Part 1. Overview Information

Key Dates

All applications are due by 5:00 PM local time of applicant organization. 

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

No late applications will be accepted for this Notice of Funding Opportunity (NOFO).

It is critical that applicants follow the Multi-Project (M) Instructions in the How to Apply - Application Guide, except where instructed to do otherwise (in this NOFO or in a Notice from the NIH Guide for Grants and Contracts). Conformance to all requirements (both in the Application Guide and the NOFO) 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 2. Full Text of Announcement

Section I. Notice of Funding Opportunity Description

Key Definitions for this NOFO

• AD/ADRD: The most common forms of dementia. While AD is the most common dementia diagnosis, ADRDs share many cognitive and pathological features and can be difficult to distinguish from AD. In fact, often, patients with an AD diagnosis present with different mixtures of brain pathologies, complicating both the diagnosis and the treatment. ADRDs include frontotemporal degeneration, Lewy body dementia, vascular contributions to cognitive impairment and dementia, and mixed etiology dementias.
• Caregiver: Caregiver, care partner, or family member or other person providing care support – whether exclusively or as part of a network of caregivers – to the patient or person living with serious illness who may need or benefit from palliative or supportive care that improves quality of life. The caregiver, who may not necessarily use the term “caregiver” to describe themselves, may be involved in co-managing the demands of the serious illness through activities such as providing emotional, logistical, or other support, coordinating care, and participating in decision-making.
• Care coordination: The deliberate organization of patient care activities among the patient and other participants involved in a patient’s care (e.g., family caregiver, clinician, care navigator, specialist) to facilitate the appropriate delivery of healthcare, social, or related home- and community-based services. Organizing care involves the marshaling of personnel and other resources needed to carry out all required patient care activities and is often managed by the exchange of information among participants responsible for different aspects of care, including medical care, social services, and long-term services and supports.
• Community engagement: The process of groups of people affiliated by geographic proximity, identity, special interest, or similar circumstances working collaboratively to build relationships and address issues affecting the well-being of those people. Many core principles of community engagement (trust, inclusivity, culturally-centered, etc.) are outlined in the National Academy of Medicine’s conceptual model for assessing meaningful community engagement. Community engagement should include practices that incorporate genuine bidirectional communication and education about culture, beliefs, motives, health, and clinical research. Continued respectful, equitable, and bidirectional knowledge transfer during community engagement can improve community research participation, trial retention, adherence to the study protocol, and health empowerment. While these principles of community engagement are useful and valuable for any populations of interest, they are critically needed for populations that experience health disparities who have been understudied in clinical studies.
• Community-engaged research: In community-engaged research, scientists or research teams use community engagement strategies to develop research questions, design studies, collect data, interpret results, or disseminate findings as it relates to the specific community’s health. Incorporation of these strategies into studies investigating health inequities can promote health and build bi-directional trust thereby reducing barriers that limit research participation, underlie medical mistrust, and drive research exclusion across NIH-designated populations that experience health disparities. The information and input iteratively collected throughout the community engagement process should be visibly reflected across the research study and within the study design. Effective community-engaged research will include plans to secure shared understanding, power and resource sharing, and mutually beneficial findings dissemination across research and community partners participating in the study. Engaging the community in research contributes to successful health equity study design that is inclusive of a variety of participants and perspectives across the research continuum and provides infrastructure to ensure culturally appropriate research strategies, tools, and communication are incorporated throughout the study process. Partnering with the community supports the development of sustainable interventions and the translation of study results into practice. Within the scope of this NOFO, we specifically focus on community-engaged research with populations that experience health disparities (see “Priority Populations” in the NIA Health Disparities Research Framework).
• Consortium: A network of personnel, resources, and services organized across institutions around a central purpose. The Consortium resulting from this NOFO also includes any pilot project, research study, or research education participants supported by the U54 award; members of the Consortium’s palliative care network of partnerships; and future award recipients associated with the overall effort.
• Developmental project: Projects aimed at technology, resource, and/or methods development to establish new methods or technologies that will enrich the resources or services provided by the Consortium and its individual components. Developmental projects are not intended to duplicate pilot or exploratory studies or the research study opportunities in the Research Education C omponent.
• NIA Health Disparities Research Framework: A conceptual, integrative tool that highlights important factors to be addressed in research to address or eliminate health disparities (Hill et al., 2015). The framework provides a cohesive structure that may help researchers (1) identify additional team members that possess specific expertise to lead or develop key areas of a study; (2) facilitate ways to identify causal pathways among and between different multiple priority populations, and (3) distinguish levels of analysis that include social-cultural, behavioral, environmental, to the biological factors that impact health and drive health disparities. The framework also expands the list of potential variables researchers may target.
• NIH Stage Model for Behavioral Intervention Development (NIH Stage Model): A model of non-pharmacological intervention development composed of six non-linear stages that encourages examination of mechanisms of behavior change is encouraged in every stage of intervention development. Training videos and other resources on the NIH Stage Model are available online.
• Palliative care: Active holistic interdisciplinary care focused on improving quality of life for persons with serious illness across the lifespan and their families and caregivers (Kelley & Morrison, 2015; Radbruch et al., 2020). The core elements of palliative care include treating symptoms such as pain and psychological and spiritual distress, eliciting goals of care, promoting care concordant with those goals, and facilitating coordination of care. Palliative care may occur alongside other care intended to cure or forestall progression of underlying disease and is initiated as early as the time of diagnosis. Palliative care teams can include members from a range of medical specialties (e.g., internal medicine, pediatrics, surgery, psychiatry, neurology) and disciplines (e.g., physician assistants, nurse practitioners, social workers, chaplains). Toward the final weeks or months of life, an individual may elect to forego curative treatment while maintaining focus on quality of life and relief of suffering (i.e., end-of-life care). This focused care may be provided in hospice when a patient has an expected survival of 6 months or less. In this NOFO, the term “palliative care” includes, but is not limited to, advance care planning, end-of-life care, and hospice care.
• Serious illness: A health condition that carries a high risk of mortality AND either negatively impacts a person's daily function or quality of life, OR excessively strains their caregivers (Kelley & Bollens-Lund, 2018).
• Underserved populations: “Priority Populations” in the NIA Health Disparities Research Framework, as such populations may experience barriers to accessing needed health care services or to have inadequate or inequitable healthcare coverage.
• Underrepresented populations: Populations that are underrepresented in the U.S. biomedical, clinical, behavioral, and social sciences research enterprise (see NOT-OD-20-031).

Background

Palliative care aims to alleviate symptoms, deliver goal-concordant care, and facilitate care coordination for persons living with serious illness(es) across the lifespan and has been associated with improved care quality and, in some cases, length of life. Due to the growing evidence on the positive impact of palliative care, many professional organizations recommend its delivery concurrently with disease-focused treatment. Equitable access to reliable high-quality palliative care for a range of serious illnesses across the life span is a growing public health priority. It is estimated that about 12 million adults and hundreds of thousands of children are living in the U.S. with serious illnesses, such as cancer, heart disease, kidney disease, or AD/ADRD, and many are living longer with disease. This problem is further exacerbated by the projected increase in older adults, the majority of whom will be living with multiple chronic conditions.

Given the trans-disciplinary nature of palliative care research for populations across the lifespan – spanning ages, conditions, specialties – there is a need for a coordinated research infrastructure to build a more inclusive and representative palliative care clinical workforce (AAHPM & The George Washington University Health Workforce Institute, 2016) and support innovative, high-quality palliative care research, including on health and healthcare disparities, to build a cumulative evidence base. 

Purpose

This NOFO invites applications proposing the development of a Consortium to diversify, coordinate, integrate, and advance palliative care research across the lifespan. The aim of the Consortium will be to provide resources, expertise, and coordination to advance innovative, high-quality research on palliative care for those living with serious illnesses across the lifespan. The research infrastructure will encompass AD/ADRD, cancer, and other serious illnesses and populations relevant to NIH’s partnering ICOs. An important focus will be research to understand and address disparities in access, quality, and use of palliative care services for health disparities populations (as defined by the  NIA Health Disparities Framework  priority populations). NIH currently funds many palliative care research projects across its ICOs, and there is a need for a structure to leverage synergies, coordinate efforts, develop the scientific workforce, and address remaining gaps in the field. The resulting Consortium is intended to expand and intensify NIH’s investment in palliative care research across the lifespan.

This NOFO utilizes the Specialized Center--Cooperative Agreement (U54) activity code, with an embedded Linked Education Project (RL5) activity code, that allows for multiple core components and substantial scientific and programmatic involvement of NIH staff.

Specific Interests of Participating ICOs

Advancing palliative care research is consistent with the missions of multiple NIH's ICOs. For the purpose of this NOFO, “palliative care research across the lifespan and a range of serious illnesses” is inclusive of all age groups, populations, and diseases and conditions of interest to the participating ICOs, including in geriatric, pediatric, neonatal, pregnant, and lactating populations and for individuals living with AD/ADRD, cognitive impairment, cancer, mental health or psychiatric disorders, and serious heart, lung, blood, and sleep illnesses. Below are the specific research interests of the majority of ICOs participating in the NOFO:

National Institute on Aging (NIA)
NIA's research interest includes the following:  

• Research focused on palliative care in individuals and populations with age-related diseases, conditions, and/or special problems and needs associated with older age, such as AD/ADRD, cognitive impairment, multiple chronic conditions, polypharmacy, and other geriatric diseases or conditions.
• Research to understand and address gender, racial, ethnic, geographic, and socioeconomic disparities in access, delivery, and outcomes of palliative care for older adults with serious illness and their caregivers.
• For research studies, resources, and guidance focused on behavioral interventions, including pragmatic trials and trials involving health systems interventions, NIA seeks approaches aiming to develop interventions that: 1) are defined by their principles (mechanisms) and 2) ultimately can be delivered with fidelity in the community, in accordance with the NIH Stage Model.

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
In pediatrics, as advances have been made in critical care and neonatology, mortality rates have continued to decrease while morbidities have climbed leading to an increased prevalence of children with medical complexity. Therefore, NICHD's research interest includes the following: 

• Pediatric palliative care research for pediatric, neonatology, and pregnant and lactating persons with serious illness.  

National Institute of Mental Health (NIMH)
NIMH's research interest includes the following:

• Pilot projects that will determine the feasibility of evidence-based treatments for the psychiatric manifestations associated with palliative care.
• Projects to support the development of new and early-stage investigators in the delivery of mental health services to this population.

National Institute of Nursing Research (NINR) 
The National Institute of Nursing Research (NINR) supports research aligned with our mission and strategic priorities, conducted by scientists from any discipline. NINR discovers solutions to health challenges through the lenses of health equity, social determinants of health, population and community health, prevention and health promotion, and systems and models of care. Drawing on the strengths of nursing’s holistic, contextualized perspective, core values, and broad reach, NINR funds multilevel and cross-sectoral research that examines the factors that impact health across the many settings in which nurses practice, including homes, schools, workplaces, clinics, justice settings, and the community.

National Cancer Institute (NCI)
Given the evolving landscape of cancer diagnosis and treatment, many people are living longer both with cancer and after cancer treatment.  Therefore, NCI is specifically interested in:

• Studies focused on advancing the science of palliative care in the context of cancer patients diagnosed at any stage and age, cancer survivors, and other persons affected by cancer, including cancer caregivers.
• Studies developing and testing tailored palliative care strategies that aim to identify and mitigate cancer- and cancer treatment-related symptoms.
• Studies focused on identifying sustainable models of palliative care in the context of people living with advanced cancer.
• Studies focused on mitigation and alleviation of health disparities in cancer palliative care research and practice.
• Multi-level studies focused on increasing uptake of evidence-based palliative care interventions in cancer care delivery settings.

Studies above could be conducted in either the investigator-initiated setting or through collaboration with The NCI Community Oncology Research Program (NCORP) which brings clinical research studies to individuals in their own communities.

Research Objectives

The overall goals of the Consortium are to:

1. Create new scientific knowledge on delivery and outcomes of palliative care approaches across the lifespan and across a range of populations and serious illnesses. An important focus will be research to understand and address disparities in access, quality, and use of palliative care services for minority health and NIH-designated populations that experience health disparities (as defined by the NIA Health Disparities Framework priority populations).
2. Foster development of early- and mid-career investigators pursuing research careers in palliative care as well as established investigators shifting to palliative care research, with a goal of diversifying and expanding the palliative care research workforce.
3. Serve as a national platform that provides resources and expertise to facilitate high-quality research on palliative care across the lifespan and across a range of populations and serious illnesses, including clinical trials, observational, quasi-experimental, and qualitative research.
4. Engage healthcare systems, including long term care settings; home- and community-based services organizations; and other community partners, to inform the design and conduct of palliative care research studies, including pragmatic clinical trials.
5. Disseminate research findings and their implications for clinical practice, methodologic approaches, best practices, toolkits, and other impactful resources for researchers, clinicians, patients, and other relevant audiences.

Applicants are encouraged to address how the design and conduct of all activities of the Consortium will consider from the beginning how the resulting information, best practices, guidance, data, or other resources will be disseminated to the broader research community. The Consortium is encouraged to interact with and leverage existing NIA- and NIH-supported networks and centers to create synergies while avoiding duplication of existing efforts, including, for example, the NIH Pragmatic Trials Collaboratory, AD/ADRD IMPACT Collaboratory, Cancer and Aging Research Group (CARG), Geriatric Emergency care Applied Research Network (GEAR), Clin-STAR, the Research Centers Collaborative Network (RCCN), the Collaborative Pediatric Critical Care Research Network, the NCI Community Oncology Research Program (NCORP), the Brain Donor Project, and other NIH-supported research infrastructures. 

Organizational Structure

The Consortium will consist of seven required components and up to four optional components. Henceforth, the terms “component(s)” and “Core(s)” will be used interchangeably to reference the components of this NOFO. A brief description of each C omponent is provided below.  A complete list of requirements for each C omponent is detailed in Section IV of this NOFO. 

1. Overall (required): This component will comprise the general organizational structure of the Consortium and all its activities.
2. Leadership and Administrative C omponent (required): This C omponent will maximize the overall impact of the Consortium by providing effective governance, leadership, and coordination for all components of the Consortium and ensure that strategies to foster diversity, equity, inclusion, and accessibility (DEIA) are embedded throughout all Consortium activities.
3. Research Education C omponent (REC) (required): This C omponent will facilitate the development of a diverse palliative care research workforce by supporting early- and mid-career REC Scholars from diverse backgrounds, such as individuals from underrepresented groups in their career development and through other research experiences, mentoring activities, curriculum or methods development, courses for skills development, and/or outreach activities.
4. Pilot / Exploratory Studies Component (required): This Component will support rigorous and innovative palliative care research informed by current research priorities, gaps, and opportunities to advance palliative care science and impact clinical practice by supporting pilot projects and exploratory studies.
5. Research Design and Methodology C omponent (required): This C omponent will facilitate rigorous palliative care research by providing expertise, training, trial design resources, biostatistics and analysis guidance, support for community-based participatory research approaches, and other methodological support and consultation, including tools and best practices for recruitment and retention, particularly for underserved populations, and safety reporting guidance to pilot and exploratory study recipients  and the broader Consortium community.
6. Measures and Measurement Development C omponent (required): This C omponent will facilitate the advancement of a cumulative and integrated palliative care research knowledge base by supporting the development, testing, harmonization, and implementation of measures of key outcomes, including those that matter most to patients and caregivers.
7. Health Disparities Research and Community Engagement C omponent (required): This C omponent will facilitate high-quality research to understand and address health disparities in palliative care access, use, and quality for health disparities populations and/or populations living in underserved areas and facilitate community-engaged research.
8. Optional C omponents (optional): Applicants may propose up to four investigator-initiated C omponents that will benefit the overall Consortium. Applicants may want to consider topics such as the following:
   • Data science, including clinical informatics, interoperability (e.g., to improve data standardization across research studies, support data sharing).
   • Cost-effectiveness and health economics, as described in NOT-OD-16-025, and aligned with NIA’s research priorities (for example, see NIA AD/ADRD Research Implementation Milestone 13.P).
   • Bioethics (e.g., to develop ethics guidelines, particularly for situations in which the patient lacks capacity to consent).
   • Implementation and dissemination (e.g., summarize and disseminate evidence base and best practices for large scale, real-world implementation, ensure scalability of tools and methods).
   • Biostatistics and analysis (e.g., advancing knowledge of lessons learned from within-group analysis that better explains nuanced experiences within a particular group, rather than using classic between group analyses that may perpetuate assumptions about a specific population of the field of palliative care).

A Consortium Steering Committee for the cooperative agreement award will be established to address issues that span C omponents and activities, provide input towards the policies and processes of the Consortium, and assist in dissemination of policies and processes that enable research in partnership with healthcare and social service systems, their patients and caregivers, and practitioners.

To ensure that the Consortium achieves its objectives under the cooperative agreement, an External Advisory Panel (EAP) will provide input to the Consortium Steering Committee.

For more information, see “Cooperative Agreement Terms and Conditions of Award” in Section VI of this NOFO.

Staff in the Office of Planning, Analysis, and Evaluation at NIA may conduct a program evaluation of the Consortium, in addition to the activities of the EAP.

Non-Responsiveness Criteria

The following types of applications will be considered non-responsive to this NOFO and will be administratively withdrawn prior to scientific peer review:

• Applications that do not provide all required elements for all required components 

Resources for Applicants

• FAQs: Responses to frequently asked questions about this NOFO will be posted here.
•  Pre-Application Webinar: A webinar is planned to provide prospective applicants the opportunity to understand and ask questions on the scientific scope of this NOFO and technical details for applying. The webinar will be open to all prospective applicants. Participation in the webinar is not a prerequisite to applying to this NOFO, but prospective applicants will need to register in order to participate. Prospective applicants are also encouraged to submit their questions in advance of the webinar. Further details on where to submit the questions and registration information are provided here. 

OutreachPro

NIA is committed to ensuring that clinical research studies have diverse and inclusive representation, particularly of those communities understudied in research. NIA’s National Strategy for Recruitment and Participation in Alzheimer’s and Related Dementias Clinical Research provides an emphasis on the urgent need for more research volunteers and from various populations and it encourages examining  research study populations across multiple factors such as age, race, ethnicity, sex, education, socioeconomic status, geographic location, comorbidities, and cognitive status. To  increase participation in AD/ADRD clinical trials, NIA developed a public facing tool, OutreachPro. OutreachPro is an online recruitment materials generator that enables grantees to develop customizable and culturally appropriate materials in multiple languages to raise awareness of, and interest in, AD/ADRD clinical trials. Grantees and research teams are encouraged but not required to use this free online resource to enhance their recruitment and retention plans and related activities for their NIA-funded clinical studies.

Clinical Research Operations Management System 

NIA uses a central resource to NIA staff and extramural investigators to facilitate/support the conduct and management of clinical research. NIA Clinical Research Operations & Management System (CROMS) is a comprehensive data management system to support the business functions, management, and oversight responsibilities of NIA grants that support the conduct of clinical research with human subjects. NIA investigators of grants, contracts, and cooperative agreements that are active as of July 1, 2021, including clinical trials funded as pilots, exploratory studies, or other projects through this Consortium, and support human subjects research as defined by the DHS HHS OHRP regulations at 45 CFR 46 will be required to interact with and use existing and future components of CROMS as required by NIA throughout the lifecycle of the grant, as described in NOT-AG-23-017. Data to be submitted to NIA CROMS includes those elements reported in the standard NIH requirement annual progress report (GPS 4.1.15.7). Details regarding the standard operating procedures for CROMS can be found on the NIA CROMS website. 

When applicable, all NIA grantees must ensure: 

1. The study’s Informed Consent Document (ICD) lists “The National Institutes of Health (NIH) and its authorized representatives” as one of the organizations that may look at or receive copies of information in participants’ study records. According to DHS HHS OHRP 45 CFR 46 §46.116, all ICDs must contain “A statement describing the extent, if any, to which confidentiality of records identifying the participant will be maintained.” If using the NIA informed consent template, please see Section 6: Statement of Confidentiality.  

2. An assigned NIH ClinicalTrials.gov identifier (NCT number) is reported in its respective CROMS study record within three months after assignment, and the reporting of final enrollment data to CROMS is consistent with final enrollment data reported in ClinicalTrials.gov. 

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

Investigators proposing NIH-defined clinical trials may refer to the Research Methods Resources website for information about developing statistical methods and study designs.

Section II. Award Information

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

Section III. Eligibility Information

1. Eligible Applicants

Higher Education Institutions

• 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:

• Hispanic-serving Institutions
• Historically Black Colleges and Universities (HBCUs)
• Tribally Controlled Colleges and Universities (TCCUs)
• Alaska Native and Native Hawaiian Serving Institutions
• 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)

Local 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)

Federal Governments

• 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 Organization) 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 How to Apply- 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. Failure to complete registrations in advance of a due date is not a valid reason for a late submission, please reference NIH Grants Policy Statement Section 2.3.9.2 Electronically Submitted Applications for additional information.

• System for Award Management (SAM) – 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.
  • Unique Entity Identifier (UEI) - A UEI is issued as part of the SAM.gov registration process. The same UEI must be used for all registrations, as well as on the grant application.
• eRA Commons - Once the unique organization identifier is established, organizations can register with eRA Commons in tandem with completing their Grants.gov registration; all registrations must be in place by time of submission. 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 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 diverse backgrounds, including underrepresented racial and ethnic groups, individuals with disabilities, and women are always encouraged to apply for NIH support. See, Reminder: Notice of NIH's Encouragement of Applications Supporting Individuals from Underrepresented Ethnic and Racial Groups as well as Individuals with Disabilities, NOT-OD-22-019. 

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

2. Cost Sharing

This NOFO does not require cost sharing as defined in the NIH Grants Policy Statement Section 1.2- Definitions of Terms.

3. Additional Information on Eligibility

Number of Applications

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 per NIH Grants Policy Statement Section 2.3.7.4 Submission of Resubmission Application. 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 NIH Grants Policy Statement 2.3.9.4 Similar, Essentially Identical, or Identical Applications).

Section IV. Application and Submission Information

1. Requesting an Application Package

The application forms package specific to this opportunity must be accessed through ASSIST or an institutional system-to-system solution. A button to apply using ASSIST is available in Part 1 of this NOFO. See the administrative office for instructions if planning to use an institutional system-to-system solution.

2. Content and Form of Application Submission

It is critical that applicants follow the Multi-Project (M) Instructions in the How to Apply - Application Guide, except where instructed in this notice of funding opportunity 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.

Letter of Intent

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

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

• 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 [email protected].

Page Limitations

All page limitations described in the How to Apply- Application Guide and the Table of Page Limits must be followed. The application should consist of the following components:

Instructions for the Submission of Multi-Component Applications

The following section supplements the instructions found in How to Apply- Application Guide and should be used for preparing a multi-component application.

Overall Component

When preparing the application, use Component Type ‘Overall’.

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

SF424(R&R) Cover (Overall)

Complete entire form.

PHS 398 Cover Page Supplement (Overall)

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

Research & Related Other Project Information (Overall)

Follow standard instructions.

Project/Performance Site Locations (Overall)

Enter primary site only.

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

Research and Related Senior/Key Person Profile (Overall)

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

Senior/key personnel must have:

• Experience conducting and leading palliative care research for serious illnesses across the lifespan and across a range of populations and serious illnesses. 
• Experience conducting research on palliative care health disparities and/or disparities in palliative care access, quality, or utilization.
• Proficiency in translating and disseminating palliative care research findings to a wide range of stakeholders.
• Experience in project management, from idea conception through implementation, tracking, and completion, with a focus on developing funding competitions and supporting research projects.
• Experience engaging a wide range of partners, such as public entities, academia, industry representatives, healthcare systems, providers, community-based organizations, professional associations, advocacy groups, and individuals directly affected by serious illness and their caregivers.
• Experience working in research consortia or other collaborative projects, with a demonstrated ability to achieve shared goals and objectives and foster communication and collaboration among multiple components.
• Demonstrated track record of understanding and management of the budgetary requirements and constraints for research projects and consortium cores, including direct cost limitations and funding allocations.
• Demonstrated track record of supporting and promoting diversity, equity, inclusion, and accessibility (DEIA) among scientific workforce members of  research teams  and/or research infrastructure activities.
• Experience providing a supportive environment and mentoring experiences for new and early-stage investigators from   diverse backgrounds, including individuals from underrepresented groups  (see Notice of NIH's Interest in Diversity, NOT-OD-20-031). 

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

Budget (Overall)

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

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

PHS 398 Research Plan (Overall)

Specific Aims: Describe the aims of the overall Consortium and outline how the Cores will synergistically contribute to these aims. 

Research Strategy: Organize the Research Strategy into sections on Significance, Approach, and Innovation. Applications must include the following:

Significance: Focusing on the Consortium as a whole, applications are required to address the following:

• The importance of the problem or critical barrier to progress in palliative care research across the lifespan and across a range of populations and serious illnesses;
• How the proposed Consortium activities will integrate and promote DEIA and improve scientific knowledge, technical capability, and/or practice in palliative care.
• How the concepts, methods, technologies, treatments, services, or preventive interventions that drive this field will be changed if the proposed aims are achieved. 

Approach: Focusing on the Consortium as a whole, applications are required to do the following:

• Present the Consortium’s overall strategy for serving as a sustainable resource to the palliative care research field. 
• Describe how it will accomplish the innovation, intellectual leadership, translational, interdisciplinary, collaborative, and investigator development functions expected of the Consortium. 
• Describe how the Consortium will provide a supportive environment for early-stage and new investigators from diverse backgrounds, such as individuals from underrepresented groups (see Notice of NIH's Interest in Diversity, NOT-OD-20-031). 
• Describe how the different Cores of the Consortium will interact synergistically to help accomplish its aims, how the approaches of the Cores complement each other or are interdependent, the mechanisms to ensure coherence of the Consortium and maintenance of scientific focus, and the mechanisms to be used in assessing progress toward the Consortium’s goals. 
• Where appropriate, provide timelines and organizational charts. Note the major Core components and other activities, referencing, but not repeating, appropriate subsequent sections of this application that contain more detail. For illustrative purposes, applications may, but are not required to, include a diagram of the organizational structure of the proposed Consortium.  
• Present preliminary data or evidence of preparatory activities or prior relevant work for establishing this Consortium. Applications may describe preliminary organizational work and/or experience with, and potential for, developing new and innovative palliative care research, as well as specific plans for organization and implementation of the new program. 

Innovation: Focusing on the Consortium as a whole, applications are required to do the following: 

• Describe how the proposed Consortium seeks to shift current research or practice paradigms through use of novel concepts, approaches, methodologies, instrumentation, or interventions. 
• Describe how these concepts, approaches, methodologies, instrumentation, or interventions are novel to the research field or novel in a broad sense. 
• Describe how the proposed work refines, improves, or applies, in a new way, the concepts, approaches, methodologies, instrumentation, or interventions proposed. 
• Describe how the proposed Consortium will achieve an impact on the field of palliative care research broadly beyond the institutions involved in the Consortium or its components.

Letters of Support: Evidence of institutional commitment to the Consortium is required. Include letters of support from institutional officials from the applicant institution(s), affiliated institution(s), and institutions of other collaborative partners. Letters should include commitments of time, human capital, and other resources required by the Consortium. Letters from the investigators of the research community, or those providing needed resources, may be provided to document their research interests and/or current or planned interactions. Letters may also be from collaborators or communities that would benefit from the Consortium activities and resources, such as knowledge.

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.

Other Plan(s):

Note: Effective for due dates on or after January 25, 2023, the Data Management and Sharing Plan will be attached in the Other Plan(s) attachment in FORMS-H application forms packages. If required, the Data Management and Sharing (DMS) Plan must be provided in the Overall component. 

All instructions in the How to Apply- Application Guide must be followed, with the following additional instructions:

• All applicants planning research (funded or conducted in whole or in part by NIH) that results in the generation of scientific data are required to comply with the instructions for the DMS Plan. All applications, regardless of the amount of direct costs requested for any one year, must address a DMS Plan.

Appendix:

Only limited items are allowed in the Appendix. Follow all instructions for the Appendix as described in How to Apply- Application Guide; any instructions provided here are in addition to the Application Guide instructions.

PHS Human Subjects and Clinical Trials Information (Overall)

When involving human subjects research, clinical research, and/or NIH-defined clinical trials follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the SF424 (R&R) Application Guide, with the following additional instructions:

If you answered “Yes” to the question “Are Human Subjects Involved?” on the R&R Other Project Information form, there must be at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or a Delayed Onset Study record within the application. The study record(s) must be included in the component(s) where the work is being done, unless the same study spans multiple components. To avoid the creation of duplicate study records, a single study record with sufficient information for all involved components must be included in the Overall component when the same study spans multiple components.

Study Record: PHS Human Subjects and Clinical Trials Information

All instructions in the SF424 (R&R) Application Guide must be followed.

Delayed Onset Study

Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start). All instructions in the How to Apply- Application Guide must be followed.

PHS Assignment Request Form (Overall)

All instructions in the How to Apply- Application Guide must be followed.

Leadership and Administrative Core (LAC)

Core functions should include:

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

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

Note: Effective for due dates on or after January 25, 2023, the DMS Plan will be attached in the Other Plan(s) attachment in FORMS-H application forms packages. If required, the DMS Plan must be provided in the Overall component.

SF424 (R&R) Cover (LAC)

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 (LAC)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (LAC)

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) (LAC)

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 (LAC)

• In the Project Director/Principal Investigator section of the form, use Project Role of ‘Other’ with Category of ‘Project 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.
• The PD(s)/PI(s) for the Consortium application must be the Core Lead(s) for the LAC. The Core Lead(s) must have demonstrated leadership and administrative skills and sufficient time to devote to the Core to ensure that the aims are met and required functions are carried out efficiently. An Associate Director may be named who will be involved in the administrative and scientific efforts of the Consortium.
• The PD(s)/PI(s) must have extensive experience conducting and coordinating palliative care research across the lifespan; organizing research infrastructure; and successfully mentoring early career investigators for independent research careers, including faculty from diverse backgrounds, including individuals from underrepresented groups(see Notice of NIH's Interest in Diversity, NOT-OD-20-031). The PD(s)/PI(s) biographical sketch should present evidence of experience relevant to the scientific areas and themes of the Consortium and demonstrate the capacity for leadership of the Consortium.
• The application must provide an explanation of how the leadership team and key personnel have richly varied and heterogeneous perspectives, academic backgrounds, and scientific and technical disciplines. NIH will use the information provided in the explanation in a manner consistent with applicable law.

Budget (LAC)

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

Application budgets must include funds for planning and implementing (e.g., meeting logistics, travel, virtual logistics, notetaking) hybrid Consortium research and EAP meetings in the Washington, DC metro area beginning in Year 1 to be held at least annually, including preparation of a meeting report. Applicants should budget appropriately for secretarial support for notetaking and travel services for the Consortium investigators and External Advisory Panel members.

Applicants may propose and budget for a standing DSMB and/or individual safety officers to provide safety oversight for human subjects intervention studies supported by the Consortium. 

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 (LAC)

Specific Aims: State the goals of the proposed LAC concisely and summarize the expected outcome(s).   

Research Strategy Organize the Research Strategy into sections on Significance, Approach, and Innovation. Applications must include the following:

Significance: Describe the overall role of the LAC in the Consortium as a whole and as a resource for other ongoing palliative care research activities of the Consortium.

Approach and Innovation: Applications must describe how the LAC will conduct and organize the following activities:

Leadership and Overall Oversight

• Provide scientific and intellectual leadership and strategic direction for the Consortium.
• Maintain the scientific focus and promote innovation in Consortium activities.
• Foster and meaningfully integrate DEIA throughout the Consortium activities, practices, and procedures.
• Provide administrative oversight and create mechanisms and procedures for ensuring interaction between the Consortium Cores and specify the objectives of that interaction.
• Provide plans to support and operate a Consortium Steering Committee to address issues that span cores and activities, provide input towards the policies and processes of the Consortium, and assist in dissemination of policies and processes that enable research in partnership with healthcare and social service systems, their patients and caregivers, and practitioners. The Steering Committee should be composed of, at minimum, the PDs/PIs of the Consortium; Core leaders, as needed; the NIA Program Official; and one or more NIH Project Scientist(s). The combined vote of NIA/NIH membership will not constitute a majority of eligible votes.
• Provide plans to organize and support additional committee(s) as appropriate to the applicant's aims, such as an executive committee, etc.
• Ensure compliance with human subjects, animal welfare, scientific integrity, data and sample sharing as appropriate, as well as financial policy requirements of the NIH.
• Describe the internal institutional plans and procedures to ensure that all projects supported from this award will comply fully with all applicable Federal regulations, policies, and guidelines for research involving human subjects, including the evaluation of risks and protections in project proposals, appropriate ethical oversight and funded projects, and plans for data and safety monitoring for clinical trials. All plans must be consistent with all relevant NIH policies and the NIA policies for human intervention studies. A Data and Safety Monitoring Plan (DSMP) must be included for each Consortium supported study or project proposed that involves human subjects.
• Applicants should propose a consolidated or centralized IRB approach consistent with NIH single IRB policy for multi-site research and the federal regulation for cooperative research at 45 CFR46.114 for trial oversight to facilitate both appropriate and timely study implementation. 
• Describe previous preliminary organizational work and institutional experience mentoring junior investigators from diverse backgrounds, including individuals from underrepresented groups (see Notice of NIH's Interest in Diversity, NOT-OD-20-031) for independent research careers.
• Describe experience in, and potential for, developing new and innovative palliative care research across the lifespan and range of serious illness and specific plans for implementation.

Stakeholder Engagement

• Identify potential areas for collaboration between the Consortium cores and other NIA- and/or NIH-funded Centers or programs, and identify any potential collaborative activities, if merited, including, for example, the NIH Pragmatic Trials Collaboratory, AD/ADRD IMPACT Collaboratory, CARG,  GEAR, Clin-STAR, RCCN, the Collaborative Pediatric Critical Care Research Network, and NCORP.
• Develop and maintain partnerships to inform design and conduct of pragmatic palliative care research studies with a variety of healthcare systems, including long-term care settings; home- and community-based services organizations; and other potential service providers, organizations, or community members.

Dissemination and Implementation

• Design, develop, and launch a public website for communication and sharing of activities, events, products, data, and resources of the Consortium.
• Develop standards and processes for publicly sharing knowledge, tools, data, and other resources generated by the Consortium and its cores and components and a plan for the sustainability of these resources for the research community beyond the funding period of the Consortium.
• Disseminate research findings, methodologic approaches, best practices, toolkits, data resources, and other impactful information for researchers, clinicians, patients, and other relevant audiences.
• If applicants propose dissemination and implementation functions in one of the optional cores, these required functions may shift to that core with oversight from the LAC.

Evaluation

• Present a plan for evaluating all activities supported by the award as a whole. 
• Create and maintain a system for 1) tracking REC Scholars, pilot project, and exploratory study awardees using ORCID IDs as unique identifiers through and beyond the award of independent research funding and 2) sharing information and data related to scientists and mentors (e.g., study aims of pilots, other research projects, collaborations, and publications and other accomplishments and shareable training materials and research resources to facilitate the completion of the Consortium’s Annual Report and for program evaluation.
• Specify baseline metrics as well as measures to gauge the short and/or long-term success of the award in achieving its objectives. Applicants must describe concrete indicators of progress toward the research project objectives of the initiative, including measures, potential data sources, and a timeline. Applicants must build evaluation metrics into a proposed approach that will be assessed by peer review.
• Include measures to assess the administrative and scientific accomplishments of the Consortium, both yearly and overall. Evaluation results should be included in each annual progress report and as part of the final report for the grant.

Letters of Support: Only letters of support specific to "Leadership and Administrative Core" should be attached to this section. Applicants should include letters of support from healthcare system and other community partners, as appropriate.

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:

Appendix:

Only limited items are allowed in the Appendix. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide; any instructions provided here are in addition to the SF424 (R&R) Application Guide instructions.

PHS Human Subjects and Clinical Trials Information (LAC)

When involving human subjects research, clinical research, and/or NIH-defined clinical trials follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the SF424 (R&R) Application Guide, with the following additional instructions:

If you answered “Yes” to the question “Are Human Subjects Involved?” on the R&R Other Project Information form, you must include at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or a Delayed Onset Study record.

Study Record: PHS Human Subjects and Clinical Trials Information

All instructions in the SF424 (R&R) Application Guide must be followed.

Delayed Onset Study

Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start). All instructions in the SF424 (R&R) Application Guide must be followed.

Research Education Core (REC) (RL5)

When preparing your application, use Component Type ‘REC.’

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

Note: Effective for due dates on or after January 25, 2023, the DMS Plan will be attached in the Other Plan(s) attachment in FORMS-H application forms packages. If required, the DMS Plan must be provided in the Overall component.

SF424 (R&R) Cover (REC)

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 (REC)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (REC)

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) (REC)

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 (REC)

• In the Project Director/Principal Investigator section of the form, use Project Role of ‘Other’ with Category of ‘Project 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. Note: Neither REC Scholars nor Program Faculty are considered Senior/Key personnel in the REC.  
• 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.
• REC Leads must have extensive experience in palliative care research; experience in successfully mentoring early-career and new investigators from diverse backgrounds, including individuals from underrepresented groups (see Notice of NIH's Interest in Diversity, NOT-OD-20-031); and experience implementing strategies to promote DEIA.
• Applicants are encouraged to include individuals who have richly varied and heterogeneous perspectives, academic backgrounds, and scientific and technical disciplines, as well as individuals with experience in health disparities research as REC key personnel.

Budget (REC)

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

• Funds for salaries and other expenses of the Core Lead(s), information resources, and support staff may be requested.
• The REC provides support for REC activities, including mentoring activities and the funding of mentored pilot projects conducted by REC Scholars. The REC may also offer short courses or workshops for skills development. REC Scholar costs must be itemized in the proposed budget.
• There is no minimum salary or professional effort requirement for REC Scholars. REC Scholars may receive salary support from other federal sources consistent with the institution's salary scale if those sources do not specifically prohibit such salary supplementation. Individuals supported by NIH training and career development mechanisms (i.e., K, T, or F awards) may receive, and indeed are encouraged to receive, educational experiences supported by the REC as scholars, but K, T, and F grantees may not receive salary or stipend supplementation from the REC.
• Allowable REC Scholar costs depend on the educational level/career status of the individuals to be selected to participate in the program.
• Because the RL5 program is not intended as a substitute for a NIH National Research Service Award (NRSA) institutional training program (e.g., T32), costs to support full-time scholars (i.e., those supported for 40 hours/week for a continuous 12-month period) are not allowable.
• All costs related to individual REC Scholar support (e.g., salary support, fringe benefits, research project costs, tuition expenses, travel to conferences and Consortium annual research meeting) may not exceed a direct cost of $150,000 per participant per year for up to 2 years.
• The REC must support at least 10 new scholars per year.
• Expenses for foreign travel must be exceptionally well justified.

Indirect costs (Facilities & Administrative costs) are reimbursed at 8% of modified total direct costs (exclusive of tuition, fees, and expenditures for equipment).

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 (REC)

Specific Aims: State the goals of the proposed REC concisely and summarize the expected outcome(s).   

Research Strategy: 

The Research Strategy section must be used to upload a Research Education Program Plan. The plan must include the following sections:

1. Proposed Research Education Program
2. Core Lead(s)
3. Program Faculty
4. Program Participants
5. Recruitment Plan to Enhance Diversity
6. Plan for Instruction in the Responsible Conduct of Research
7. Evaluation Plan

Details regarding what must be addressed in each section are provided below:

1. Proposed Research Education Program

While the proposed research education program may complement ongoing research training and education occurring at the applicant institution, the proposed educational experiences must be distinct from those research training and research education programs currently receiving federal support. When research training programs are ongoing in the same department, the applicant organization must clearly distinguish between the activities in the proposed research education program and the research training supported by the established training program.

The research education program must provide a variety of education activities, such as mentored research experiences, other mentored activities, curriculum or methods development, courses for skills development, and outreach activities. Additional activities, such as webinars, scientific workshops, networking events, and scientific interest groups may also be proposed. The research education program must be integrated with other activities of the Consortium such that tools, methods, and services from other Cores are included in REC training activities. 

Applications must describe: 

• The objectives of the program and the program activities that will be used to meet these objectives.
• Plans to accommodate differences in preparation among scholars.
• How the REC will promote development of future research leaders in palliative care, including mentorship from an assigned member of the Consortium with relevant expertise.
• A plan for administering a national competition at least annually for REC Scholars.
• Plans for solicitation, recruitment, selection, mentoring, monitoring, and tracking outcomes of REC Scholars over the proposed award period.
• The committee and/or advisory body involved in the selection of REC Scholars. Applicants may wish to cross-reference information about selection and review committees in the LAC or other cores.

Mentored research projects may be supported by the REC. If proposed, applications must describe the process through which such projects will be identified, administered, and tracked. Research projects must have a focus on palliative care and serious illnesses across the lifespan.

2. Core Lead(s)

Applications must:

• Describe arrangements for administration of the program.
• Provide evidence that the Core Lead(s) is/are actively engaged in research and/or teaching in an area related to palliative care, and that the Core Lead(s) can organize, administer, monitor, and evaluate the research education program.
• For programs proposing multiple Core Leads, describe the complementary and integrated expertise of the Leads, their leadership approach, and governance appropriate for the planned program.

3. Program Faculty

Researchers from diverse backgrounds, including individuals from underrepresented groups  are encouraged to participate as Program Faculty (See Notice of NIH's Interest in Diversity, NOT-OD-20-031) to help REC Scholars gain access to potential role models within the program and to enhance the excellence of the research education program. Faculty must have research experience relevant to the proposed program and demonstrate a history of, or the potential for, serving in their intended roles.

Applications must describe:

• How the Program Faculty will serve as preceptors/mentors and provide guidance and expertise appropriate to the level of the scholars proposed in the application.
• The complementary expertise and experiences of the proposed Program Faculty as role models by virtue of their scientific accomplishments, including active research and other scholarly activities in which the faculty are engaged, as well as experience mentoring and training individuals at the proposed career stage(s).
• A plan to ensure successful participant guidance by these individuals for any proposed Program Faculty lacking research education experience. 
• The criteria used to appoint and remove individuals as Program Faculty and to evaluate their participation.

Biosketches for Program Faculty should not be included in the application unless they are senior/key personnel in this or other cores.

4. Program Scholars

Applications must:

• Describe eligibility criteria and/or specific educational background characteristics required to participate in the proposed research education program.
• Identify the career levels for which the proposed program is planned. Present brief descriptions of research and training backgrounds, research activities, and mentoring plans of representative scholars.

REC support is intended mainly for early career faculty and postdoctoral research associates. Mid-career investigators are also eligible for REC support if they are transitioning to palliative care research. REC support should be integrated where allowable with other sources of career support that scholars may be receiving (e.g., GEMSSTAR, RCMAR, fellowships, non-NIH career development awards) in concerted programs for research education. REC support is intended primarily for U.S. citizens and permanent residents, unless there is strong justification otherwise based on exceptional relevance to NIH. 

5. Recruitment Plan to Enhance Diversity  (NOT-OD-20-031):

All applications must include a Recruitment Plan to Enhance Diversity, which must describe:

• Outreach strategies and activities designed to recruit prospective REC Scholar participants and Program Faculty from the underrepresented groups described in the Notice of NIH's Interest in Diversity.
• Specific efforts to be undertaken by the program and how the proposed plan reflects prior experience in recruiting individuals from underrepresented groups.
• Recruitment  plans and processes that include enhanced outreach to a variety of institution types including minority-serving institutions, such as Historically Black Colleges and Universities (HBCUs), Hispanic-Serving Institutions (HSIs), Tribal Colleges and Universities (TCUs), and Asian American and Pacific Islander Serving Institutions (AAPISIs).

Applications lacking a Recruitment Plan to Enhance Diversity will not be reviewed.

6. Plan for Instruction in the Responsible Conduct of Research

All applications must include a plan to fulfill NIH requirements for instruction in the Responsible Conduct of Research (RCR). The plan must address the following five required instructional topics outlined in the NIH policy: 

1. Format - the required format of instruction, i.e., face-to-face lectures, coursework, and/or real-time discussion groups (a plan with only online instruction is not acceptable); 
2. Subject Matter - the breadth of subject matter, e.g., conflict of interest, authorship, data management, human subjects and animal use, laboratory safety, research misconduct, research ethics; 
3. Faculty Participation - the role of the program faculty in the instruction; 
4. Duration of Instruction - the number of contact hours of instruction, taking into consideration the duration of the program; and 
5. Frequency of Instruction –instruction must occur during each career stage and at least once every four years.
    

See also NOT-OD-10-019. The plan should be appropriate and reasonable for the nature and duration of the proposed program.

7. Evaluation Plan

Applications must include a plan for evaluating the activities supported by the research education program in collaboration with the LAC’s overall evaluation efforts. The application must specify baseline metrics (e.g., numbers, educational levels, and other characteristics of scholars), as well as measures to gauge the short- or long-term success of the research education program in achieving its objectives. Wherever appropriate, applicants are encouraged to obtain feedback from scholars to help identify weaknesses and provide suggestions for improvements.

Letters of Support: Only letters of support specific to the "Research Education Component Core" should be attached to this section.

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:

Appendix:

Only limited items are allowed in the Appendix. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide; any instructions provided here are in addition to the SF424 (R&R) Application Guide instructions.

PHS Human Subjects and Clinical Trials Information (REC)

When involving human subjects research, clinical research, and/or NIH-defined clinical trials follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the SF424 (R&R) Application Guide, with the following additional instructions:

If you answered “Yes” to the question “Are Human Subjects Involved?” on the R&R Other Project Information form, you must include at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or a Delayed Onset Study record.

Study Record: PHS Human Subjects and Clinical Trials Information

All instructions in the SF424 (R&R) Application Guide must be followed.

Delayed Onset Study

Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start). All instructions in the SF424 (R&R) Application Guide must be followed.

Pilot/Exploratory Studies  Component (Pilot )

When preparing your application, use Component Type ‘Pilot .’

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

Note: Effective for due dates on or after January 25, 2023, the DMS Plan will be attached in the Other Plan(s) attachment in FORMS-H application forms packages. If required, the DMS Plan must be provided in the Overall component.

SF424 (R&R) Cover (Pilot )

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 (Pilot )

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Pilot )

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) (Pilot )

List all performance sites that apply to the specific component.

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

Research & Related Senior/Key Person Profile (Pilot )

• In the Project Director/Principal Investigator section of the form, use Project Role of ‘Other’ with Category of ‘Project 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.

Budget (Pilot )

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

Each pilot/exploratory study supported through this  component must not exceed a direct cost of $250,000 per year for a maximum duration of 2 years and may include funds for attending the annual Consortium research meeting. The Consortium may grant varying award levels based on need, scope, and other parameters. For example, smaller pilot studies may have a direct cost cap of $100,000 and a duration of 1 year, while larger exploratory studies may have a direct cost cap of $250,000 and a duration of 2 years. Other variations are permissible within the overall limits described above.

The Pilot  should aim to award at least 8-10 new studies per year.

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

PHS 398 Research Plan (Pilot )

Specific Aims: State the goals of the proposed Pilot  concisely and summarize the expected outcome(s).

Research Strategy: The objective of the Pilot  is to manage and support innovative pilot and exploratory studies informed by identified palliative care research priorities, gaps, and opportunities that serve to advance palliative care science and impact clinical practice.

Applicants must briefly describe at least 5 specific knowledge gaps or research opportunities, including the significance, approach, and any innovative aspects, that would be targeted in calls for pilot/exploratory palliative care study applications, including opportunities relevant to AD/ADRD, cancer, and health disparities.

Applicants must describe plans to administer a national competition to invite applications, at least annually, for pilot and exploratory study awards. Applicants are encouraged to consider solicitation plans and processes that include enhanced outreach to a variety of institution types, including outreach to minority-serving institutions. 

The plans must include a national competition process that:

• Is inclusive of palliative care research across the lifespan and across a range of serious illnesses and populations relevant to participating ICOs.
• Is inclusive of a range of research methods, study designs, and disciplines.
• Is structured to maximize geographic and institutional heterogeneity  among the awardees.
• Includes peer review of pilot and exploratory study applications; criteria and procedures for selecting applications for award; and plans for managing and supporting the awarded investigators and their projects.  

Applicants must also describe:

• A process to collect and track outcomes from each pilot and exploratory study supported by the Consortium and reporting on pilot and research study progress in required annual progress reports.
• How funding announcements for clinical trials will be in alignment with the NIH Stage Model, which has an emphasis on identifying the mechanisms (e.g., behavioral, social, institutional) responsible for an intervention’s effects and considering implementation in real-world contexts at the earliest stages of intervention development.
• Procedures to collect, store, and share data generated by pilot/exploratory studies, when appropriate, for reuse by the research community.

Applicants may wish to consider more than one call for applications per year, possibly with different foci. Award levels may differ on factors including research scope, applicant’s career stage, and if applicable, the relevant stage of intervention development research, if applicable (see NIH Stage Model).

Letters of Support: Only letters of support specific to the "Pilot/Exploratory Studies Component " should be attached to this section.

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:

Appendix:

Only limited items are allowed in the Appendix. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide; any instructions provided here are in addition to the SF424 (R&R) Application Guide instructions.

PHS Human Subjects and Clinical Trials Information (Pilot )

When involving human subjects research, clinical research, and/or NIH-defined clinical trials follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the SF424 (R&R) Application Guide, with the following additional instructions:

If you answered “Yes” to the question “Are Human Subjects Involved?” on the R&R Other Project Information form, you must include at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or a Delayed Onset Study record.

Study Record: PHS Human Subjects and Clinical Trials Information

All instructions in the SF424 (R&R) Application Guide must be followed.

Delayed Onset Study

Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start). All instructions in the SF424 (R&R) Application Guide must be followed.

Research Design and Methodology Core (Design Core)

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

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

Note: Effective for due dates on or after January 25, 2023, the DMS Plan will be attached in the Other Plan(s) attachment in FORMS-H application forms packages. If required, the  DMS Plan must be provided in the Overall component.

SF424 (R&R) Cover (Design 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 (Design Core)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Design 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) (Design 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 (Design Core)

• In the Project Director/Principal Investigator section of the form, use Project Role of ‘Other’ with Category of ‘Project 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.
• The application must include evidence that the collective experience of the proposed Design Core leads and key personnel include a range of methodological approaches, research designs, and clinical trial designs, including qualitative and quantitative methods, community-based participatory research approaches, and pragmatic clinical trial designs.  

Budget (Design Core)

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

Funds in this Core budget are not intended to support exploratory studies or clinical trials directly.

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 (Design Core)

Specific Aims: State the goals of the proposed Design Core concisely and summarize the expected outcomes.

Research Strategy: The objective of this Core is to provide expertise; training; clinical trial design resources; other study design and methodological support; biostatistics and analysis; consultation, including tools and best practices for recruitment and retention of palliative care research participants, including those from underserved and health disparities populations; and safety reporting guidance to the following: (1) pilot and exploratory study and REC Scholars applicants, (2) pilot and exploratory study awardees, REC Scholars, and (3) the broader Consortium community.

Applicants must describe plans to:

1. Provide clinical trial design, other study design, and methods consultations, resources, guidance, and support to the following: (1) pilot and exploratory study and REC Scholar applicants at some stage in the application process, (2) pilot and exploratory study awardees and REC Scholars, and (3) other Consortium supported projects. 
   • Clinical trial design support described must allow for a range of clinical trial designs (e.g., traditional randomized controlled trial (RCT), embedded pragmatic clinical trial, step-wedge, multiphase optimization strategy (MOST) and all NIH Stage Model stages (e.g., pilot, efficacy, effectiveness, pragmatic, dissemination and implementation trials)
   • Clinical trial design guidance provided by this Core must be in alignment with the NIH Stage Model, including emphases on identifying the mechanisms (e.g., behavioral, social, institutional) responsible for an intervention’s effects and preparing interventions for implementation in real-world contexts at the earliest stages of intervention development.
   • Other methodological and study design support must be inclusive of a range of approaches, including qualitative and quantitative research, mixed methods, basic science, observational studies, cost-effectiveness analyses, basic experimental studies involving humans (BESH) or mechanistic studies, and community-based participatory research.
   • Describe plans to disseminate resources, technical assistance, and/or guidance to the following: (1) pilot and exploratory study and REC Scholar applicants at some stage in the application process, (2) pilot and exploratory study awardees and REC Scholars, and (3) other Consortium member studies.
      
2. Provide biostatistics and analysis consultations, resources, guidance, and support to the following: (1) pilot and exploratory study and REC Scholar applicants at some stage in the application process, (2) pilot and exploratory study awardees and REC Scholars, and (3) other Consortium supported projects, in part, to ensure to the extent possible studies supported by and affiliated with the Consortium are adequately powered such that analyses are accurate and generalizable to individuals from understudied populations. Applicants may propose to consolidate biostatistics and analysis support in a separate optional core, in which case, this element is required in the optional core and not required in the Design Core. 
    
3. Facilitate inclusion of health disparities populations (as defined by the NIA Health Disparities Framework priority populations) meaningfully and sustainably in the research process and as research participants in Consortium-supported studies by:
   • Developing and disseminating resources and best practices for recruiting and retaining heterogeneous palliative care research participants, including resources that consider the unique needs of persons living with AD/ADRD, caregivers, and underserved populations.
   • Developing and disseminating resources, tools, and best practices for recruitment and retention of heterogeneous participants that are evidence based and leverage existing resources where appropriate (e.g., NIA’s OutreachPro for AD/ADRD clinical trials, AD/ADRD IMPACT Collaboratory, and NIH Pragmatic Trials Collaboratory).
      
4. Provide support and guidance to Consortium supported study teams in meeting the requirements of the NIA Clinical Research Operations & Management System (CROMS).
    
5. Coordinate with and leverage resources and expertise from the other Consortium Cores.
    
6. Disseminate methodological resources and best practices to the broader palliative care research community.

Developmental Projects

This Core may also support developmental projects that allow for development and testing of novel technology, resources, and/or methods related to the services and resources of this Core. If proposed, applicants must describe a plan to identify, prioritize, select, and support developmental projects.  

Letters of Support: Only letters of support specific to “Research Design and Methodology Core" should be attached to this section.

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:

Appendix:

Only limited items are allowed in the Appendix. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide; any instructions provided here are in addition to the SF424 (R&R) Application Guide instructions.

PHS Human Subjects and Clinical Trials Information (Design Core)

When involving human subjects research, clinical research, and/or NIH-defined clinical trials follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the SF424 (R&R) Application Guide, with the following additional instructions:

If you answered “Yes” to the question “Are Human Subjects Involved?” on the R&R Other Project Information form, you must include at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or a Delayed Onset Study record.

Study Record: PHS Human Subjects and Clinical Trials Information

All instructions in the SF424 (R&R) Application Guide must be followed.

Delayed Onset Study

Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start). All instructions in the SF424 (R&R) Application Guide must be followed.

Measures and Measure Development Core (Measurement Core)

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

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

Note: Effective for due dates on or after January 25, 2023, the DMS Plan will be attached in the Other Plan(s) attachment in FORMS-H application forms packages. If required, the DMS Plan must be provided in the Overall component.

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 ‘Project 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.

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: State the goals of the proposed Measurement Core concisely and summarize the expected outcome(s).

Research Strategy: The objective of this Core is to support the development and harmonization of reliable and valid measures of core outcomes that can be used with heterogeneous populations with various serious illnesses in research and/or clinical practice, including those that matter most to patients and caregivers.

Applicants must describe plans to meet the stated objective of this Core by describing their approach to do the following:

1. Assess the state of existing measures or needs for measurement development for clinical and population-based palliative care research with heterogenious populations and conditions (e.g., range of age groups, serious illnesses, including AD/ADRD, racial/ethnic groups, geographic locations or types).
2. Facilitate development and/or harmonization of measures of outcomes that matter to patients with serious illness and/or their caregivers/care partners in collaboration with other Cores, as appropriate.
3. Facilitate development, adaptation, or testing of measures of the hypothesized mechanisms (e.g., behavioral, social, institutional modifiable processes or targets) responsible for a palliative care intervention’s effects consistent with the NIH Stage Model of behavioral intervention development.
4. Address ethical considerations for proxy report measures from caregivers or care partners.
5. Facilitate integration of measures into electronic health records and clinical workflows, as appropriate (e.g., for pragmatic trials in real-world settings).
6. Conduct consensus development for common data elements and/or key outcome sets to be used across Consortium-funded projects. Common data elements should be recognized by the relevant research field(s), shown to be reliable and valid, and include measures that matter to persons with serious illness. Applicants may want to leverage existing resources and infrastructure such as the NIH Common Data Element Repository.
7. Include an approach to develop and support measure harmonization across Consortium studies (e.g., hosting webinar grand rounds, virtual discussions, or developing toolkits and resources for all pilot, exploratory, and REC awardees).
8. Facilitate development of and/or conduct psychometric validation of existing measures translated into languages of underserved populations and culturally appropriate measures in heterogeneous populations.

Developmental Projects

This Core may also support developmental projects that allow for development and testing of novel technology, resources, and/or methods related to the services and resources of this Core. If proposed, applicants must describe a plan to identify, prioritize, select, and support developmental projects.  

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:

Appendix:

Only limited items are allowed in the Appendix. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide; any instructions provided here are in addition to the SF424 (R&R) Application Guide instructions.

PHS Human Subjects and Clinical Trials Information (Measurement Core)

When involving human subjects research, clinical research, and/or NIH-defined clinical trials follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the SF424 (R&R) Application Guide, with the following additional instructions:

If you answered “Yes” to the question “Are Human Subjects Involved?” on the R&R Other Project Information form, you must include at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or a Delayed Onset Study record.

Study Record: PHS Human Subjects and Clinical Trials Information

All instructions in the SF424 (R&R) Application Guide must be followed.

Delayed Onset Study

Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start). All instructions in the SF424 (R&R) Application Guide must be followed.

Health Disparities Research and Community Engagement Core (Engagement Core) 

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

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

Note: Effective for due dates on or after January 25, 2023, the DMS Plan will be attached in the Other Plan(s) attachment in FORMS-H application forms packages. If required, the DMS Plan must be provided in the Overall component.

SF424 (R&R) Cover ( Engagement 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 ( Engagement Core)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information ( Engagement 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) ( Engagement 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 ( Engagement Core)

• In the Project Director/Principal Investigator section of the form, use Project Role of ‘Other’ with Category of ‘Project 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.
• Engagement Core key personnel must include experience in health disparities research and in community or stakeholder engagement approaches to research.

Budget (Engagement 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 (Engagement Core)

Specific Aims: State the goals of the proposed Engagement Core concisely and summarize the expected outcome(s).

Research Strategy: The objectives of the Engagement Core are to (1) support and facilitate high-quality research to understand and address health disparities in palliative care access, use, and quality for health disparities populations (as defined by the NIA Health Disparities Framework priority populations) and/or underserved areas; and (2) facilitate community-engaged research.

1. Applications must describe plans to facilitate and support high-quality research to understand and address health disparities in palliative care access, use, and quality for health disparities populations and/or underserved areas, including disparities impacted by structural and social determinants of health by:
   • Developing and disseminating resources, technical assistance, and/or guidance to the following: (1) pilot and exploratory study and REC Scholar applicants at some stage in the application process, (2) pilot and exploratory study awardees and REC Scholars, and (3) other Consortium supported projects.
   • Disseminating resources and best practices to the Consortium research community.
   • Providing guidance to investigators to ensure that health equity considerations are integrated into all aspects of the design, conduct, and reporting of Consortium supported studies.
      
2. Applications must include a Community Engagement and Research Inclusion Plan. The plan must describe an approach to foster community engagement strategies and community-engaged research throughout the Consortium and Consortium-supported studies, and the plan must include these five topics: a) communities of interest, b) community partners, c) partnership agreement, d) incorporation of input, and e) success evaluation metrics. Applicants should consider the following information when drafting the plan:
   • The “community(ies) of interest” should include people with lived experience (i.e., lived experience as a member of a health disparities population community(ies)) with serious illness. Community partner(s) include those who represent communities of interest. A community partner is a person(s), group, or organization with demonstrated experience leading, advocating, representing, or partnering on behalf of the interest of or perspectives of health disparities communities. Examples of community partner(s) include community champions, key informants, community advisory board, patient advisory board, advocacy organization, community organization, community health worker, Federally Qualified Health Center social worker, community faith leader, etc. A partnership agreement should describe the roles of community partners, the organizational and decision-making structure for the partnerships and the degree of recurring discussions between research team and community partners.
   • It is expected that a robust plan for facilitating community-engaged research will include incorporation of input collected through community engagement strategies in at least two phases of Consortium supported studies, when applicable: planning/design (i.e., participant outreach, IRB development, advisory board development); data collection (i.e., culturally appropriate materials, researcher/coordinators/practitioner health disparities population interviewer style/language); findings interpretation (i.e., health disparities populations participant research attitudes, cultural context relevant to participant responses), or communication of findings (i.e., community newsletter, community seminar, health empowerment materials).
   • The plan should also describe (1) metrics to evaluate and assess meaningful community engagement (see the National Academy of Medicine’s Advancing Health Equity and Systems Transformation through Community Engagement, for example); and (2) plans for coordinating with other Cores and disseminating community-engaged research best practices to the Consortium research community.

Developmental Projects

This Core may also support developmental projects that allow for development and testing of novel technology, resources, and/or methods related to the services and resources of this Core. If proposed, applicants must describe a plan to identify, prioritize, select, and support developmental projects. 

Letters of Support: Only letters of support specific to the "Health Disparities Research and Community Engagement Core" should be attached to this section.

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:

Appendix:

Only limited items are allowed in the Appendix. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide; any instructions provided here are in addition to the SF424 (R&R) Application Guide instructions.

PHS Human Subjects and Clinical Trials Information (Engagement Core)

When involving human subjects research, clinical research, and/or NIH-defined clinical trials follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the SF424 (R&R) Application Guide, with the following additional instructions:

If you answered “Yes” to the question “Are Human Subjects Involved?” on the R&R Other Project Information form, you must include at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or a Delayed Onset Study record.

Study Record: PHS Human Subjects and Clinical Trials Information

All instructions in the SF424 (R&R) Application Guide must be followed.

Delayed Onset Study

Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start). All instructions in the SF424 (R&R) Application Guide must be followed.

Optional Cores

The following information applies to the following optional components:

1. Optional Core 1
2. Optional Core 2
3. Optional Core 3
4. Optional Core 4

Optional cores are additional cores that the PD(s)/PI(s) may propose. Up to four optional cores may be proposed. For each proposed core, applicants must do the following: 

• When preparing your application for Optional Core 1, use Component Type ‘ Optional Core 1.’
• When preparing your application for Optional Core 2, use Component Type ‘ Optional Core 2.’
• When preparing your application for Optional Core 3, use Component Type ‘ Optional Core 3.’
• When preparing your application for Optional Core 4, use Component Type ‘ Optional Core 4.’

Henceforth, Optional Core 1, Optional Core 2, Optional Core 3, and Optional Core 4 will be referenced collectively as “Optional Cores.” 

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

Note: Effective for due dates on or after January 25, 2023, the DMS Plan will be attached in the Other Plan(s) attachment in FORMS-H application forms packages. If required, the DMS Plan must be provided in the Overall component.

SF424 (R&R) Cover (Optional 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 (Optional Cores)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Optional Cores)

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) (Optional Cores)

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 (Optional Cores)

• In the Project Director/Principal Investigator section of the form, use Project Role of ‘Other’ with Category of ‘Project 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.

Budget (Optional Cores)

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 (Optional Cores)

Specific Aims: State the goals of the proposed Core concisely and summarize the expected outcome(s), including the impact that the results of the proposed research will exert on the palliative care research field(s) involved. List the specific objectives of the research proposed succinctly and state how it will benefit the Consortium overall.

Research Strategy:  PD(s)/PI(s) must specify how this optional core will benefit the overall Consortium, expected outcome(s), including the impact of the core on the overall Consortium.

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:

Appendix:

Only limited items are allowed in the Appendix. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide; any instructions provided here are in addition to the SF424 (R&R) Application Guide instructions.

PHS Human Subjects and Clinical Trials Information (Optional Cores)

When involving human subjects research, clinical research, and/or NIH-defined clinical trials follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the SF424 (R&R) Application Guide, with the following additional instructions:

If you answered “Yes” to the question “Are Human Subjects Involved?” on the R&R Other Project Information form, you must include at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or a Delayed Onset Study record.

Study Record: PHS Human Subjects and Clinical Trials Information

All instructions in the SF424 (R&R) Application Guide must be followed.

Delayed Onset Study

Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start). All instructions in the SF424 (R&R) Application Guide must be followed. 

3. Unique Entity Identifier and System for Award Management (SAM)

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

4. Submission Dates and Times

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 Grants Policy Statement Section 2.3.9.2 Electronically Submitted Applications.

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 How to Apply- Application Guide.

5. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

6. Funding Restrictions

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

Pre-award costs are allowable only as described in the NIH Grants Policy Statement Section 7.9.1 Selected Items of Cost.

7. Other Submission Requirements and Information

Applications must be submitted electronically following the instructions described in the How to Apply- Application Guide. Paper applications will not be accepted.

For information on how applications will be automatically assembled for review and funding consideration after submission, refer 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 How to Apply – Application Guide. If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Dealing with System Issues guidance. 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 form. 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 unique entity identifier provided on the application is the same identifier used in the organization’s profile in the eRA Commons and for the System for Award Management. Additional information may be found in How To Apply- Application Guide.

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

In order to expedite review, applicants are requested to notify the NIA Referral Office by email at [email protected] when the application has been submitted. Please include the NOFO number and title, PD/PI name, and title of the application.

Post Submission Materials

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

Section V. Application Review Information

1. Criteria

Only the review criteria described below will be considered in the review process. Applications submitted to NIH in support of the NIH mission are evaluated for scientific and technical merit through the NIH peer review system.

A proposed Clinical Trial application may include study design, methods, and intervention that are not by themselves innovative but address important questions or unmet needs. Additionally, the results of the clinical trial may indicate that further clinical development of the intervention is unwarranted or lead to new avenues of scientific investigation.

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

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

Significance

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

In addition, for applications involving clinical trials

Are the scientific rationale and need for a clinical trial to test the proposed hypothesis or intervention well supported by preliminary data, clinical and/or preclinical studies, or information in the literature or knowledge of biological mechanisms? For trials focusing on clinical or public health endpoints, is this clinical trial necessary for testing the safety, efficacy or effectiveness of an intervention that could lead to a change in clinical practice, community behaviors or health care policy? For trials focusing on mechanistic, behavioral, physiological, biochemical, or other biomedical endpoints, is this trial needed to advance scientific understanding?

Investigator(s)

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

Specific to this NOFO: 

• How adequately does the application propose key personnel with appropriate experience in palliative care research across the lifespan and across a range of populations and serious illnesses?
• How adequately does the application propose key personnel with appropriate experience conducting palliative care health disparities research and/or disparities in palliative care access, quality, or utilization?
• How adequately does the application propose key personnel with sufficient experience working in research consortia or other collaborative projects with a demonstrated ability to achieve shared goals and objectives and foster communication and collaboration among multiple components?
• How adequately does the application propose key personnel with a demonstrated track record of supporting and promoting diversity, equity, inclusion, and accessibility (DEIA) among scientific workforce members of research teams  and/or research infrastructure activities?

In addition, for applications involving clinical trials

With regard to the proposed leadership for the project, do the PD/PI(s) and key personnel have the expertise, experience, and ability to organize, manage and implement the proposed clinical trial and meet milestones and timelines? Do they have appropriate expertise in study coordination, data management and statistics? For a multicenter trial, is the organizational structure appropriate and does the application identify a core of potential center investigators and staffing for a coordinating center?

Innovation

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

Specific to this NOFO: 

• How well does the application address how the Consortium will achieve an impact on the field of palliative care research beyond the institutions involved in the Consortium or its components?

In addition, for applications involving clinical trials

Does the design/research plan include innovative elements, as appropriate, that enhance its sensitivity, potential for information or potential to advance scientific knowledge or clinical practice?

Approach

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Have the investigators included plans to address weaknesses in the rigor of prior research that serves as the key support for the proposed project? Have the investigators presented strategies to ensure a robust and unbiased approach, as appropriate for the work proposed? Are potential problems, alternative strategies, and benchmarks for success presented? If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed? Have the investigators presented adequate plans to address relevant biological variables, such as sex, for studies in vertebrate animals or human subjects?

If the project involves human subjects and/or NIH-defined clinical research, are the plans to address:

1) the protection of human subjects from research risks, and
2) inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion or exclusion of individuals of all ages (including children and older adults), justified in terms of the scientific goals and research strategy proposed?

Specific to this NOFO: 

• How well does the application address how the different Cores will interact synergistically to help accomplish the Consortium’s aims?
• How well does the application describe how the approaches of the Cores complement each other or are interdependent?
• How well does the application describe the proposed mechanisms to ensure coherence of the Consortium, maintenance of scientific focus, and to be used in assessing progress toward the Consortium’s goals?

In addition, for applications involving clinical trials

Does the application adequately address the following, if applicable

Study Design

Is the study design justified and appropriate to address primary and secondary outcome variable(s)/endpoints that will be clear, informative and relevant to the hypothesis being tested? Is the scientific rationale/premise of the study based on previously well-designed preclinical and/or clinical research? Given the methods used to assign participants and deliver interventions, is the study design adequately powered to answer the research question(s), test the proposed hypothesis/hypotheses, and provide interpretable results? Is the trial appropriately designed to conduct the research efficiently? Are the study populations (size, gender, age, demographic group), proposed intervention arms/dose, and duration of the trial, appropriate and well justified?

Are potential ethical issues adequately addressed? Is the process for obtaining informed consent or assent appropriate? Is the eligible population available? Are the plans for recruitment outreach, enrollment, retention, handling dropouts, missed visits, and losses to follow-up appropriate to ensure robust data collection? Are the planned recruitment timelines feasible and is the plan to monitor accrual adequate? Has the need for randomization (or not), masking (if appropriate), controls, and inclusion/exclusion criteria been addressed? Are differences addressed, if applicable, in the intervention effect due to sex/gender and race/ethnicity?

Are the plans to standardize, assure quality of, and monitor adherence to, the trial protocol and data collection or distribution guidelines appropriate? Is there a plan to obtain required study agent(s)? Does the application propose to use existing available resources, as applicable?

Data Management and Statistical Analysis

Are planned analyses and statistical approach appropriate for the proposed study design and methods used to assign participants and deliver interventions? Are the procedures for data management and quality control of data adequate at clinical site(s) or at center laboratories, as applicable? Have the methods for standardization of procedures for data management to assess the effect of the intervention and quality control been addressed? Is there a plan to complete data analysis within the proposed period of the award?

Environment

Will the scientific environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment and other physical resources available to the investigators adequate for the project proposed? Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements?

In addition, for applications involving clinical trials

If proposed, are the administrative, data coordinating, enrollment and laboratory/testing centers, appropriate for the trial proposed?

Does the application adequately address the capability and ability to conduct the trial at the proposed site(s) or centers? Are the plans to add or drop enrollment centers, as needed, appropriate?

If international site(s) is/are proposed, does the application adequately address the complexity of executing the clinical trial?

If multi-sites/centers, is there evidence of the ability of the individual site or center to: (1) enroll the proposed numbers; (2) adhere to the protocol; (3) collect and transmit data in an accurate and timely fashion; and, (4) operate within the proposed organizational structure?

Additional Review Criteria - Overall

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

Study Timeline

Specific to applications involving clinical trials

Is the study timeline described in detail, taking into account start-up activities, the anticipated rate of enrollment, and planned follow-up assessment? Is the projected timeline feasible and well justified? Does the project incorporate efficiencies and utilize existing resources (e.g., CTSAs, practice-based research networks, electronic medical records, administrative database, or patient registries) to increase the efficiency of participant enrollment and data collection, as appropriate?

Are potential challenges and corresponding solutions discussed (e.g., strategies that can be implemented in the event of enrollment shortfalls)?

Protections for Human Subjects

For research that involves human subjects but does not involve one of the 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 categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials. For additional information on review of the Human Subjects section, please refer to the Guidelines for the Review of Human Subjects.

Inclusion of Women, Minorities, and Individuals Across the Lifespan

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

Vertebrate Animals

The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following three points: (1) a complete description of all proposed procedures including the species, strains, ages, sex, and total numbers of animals to be used; (2) justifications that the species is appropriate for the proposed research and why the research goals cannot be accomplished using an alternative non-animal model; and (3) interventions including analgesia, anesthesia, sedation, palliative care, and humane endpoints that will be used to limit any unavoidable discomfort, distress, pain and injury in the conduct of scientifically valuable research. Methods of euthanasia and justification for selected methods, if NOT consistent with the AVMA Guidelines for the Euthanasia of Animals, is also required but is found in a separate section of the application. For additional information on review of the Vertebrate Animals Section, please refer to the Worksheet for Review of the Vertebrate Animals Section.

Biohazards

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

Resubmissions

Not Applicable. 

Renewals

Not Applicable.

Revisions

Not Applicable.

Additional Review Considerations - Overall

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

Applications from Foreign Organizations

Not Applicable

Select Agent Research

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

Resource Sharing Plans

Reviewers will comment on whether the Resource Sharing Plan(s) (e.g., Sharing Model Organisms) or the rationale for not sharing the resources, is reasonable.

Authentication of Key Biological and/or Chemical Resources:

For 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.

Budget and Period of Support

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

Scored Review Criteria - LAC

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

Significance

Does the proposed LAC address the needs of the research consortium that it will coordinate? Is the scope of activities proposed for the Core appropriate to meet those needs? Will successful completion of the aims bring unique advantages or capabilities to the research consortium?

Investigator(s)

Are the PD(s)/PI(s) and other personnel well suited to their roles in the LAC? Do they have appropriate experience and training, and have they demonstrated experience and an ongoing record of accomplishments in managing [adjective] research? Do the investigators demonstrate significant experience with coordinating collaborative [basic or 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 Core? Does the applicant have experience overseeing selection and management of subawards, if needed?

Specific to this NOFO: 

• How adequate is the information provided that explains how the leadership team and key personnel are richly varied and heterogeneous in perspectives, academic backgrounds, and scientific and technical disciplines?

Innovation

Does the application propose novel organizational concepts, management strategies, or instrumentation in coordinating the research consortium the LAC 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 organizational concepts, management strategies or instrumentation proposed?

Approach

Are the overall strategy, operational plan, and organizational structure well-reasoned and appropriate to accomplish the goals of the research consortium the Core will serve? Will the investigators promote strategies to ensure a robust and unbiased scientific approach across the consortium, as appropriate for the work proposed? Are potential problems, alternative strategies, and benchmarks for success presented? If the consortium is in the early stages of operation, does the proposed strategy adequately establish feasibility and manage the risks associated with the activities of the consortium? 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 NOFO: 

• How adequately does the application describe how this Core will address required leadership and overall oversight activities?
• How adequately does the application describe how this Core will address required stakeholder engagement activities?
• How adequately does the application describe how this Core will address required dissemination and implementation activities?
• How adequately does the application describe how this Core will address required evaluation activities?

Environment

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

Additional Review Criteria - LAC

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

Protections for Human Subjects

For research that involves human subjects but does not involve one of the 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 categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials. For additional information on review of the Human Subjects section, please refer to the Guidelines for the Review of Human Subjects.

Inclusion of Women, Minorities, and Individuals Across the Lifespan

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

Vertebrate Animals

The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following 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 Animals Section.

Biohazards

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

Resubmissions

Not Applicable.  

Renewals

Not Applicable. 

Revisions

Not Applicable. 

Additional Review Considerations - LAC

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

Applications from Foreign Organizations Not Applicable

Select Agent Research

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

Resource Sharing Plans

Reviewers will comment on whether the Resource Sharing Plan(s) (e.g., Sharing Model Organisms) or the rationale for not sharing the resources, is reasonable.

Authentication of Key Biological and/or Chemical Resources:

For 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.

Budget and Period of Support

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

Scored Review Criteria - REC

Reviewers will consider each of the review criteria below in the determination of scientific merit, and will provide an overall impact score. Individual criterion scores will not be provided. An application does not need to be strong in all categories to be judged likely to have major scientific impact.

Significance

Does the proposed program address a key audience and an important aspect or important need in research education? Is there convincing evidence in the application that the proposed program will significantly advance the stated goal of the program?

Investigator(s)

Is the PD/PI capable of providing both administrative and scientific leadership to the development and implementation of the proposed program? Is there evidence that an appropriate level of effort will be devoted by the program leadership to ensure the program's intended goal is accomplished? If applicable, is there evidence that the participating faculty have experience in mentoring students and teaching science? If applicable, are the faculty good role models for the participants by nature of their scientific accomplishments? If the project is collaborative or multi-PD/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project?

Specific to this NOFO: 

• How adequate is the proposed REC Leads'  experience in (1) successfully mentoring early-career and new investigators from diverse backgrounds, including individuals from underrepresented groups,  (see Notice of NIH's Interest in Diversity, NOT-OD-20-031), and (2) in implementing strategies to promote DEIA? 

Innovation

Taking into consideration the nature of the proposed research education program, does the applicant make a strong case for this program effectively reaching an audience in need of the program’s offerings? Where appropriate, is the proposed program developing or utilizing innovative approaches and latest best practices to improve the knowledge and/or skills of the intended audience?

Approach

Does the proposed program clearly state its goals and objectives, including the educational level of the audience to be reached, the content to be conveyed, and the intended outcome? Is there evidence that the program is based on a sound rationale, as well as sound educational concepts and principles? Is the plan for evaluation sound and likely to provide information on the effectiveness of the program? If the proposed program will recruit participants, are the planned recruitment, retention, and follow-up (if applicable) activities adequate to ensure a highly qualified participant pool?

Environment

Will the scientific and educational environment of the proposed program contribute to its intended goals? Is there a plan to take advantage of this environment to enhance the educational value of the program? Is there tangible evidence of institutional commitment? Is there evidence that the faculty have sufficient institutional support to create a sound educational environment for the participants? Where appropriate, is there evidence of collaboration and buy-in among participating programs, departments, and institutions?

Additional Review Criteria - REC

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

Protections for Human Subjects

For research that involves human subjects but does not involve one of the 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 categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials. For additional information on review of the Human Subjects section, please refer to the Guidelines for the Review of Human Subjects.

Inclusion of Women, Minorities, and Individuals Across the Lifespan

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

Vertebrate Animals

The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following 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 Animals Section.

Biohazards

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

Resubmissions

Not Applicable.  

Renewals

Not Applicable. 

Revisions

Not Applicable. 

Additional Review Considerations - REC

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

Recruitment Plan to Enhance Diversity

Peer reviewers will separately evaluate the Recruitment Plan to Enhance Diversity after the overall score has been determined. Reviewers will examine the strategies to be used in the recruitment of individuals from underrepresented groups. The review panel’s evaluation will be included in the summary statement. Plans will be rated as acceptable or unacceptable, and the summary statement will provide the consensus of the review committee.

Training in the Responsible Conduct of Research

Taking into account the specific characteristics of the proposed research education program, the level of participant experience, the reviewers will evaluate the adequacy of the proposed RCR training in relation to the following five required components: 1) Format - the required format of instruction, i.e., face-to-face lectures, coursework, and/or real-time discussion groups (a plan with only on-line instruction or video conferencing is not acceptable); 2) Subject Matter - the breadth of subject matter, e.g., conflict of interest, authorship, data management, human subjects and animal use, laboratory safety, research misconduct, research ethics; 3) Faculty Participation - the role of the program faculty in the instruction; 4) Duration of Instruction - the number of contact hours of instruction, taking into consideration the duration of the program; and 5) Frequency of Instruction –instruction must occur during each career stage and at least once every four years. See also: NIH Grants Policy Statement Section 12.4.1.4 Training in the Responsible Conduct of Research. The review panel’s evaluation will be included in the summary statement. Plans will be rated as acceptable or unacceptable, and the summary statement will provide the consensus of the review committee.

Applications from Foreign Organizations

Not Applicable

Select Agent Research

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

Resource Sharing Plans

Reviewers will comment on whether the Resource Sharing Plan(s) (e.g., Sharing Model Organisms) or the rationale for not sharing the resources, is reasonable.

Authentication of Key Biological and/or Chemical Resources:

For 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.

Budget and Period of Support

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

Scored Review Criteria - Pilot 

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

Significance

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

Investigator(s)

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

Innovation

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

Approach

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the Component ? Have the investigators included plans to address weaknesses in the rigor of prior research that serves as the key support for the proposed Component ? Have the investigators presented strategies to ensure a robust and unbiased approach, as appropriate for the work proposed? Are potential problems, alternative strategies, and benchmarks for success presented? If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed? Have the investigators presented adequate plans to address relevant biological variables, such as sex, for studies in vertebrate animals or human subjects?

If the project involves human subjects and/or NIH-defined clinical research, are the plans to address:

1) the protection of human subjects from research risks, and
2) inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion or exclusion of individuals of all ages (including children and older adults), justified in terms of the scientific goals and research strategy proposed?

Specific to this NOFO: 

• How adequately does the application describe a proposed process for a national pilot and exploratory study award competition that is inclusive of palliative care research across the lifespan and across a range of serious illnesses, including those relevant to participating ICOs; inclusive of a range of research methods, study designs, and disciplines; and structured to maximize geographic and institutional heterogeneity among the awardees?
• How adequately does the application describe a proposed process for peer review of pilot and exploratory study applications; criteria and procedures for selecting applications for award; and plans for managing and supporting the awarded investigators and their projects?

Environment

Will the scientific environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment and other physical resources available to the investigators adequate for the project proposed? Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements?

Additional Review Criteria - Pilot 

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

Protections for Human Subjects

For research that involves human subjects but does not involve one of the 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 categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials. For additional information on review of the Human Subjects section, please refer to the Guidelines for the Review of Human Subjects.

Inclusion of Women, Minorities, and Individuals Across the Lifespan

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

Vertebrate Animals

The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following 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 Animals Section.

Biohazards

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

Resubmissions

Not Applicable.  

Renewals

Not Applicable. 

Revisions

Not Applicable. 

Additional Review Considerations - Pilot 

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

Applications from Foreign Organizations

Not Applicable

Select Agent Research

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

Resource Sharing Plans

Reviewers will comment on whether the Resource Sharing Plan(s) (e.g., Sharing Model Organisms) or the rationale for not sharing the resources, is reasonable.

Authentication of Key Biological and/or Chemical Resources:

For 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.

Budget and Period of Support

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

Scored Review Criteria - Design Core

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

Significance

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

Investigator(s)

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

Specific to this NOFO: 

• How adequately does the evidence provided show that the collective experience of the proposed Core leads and key personnel include a range of methodological approaches, research designs, and clinical trial designs, including qualitative and quantitative methods, community-based participatory research approaches, and pragmatic clinical trial designs?

Innovation

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

Approach

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the Core? Have the investigators included plans to address weaknesses in the rigor of prior research that serves as the key support for the proposed Core? Have the investigators presented strategies to ensure a robust and unbiased approach, as appropriate for the work proposed? Are potential problems, alternative strategies, and benchmarks for success presented? If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed? Have the investigators presented adequate plans to address relevant biological variables, such as sex, for studies in vertebrate animals or human subjects?

If the project involves human subjects and/or NIH-defined clinical research, are the plans to address:

1) the protection of human subjects from research risks, and
2) inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion or exclusion of individuals of all ages (including children and older adults), justified in terms of the scientific goals and research strategy proposed?

Specific to this NOFO: 

• How adequately does the application address plans for this Core to provide clinical trial design, other study design, and methods consultations, resources, guidance, and support to pilot and exploratory study and REC Scholar applicants at some stage in the application process, pilot and exploratory study awardees and REC Scholars, and other Consortium supported projects?
• How adequately does the application address plans for this Core to provide biostatistics and analysis consultations, resources, guidance, and support to Consoritum members?
• How adequately does the application address plans for this Core to facilitate inclusion of health disparities populations (as defined by the NIA Health Disparities Framework priority populations) meaningfully and sustainably in the research process and as research participants in Consortium-supported studies?  

Environment

Will the scientific environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment and other physical resources available to the investigators adequate for the project proposed? Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements?

Additional Review Criteria - Design Core

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

Protections for Human Subjects

For research that involves human subjects but does not involve one of the 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 categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials. For additional information on review of the Human Subjects section, please refer to the Guidelines for the Review of Human Subjects.

Inclusion of Women, Minorities, and Individuals Across the Lifespan

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

Vertebrate Animals

The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following 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 Animals Section.

Biohazards

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

Resubmissions

Not Applicable.  

Renewals

Not Applicable. 

Revisions

Not Applicable. 

Additional Review Considerations -Design Core

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

Applications from Foreign Organizations

Not Applicable

Select Agent Research

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

Resource Sharing Plans

Reviewers will comment on whether the Resource Sharing Plan(s) (e.g., Sharing Model Organisms) or the rationale for not sharing the resources, is reasonable.

Authentication of Key Biological and/or Chemical Resources:

For 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.

Budget and Period of Support

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

Scored Review Criteria - Measurement Core

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

Significance

Does the Core address an important problem or a critical barrier to progress in the field? Is the prior research that serves as the key support for the proposed Core rigorous? If the aims of the Core are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?

Investigator(s)

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

Innovation

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

Approach

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the Core? Have the investigators included plans to address weaknesses in the rigor of prior research that serves as the key support for the proposed Core? Have the investigators presented strategies to ensure a robust and unbiased approach, as appropriate for the work proposed? Are potential problems, alternative strategies, and benchmarks for success presented? If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed? Have the investigators presented adequate plans to address relevant biological variables, such as sex, for studies in vertebrate animals or human subjects?

If the project involves human subjects and/or NIH-defined clinical research, are the plans to address:

1) the protection of human subjects from research risks, and
2) inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion or exclusion of individuals of all ages (including children and older adults), justified in terms of the scientific goals and research strategy proposed?

Specific to this NOFO: 

• How adequately does the application describe plans to support the development and harmonization of reliable and valid measures of core outcomes that can be used with heterogeneous populations with serious illness in research and/or clinical practice, including those that matter most to patients and caregivers? 

Environment

Will the scientific environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment and other physical resources available to the investigators adequate for the project proposed? Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements?

Additional Review Criteria - Measurement Core

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

Protections for Human Subjects

For research that involves human subjects but does not involve one of the 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 categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials. For additional information on review of the Human Subjects section, please refer to the Guidelines for the Review of Human Subjects.

Inclusion of Women, Minorities, and Individuals Across the Lifespan

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

Vertebrate Animals

The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following 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 Animals Section.

Biohazards

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

Resubmissions

Not Applicable.  

Renewals

Not Applicable. 

Revisions

Not Applicable. 

Additional Review Considerations - Measurement Core

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

Applications from Foreign Organizations

Not Applicable

Select Agent Research

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

Resource Sharing Plans

Reviewers will comment on whether the Resource Sharing Plan(s) (e.g., Sharing Model Organisms) or the rationale for not sharing the resources, is reasonable.

Authentication of Key Biological and/or Chemical Resources:

For 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.

Budget and Period of Support

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

Scored Review Criteria - Engagement Core 

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

Significance

Does the Core address an important problem or a critical barrier to progress in the field? Is the prior research that serves as the key support for the proposed Core rigorous? If the aims of the Core are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?

Investigator(s)

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

Specific to this NOFO: How adequately does the application propose Core key personnel with expertise and experience in health disparities research and in community or stakeholder engagement approaches to research?

Innovation

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

Approach

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the Core? Have the investigators included plans to address weaknesses in the rigor of prior research that serves as the key support for the proposed Core? Have the investigators presented strategies to ensure a robust and unbiased approach, as appropriate for the work proposed? Are potential problems, alternative strategies, and benchmarks for success presented? If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed? Have the investigators presented adequate plans to address relevant biological variables, such as sex, for studies in vertebrate animals or human subjects?

If the project involves human subjects and/or NIH-defined clinical research, are the plans to address:

1) the protection of human subjects from research risks, and
2) inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion or exclusion of individuals of all ages (including children and older adults), justified in terms of the scientific goals and research strategy proposed?

Specific to this NOFO: 

• How adequately does the application describe plans to facilitate and support high-quality research to understand and address health disparities in palliative care access, use, and quality for health disparities populations and/or underserved areas, including disparities impacted by structural and social determinants of health?
• How adequately does the application describe this Core's Community Engagement and Research Inclusion Plan to foster community engagement strategies and community-engaged research throughout the Consortium and Consortium-supported studies, including the five required topics: a) communities of interest, b) community partners, c) partnership agreement, d) incorporation of input, and e) success evaluation metrics.

Environment

Will the scientific environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment and other physical resources available to the investigators adequate for the Core proposed? Will the Core benefit from unique features of the scientific environment, subject populations, or collaborative arrangements?

Additional Review Criteria - Engagement Core 

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

Protections for Human Subjects

For research that involves human subjects but does not involve one of the 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 categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials. For additional information on review of the Human Subjects section, please refer to the Guidelines for the Review of Human Subjects.

Inclusion of Women, Minorities, and Individuals Across the Lifespan

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

Vertebrate Animals

The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following 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 Animals Section.

Biohazards

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

Resubmissions

Not Applicable.  

Renewals

Not Applicable. 

Revisions

Not Applicable. 

Additional Review Considerations - Engagement Core

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

Applications from Foreign Organizations

Not Applicable

Select Agent Research

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

Resource Sharing Plans

Reviewers will comment on whether the Resource Sharing Plan(s) (e.g., Sharing Model Organisms) or the rationale for not sharing the resources, is reasonable.

Authentication of Key Biological and/or Chemical Resources:

For 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.

Budget and Period of Support

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

Scored Review Criteria - Optional Core

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

Significance

Does the Core address an important problem or a critical barrier to progress in the field? Is the prior research that serves as the key support for the proposed Core rigorous? If the aims of the Core are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?

Investigator(s)

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

Innovation

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

Approach

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the Core? Have the investigators included plans to address weaknesses in the rigor of prior research that serves as the key support for the proposed project? Have the investigators presented strategies to ensure a robust and unbiased approach, as appropriate for the work proposed? Are potential problems, alternative strategies, and benchmarks for success presented? If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed? Have the investigators presented adequate plans to address relevant biological variables, such as sex, for studies in vertebrate animals or human subjects?

If the project involves human subjects and/or NIH-defined clinical research, are the plans to address:

1) the protection of human subjects from research risks, and
2) inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion or exclusion of individuals of all ages (including children and older adults), justified in terms of the scientific goals and research strategy proposed?

Environment

Will the scientific environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment and other physical resources available to the investigators adequate for the project proposed? Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements?

Additional Review Criteria - Optional Core

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

Protections for Human Subjects

For research that involves human subjects but does not involve one of the 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 categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials. For additional information on review of the Human Subjects section, please refer to the Guidelines for the Review of Human Subjects.

Inclusion of Women, Minorities, and Individuals Across the Lifespan

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

Vertebrate Animals

The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following 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 Animals Section.

Biohazards

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

Resubmissions

Not Applicable.  

Renewals

Not Applicable. 

Revisions

Not Applicable. 

Additional Review Considerations - Optional Cores

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

Applications from Foreign Organizations

Not Applicable

Select Agent Research

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

Resource Sharing Plans

Reviewers will comment on whether the Resource Sharing Plan(s) (e.g., Sharing Model Organisms) or the rationale for not sharing the resources, is reasonable.

Authentication of Key Biological and/or Chemical Resources:

For 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.

Budget and Period of Support

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

2. Review and Selection Process

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s) convened by NIA, in accordance with NIH peer review policies and practices, 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 will receive a written critique.

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.

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

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 NOFO. Following initial peer review, recommended applications will receive a second level of review by the National Advisory Council on Aging. 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.

3. Anticipated Announcement and Award Dates

After the peer review of the application is completed, the PD/PI will be able to access their 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 Section 2.4.4 Disposition of Applications.

Section VI. Award Administration Information

1. Award Notices

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

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

Recipients must comply with any funding restrictions described in Section IV.6. 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 NOFO 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.

Individual awards are based on the application submitted to, and as approved by, the NIH and are subject to the IC-specific terms and conditions identified in the NoA.

ClinicalTrials.gov: If an award provides for one or more clinical trials. By law (Title VIII, Section 801 of Public Law 110-85), the "responsible party" must register and submit results information for certain “applicable clinical trials” on the ClinicalTrials.gov Protocol Registration and Results System Information Website (https://register.clinicaltrials.gov). NIH expects registration and results reporting of all trials whether required under the law or not. For more information, see https://grants.nih.gov/policy/clinical-trials/reporting/index.htm

Institutional Review Board or Independent Ethics Committee Approval: Grantee institutions must ensure that all protocols are reviewed by their IRB or IEC. To help ensure the safety of participants enrolled in NIH-funded studies, the recipient must provide NIH copies of documents related to all major changes in the status of ongoing protocols.

Data and Safety Monitoring Requirements: The NIH policy for data and safety monitoring requires oversight and monitoring of all NIH-conducted or -supported human biomedical and behavioral intervention studies (clinical trials) to ensure the safety of participants and the validity and integrity of the data. Further information concerning these requirements is found at http://grants.nih.gov/grants/policy/hs/data_safety.htm and in the application instructions (SF424 (R&R) and PHS 398).

Investigational New Drug or Investigational Device Exemption Requirements: Consistent with federal regulations, clinical research projects involving the use of investigational therapeutics, vaccines, or other medical interventions (including licensed products and devices for a purpose other than that for which they were licensed) in humans under a research protocol must be performed under a Food and Drug Administration (FDA) investigational new drug (IND) or investigational device exemption (IDE).

Prior Approval of Pilot Projects

Recipient-selected projects (i.e., pilot studies, exploratory studies, REC Scholars, mentored research projects, and developmental projects) require prior approval by NIH prior to initiation.

• The recipient institution will comply with the NIH Guidance on Changes That Involve Human Subjects in Active Awards and That Will Require Prior NIH Approval.
• The recipient institution will provide NIH with specific plans for data and safety monitoring, and will notify the IRB and NIH of serious adverse events and unanticipated problems, consistent with NIH DSMP policies.

All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General and Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Recipients, and Activities, including of note, but not limited to:

• Federal-wide Standard Terms and Conditions for Research Grants
• Prohibition on Certain Telecommunications and Video Surveillance Services or Equipment
• Acknowledgment of Federal Funding

If a recipient is successful and receives a Notice of Award, in accepting the award, the recipient agrees that any activities under the award are subject to all provisions currently in effect or implemented during the period of the award, other Department regulations and policies in effect at the time of the award, and applicable statutory provisions.

If a recipient receives and award, the recipient must follow all applicable nondiscrimination laws. The recipient agrees to this when registering in SAM.gov. The recipient must also submit an Assurance of Compliance (HHS-690). To learn more, see the HHS Office for Civil Rights website.

HHS recognizes that NIH 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 NOFO.

n 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 2 CFR Part 200.206 “Federal awarding agency review of risk posed by applicants.” This provision will apply to all NIH grants and cooperative agreements except fellowships.”

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 (HHS) grant administration regulations at 2 CFR Part 200, 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 recipients 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 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 recipients for the project as a whole, although specific tasks and activities may be shared among the recipients and NIH as defined below.

The PD(s)/PI(s) will have the primary responsibility for:

• Recipients 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 HHS, PHS, and NIH policies.
• Designing the details of the Consortium funded through this NOFO and retaining primary responsibility for performance of the activities.
• Determining approaches, designing, and setting project milestones, and implementing the project plan for the Consortium.
• Providing integrative, organizational, and logistical support for the entire program, including tracking, scheduling, and facilitating in-person, hybrid, or virtual work group meetings, Steering Committee meetings, and other proposed recurring meetings or conference calls, including preparing concise minutes or summaries of meetings with clear action items for distribution (except for the annual EAP meetings, which NIA will support).
• Cooperating with all Consortium members in the publication and dissemination of program results and the eventual release of methods, tools, results, research protocols or approaches, and other resources to the scientific and healthcare communities.
•  
• Considering the EAP's input regarding implementation of study aims, as well as additions or changes to content and methods during the execution of the cooperative agreement(s). EAP input is not binding on the PD(s)/PI(s) who retain primary responsibility for scientific direction and implementation.
• Responding promptly and cooperatively to requests for information or input from NIA.
• Retaining custody and having primary rights to the data and software at the awardee institution developed under these awards, subject to Government rights of access consistent with current DHHS, PHS, and NIH policies and goals of this program. All research, data (it is expected the Consortium will have a Data Management and Sharing Plan that will protect human subjects), and resources generated must have broad availability through a public-facing website to facilitate collaboration, reuse, and replication, as appropriate and consistent with achieving the goals of the program.
• Ensuring that all web resources developed are transferred to any subsequent award recipient should the program be continued beyond the project period.

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

• An NIA Program Official will be responsible for the normal scientific and programmatic stewardship of the award and will be named in the award notice. The NIA Program Official will approve all major stages of the project and all new major additions/changes to planned activities, including approval of all pilot and exploratory awards, REC scholars, and developmental projects prior to funding. The NIA Program Official is an ex officio member of the EAP and will approve membership and agendas of the EAP.
• In addition to the NIA Program Official, NIH program staff from participating ICOs will be named as Project Scientists for the Consortium. NIH Project Scientists will have substantial programmatic involvement that is above and beyond the normal stewardship role in awards. The NIH Project Scientists will assist in refining study objectives and activities.
• NIA/NIH staff may participate and/or attend in work groups, implementation teams, and committees, including the Steering Committee and DSMBs, as appropriate. Participation by staff from other federal agencies may also be appropriate and advantageous to facilitate the activities of the program.
• NIA/NIH staff may serve as resources for, or interface with, other ongoing NIH activities that may be relevant to the activities in this Consortium to avoid duplication and facilitate collaboration and communication in overlapping areas.

Areas of Joint Responsibility include:

• Determining the process of setting Consortium priorities, deciding optimal administrative and governance approaches, and contributing to the adjustment of approaches as warranted.
• Developing agendas for Steering Committee meetings and annual research and business meetings.
• Participating in ongoing conference calls among PD(s)/PI(s), NIH Project Scientist(s), and/or other NIH program staff, as scheduled and agreed upon in a kickoff meeting to be held within the first three months of award.
• Considering the Steering Committee and the EAP input for modifying the Consortium’s focus to accommodate new scientific opportunities and directions.
• Sharing and reviewing annual progress among components of the Consortium and with external stakeholders.  

Consortium Steering Committee

A Consortium Steering Committee will be established to address issues that span across all cores, provide input towards the policies and processes of the Consortium, and assist in dissemination of policies and processes that enable the initiative to achieve its objectives. The Steering Committee may establish subcommittees as needed to advance the Consortium’s goals. The Steering Committee will be composed of the Consortium PD(s)/PI(s) and the NIH Project Scientist(s). The combined vote of NIH membership will not constitute a majority of eligible votes. Within the first six months of award, the Steering Committee will develop a charter for its work and a process and periodicity for NIA Program Official approval of all pilot studies, exploratory studies, REC Scholars, mentored research projects, and developmental projects prior to award. 

External Advisory Panel (EAP)

To ensure that the Consortium achieves its objectives under the cooperative agreement, the EAP will provide input to the Consortium Steering Committee.  The Steering Committee will nominate members of the EAP and propose meeting agendas; membership and agendas will be approved by the NIA Program Official. Experts, including, but not limited to, the PD(s)/PI(s), Co-Investigators, NIA staff, and invited independent experts, will make presentations to the EAP on scientific and administrative issues regarding the development and implementation of Consortium aims. NIA, in collaboration with study investigators, will develop a charter for the EAP that describes the selection, composition, tenure, and responsibilities of EAP members and guidelines for quorum and frequency and type of meetings (e.g., in person, virtual, hybrid). It is anticipated that the EAP will meet at least annually, with intermittent conference calls or virtual meetings as needed.

The EAP will:

• Review and comment on the conduct of the Consortium aims and discuss progress in meeting the goals of the initiative.
• Where appropriate, provide input to the PD(s)/PI(s) on procedures and policies necessary to successfully accomplish the initiative. Such input is not binding on the PD(s)/PI(s) who will retain primary responsibility for scientific direction and implementation.
• Provide input on activities to improve coordination to achieve the Consortium’s goals and advance palliative care research across the lifespan.
• Provide input for redirecting the Consortium’s focus to accommodate new scientific opportunities and directions within the scope of the award, if applicable.Establish subcommittees as needed to advance the Consortium’s goals.

Dispute Resolution:

Any disagreements that may arise in scientific or programmatic matters (within the scope of the award) between recipients and NIH may be brought to Dispute Resolution. A Dispute Resolution Panel composed of three members will be convened: 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 recipient. This special dispute resolution procedure does not alter the recipient's right to appeal an adverse action that is otherwise appealable in accordance with PHS regulation 42 CFR Part 50, Subpart D and HHS regulation 45 CFR Part 16.

3. Data Management and Sharing

Consistent with the 2023 NIH Policy for Data Management and Sharing, when data management and sharing is applicable to the award, recipients will be required to adhere to the Data Management and Sharing requirements as outlined in the NIH Grants Policy Statement. Upon the approval of a Data Management and Sharing Plan, it is required for recipients to implement the plan as described. 

When multiple years are involved, recipients will be required to submit the Research Performance Progress Report (RPPR) annually and financial statements as required in the NIH Grants Policy Statement.

Progress reports should briefly describe status of pilot projects, including data and safety monitoring, and should notify NIH of serious adverse events and unanticipated problems.

A final RPPR, 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. NIH NOFOs outline intended research goals and objectives. Post award, NIH will review and measure performance based on the details and outcomes that are shared within the RPPR, as described at 2 CFR Part 200.301.

The Federal Funding Accountability and Transparency Act of 2006 as amended (FFATA), includes a requirement for recipients of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later. All recipients 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 the threshold. See the NIH Grants Policy Statement for additional information on this reporting requirement.

In accordance with the regulatory requirements provided at 2 CFR Part 200.113 and Appendix XII to  2 CFR Part 200, 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 2 CFR Part 200 – Award Term and Condition for Recipient Integrity and Performance Matters.

Section VII. Agency Contacts

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, application errors and warnings, documenting system problems that threaten submission by the due date, and post-submission issues)

Finding Help Online: https://www.era.nih.gov/need-help  (preferred method of contact)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)

General Grants Information (Questions regarding application instructions, application processes, and NIH grant resources)
Email: [email protected] (preferred method of contact)
Telephone: 301-480-7075

Grants.gov Customer Support (Questions regarding Grants.gov registration and Workspace)
Contact Center Telephone: 800-518-4726
Email: [email protected]

Please direct all inquiries to the NIA scientific/research contacts at [email protected].

Alexis Bakos, PhD, MPH, RN
National Institute on Aging (NIA)
Telephone: 301-921-5970

Basil Eldadah, MD, PhD
National Institute on Aging (NIA)
Telephone: 301-496-6761

Elena Fazio, PhD
National Institute on Aging (NIA)
Telephone: 301-496-3131

Chandra Keller, EdD, MPH, MPP 
National Institute on Aging (NIA)
Telephone: 301-496-3137 

Michelle Mollica, PhD, MPH, RN, OCN
National Cancer Institute (NCI)
Telephone: 240-276-7621 
Email: [email protected]

Brennan Streck, PhD, MPH, RN
National Cancer Institute (NCI)
Telephone: (301)357-0516
Email: [email protected]

Tessie October, MD, MPH
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Telephone: 301-451-4295
Email: [email protected] 
 

Karen A. Kehl, PhD, RN
National Institute of Nursing Research (NINR)
Telephone: 301-594-8010
Email: [email protected]
 

Jovier Evans, Ph.D.
National Institute of Mental Health (NIMH)
Telephone: 301-443-6328
Email: [email protected]

Rebecca Hommer, MD
National Institute of Neurological Disorders and Stroke (NINDS)
Telephone: 301-827-2257
Email: [email protected]

Ramesh Vemuri, Ph.D.
National Institute on Aging (NIA)
Telephone: 301-402-7700
Email: [email protected]

Ryan Blakeney
National Institute on Aging (NIA)
Telephone: 301-451-9802
Email: [email protected]

Becky Brightful
National Cancer Institute
Telephone: 301-631-3011
Email: [email protected]

Margaret Young
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Telephone: 301-642-4552
Email: [email protected]

Ron Wertz
National Institute of Nursing Research (NINR)
Telephone: 301-594-2807
Email: [email protected]
 

Rita Sisco
National Institute of Mental Health (NIMH)
Telephone: 301-443-2805
Email: [email protected]

Section VIII. Other Information

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

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 2 CFR Part 200.