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

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

Part 1. Overview Information
Part 2. Full Text of the Announcement

Section I. Funding Opportunity Description
Section II. Award Information
Section III. Eligibility Information
Section IV. Application and Submission Information
Section V. Application Review Information
Section VI. Award Administration Information
Section VII. Agency Contacts
Section VIII. Other Information

Purpose

The purpose of this Funding Opportunity Announcement (FOA), is to continue support for the research and resource activities of the Palliative Care Research Cooperative (PCRC), to facilitate cutting edge end-of-life and palliative care (EOLPC) studies that need to be conducted with nationally representative samples and multiple sites, and to quantify and better understand the risks, issues, and impact of serious, advanced illness on individual and/or caregiver health outcomes.

This limited competition solicitation is open to the PCRC and its member institutions constituting the current PCRC. The aims of the original initiative included developing national capacity for collaborative, multi-site, end-of-life and palliative care (EOLPC) science in a way that maximized the quality and efficiency of research, and the effectiveness of the cooperative group; providing integrated support for EOLPC research, specifically for the conduct, analysis, and dissemination of clinically meaningful, high-quality, efficient, person- and family-centered, multi-site studies.

This FOA proposes to refine and extend the role of the PCRC as a broad resource focused on multi-site, clinical research 1) to expand EOLPC science, 2) continue the coordination and administrative functions of the cooperative group, 3) support the development of researchers at all levels choosing to specialize in EOLPC research and 4) support the ongoing development and use of a data coordination center including common data elements within a large scale palliative care science network.

The goal of this new phase is to continue to increase the productivity and impact of the cooperative group and the ability to facilitate and/or participate in greater numbers of and higher quality research studies that are responsive to key gaps in EOLPC science. By addressing the objectives of this FOA, the PCRC is expected to further develop areas of specific scientific growth through the continuation and expansion of its centers and research cores that include the following:

• Project Coordinating Center
• Investigator Development Center
• Data, Informatics and Statistics Core
• Measurement Core
• Caregiver Research Core
• Clinical Studies Core

Through this FOA, the PCRC will (a) refine the coordination and administrative functions of the cooperative group developed in the current grantees; and (b) provide support and infrastructure for scientists who are proposing and conducting research that fills key gaps in clinical EOLPC science, particularly in developing, testing and evaluating scalable interventions. The PCRC will also serve as a resource to EOLPC scientists in incorporating current and new Federal and NIH/NINR initiatives such as common data elements, clinical trial oversight, clinical pragmatic trials, the National Pain Strategy, the National Plan to Address Alzheimer’s Disease, Big Data to Knowledge (BD2K), Cancer Moonshot, Precision Medicine and Science of Behavior Change Initiatives.

Areas that PCRC applicants may choose to focus on include, but are not limited to, the examples in following sections. It is the responsibility of the applicants to determine and justify an optimal mix of resources and scientific areas of focus that will accomplish and fit with the overarching goals of the PCRC. The mission of the National Institute of Nursing Research (NINR) is to promote and improve the health of individuals, families, and communities.

Background

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 results 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 end-of-life and palliative care (EOLPC). The original PCRC RFA-NR-13-004 U24 award led to important capacity building and infrastructure creation, and the new PCRC U2C shall too demonstrate its ability to define and meet critical success metrics. These metrics include (a) specific milestones for each year of the award regarding productivity, (b) increasing the numbers of multi-site clinical trials supported with PCRC resources, (c) fiscal management such as establishing sustainable sources of long-term support, and (d) oversight of the conduct, quality and consistency of PCRC practices and PCRC resources, including research sites.

The PCRC, originally supported by funds provided to the NIH under the American Recovery & Reinvestment Act of 2009, Public Law 111-5, 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 through RFA-OD-10-005(2010 2013). The PCRC has developed the infrastructure, data systems and procedures and metrics to function as a national resource to facilitate the conduct, analysis and dissemination of high-quality research in palliative care, particularly through multi-site clinical trials through the RFA-NR-13-004, U24 cooperative agreement (2013-2018). The PCRC has also greatly expanded their role in the development of scientists committed to advancing palliative care science.

The PCRC’s mission is to develop scientifically-based methods leading to meaningful evidence for improving quality of life of individuals with serious, advanced illnesses, their caregivers including family members and providers of care. By collaborating with targeted community sites, the PCRC was designed with goals of increasing interdisciplinary collaboration, developing a uniform research infrastructure including common data elements, standardizing data collection and management processes, increasing research capacity and disseminating research information to the community. As a comprehensive, multicenter resource, the PCRC developed structures and processes to enable and support EOLPC research with nationally representative samples at multiple sites. In the first 3 years of the U24, the PCRC has expanded to over 331 members at 106 sites. The PCRC has developed infrastructure and resources, including a data repository, recommended common data elements, standardized data collection and management processes, and promoted interdisciplinary collaboration across institutions. They provide support to scientists in preparing and conducting safe and effective multi-site clinical research funded through federal and private funding agencies.

Overall Research Objectives for the PCRC U2C

The overarching goals of this limited competition (U2C) are to refine the coordination and administrative functions of the existing cooperative group and to expand its capacity to facilitate and support research to better quantify and understand the impact of serious, advanced illness and the treatment of such conditions on the health, quality of life, and the end-of-life trajectory of individuals and caregivers, and to provide evidence based options to improve the lives of individuals and caregivers with palliative care needs. Important research objectives include:

• Supporting the conduct of high quality, effective clinical research, especially multi-site clinical trials;
• Developing, testing, evaluating and refining resources for investigators at all levels of experience in the conduct of clinical trials according to current clinical, ethical and regulatory standards;
• Integrating of diverse populations and individuals in need of EOLPC care into large-scale clinical trials;
• Overcoming barriers to high-quality, effective research in palliative care using the palliative care cooperative group model and infrastructure;
• Conducting nationally representative, multi-institutional trials to advance EOLPC science;
• Expanding and utilizing common data elements and the existing PCRC core database to conduct research that transcends a particular study and provides new insight on the overall condition of those needing EOLPC care;
• Providing methodologic resources, participant access/recruitment, multiple sites, PCRC pooled data, and/or the expertise of PCRC investigators not found anywhere else for investigators proposing EOLPC studies using PCRC resources; and
• Promoting and facilitating the use of the PCRC resources by non-PCRC investigators.

Multidisciplinary research conducted through the PCRC will enhance the knowledge base regarding gaps and needs in EOLPC science, and will increase our understanding of strategies to prevent, detect early, or treat adverse outcomes of serious, advanced illness for individuals and their families. This research also will decrease the burden of serious illness and morbidity. The impact on morbidity among individuals dealing with serious, advanced illness is an important consideration. Morbidity and mortality among informal 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.

This FOA will enable the current PCRC to further mature as a cooperative group and demonstrate the following key attributes: (a) an innovative, successful, productive, and sustainable research cooperative; (b) collaborations between experienced and new investigators; (c) teams of multidisciplinary investigators that can address multi-faceted phenomena; (d) collaborations across institutions to develop studies that are representative of the national population; (e) studies that are high-impact, scalable for clinical practice and clinically relevant; and (f) recruitment of new investigators and expertise into the palliative and end-of-life care research community. Studies proposed for the program will be innovative and use the infrastructure and resources of the cooperative group. The relevant administrative/ training centers and research cores that will be maintained and expanded will support the mission of the PCRC. By providing resources to the PCRC through this FOA, NINR will facilitate the maturation 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.

General Requirements

Applicants responding to this FOA must thoroughly and comprehensively address the achievement of the current main objective of the PCRC program, which is to elevate and enhance the role of the PCRC as a resource for collaborative person- and family-oriented EOLPC research. It is expected that by the end of the proposed PCRC funding period, plans for sustained operation will be developed and refined. It is expected that all investigators involved in PCRC-sponsored research projects, including pilot projects, will submit a competing application for funding from public or private source that is based on the data gathered through the project that was sponsored by the PCRC, within a year of completion of their pilot work.

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

• Maintaining accessibility to relevant data, both quantitative and qualitative, for populations served by the collaborating PCRC institutions and investigators;
• 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 resources;
• Providing resources and sharing scientific expertise with both PCRC members and non-PCRC-affiliated researchers interested in EOLPC science, with the goal to facilitate interactions and research collaborations among researchers who might benefit from these data;
• 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, specifically, increasing the number, scope and scientific impact of research projects either conducted by teams of PCRC members working together to develop, propose and conduct multi-site clinical research and increasing number, scope and scientific impact of research projects conducted by external investigators that incorporate PCRC sites and resources.
• Facilitating development of investigators interested in EOLPC research through mentorship and participation in PCRC activities; specifically, providing leadership, training and resources to prepare and support investigators in the responsible conduct of high quality clinical trials.
• Facilitating the development of competitive funding applications by supporting small pilot studies for new and/or early stage investigators through the Investigator Development Center and supporting pilot and preliminary studies using the PCRC database.

Scientific Areas Relevant to PCRC Goals

Applicants should consider broad areas of focus that relate to palliative or end-of-life care science including, but are not limited to:

• Identify frequently encountered barriers to the conduct of scalable, high quality EOLPC science and develop methods and mechanisms to address these barriers.
• Develop resources to promote and support the responsible conduct and oversight of high-quality, nationally representative multi-site clinical trials.
• Identify clinically relevant measures, including person- and family-reported measures for palliative care science, support their use in EOLPC research, collect data from studies conducted using these clinically relevant measures and support the use of such data in new ways to advance EOLPC science.

PCRC Governance

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 continue to work with an External Advisory Board, who will be selected with approval of the Steering Committee to advise the PCRC. Details on the composition and functions of the PCRC Steering Committee are provided in Section IV.2.A. Cooperative Agreement Terms and Conditions of Award.

See Section VIII. Other Information for award authorities and regulations.

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.

Higher Education Institutions - Only the institutions of the current PD/PIs can apply.

• Public/State Controlled Institutions of Higher Education
• Private Institutions of Higher Education

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

o Hispanic-serving Institutions

o Historically Black Colleges and Universities (HBCUs)

o Tribally Controlled Colleges and Universities (TCCUs)

o Alaska Native and Native Hawaiian Serving Institutions

o Asian American Native American Pacific Islander Serving Institutions (AANAPISIs)

Nonprofits Other Than Institutions of Higher Education

• Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Higher Education)
• Nonprofits without 501(c)(3) IRS Status (Other than Institutions of Higher Education)

For-Profit Organizations

• Small Businesses
• For-Profit Organizations (Other than Small Businesses)

Governments

• State Governments
• County Governments
• City or Township Governments
• Special District Governments
• Indian/Native American Tribal Governments (Federally Recognized)
• Indian/Native American Tribal Governments (Other than Federally Recognized)
• Eligible Agencies of the Federal Government
• U.S. Territory or Possession

Other

• Independent School Districts
• Public Housing Authorities/Indian Housing Authorities
• Native American Tribal Organizations (other than Federally recognized tribal governments)
• Faith-based or Community-based Organizations
• Regional Organizations

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 allowed.

Applicant Organizations

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

• Dun and Bradstreet Universal Numbering System (DUNS) - All registrations require that applicants be issued a DUNS number. After obtaining a DUNS number, applicants can begin both SAM and eRA Commons registrations. The same DUNS number must be used for all registrations, as well as on the grant application.
• System for Award Management (SAM) (formerly CCR) Applicants must complete and maintain an active registration, which requires renewal at least annually. The renewal process may require as much time as the initial registration. SAM registration includes the assignment of a Commercial and Government Entity (CAGE) Code for domestic organizations which have not already been assigned a CAGE Code.
• NATO Commercial and Government Entity (NCAGE) Code Foreign organizations must obtain an NCAGE code (in lieu of a CAGE code) in order to register in SAM.
• eRA Commons - Applicants must have an active DUNS number and SAM registration in order to complete the eRA Commons registration. Organizations can register with the eRA Commons as they are working through their SAM or Grants.gov registration. eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to submit an application.
• Grants.gov Applicants must have an active DUNS number and SAM registration in order to complete the Grants.gov registration.

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

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

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

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

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.

The NIH will not accept duplicate or highly overlapping applications under review at the same time. This means that the NIH will not accept:

• A new (A0) application that is submitted before issuance of the summary statement from the review of an overlapping new (A0) or resubmission (A1) application.
• A resubmission (A1) application that is submitted before issuance of the summary statement from the review of the previous new (A0) application.
• An application that has substantial overlap with another application pending appeal of initial peer review (see NOT-OD-11-101).

A button to access the online ASSIST system is available in Part 1 of this FOA. See your administrative office for instructions if you plan to use an institutional system-to-system solution.

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

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

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

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 activity
• 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:

Weiqun Li, M.D., Chief, Scientific Review Branch
National Institute of Nursing Research
Telephone: 301-594-5966
Fax: 301-480-8260
Email: [email protected]

Component Types Available in ASSIST	Research Strategy/Program Plan Page Limits
Overall	12
Admin Core (Project Coordinating Center)	12
Center (Investigator Development Center)	12
Core (use for Data, Informatics and Statistics Core, Measurement Core, Caregiver Research Core, Clinical Studies/Methodology Core)	12

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

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

The application should consist of the following components:

• Overall: required
• Project Coordinating Center: required; maximum of 1
• Investigator Development Center: required; maximum of 1
• Data, Informatics and Statistics Core: Minimum 1 ; maximum of 5
• Measurement Core: Minimum 1 ; maximum of 5
• Caregiver Research Core: Minimum 1 ;maximum of 5
• Clinical Studies/Methodology Core: Minimum 1 ; maximum of 5

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

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

Complete entire form.

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

Follow standard instructions.

Enter primary site only.

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

Include only the multi-PDs/PIs (if applicable to this FOA) for the entire application. The qualifications and experience of all PD/PIs must be described, specifically documenting their respective abilities to organize and manage the PCRC and related activities.

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

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

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

Specific Aims:

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

• Ongoing, scheduled review and revision of methods, policies and procedures for refinement and optimization of coordination and administrative functions of the resource;
• Timely response and support in the conduct of multi-site intervention studies;
• Development of strategies by disciplinary specialties (e.g. geriatrics, pediatrics, critical care, oncology and nursing) organ systems (cardiovascular, pulmonary, renal, GI, neurological including Alzheimer’s and related dementias, etc.) to propose and conduct multi-site clinical studies;
• Continued development and refinement of strategies to incorporate diverse populations including underserved groups, families, caregivers, and those in geographically and regionally diverse areas.
• Development and conduct of scalable multi-site clinical trials and other studies including pragmatic trials, data science analyses, and implementation projects.
• Successful training resources/mentorship, as indicated by independent funding of new and/or early stage investigators.

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

Describe the need for the PCRC resource, scientific rationale underpinning the need for this new period, justification for recent expansion, and significance of PCRC.

Progress Report

As the work relating to this PCRC will be related to work performed in prior awards, a progress report on the current award is required. Please outline the current specific aims and progress towards them, summarize the primary accomplishment of the PCRC and include establishment, maintenance and enhancement of the resource; contributions to peer-reviewed literature; number of projects in the current funding period that have used the PCRC; pilot projects supported and their progress, including grant applications that have resulted; and how the PCRC is being used a resource for investigator-initiated research supported by external grants. Information on all studies that have worked with the PCRC should be provided.

Relevant past performance should be addressed by the applicant for the overall Cooperative Group and as relevant to each Core and Center

Infrastructure Design and Methods Overview

Please describe:

PCRC organizational structure and supporting facilities to include the planned organizational structure under which the PCRC proposes to operate. An organizational chart showing how the group will function must also be included.

Update on studies utilizing the resources of the PCRC including identification and recruitment of study subjects in existing studies.

Plans for development of procedures and protocols for communication and public access of PCRC materials to be implemented in the first year of the award.

Plans for the development of procedures and protocols for a management and resource plan for data sharing to be implemented by the Data, Informatics and Statistics Core in the first year of the award.

The application should address approaches to increase the visibility of the resources and capabilities of the PCRC and the findings of PCRC supported science.

Letters of Support:

Overall letters of support should be obtained from institutions providing resources for the PCRC as a whole, External Advisory Board Members, and National organizations with an interest in palliative care science.

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide, with the following modification:

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

Appendix:

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

PHS Assignment Request Form (Overall) All instructions in the SF424 (R&R) Application Guide must be followed.

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

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

Complete only the following fields:

• Applicant Information
• Type of Applicant (optional)
• Descriptive Title of Applicant’s Project
• Proposed Project Start/Ending Dates

PHS 398 Cover Page Supplement (Project Coordinating Center)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Project Coordinating Center)

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

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

Project Narrative: Do not complete. Note: ASSIST screens will show an asterisk for this attachment indicating it is required. However, eRA systems only enforce this requirement in the Overall component and applications will not receive an error if omitted in other components.

Project /Performance Site Location(s) (Project Coordinating Center)

The Project Coordinating Center (PCC) is expected to function as a central office, located at the lead Program Director(s)/Principal Investigator(s)' institution.

List all performance sites that apply to the Project Coordinating Center (PCC). This would include sites where PCC activities take place, all current sub-contacted PCRC sites, which should be clearly identified as sub-contacted sites. Currently non-contracted, enrolling PCRC sites may also be listed, and should be clearly identified as non-contracted.

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

Research & Related Senior/Key Person Profile (Project Coordinating Center)

• In the Project Director/Principal Investigator section of the form, use Project Role of Other with Category of Project Coordinating Center Lead and provide a valid eRA Commons ID in the Credential field.
• In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component.
• Include a single Biographical Sketch for each Senior/Key person listed in the application regardless of the number of components in which they participate. When a Senior/Key person is listed in multiple components, the Biographical Sketch can be included in any one component.
• If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used.
• Members of the Executive Committee, Steering Committee, Center Directors and Core Directors are to be considered key personnel for this FOA.

Budget (Project Coordinating Center)

Budget forms appropriate for the specific component will be included in the application package. The PCRC must dedicate a minimum of 15-20% of the direct costs in year 1 to PCRC-sponsored pilot projects which will lead to the conduct of multi-site clinical trials in palliative care. Additional funds may be dedicated to other PCRC-sponsored research projects (e.g. other delayed onset clinical trials, preliminary studies and/or secondary analyses of data in the PCRC data registry, etc.). The amount of the direct budget dedicated to PCRC-sponsored research projects, including pilot awards should increase (for example by a minimum of 1-2%) in each year of the award. A resource allocation plan showing movement of greater funds into pilot and other research projects in each year of the award should be submitted and should include the number, type and amount set aside for each award in subsequent years.

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

Specific Aims: Applications should describe how the Project Coordinating Center will provide overall administrative and organizational infrastructure for the entire resource

Research Strategy:

Describe how it will provide: data management, finance and regulatory staff and other administrative staff, as needed.

Governance Plan

Describe the plans for development of written guidance for governance in the first year of the award and a schedule for review of this guidance. This written guidance for governance should include clear plans for: a) the role and composition of the Steering Committee, b) the role and composition of the External Advisory Board, c) how members of the Steering Committee and External Advisory Board are selected, the length of the term of service, how conflicts of interest are identified and the frequency and type of meeting for each group should be included. The members for each of these committees and boards should be named. The governance plan should also specify how core and center chairs are selected and how frequently and to whom they report. Also, the plan should address the standing committees, including how members and chairs are selected, the length of the term of service, and how frequently and to whom the committees report. Describe the plans for the development in the first year of by-laws or another form of written guidance for governance of the PCRC during the first year of funding, and review in subsequent years.

Multiple PD/PI Leadership Plan

Describe the leadership plan including governance and organizational structure of the MPD/MPI leadership team, including communication plans, process for making decision and procedures for resolving conflicts. The roles and administrative, technical, and scientific responsibilities for the program should be delineated for each PD/PI.

Please describe:

• The Leadership plan for operation of the PCC and the communication structures .
• Plans for quality management and oversight of all PCRC sites participating in research over the course of the award.
• The fiscal management plan including milestones for sustainability and a detailed plan to communicate allocations of resources distributed over the years of the award;
• Methods for ongoing surveillance of the studies in progress including accrual, fidelity and quality control;
• Strategies for PCRC plans to sustain studies when a site is unable to perform as contracted including recruitment, fidelity to protocol, coordination of data, management of activities and tracking should be included; Include approaches to communication, education and maintaining contacts with the principal investigators (PIs), site directors, site study staff and study participants.

Letters of Support: Letters of support should be obtained from institutions providing resources to the Project Coordinating Center, all enrolling sites (both those with and without sub-contracts) and any consultants to this center.

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide, with the following modification:

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

Appendix:

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

Samples of quality management monitoring data collection instruments must be included.

PHS Inclusion Enrollment Report (Project Coordinating Center)

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

When preparing your application in ASSIST, use Component Type Center.

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

SF424 (R&R) Cover (Investigator Development Center)

Complete only the following fields:

• Applicant Information
• Type of Applicant (optional)
• Descriptive Title of Applicant’s Project
• Proposed Project Start/Ending Dates

PHS 398 Cover Page Supplement (Investigator Development Center)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Investigator Development Center)

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

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

Project Narrative: Do not complete. Note: ASSIST screens will show an asterisk for this attachment indicating it is required. However, eRA systems only enforce this requirement in the Overall component and applications will not receive an error if omitted in other components.

Project /Performance Site Location(s) (Investigator Development Center)

List all performance sites that apply to the Investigator Development Center (IDC).

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

Research & Related Senior/Key Person Profile (Investigator Development Center)

In the Project Director/Principal Investigator section of the form, use Project Role of Other with Category of Investigator Development Center Lead and provide a valid eRA Commons ID in the Credential field.

• In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component. The Investigator Development Center Director is considered key personnel for this FOA.
• Include a single Biographical Sketch for each Senior/Key person listed in the application regardless of the number of components in which they participate. When a Senior/Key person is listed in multiple components, the Biographical Sketch can be included in any one component.
• If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used.

Budget (Investigator Development Center)

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

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

PHS 398 Research Plan (Investigator Development Center)

Specific Aims: Applications should describe how the PCRC Investigator Development Center (IDC) impacts the development of investigators at all stages and roles and how the PCRC provides resources, including advising for successful conduct of multi-site, clinical research in the area of EOLPC science.

Research Strategy: Plans for the continuing development and expansion of activities under the current award (e.g. Clinical Trial Intensives, monthly webinars, etc.) should be described. Plans for new ongoing activities as well as periodic or one-time opportunities should be described, along with plans for evaluating the success of each.

A description of the plans for conferences, meetings and educational programs and materials should be submitted. Plans for making the investigator development resources available to PCRC members and non-members should also be included.

A detailed plan of a pilot award program to promote development of the skills needed to conduct multi-site clinical trials and to provide necessary preliminary data for competitive research proposals should be included.

Clear and measureable milestones for progress and fiscal management of the IDC in each year of the award should be described.

Letters of Support: Letters of support should be obtained from institutions providing resources to this center, and to any ongoing faculty or external consultants for this center.

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide, with the following modification:

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

Appendix:

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

• An outline of the curriculum for the PCRC Palliative Care Clinical Trials Intensive must be included in the Appendix.

PHS Inclusion Enrollment Report (Investigator Development Center)

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

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

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

SF424 (R&R) Cover (Data, Informatics and Statistics Core)

Complete only the following fields:

• Applicant Information
• Type of Applicant (optional)
• Descriptive Title of Applicant’s Project
• Proposed Project Start/Ending Dates

PHS 398 Cover Page Supplement (Data, Informatics and Statistics Core)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Data, Informatics and Statistics Core)

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

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

Project Narrative: Do not complete. Note: ASSIST screens will show an asterisk for this attachment indicating it is required. However, eRA systems only enforce this requirement in the Overall component and applications will not receive an error if omitted in other components.

Project /Performance Site Location(s) (Data, Informatics and Statistics Core)

List all performance sites that apply to the specific component.

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

Research & Related Senior/Key Person Profile (Data, Informatics and Statistics Core)

The DISC must be coordinated by a lead biostatistician.

• In the Project Director/Principal Investigator section of the form, use Project Role of Other with Category of Core Lead and provide a valid eRA Commons ID in the Credential field.
• In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component. The lead of the Data, Informatics and Statistics Core is considered key personnel for this FOA.
• Include a single Biographical Sketch for each Senior/Key person listed in the application regardless of the number of components in which they participate. When a Senior/Key person is listed in multiple components, the Biographical Sketch can be included in any one component.
• If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used.

Budget (Data, Informatics and Statistics Core)

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

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

PHS 398 Research Plan (Data, Informatics and Statistics Core)

Specific Aims: Applications should describe how the Data, Informatics and Statistics Core (DISC) will ensure accuracy in collection and management of the data in the PCRC . This will be done in collaboration with the Project Coordinating Center.

Research Strategy:

• Describe how the DISC will also be a resource for design of statistical analysis plans for multi-site clinical trials and will provide bio statistical support to the majority of multi-site clinical trials and data-analysis projects using PCRC resources. Describe how the DISC will review the statistical plans of all research proposals using PCRC resources.
• Plans for development of a data sharing plan to be implemented in the first year of the award must be described. The data sharing plan should include protocols on data submission, including who may submit data; procedures for approval of data submission, cleaning, harmonization and depositing; verification of data integrity; and plans for maintaining data for the PCRC data repository. It should also include policies, protocols and procedures for access and use of the data by PCRC members and non-members for future research and plans for management and quality control of data collected by the PCRC.
• Milestones for progress and fiscal management of the DISC in each year of the award should be described.

Letters of Support: Letters of support should be obtained from institutions providing resources to the Data, Informatics and Statistics Core and from any external consultants for this core.

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide, with the following modification:

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

Appendix:

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

PHS Inclusion Enrollment Report (Data, Informatics and Statistics Core)

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

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

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

SF424 (R&R) Cover (Measurement Core)

Complete only the following fields:

• Applicant Information
• Type of Applicant (optional)
• Descriptive Title of Applicant’s Project
• Proposed Project Start/Ending Dates

PHS 398 Cover Page Supplement (Measurement Core)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Measurement Core)

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

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

Project Narrative: Do not complete. Note: ASSIST screens will show an asterisk for this attachment indicating it is required. However, eRA systems only enforce this requirement in the Overall component and applications will not receive an error if omitted in other components.

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

List all performance sites that apply to the specific component.

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

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

• In the Project Director/Principal Investigator section of the form, use Project Role of Other with Category of Core Lead and provide a valid eRA Commons ID in the Credential field.
• In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component. The lead of the Measurement Core is considered key personnel for this FOA.
• Include a single Biographical Sketch for each Senior/Key person listed in the application regardless of the number of components in which they participate. When a Senior/Key person is listed in multiple components, the Biographical Sketch can be included in any one component.
• If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used.

Budget (Measurement Core)

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

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

PHS 398 Research Plan (Measurement Core)

Specific Aims: Applications should describe how the Measurement Core will identify the next steps in EOLPC research and the core measures, outcomes and instruments needed to develop and maintain a robust group of objective measures in EOLPC across ethno-culturally diverse and medically underserved populations, inclusive of disparities by gender, geography and age.

Research Strategy: A description of the plans to review, revise and expand the PCRC Common Data Elements (CDEs) that are recommended by the PCRC is also required. Specifically, applications should describe how the Measurement Core will oversee all proposed measures including:

• Continuously assess, develop, test, and refine key person- and family-reported outcome measures needed in EOLPC research and recommend a core set of outcomes to standardize the field.
• Continuously assess, develop, test and refine quality of life (QOL) and other key person- and family-outcomes. QOL continues to be a critical issue without which comparative effectiveness and cost effectiveness analyses cannot be conducted.
• Milestones for progress and fiscal management of the Measurement Core in each year of the award should be described.

Letters of Support: Letters of support should be obtained from institutions providing resources to the Measurement Core and from any external consultants for this core.

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide, with the following modification:

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

Appendix:

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

PHS Inclusion Enrollment Report (Measurement Core)

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

When preparing your application in ASSIST, use Component Type Core

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

SF424 (R&R) Cover (Caregiver Research Core)

Complete only the following fields:

• Applicant Information
• Type of Applicant (optional)
• Descriptive Title of Applicant’s Project
• Proposed Project Start/Ending Dates

PHS 398 Cover Page Supplement (Caregiver Research Core)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Caregiver Research Core)

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

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

Project Narrative: Do not complete. Note: ASSIST screens will show an asterisk for this attachment indicating it is required. However, eRA systems only enforce this requirement in the Overall component and applications will not receive an error if omitted in other components.

Project /Performance Site Location(s) (Caregiver Research Core)

List all performance sites that apply to the specific component.

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

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

• In the Project Director/Principal Investigator section of the form, use Project Role of Other with Category of Core Lead and provide a valid eRA Commons ID in the Credential field.
• In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component. The lead of the Caregiver Research Core is considered key personnel for this FOA.
• Include a single Biographical Sketch for each Senior/Key person listed in the application regardless of the number of components in which they participate. When a Senior/Key person is listed in multiple components, the Biographical Sketch can be included in any one component.
• If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used.

Budget (Caregiver Research Core)

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

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

PHS 398 Research Plan (Caregiver Research Core)

Specific Aims: Applications should describe how the Caregiver Research Core (CRC) will facilitate the continuous development, refinement and testing of caregiver research studies that examine the impact of a spouse or partner’s diagnosis with a serious, advanced 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.

Research Strategy: A description of the plans to review, revise and expand the activities of the Caregiver Research Core should include, but is not limited to description of:

• Development, testing and evaluation of new methods and mechanisms for EOLPC caregiver research with attention to caregiver population diversity
• Continual review and recommendation of high quality instruments and measurements for caregiver research that will form a set of Common Data Elements (CDEs) for EOLPC caregiver research.
• Milestones for progress and fiscal management of the CRC in each year of the award should be described.

Letters of Support: Letters of support should be obtained from institutions providing resources to the Caregiver Research Core and from any external consultants for this core.

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide, with the following modification:

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

Appendix:

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

PHS Inclusion Enrollment Report (Caregiver Research Core)

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

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

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

SF424 (R&R) Cover (Clinical Studies Core)

Complete only the following fields:

• Applicant Information
• Type of Applicant (optional)
• Descriptive Title of Applicant’s Project
• Proposed Project Start/Ending Dates

PHS 398 Cover Page Supplement (Clinical Studies Core)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Clinical Studies Core)

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

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

Project Narrative: Do not complete. Note: ASSIST screens will show an asterisk for this attachment indicating it is required. However, eRA systems only enforce this requirement in the Overall component and applications will not receive an error if omitted in other components.

Project /Performance Site Location(s) (Clinical Studies Core)

List all performance sites that apply to the specific component.

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

Research & Related Senior/Key Person Profile (Clinical Studies Core)

• In the Project Director/Principal Investigator section of the form, use Project Role of Other with Category of Core Lead and provide a valid eRA Commons ID in the Credential field.
• In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component. The lead of the Clinical Studies Core is considered key personnel for this FOA.
• Include a single Biographical Sketch for each Senior/Key person listed in the application regardless of the number of components in which they participate. When a Senior/Key person is listed in multiple components, the Biographical Sketch can be included in any one component.
• If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used.

Budget (Clinical Studies Core)

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

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

PHS 398 Research Plan (Clinical Studies Core)

Specific Aims: Applications should describe how the Clinical Studies Core (CSC) will identify the key gaps in EOLPC science and methods needed to develop theoretically sound research that will improve the quality of life for individuals with serious, advanced illness and their caregivers, including family.

Research Strategy:

The research strategy should include, but is not limited to:

• A description of the Clinical Studies core in providing consultative services in methodology, advising, and reviewing the quality of the science of investigators research plans should be included.
• Plans for stimulating innovative methods that minimize participant burden and maximize the scientific strength and significance of EOLPC research should be outlined.
• Plans for developing groups of PCRC Members who will collaborate on the development, proposal, submission and conduct of scalable, multi-site, nationally representative clinical trials that address important issues in EOLPC science should be outlined.
• Milestones for progress and fiscal management of the CSC in each year of the award should be described.

Letters of Support: Letters of support should be obtained from institutions providing resources to the Clinical Studies Core and from any external consultants for this core.

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide, with the following modification:

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

Appendix:

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

PHS Inclusion Enrollment Report (Clinical Studies Core)

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

See Part 1. Section III.1 for information regarding the requirement for obtaining a unique entity identifier and for completing and maintaining active registrations in System for Award Management (SAM), NATO Commercial and Government Entity (NCAGE) Code (if applicable), eRA Commons, and Grants.gov.

Part I. Overview Information contains information about Key Dates and times. Applicants are encouraged to submit applications before the due date to ensure they have time to make any application corrections that might be necessary for successful submission. When a submission date falls on a weekend or Federal holiday, the application deadline is automatically extended to the next business day.

Organizations must submit applications to Grants.gov (the online portal to find and apply for grants across all Federal agencies) using ASSIST or other electronic submission systems. Applicants must then complete the submission process by tracking the status of the application in the eRA Commons, NIH’s electronic system for grants administration. NIH and Grants.gov systems check the application against many of the application instructions upon submission. Errors must be corrected and a changed/corrected application must be submitted to Grants.gov on or before the application due date and time. If a Changed/Corrected application is submitted after the deadline, the application will be considered late. Applications that miss the due date and time are subjected to the NIH Policy on Late Application Submission.

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

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

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

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

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

For assistance with your electronic application or for more information on the electronic submission process, visit Applying Electronically. If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Guidelines for Applicants Experiencing System Issues. For assistance with application submission, contact the Application Submission Contacts in Section VII.

Important reminders:

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

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

See more tips for avoiding common errors.

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

Applicants are required to follow the instructions for post-submission materials, as described in the policy.

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 Cooperative Group 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 Cooperative Group that by its nature is not innovative may be essential to advance a field.

Does the proposed Center address the needs of the research Cooperative Group that it will serve? Is the scope of activities proposed for the Center appropriate to meet those needs? Will successful completion of the aims bring unique advantages or capabilities to the research Cooperative Group?

Are the PD(s)/PI(s) and other personnel well suited to their roles in the Center? Do they have appropriate experience and training, and have they demonstrated experience and an ongoing record of accomplishments in managing palliative care research? Do the investigators demonstrate significant experience with coordinating collaborative clinical research? If the Center is multi-PD/PI, do the investigators have complementary and integrated expertise and skills; are their leadership approach, governance, plans for conflict resolution, and organizational structure appropriate for the Center? Does the applicant have experience overseeing selection and management of subawards, if needed??

Does the application propose novel organizational concepts, management strategies, or instrumentation in coordinating the research Cooperative Group the Center will serve? Are the concepts, strategies, or instrumentation novel to one type of research program or applicable in a broad sense? Is a refinement, improvement, or new application of these organizational concepts, management strategies or instrumentation proposed?

Are the overall strategy, operational plan, and organizational structure well-reasoned and appropriate to accomplish the goals of the research Cooperative Group the Center will serve? Will the investigators promote strategies to ensure a robust and unbiased scientific approach across the Cooperative Group, as appropriate for the work proposed? Are potential problems, alternative strategies, and benchmarks for success presented? Are an appropriate plan for work-flow and a well-established timeline proposed? Have the investigators presented adequate plans to ensure consideration of relevant biological variables, such as sex, for studies of vertebrate animals or human subjects?

Specific to this FOA: Are there appropriate plans for the rigorous management and quality control of data 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 ways that PCRC results will have greater visibility in EOLPC research? Have the investigators suggested strategies to facilitate multi-disciplinary groups developing, proposing and implementing clinical trials in a timely manner over the course of the award?

Have the Cores and Centers been adequately described with detailed objectives and timelines?

Will the institutional environment in which the Center will operate contribute to the probability of success in facilitating the research Cooperative Group it serves? Are the institutional support, equipment and other physical resources available to the investigators adequate for the Center proposed? Will the Center benefit from unique features of the institutional environment, infrastructure, or personnel? Are resources available within the scientific environment to support electronic information handling?

As applicable for the Cooperative Group 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.

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

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

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

The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following criteria: (1) description of proposed procedures involving animals, including species, strains, ages, sex, and total number to be used; (2) justifications for the use of animals versus alternative models and for the appropriateness of the species proposed; (3) interventions to minimize discomfort, distress, pain and injury; and (4) justification for euthanasia method if NOT consistent with the AVMA Guidelines for the Euthanasia of Animals. Reviewers will assess the use of chimpanzees as they would any other application proposing the use of vertebrate animals. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal Section.

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.

Not Applicable

For Renewals, the committee will consider the progress made in the last funding period. Is there evidence of the success of the PCRC in the past to support productive scientific projects (as measured by related grants, publications, completion of pilot studies or successful development of cooperative group)? Has the applicant been successful in completing previously proposed PCRC aims and activities?

Not Applicable

As applicable for the Cooperative Group 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.

Not Applicable

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).

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) Genomic Data Sharing Plan

For Cooperative Group projects involving key biological and/or chemical resources, reviewers will comment on the brief plans proposed for identifying and ensuring the validity of those resources.

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 in response to this FOA.

Applications will be assigned to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications submitted in response to this FOA. Following initial peer review, recommended applications will receive a second level of review by the National Advisory Council for Nursing Research . 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. Refer to Part 1 for dates for peer review, advisory council review, and earliest start date.

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 terms and conditions found on the Award Conditions and Information for NIH Grants website. This includes any recent legislation and policy applicable to awards that is highlighted on this website.

All awardee-selected pilot projects and other research projects, including secondary data analyses require prior approval by NINR prior to initiation.

• The awardee institution will provide NINR 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 NINR 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.
• The awardee institution with provide NINR with specific plans for inclusion of women, children and minorities, including planned enrollment tables for each project.

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.

Recipients of federal financial assistance (FFA) from HHS must administer their programs in compliance with federal civil rights law. This means that recipients of HHS funds must ensure equal access to their programs without regard to a person’s race, color, national origin, disability, age and, in some circumstances, sex and religion. This includes ensuring your programs are accessible to persons with limited English proficiency. HHS recognizes that research projects are often limited in scope for many reasons that are nondiscriminatory, such as the principal investigator’s scientific interest, funding limitations, recruitment requirements, and other considerations. Thus, criteria in research protocols that target or exclude certain populations are warranted where nondiscriminatory justifications establish that such criteria are appropriate with respect to the health or safety of the subjects, the scientific study design, or the purpose of the research.

For additional guidance regarding how the provisions apply to NIH grant programs, please contact the Scientific/Research Contact that is identified in Section VII under Agency Contacts of this FOA. HHS provides general guidance to recipients of FFA on meeting their legal obligation to take reasonable steps to provide meaningful access to their programs by persons with limited English proficiency. Please see http://www.hhs.gov/ocr/civilrights/resources/laws/revisedlep.html. The HHS Office for Civil Rights also provides guidance on complying with civil rights laws enforced by HHS. Please see http://www.hhs.gov/ocr/civilrights/understanding/section1557/index.html; and http://www.hhs.gov/ocr/civilrights/understanding/index.html. Recipients of FFA also have specific legal obligations for serving qualified individuals with disabilities. Please see http://www.hhs.gov/ocr/civilrights/understanding/disability/index.html. Please contact the HHS Office for Civil Rights for more information about obligations and prohibitions under federal civil rights laws at http://www.hhs.gov/ocr/office/about/rgn-hqaddresses.html or call 1-800-368-1019 or TDD 1-800-537-7697. Also note it is an HHS Departmental goal to ensure access to quality, culturally competent care, including long-term services and supports, for vulnerable populations. For further guidance on providing culturally and linguistically appropriate services, recipients should review the National Standards for Culturally and Linguistically Appropriate Services in Health and Health Care at http://minorityhealth.hhs.gov/omh/browse.aspx?lvl=2&lvlid=53.

In accordance with the statutory provisions contained in Section 872 of the Duncan Hunter National Defense Authorization Act of Fiscal Year 2009 (Public Law 110-417), NIH awards will be subject to the Federal Awardee Performance and Integrity Information System (FAPIIS) requirements. FAPIIS requires Federal award making officials to review and consider information about an applicant in the designated integrity and performance system (currently FAPIIS) prior to making an award. An applicant, at its option, may review information in the designated integrity and performance systems accessible through FAPIIS and comment on any information about itself that a Federal agency previously entered and is currently in FAPIIS. The Federal awarding agency will consider any comments by the applicant, in addition to other information in FAPIIS, in making a judgement about the applicant’s integrity, business ethics, and record of performance under Federal awards when completing the review of risk posed by applicants as described in 45 CFR Part 75.205 Federal awarding agency review of risk posed by applicants. This provision will apply to all NIH grants and cooperative agreements except fellowships.

Cooperative Agreement Terms and Conditions of Award

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 Part 75, 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(s)/PI(s) will have the primary responsibility for:

• For the project as a whole.
• Preparation of all study documents. The study documents include questionnaires, medical record abstract forms, database use form and field procedure manuals.
• Establishment and maintenance of quality control in all data and materials collection and management procedures.
• Chairing the Steering Committee.
• Cooperating with NINR programmatic, technical and administrative staff.
• 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:

• A PhD prepared scientist will act as Project Scientist and as the nominee of the Director of Extramural Science Programs and will have substantial involvement including activities such as:
• Cooperation or coordination with, or assistance to, awardees in performing project activities, e.g., development of research protocols; data collection, analyses, and interpretations; re-establishment of objectives during the course of a project; or holding FDA Investigational New Drugs (INDs) for investigational drugs;
• Providing for an option to halt a project activity if technical performance requirements are not met or if program objectives have already been met;
• Specifying under the terms and conditions of award that the project be structured in stages and that NIH staff review and approve each stage before work may begin on such stage, e.g. concepts for research projects;
• Assistance with the selection of contractors or sub-awardees under the assistance award, and in the selection of key project personnel other than principal investigators of projects or sub-projects;
• Technical monitoring to permit specific direction of the project, including recommending approval of changes in experimental approaches;
• Participation on committees (other than peer review, see below) as a voting member as needed (the chairperson will be someone other than an IC staff member) or in other functions responsible for helping to guide the course of long-term projects or activities; and
• Participation in the presentation of research results, including publications from the project;
• Generally, not involved in normal programmatic stewardship of the project;
• May not attend peer review meetings of Renewal or Revision applications unless IC waiver obtained per IC procedures for management of concern about bias.

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. The NINR Program Official will be responsible for:

• Enforcement of general statutory, regulatory, or policy requirements;
• Approval of awardee plans prior to award and review of performance after completion;
• Evaluation of progress by reviews of technical or fiscal reports, site visits, or external consultants, to determine that performance is consistent with the terms and conditions of the award;
• Technical assistance requested by awardees, or unanticipated procedures to correct programmatic or financial deficiencies in awardees' performance;
• Scientific/technical discussions with awardees, or actions to facilitate or expedite interactions between awardees, e.g., organizing and holding meetings of investigators.

Areas of Joint Responsibility include:

The PCRC Steering Committee will serve as the main governing board for PCRC and consist of the PD/PI(s), 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 at least 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 and/or central IRB 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 Project Coordinating Center, the Investigator Development Center and Data, Informatics and Statistics Core, Measurement Core, Clinical Studies Core, and any other cores developed by the PCRC; Reviewing Member Sites actively being used for subawards under this FOA's cooperative agreement 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 research projects, formally presented either by investigators from Member Sites or by investigators external to the network for fit with the PCRC mission and resources; review and approval of fiscal plans; review and approval of a clear sustainability plan that will allow the PCRC to continue operation after the period of this award.

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 Research Performance Progress Report (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.

In accordance with the regulatory requirements provided at 45 CFR 75.113 and Appendix XII to 45 CFR Part 75, recipients that have currently active Federal grants, cooperative agreements, and procurement contracts from all Federal awarding agencies with a cumulative total value greater than $10,000,000 for any period of time during the period of performance of a Federal award, must report and maintain the currency of information reported in the System for Award Management (SAM) about civil, criminal, and administrative proceedings in connection with the award or performance of a Federal award that reached final disposition within the most recent five-year period. The recipient must also make semiannual disclosures regarding such proceedings. Proceedings information will be made publicly available in the designated integrity and performance system (currently FAPIIS). This is a statutory requirement under section 872 of Public Law 110-417, as amended (41 U.S.C. 2313). As required by section 3010 of Public Law 111-212, all information posted in the designated integrity and performance system on or after April 15, 2011, except past performance reviews required for Federal procurement contracts, will be publicly available. Full reporting requirements and procedures are found in Appendix XII to 45 CFR Part 75 Award Term and Conditions for Recipient Integrity and Performance Matters.

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

eRA Service Desk (Questions regarding ASSIST, eRA Commons registration, submitting and tracking an application, documenting system problems that threaten submission by the due date, post submission issues)
Finding Help Online: http://grants.nih.gov/support/ (preferred method of contact)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)

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

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Email: [email protected] (preferred method of contact)
Telephone: 301-945-7573

Karen A. Kehl, Ph.D., R.N., F.P.C.N.
National Institute of Nursing Research (NINR)
Telephone: 301-594-8010
Email: [email protected]

Weiqun Li, M.D.
National Institute of Nursing Research (NINR)
Telephone: 301-594-5966
Email: [email protected].

Ron Wertz
National Institute of Nursing Research (NINR)
Telephone: 301-594-2870
Email: [email protected]

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 Part 75.