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 Symptom Science: Building Research Teams for the Future (P20)

Activity Code

P20 Exploratory Grants

Announcement Type

Reissue of RFA-NR-09-001.

Related Notices

None

Funding Opportunity Announcement (FOA) Number

RFA-NR-12-009

Companion Funding Opportunity

RFA-NR-12-006, P30 Center Core Grants

Number of Applications

Only one application per institution (normally identified by having a unique DUNS number or NIH IPF number) is allowed Section III. 3. Additional Information on Eligibility.

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

93.361

Funding Opportunity Purpose

The National Institute of Nursing Research (NINR) invites applications to establish Centers of Excellence for Symptom Science: Building Research Teams for the Future (P20). This FOA supports applications to develop interdisciplinary biobehavioral nursing research capacity in Symptom Science Research.   

Key Dates
Posted Date

March 9, 2012

Letter of Intent Due Date

April 16, 2012

Application Due Date(s)

May 16, 2012

AIDS Application Due Date(s)

Not Applicable

Scientific Merit Review

June/July, 2012

Advisory Council Review

August, 2012

Earliest Start Date(s)

September, 2012

Expiration Date

May 17, 2012

Due Dates for E.O. 12372

Not Applicable

Required Application Instructions

It is critical that applicants follow the instructions in the PHS398 Application Guide except where instructed to do otherwise (in this FOA or in a Notice from the NIH Guide for Grants and Contracts). Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. While some links are provided, applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions. Applications that do not comply with these instructions may be delayed or not accepted for review.

Table of Contents

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

Part 2. Full Text of Announcement

Section I. Funding Opportunity Description

1. Research Objectives

The National Institute of Nursing Research (NINR) invites applications to establish Centers of Excellence for Symptom Science Research: Building Research Teams for the Future (P20).The purpose of the proposed grant program is to plan and develop the sustainability of and to enhance interdisciplinary, biobehavioral research for scientists conducting Symptom Science Research by enabling development of 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 Symptom Science research;

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

(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.

Chronic diseases and their symptoms account for 70% of all deaths in the U.S., which is 1.7 million each year. These diseases also cause major limitations in daily living for almost 1 out of 10 Americans or about 25 million people. Symptom management is an urgent public health concern. Each year chronic pain alone affects over 116 million Americans and accounts for $650 billion in health care costs and lost productivity (IOM report, June 2011). Fifty to 70 million Americans chronically suffer from sleep difficulties, hindering daily functioning and adversely affecting health and longevity (Report Brief: Sleep Disorders and Sleep Deprivation: An Unmet Public Health Problem, 2006, April National Academy of Sciences). Depressive symptomatology and depression significantly affect approximately 7 - 25 percent of the US population and are associated with increased medical illness, higher rates of comorbid conditions such as obesity and cardiovascular disease, and increased mortality.

Symptoms are the result of a complex interaction of biological, cognitive, behavioral, sociocultural, spiritual, and environmental factors. The responses to symptom treatment and management are equally complex. Managing recurring or chronic symptoms is often challenging as symptoms rarely remain static. Some patients may experience isolated symptoms (e.g., headache pain); however, many conditions result in characteristic symptom clusters (e.g., pain, sleep difficulties, and mood changes). Symptom management research seeks to identify and test interventions that will reduce the burden of symptoms on affected persons and improve their quality of life.

Begun in 2004 as part of the NIH Roadmap for Medical Research, the PROMIS (Patient-Reported Outcomes Measurement Information System) initiative is developing new ways to measure symptoms or patient-reported outcomes (PROs), such as pain, fatigue, physical functioning, emotional distress, and social role participation that have a major impact on quality of life across a variety of chronic diseases (http://nihroadmap.nih.gov/clinicalresearch/overview-dynamicoutcomes.asp). In addition, it is developing a web-based system to give clinical researchers access to the item banks and the computer adaptive testing (CAT) system.

NINR seeks to support research that will leverage the successes of initiatives like PROMIS to:

1. Delineate causative mechanisms underlying symptoms.

2. Improve recognition of symptoms by patients, their caregivers, and health care providers.

3. Develop technologies and interventions that improve patient response and adaptation to symptoms and symptom clusters in discrete and co-morbid conditions.

4. Design strategies to improve management of symptoms over disease trajectories, including the transition from acute to chronic illness and periods of long-term survivorship of formerly life-threatening illnesses.

5. Develop strategies for assessment and intervention to improve health-related quality of life in persons with chronic or life-threatening illnesses.

This call for Center applications focuses on the most frequently reported symptoms already being studied by PROMIS:

1. pain,

2. sleep disturbances,

3. fatigue, and

4. cognitive/affect changes, as well as their interactions.

Applicants must select one of these symptoms and build their Center application around this symptom, the organizing central theme of the application, so as to develop strong expertise in this research domain and move the field of science forward significantly.

NINR Centers

NINR currently supports a number of Exploratory/Developmental Center (P20s) and Centers of Excellence (P30s) grants. The purpose of an NINR P20 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 symptom 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).

The Public Health Service (PHS) is committed to achieving the symptom management and health promotion and disease prevention objectives of "Healthy People 2020," a PHS-led national activity for setting priority areas. This FOA is related to one or more of the priority areas. Potential applicants may obtain a copy of "Healthy People 2020" at http://www.health.gov/healthypeople/.

Interdisciplinary and biobehavioral approaches to improve understanding of symptom science is needed. Attention to health disparities in symptom management is encouraged. Applicant organizations should submit nursing research proposals in areas specific to the Symptom Science 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 but is not limited to the following examples of Symptom Science areas of scientific opportunity at NINR:

1. Improves knowledge of biological and genomic mechanisms associated with symptoms and symptom clusters

2. Designs interventions to improve the assessment and management of symptoms over disease trajectories, including the transition from acute to chronic illness

3. Studies the multiple factors that influence the management of symptoms and applies this knowledge to the design of personalized interventions

4. Develops strategies to improve self-management of chronic illness across the lifespan, particularly in the context of comorbidities

5. Develops strategies to assist individuals and their caregivers in managing chronic illness, including analyses of caregiver burden and cost-effectiveness

Section II. Award Information
Funding Instrument

Grant

Application Types Allowed

New
Renewal

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

Funds Available and Anticipated Number of Awards

It is anticipated that $2.1 million will be available to support scientifically meritorious applications responding to this P20 and the companion P30 FOA constituting the FY2012 NINR Centers initiative.

Award Budget

It is anticipated that support will be provided for up to 2-3 new P20 Centers for Building the Research Teams of the Future. Support may be requested for up to 5 years, not to exceed $300,000 total costs (direct plus F&A costs) per year.

Award Project Period

Scope of the proposed project should determine the project period. The maximum period is 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

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

Required Registrations

Applicant organizations must complete the following registrations as described in the PHS398 Application Guide to be eligible to apply for or receive an award. Applicants must have a valid Dun and Bradstreet Universal Numbering System (DUNS) number in order to begin each of the following registrations.

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

All registrations must be completed by the application due date. Applicant organizations are strongly encouraged to start the registration process at least4-6 weeks prior to the application due date.

Eligible Individuals (Program Director(s)/Principal Investigator(s))

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 PD(s)/PI(s), visit the Multiple Program Director(s)/Principal Investigator(s) Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the PHS398 Application Guide.     

2. Cost Sharing

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

3. Additional Information on Eligibility

Number of Applications

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

NIH will not accept any application in response to this FOA that is essentially the same as one currently pending initial peer review unless the applicant withdraws the pending application. NIH will not accept any application that is essentially the same as one already reviewed.

Applicant organizations with current P30 or P20 Centers awarded from NINR are eligible to apply under 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 Symptom Science.

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. Applicants from schools of nursing that are partnered with CTSAs are encouraged to apply.

Section IV. Application and Submission Information

1. Address to Request Application Package

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

2. Content and Form of Application Submission

It is critical that applicants follow the instructions in the PHS398 Application Guide, except where instructed in this funding opportunity announcement to do otherwise. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.

Letter of Intent

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

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


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

Application Submission

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

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

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

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

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

Research Plan

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

General Submission Requirements:

REQUIRED COMPONENTS OF THE APPLICATION: The Centers of Excellence in Symptom Science Research (P20) must include the following 3 components:

Administrative Core (Center PD(s)/PI(s ) should be the Administrative Core Director and contribute no less than 1.5 person months time and effort to this core’s activities).

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.

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. Each Core should be directed by an investigator/faculty with substantial expertise in the topic. 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 Symptom Science 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 applicant organization, including both Program Director(s)/Principal Investigator(s)within the Center, as well as investigators in the larger research community affiliated with the applicant organization. Likewise, proposed Program Director(s)/Principal Investigator(s) must describe how they plan to utilize each Center Core. In the application, the description of each Core is limited to six (6) pages.

ADMINISTRATIVE CORE (MANDATORY), 6 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, DSMB/DSMP and IACUC approvals) compliance is also the responsibility of the Administrative Core.  The application should include a description of the organization and structure of the Center and illustrate all components in an organizational chart.

The Administrative Core must contain:

1. The applicant Program Director(s)/Principal Investigator(s) identified as the Administrative Core Director (committed to no less than 1.5 person months 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 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.

RESEARCH PROJECTS (Three (3) MANDATORY), 6 PAGE LIMIT PER PROJECT WITHIN THE CENTER:

The Center application must include at minimum 3 research projects that will be undertaken during the period of Center support. All projects must come in with the application. Each research Project should be 2 to 3 years in duration and should include:

1. Specified Project Director

2. Title and Abstract (not the PHS 398 face page)

3. Specific Aims

4. Research Plan

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 four (4) Projects. They are intended to enable eligible investigators to explore a scientific topic on Symptom Science, 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 cannot 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 PD(s)/PI(s) and collaborators include:

1. The PD(s)/PI(s) is an investigator who has not been a PD(s)/PI(s) in the past, or who is not currently funded by a DHHS research Project grant (i.e., R01, R03, R15 or R21); or

2. Established investigators who wish to develop skill and expertise in conducting Symptom science 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 PD(s)/PI(s) . Evidence that this Project represents a new research career path that will be sustained by the PD(s)/PI(s) 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, DSMB or DSMP,

 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 explained, as well as a brief statement of fit within the Center as a whole. Each Project is limited to a total of 6 pages  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 Symptom Management topic, and how the Project will utilize and interact with Center Core resources.

EVALUATION PLAN (MANDATORY), 12 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 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).

ADDITIONAL CORES (OPTIONAL), 6 PAGE LIMIT PER CORE:

Additional Cores may be proposed to support and enhance the activities of the Center, including but not limited to Design/Methodology/Statistics Core, or a Biobehavioral Tools Core, may be added to 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 Symptom Management 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 applicant organization, 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 1.2 person months 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 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.

Institutional Commitment

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.

Resource Sharing Plan

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

Appendix

Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix (please note all format requirements) as described in the PHS398 Application Guide, with the following modifications:

3. Submission Dates and Times

Part I. Overview Information contains information about Key Dates. 

Information on the process of receipt and determining if your application is considered “on-time” is described in detail in the PHS398 Application Guide.

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

4. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

5. Funding Restrictions

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

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

6. Other Submission Requirements and Information

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

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

Post Submission Materials

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

Section V. Application Review Information

1. Criteria

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

Overall Impact - Overall Center Application

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

Scored Review Criteria - Overall Center Application

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

Significance

Does the project address an important problem or a critical barrier to progress in the field? If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?

Investigator(s)

Are the PD(s)/PI(s), collaborators, and other researchers well suited to the project? If Early Stage Investigators or New Investigators, or in the early stages of independent careers, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the project is collaborative or multi-PD(s)/PI(s), 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 leader have the ability to provide scientific and administrative leadership and direction? Does the application indicate that the Center Director has the authority to appoint new members to the Center and discontinue membership status, when appropriate?  Is the Co-Director qualified to serve in the absence of the Director?  

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 Symptom Science 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 project? Are potential problems, alternative strategies, and benchmarks for success presented? If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed? 

If the project involves clinical research, are the plans for 1) protection of human subjects from research risks, and 2) inclusion of minorities and members of both sexes/genders, as well as the inclusion of children, justified in terms of the scientific goals and research strategy proposed?

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?   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 symptom science ? 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

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?

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 Symptom Science 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 – Individual RESEARCH PROJECTS: 

Significance: Does the project address an important problem or a critical barrier to progress in the field? If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?

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

Approach: Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Are potential problems, alternative strategies, and benchmarks for success presented? If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed? 

If the project involves clinical research, are the plans for 1) protection of human subjects from research risks, and 2) inclusion of minorities and members of both sexes/genders, as well as the inclusion of children, justified in terms of the scientific goals and research strategy proposed?

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?

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?

Review Criteria - EVALUATION PLAN

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 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?

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?

Review Criteria - Each Additional OPTIONAL CORE

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)?

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 Symptom Science research, including provision of resources and recognition, convincing?

Additional Review Criteria

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

Protections for Human Subjects

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

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

Inclusion of Women, Minorities, and Children 

When the proposed project involves clinical research, the committee will evaluate the proposed plans for inclusion of minorities and members of both genders, as well as the inclusion of children. For additional information on review of the Inclusion section, please refer to the Human Subjects Protection and Inclusion Guidelines.

Vertebrate Animals

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

Biohazards

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

Resubmissions

Not Applicable

Renewals

For Renewals, the committee will consider the progress made in the last funding period

Revisions

Not Applicable

Additional Review Considerations

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

Applications from Foreign Organizations

Not Applicable

Select Agent Research

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

Resource Sharing Plans

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

Budget and Period of Support

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

2. Review and Selection Process

Applications will be evaluated for scientific and technical merit by (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. Review assignments will be shown in the eRA Commons.


As part of the scientific peer review, all applications:

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

Applications will be assigned to the appropriate NIH Institute or Center and will compete for available funds with all other recommended applications submitted in response to this FOA. Following initial peer review, recommended applications will receive a second level of review by the National Advisory Council for Nursing Research. 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(s)/PI(s) 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, CCR Registration, and Transparency Act requirements as noted on the Award Conditions and Information for NIH Grants website.

2. Administrative and National Policy Requirements

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

Cooperative Agreement Terms and Conditions of Award

Not Applicable.

3. Reporting

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

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

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

Section VII. Agency Contacts

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

Application Submission Contacts

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

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

Scientific/Research Contact(s)

Scientific Contact:

Susan Marden, PhD, Program Director, Office of Extramural Programs
National Institute of Nursing Research (NINR)
Telephone: (301) 496-9623
Email: mardens@mail.nih.gov

Centers Contact:

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

Peer Review Contact(s)

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

Financial/Grants Management Contact(s)

Judy Sint, Grants Management Specialist, Office of Grants Management
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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