Part I Overview Information


Department of Health and Human Services

Participating Organizations
National Institutes of Health (NIH), (http://www.nih.gov)
Department of Defense (DoD) (http://www.defenselink.mil/)
Heart and Stroke Foundation of Canada (HSFC) (http://www.heartandstroke.ca/)
Canadian Institutes of Health Research (CIHR) (http:www.cihr-irsc.gs.ca)

Components of Participating Organizations
National Heart, Lung, and Blood Institute (NHLBI) (http://www.nhlbi.nih.gov)
United States Army Materiel Research Command (USAMRC) (https://www.usaccc.org/index.jsp)
Institute of Circulatory and Respiratory Health (ICRH) (http://www.cihr-irsc.gc.ca)

Title: Limited Competition for the Continuation of the Resuscitation Outcomes Consortium (Limited Competition) (U01)

Announcement Type
This Funding Opportunity Announcement (FOA) is a reissue of RFA-HL-04-001.

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

Request For Applications (RFA) Number: RFA-HL-10-006

Catalog of Federal Domestic Assistance Number(s)
93.837, 12.420

Key Dates  
Release Date: February 23, 2009
Letters of Intent Receipt Date: March 7, 2009
Application Receipt Date: April 7, 2009
Peer Review Date(s): July-August, 2009
Council Review Date: October 2009
Earliest Anticipated Start Date: December 1, 2009
Additional Information To Be Available Date (Url Activation Date): N/A
Expiration Date: March 31, 2009

Due Dates for E.O. 12372

Not Applicable

Additional Overview Content

Executive Summary

Table of Contents


Part I Overview Information

Part II Full Text of Announcement

Section I. Funding Opportunity Description
1. Research Objectives

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

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

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

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

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

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

Section VIII. Other Information - Required Federal Citations

Part II - Full Text of Announcement


Section I. Funding Opportunity Description


1. Research Objectives

Sudden cardiac arrest and severe traumatic injury afflict as many North Americans as does major acute myocardial infarction or heart failure, but the odds of surviving are vastly different. Most myocardial infarction and acutely decompensated heart failure patients survive; conversely, 90-95% of sudden cardiac arrest and 60% of severe traumatic injury patients do not survive their acute event in the out-of-hospital setting.  Current resuscitation practice is based largely on empirical observation and findings from animal research. Few controlled clinical studies have been conducted to establish the actual benefit of interventions presently employed.  Results of basic research that have improved our understanding of the complex biochemical pathways involved in arrest-related ischemia and reperfusion in the heart and brain have not yet greatly affected resuscitation management and subsequent patient outcomes. Both the immediate pre- and post-resuscitation periods represent critical periods that are under-investigated and that may be amenable to therapeutic interventions to improve patient survival.

In recognition of the need to improve resuscitation traumatic injury and cardiopulmonary arrest, the NHLBI, National Institute of Child Health Diseases (NICHD), National Institute of General Medical Sciences (NIGMS), National Institute of Neurological Diseases and Stroke (NINDS), Food and Drug Administration (FDA) and Department of Defense (DoD) cosponsored the Post-Resuscitation and Initial Utility in Life Saving Efforts (PULSE) workshop on June 29-30, 2000 (http://www.nhlbi.nih.gov/meetings/pulse/). A major recommendation of this workshop was to form a research consortium that would allow for the rapid testing of promising therapeutic strategies in appropriate populations of arrest patients. In response to the workshop recommendations, the Resuscitation Outcomes Consortium (ROC) was funded providing a unique collaborative infrastructure of academic centers and regional/local Emergency Medical Services (EMS) necessary for conducting clinical studies in the area of cardiac arrest and life-threatening trauma predominantly in an out-of-hospital setting.  The ROC consists of one Data Coordinating Center (DCC) and nine Regional Clinical Centers (RCC) which involve 268 EMS and fire services, with more than 36,000 EMS providers who serve a combined population of nearly 24 million persons from diverse urban, suburban, rural, and frontier regions.  The ROC also presents a very rich and diverse environment for young investigators to be exposed to and develop additional research skills in resuscitative medicine.

The primary objectives of the ROC will remain to: (1) conduct multiple collaborative clinical protocols to evaluate strategies to treat arrest patients, with an emphasis on out-of-hospital arrest, (2) provide a knowledge base that will improve therapeutic decision-making by testing approaches to management of cardiopulmonary arrest and life-threatening trauma, and (3) facilitate the training of resuscitation and emergency medicine physicians in clinical investigation.

Four expanded activities in the ROC will be emphasized in the renewal period: (1) procedures to monitor and manage RCC and satellite sites using performance-based funding and data quality, academic contribution within the ROC; (2) allowance of flexibility of ROC sites’ participation in proposed protocols to optimize recruitment while maintaining balance of all ongoing protocols enrollment; (3) conduct of Phase II trials that provide a basis for Phase III studies on resuscitation strategies aimed at improving outcome following cardiac arrest and life-threatening trauma; and (4) conduct of Phase III clinical trials testing resuscitation management strategies to improve clinical outcomes following cardiac arrest and life-threatening trauma. These activities will include procedures for selection, monitoring, and management of ROC protocols enabling collaboration with other NIH-funded research programs to increase the efficiency of recruitment of a limited pool of patients.

The NHLBI seeks to continue support of the ROC for an additional six years through a Limited Competition in order to implement studies that are currently in development and to take advantage of new research opportunities as they arise.  The Limited Competition takes advantage of existing ROC U01 awardees’ unique collaborative infrastructure of academic centers and regional/local EMS capable of implementing clinical studies under waiver of consent through FDA mandated community notification procedures.

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

Section II. Award Information


1. Mechanism of Support

This funding opportunity will use the Cooperative Agreement (U01) award mechanism(s).
The Project Director/Principal Investigator (PD/PI) will be solely responsible for planning, directing, and executing the proposed project.  

This FOA uses “Just-in-Time” information concepts. It also uses non-modular budget formats described in the PHS 398 application instructions (see http://grants.nih.gov/grants/funding/phs398/phs398.html). 

This funding opportunity will use a cooperative agreement award mechanism. In the cooperative agreement mechanism, the Project Director/Principal Investigator (PD/PI) retains the primary responsibility and dominant role for planning, directing, and executing the proposed project, with NIH staff being substantially involved as a partner with the Principal Investigator, as described under the Section VI. 2. Administrative Requirements, "Cooperative Agreement Terms and Conditions of Award."

There are no plans at present to reissue this FOA.

2. Funds Available  

Because the nature and scope of the proposed research will not vary from application to application, it is also anticipated that the size and duration of each award will not 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:

Organizations/institutions must already have been recipients of an award from RFA-HL-04-001.

For DCC:

University of Washington

For RCC:

Medical College of Wisconsin
University of Washington
University of Pittsburgh
St. Michael’s Hospital Toronto
Oregon Health & Science University
University of Alabama at Birmingham
Ottawa Health Research Institute
University of Texas SW Medical Center at Dallas
University of California San Diego

1.B. Eligible Individuals

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.

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 NOT submit more than one application.

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

Renewals. Renewal applications are permitted in response to this FOA.

CIHR Eligible Individuals and Institutions: Please refer to the Eligibility Requirements for CIHR Grants and Awards (http://www.cihr-irsc.gc.ca/e/22630.html#F1).  Researchers employed by Canadian federal government departments or agencies and for-profit organizations are not eligible to apply for CIHR grants as Principal Applicants unless they hold an eligible university academic appointment, in which case, the university must agree to be the "Institution Paid" (see the subsection titled "Responsibilities of Eligible Institutions," below).

Section IV. Application and Submission Information


1. Address to Request Application Information

The PHS 398 application instructions are available at http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive format. Applicants must use the currently approved version of the PHS 398. For further assistance contact GrantsInfo, Telephone (301) 435-0714, Email: GrantsInfo@nih.gov.

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

2. Content and Form of Application Submission

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

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

Foreign Organizations (Non-domestic (non-U.S.) Entity)

NIH policies concerning grants to foreign (non-U.S.) organizations can be found in the NIH Grants Policy Statement at: http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part12.htm#_Toc54600260.

Applications from foreign organizations must:

In addition, for applications from foreign organizations:

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

3. Submission Dates and Times

Applications must be received on or before the receipt date described below (Section IV.3.A). Submission times N/A.

3.A. Receipt, Review and Anticipated Start Dates
Letters of Intent Receipt Date: March 7, 2009
Application Receipt Date: April 7, 2009
Peer Review Date(s): July-August, 2009
Council Review Date: October 2009
Earliest Anticipated Start Date: December 1, 2009

3.A.1. Letter of Intent

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

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

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

The letter of intent should be sent to:

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

3.B. Sending an Application to the NIH

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

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

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

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

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

3.C. Application Processing

Applications must be received on or before the application receipt date described above (Section IV.3.A.). If an application is received after that date, the application may be delayed in the review process or not reviewed.  Upon receipt, applications will be evaluated for completeness by the CSR and for responsiveness by the reviewing Institute. Incomplete and/or non-responsive applications will not be reviewed.

The NIH will not accept any application in response to this funding opportunity that is essentially the same as one currently pending initial review, unless the applicant withdraws the pending application. However, when a previously unfunded application, originally submitted as an investigator-initiated application, is to be submitted in response to a funding opportunity, it is to be prepared as a NEW application. That is, the application for the funding opportunity must not include an Introduction describing the changes and improvements made, and the text must not be marked to indicate the changes from the previous unfunded version of the application.

Information on the status of an application should be checked by the Principal Investigator in the eRA Commons at: https://commons.era.nih.gov/commons/.

4. Intergovernmental Review

This initiative is not subject to intergovernmental review.

5. Funding Restrictions

All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement. The Grants Policy Statement can be found at NIH Grants Policy Statement.

Pre-award costs are allowable. A grantee may, at its own risk and without NIH prior approval, incur obligations and expenditures to cover costs up to 90 days before the beginning date of the initial budget period of a new or renewal award if such costs: (1) are necessary to conduct the project; and (2) would be allowable under the grant, if awarded, without NIH prior approval. If specific expenditures would otherwise require prior approval, the grantee must obtain NIH approval before incurring the cost. NIH prior approval is required for any costs to be incurred more than 90 days before the beginning date of the initial budget period of a new or renewal award.

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

6. Other Submission Requirements and Information

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

Each Regional Clinical Center (RCC) conducts the ROC approved protocols and assists in the development of a uniform research agenda.  Each RCC will have a uniform Research Plan which includes a detailed description of the ROC study pipeline.  This pipeline includes ongoing trials, trials and studies ready for implementation, protocols in development, and future studies at the conceptual stage.  Thus, all RCC applications will contain the same Research Plan (sections A through D, outlined in the PHS 398).   However, each RCC application should include a description of the site’s recruitment activities in ongoing protocols using a ROC-developed uniform matrix, including a table specifying the number of subject enrolled and time frame within which the recruitment will be completed for each protocol (both ongoing and future protocols), a review of the site’s progress including challenges and successes in establishing local infrastructure, Budget pages, Biosketches, Resources, and Checklist.  The application from the DCC should include a review of progress made by the ROC, a plan to monitor and manage RCC and non-RCC (satellites) centers performance, funding, and status within the ROC. 

For the Clinical Research Skills Development Core (Training Core) applications, each Training Core plan should include a detailed description of the type of environment needed for young investigators to develop additional research skills in the area of resuscitation science. This includes citing specific training opportunities and activities. The Training Core application should include a review of progress made by those RCC with previously funded Training Core, and a plan to monitor and manage Training Core performance, funding, and status within the ROC. A Training Core is not a required component of an RCC application and its absence will not disadvantage the RCC applicant. The priority score of the Training Core will be determined for each RCC individually and will have no effect on the overall score of RCC application. For RCC applications, which include an application for a Training Core, then the Training Core should be mentioned in both the Abstract and the Table of Contents., . 

Requests for Core funds should be included in the body of ROC applications as it is expected that this aspect of the ROC will be supported from the allocated ROC funds but treated as a separate budget category. Thus, applicants should provide a separate budget page for the Core and add the cost of the Core as a line item into the total request for funds. Applicants should read the specific requirements and other instructions for applying at http://www.nhlbi.nih.gov/funding/policies/ntwk_skill.htm.

Research Plan Page Limitations

The Research Plan for the RCC is limited to 35 pages, and the Research Plan for the DCC is limited to 25 pages.  Up to four additional pages may be used to describe the proposed Clinical Research Skills Development Core. This text will not be counted toward the 35-page limit for the total Research Plan specified by the Form 398 instructions.

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: Investigators seeking $500,000 or more in direct costs in any year 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/.

Specific Instructions for Foreign Applications

All foreign applicants must complete and submit budget requests using the Research & Related Budget component found in the application package for this FOA. See NOT-OD-06-096, August 23, 2006.

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

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 National Heart, Lung, and Blood Institute and in accordance with NIH peer review procedures (http://grants1.nih.gov/grants/peer/), using the review criteria stated below.

As part of the scientific peer review, all applications will:

The following will be considered in making funding decisions:

The ROC network RCC applications will have the same uniform research plan and participate in ROC approved protocols.  Therefore, one single overall score will be given for all the applications based on the scientific merit of the RCC applications and the DCC application which should reflect the overall synergy of the network. This score will reflect the accomplishments of the original ROC objectives put forth in RFA-HL-04-001, and responsiveness to this RFA.  The original FOA provided support for the establishment of a Resuscitation Research Consortium (ROC) as the necessary infrastructure to conduct multiple collaborative trials to aid rapid translation of promising scientific and clinical advances to improve resuscitation outcomes.

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 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).  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.

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. 

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? Are the conceptual or clinical framework, design, methods, and analyses adequately developed, well integrated, well reasoned, and appropriate to the aims of the project? Does the applicant acknowledge potential problem areas and consider alternative tactics?

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?

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? Is the proposed scientific agenda original and innovative and how the proposed protocols fit in the scientific directions and overall proposed program?

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?

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? 

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

Specific considerations for each Regional Clinical Center (RCC) and Data Coordinating Center (DCC) applications:

Regional Clinical Centers (RCCs):

Data Coordinating Center:

The Clinical Research Skills Development Core

Each Core application will receive an impact/priority score based on the review criteria below, but the impact/priority score will not enter into the overall ROC RCC application impact/priority score. 

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.

Renewal Applications.  When reviewing a Renewal application (formerly called a competing continuation application), the committee will consider the progress made in the last funding period.

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.

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 score.

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 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).

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

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).

3. Anticipated Announcement and Award Dates

Not Applicable.

Section VI. Award Administration Information


1. Award Notices

After the peer review of the application is completed, the PD/PI will be able to access his or her Summary Statement (written critique) via the eRA Commons.

If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant. For details, applicants may refer to the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General.

A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization. The NoA signed by the grants management officer is the authorizing document. Once all administrative and programmatic issues have been resolved, the NoA will be generated via email notification from the awarding component to the grantee business official (designated in item 12 on the Application Face Page). If a grantee is not email enabled, a hard copy of the NoA will be mailed to the business official.

Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs. See Also Section IV.5. Funding Restrictions.

2. Administrative and National Policy Requirements

All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General (http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part4.htm) and Part II Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Grantees, and Activities (http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_part9.htm).

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

2.A. Cooperative Agreement Terms and Conditions of Award

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

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

2. A.1. Principal Investigator Rights and Responsibilities

The 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 a Steering Committee, 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 a Steering Committee.

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 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.

2. A.2. NIH Responsibilities

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 will serve on the Steering Committee; he/she or other NHLBI scientists may serve on other study committees, when appropriate. The NHLBI Project Scientist (and other NHLBI staff) may work with awardees on issues coming before the Steering Committee and, as appropriate, other committees, e.g., recruitment, intervention, follow-up, quality control, adherence to protocol, assessment of problems affecting the study and possible changes in protocol, interim data and safety monitoring, 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.

2. A.2.a Canadian Funding Partners

The Canadian Institutes of Health Research (CIHR)

The CIHR is Canada's premier federal funding agency for health research. Its objective is to excel, according to internationally accepted standards of scientific excellence, in the creation of new knowledge and its translation into improved health for Canadians, more effective health services and products and a strengthened Canadian health care system.

For all CIHR-ICRH funded researchers:  CIHR funding will follow the General Guidelines for Grant Programs (Link: http://www.cihr-irsc.gc.ca/e/22632.html#F6

Applicants are encouraged to demonstrate the use of Gender and Sex-Based Analysis in applications. (Link:http://www.cihr-irsc.gc.ca/e/22630.html#F11

The Heart and Stroke Foundation of Canada (HSFC)

The HSFC , a volunteer based health charity leads in eliminating heart disease and stroke and reducing their impact through the advancement of research and its application, the promotion of healthy living, and advocacy.  Resuscitation is one of three mission priorities for the Foundation.  www.heartandstroke.ca

CIHR and HSFC will provide and administer a portion of the funds for RCCs awarded to successful principal investigators located in Canada. CIHR and HSFC staff will work with NHLBI to assess responsiveness, collaborate with the NHLBI concerning peer review process and administration, and advise the NHLBI on matters related to the management of the ROC.  NHLBI, CIHR and HSFC staff will share communications concerning this program (such as inquiries, letters of intent and other correspondence, and post-award progress reports) as appropriate.  In addition, regularly scheduled meetings (e.g., steering committee meetings) will be attended by both agencies.

2. A.2.b The United States Army Medical Research and Materiel Command (USAMRMC) Responsibilities

The USAMRMC will provide a portion of the funds for RCCs awarded to successful principal investigators located in Canada. ICRH staff will work with NHLBI to assess responsiveness, collaborate with the NHLBI concerning peer review process and administration, and advise the NHLBI on matters related to the management of the ROC.  NHLBI and USAMRMC staff will share communications concerning this program (such as inquiries, letters of intent and other correspondence, and post-award progress reports) as appropriate.  In addition, regularly scheduled meetings (e.g., steering committee meetings) will be attended jointly by both agencies.

2.A.3. Collaborative Responsibilities

Awardee(s) agree to the governance of the study through a Steering Committee (SC). 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 Steering Committee will be required to accept and implement policies approved by the Steering Committee. Meetings of the Steering Committee 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.

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. Arbitration Process

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

3. Reporting

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

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

Section VII. Agency Contacts


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

1. Scientific/Research Contacts:

NHLBI

George Sopko, M.D., M.P.H.
ROC Program Director
Division of Cardiovascular Diseases
National Heart, Lung and Blood Institute
National Institutes of Health
6701 Rockledge Drive
Bethesda, MD 20892-7956
Tel:  301-435-0504
FAX:  301-480-1336
E-mail: sopkog@nhlbi.nih.gov

Department of Defense

COL Dallas C. Hack
U.S. Army Medical Research and Materiel Command
Research Area Director for Combat Casualty Care
504 Scott Street
Ft. Detrick, MD, 21702-5012
Telephone: 301-619-7591
FAX: 301-619-7067
email: Dallas.Hack@amedd.army.mil

ICRH

Ilana Gombos, Ph.D.
Assistant Director, ICRH
Institute of Circulatory and Respiratory Health
Canadian Institut de la sante circulatoire et respiratoire des IRSC
60 Elgin Street
Ottawa, Ontario, Canada
K1A 0W9
Telephone: 613-954-0544
Fax: 613-954-1800
Email: IGombos@cihr-irsc.gc.ca

HSFC

Jennifer Campbell
Assistant Director
Strategic Research Initiatives
Heart and Stroke Foundation of Canada
222 Queen Street #1402
Ottawa, Ontario  K1P 5V9
Canada
Tel:  (613) 569-4361, ext. 350
Fax:  (613) 569-3278
E-mail:  jcampbell@hsf.ca

2. Peer Review Contacts:

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

3. Financial or Grants Management Contacts:

Carol Lander
Grants Management Specialist
Division of Extramural Research Activities
National Heart, Lung, and Blood Institute
National Institutes of Health
6701 Rockledge Drive, MSC 7926
Bethesda, MD  20892-7926
Telephone: 301-435-0185
FAX: 301- 451-5462
Email:   landerc@nhlbi.nih.gov

Section VIII. Other Information


Required Federal Citations

Use of Animals in Research:
Recipients of PHS support for activities involving live, vertebrate animals must comply with PHS Policy on Humane Care and Use of Laboratory Animals (http://grants.nih.gov/grants/olaw/references/PHSPolicyLabAnimals.pdf) as mandated by the Health Research Extension Act of 1985 (http://grants.nih.gov/grants/olaw/references/hrea1985.htm), and the USDA Animal Welfare Regulations (http://www.nal.usda.gov/awic/legislat/usdaleg1.htm) as applicable.

Human Subjects Protection:
Federal regulations (45CFR46) require that applications and proposals involving human subjects must be evaluated with reference to the risks to the subjects, the adequacy of protection against these risks, the potential benefits of the research to the subjects and others, and the importance of the knowledge gained or to be gained (http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm).

Data and Safety Monitoring Plan:
Data and safety monitoring is required for all types of clinical trials, including physiologic toxicity and dose-finding studies (Phase I); efficacy studies (Phase II); efficacy, effectiveness and comparative trials (Phase III). Monitoring should be commensurate with risk. The establishment of data and safety monitoring boards (DSMBs) is required for multi-site clinical trials involving interventions that entail potential risks to the participants (NIH Policy for Data and Safety Monitoring, NIH Guide for Grants and Contracts, http://grants.nih.gov/grants/guide/notice-files/not98-084.html).

Sharing Research Data:
Investigators submitting an NIH application seeking $500,000 or more in direct costs in any single year are expected to include a plan for data sharing or state why this is not possible (http://grants.nih.gov/grants/policy/data_sharing).

Investigators should seek guidance from their institutions, on issues related to institutional policies and local IRB rules, as well as local, state and federal laws and regulations, including the Privacy Rule. Reviewers will consider the data sharing plan but will not factor the plan into the determination of the scientific merit or the priority score.

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

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

Sharing of Model Organisms:
NIH is committed to support efforts that encourage sharing of important research resources including the sharing of model organisms for biomedical research (see http://grants.nih.gov/grants/policy/model_organism/index.htm). At the same time the NIH recognizes the rights of grantees and contractors to elect and retain title to subject inventions developed with Federal funding pursuant to the Bayh Dole Act (see the NIH Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps_2003/index.htm). All investigators submitting an NIH application or contract proposal, beginning with the October 1, 2004, receipt date, are expected to include in the application/proposal a description of a specific plan for sharing and distributing unique model organism research resources generated using NIH funding or state why such sharing is restricted or not possible. This will permit other researchers to benefit from the resources developed with public funding. The inclusion of a model organism sharing plan is not subject to a cost threshold in any year and is expected to be included in all applications where the development of model organisms is anticipated.

Inclusion of Women And Minorities in Clinical Research:
It is the policy of the NIH that women and members of minority groups and their sub-populations must be included in all NIH-supported clinical research projects unless a clear and compelling justification is provided indicating that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43). All investigators proposing clinical research should read the "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html); a complete copy of the updated Guidelines is available at http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm. The amended policy incorporates: the use of an NIH definition of clinical research; updated racial and ethnic categories in compliance with the new OMB standards; clarification of language governing NIH-defined Phase III clinical trials consistent with the new PHS Form 398; and updated roles and responsibilities of NIH staff and the extramural community. The policy continues to require for all NIH-defined Phase III clinical trials that: (a) all applications or proposals and/or protocols must provide a description of plans to conduct analyses, as appropriate, to address differences by sex/gender and/or racial/ethnic groups, including subgroups if applicable; and (b) investigators must report annual accrual and progress in conducting analyses, as appropriate, by sex/gender and/or racial/ethnic group differences.

Inclusion of Children as Participants in Clinical Research:
The NIH maintains a policy that children (i.e., individuals under the age of 21) must be included in all clinical research, conducted or supported by the NIH, unless there are scientific and ethical reasons not to include them.

All investigators proposing research involving human subjects should read the "NIH Policy and Guidelines" on the inclusion of children as participants in research involving human subjects (http://grants.nih.gov/grants/funding/children/children.htm).

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

Human Embryonic Stem Cells (hESC):
Criteria for federal funding of research on hESCs can be found at http://stemcells.nih.gov/index.asp and at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-005.html. Only research using hESC lines that are registered in the NIH Human Embryonic Stem Cell Registry will be eligible for Federal funding (http://escr.nih.gov). It is the responsibility of the applicant to provide in the project description and elsewhere in the application as appropriate, the official NIH identifier(s) for the hESC line(s) to be used in the proposed research.

NIH Public Access Policy Requirement:
In accordance with the NIH Public Access Policy (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-033.html) investigators must submit or have submitted for them their final, peer-reviewed manuscripts that arise from NIH funds and are accepted for publication as of April 7, 2008 to PubMed Central (http://www.pubmedcentral.nih.gov/), to be made publicly available no later than 12 months after publication. As of May 27, 2008, investigators must include the PubMed Central reference number when citing an article in NIH applications, proposals, and progress reports that fall under the policy, and was authored or co-authored by the investigator or arose from the investigator’s NIH award.  For more information, see the Public Access webpage at http://publicaccess.nih.gov/.

Standards for Privacy of Individually Identifiable Health Information:
The Department of Health and Human Services (DHHS) issued final modification to the "Standards for Privacy of Individually Identifiable Health Information," the "Privacy Rule," on August 14, 2002. The Privacy Rule is a federal regulation under the Health Insurance Portability and Accountability Act (HIPAA) of 1996 that governs the protection of individually identifiable health information, and is administered and enforced by the DHHS Office for Civil Rights (OCR).

Decisions about applicability and implementation of the Privacy Rule reside with the researcher and his/her institution. The OCR website (http://www.hhs.gov/ocr/) provides information on the Privacy Rule, including a complete Regulation Text and a set of decision tools on "Am I a covered entity?" Information on the impact of the HIPAA Privacy Rule on NIH processes involving the review, funding, and progress monitoring of grants, cooperative agreements, and research contracts can be found at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-025.html.

URLs in NIH Grant Applications or Appendices:
All applications and proposals for NIH funding must be self-contained within specified page limitations. For publications listed in the appendix and/or Progress report, internet addresses (URLs) must be used for publicly accessible online journal articles.  Unless otherwise specified in this solicitation, Internet addresses (URLs) should not be used to provide any other information necessary for the review because reviewers are under no obligation to view the Internet sites. Furthermore, we caution reviewers that their anonymity may be compromised when they directly access an Internet site.

Healthy People 2010:
The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2010," a PHS-led national activity for setting priority areas. This FOA is related to one or more of the priority areas. Potential applicants may obtain a copy of "Healthy People 2010" at http://www.health.gov/healthypeople.

Authority and Regulations: This program is described in the Catalog of Federal Domestic Assistance at http://www.cfda.gov/ and is not subject to the intergovernmental review requirements of Executive Order 12372. Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement. The NIH Grants Policy Statement can be found at http://grants.nih.gov/grants/policy/policy.htm.

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

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


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