Department of Health and Human Services


Part 1. Overview Information
Participating Organization(s)

National Institutes of Health (NIH)

Components of Participating Organizations

National Institute of Nursing Research (NINR)

Funding Opportunity Title

Centers of Excellence in Self-Management Research (P30)

Activity Code

P30 Center Core Grants

Announcement Type

New

Related Notices

None

Funding Opportunity Announcement (FOA) Number

RFA-NR-14-002

Companion Funding Opportunity

RFA-NR-14-001, P20 Exploratory Grants

Number of Applications

See Section III. 3. Additional Information on Eligibility.

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

93.361   

Funding Opportunity Purpose

This Funding Opportunity Announcement invites applications to establish Centers of Excellence for Self-Management Research: Building Research Teams for the Future (P30). The purpose of the program is to enhance interdisciplinary, biobehavioral research for scientists conducting self-management research by enabling development of a sustainable research infrastructure and centralized resources in support of research programs in various science areas.     

Key Dates
Posted Date

January 10, 2014

Open Date (Earliest Submission Date)

February 11, 2014  

Letter of Intent Due Date(s)

February 11, 2014  

Application Due Date(s)

March 11, 2014, by 5:00 PM local time of applicant organization.

Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date.

AIDS Application Due Date(s)

March 11, 2014, by 5:00 PM local time of applicant organization.

Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date.

Scientific Merit Review

June/July  2014

Advisory Council Review

August 2014   

Earliest Start Date

September 1, 2014

Expiration Date

March 12, 2014

Due Dates for E.O. 12372

Not Applicable

** ELECTRONIC APPLICATION SUBMISSION REQUIRED**

NIH’s new Application Submission System & Interface for Submission Tracking (ASSIST) is available for the electronic preparation and submission of multi-project applications through Grants.gov to NIH. Applications to this FOA must be submitted electronically; paper applications will not be accepted. ASSIST replaces the Grants.gov downloadable forms currently used with most NIH opportunities and provides many features to enable electronic multi-project application submission and improve data quality, including: pre-population of organization and PD/PI data, pre-submission validation of many agency business rules and the generation of data summaries in the application image used for review.

Required Application Instructions

It is critical that applicants follow the instructions in the SF424 (R&R) Application Guide, except where instructed to do otherwise (in this FOA or in a Notice from the NIH Guide for Grants and Contracts) and where instructions in the Application Guide are directly related to the Grants.gov downloadable forms currently used with most NIH opportunities. Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions. Applications that do not comply with these instructions may be delayed or not accepted for review.

Table of Contents

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

Part 2. Full Text of Announcement

Section I. Funding Opportunity Description

Purpose

This Funding Opportunity Announcement (FOA) invites applications to establish Centers of Excellence for Self-Management Research (P30). The purpose of the program is to enhance interdisciplinary, biobehavioral research for scientists conducting self-management research by enabling development of a sustainable research infrastructure and centralized resources in support of research programs in these science areas:

(1) enhance research infrastructure by expanding and targeting research resources available to promote and support self-management;

(2) expand the number and quality of research projects aimed at improving self-management in (a) persons of all ages with chronic and acute disorders, (b) persons with function-impairing symptoms and their caregivers, or (c) projects aimed at improving health and quality of life in chronically ill persons, including those with multiple chronic conditions;

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

(4) increase the quantity and quality of research projects utilizing genetics/genomics, and 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 conditions 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 is essential across the lifespan. In young people, 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 (https://www.ninr.nih.gov/sites/www.ninr.nih.gov/files/ninr-strategic-plan-2011.pdf).

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 led to poor health. Greater self-management of chronic conditions in middle aged adults may lessen caregiver burden and decrease healthcare costs, 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 and financial burdens on care. In addition, 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.

Programs that are sustainable are needed for self-management to improve quality of life of individuals living with chronic illness. Self-management is intended to improve well-being and strengthen self-determination and participation in health care, while reducing 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.

NINR Centers

NINR currently supports a number of Exploratory/Developmental Center (P20s) and Centers of Excellence (P30s) grants.

The purpose of an NINR P30 Center is to: (1) develop sustainable interdisciplinary, biobehavioral research capacity for scientists conducting nursing research 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 all patients and their caregivers, across the NINR research mission areas and strategies presented in the 2011 NINR Mission and Strategic Plan (http://www.ninr.nih.gov/ AboutNINR/NINRMissionandStrategicPlan ).

Interdisciplinary and biobehavioral approaches to improve understanding of self-management are needed as well as attention to health disparities in self-management. Applicant organizations should submit nursing research applications in areas specific to the self-management research areas in the NINR strategic plan priority areas. Applicants are to select a topical area for their application 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 FOA, 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 areas of scientific opportunity at NINR:

Self-Management Areas of Opportunity

In creating a Center of Excellence designed to build research teams of the future in self-management of chronic conditions, the following areas of science may be considered but are not limited to:

Section II. Award Information
Funding Instrument

Grant: A support mechanism providing money, property, or both to an eligible entity to carry out an approved project or activity.

Application Types Allowed

New

The OER Glossary and the SF424 (R&R) Application Guide provide details on these application types.

Funds Available and Anticipated Number of Awards

The National Institute of Nursing Research intends to commit $2.1 million to support 2-3 awards from this P30 FOA and 2-3 awards form  the P20 FOA (RFA-NR-14-001).

Award Budget

Award budgets are limited to $480,000 total costs (direct costs plus F&A costs) per year.  

Award Project Period

The total project period for an application submitted in response to this funding opportunity may not exceed 5 years.  

NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made in response to this FOA.

Section III. Eligibility Information

1. Eligible Applicants

Eligible Organizations

Higher Education Institutions

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

Nonprofits Other Than Institutions of Higher Education

For-Profit Organizations

Governments

Other

Foreign Institutions

Non-domestic (non-U.S.) Entities (Foreign Institutions) are not eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.

Foreign components, as defined in the NIH Grants Policy Statement, are not allowed.

Required Registrations

Applicant Organizations

Applicant organizations must complete and maintain the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award. All registrations must be completed prior to the application being submitted. Registration can take 6 weeks or more, so applicants should begin the registration process as soon as possible. The NIH Policy on Late Submission of Grant Applications states that failure to complete registrations in advance of a due date is not a valid reason for a late submission.

Program Directors/Principal Investigators (PD(s)/PI(s))

All PD(s)/PI(s) must have an eRA Commons account and should work with their organizational officials to either create a new account or to affiliate an existing account with the applicant organization’s eRA Commons account. If the PD/PI is also the organizational Signing Official, they must have two distinct eRA Commons accounts, one for each role. Obtaining an eRA Commons account can take up to 2 weeks.

Eligible Individuals (Program Director/Principal Investigator)

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with his/her organization to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support.

For institutions/organizations proposing multiple PDs/PIs, visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the SF424 (R&R) Application Guide.

2. Cost Sharing

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

3. Additional Information on Eligibility

Number of Applications

Applicant organizations may submit more than one application, provided that each application is scientifically distinct. Applicant organizations with current P30 or P20 Center awards from NINR are only eligible to apply to this FOA if, at the time of application, their total period of Center support is less than eight (8) years and they have a research focus on self-management research. 

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

Section IV. Application and Submission Information

1. Requesting an Application Package

Applicants can access the SF424 (R&R) application package associated with this funding opportunity using the “Apply for Grant Electronically” button in this FOA or following the directions provided at Grants.gov.

Most applicants will use NIH’s ASSIST system to prepare and submit applications through Grants.gov to NIH. Applications prepared and submitted using applicant systems capable of submitting electronic multi-project applications to Grants.gov will also be accepted.

2. Content and Form of Application Submission

It is critical that applicants follow the instructions in the SF424 (R&R) Application Guide, except where instructed in this funding opportunity announcement to do otherwise and where instructions in the Application Guide are directly related to the Grants.gov downloadable forms currently used with most NIH opportunities. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.

For information on Application Submission and Receipt, visit Frequently Asked Questions – Application Guide, Electronic Submission of Grant Applications.

Letter of Intent

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

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

The letter of intent should be sent to:

Dr. Yujing Liu, Chief Office of Review
National Institute of Nursing Research
6701 Democracy Plaza; Suite 710
Bethesda, MD 20892-4870
Telephone: (301) 451-5152
Fax: 301-480-8260
Email: LiuYujin@mail.nih.gov

Page Limitations

Component Types Available in ASSIST

Research Strategy/Program Plan Page Limits

Overall

6 pages

Admin Core

12 pages

Pilot Projects Core

12 pages

Core  (Use for Cores (Other))

6 pages each

Additional page limits described in the SF424 Application Guide and the Table of Page Limits must be followed.

Instructions for the Submission of Multi-Component Applications

The following section supplements the instructions found in the SF424 (R&R) Application Guide, and should be used for preparing a multi-component application.

The application should consist of the following components:

Overall Component

When preparing your application in ASSIST, use Component Type ‘Overall’.

All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions, as noted.

SF424 (R&R) Cover (Overall)

Complete entire form.

PHS 398 Cover Page Supplement  (Overall)

Note: Human Embryonic Stem Cell lines from other components should be repeated in cell line table in Overall component.

Research & Related Other Project Information (Overall)

Follow standard instructions.

Project Summary/Abstract: Describe the scientific theme and goal of the Center and provide a brief overview as it relates to the theme and goal of the Center.

Project Narrative: In 1-3 sentences describe the relevance of the Center activities on public health.

Facilities and Other Resources: Describe the existing environment and facilities available to the Center and the process including fee structure to access facilities.

The Institutional Commitment at the applicant institution will be a major consideration in ensuring the goals of the Center. The parent institution should recognize the Center as a formal organizational component and provide documented evidence of space dedicated to the needs of the Center, protected time to devote to Center activities, staff recruitment, dedicated equipment, or other financial support for the proposed Center.

The parent institution should provide assurance of its commitment to continuing support of the Center in the event of a change in directorship and a well-defined plan for this eventuality should be in place. In addition, it is expected that the Institution will support the goal of providing to Center members’ priority access to Institution’s and Center’s facilities and services at minimal or reduced cost.

Equipment: A general listing of major, shared pieces of equipment to be used by Center members should be provided and the process including fee structure (if any) to access shared equipment.

Other Attachments: The following "Other Attachments" should be included with the Overall Component in order to aid in the review of applications. The filename provided for each attachment will be the name used for the bookmark in the application image. All attachments need to be in pdf format.

Project/Performance Site Location(s) (Overall)

Enter primary site only.

A summary of Project/Performance Sites in the Overall section of the assembled application image in eRA Commons compiled from data collected in the other components will be generated upon submission.

Research & Related Senior/Key Person Profile (Overall)

Include only the Project Director/Principal Investigator (PD/PI) and any multi-PDs/PIs (if applicable to this FOA) for the entire application.

The PD/PI (overall Center Director) must be a doctorally prepared nurse scientist currently employed at a school of nursing.

A summary of Senior/Key Persons followed by their Biographical Sketches in the Overall section of the assembled application image in eRA Commons will be generated upon submission.

Budget (Overall)

The only budget information included in the Overall component is the Estimated Project Funding section of the SF424 (R&R) Cover.

A budget summary in the Overall section of the assembled application image in eRA Commons compiled from detailed budget data collected in the other components will be generated upon submission.

PHS 398 Research Plan (Overall)

Specific Aims:   Describe the specific aims of the Center, overall.     

Research Strategy:  The application must:

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans (Data Sharing Plan, Sharing Model Organisms, and Genome Wide Association Studies (GWAS)) as provided in the SF424 (R&R) Application Guide, with the following modification:

All applications, regardless of the amount of direct costs requested for any one year, should address a Data Sharing Plan.

Appendix: Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.   

Administrative Core

When preparing your application in ASSIST, use Component Type ‘Admin Core.’

All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions, as noted.

SF424 (R&R) Cover (Administrative Core)

Complete only the following fields:

PHS 398 Cover Page Supplement (Administrative Core)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Administrative Core)

Human Subjects: Answer only the ‘Are Human Subjects Involved?’ and 'Is the Project Exempt from Federal regulations?’ questions.

Vertebrate Animals: Answer only the ‘Are Vertebrate Animals Used?’ question.

Project Narrative:  Do not complete.

Project /Performance Site Location(s) (Administrative Core)

List all performance sites that apply to the specific component.

Note: The Project Performance Site form allows up to 300 sites, prior to using additional attachment for additional entries.

Research & Related Senior/Key Person Profile (Administrative Core)

Budget (Administrative Core)

Budget forms appropriate for the specific component will be included in the application package.

The Administrative Core Director must contribute no less than 1.8 person months (15% time and effort) to the Core’s activities.

Note: The R&R Budget form included in many of the component types allows for up to 100 Senior/Key Persons in section A and 100 Equipment Items in section C prior to using attachments for additional entries. All other SF424 (R&R) instructions apply.

PHS 398 Research Plan (Administrative Core)

Specific Aims:   Describe the specific aims of the Administrative Core.     

Research Strategy:  The Administrative Core should manage the overall activities of the Center, including developing, promoting, and managing use of Center resources.

The Administrative Core must contain the following:

The Administrative Core is responsible:

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

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

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) is emphasized. This will allow for annual planned evaluation of goals attainment and subsequent medial 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 Pilot Projects, and the overall Center are 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.

The Evaluation Plan should include

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans (Data Sharing Plan, Sharing Model Organisms, and Genome Wide Association Studies (GWAS)) as provided in the SF424 (R&R) Application Guide, with the following modification:

Appendix: Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.   

Planned Enrollment Report  (Administrative Core)

When conducting clinical research, follow all instructions for completing Planned Enrollment Reports as described in the SF424 (R&R) Application Guide. 

PHS 398 Cumulative Inclusion Enrollment Report (Administrative Core)

When conducting clinical research, follow all instructions for completing Cumulative Inclusion Enrollment Report as described in the SF424 (R&R) Application Guide. 

Pilot Projects Core

When preparing your application in ASSIST, use Component Type ‘Core.’

Applications must propose a minimum of two Pilot Projects to be started during the first year.

All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions, as noted.

SF424 (R&R) Cover (Pilot Projects Core)

Complete only the following fields:

PHS 398 Cover Page Supplement (Pilot Projects Core)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Pilot Projects Core)

Human Subjects: Answer only the ‘Are Human Subjects Involved?’ and 'Is the Project Exempt from Federal regulations?’ questions.

Vertebrate Animals: Answer only the ‘Are Vertebrate Animals Used?’ question.

Project Narrative:  Do not complete.

Project /Performance Site Location(s) (Pilot Projects Core)

List all performance sites that apply to the specific component.

Note: The Project Performance Site form allows up to 300 sites, prior to using additional attachment for additional entries.

Research & Related Senior/Key Person Profile (Pilot Projects Core)

The Pilot Project Core Director must hold a doctorate from a research training program (e.g., PhD) and be a faculty member or senior investigator of equivalent rank at the applicant institution.

An eligible Pilot Project Investigator i includes:

The Center Director (PD/PI) and any of the Core Directors may not serve as a Pilot Project Investigator.

Budget (Pilot Projects Core)

Budget forms appropriate for the specific component will be included in the application package.

No one Pilot Project should constitute greater than one third of the dollars allocated for Core projects.

Two research projects are required to be completed in the first two years of the grant with new projects developed in subsequent years with a minimum of 1-2 projects ongoing each year and must be developed during the course of the award. They are intended to enable eligible investigators to explore a scientific topic on self-management, and to amass sufficient expertise and data to complete the study and develop an independent research track and applications (e.g., NIH R01).

Pilot Projects cannot be used to supplement already-funded research at the applicant organization.

Note: The R&R Budget form included in many of the component types allows for up to 100 Senior/Key Persons in section A and 100 Equipment Items in section C prior to using attachments for additional entries. All other SF424 (R&R) instructions apply.

PHS 398 Research Plan (Pilot Projects Core)

Specific Aims:   Describe the specific aims of the Pilot Project Core 

Research Strategy:  Applications must propose a minimum of two Pilot Projects to be started during the first year and that are determined acceptable by the reviewers. These two Pilot Projects must be undertaken and completed during the first two years of Center grant support.  Pilot projects should not be used to fund phase 3 clinical trials. New projects must be developed in subsequent years (with a minimum of 1-2 projects ongoing each year). 

Each Pilot Project must follow these guidelines:

The Research Strategy for this core should include a description of the process to select and review Pilot Projects. The Center review process may be carried out by the Advisory Committee, by an ad hoc Review Committee, by a mail review, or by a combination of these methods. It is recommended that the Center Director use at least two scientists with expertise relevant to the scientific area of inquiry of the Center from outside the institution during the review process.

Human Subjects and/or Vertebrate Animals: The center must include the internal institutional plans and procedures to ensure that all projects supported from this award will comply fully with all applicable Federal regulations, policies, and Guidelines, including those for research involving human subjects, including the evaluation of risks and protections in project proposals and appropriate ethical oversight of funded projects. Human Subject and Animal Subject approval dates for Pilot and Feasibility projects should NOT be submitted with the application, but should be provided to NINR for approval with Just in Time information, or prior to the start of the pilot project, and with annual progress reports. Otherwise indicate in the appropriate section that human subjects or vertebrate animals are not involved.

Pilot projects selected after the Center Grant is awarded require prior approval by NINR prior to initiation (see the NIH Grants Policy Statement 8.1.3 Requests for Prior Approval for instructions on submitting a request).

Common Data Elements: NINR encourages the use of common data elements (CDEs) in basic, clinical, and applied research, patient registries, and other human subject research to facilitate broader and more effective use of data and advance research across studies. CDEs are data elements that have been identified and defined for use in multiple data sets across different studies.  Use of CDEs can facilitate data sharing and standardization to improve data quality and enable data integration from multiple studies and sources, including electronic health records. 

NIH ICs have identified CDEs for many clinical domains (e.g., neurological disease), types of studies (e.g. genome-wide association studies (GWAS)), types of outcomes (e.g., patient-reported outcomes), and patient registries (e.g., the Global Rare Diseases Patient Registry and Data Repository).  NIH has established a “Common Data Element (CDE) Resource Portal" (http://cde.nih.gov/) to assist investigators in identifying NIH-supported CDEs when developing protocols, case report forms, and other instruments for data collection.  The Portal provides guidance about and access to NIH-supported CDE initiatives and other tools and resources for the appropriate use of CDEs and data standards in NIH-funded research. Investigators are encouraged to consult the Portal and describe in their applications any use they will make of NIH-supported CDEs in their projects. 

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans (Data Sharing Plan, Sharing Model Organisms, and Genome Wide Association Studies (GWAS)) as provided in the SF424 (R&R) Application Guide, with the following modification:

Appendix: Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.   

Planned Enrollment Report  (Pilot Projects Core)

When conducting clinical research, follow all instructions for completing Planned Enrollment Reports as described in the SF424 (R&R) Application Guide. 

PHS 398 Cumulative Inclusion Enrollment Report (Pilot Projects Core)

When conducting clinical research, follow all instructions for completing Cumulative Inclusion Enrollment Report as described in the SF424 (R&R) Application Guide. 

Cores - Other

When preparing your application in ASSIST, use Component Type ‘Core.’

Optional cores, including but not limited to a Design/Methodology/Statistics Core, or a Biobehavioral Tools Core, may be added to facilitate the achievement of goals and objectives. 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 research.

All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions, as noted.

SF424 (R&R) Cover (Cores - Other)

Complete only the following fields:

PHS 398 Cover Page Supplement (Cores - Other)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Cores - Other)

Human Subjects: Answer only the ‘Are Human Subjects Involved?’ and 'Is the Project Exempt from Federal regulations?’ questions.

Vertebrate Animals: Answer only the ‘Are Vertebrate Animals Used?’ question.

Project Narrative:  Do not complete.

Project /Performance Site Location(s) (Cores - Other)

List all performance sites that apply to the specific component.

Note: The Project Performance Site form allows up to 300 sites, prior to using additional attachment for additional entries.

Research & Related Senior/Key Person Profile (Cores - Other)

A Core Director must hold a doctorate from a research training program (e.g., PhD) and be a faculty member or senior investigator of equivalent rank at the applicant institution

Budget (Cores - Other)

Budget forms appropriate for the specific component will be included in the application package.

These items also need to be followed.

1. A Core Director must contribute no less than 1.8 person months (15% time and effort) to the Core’s activities.

2. 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.

3. No one core should constitute greater than one third of the dollars allocated for Core projects.

Note: The R&R Budget form included in many of the component types allows for up to 100 Senior/Key Persons in section A and 100 Equipment Items in section C prior to using attachments for additional entries. All other SF424 (R&R) instructions apply.

PHS 398 Research Plan (Cores - Other)

Specific Aims:  Describe the specific aims of the Core.           

Research Strategy:  The Research Strategy must include the following:

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans (Data Sharing Plan, Sharing Model Organisms, and Genome Wide Association Studies (GWAS)) as provided in the SF424 (R&R) Application Guide, with the following modification:

Appendix: Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.   

Planned Enrollment Report  (Cores - Other)

When conducting clinical research, follow all instructions for completing Planned Enrollment Reports as described in the SF424 (R&R) Application Guide. 

PHS 398 Cumulative Inclusion Enrollment Report (Cores - Other)

When conducting clinical research, follow all instructions for completing Cumulative Inclusion Enrollment Report as described in the SF424 (R&R) Application Guide. 

3. Submission Dates and Times

Part I. Overview Information contains information about Key Dates. Applicants are encouraged to submit applications before the due date to ensure they have time to make any application corrections that might be necessary for successful submission.

Organizations must submit applications to Grants.gov (the online portal to find and apply for grants across all Federal agencies) using ASSIST or other electronic submission systems. Applicants must then complete the submission process by tracking the status of the application in the eRA Commons, NIH’s electronic system for grants administration.

Applicants are responsible for viewing their application before the due date in the eRA Commons to ensure accurate and successful submission.

Information on the submission process and a definition of on-time submission are provided in the SF424 (R&R) Application Guide.

4. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

5. Funding Restrictions

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

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

6. Other Submission Requirements and Information

Applications must be submitted electronically following the instructions described in the SF424 (R&R) Application Guide.  Paper applications will not be accepted.

For information on how your application will be automatically assembled for review and funding consideration after submission go to: http://grants.nih.gov/grants/ElectronicReceipt/files/Electronic_Multi-project_Application_Image_Assembly.pdf.

Applicants must complete all required registrations before the application due date. Section III. Eligibility Information contains information about registration.

For assistance with your electronic application or for more information on the electronic submission process, visit Applying Electronically.

Important reminders:
All PD(s)/PI(s) and component Project Leads must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile Component of the SF424(R&R) Application Package. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to NIH.

The applicant organization must ensure that the DUNS number it provides on the application is the same number used in the organization’s profile in the eRA Commons and for the System for Award Management (SAM). Additional information may be found in the SF424 (R&R) Application Guide.

See more tips for avoiding common errors.

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

Post Submission Materials

Applicants are required to follow the instructions for post-submission materials, as described in NOT-OD-13-030.

Section V. Application Review Information

1. Criteria

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

Overall Impact - Overall

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

Scored Review Criteria - Overall

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

Significance

Does the Center address an important problem or a critical barrier to progress in the field? If the aims of the Center 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?   

Investigator(s)

Are the PD(s)/PI(s), collaborators, and other researchers well suited to the project? If Early Stage Investigators or New Investigators, or in the early stages of independent careers, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the Center is collaborative or multi-PD/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project? 

Does the Center Director or Core Director have the ability to provide scientific and administrative leadership and direction?  

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?

Will the Center make a unique contribution or fill a significant gap in the area of Self-Management research? Will the Center resources provide a unique contribution to the research infrastructure at the applicant organization?   

Approach

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the Center? 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 Center involves human subjects and/or NIH-defined clinical research, are the plans to address 1) the protection of human subjects from research risks, and 2) inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion or exclusion of children, justified in terms of the scientific goals and research strategy proposed?  

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 Pilot 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? Will the plans, as proposed, bring investigators into the Center from within and outside the institution?  

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?   

Does the Center have the technologies and capacity to foster interdisciplinary, state-of-the-art, and innovative research? Does the proposed Center have a sufficient base of NIH funded research directly relevant to Self-Management research? Does the Center take advantage of the capability of its research base to maximize scientific productivity, particularly through interdisciplinary coordination and collaboration?   

Review Criteria - Administrative Core

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

Significance

Does the Admin Core 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?

Investigator(s)

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?

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?

Innovation  

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

Approach

Is the 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 Center scientific growth and development over the Project period appropriate and adequately described? Are plans for sustainability and long-term management of the Center appropriate?

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 include an accounting of resources and resource utilization, as well as efforts taken to maximize the research utilization of these resources? Does the evaluation plan include plans for sustainability of the Center?

Environment

Is institutional commitment to the pursuit of Self-Management 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?

Review Criteria – Pilot Projects Core 

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

Significance

Does the Pilot Projects Core 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?

Investigators

Are the Core Director, collaborators, and other researchers well suited to the Pilot Projects Core? If Early Stage Investigators or New Investigators, or in the early stages of independent careers, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the project is collaborative or multi-lead, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project?

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?

Innovation

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

Approach

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the Pilot Projects Core? 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?

Is the 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 applicant organization? 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)?

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?

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

Review Criteria - Optional Cores

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

Significance

Does the Core 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?

Investigator(s)

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?

Innovation

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

Approach

Is the 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 applicant organization? 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)?

Environment

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

Additional Review Criteria - Overall

As applicable for the project proposed, reviewers will evaluate the following additional items while determining scientific and technical merit, and in providing an overall impact score, but will not give separate scores for these items.

Protections for Human Subjects

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

For research that involves human subjects and meets the criteria for one or more of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials. For additional information on review of the Human Subjects section, please refer to the Guidelines for the Review of Human Subjects.

Inclusion of Women, Minorities, and Children 

When the proposed project involves human subjects and/or NIH-defined clinical research, the committee will evaluate the proposed plans for the inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion (or exclusion) of children to determine if it is justified in terms of the scientific goals and research strategy proposed.  For additional information on review of the Inclusion section, please refer to the Guidelines for the Review of Inclusion in Clinical Research.

Vertebrate Animals

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

Biohazards

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

Resubmissions

Not Applicable

Renewals

Not Applicable

Revisions

Not Applicable

Additional Review Considerations - Overall

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

Applications from Foreign Organizations

Not Applicable

Select Agent Research

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

Resource Sharing Plans

Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable: 1) Data Sharing Plan; 2) Sharing Model Organisms; and 3) Genome Wide Association Studies (GWAS).

Budget and Period of Support

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

2. Review and Selection Process

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

As part of the scientific peer review, all applications:

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

Applications will be assigned to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications submitted in response to this FOA. Following initial peer review, recommended applications will receive a second level of review by the National Advisory Council for Nursing Research (NACNR). The following will be considered in making funding decisions:

3. Anticipated Announcement and Award Dates

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

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

Section VI. Award Administration Information

1. Award Notices

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

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

Awardees must comply with any funding restrictions described in Section IV.5. Funding Restrictions. Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs.      

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

Prior Approval of Pilot Projects

Awardee-selected projects that involve {clinical trials or studies involving greater than minimal risk to human subjects} require prior approval by NIH prior to initiation. 

2. Administrative and National Policy Requirements

All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General  and Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Grantees, and Activities. More information is provided at Award Conditions and Information for NIH Grants.

Cooperative Agreement Terms and Conditions of Award

Not Applicable

3. Reporting

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

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

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

Section VII. Agency Contacts

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

Application Submission Contacts

eRA Commons Help Desk (Questions regarding eRA Commons registration, submitting and tracking an application, documenting system problems that threaten submission by the due date, post submission issues)Telephone: 301-402-7469 or 866-504-9552 (Toll Free)

Web ticketing system: https://public.era.nih.gov/commonshelp
TTY: 301-451-5939
Email: commons@od.nih.gov

Grants.gov Customer Support (Questions regarding Grants.gov registration and submission, downloading forms and application packages)
Contact Center Telephone: 800-518-4726

Web ticketing system: https://grants-portal.psc.gov/ContactUs.aspx
Email: support@grants.gov

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

Scientific/Research Contact(s)

Donna Jo McCloskey, PhD
National Institute of Nursing Research (NINR)
Telephone: 301-594-5971
Email: mccloskd@mail.nih.gov

Peer Review Contact(s)

Yujing Liu, MD, PhD
National Institute of Nursing Research (NINR)
Telephone: 301-451-5152
Email: LiuYujin@mail.nih.gov

Financial/Grants Management Contact(s)

Judy Sint
National Institute of Nursing Research (NINR)
Telephone: 301-402-6959
Email: sintj@mail.nih.gov

Section VIII. Other Information

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

Authority and Regulations

Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and 45 CFR Parts 74 and 92.


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