701 Rockledge Drive, Suite 700
Bethesda, MD 20892-7924
Telephone 301-435-0166
FAX: 301 451-5642
Email: [email protected]

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 (45 CFR 46) 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 institutional review board (IRB) rules, as well as local, state and federal laws and regulations, including the Privacy Rule.

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

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. Beginning October 1, 2004, all investigators submitting an NIH application or contract proposal 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.

Access to Research Data through the Freedom of Information Act:
The Office of Management and Budget (OMB) Circular A-110 has been revised to provide access to research data through the Freedom of Information Act (FOIA) under some circumstances. Data that are: (1) first produced in a project that is supported in whole or in part with Federal funds; and (2) cited publicly and officially by a Federal agency in support of an action that has the force and effect of law (i.e., a regulation) may be accessed through FOIA. It is important for applicants to understand the basic scope of this amendment. NIH has provided guidance at http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm. Applicants may wish to place data collected under this funding opportunity in a public archive, which can provide protections for the data and manage the distribution for an indefinite period of time. If so, the application should include a description of the archiving plan in the study design and include information about this in the budget justification section of the application. In addition, applicants should think about how to structure informed consent statements and other human subjects procedures given the potential for wider use of data collected under this award.

Inclusion of Women And Minorities in Clinical Research:
It is the policy of the NIH that women and members of minority groups and their sub-populations must be included in all NIH-supported clinical research projects unless a clear and compelling justification is provided indicating that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43). All investigators proposing clinical research should read the "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html); a complete copy of the updated Guidelines is available at http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm. The amended policy incorporates: the use of an NIH definition of clinical research; updated racial and ethnic categories in compliance with the new OMB standards; clarification of language governing NIH-defined Phase III clinical trials consistent with the SF424 (R&R) application; and updated roles and responsibilities of NIH staff and the extramural community. The policy continues to require for all NIH-defined Phase III clinical trials that: a) all applications or proposals and/or protocols must provide a description of plans to conduct analyses, as appropriate, to address differences by sex/gender and/or racial/ethnic groups, including subgroups if applicable; and b) investigators must report annual accrual and progress in conducting analyses, as appropriate, by sex/gender and/or racial/ethnic group differences.

Inclusion of Children as Participants in Clinical Research:
The NIH maintains a policy that children (i.e., individuals under the age of 21) must be included in all clinical research, conducted or supported by the NIH, unless there are scientific and ethical reasons not to include them. All investigators proposing research involving human subjects should read the "NIH Policy and Guidelines" on the inclusion of children as participants in research involving human subjects (http://grants.nih.gov/grants/funding/children/children.htm).

Required Education on the Protection of Human Subject Participants:
NIH policy requires education on the protection of human subject participants for all investigators submitting NIH applications for research involving human subjects and individuals designated as key personnel. The policy is available at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html.

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

NIH Public Access Policy Requirement:
In accordance with the NIH Public Access Policy, investigators funded by the NIH must submit or have submitted for them to the National Library of Medicine’s PubMed Central (see http://www.pubmedcentral.nih.gov/), an electronic version of their final, peer-reviewed manuscripts upon acceptance for publication, to be made publicly available no later than 12 months after the official date of publication. The NIH Public Access Policy is available at (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-033.html). 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 (HHS) 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 HHS 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) or PubMed Central (PMC) submission identification numbers must be used for publicly accessible on-line journal articles. Publicly accessible on-line journal articles or PMC articles/manuscripts accepted for publication that are directly relevant to the project may be included only as URLs or PMC submission identification numbers accompanying the full reference in either the Bibliography & References Cited section, the Progress Report Publication List section, or the Biographical Sketch section of the NIH grant application. A URL or PMC submission identification number citation may be repeated in each of these sections as appropriate. There is no limit to the number of URLs or PMC submission identification numbers that can be cited.

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 Part 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 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/.