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Part I Overview Information

Department of Health and Human Services

Participating Organizations
National Institutes of Health (NIH) (http://www.nih.gov)

Components of Participating Organizations
National Institute of Nursing Research (NINR), ( http://www.ninr.nih.gov)

Title: Nursing Science Centers in Self-Management or End-of-Life Research:  Building Research Teams for the Future (P20)

Announcement Type
New

Request For Applications (RFA) Number: RFA-NR-07-004

Catalog of Federal Domestic Assistance Number(s)
93.361

Key Dates
Release Date:  February 14, 2007
Letters of Intent Receipt Date(s): April 10, 2007
Application Receipt Date(s): May 10, 2007
Peer Review Date(s): July 2007
Council Review Date(s): August 2007
Earliest Anticipated Start Date(s): September 30, 2007
Additional Information To Be Available Date (Url Activation Date): Not Applicable
Expiration Date: May 11, 2007

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 and Review and Anticipated Start Dates
      1. Letter of Intent
    B. Sending an Application to the NIH
    C. Application Processing
  4. Intergovernmental Review
  5. Funding Restrictions
  6. Other Submission Requirements

Section V. Application Review Information
  1. Criteria
  2. Review and Selection Process
    A. Additional Review Criteria
    B. Additional Review Considerations
    C. Sharing Research Data
    D. Sharing Research Resources
  3. Anticipated Announcement and Award Dates

Section VI. Award Administration Information
  1. Award Notices
  2. Administrative and National Policy Requirements
  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

The National Institute of Nursing Research (NINR) invites applications to establish Nursing Science Centers in Self-Management or End-of-Life Research: Building Research Teams for the Future (P20).  The purpose of the proposed grant program is to plan and develop sustainable interdisciplinary, biobehavioral research capacity for scientists conducting Self-Management or End-of-Life research at Schools/Colleges/Departments of Nursing by enabling development of research infrastructure and centralized resources in support of these research programs. 

The objectives of this program are to:

(1) facilitate the development of research infrastructure at Schools/Departments/Colleges/Divisions of Nursing by establishing research resources to plan, promote and support Self-Management or End-of-Life research

(2) expand the number and quality of research projects aimed at (a) improving self-management in persons of all ages with chronic and acute disorders, or (b) the quality of life in persons at the end of life and their caregivers;

(3) expand the number of nurse investigators involved in interdisciplinary research;

(4) increase the quantity and quality of research projects utilizing biobehavioral methods;

(5) plan for and develop sustainability of research programs by building an active and growing research program with collaborations and partnerships both inside and outside of the applicant organization.

Self-Management Research

Chronic diseases impair the quality of life (QOL) of more than 90 million Americans.  Self-management has become an essential component of disease management and a major goal for the 15%-20% of children and 80% of older adults who have one or more chronic conditions.

Promoting self-management in young people with chronic illness can be difficult, typically requiring the engagement of both child and their parent(s) and sibling(s).  Research elucidating the best timing and means to transition children from partial to full responsibility for self-management is critically needed.  The economic and QOL costs of chronic illness, disability, developmental delay, and behavior problems in children and adolescents are devastating to families and are predicted both to grow and be enduring.  Research to improve family functioning and QOL in the context of interventions designed to improve self-management in children are key aims in the NINR Strategic Plan (http://www.ninr.nih.gov/AboutNINR/NINRMissionandStrategicPlan/).

Much of the self-management research to date has focused on older populations.  With the graying of America, the caregiving burden and costs of chronic illness and disability in older adults has lead to catastrophic health care projections.  Greater self-management of middle aged adults with chronic conditions may lessen this burden and lead to the enhancement of QOL and reduced disability as these adults age.  Likewise, older adults may acquire greater self-management skills, thus reducing or slowing their decline and lessening the significant economic, financial, and QOL burdens on those left to care for them.

Even though the specific concerns in chronic illnesses may vary greatly by disease and developmental stage, children, adults, and families dealing with any chronic illness have much in common.  Learning to live with a chronic condition poses a significant challenge at any age.  Recruiting the cooperation and assistance of family members, friends, and health care providers can add to this challenge.  Successful self-management cannot be attained without attention to the psychosocial environment of the person living with chronic illness.  Poor family relationships and low levels of family support are associated with poorer adherence with treatment regimens, while high levels of family functioning and family support are associated with better treatment adherence.  Although engagement in self-management does not assure good adherence (which is known to reflect many different variables), poor understanding and poor commitment to treatment regimens are known barriers to adherence. 

Self-management is intended to improve well-being and strengthen self-determination and participation in health care, while reducing inappropriate health care utilization and health care costs.  Research on the effects of self-management, both on the individual with a chronic disorder, on those around them, and on society at large must be developed in order to plan for the health and wellbeing of the nation.  Research to predict who will benefit from self-management interventions is essential.  Biobehavioral measures and new research and intervention methods are needed to maximize the benefits of self-management relative to the costs, both economic and psychosocial, of illness.

End-of-Life Research

Despite advances in medical treatment and care helping people with multiple chronic and complex health conditions live longer, chronic diseases account for 7 of every 10 US deaths.  Thus medical care is extending life expectancy with illness and disability.  This increase in life expectancy can have an impact on quality-of-life (QOL) near the end of life. Management of chronic illnesses must address not only the treatment of symptoms such as pain, fatigue, and depression, but also respect patient and family decision making regarding treatment choices and use of alternative therapies. Ideally, health care planning that incorporates palliative and/or hospice care also acknowledges the end of life as an important phase of life.

The 1997 publication of the Institute of Medicine report "Approaching Death: Improving Care at the End of Life" triggered a series of activities to improve the quality of care and the quality of life at the end of life.  In response, NINR and other NIH Institutes have issued research calls that have included: the clinical management of symptoms at the end of life; patterns of communication among patients, families, and providers; ethics and healthcare decision making; caregiver support; the context of care delivery; complementary and alternative medicine at the end of life; dying children of all ages and their families; and informal caregiving.

The NIH convened a State-of-the-Science Conference “Improving End-of-Life Care” on December 6-8, 2004, at the NIH in Bethesda, Maryland to examine the results of these many efforts, to evaluate the current state of the science regarding care at the end of life, and to identify directions for future research.  The proceedings were published in the Journal of Palliative Medicine (2005:8(S1)).  Although End-of-Life research is still in its infancy, this conference highlighted a number of important early findings and encouraged coordinated research programs. The panel issued a final statement calling for further research to understand patient, caregiver, and health care system influences at the end of life particularly involving areas such as conceptual model development, methodological issues, ethical considerations and interventions to improve care.  Research that enhances the end-of-life experience for patients and their families remains one of NINR's strategic goals.

NINR Centers

NINR currently supports a number of Core Center (P30s) and non-partnership Exploratory/Developmental Center (P20s) grants.  The purpose of an NINR P20 Center is to: (1) develop sustainable interdisciplinary, biobehavioral research capacity for scientists conducting research at the SON and wider scientific community by establishing centralized research resources and a research infrastructure; (2) advance the Center’s thematic science area through complementary, synergistic research activities; and (3) enable feasibility research that will develop into new programs of research and independent investigator research applications.

It is expected that new biomedical and behavioral knowledge will be discovered for improving self-management of persons with acute and chronic disorders, and for improving the quality-of-life of persons at end of life and their caregivers, across the NINR research mission areas and strategies presented in the 2006 NINR Mission and Strategic Plan (http://www.ninr.nih.gov/AboutNINR/NINRMissionandStrategicPlan).

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 RFA 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/.

Interdisciplinary and biobehavioral approaches to improve self-management or end-of-life care are needed.  Attention to health disparities in self-management or in end of life care is encouraged.  Applicant SONs should submit nursing research proposals in areas specific to the Self-Management or End-of-Life research areas in the NINR strategic plan priority areas.  Applicants should select a scientific area of inquiry based on a conceptually sound integration of the currently funded projects that comprise the research base of the Center.  Applications should propose innovative ideas consistent with NINR's mission.  Although not inclusive of all topics that would be considered responsive to this RFA, applicants are encouraged to review the NINR’s Strategic Plan document (http://www.ninr.nih.gov/AboutNINR/NINRMissionandStrategicPlan/) that includes the following examples of Self-Management and End-of-Life areas of scientific opportunity at NINR:

Self-Management Areas of Opportunity

End-of-Life Areas of Opportunity

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

Section II. Award Information

1. Mechanism(s) of Support

This funding opportunity will use the P20 award mechanism.  As an applicant, you will be solely responsible for planning, directing, and executing the proposed project.

This funding opportunity uses the just-in-time budget concepts. It also uses the non-modular budget format described in the PHS 398 application instructions (see http://grants.nih.gov/grants/funding/phs398/phs398.html). A detailed categorical budget for the "Initial Budget Period" and the "Entire Proposed Period of Support" is to be submitted with the application.

This FOA is a one-time research opportunity.  Successful applications are not renewable.  There are no plans to reissue this FOA.  Support will be available for up to 5 years only.

2. Funds Available

It is anticipated that $2.0 million/year for 5 years will be available to support scientifically meritorious applications responding to this P20 FOA and the companion P30 FOA (RFA-NR-07-005).   It is anticipated that support will be provided for up to 2-3 new P20 Centers for Building the Research Teams of the Future.  Individual P20 awards are expected to be $200,000 to $250,000 per year in direct cost; $300,000 is the maximum amount that may be requested in total costs (i.e., direct plus F&A) per year. 

Because the nature and scope of the proposed research will vary from application to application, it is anticipated that the size and duration of each award will also vary. Although the financial plans of the IC(s) provide support for this program, awards pursuant to this funding opportunity are contingent upon the availability of funds and the receipt of a sufficient number of meritorious applications.

Facilities and administrative costs requested by consortium participants are not included in the direct cost limitation, see NOT-OD-05-004.

Section III. Eligibility Information

1. Eligible Applicants

1.A. Eligible Institutions

You may submit (an) application(s) if your organization has any of the following characteristics:

Within the eligible organizations, eligibility is limited to schools/colleges/departments of nursing. 

To be eligible, applicant organizations must operate within the United States or territories and must document at least two (2) peer reviewed Self-Management, Quality of Life, or End-of-Life research projects at the R01, R15, or R21 mechanism level that are active at the time of P20 application submission.  Peer-reviewed research projects supported by State governments or private foundations that are awarded for 2 or more years’ duration may also be qualifying.  If State government or foundation awards are used to demonstrate research focus in Self Management or End-of-Life, at least one award must be supported by DHHS.  Awards from an applicant organization will not be considered as supporting evidence of a research focus.  A description of the qualifying research activities must be included in the application. 

Applicant organizations that have previously been or are currently the recipient of a non-Partnership Developmental P20 or P30 Center award funded by NINR are not eligible to apply to this FOA.  However, applicant organizations that are Minority Serving Institutions (MSIs) and currently hold a Partnership P20 Center previously awarded by the NINR are eligible to apply under this FOA.

1.B. Eligible Individuals

Any individual with the skills, knowledge, and resources necessary to carry out the proposed research project is invited to work with their institution to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support.  Principal Investigators must be nurse researchers doctorally-prepared by a research training program, who have current NIH funding at the R01, R03, R15, or R21 level.

Applications with Multiple PDs/PIs

When multiple PDs/PIs are proposed, NIH requires one PD/PI to be designated as the "Contact” PI, who will be responsible for all communication between the PDs/PIs and the NIH, for assembling the application materials, and for coordinating progress reports for the project. The contact PD/PI must meet all eligibility requirements for PD/PI status in the same way as other PDs/PIs, but has no other special roles or responsibilities within the project team beyond those mentioned above.  Please remember that all PDs/PIs must be registered in the eRA Commons prior to application submission. 

All applications proposing Multiple PDs/PIs will be required to include a new section describing the leadership of the project.

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

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

Applicant organizations wishing to submit a multiple PD/PI application should review the guidance on multiple PI applications at http://grants2.nih.gov/grants/multi_pi/ , as well as the NINR Center multiple PI guidance (http://www.ninr.nih.gov/ResearchAndFunding/GrantDevelopmentandManagementResources/CtrGrant+AdminReportingGuidance/MultiPI.htm).  Multi-PI applicants are also encouraged to contact the NINR Center Program Coordinator for additional detailed guidance on completing the PHS 398 application.

2. Cost Sharing or Matching

Not required

The most current Grants Policy Statement can be found at: http://grants.nih.gov/grants/policy/nihgps_2003/nihgps_Part2.htm#matching_or_cost_sharing

3. Other-Special Eligibility Criteria

An applicant organization may submit only one application under this FOA.  Successful applicants should plan to participate in NINR-sponsored conferences to share information, discuss problems, and collaborate with other awardees.  It is therefore strongly recommended that costs associated with attendance of the principal investigator at one such conference per year be included as a part of the budget proposal.  Applicants are also encouraged to include funds to support the creation and maintenance of a Center website, on which they can disseminate their Center-related activities and research products.

Section IV. Application and Submission Information

1. Address to Request Application Information

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

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

2. Content and Form of Application Submission

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

The title and number of this funding opportunity must be typed on line 2 of the face page of the application form and the YES box must be checked.

Guidance on appendix materials can be found in NOT-OD-07-018 ( http://grants.nih.gov/grants/guide/notice-files/NOT-OD-07-018.html).  The number of allowed appendices has been changed for this FOA only.  Using the guidance in the above Notice, applicants may submit one (1) appendix per Center component (i.e., one per Core or Project), up to a maximum of 9 total appendices for any Center application. 

Applicants are encouraged to send Appendix materials on a CD in PDF format in lieu of the five collated sets.   See PHS 398 paper application instructions for details on preparing CDs.  Only a single CD need be sent, but it must be sent to the NINR Office of Review.

IMPORTANT NOTE: NIH has published new limitations on grant application appendix materials to encourage applications to be as concise as possible while containing the information needed for expert scientific review.  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.  Applications must adhere to the most current guidance regarding appendices (NOT-OD-07-018; http://grants.nih.gov/grants/guide/notice-files/NOT-OD-07-018.html). 

3. Submission Dates and Times

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

3.A. Receipt, Review and Anticipated Start Dates
Letter of Intent Receipt Date(s): April 10, 2007
Application Receipt Date(s): May 10, 2007
Peer Review Date(s): July 2007
Council Review Date(s): August 2007
Earliest Anticipated Start Date(s): September 30, 2007

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 at the beginning of this document.

The letter of intent should be sent to:

Dr. Kathy Mann Koepke, Centers Program Coordinator
Office of Extramural Programs
National Institute of Nursing Research
6701 Democracy Plaza; Suite 710
Bethesda, MD 20892-4870
Telephone: (301) 496-9623
FAX: 301-451-5650
Email: [email protected]

3.B. Sending an Application to the NIH

Applications must be prepared using the research grant applications 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 (3) 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 (2) additional copies of the application and all copies of the appendix material (including CD, if applicable) must be sent to:

Dr. John Richters, Chief
Office of Review
National Institute of Nursing Research
6701 Democracy Plaza; Suite 710
Bethesda, MD 20892-4870
Telephone: (301) 594-5971
FAX: 301-480-8260
Email: [email protected]

Using the RFA Label: The RFA label available in the PHS 398 application instructions must be affixed to the bottom of the face page of the application. Type the RFA number on the label. Failure to use this label could result in delayed processing of the application such that it may not reach the review committee in time for review. In addition, the RFA title and number must be typed on line 2 of the face page of the application form and the YES box must be marked. The RFA label is also available at: http://grants.nih.gov/grants/funding/phs398/labels.pdf.

3.C. Application Processing

Applications must be received on or before the application receipt date(s) described above (Section IV.3.A.).  If an application is received after that date, it will be returned to the applicant without review.  Upon receipt, applications will be evaluated for completeness by the CSR and responsiveness by the (NINR). Incomplete and 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 http://grants.nih.gov/grants/policy/policy.htm.

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 competing continuation award if such costs: are necessary to conduct the project, and 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 competing continuation 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.

Applicants should be aware that stipends and honoraria are prohibited costs on a P20 grant.  NINR will only consider administrative requests for research supplements to support underrepresented minorities or persons with disabilities on research components of a P20 grant.

6. Other Submission Requirements

GENERAL SUBMISSION REQUIREMENTS

REQUIRED COMPONENTS OF THE APPLICATION:    The Nursing Science Centers in Self-Management or End-of-Life Research: Building Research Teams for the Future (P20) must include the following:  

1.  Administrative Core (Center PI should be the Administrative Core Director and contribute no less than 15% time and effort to this core’s activities)

2.   Three (3) to six (6) research projects (each of 2-3 years duration) that will be performed during or dispersed throughout the Project period.  No one Project should constitute greater than one third of the dollars allocated to Projects.  Funds for these Projects should be allocated within the Administrative Core under the “Other Expenses” and listed separately for each project.

3.   Evaluation Plan (must include quantifiable evaluation of success and outcomes and a plan for sustainability of the Center).  While it is a required separate component of the application, the evaluation plan activities and responsibility reside within the Administrative Core.

Other cores, such as a Research Outreach/Dissemination Core, a Design/Methodology/ Statistics Core, or a Biobehavioral Tools Core, are optional, and may be added to help facilitate the achievement of goals and objectives outlined in the application.  Each Core should be directed by an investigator/faculty with substantial expertise related to the Core.  An important consideration is the degree to which core facilities (a) will be utilized by and benefit ongoing and/or proposed Projects and Center investigators and (b) will assist in the development of the activities related to Self Management or End-of-Life research. 

It is not sufficient for the applicant to merely identify resources that will be shared by Center investigators.  Rather, applicants must describe how each optional Core will augment or enhance the present capabilities of the investigators/faculty at the SON, including both Project investigators within the Center, as well as investigators in the larger research community affiliated with the applicant organization.  Likewise, proposed Project investigators must describe how they plan to utilize each Center Core.  In the application, the description of each Core is limited to five (5) pages. 

6.1 ADMINISTRATIVE CORE (MANDATORY), 5 page limit

An Administrative Core is mandatory for all Centers.   The Administrative Core should manage the overall activities of the Center, including developing, promoting, and managing use of Center resources.  The Administrative Core should also actively develop means for and promote Center investigators networking and collaborating with the larger research community.  The Administrative Core is responsible for the development and execution of an evaluation plan and a plan for sustainability.  Active monitoring of all Center components for federal research guidelines (e.g., IRB and IACUC approvals) compliance is also the responsibility of the Administrative Core. 

The Administrative Core must contain:

1.  The applicant PI identified as the Administrative Core Director (committed to no less than 15% time and effort in the Administrative Core);

2.  A description of the administrative structure; and

3.  A general description of activities and institutional support of the Core. 

It is expected that the Center Administrative structure will accomplish the following: 

1.  Coordinate and oversee the administrative functions of the Center;

2.  Review utilization of funds, including funds for research Projects and other Core(s) activities, and assure the appropriate expenditure of these funds;

3.  Optimize the utilization of the shared resources of the Center, such as all Core(s) resources; 

4.  Establish and maintain a Center website that highlights Center resources and research outcomes (e.g., publications, developed tools), promotes the Center as a research community resource, and enables sharing across NINR-funded Centers; and

5.  Plan for the sustainability of the Center after the period of support is completed, including development of collaboration(s) and preparation for seeking NIH support. 

An Evaluation Plan, developed, executed and tracked by the Administrative Core, is also required, but should be presented in a separate section from the Administrative Core (see 6.3 below). 

While the final administrative structure of the Center will, for the most part, be left to the discretion of the applicant organizations, NIH's experience has demonstrated that the effective development of Center programs requires interaction among the Director(s), Core Leaders, directors of the research Projects, appropriate institutional administrative personnel, and the staff of the awarding agency. To facilitate communication among the Center staffs and the NINR, NINR expects that each Center application must include funds for the Center Director to travel to an annual meeting in Bethesda, Maryland.   

An Executive Committee, consisting of the heads of all Cores and appropriate business official(s), should be established to assist the Director in the allocation of Center resources, the identification and selection of key personnel, and the planning and execution of Center activities.  Other members can be added to the Executive Committee at the Director’s discretion. 

The complex nature of administrative requirements of centers will necessitate the assistance of a person with business management expertise.  It is important that such an official is identified and is directly involved with the fiscal aspects of the application and grant.  An appropriate amount of this individual's time and effort should be committed for this purpose.  The institutional business official should be a member the Executive Committee.  While budget formulation and planning will undoubtedly begin with the Director in collaboration with the scientific staff, the business official should be involved in the process, provide consultation in matters of fiscal administration, and evaluate such issues as equipment on hand versus that requested for the core facilities.  Additionally, this institutional official can assist the Director in determining the compliance with NIH research guidelines.  

An External Advisory Committee of scientists and administrators should be established and composed of at least two (2) scientists from outside the applicant organization, with expertise and experiences relevant to the scientific program of the Center.  This committee should be used in evaluating the overall research programs of the Center, the development and utilization of research resources, the effectiveness of communications within the Center, and any activities in which problems arise for which expertise is required or desirable.  The External Advisory Committee should meet in person at least once annually. However, the nature of its responsibilities may require ad hoc meetings at more frequent intervals. A member of the NINR extramural program staff is to be invited to attend each meeting as an observer, and provided a copy of the meeting minutes within weeks of each meeting.  

6.2 RESEARCH PROJECTS (THREE MANDATORY), 10 page limit per Project within the Center.

The Center application must include 3-6 research projects that will be undertaken during or dispersed throughout the period of Center support.  Each research Project should be 2 to 3 years in duration and should include: 

1.  Specified Project Director;
2.  Title and Abstract
3.  Specific Aims
4.  Research Plan (Sections a.-d.) 
5.  If human subjects are to be participants, a Human Subjects section, including the
     Target Enrollment table
6.  Budget  (detailed and with justification)

Three research Projects over the period of support for the Center are mandatory, additional Projects may be proposed up to a total of six (6) Projects.  They are intended to enable eligible investigators to explore a scientific topic on Self-Management or End-of-Life, and to amass sufficient expertise and data to complete the study and develop an independent research track and applications (e.g., NIH R01).  Research projects can not be used to supplement already-funded research at the applicant organization.  The Center should have at least one ongoing research Project at all times during the period of support. 

Eligible Project directors, co-investigators, and collaborators include: 

1.   The Project Director(s) is an investigator who has not been a Principal Investigator in the past, or who is not currently funded by a DHHS research Project grant (i.e., R01, R15 or R21); or

2.   Established investigators who wish to develop skill and expertise in conducting Self-

Management or End-of-Life research and for whom this area represents a clear and distinct departure from his/her ongoing research interests.  Strong justification must be made in the application to include an established investigator as a Project Director.  Evidence that this Project represents a new research career path that will be sustained by the Project Director is required.

3.   The applicant Center Principal Investigator (PI) and Core Leaders may not serve as a Project Director. 

4.   The Project Director must hold a doctorate from a research training program (e.g., PhD) and be a faculty member or senior post-doctoral fellow or investigator of equivalent rank at the applicant organization. 

Based on their own scientific merit, research projects will receive individual scores separate from the overall P20 Center score.  Standard guidelines for IRB/IACUC approval, targeted enrollment table(s) for human research, and educational training for the protection of human subjects apply.  The theoretical basis for the research projects must be clearly explicated, as well as a brief statement of fit within the Center as a whole.  Each Project is limited to a total of 10 pages of description for the Research Plan, Sections a. through d., which should delineate the question being asked, detail the procedures to be followed, and discuss how the data will be analyzed.  The application must indicate how the proposed study addresses a Self Management or End-of-Life topic, and how the Project will utilize and interact with Center Core resources.  

6.3 EVALUATION PLAN (MANDATORY), 10 page limit

The National Advisory Council for Nursing Research (NACNR) reviewed and approved the NINR Centers Program concept.  The need for collecting appropriate data (such as publications, presentations, grant awards, and other accomplishments that accrue as a result of the Center activity and presence) was emphasized.  This will allow for annual planned evaluation of goals attainment and subsequent remedial action as needed.  As a result of this guidance and the need of Centers to ensure their own success, a plan for ongoing evaluation of progress toward meeting the aims and goals of all Cores, Projects, and the overall Center is required.  This plan should include the specific criteria and methods that will be used for the evaluation.  The plan should specify the types of evaluation information that will be submitted in the Center's annual progress report. 

1.  The Center Director, the Administrative Core, and other Center components as the Director deems appropriate are responsible for the evaluation plan.

2.  The evaluation plan must include measurable goals for each Project year relating to progress of each Core and research Project, collaborative research activities,      dissemination and impact of knowledge gained from research projects, and efforts to facilitate sustainability.

3.  The plan for evaluating progress must include maintaining a detailed record of the research projects, oral and poster presentations and publications derived from Center activity and funding, grant submission activity resulting from Center activities, and collaboration by Center investigators with other schools and institutions.

4.  Evaluation must also include an accounting of resources and resource utilization, as well as efforts taken to maximize the research utilization of these resources.

5.  The evaluation plan must include a section addressing sustainability of the Center and its research, including plans for attracting new investigators and resources into Center research activities. 

6.  The evaluation plan must include an annual assessment of goals achievement. 

After an award is made, the NINR will require detailed documentation (in the required annual PHS2590 Progress Report) of presentations, publications, resource sharing, collaborations, and grant submission activities (see “NINR Guidance on Center Reporting” http://www.ninr.nih.gov/ResearchAndFunding/GrantDevelopmentandManagementResources/CtrGrant%20AdminReportingGuidance/NINRGuidanceonReporting.htm for details). 

6.4 ADDITIONAL CORES (OPTIONAL), 5 page limit per Core

Additional Cores may be proposed to support and enhance the activities of the Center, such as a Research Outreach/Dissemination Core, a Design/Methodology/Statistics Core, or a Biobehavioral Tools Core, and may be added to help facilitate the achievement of goals and objectives outlined in the application.  Each core should be directed by a doctorally prepared investigator with substantial expertise related to the Core activities.  An important consideration is the degree to which a Core facility (a) will be utilized by and benefit ongoing and/or proposed Projects and Center investigators and (b) will assist in the development of the activities related to Self Management or End-of-Life research, both within the Center and in the larger research community at the applicant organization.  It is not sufficient for the applicant to merely identify resources that will be shared by Center investigators.  Rather, applicants must describe how each Core will augment or enhance the present capabilities of the investigators/faculty at the SON, including both Project investigators within the Center, as well as investigators in the larger research community affiliated with organization.  Likewise, proposed Center Project investigators must describe how they plan to utilize each Center Core. 

Each Core description must include:

1.  Specifically designated/named Core Leader, with a minimum of 10% time and effort committed;
2.  Description of the Core service or resource, and evidence of need for Core;
3.  Demonstration of the necessary expertise/resources to provide the services or materials proposed;
4.  Evidence of and plans for interaction with all Center Projects and other Center Cores;
5.  Plan for and mechanism to announce availability of Core resource to larger SON research community (i.e., beyond Center investigators);
6.  Core resource sharing plan to determine how, when, and to whom Core resources should be dispensed; and 
7.  Mechanism to track the nature and amount/duration of each service exchange. 

Core investigators may collaborate and co-author research with other Center investigators, but Core budgets may not be used to supplement any research Project within or outside of the Center.  Cores are not intended to function as independent research projects, however, they may investigate the benefit of the Core’s services/resources, or means of enhancing Core services/resource provision. 

6.5 APPENDICES (Optional) maximum of 9 appendices total

Guidance on appendix materials can be found in NOT-OD-07-018 (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-07-018.html).  The number of allowed appendices has been changed for this FOA only.  Using the guidance in the above Notice, applicants may submit one (1) appendix per Center component (i.e., one per Core or Project), up to a maximum of nine (9) total appendices for any Center application.  For example, if a Center application has two (2) Cores and three (3) Projects, the maximum number appendices is a total of five (5) appendices (i.e., 5 components).   

Applicants are encouraged to send Appendix materials on a CD in PDF format in lieu of the five collated sets.   See PHS 398 paper application instructions for details on preparing CDs.  Only a single CD need be sent. 

Plan for Sharing Research Data

All applicants are strongly encouraged to plan for data sharing as appropriate and to include such a plan in their application.  All Phase III clinical trials (i.e., efficacy trials), regardless of the number of subjects enrolled, must plan for data sharing.  The NIH data sharing policy is available at http://grants.nih.gov/grants/policy/data_sharing.  All investigators responding to this funding opportunity should include a description of how final research data will be shared, or explain why data sharing is not required or is not possible.

The precise content of the data-sharing plan will vary, depending on the data being collected and how the investigator is planning to share the data. Applicants who are planning to share data may wish to describe briefly the expected schedule for data sharing, the format of the final dataset, the documentation to be provided, whether or not any analytic tools also will be provided, whether or not a data-sharing agreement will be required and, if so, a brief description of such an agreement (including the criteria for deciding who can receive the data and whether or not any conditions will be placed on their use), and the mode of data sharing (e.g., under their own auspices by mailing a disk or posting data on their institutional or personal website, through a data archive or enclave). Investigators choosing to share under their own auspices may wish to enter into a data-sharing agreement. References to data sharing may also be appropriate in other sections of the application.

The reasonableness of the data sharing plan or the rationale for not sharing research data will be assessed by the reviewers. However, reviewers will not factor the proposed data sharing plan into the determination of scientific merit or the priority score.
 
Sharing Research Resources

NIH policy expects that grant recipients make unique research resources readily available for research purposes to qualified individuals within the scientific community after publication (NIH Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps_2003/index.htm and http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part7.htm#_Toc54600131).  Investigators responding to this funding opportunity should include a plan for sharing research resources addressing how unique research resources will be shared or explain why sharing is not possible.

The adequacy of the resources sharing plan and any related data sharing plans will be considered by Program staff of the funding organization when making recommendations about funding applications. The effectiveness of the resource sharing will be evaluated as part of the administrative review of each non-competing Grant Progress Report (PHS 2590, http://grants.nih.gov/grants/funding/2590/2590.htm). See Section VI.3. Reporting.

Section V. Application Review Information

1. Criteria

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

The following will be considered in making funding decisions:

2. Review and Selection Process

Applications that are complete and responsive to the RFA will be evaluated for scientific and technical merit by an appropriate peer review group convened by NINR in accordance with the review criteria stated below.

As part of the initial merit review, all applications will:

The goals of NIH supported research are to advance our understanding of biological systems, to improve the control of disease, and to enhance health. In their written critiques, reviewers will be asked to comment on each of the following criteria in order to judge the likelihood that the proposed research will have a substantial impact on the pursuit of these goals.   Each of these criteria will be addressed and considered in assigning the overall score, weighting them as appropriate for each application. Note that an application does not need to be strong in all categories to be judged likely to have major scientific impact and thus deserve a high priority score. For example, an investigator may propose to carry out important work that by its nature is not innovative but is essential to move a field forward.

Significance: Does this study address an important problem? If the aims of the application are achieved, how will scientific knowledge or clinical practice be advanced? What will be the effect of these studies on the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?

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

Innovation: Is the project original and innovative? For example: Does the project challenge existing paradigms or clinical practice; address an innovative hypothesis or critical barrier to progress in the field? Does the project develop or employ novel concepts, approaches, methodologies, tools, or technologies for this area?

Investigators: Are the investigators appropriately trained and well suited to carry out this work? Is the work proposed appropriate to the experience level of the principal investigator and other researchers? Does the investigative team bring complementary and integrated expertise to the project (if applicable)?

Environment: Does the scientific environment in which the work will be done contribute to the probability of success? Do the proposed studies benefit from unique features of the scientific environment, or subject populations, or employ useful collaborative arrangements? Is there evidence of institutional support?

The initial review for scientific and technical merit of applications will emphasize three major aspects:

1.    the merit and responsiveness of all required and optional components (administrative & other Cores, and the evaluation & sustainability plan);

2.   the scientific and technical merit and fit of the proposed research Projects; and

3.   the review of the proposed Center as an integrated whole working together to focus on improving Self Management or End-of-Life research, and its potential to favorably establish or enhance the fields of Self Management or End-of-Life research at the SON.

The second level of review will be performed by the National Advisory Council for Nursing Research (NACNR).  Applications recommended by the NACNR will be considered for funding on the basis of the overall scientific merit of the application as determined by peer review, as well as such considerations as program balance, relevance to the mission and goals of the NINR, geographic distribution, inclusion of health disparity populations, research program priorities, and availability of funds.  In their written critiques, reviewers will be asked to comment on each of the following criteria in order to judge the likelihood that the proposed research will have a substantial impact on the pursuit of these goals.

CENTER AS AN INTEGRATED WHOLE will be evaluated with the following criteria:

Significance: Do the Center’s research goals address an important problem?  Is there potential for favorably impacting the fields of self-management or End-of-Life research, and the research capacity of the applicant organization?

Approach: Does the Center demonstrate a multi- and inter-disciplinary biobehavioral approach appropriate for its goals?  Is the coordination among the Administrative Core, the optional Cores, and the research Projects adequately explained?  Is there synergistic potential among the Center’s research components?  Is the evaluation plan likely to ensure the advance of the Center research aims?  Is there justification for each research and Core component in terms of the overall goals of the Center?  Does the Center have the potential to achieve a whole greater than the sum of its parts?  Is there evidence that Center activities and resources can be sustained beyond the period of funding?

Innovation: Will the Center make a unique contribution or fill a significant gap in the area of Self-Management or End-of-Life research?  Will the Center resources provide a unique contribution to the research infrastructure at the SON and larger institution?

Investigators: Are the investigators appropriately trained and well suited to carry out this work?  Do the investigators bring complementary and integrated expertise to the Center?  Is the Center Director capable of providing the scientific leadership and administrative oversight required to lead a Center?  Are the plans for External Advisory Committee input well integrated into the Center decision-making processes?

Environment: Is the academic and physical environment in which the research will be conducted, including availability of space, equipment, research subjects, and materials well defined?  Is there evidence of long-term institutional commitment to the pursuit of self-management or End-of-Life research?  Is the environment within and around the institution suitable for the advancement of self-management or End-of-Life research? Is there evidence of true collaboration with institutional partners and multidisciplinary research?  

The ADMINISTRATIVE CORE will be evaluated with the following criteria:

Approach: Are the arrangements and organizational structure adequately developed, well reasoned and appropriate to the aims of the Center? Does the application describe how day-to-day management of the Center will be accomplished? Are the plans to facilitate and monitor attainment of Center objectives appropriate?  Are contractual and consortium arrangements adequately described, if applicable? Are plans for sustainability and long-term management of the Center appropriate?  Are plans for Center scientific growth and development over the Project period appropriate and adequately described?   

Investigator: Are the qualifications, experience, commitment and administrative competence of the Administrative Core Director appropriate? Is there an appropriate time and effort commitment made by the Administrative Core Director? Is there evidence that the Administrative Core, other Cores, and research Projects staff have worked closely together in the preparation of the application and will continue to do so in meeting the proposed Center objectives?

Environment: Is institutional commitment to the pursuit of Self Management or End-of-Life research and other proposed activities, including provision of resources, administrative authority and recognition, convincing?  Is there evidence of institutional commitment to incorporate and highlight the Center and its activities at the institution level and beyond?

Each additional OPTIONAL CORE will be evaluated with the following criteria:

Approach: Are the arrangements and organizational structure adequately developed, well reasoned and appropriate to the aims of the Core? Does the application describe how day-to-day management of Core resources will be accomplished? Are there plans to identify emerging Core resource needs of the Center and SON?  Are Core plans appropriate to facilitate and monitor attainment of Center objectives?  Does the Core enhance and complement the Center’s scientific goals (i.e., is there a good “fit” of the Core to the Center)?

Investigator: Are the qualifications, experience, commitment and competence of the Core Director appropriate? Is there an appropriate time and effort commitment made by the Core Director? Is there evidence that the researchers and faculty of the Core and the Projects and Administrative Core have worked closely together in the preparation of the application relative to the Core resources and will continue to do so in meeting the proposed Center objectives?

Environment: Is institutional commitment to the Core in its pursuit of resources to support Self Management or End-of-Life research, including provision of resources and recognition, convincing? 

The EVALUATION PLAN will be evaluated with the following criteria:

Approach: Is the evaluation plan adequately developed, well reasoned and appropriate to the aims of the Center? Does the application describe how monitoring, tracking, and corrective adjustments in activity will be determined or take place? Does this tracking accommodate the information required for annual progress reports to NINR?  Does the evaluation plan include well-defined and quantifiable outcome measures?  Are the overall plans to facilitate and monitor attainment of Center objectives appropriate?  Does the evaluation plan include plans for sustainability of the Center?

Investigator: Has an investigator been named to head the evaluation effort?  Does this individual have the qualifications, experience, commitment and competence to accomplish the task?  Is there evidence that the researchers and faculty of the Center have worked closely together in the preparation of the evaluation and sustainability plan and will continue to do so in annually evaluating progress?  

The RESEARCH PROJECTS will be evaluated with the following criteria:

In their written critiques, reviewers will be asked to comment on each of the following criteria in order to judge the likelihood that the proposed research will have a substantial impact on the pursuit of Center goals. Each of these criteria will be addressed and considered in assigning the overall score, weighting them as appropriate for each project. Note that a project does not need to be strong in all categories to be judged likely to have major scientific impact and thus deserve a high priority score. For example, an investigator may propose to carry out important work that by its nature is not innovative but is essential to move a field forward.   Reviewers will be asked to review each Project separately and assign it a score.  These scores will be taken into account when assigning an overall score to the Center.

Significance: Does this study address an important problem?  If the aims of the project are achieved, how will scientific knowledge or clinical practice be advanced?  What will be the effect of these studies on the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?  Does the proposed research address a significant problem and/or gap in Self-Management or End-of-Life research or care? 

Approach: Are the conceptual or clinical framework, design, methods, and analyses adequately developed, well integrated, well reasoned, and appropriate to the aims of the project?  Does the applicant acknowledge potential problem areas and consider alternative tactics?  Are the proposed approaches appropriate for research in populations at the end of life or with disorders in need to self-management skills?  Does the Project enhance and complement the Center’s scientific goals (i.e., is there a good “fit” of the Project to the Center)?

Innovation: Is the Project original and innovative?  For example: Does the Project challenge existing paradigms or clinical practice; address an innovative hypothesis or critical barrier to progress in the field?  Does the Project develop or employ novel concepts, approaches, methodologies, tools, or technologies for this area?  Are there plans to later develop this Project into an independent grant application?  Is this Project likely to develop results worthy of publication?

Investigators: Are the investigators appropriately trained and well suited to carry out this work?  Is the work proposed appropriate to the experience level of the Project Director and other researchers?  Does the investigative team bring complementary and integrated expertise to the Project (if applicable)?  

Environment: Does the scientific environment in which the work will be done contribute to the probability of success? Does the proposed study benefit from unique features of the scientific environment, or subject populations, or employ useful collaborative arrangements? Is there evidence of institutional support? Does the proposed Project benefit from the resources available at the Center?  Does the application demonstrate the role of the Center Cores in the accomplishment of this project?

2.A. Additional Review Criteria:

In addition to the above criteria, the following items will continue to be considered in the determination of scientific merit and the priority score:

Protection of Human Subjects from Research Risk: The involvement of human subjects and protections from research risk relating to their participation in the proposed research will be assessed (see the Research Plan, Section E on Human Subjects in the PHS Form 398).

Inclusion of Women, Minorities and Children in Research: The adequacy of plans to include subjects from both genders, all racial and ethnic groups (and subgroups), and children as appropriate for the scientific goals of the research will be assessed. Plans for the recruitment and retention of subjects will also be evaluated (see the Research Plan, Section E on Human Subjects in the PHS Form 398).

Care and Use of Vertebrate Animals in Research: If vertebrate animals are to be used in the project, the five items described under Section F of the PHS Form 398 research grant application instructions will be assessed.

Biohazards: If materials or procedures are proposed that are potentially hazardous to research personnel and/or the environment, determine if the proposed protection is adequate.

2.B. Additional Review Considerations

Budget: The reasonableness of the proposed budget and the requested period of support in relation to the proposed research. The priority score should not be affected by the evaluation of the budget. :  A detailed first year budget is required for each Center component (i.e., all Cores and Projects). 

2.C. Sharing Research Data

Data Sharing Plan: The reasonableness of the data sharing plan or the rationale for not sharing research data may be assessed by the reviewers. However, reviewers will not factor the proposed data sharing plan into the determination of scientific merit or the priority score. The funding organization will be responsible for monitoring the data sharing policy. http://grants.nih.gov/grants/policy/data_sharing.

2.D. Sharing Research Resources

NIH policy expects that grant recipients make unique research resources readily available for research purposes to qualified individuals within the scientific community after publication (See the NIH Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps/part_ii_5.htm#availofrr and http://www.ott.nih.gov/policy/rt_guide_final.html). Investigators responding to this funding opportunity should include a sharing research resources plan addressing how unique research resources will be shared or explain why sharing is not possible.

Program staff will be responsible for the administrative review of the plan for sharing research resources.

The adequacy of the resources sharing plan will be considered by Program staff of the funding organization when making recommendations about funding applications. Program staff may negotiate modifications of the data and resource sharing plans with the awardee before recommending funding of an application. The final version of the data and resource sharing plans negotiated by both will become a condition of the award of the grant. The effectiveness of the resource sharing will be evaluated as part of the administrative review of each non-competing Grant Progress Report (PHS 2590). See Section VI.3. Reporting.

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 (http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_part4.htm).

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 P20 applications that propose or have the potential to support human subjects research must obtain IRB approval for the Center as a whole prior to funding.  Individual Projects that include human or animal subjects must also obtain the appropriate institutional protocol approval (i.e., IRB or IACUC approval) prior to commencing research activities.  

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).

3. Reporting

Awardees will be required to submit the PHS Non-Competing Grant Progress Report, Form 2590 annually (http://grants.nih.gov/grants/funding/2590/2590.htm) and financial statements as required in the NIH Grants Policy Statement, including a detailed budget for each component of the Center.

Evaluation and tracking reports as described in Sections IV.6.3 (Evaluation Plan) and IV.6.4 (Additional Cores) of this announcement should be included annually as part of the PHS2590 Progress Report.   These reports must, at minimum, include Center progress tracking data (e.g., Core resources utilization data, collaborations established and their outcomes, developed products, new research applications spawned as a result of the Center), all new Center supported publications, and External Advisory Committee meeting minutes.  The Center as a whole, as well as each Core and Project must provide a report of their progress and updated administrative approvals (e.g., IRB/IACUC approvals).  See the website “NINR Guidance on Center Reporting” (http://www.ninr.nih.gov/ResearchAndFunding/GrantDevelopmentandManagementResources/CtrGrant%20AdminReportingGuidance/NINRGuidanceonReporting.htm) for reporting guidance.  The Center investigators and directors may chose to include additional information regarding progress and outcomes as appropriate.

Copies (paper or electronic) of publications (in press or in print) that are developed as a result of this support must be provided to NINR.  NINR must be acknowledged by the awardee (via inclusion of grant number) as the source of support for the work in all publications and presentations.  

NIH encourages all grantees to submit to the NIH National Library of Medicine's (NLM) PubMed Central (PMC) an electronic version of the author's final manuscript upon acceptance for publication, resulting from research supported, in whole or in part, from NIH. The author's final manuscript is defined as the final version accepted for journal publication, and includes all modifications from the publishing peer review process (http://grants2.nih.gov/grants/guide/notice-files/NOT-OD-05-022.html).  The Public Access website (http://publicaccess.nih.gov/) provides instructions on submitting manuscripts.

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:

Dr. Kathy Mann Koepke, Centers Program Coordinator
Office of Extramural Programs
National Institute of Nursing Research
6701 Democracy Plaza; Suite 710
Bethesda, MD 20892-4870
Telephone: (301) 496-9623
FAX: 301-451-5650
Email: [email protected]

2. Peer Review Contacts:

Dr. John Richters, Chief
Office of Review
National Institute of Nursing Research
6701 Democracy Plaza; Suite 710
Bethesda, MD 20892-4870
Telephone: (301) 594-5971
FAX: 301-480-8260
Email: [email protected]

3. Financial or Grants Management Contacts:

Brian Albertini, Chief
Office of Grants and Contract Management
National Institute of Nursing Research
6701 Democracy Plaza; Suite 710
Bethesda, MD 20892-4870
Telephone: (301) 594-6869
FAX: 301-480-8260
Email: [email protected]

Section VIII. Other Information

Required Federal Citations

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

Human Subjects Protection:
Federal regulations (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.

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

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

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

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

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

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

Human Embryonic Stem Cells (hESC):
Criteria for federal funding of research on hESCs can be found at http://stemcells.nih.gov/index.asp and at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-005.html. Only research using hESC lines that are registered in the NIH Human Embryonic Stem Cell Registry will be eligible for Federal funding (http://escr.nih.gov). It is the responsibility of the applicant to provide in the project description and elsewhere in the application as appropriate, the official NIH identifier(s) for the hESC line(s)to be used in the proposed research. Applications that do not provide this information will be returned without review.

NIH Public Access Policy:
NIH-funded investigators are requested to submit to the NIH manuscript submission (NIHMS) system (http://www.nihms.nih.gov) at PubMed Central (PMC) an electronic version of the author's final manuscript upon acceptance for publication, resulting from research supported in whole or in part with direct costs from NIH. The author's final manuscript is defined as the final version accepted for journal publication, and includes all modifications from the publishing peer review process.

NIH is requesting that authors submit manuscripts resulting from 1) currently funded NIH research projects or 2) previously supported NIH research projects if they are accepted for publication on or after May 2, 2005. The NIH Public Access Policy applies to all research grant and career development award mechanisms, cooperative agreements, contracts, Institutional and Individual Ruth L. Kirschstein National Research Service Awards, as well as NIH intramural research studies. The Policy applies to peer-reviewed, original research publications that have been supported in whole or in part with direct costs from NIH, but it does not apply to book chapters, editorials, reviews, or conference proceedings. Publications resulting from non-NIH-supported research projects should not be submitted.

For more information about the Policy or the submission process please visit the NIH Public Access Policy Web site at http://publicaccess.nih.gov/ and view the Policy or other Resources and Tools including the Authors' Manual (http://publicaccess.nih.gov/publicaccess_Manual.htm).

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

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

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

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

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

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

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

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