Participating Organization(s)	National Institutes of Health (NIH)
Components of Participating Organizations	National Institute of Nursing Research (NINR)
Funding Opportunity Title	Limited Competition: Palliative Care Research Co-Operative (PCRC) (U24)
Activity Code	U24 Resource-Related Research Projects Cooperative Agreements
Announcement Type	None
Related Notices	April 07, 2017 - This RFA has been reissued as RFA-NR-17-001. August 11, 2016 - Notice of Intent to Publish a Funding Opportunity Announcement for The Palliative Care Research Co-Operative (PCRC) (U24). See Notice NOT-NR-16-004.
Funding Opportunity Announcement (FOA) Number	RFA-NR-13-004
Companion Funding Opportunity	Not Applicable
Number of Applications	See Section III. 3. Additional Information on Eligibility.
Catalog of Federal Domestic Assistance (CFDA) Number(s)	93.361
Funding Opportunity Purpose	The purpose of this Funding Opportunity Announcement (FOA), issued by the National Institute of Nursing Research (NINR), is to continue support for the research and resource activities of the Palliative Care Research Cooperative (PCRC); and facilitate cutting edge palliative care and end of life (PCEOL) research studies that need to be conducted quickly, with larger samples and multiple sites.

Posted Date	November 21, 2012
Letter of Intent Due Date(s)	December 23, 2012
Application Due Date(s)	January 23, 2013
AIDS Application Due Date(s)	Not Applicable
Scientific Merit Review	February/March 2013
Advisory Council Review	May, 2013
Earliest Start Date	July, 2013
Expiration Date	January 24, 2013
Due Dates for E.O. 12372	Not Applicable

Required Application Instructions

It is critical that applicants follow the instructions in the PHS 398 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.

Looking ahead: NIH is committed to transitioning all grant programs to electronic submission using the SF424 Research and Related (R&R) format and is currently investigating solutions that will accommodate NIH’s multi-project programs. NIH will announce plans to transition the remaining programs in the NIH Guide to Grants and Contracts and on NIH’s Applying Electronically website.

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

The purpose of this Funding Opportunity Announcement (FOA) Limited Competition, issued by the National Institute of Nursing Research (NINR), is to continue support for the research and resource activities of the Palliative Care Research Cooperative (PCRC), to facilitate cutting edge studies that need to be conducted quickly and with larger samples and multiple sites, and to quantify and better understand the risks, issues, and impact of Life Limiting Diseases (LLDs) on patient and caregiver health outcomes.

This limited competition solicitation is open to the PCRC and its member institutions constituting the current PCRC cooperative group funded by NINR UC4NR012584. The aims of the original UC4 included formulating, developing, and implementing a successful and functional co-operative group; laying the foundations for and conducting a proof of concept clinical trial; and developing metrics of success. The infrastructure and research capacity to create and build for the first time, a functioning Cooperative Group around, a specific scientific area (Palliative and End of Life care research) were accomplished during the first three years of this endeavor through a UC4 cooperative Agreement.

This FOA proposes to refine the role of the PCRC as a broader resource for researchers, both junior and senior, who are a part of the PCRC and its member institutions, to maintain its cooperative group structure, and to support the development of specific research areas of growth in understudied areas in palliative care end of life (PCEOL) science that the PCRC will develop expertise in.

The PCRC is a unique PCEOL research nexus that will provide:

• Access to integrated clinical, bio-behavioral, epidemiologic, and comparative effectiveness research studies and clinical trials; and
• Collaborations with and access to the unique expertise of PCRC researchers in the conduct of PCEOL research at multiple sites and among large and diverse study populations not found elsewhere.

The goal of this new phase is to rapidly increase the capacity of the cooperative group to develop and conduct greater numbers and enhance the scope of, high quality research studies that are responsive to key gaps in knowledge in PCEOL science. By addressing the objectives of this FOA, the PCRC is expected to develop areas of specific scientific growth through the creation and implementation of new administrative/training centers and research cores that include the following:

• Project Coordinating Center
• Junior Investigators Training Center
• Data and Statistics Center
• Methodology, Measures, Metrics and Patient Outcomes Core
• Caregiver Research Core
• Intervention, Clinical Trials and Biobehavioral Core

Through this limited competition U24, the PCRC will (a) Maintain the cooperative group created under the UC4; and (b) Develop specific areas of growth in understudied scientific areas in palliative and end of life care science, in particular relating to:

(1) Caregiver Research and

(2) Lifespan and Development Stages and their impact on patients and caregiver outcomes such as symptoms, bio-behavioral basis of health outcomes, Quality of life, and burden of illness.

Areas that PCRC applicants may choose to focus on include, but are not limited to, the examples listed and those in following sections. It is the responsibility of the applicants to determine and justify an optimal mix of scientific areas that will accomplish and fit with the overarching goals of the PCRC.

For the past 50 years, the NIH Cooperative Group Program has played a key role in testing cancer therapies through large-scale, multicenter trials yielding groundbreaking therapies and scientific breakthroughs that are now routinely incorporated as standards of care. Building on the framework of the cooperative group program, the goal for the 2010 to 2013 NINR funded PCRC was to take on the challenge of providing similar scientific advances in the critical scientific areas of palliative care and end of life (PCEOL). The original PCRC led to important capacity building and infrastructure creation, and the new PCRC U24 will need to demonstrate its ability to define and meet critical success metrics in PCEOL.

The PCRC, originally supported by funds provided to the NIH under the American Recovery & Reinvestment Act of 2009, Public Law 111-5, in response to the NIH Director’s Opportunity for Research in Five Thematic Areas (RC4) intended to address research that would have high short-term impact, and a high likelihood of enabling growth and investment in biomedical research and development, public health, and health care delivery. The RC4 was converted to a cooperative agreement (UC4)(2010 2013).

The PCRC’s mission was to develop scientifically-based methods leading to meaningful evidence for decreasing the suffering of patients with advanced and/or potentially life-limiting illnesses, and their caregivers including family members and providers of care. By collaborating with targeted community sites, the PCRC was designed to increase interdisciplinary collaboration, develop a uniform research infrastructure including standardized data collection and management processes, increase research capacity and dissemination of research information to the community. As a comprehensive, multicenter resource, the PCRC developed structures and processes to enable and support PCEOL research more rapidly and with large samples at multi-sites across the United States (North Caroline, Colorado, New York, Illinois, Minnesota, Alabama, and California). In its first 2 years, the PCRC has developed a uniform research infrastructure, including standardized data collection and management processes, and interdisciplinary collaboration. These achievements led to the initiation of a proof of concept clinical trial to evaluate the impact of discontinuation of statins in people nearing the end-of-life. This pilot study commenced in July 2011 and all 11 member sites are participating.

The overarching goals of this limited competition (U24) are to maintain its existing cooperative group infrastructure and to expand its research trajectory to better quantify and understand the impact of Life Limiting Diseases (LLDs) and their treatments on the health, quality of life, and end of life trajectory of patients and caregivers. Important research objectives include:

• Examination of behavioral, comorbid, and sociodemographic factors and their relationship to health outcomes for patients and their caregivers with advanced or LLDs
• Examination of risk factors predictive of negative outcomes among patients with advanced or LLDs and their caregivers
• Development and testing of interventions that mitigate or address poor or negative physical, medical, or psychosocial health outcomes
• Development of models of care that will lead to optimal care strategies for those with LLDs interest.
• Integration of individuals in need of PCEOL care into large-scale clinical trials
• Overcome barriers to research in palliative care using the palliative care cooperative group model and infrastructure
• Conduct large-scale, multi-institutional trials to advance PCEOL research
• Investigators from PCRC sites should be able to propose PCEOL studies that use the PCRC for methodologic resources, patient access/ recruitment, multiple sites , and the expertise of PCRC investigators not found anywhere else;
• Promote and facilitate the use of the PCRC resource by non-PCRC investigators.

Multidisciplinary research conducted by the PCRC will enhance the knowledge base regarding gaps and needs in palliative care and end of life research, and will increase our understanding of strategies to prevent, detect early, or treat adverse outcomes of serious life limiting diseases or their treatments. This research also will decrease the burden of illness associated with life limiting diseases and morbidity. Results and the success of the various strategies will lay the groundwork for definitive studies in models of care or bio-behavioral interventions that will detect early patients, caregivers, families, or providers who are at a greater risk for negative health outcomes. The impact on morbidity among patients dealing with life limiting diseases is an important consideration. Morbidity and mortality among their caregivers are important. For example, caregivers may be in good health and an important goal will be to prevent decrements in their health and longevity.

The following dimensions of characteristics or research domains will be of particular importance to meet the aforementioned objectives and will need to be explored and tested within the PCRC U24:

• Symptom management
• Quality of life for patients and their caregivers
• Decision making for patients and their caregivers
• Outcomes of clinical trials and interventions that focus on mitigating adverse outcomes among patients and caregivers

The U24 will enable the current PCRC to further mature as a cooperative group and demonstrate the following key values: (a) innovative, successful, productive, and sustainable research cooperative; (b) collaborations between experienced and new investigators; (c) teams of multidisciplinary investigators; (d) studies that are high-impact and clinically relevant; and (e) recruitment of new investigators and expertise into the palliative and end of life care research community. Studies proposed for the U24 will be integrated and the relevant administrative/ training centers and research cores that will be established will support the mission of the PCRC U24. By providing resources to the PCRC through this FOA, NINR will facilitate the creation of a system that has moved beyond cooperation to integration by streamlining its critical research and clinical trial structures and operations into a unique and sustainable network

Applicants responding to this FOA must thoroughly and comprehensively address the current main objective of the PCRC U24 program, which is to elevate and enhance the role of the PCRC as a resource for collaborative-patient oriented PCEOL research. It is expected that by the end of the proposed PCRC funding period investigators involved in PCRC-sponsored projects will have submitted a competing application for other funding (based on the data gathered through either grants in which the PCRC is incorporated into the design and conduct of the proposed study or other PCRC related projects).

The PCRC U24 is expected to function as a resource to the PCEOL community mainly through the following activities:

• Maintaining accessibility to relevant data for patient populations served by the collaborating PCRC institutions;
• Facilitating and coordinating access to these data for research conducted by PCRC-affiliated and non-affiliated investigators using approaches and solutions that can increase resource usage and are conducive to collaborative efforts;
• Maintaining high level of expertise and competency in scientific areas relevant to PCRC and of potential interest to non-PCRC-affiliated users of the resource;
• Sharing scientific expertise with other (non-PCRC-affiliated) PCEOL researchers with the goal to facilitate interactions and research collaborations among PCEOL researchers who might benefit from these data;
• Increasing participation of PCRC investigators in independently funded research relevant to their areas of expertise, including efforts to increase the number, scope, and scientific impact of research projects conducted by external investigators in collaboration with the PCRC;
• Conducting projects that incorporate the PCRC into the study design and implementation and where the PCRC is essential to the conduct and completion of the study; and may also include small projects based on pilot seed moneys provided to junior investigators through the junior investigator training center. These resources will allow PCRC investigators to develop competing applications for large-scale research projects or nurture and support junior investigator training.

Broad areas that PCRC applicants may choose to focus on relating to palliative or end of life care research include, but are not limited to:

• Identify high risk populations suffering from (as patients) or affected by (as caregivers) the impact of LLDs;
• Examine the outcomes and issues of LLDs among patients, caregivers, and providers;
• Study the latent impact and effects of LLDs and their treatment on patients and caregivers
• Quantify the magnitude of the risk for potential negative health, QOL, or treatment / provider outcomes among those diagnosed and living with LLD's;
• Develop data to guide the development of risk-based prevention (e.g., diabetes or heart disease in an individual with metastatic breast cancer), management (e.g., chronic conditions for those undergoing cancer treatment and post care), or screening guidelines (e.g., acute or chronic conditions not related to the original life limiting disease);
• Develop screening guidelines to identify patients at risk and administer timely and effective interventions to prevent, detect early, or manage negative outcomes;
• Conceptualize, develop and test interventions to prevent or minimize negative health, QOL, treatment, provider, and system related or other outcomes;
• Examine the bio-behavioral basis underlying negative outcomes among patients and / or caregivers and develop bio-behavioral interventions to mitigate the negative impact;
• Identify dimensions of optimal quality of care for patients with LLD's and or their caregivers and test various care strategies;
• Examine the impact of the interaction between LLDs and other complex comorbid conditions.

The PCRC research resource will be governed by the PCRC Steering Committee. The Steering Committee will also be responsible for overall scientific oversight of the PCRC research resource. A Steering Committee will form a subcommittee of experts (Scientific Consulting Panel) as advisors to the PCRC. Details on the composition and functions of the PCRC Steering Committee and the Scientific Consulting Panel are provided in Section VI.2.A. Cooperative Agreement Terms and Conditions of Award.

Funding Instrument	Cooperative Agreement: A support mechanism used when there will be substantial Federal scientific or programmatic involvement. Substantial involvement means that, after award, NIH staff will assist, guide, coordinate, or participate in project activities.
Application Types Allowed	New The OER Glossary and the PHS 398 Application Guide provide details on these application types.
Funds Available and Anticipated Number of Awards	NINR intends to commit $2,000,000 in FY 2013.
Award Budget	Application budgets are limited to $2,000,000 in total costs per year.
Award Project Period	The Scope of the proposed project should determine the project period. The maximum period for a U24 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.

Only current recipients of the UC4 PCRC award are eligible to apply. Consortium members (affiliated under subcontractual arrangements) are generally expected to be Domestic institutions, although Canadian institutions are also eligible as application components. Other Foreign (non-U.S. and non-Canadian) Institutions are NOT allowed to participate on the application submitted in response to this FOA.

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.

Applicant organizations must complete the following registrations as described in the PHS 398 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.

• System for Award Management (SAM) must maintain an active entity registration (formerly CCR registration), to be renewed at least annually. Use the Sam.gov Manage Entity function to manage your entity registrations. See the Grants Registration User Guide at SAM.gov for additional information.
• eRA Commons

All Program Directors/Principal Investigators (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 least 6 weeks prior to the application due date.

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 PHS 398 Application Guide.

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

Applicant organizations may submit more than one application, provided that each application is scientifically distinct.

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:

• To an RFA of an application that was submitted previously as an investigator-initiated application but not paid;
• Of an investigator-initiated application that was originally submitted to an RFA but not paid; or
• Of an application with a changed grant activity code.

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

It is critical that applicants follow the instructions in the PHS 398 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.

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

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

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

The letter of intent should be sent to:

Yujing Liu, PhD
Chief, Office of Review
National Institute of Nursing Research (NINR/NIH)
6701 Democracy Blvd. Suite 710
Bethesda, MD 20892
Telephone: (301) 451-5152
FAX: 301-480-8260
Email: Yujing_liu@nih.gov

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:

Yujing Liu, PhD
Chief, Office of Review
National Institute of Nursing Research (NINR/NIH)
6701 Democracy Blvd. Suite 710
Bethesda, MD 20892
Telephone: (301) 451-5152
FAX: 301-480-8260
Email: Yujing_liu@nih.gov

All page limitations described in the PHS 398 Application Guide and the Table of Page Limits must be followed, with the following exceptions or additional requirements:

• Overall Research Strategy section, including tables, graphs, figures, diagrams, and charts is limited to 12 pages
• Project Coordinating Center Research Strategy section is limited to 12 pages
• Junior Investigator Training Center Research Strategy section is limited to 12 pages
• Data and Statistics Center Research Strategy section is limited to 12 pages
• Methodology, Measures and Metrics, and Patient Outcomes Core Research Strategy section is limited to 12 pages
• Caregiver Research Core Research Strategy section is limited to 12 pages
• Interventions, Clinical Trials and Bio-Behavioral Core is limited to 12 pages
• Leadership and Administrative Structure is limited to 6 pages

Key/Senior Personnel. A designated contact PD/PI is required. A substitute PD/PI candidate should be identified to assure continuity in the event of resignation of the PD/PI. The qualifications and experience of both persons must be described, specifically documenting their respective abilities to organize and manage the PCRC and related activities. Data and Statistics Center: The Data and Statistics Center must be coordinated by a lead biostatistician.

The qualifications, experience, and proposed duties of all proposed support personnel should be described.

All instructions in the PHS 398 Application Guide must be followed, with the following additional instructions:

Introduction to Resubmission

As the work relating to this PCRC will be related to work performed in prior studies, summarize the primary accomplishments of the PCRC and include establishment, maintenance and enhancement of the resource; contributions to peer-reviewed literature; and a resource for investigator-initiated research support by external grants.

Relevant past performance should be addressed by the applicant for the overall consortium and as relevant to each core.

Specific Aims

Applicants responding to this FOA must thoroughly and comprehensively address the current main objective of the PCRC U24 program, which is to elevate and enhance the role of the PCRC as a resource for collaborative-patient oriented PCEOL research. The PCRC U24 is expected to assemble (or continue) a consortium of collaborating institutions and researchers with appropriate expertise and interest in palliative care and end-of-life (PCEOL) research who can provide access to the necessary patient populations, demographics, and investigator expertise in PCEOL research. Specific Aims should address these goals and should specifically include:

• Completion of expanded methods and samples and merger of U24 with initial UC4 and maintenance of both;
• Timely conception, implementation and conduct of intervention studies;
• Development of strategies by organ system;
• Development and conduct of hypothesis-testing molecular genetic studies;
• Identification and collaboration with other groups internationally;
• Successful training/mentorship.

Research Strategy

As part of this section, for the PCRC as a whole, the applicant should address the following:

Infrastructure Design and Methods

• Overview
• A description of the initial samples (and expanded) should include a breakdown by percentage of gender and racial/ethnic subpopulations.
• PCRC organizational structure and supporting facilities including the current and/or planned organizational structure under which the PCRC proposes to operate. An organizational chart showing how the group will function must also be included. The availability of facilities must be described.
• Ongoing surveillance of the Initial Study including validation and quality control;
• Update on expansion studies of PCRC including identification and recruitment of study subjects and expanded sibling population. A description of the merger of the X Studies (UC4 and U24) and plans for maintaining the merged cohort should be included in the application.
• Update on Collection, Processing and Storage of Biological Specimens including quality control and sample management procedures.
• Include approaches to communication, education and maintaining contacts with the study participants.
• Include a description of biostatistics and database management including quality control
• Include a description of public access to PCRC Resource.
• The application should describe the PCRC group's plan for methodological research aimed at developing, testing, and validating new methods and approaches to improve the proposed cohort infrastructure.
• The application should include a broad research agenda that the cohort will be designed to support in the short, medium and long range. The application should also include experience with intervention studies and future plans for timely conception, implementation and conduct of additional intervention studies.
• The application should include a strategy of approaching late effects by organ system.
• The application should address approaches to increase the visibility of the findings of PCRC in other Oncology Group statements
• The application should provide a description of how PCRC impacts the training of young investigators and role of PCRC investigators in mentoring them for future involvement in the area of palliative care and end of life science.

Research Program: Methodologic research (if applicable) and Broad Research agenda.

Studies and Samples Overview

Describe the PCRC's Accomplishments relative to mortality, morbidity and quality of life of long-term survivors of cancer, STATIN TRIAL PARTICIPANTS, ETC with illustrative examples. Describe the need for the PCRC resource, justification for recent expansion, OTHER cohort and significance of PCRC.

Background and Experience. Describe the group's history and experience in designing and implementing the PCRC. The application should describe the scientific rationale underpinning the need for the cohort.

Multiple PD/PI Leadership Plan

As part of this section, for the PCRC as a whole, the applicant should address the following:

Leadership and Administrative Structure. Applicants are strongly encouraged to take advantage of the multiple PD/PI option and designate a lead PD/PI and a second PD/PI, who would share the responsibilities but would also be capable of leading the entire PCRC (e.g., in case the lead PD/PI is unable to continue serving in this role). PD/PI(s) are expected to work closely with, or be members of, the Steering Committee as a governing body for the PCRC U24 (for details see Terms and Conditions of Cooperative Agreement). If the multiple PD/PI option is not used, an appropriate qualified individual from the key personnel must be identified as a potential PD/PI substitute.

In addition, the application should describe the strategy used by the PD/PI and Institutional official to delegate leadership responsibility and how the responsibility is delegated among key/senior individuals.

Specific Aims

All instructions in the PHS 398 Application Guide must be followed.

Research Strategy

Applications should describe how the Project Coordinating Center will provide overall administrative and organizational infrastructure for the entire U24. The Project Coordinating Center is expected to function as a central office, located at the lead Program Director(s)/Principal Investigator(s)' institution. It must provide: data management, finance and regulatory staff and other administrative staff, as needed.

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 PHS 398 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.

Specific Aims

All instructions in the PHS 398 Application Guide must be followed.

Research Strategy

Applications should describe how the Junior Investigator Training Center will provide educational opportunities and facilitate the mentoring of junior investigators with the goal of transitioning them to become independent researchers in PCEOL.

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 PHS 398 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.

Specific Aims

All instructions in the PHS 398 Application Guide must be followed.

Research Strategy

Applications should describe how the Data and Statistics Center will ensure accuracy in collection and management of the data in the PCRC U24. This will be done in collaboration with the Project Coordinating Center. The Data and Statistics Center will also provide biostatistical support to the majority of data-analysis projects and review all research proposals.

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 PHS 398 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.

Specific Aims

All instructions in the PHS 398 Application Guide must be followed.

Research Strategy

Applications should describe how the Methodology, Measures and Metrics, and Patient Outcomes Core will oversee all proposed methodologies and metrics, including:

• develop and test the key patient reported outcomes needed by the PCRC and recommend a core set of outcomes to standardize the field
• assess and refine key patient and caregiver research needs and outcomes and related methodologies to address gaps in knowledge and health disparities based on ethnocultural diversity and /or medically underserved status
• develop, test, and refine Quality of life (QOL) and other key patient reported outcomes (QOL is a critical issue without which comparative effectiveness and cost effectiveness analyses cannot be conducted)

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 PHS 398 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.

Specific Aims

All instructions in the PHS 398 Application Guide must be followed.

Research Strategy

Applications should describe how the Caregiver Research Core will facilitate the development, refinement and testing of caregiver research studies that examine the impact of a spouse or partner s diagnosis with a life limiting illness on caregiver health, behaviors, impact on comorbidities and their management among the caregivers, effect on caregiver health status in terms of physical, functional, and psychosocial outcomes, health seeking behavior, utilization of social support and its impact, isolation and other poor outcomes across diverse populations of caregivers, and morbidity and mortality across diverse and medically underserved caregivers and by gender, geography and age.

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 PHS 398 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.

Specific Aims

All instructions in the PHS 398 Application Guide must be followed.

Research Strategy

Applications should describe how the Interventions, Clinical Trials and Bio-Behavioral Core will identify the next steps in PCEOL intervention research and the core measures and instruments, biobehavioral outcomes and methods, and bioassays needed to develop a robust group of objective measures and outcomes in PCEOL across ethno-culturally diverse and medically underserved populations, inclusive of disparities by gender, geography and age. Bio-behavioral studies that identify biomarkers or are based on interventions delineating bio-behavioral mechanisms for those at high risk for adverse outcomes will also be tested in this Core.

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 PHS 398 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 (please note all format requirements) as described in the PHS 398 Application Guide.

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 PHS 398 Application Guide.

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

This initiative is not subject to intergovernmental review.

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.

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.

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

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.

Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the PCRC 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 PCRC study proposed).

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 PCRC study that by its nature is not innovative may be essential to advance a field.

Significance

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

How likely is that the PD/PI will be successful in achieving the overall scientific agenda that the cohort is intended to address?

Investigator(s)

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

Innovation

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

Approach

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the PCRC study? 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 PCRC study 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?

Are there appropriate plans for the rigorous management and quality control of data and biospecimens collected by the PCRC? Are the PCRC design and methods adequate to achieve the stated objectives and to support the stated overall research agenda? Are the PCRC objectives described likely to be completed during the requested periods? How adequate are the administrative and communication structures in terms of efficiently supporting the PCRC activities?

Have the investigators suggested strategies to develop and implement intervention studies in a timely manner? Have the investigators proposed appropriate approaches to develop and conduct studies? Have the investigators suggested ways that PCRC results will have greater visibility in PCEOL research and the development of LLD guidelines? Does the application address the development and conduct of hypothesis-testing molecular or genetic studies? Does the application address strategies to collaborate internationally with other PCEOL and/or other LLD groups?

Specific to this FOA: Is there evidence of the success of the PCRC in the past to support productive scientific projects (as measured by publications and related grants or successful development of cooperative group)? Are the proposed studies and methodologies appropriate and the number of outcome variables tracked appropriate to the related research scope? Is the PCRC sample representative or unique? Has the applicant been successful in completing previously proposed PCRC aims and activities?

Is the approach to conduct scientific studies and identification of samples and study participants appropriate? Are the plans as outlined to conduct the studies and recruit and retain participants appropriate? Have the Cores and Centers been adequately described with detailed objectives and timelines?

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?

As applicable for the PCRC study 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 Human Subjects Protection and Inclusion Guidelines.

Inclusion of Women, Minorities, and Children

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

Vertebrate Animals

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

Biohazards

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

Resubmissions

Not Applicable

Renewals

Not Applicable

Revisions

Not Applicable.

As applicable for the PCRC study 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.

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:

• May undergo a selection process in which only those applications deemed to have the highest scientific and technical merit (generally the top half of applications under review) will be discussed and assigned an overall impact score.
• Will receive a written critique.

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 on Nursing Research. The following will be considered in making funding decisions:

• Scientific and technical merit of the proposed project as determined by scientific peer review.
• Availability of funds.
• Relevance of the proposed project to program priorities.

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.

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.

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.

• The awardee institution will provide NIH with written study protocols that address risks and protections for human subjects in accordance with NIH s Instructions for Preparing the Human Subjects Section of the Research Plan.
• The awardee institution will provide NIH with specific plans for data and safety monitoring, and will notify the IRB and NIH of serious adverse events and unanticipated problems, consistent with NIH DSMP policies.

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.

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

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

The PD/PI will have the primary responsibility for:

• For the project as a whole.
• Research design and the development of a common study protocol.
• Preparation of all study documents. The study documents include questionnaires, medical record abstract forms and field procedures manuals.
• Establishment and maintenance of quality control in all data and materials collection and management procedures.
• Final data analysis and interpretation; preparation of publication of the study findings.
• Chairing the Steering Committee.
• Cooperating with NINR programmatic, technical and administrative staff;
• Administratively managing the U24 award.

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

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

NINR will have substantial programmatic involvement (program officer and project scientist) that is above and beyond the normal stewardship role in awards, as described below:

• An MD, PhD prepared scientist will act as a project scientist and as the nominee of the Chief of Office Extramural Program, NINR will:
  • Approve/disapprove changes in key personnel.
  • Assist in the development of the protocol which specifies the methods of research to be followed.
  • Assist in the interpretation and reporting of the collected information.
  • Monitor study progress. This may include periodic site visits for discussions with awardee research teams, observation of field data collection and management techniques, fiscal review and other matters.
  • Establish milestones upon which study continuation will be judged, and evaluate whether support shall be continued, modified, withheld, suspended or terminated.
  • Coordinate future activities, if any, with the other cooperative Groups or other studies especially in data retrieval from existing databases; co-author papers and present results at scientific conferences; etc, etc.
  • Facilitate collaborations between the awardees and other NIH/NINR sponsored programs, investigators, or organizations that may contribute to the projects' goals.
  • Serve as a liaison between the research awardees and NIH/NINR staff members and investigators involved in the program, facilitating interactions and scientific integration between the U24 awardee;
  • Act as the official point of contact for the U24
  • Promote and help coordinate collaborative research efforts that involve interactions with other NIH-supported projects, programs, and centers;
  • Evaluate the adherence of the awardees to the approved data sharing plans

The NIH reserves the right to terminate or curtail the study in the event of (a) substantial shortfall in participant recruitment, follow-up, data reporting, quality control, or other major breach of the protocol, (b) substantive changes in the agreed-upon protocol to which the NIH/NINR does not agree, (c) reaching a major study endpoint substantially before schedule with persuasive statistical significance, or (d) human subject ethical issues that may dictate termination.

Additionally, an agency program official or IC program director will be responsible for normal scientific and programmatic stewardship of the award in collaboration with the Project Scientist.

Areas of Joint Responsibility include:

The PCRC Steering Committee will serve as the main governing board for PCRC and consist of the PD/PI, Project Scientist, Working Group chairs, NIH Collaborators, Directors of the support facilities and other members as deemed necessary by the PD/PI. The PD/PI will have a designated back up senior investigator who will also be a member of the Steering Committee. The Steering Committee may also form subcommittees as needed. The Steering Committee will be chaired by the PCRC PD/PI and NINR Project Scientist will be a voting member. In the absence of PD/PI, the second PCRC PI (or a designated senior investigator) will chair Steering Committee meeting. The Steering Committee will conduct one face to face meeting a year with additional teleconferences or meetings as needed. The Steering Committee will be responsible for any changes to the PCRC organizational structure and Standard Operating Procedures. The Steering Committee will have primary responsibility to establish priorities, and to develop and provide preliminary approval of projects and or protocols. A DSMB may also be developed;

The Steering Committee will be responsible for the following aspects of PCRC activities:

Reviewing on a regular basis the performance of the Central Operations and Statistical Center; Reviewing Member Sites for adequate performance, and will have the authority to place on probation and to suspend Members and add new Members suspended by the PCRC; Evaluating and approving all potential treatment concepts as well as correlative science proposals, formally presented either by investigators from Member Sites or by investigators external to the network

Dispute Resolution:

Any disagreements that may arise in scientific or programmatic matters (within the scope of the award) between award recipients and the NIH may be brought to Dispute Resolution. A Dispute Resolution Panel composed of three members will be convened. It will have three members: a designee of the Steering Committee chosen without NIH staff voting, one NIH designee, and a third designee with expertise in the relevant area who is chosen by the other two; in the case of individual disagreement, the first member may be chosen by the individual awardee. This special dispute resolution procedure does not alter the awardee's right to appeal an adverse action that is otherwise appealable in accordance with PHS regulation 42 CFR Part 50, Subpart D and DHHS regulation 45 CFR Part 16.

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.

The PCRC program will be subject to external evaluation near the end of the funding period. Such evaluation is part of NIH efforts to optimize the efficiency of the funded research. The evaluation process will involve monitoring and assessing the progress of the PCRC toward achieving its goals. This aspect includes evaluating the quality, value, and accessibility of the PCRC as a research resource and the quality and scientific impact of the research that utilizes PCRC data and expertise. For the efficient evaluation of the Program, cooperation of the PCRC awardee will be important and expected.

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

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Telephone 301-710-0267
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

Noreen M. Aziz, MD PHD MPH, Office of Extramural Programs
National Institute of Nursing Research (NINR)
Telephone: 301-594-2542
Email: AZIZN@mail.nih.gov

Yujing Liu, PhD, Chief, Office of Review
National Institute of Nursing Research (NINR/NIH)
Telephone: (301) 451-5152
FAX: 301-480-8260
Email: Yujing_liu@nih.gov

Ron Wertz, Grants Management Specialist, Office of Grants Management
National Institute of Nursing Research (NINR)
Telephone: (301) 594-2870
Email: wertzr@mail.nih.gov

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.

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.