Department of Health and Human Services

Part 1. Overview Information
Participating Organization(s)

National Institutes of Health (NIH)

Components of Participating Organizations

National Heart, Lung, and Blood Institute (NHLBI)

Funding Opportunity Title

Trans-Agency Research Consortium for Trauma-Induced Coagulopathy (TACTIC) (UM1)

Activity Code

UM1 Multi-Component Research Project Cooperative Agreements

Announcement Type

New

Related Notices

  • December 5, 2012 - See Notice NOT-HL-12-163. Notice of Correction of URL Link to Additional Information.

Funding Opportunity Announcement (FOA) Number

RFA-HL-13-025

Companion Funding Opportunity

None

Number of Applications

See Section III. 3. Additional Information on Eligibility.

Catalog of Federal Domestic Assistance (CFDA) Number(s)

93.839

Funding Opportunity Purpose

The purpose of the Trans-Agency Research Consortium for Trauma-Induced Coagulopathy (TACTIC) is to support a single multi-component basic collaborative Research Program to conduct  hypothesis-driven studies of trauma induced coagulopathy (TIC). Through this initiative, the National Heart, Lung and Blood Institute (NHLBI) and the Department of Defense (DoD) are in partnership to form a consortium with the UM1 Research Program to address TIC research. The TACTIC program will link clinical investigators involved with ongoing DoD funded trauma-related clinical trials with the UM1 Research Program scientists who will have the unique opportunity to utilize patient samples in their basic research in TIC.

Additional Information Available at URL: http://lassie.nhlbi.nih.gov/funding/inits/index.htm#rfa

Key Dates
Posted Date

November 21, 2012

Letter of Intent Due Date(s)

January 6, 2013

Application Due Date(s)

February 6, 2013

AIDS Application Due Date(s)

Not Applicable

Scientific Merit Review

June/July 2013

Advisory Council Review

August 2013

Earliest Start Date

September 2013

Expiration Date

February 7, 2013

Due Dates for E.O. 12372

Not Applicable

Required Application Instructions

It is critical that applicants follow the instructions in the PHS 398 Application Guide except where instructed to do otherwise (in this FOA or in a Notice from the NIH Guide for Grants and Contracts). Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. While some links are provided, applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions. Applications that do not comply with these instructions may be delayed or not accepted for review.

Looking ahead: NIH is committed to transitioning all grant programs to electronic submission using the SF424 Research and Related (R&R) format and is currently investigating solutions that will accommodate NIH’s multi-project programs. NIH will announce plans to transition the remaining programs in the NIH Guide to Grants and Contracts and on NIH’s Applying Electronically website.

Table of Contents

Part 1. Overview Information
Part 2. Full Text of Announcement
Section I. Funding Opportunity Description
Section II. Award Information
Section III. Eligibility Information
Section IV. Application and Submission Information
Section V. Application Review Information
Section VI. Award Administration Information
Section VII. Agency Contacts
Section VIII. Other Information

Part 2. Full Text of Announcement

Section I. Funding Opportunity Description

Purpose

This Funding Opportunity Announcement (FOA) will support one UM1 multi-component Research Program that will become part of an NHLBI-Department of Defense (DoD) Trans-Agency Research Consortium for Trauma-Induced Coagulopathy (TACTIC) to address multiple research aspects of trauma-induced coagulopathy (TIC).  The objective of TACTIC is to support hypothesis-driven basic research studies of the pathophysiological mechanisms underlying TIC. To support this goal, the NHLBI invites a multidisciplinary team, led by a single or multiple investigators, to establish innovative basic research collaborations to support hypothesis-driven research in TIC.  This FOA creates a unique opportunity to provide TACTIC researchers with access to biological samples from patients who have experienced severe trauma. These biological samples (linked to clinical data) will be obtained as soon as possible following trauma injury including from the arrival of EMT personnel and initial resuscitation, through transportation and early hospital care, to surgery and post-surgical management. Through TACTIC, investigators will have timely access to patient samples collected on site from DoD-supported trauma trials at Level I Trauma Centers and will have access to data exchange with the DoD Systems Biology Program in Coagulopathy of Trauma.

Background  

Trauma is the major cause of death in individuals less than 34 years of age and the third leading cause of mortality in the United States, with uncontrolled hemorrhage representing the major cause of preventable deaths. Each year there are nearly 50 million injuries in the US that result in more than 170,000 deaths. Severe injury often leads to the multiple profound maladaptive responses manifested by TIC that synergistically contribute to the associated high mortality.

Recent scientific advances have identified a number of systems affected by the complex biology of TIC, including hemostatic, inflammatory, hormonal, cardiovascular, neurological, and reticuloendothelial systems. Contributing factors include: hypo-perfusion, abnormalities of microcirculation, nature and extent of injury, timing of events, and disruption of coagulation and inflammatory cascades. These processes are intricately connected at sub-cellular, cellular, organ, and system levels. Understanding the biology of TIC and interactions among these various systems may allow for the identification of specific pathways that could be targeted for the development of  biomarkers of effective treatment strategies and improved prognosis.

The major obstacles preventing progress in mechanistic and translational research in TIC are:

The DoD recently initiated a large clinical trials program in trauma addressing treatment in pre-hospital and early hospital settings.  The DoD program is designed to answer specific therapeutic questions that will have practical implications on patient care.  It also  provides the research community with access to temporal and longitudinal trauma patient samples with linked clinical data. Capitalizing on this opportunity, NHLBI and DoD have developed a collaborative partnership to address multiple research aspects of TIC by linking clinical investigators of the ongoing DoD-funded clinical trials at Level I Trauma Centers with basic scientists who have the capacity to use collected patient samples to study the pathophysiology of TIC.

TACTIC Research Program Structure

The TACTIC Research Program creates the mechanism for investigators to gain access to trauma patient samples and use those samples to conduct fundamental research in TIC. The TACTIC Research Program is a UM1 cooperative agreement consisting of three required components: two Research Components and a Coordinating Center. The Program may be structured with multiple Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) or a PD/PI with co-investigators.  While the UM1 will be awarded to one primary institution, it may include multiple collaborative sites.  Foreign organizations or foreign components of US organizations are not eligible to apply.

Program  Components:

TACTIC's two Research Components should be designed to investigate biological interactions in the coagulation, vascular-endothelial, and inflammatory systems.  The Research Components will conduct hypothesis-driven studies that target high priority scientific areas such as those identified by the Trans-Agency Coagulopathy in Trauma Workshop http://www.nhlbi.nih.gov/meetings/workshops/tactrauma.htm.   

While focused on the development of new biomarkers and novel therapeutic targets for TIC, it is expected that the Research Components will consider the following hypotheses:

TACTIC Research Components: 

1. The Coagulation Research Component (CRC) will assess the coagulation status of trauma patients, investigate  pathophysiology that may contribute to the development of coagulopathy, and identify biomarkers predictive of clinical outcomes.  Investigations must include studies that require utilization of the samples collected from the DoD clinical trials.  Supportive research using in vitro and in vivo animal models may be included. CRC investigators will have access to trauma patient samples through the Program's Coordinating Center.

2. The Inflammation and Vascular Research Component (IVRC) will investigate the role of systemic and local inflammation, and autoimmune processes, as causative agents of vascular and micro-vascular injury during the development of TIC. This Component will also identify mechanisms by which acquired vascular abnormalities may potentiate systemic coagulopathy, and identify biomarkers predictive of clinical outcomes.  Investigations must include studies that require utilization of the samples collected from the DoD clinical trials.  Supportive research using in vitro and in vivo animal models may be included. IVRC investigators will have access to trauma patient samples through the Program's Coordinating Center.

TACTIC Coordinating Center:

3. The Coordinating Center (CC) is an essential part of TACTIC and a key contributor to the overall success of the program.  The CC has several responsibilities:  1) to establish a process for coordination with the DoD Trauma Center clinical investigators to obtain trauma patient samples from multiple sites; 2)  develop the necessary approaches for time sensitive sample processing, preservation, shipping, storage, and distribution to the TACTIC Research Component investigators; 3)  identify, assign, train and support technicians for the on-site and timely processing of trauma patient samples; 4) create a data management system and establish a process for ongoing clinical and phenotypic data exchange between the UM1 investigators and the DoD TACTIC components; and 5) coordinate the activities of the TACTIC Steering Committee described below. 

The Coordinating Center will be responsible for  providing the logistics for and funding any required travel expenses for the TACTIC Steering Committee.  The Steering Committee will be responsible for overall scientific direction, coordination and oversight of the TACTIC Research Program.  The Steering Committee will be composed of the Research Components and Coordinating Center leaders, the NHLBI Project Scientist, and a DoD representative. The Steering Committee will be chaired by an investigator selected by the NHLBI. In the first year of funding, the Steering Committee will meet in person for an implementation meeting at the start of the project period and by conference call at least quarterly. In the second through fifth year of funding, the Steering Committee will meet at least once a year in person in or near Bethesda, MD. The applicant’s Coordinating Center budget should include funds for appropriate staff travel and related expenses of the Steering Committee.

DoD Components and Resources Available in the TACTIC Consortium:

1.  The DoD has agreed to provide access to patient samples and institutions involved in DoD-sponsored clinical trials at Level I Trauma Centers. This collaboration has created a unique opportunity to provide the TACTIC Research Program with access to patient’s samples prospectively obtained from the time of trauma, through initial resuscitation, transportation, early hospital care, surgery and post-surgical management.  Patient's samples will be linked to clinical data in agreed upon formats established between the DoD clinical trial investigators and TACTIC investigators.  The samples will be collected by the DoD clinical trial staff and will be made immediately available for processing by the on-site trained technicians that are supported through the UM1 Coordinating Center. The expectation is that samples from both current and future DoD clinical studies will be available to investigators and will include at a minimum:

a.  Three clinical tauma trials that are expected to begin enrollment in early 2013. Total   enrollment into these studies is expected to be approximately 1000 patients. These three studies include:   

b.  Access to patients/institutions involved in the multicenter study conducted by the USAMRMC Systems Biology Coagulopathy of Trauma Consortium.  These studies are expected to accrue approximately 400 patients and are currently underway.

c.  Access to patients/institutions involved in additional studies that are expected to begin in late 2013 or early 2014.  These studies are not yet defined but will address trauma patients in the pre-hospital/early in-hospital time frame.

2.  The Systems Biology Program in Coagulopathy of Trauma, recently initiated by the USAMRMC, DoD, is designed to support genomic, proteomic, metabolomic and multi-scale computational modeling studies on the same clinical trials patient population as TACTIC.  Through a formalized process of data exchange between the Systems Biology Program  and the UM1 Coordinating Center, TACTIC investigators will be provided with genetic and other "omics" data relevant to goals of their studies in TIC.

3.  DoD is supporting the collection of blood samples from all screened patients as well as longitudinal samples from all enrolled subjects for standard clinical and trial outcome-related monitoring assays to be performed according to the clinical trial protocols. These results will be provided to TACTIC investigators as a part of the clinical phenotype database on subjects whose samples are included in the mechanistic studies. The DoD does not have the capability to support on-site sample processing, specific for testing the scientific hypotheses targeted for TACTIC.

Selected Research Examples:

The following are examples of possible topics for TACTIC Research Program applications, but there are many other important challenges that would also be responsive:

Applications Not Responsive to this FOA:

Section II. Award Information
Funding Instrument

Cooperative Agreement: A support mechanism used when there will be substantial Federal scientific or programmatic involvement. Substantial involvement means that, after award, NIH staff will assist, guide, coordinate, or participate in project activities.

Application Types Allowed

New

The OER Glossary and the PHS 398 Application Guide provide details on these application types.

Funds Available and Anticipated Number of Awards

NHLBI intends to fund one award and commit $24,000,000 total costs over a period of five years.  A total cost of $4.8 million will be committed for FY 2013..

Award Budget

Application budgets are limited to $4.8 million total costs per year. Total costs include direct costs to the primary institution, consortium total costs [direct costs plus Facilities and Administrative costs (F&A)], and F&A costs to the primary institution.

Award Project Period

5 years

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

Eligible Organizations

Higher Education Institutions

The following types of Higher Education Institutions are always encouraged to apply for NIH support as Public or Private Institutions of Higher Education:

Nonprofits Other Than Institutions of Higher Education

For-Profit Organizations

Governments

Other

Foreign Institutions

Non-domestic (non-U.S.) Entities (Foreign Institutions) are not eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.
Foreign components, as defined in the NIH Grants Policy Statement, are not allowed.

Required Registrations

Applicant organizations must complete the following registrations as described in the PHS 398 Application Guide to be eligible to apply for or receive an award. Applicants must have a valid Dun and Bradstreet Universal Numbering System (DUNS) number in order to begin each of the following registrations.

All Program Directors/Principal Investigators (PD(s)/PI(s)) must also work with their institutional officials to register with the eRA Commons or ensure their existing eRA Commons account is affiliated with the eRA Commons account of the applicant organization.

All registrations must be completed by the application due date. Applicant organizations are strongly encouraged to start the registration process at least 6 weeks prior to the application due date.

Eligible Individuals (Program Director/Principal Investigator)

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with his/her 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.

For institutions/organizations proposing multiple PDs/PIs, visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the PHS 398 Application Guide.

2. Cost Sharing

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

3. Additional Information on Eligibility

Number of Applications

Applicant organizations may submit more than one application, provided that each application is scientifically distinct.

NIH will not accept any application that is essentially the same as one already reviewed within the past thirty-seven months (as described in the NIH Grants Policy Statement), except for submission:

Section IV. Application and Submission Information

1. Address to Request Application Package

Applicants are required to prepare applications according to the current PHS 398 application forms in accordance with the PHS 398 Application Guide.

2. Content and Form of Application Submission

It is critical that applicants follow the instructions in the PHS 398 Application Guide, except where instructed in this funding opportunity announcement to do otherwise. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.

Letter of Intent

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.

By the date listed in Part 1. Overview Information, prospective applicants are asked to submit a letter of intent that includes the following information:

The letter of intent should be sent to:

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

Application Submission

Applications must be prepared using the PHS 398 research grant application forms and 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)

At the time of submission, two additional paper copies of the application and all copies of the Appendix files must be sent to:

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

Page Limitations

All page limitations described in the PHS 398 Application Guide and the Table of Page Limits must be followed, with the following exceptions or additional requirements:

Application Format

The TACTIC Research Program is a UM1 cooperative agreement consisting of three required components: two Research Components and a Coordinating Center. Follow all instructions in the PHS398 Application Guide. Each component should be presented individually with its accompanying individual categorical budget and justification, biographical sketches, other support pages.

Place the components in the following order: Overall Component, Coagulation Research Component, Inflammation and Vascular Research Component, and Coordinating Center.  The Application Order for each component is as follows:

Appendix. Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix (please note all format requirements) as described in the PHS 398 Application Guide.

3. Submission Dates and Times

Part I. Overview Information contains information about Key Dates. 

Information on the process of receipt and determining if your application is considered “on-time” is described in detail in the PHS 398 Application Guide.

Applicants may track the status of the application in the eRA Commons, NIH’s electronic system for grants administration.

4. Intergovernmental Review (E.O. 12372)

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.

Pre-award costs are allowable only as described in the NIH Grants Policy Statement.

6. Other Submission Requirements and Information

Applications must be received on or before the due dates in Part I. Overview Information. If an application is received after that date, it will not be reviewed.

Upon receipt, applications will be evaluated for completeness by the Center for Scientific Review and responsiveness by components of participating organizations, NIH. Applications that are incomplete and/or nonresponsive will not be reviewed.   

Post Submission Materials

Applicants are required to follow the instructions for post-submission materials, as described in NOT-OD-10-115.

Section V. Application Review Information

1. Criteria

Only the review criteria described below will be considered in the review process. As part of the NIH mission, all applications submitted to the NIH in support of biomedical and behavioral research are evaluated for scientific and technical merit through the NIH peer review system.

For this particular announcement, note the following: A single overall impact score will be given for the entire application.

Overall Impact - Overall

Reviewers will provide an overall impact 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 review criteria and additional review criteria (as applicable for the project proposed).

Scored Review Criteria - Overall

Reviewers will consider each of the review criteria below in the determination of scientific 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? To what degree does the proposed plan for discovery of early biomarkers and novel therapeutic targets support the clinical needs for Trauma Induced Coagulopathy (TIC)? What is the likelihood that the Program will identify new early biomarkers or novel therapeutic targets?          

Investigator(s)

Are the PD(s)/PI(s), collaborators, and other researchers well suited to the project? If Early Stage Investigators or New Investigators, or in the early stages of independent careers, 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? Do the investigators have complementary and integrated expertise?  Are their leadership approach, governance and organizational structure appropriate for the project?  Have collaborations been established or consultants identified to provide the appropriate depth and breadth of expertise required for the program? Has the PD(s)/PI(s) demonstrated leadership in development, implementation, and management of comprehensive and complex research programs? Is there evidence for appropriate communication and collaboration plans?   

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? Are the hypotheses under investigation for early biomarkers and/or therapeutic targets novel?    

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 scientific disciplines represented in Research Components and Coordinating Center adequate to achieve the TACTIC objectives? Is there a sound scientific rationale for the proposed research directions? Is there an effective plan described in how the Coordinating Center will interact with the Research Components and the DoD components?    

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 and competence of the applying Institution(s) to carry out the Coordinating Center responsibilities? Does the research team demonstrate a track record in successfully coordinating basic research with clinical trials and research studies and completing proposed studies within projected timelines?

Interaction:  Do the investigators state their willingness to collaborate extensively and share information fully? Is the research infrastructure designed to benefit from the collaboration with DoD-established clinical studies?    

Additional Review Criteria - Overall

As applicable for the project proposed, reviewers will evaluate the following additional items while determining scientific and technical merit, and in providing an overall impact score, 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. For additional information on review of the Human Subjects section, please refer to the Human Subjects Protection and Inclusion Guidelines.

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. For additional information on review of the Inclusion section, please refer to the Human Subjects Protection and Inclusion Guidelines.

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. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal Section.

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.

Resubmissions

Not Applicable

Renewals

Not Applicable

Revisions

Not applicable

Additional Review Considerations - Overall

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

Applications from Foreign Organizations

Not Applicable

Select Agent 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; 2) Sharing Model Organisms; and 3) Genome Wide Association Studies (GWAS).

Budget and Period of Support

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

2. Review and Selection Process

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s) convened by the NHLBI, in accordance with NIH peer review policy and procedures, using the stated review criteria. Assignment to a Scientific Review Group will be shown in the eRA Commons.

As part of the scientific peer review, all applications:

Appeals of initial peer review will not be accepted for applications submitted response to this FOA.

Applications will be assigned on the basis of established PHS referral guidelines to the appropriate NIH Institute or Center and will compete for available funds with all other recommended applications submitted in response to this FOA. Following initial peer review, recommended applications will receive a second level of review by the National Heart, Lung, and Blood Advisory Councill. The following will be considered in making funding decisions:

3. Anticipated Announcement and Award Dates

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

Information regarding the disposition of applications is available in the NIH Grants Policy Statement.

Section VI. Award Administration Information

1. Award Notices

If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant as described in the NIH Grants Policy Statement.

A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization for successful applications. The NoA signed by the grants management officer is the authorizing document and will be sent via email to the grantee’s business official.

Awardees must comply with any funding restrictions described in Section IV.5. Funding Restrictions. 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.      

Any application awarded in response to this FOA will be subject to the DUNS, SAM Registration, and Transparency Act requirements as noted on the Award Conditions and Information for NIH Grants website.

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  and Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Grantees, and Activities. More information is provided at Award Conditions and Information for NIH Grants.

Cooperative Agreement Terms and Conditions of Award

The following special terms of award are in addition to, and not in lieu of, otherwise applicable U.S. Office of Management and Budget (OMB) administrative guidelines, U.S. Department of Health and Human Services (DHHS) 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 is a cooperative agreement (U01) an "assistance" mechanism (rather than an "acquisition" mechanism) in which substantial NIH scientific and/or programmatic involvement with the awardee is anticipated during performance of the activity. Under the cooperative agreement, the NIH purpose is to support and/or stimulate the recipient's activity by involvement in and otherwise working jointly with the award recipient in a partner role, but it is not to assume direction, prime responsibility, or a dominant role in the activity. Consistent with this concept, the dominant role and prime responsibility for the activity resides with the awardee(s) for the project as a whole, although specific tasks and activities in carrying out the studies will be shared among the awardees and the NHLBI Project Officer.

The PD(s)/PI(s) will have the primary responsibility for:

Awardees will have primary and lead responsibilities for the project as a whole, including research design and protocol development, participant recruitment and follow-up, data collection, quality control, interim data and safety monitoring, final data analysis and interpretation, preparation of publications, as well as collaborations with other awardees. Upon completion of the project, awardees are expected to put their data into the public   domain and/or make them available to other investigators, according to the approved plan for making data and materials available to the scientific community and the NHLBI for the conduct of research at no charge other than the costs of reproduction and distribution.

NIH staff have substantial programmatic involvement that is above and beyond the normal stewardship role in awards, as described below:

The NHLBI Project Officer, Dr. Andrei Kindzelski (and other NHLBI scientists as needed) will have substantial involvement in the study. He will serve on the Steering Committee as a voting member; he or another NHLBI scientist may serve on other study committees when appropriate. The NHLBI Project Officer (and the other cited NHLBI scientists) may work with awardees on issues coming before the Steering Committee and, as appropriate, other committees, e.g.: recruitment, intervention, follow-up, quality control, adherence to protocol, assessment of problems affecting the study and 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. 

Final decision-making authority on matters of budgetary and funding actions, grants management actions, and management of intellectual property issues is assigned to NHLBI staff other than the Project Scientist. The responsibility for final decision making may reside with Senior Institute management, separate organizational components and/or oversight committees.  Because it is anticipated that the Project Scientist will participate in activities that rise to a level of involvement that results in conflicts of interest, for example, co-publication, etc., other staff members such as direct line supervisors and/or other Senior NHLBI Program management staff will serve as agency Program Officials and will be responsible for the normal scientific and programmatic stewardship of the award.  The NHLBI policy on authorship and manuscript review of NHLBI sponsored extramural research protects against conflicts of interest with the Program Officer. 

The NHLBI reserves the right to phase out or curtail the study (or an individual award) in the event of (a) failure to develop or implement a mutually agreeable protocol, (b) substantial shortfall in subject recruitment, consortium participation and collaboration with other awardees, (c) substantive changes in the agreed-upon methodologies and tools with which NIH cannot concur, (d) human subject ethical issues that may dictate a premature termination, or (e) results that substantially diminish the scientific value of study continuation.

Areas of Joint Responsibility include:

Awardees will retain custody of and have primary rights to their data developed under these awards, subject to Government rights of access consistent with current HHS, PHS, and NIH policies. The Principal Investigator of this award will be required to participate in periodic meetings and telephone conference calls with other investigators performing large-scale genome wide association studies supported by the NHLBI. These meetings and calls will be arranged by NHLBI staff to promote sharing of information among investigators regarding state of science technologies, data management techniques, analytical strategies and tools, and data sharing. Support or other involvement of industry or any other third party in the study -- e.g., participation by the third party; involvement of study resources or citing the name of the study or NHLBI support; or special access to study results, data, findings or resources -- may be advantageous and appropriate. However, except for licensing of patents or copyrights, support or involvement of any third party will occur only following notification of and concurrence by NHLBI.

Study investigators are encouraged to publish and to release publicly and disseminate results, tools, resources and other products of the study, in accordance with the study protocols and governance. It is expected that all methods, analyses, software, and algorithms will be made available in a timely matter to the scientific community. A plan for dissemination of study results will be developed by the awardee and approved by the NIH Project Scientist. Within 3 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 in accordance with the NHLBI Data Sharing Policy available at http://www.nhlbi.nih.gov/funding/datasharing.htm.

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 Dispute Resolution. 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 regulation 42 CFR Part 50, Subpart D and DHHS regulation 45 CFR Part 16.

3. Reporting

When multiple years are involved, awardees will be required to submit the Non-Competing Continuation Grant Progress Report (PHS 2590 or RPPR) annually and financial statements as required in the NIH Grants Policy Statement.

A final progress report, invention statement, and the expenditure data portion of the Federal Financial Report are required for closeout of an award, as described in the NIH Grants Policy Statement.

The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for awardees of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later.  All awardees of applicable NIH grants and cooperative agreements are required to report to the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over $25,000.  See the NIH Grants Policy Statement for additional information on this reporting requirement. 

Section VII. Agency Contacts

We encourage inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants.

Application Submission Contacts

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Telephone 301-435-0714
TTY 301-451-5936
Email: GrantsInfo@nih.gov

eRA Commons Help Desk (Questions regarding eRA Commons registration, tracking application status, post submission issues)
Phone: 301-402-7469 or 866-504-9552 (Toll Free)
TTY: 301-451-5939
Email: commons@od.nih.gov

Scientific/Research Contact(s)

Andrei L Kindzelski, M.D., Ph.D.
National Heart, Lung, and Blood Institute (NHLBI)
Telephone: 301-435-0070
Email: kindzelskial@nhlbi.nih.gov

Peer Review Contact(s)

Director, Office of Scientific Review
Division of Extramural Research Activities
National Heart, Lung, and Blood Institute (NHBLI)
Telephone: 301-435-0270
Email: nhlbichiefreviewbranch@nhlbi.nih.gov

Financial/Grants Management Contact(s)

Dianna Jessee
National Heart, Lung, and Blood Institute (NHLBI)
Telephone: 301-435-0166
Email: jesseed@nhlbi.nih.gov

Section VIII. Other Information

Recently issued trans-NIH policy notices may affect your application submission. A full list of policy notices published by NIH is provided in the NIH Guide for Grants and Contracts. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.

Authority and Regulations

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.


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