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) (http://www.nhlbi.nih.gov)

Funding Opportunity Title

Limited Competition: Revision for Resuscitation Outcomes Center Randomized Clinical Trial (U01)

Activity Code

U01 Research Project – Cooperative Agreements

Announcement Type

New

Related Notices

None

Funding Opportunity Announcement (FOA) Number

RFA-HL-11-036

Companion FOA

None

Number of Applications

Only one application per institution is allowed, as defined in Section III See Section III. 3. Additional Information on Eligibility.

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

93.837

FOA Purpose

The National Heart, Lung, and Blood Institute (NHLBI) invites research grant applications for a Revision award (formerly referred to as a “competing supplement”) for the Resuscitation Outcomes Consortium (RFA-HL-10-006) to conduct a multi-center, randomized, phase III trial that will test acute survival benefits of increased plasma: platelets: RBCs ratio (1:1:1) compared to 1:1:higher ratio (1:1:2 or 1:1:3), among patients predicted to receive massive blood transfusions.

Key Dates
Posted Date
Letter of Intent Due Date

April 4, 2011

Application Due Date(s)

May 3, 2011

AIDS Application Due Date(s)

Not Applicable

Scientific Merit Review

July 2011

Advisory Council Review

August 2011

Earliest Start Date(s)

September 30,2011

Expiration Date

May 4, 2011

Due Dates for E.O. 12372

Not Applicable

Required Application Instructions

It is critical that applicants follow the instructions in the PHS398 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.

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

The National Heart, Lung, and Blood Institute (NHLBI) invites grant applications for a Revision award (formerly referred to as a “competing supplement”) to expand the scope of the current award to the Resuscitation Outcomes Consortium (ROC). The proposed topic must be related to the NHLBI’s resuscitation research agenda. The Revison application may propose to expand the number of sites in ROC as well as add core facilities.

NHLBI plans to limit the request for applications to the incumbent Resuscitation Outcomes Centers.

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, scientific or program staff will assist, guide, coordinate, or participate in project activities.

Application Types Allowed

Revision

The OER Glossary and the PHS398 Application Guide provide details on these application types.

Funds Available and Anticipated Number of Awards

The award is contingent upon NIH appropriations, and the submission of a sufficient number of meritorious applications.

Award Budget

Application budgets are not limited, but need to reflect actual needs of the proposed project.

Award Project Period

The maximum period of support is limited by the time remaining on the Parent award and may be no more than five 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

Only the currently funded NHLBI Resuscitation Outcomes Centers are eligible to apply.

Required Registrations

Applicant organizations must complete the following registrations as described in the PHS398 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/PIs) 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 four (4) weeks prior to the application due date.

Eligible Individuals (Project Director/Principal Investigator)

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Project Director/Principal Investigator (PD/PI) 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 PHS398 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 in response to this FOA that is essentially the same as one currently pending initial peer review unless the applicant withdraws the pending application. NIH will not accept any application that is essentially the same as one already reviewed. Resubmission applications may not be submitted.

Only one application per institution (normally identified by having a unique DUNS number or NIH IPF number) is allowed.”

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 PHS398 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:

Descriptive title of proposed research
Name, address, and telephone number of the PD(s)/PI(s)
Names of other key personnel
Participating institutions
Number and title of this funding opportunity

The letter of intent should be sent to:

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

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 20892-7924 (Express mail code: 20817)
Telephone: (301) 435-0270
Fax: (301) 480-0730
Email: nhlbichiefreviewbranch@nhlbi.nih.gov

Page Limitations

All page limitations described in the PHS398 Application Guide and the Table of Page Limits must be followed.

Research Plan

All instructions in the PHS398 Application Guide must be followed, with the following additional instructions:

Resource Sharing Plan

Individuals are required to comply with the instructions for the Resource Sharing Plans (Data Sharing Plan, Sharing Model Organisms, and Genome Wide Association Studies (GWAS) as provided in the PHS398 Application Guide.

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 PHS398 Application Guide, with the following modifications:

Foreign Organizations

No foreign applications are allowed.

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 PHS398 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 the NHLBI, 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.

Overall Impact - Overall

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 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? Will the proposed study advance, extend or challenge existing paradigms in life-threatening trauma injury areas? Will the results of the proposed studies develop critical, new knowledge about resuscitative strategies leading to advances in clinical practice and improved outcomes for patients suffering life-threatening trauma injury?

Investigator(s)

Are the PD/PIs, 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 experience conducting multi-center phase III trials or other clinical studies in comparable populations? What is the quality of experience with the coordination of clinical studies at Level I Adult Trauma Centers in North America, including the availability of 24/7 data collectors and blood bank technicians in each site research team? What is the quality of the regulatory, biostatistical, trauma, and transfusion medicine expertise? What is the experience of the investigators with conducting clinical research under Exemption to Informed Consent requirements? Do the investigators demonstrate the ability to identify and manage repositories and central laboratories? What is the quality of the team in recruiting high-performing clinical sites with demonstrated ability to meet target patient recruitment goals on time? What is the quality of the leadership in study design, data acquisition and management, data quality and data analysis?

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? What is the quality of the plans to integrate laboratory findings in trauma induced coagulopathy in severely injured patients into clinical prediction model(s) that predict coagulopathic phenotypes after trauma and can be used to guide individualized medical and surgical treatment for wounded patients?

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? Does the applicant acknowledge potential problem areas and consider alternative strategies? Does the research plan demonstrate understanding of the scientific, statistical, logistical, and technical issues underlying this multi-center clinical trial, including the assessment of outcomes relating to treatment and management of life-threatening trauma?

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 plans to conduct clinical research under Exemption to Informed Consent requirements adequately described?

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? Do the investigators demonstrate that the facilities, equipment, and organizational structure to effectively coordinate this trial's activities; assist clinical sites in implementing the study protocol; and collect, securely store and analyze study data are adequate?

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/priority 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

For Revisions, the committee will consider the appropriateness of the proposed expansion of the scope of the project. If the Revision application relates to a specific line of investigation presented in the original application that was not for recommended approval by the committee, then the committee will consider whether the responses to comments from the previous scientific review group are adequate and whether substantial changes are clearly evident.

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/priority 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 a Scientific Review Group convened by the NHLBI Office of Scientific Review, in accordance with NIH peer review policy and procedures, using the stated review criteria. Review assignments will be shown in the eRA Commons.

As part of the scientific peer review, all applications:

Applications 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 appropriate national Advisory Council or Board. 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 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, CCR 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

All revision applications will be funded with the cooperative agreement terms that are standard to the parent study:

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.

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

The ROC will be a cooperative clinical network consisting of up to nine Regional Clinical Centers (RCC), a single Data and Coordinating Center (DCC), and the NHLBI and include Executive and Management Steering Committees; Protocol Review Committee (PRC), Data and Safety Monitoring Board (DSMB), and Clinical Research Skills Development Core(s).

The Principal Investigators will have the primary responsibility for: lead responsibilities in all aspects of the ROC studies, including any modification of study designs; conduct of the studies; quality control; data analysis and interpretation; preparation of publications; and collaboration with other investigators, unless otherwise provided for in these terms or by action of the Steering Committee. Principal Investigator(s) agree to the governance of the study through Executive and Management Steering Committees.

The RCC Principal Investigators will be responsible for proposing protocols, estimating their costs, participating in their overall development, recruiting subjects, conducting the research, assuring quality of subject care and protocol adherence, assuring the accurate and timely transmission of data collected in conjunction with the Data Coordinating Center, and disseminating research findings.

The DCC Principal Investigator will coordinate, administer, and support all ROC clinical research activities. The DCC Principal Investigator will be responsible for oversight of protocol development, data collection, data safety and confidentiality, quality assurance, data analysis and distributed coordination. 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.

The collaborative protocol and governance policies will call for the continued submission of data centrally to the DCC for a collaborative database; the submission of copies of the collaborative datasets to each principal investigator upon completion of the study; procedures for data analysis, reporting and publication; and procedures to protect and ensure the privacy of medical and genetic data (if applicable) and records of individuals. The NHLBI Program Scientist, on behalf of the NHLBI, will have the same access, privileges and responsibilities regarding the collaborative data as the other members of the Executive Steering Committee.

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 NHLBI. Awardees must follow NHLBI policy concerning third party agreements.

Study investigators are encouraged to publish and to release publicly and disseminate results and other products of the study 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 the above paragraph. In addition, study investigators must establish a plan for making data sets and materials available to the scientific community and to the NHLBI immediately upon completion of the three-year period following the end of the period of NHLBI support.

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

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

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.

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

The NHLBI will oversee the organization of the ROC and thus will be substantially involved with the awardees in a partnership. NHLBI will appoint the Network Chairperson(s), all members of the Protocol Review Committee (PRC), and the Data and Safety Monitoring Board (DSMB). The Network Chairperson(s) will be responsible for ensuring that there are well-documented policies, procedures, and bylaws to guide all aspects of Network activities and operations.

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

The NHLBI Project Scientist, Dr. George Sopko, will serve on the Executive and Management Steering Committees; he or other NHLBI scientists may serve on other study committees, when appropriate. The NHLBI Project Scientist (and other NHLBI staff) may work with awardees on issues coming before the Executive and Management Steering Committees and, as appropriate, other committees, e.g., recruitment, intervention, follow-up, quality control, adherence to protocol, assessment of problems affecting the study and possible changes in protocol, interim data and safety monitoring, preparation of publications, and development of solutions to major problems such as insufficient participant enrollment.

The NHLBI reserves the right to terminate or curtail the study (or an individual award) in the event of (1) failure to develop or implement a mutually agreeable collaborative protocol; (2) substantial shortfall in participant recruitment, follow-up, data reporting, or quality control; (3) major breach of the protocol or substantive changes in the agreed-upon protocol with which NHLBI cannot concur;

(4) attaining of a major study endpoint before schedule with persuasive statistical significance; or

(5) human subject ethical issues that may dictate a premature termination.

Additionally, a NHLBI Program Official will be responsible for the normal scientific and programmatic stewardship of the award and will be named in the award notice. The NHLBI Program Official will monitor subject recruitment and study progress, ensure disclosure of conflicts of interest, and ensure adherence to NHLBI policies.

Areas of Joint Responsibility include:

Awardee(s) agree to the governance of the study through Executive and Management Steering Committees. Steering Committee voting membership shall consist of the Principal Investigators (or designated alternates) of the CCs and the DCC (i.e., cooperative agreement awardees), the NHLBI Project Scientist, and the ROC Chairperson(s). Each full member will have one vote. The ROC Chairs will plan ROC activities, oversee its functions and conduct SC meetings. The SC will develop and ensure compliance with ROC policies and procedures, identify and prioritize topics for investigation, evaluate protocols proposed by the RCCs, develop consensus protocols for submission to the PRC, and ensure that studies are properly conducted, monitored, and that study results are reported in the scientific literature and disseminated in a timely manner. All major scientific decisions will be determined by majority vote of the SC. The SC has final responsibility for approving the protocol before review by the PRC or DSMB. Subcommittees of the SC will be established as necessary and would be expected to include a Publications and Presentations Subcommittee and an Ancillary Studies Subcommittee. Awardee members of the Executive and Management Steering Committees will be required to accept and implement policies approved by the Committees. Meetings will ordinarily be held by telephone conference call or in the metropolitan Washington Area.

An independent Protocol Review Committee (PRC), established by the NHLBI, will provide external review for each ROC protocol. Because the PRC serves as an independent group advisory to the NHLBI, study investigators will not communicate with PRC members regarding study issues, except as authorized by the PRC's Executive Secretary. The independent PRC will be appointed by and be advisory to the NHLBI. It will consist of a chairperson and scientists with expertise in emergency medicine, trauma surgery, cardiovascular medicine, clinical research, clinical trial design, biostatistics, critical care medicine, outcome measures, and other areas of expertise as needed. The exact number and duration of protocols supported in the six-year program will depend on the nature and extent of the investigations proposed by the SC. The PRC will evaluate protocols proposed by the SC based on the importance of the question to be addressed, scientific merit of the experimental design and approach, feasibility, appropriateness for the ROC and consistency with NHLBI missions and policies. The PRC will provide a written critique of each proposal and a final recommendation to the NHLBI. All study protocols performed by the ROC must be recommended by the PRC and approved by the NHLBI before initiation.

An independent Data and Safety Monitoring Board (DSMB) will be appointed by the Director, NHLBI and be advisory to the NHLBI to provide overall monitoring of interim data and safety issues. Meetings of the DSMB will ordinarily be held in Bethesda, Maryland. An NHLBI scientist, other than the NHLBI Program Official, shall serve as Executive Secretary to the Board. Because the DSMB serves as an independent group advisory to the NHLBI, study investigators will not communicate with the DSMB members regarding study issues, except as authorized by the DSMB?s Executive Secretary. The DSMB will consist of a chairperson and scientists with expertise in emergency medicine, trauma surgery, cardiovascular medicine, bioethics, clinical research, clinical trial design, biostatistics, critical care medicine, outcome measures, and other areas of expertise as needed. The DSMB will provide a written critique of each protocol conduct and a final recommendation to the NHLBI. All study protocols performed by the ROC must be recommended by the DSMB and approved by the NHLBI before initiation.

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. An Arbitration Panel composed of three members will be convened. It will have three members: a designee of the Steering Committee chosen without NIH staff voting, one NIH designee, and a third designee with expertise in the relevant area who is chosen by the other two; in the case of individual disagreement, the first member may be chosen by the individual awardee. This special arbitration procedure in no way affects the awardee's right to appeal an adverse action that is otherwise appealable in accordance with PHS regulations 42 CFR Part 50, Subpart D and HHS regulations 45 CFR Part 16.

3. Reporting

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

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

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 sub awards 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 Sub award Reporting System (FSRS) available at www.fsrs.gov on all sub awards 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)

Gail Pearson, M.D.
Division of Cardiovascular Diseases
National Heart, Lung and Blood Institute
National Institutes of Health
6701 Rockledge Drive
Bethesda, MD 20892-7956
Tel: 301-435-0510
FAX: 301-480-1454
E-mail: pearsong@nhlbi.nih.gov

Peer Review Contact(s)

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 20892-7924 (Express mail code: 20817)
Telephone: (301) 435-0270
Fax: (301) 480-0730
Email: nhlbichiefreviewbranch@nhlbi.nih.gov

Financial/Grants Management Contact(s)

Robert Tarwater
Grants Management Specialist
DERA, OGM
NHLBI, NIH, DHHS
Two Rockledge Centre, Suite 7150
6701 Rockledge Drive MSC7926
Bethesda, MD 20892 (Express zip code 20817)
Telephone: 301-402-6090
Fax: 301-451-5462
Email:tarwater@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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NIH Funding Opportunities and Notices


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