End-of-Life and Palliative Needs of Adolescents and Young Adults (AYA) with Serious Illnesses (R21 Clinical Trial Optional)

Department of Health and Human Services

Part 1. Overview Information

Participating Organization(s)

National Institutes of Health (NIH)

Components
of Participating Organizations

National Institute of Nursing Research (NINR)

National Cancer Institute (NCI)

Funding Opportunity Title

End-of-Life and Palliative Needs of
Adolescents and Young Adults (AYA) with Serious Illnesses (R21 Clinical Trial
Optional)

Activity Code

R21 Exploratory/Developmental Research Grant

Funding Opportunity Announcement (FOA) Number

PAR-19-153

Companion Funding Opportunity

PAR-19-136, R01 Research Project Grant

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

93.361, 93.399

Funding Opportunity Purpose

The purpose of this funding opportunity announcement (FOA)
is to foster research on the unique perspectives, needs, wishes, and
decision-making processes of adolescents and young adults (AYA; defined by
the World Health Organization and the Centers for Disease Control and
Prevention as youth between 12–24 years of age) with serious, advanced
illnesses; and research focused on specific end-of-life/palliative care
(EOLPC) models that support the physical, psychological, spiritual, and
social needs of AYA with serious illness, their families and caregivers.    

Key Dates

Posted Date

January 8, 2019

Open Date (Earliest Submission Date)

January 16, 2019

Letter of Intent Due Date(s)

Not Applicable

Application Due Date(s)

Standard
dates
apply, by 5:00 PM local time of applicant organization. All types of non-AIDS applications allowed
for this funding opportunity announcement are due on these dates.

The first standard application due date for this FOA is
February 16, 2019.

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

AIDS Application Due Date(s)

Standard AIDS
dates
apply by 5:00 PM local time of applicant organization. All types of AIDS and AIDS-related applications allowed for this funding opportunity announcement are due on these dates.

The first AIDS application due date for this FOA is May 7,
2019.

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.

Expiration Date

January 8, 2022

Due Dates for E.O. 12372

Not Applicable

Required
Application Instructions

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

There are several options available to submit your application through Grants.gov to NIH and
Department of Health and Human Services partners. You must use one of these submission
options to access the application forms for this opportunity.

  1. Use the NIH ASSIST system to prepare, submit and track your application online.
  2. Use an institutional system-to-system (S2S) solution to prepare and submit your application
    to Grants.gov and eRA Commons to track your
    application. Check with your institutional officials regarding availability.
  3. Use Grants.gov Workspace to prepare and submit your application and eRA Commons to track your application.
  4. Table of Contents

    Part 1. Overview Information

    Part 2. Full Text of the Announcement

    Section
    I. Funding Opportunity Description

    Section II. Award InformationSection III. Eligibility InformationSection IV. Application and Submission
    Information
    Section V. Application Review InformationSection VI. Award Administration InformationSection VII. Agency ContactsSection VIII. Other Information



    Part 2.
    Full Text of Announcement

    Section I. Funding Opportunity Description

    The purpose of this funding opportunity announcement (FOA)
    is to foster research on the unique perspectives, needs, wishes, and
    decision-making processes of adolescents and young adults (AYA; defined by the
    World Health Organization and the Centers for Disease Control and Prevention as
    youth between 12 – 24 years of age) with serious, advanced illnesses; and
    research focused on specific end-of-life/palliative care (EOLPC) models that
    support the physical, psychological, spiritual, and social needs of AYA with
    serious illness, their families and caregivers. The objective is to support
    targeted clinical studies aimed at: 1) increasing this knowledge base, 2) the
    development of AYA-appropriate measurement tools and, 3) the design, testing,
    and evaluation of AYA-specific EOLPC models of care, and interventions that
    positively impact health -related quality of life for AYA with serious illness
    and their families/caregivers. The intent of EOLPC is multifaceted and includes
    care that seeks to prevent, relieve, reduce or soothe disease-related symptoms,
    mitigating the impact of co-morbidities, and enabling a positive influence
    across the course of illness and eventual death, for patients and their family
    caregivers. EOLPC may integrate the emotional, psychological, social, and
    physical aspects of care with a focus on enhanced quality of life. This FOA
    will advance the science of EOLPC in AYA, where age-specific and developmentally
    appropriate EOLPC care strategies that meet the needs of this population are
    understudied, despite a growing emphasis to address their unique needs.

    Background

    This FOA is responding, in part, to a recent Institute of
    Medicine (IOM) report and a recent workshop. In September of 2014 the IOM
    released the report, Dying in America: Improving Quality and Honoring
    Individual Preferences Near the End of Life, which called for the development
    of guidelines and research in adolescent EOLPC stating the need for, “. .
    . an increased understanding of ways to improve participation in effective
    advance care planning and shared decision making among patients and families,
    including seriously ill children and adolescents, who may be able to
    participate in end-of-life decision making on their own behalf.” Further,
    the report recommended that AYA “. . . should have the opportunity to
    participate actively in their health care decision making throughout their
    lives and as they approach death, and receive medical and related social
    services consistent with their values, goals and informed preferences.”
    The workshop, “The Spectrum of Caregiving and Palliative Care in Serious,
    Advanced, Rare Diseases” hosted by the NINR and the NCATS Office of Rare
    Diseases Research (ORDR), examined the current state of the science and
    identified knowledge gaps with regard to palliative care needs for patients and
    caregivers. Among the issues brought forth was a need to develop
    AYA-appropriate EOLPC support models and interventions that are not only based
    on chronological age, but also on developmental stage, psychosocial needs and
    emotional maturity; as well as the need to understand how AYA comprehend their
    illness, and how they approach and make decisions regarding advanced illness
    care across the developmental and disease spectrum.

    Beginning at time of diagnosis, adolescents and young adults
    with serious illnesses experience unique vulnerabilities, complex health
    concerns, and barriers to accessing palliative and/or hospice care. Medical advancements
    have led to an increased prevalence of children with serious illnesses who are
    now surviving into adolescence and young adulthood, and research indicates that
    these youth present with more advanced or complicated conditions than younger
    age groups. As a result, the need for EOLPC for this population is increasing
    despite limited research in this area. Many of these AYAs age into adult
    palliative or hospice care programs without a timely transition to appropriate
    young adult services. This deficiency in end-of-life and palliative care across
    the disease trajectory impacts the quality of life for AYA, their families and
    caregivers. According to the American Academy of Pediatrics (AAP), palliative
    care for adolescents and young adults should be patient centered and family
    engaged, offering a respectful partnership that is concerned about quality,
    access, and equity. Specifically, the AAP recommends that ‘pediatric’
    palliative care offer support across the age spectrum and life span. However,
    data show that 72 percent of adolescents die in ICUs without receipt of
    palliative care, even though the vast majority of AYA have discussed advance
    care plans about EOL issues and indicated preferences to die in their homes or
    hospice settings. This underscores that few AYA and their families access the
    full benefits and support of EOLPC services.

    Despite the need for evidence-based knowledge to support the
    development of appropriate models of support and care for AYA with serious,
    advanced illnesses and their family caregivers, limited research exists on the
    unique needs, perspectives and decision-making processes of these individuals.
    Because statistical analyses of research generally group a large proportion of
    AYA with ‘all children’ (0 – 18 years), it is difficult to discern their
    specific palliative and end-of-life care needs. Of the few studies that focused
    specifically on AYA palliative or hospice care, a majority were written by just
    two authors – illustrating a lack of depth in the field. The few published
    studies note that AYA who receive EOLPC services benefit from this care – they
    are less likely to receive invasive procedures, take fewer medications, and are
    less likely to die in the ICU. Still needed, however, are evidence-based
    interventions that clearly discern the unique needs of these emerging young
    adults, and offer AYA-specific strategies to support the EOLPC needs of these
    youth, their families and caregivers.

    Research Objectives

    Research projects should include studies that incorporate
    variables such as: age, developmental stage, emotional maturity, diagnosis,
    prognosis, uncertain disease trajectory, sex/gender, culture/ethnicity,
    socioeconomic status, geographic location, language, and family structures,
    among other parameters. Studies may also consider differences across time
    points and disease progression, as well as ways in which EOLPC and planning can
    adapt to meet changing needs.

    Research projects of interest include, but are not limited
    to, those that:

  • Examine the unique perspectives, preferences/needs/wishes and
    decision-making processes of AYA living with advanced, serious illness.
  • Characterize AYA-specific processes in comprehending advanced,
    serious illness to better understand how AYA can contribute to decisions around
    their care and end-of-life preferences.
  • Determine AYA-specific psychosocial effects of an advanced,
    serious illness diagnosis (e.g. body image, self-esteem or reintegration into
    ‘normal’ life) and the impact on their families and caregivers.
  • Distinguish significant transition points for AYA across the
    spectrum of the disease trajectory.
  • Develop AYA-appropriate models of care to improve care
    continuity, ease care transitions and care coordination, and referral to EOL
    care with the goal of improving quality of life for AYA and their families and
    caregivers.
  • Identify knowledge gaps in AYA-specific developmental, cultural,
    social, educational, and language differences that impact the use of EOLPC
    services and resources.
  • Design, test, evaluate, and compare AYA-specific EOLPC
    interventions or models of care that support the physical, sociocultural,
    psychological, spiritual, and/or social needs of AYA, their families and
    caregivers, with the aim of improving quality of life and family satisfaction
    with care.
  • Investigate and determine appropriate language, terminology, and
    timing for EOLPC communication between clinicians and AYA, families/caregivers
    and AYA, families/caregivers and clinicians.
  • Design and test communication strategies/interventions to improve
    communication between clinicians and AYA, families/caregivers and AYA,
    families/caregivers and clinicians, with the aim of decreasing discordance,
    improving quality of life, and increasing satisfaction with care for AYA and
    families/caregivers.
  • Develop reliable and valid AYA-appropriate screening/measurement
    methods, instruments or tools such as those for early detection of physical,
    emotional, and/or psychosocial symptoms, non-adherence to treatment, need for
    referral to palliative care or hospice, health-related quality of life, or
    measurement of family well-being, among other considerations, in AYA living
    with advanced illness and/or approaching death.
  • Consider ethical concerns surrounding AYA involvement in
    family-centered advance care planning, and/or create tools/strategies/guidelines
    for managing discordance between AYA, families and/or health care providers.
  • Develop and test AYA-appropriate innovative technologies for use
    in palliative and/or hospice care models.
  • Develop AYA-appropriate metrics to determine the optimal timing
    of referral to palliative and/or hospice teams.

Interdisciplinary collaborations that include nurse
scientists in the project team are strongly encouraged.

The evolution and vitality of the biomedical sciences
require a constant infusion of new ideas, techniques, and points of view. These
may differ substantially from current thinking or practice and may not yet be
supported by substantial preliminary data. By using the R21 mechanism, the NIH
seeks to foster the introduction of novel scientific ideas, model systems,
tools, agents, targets, and technologies that have the potential to
substantially advance biomedical research.

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

Section II. Award
Information

Funding Instrument

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

Application Types Allowed

New


Resubmission


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

Funds Available and Anticipated Number of Awards

The number of awards is contingent upon NIH appropriations
and the submission of a sufficient number of meritorious applications.

Award Budget

The combined budget for direct costs for the two-year
project period may not exceed $275,000. No more than $200,000 may be
requested in any single year.

Award Project Period

The maximum project period is 2 years.     

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

Section III. Eligibility
Information

1. Eligible Applicants

Eligible Organizations

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:

o   Hispanic-serving Institutions

o   Historically Black Colleges and Universities (HBCUs)

o   Tribally Controlled Colleges and Universities (TCCUs)

o   Alaska Native and Native Hawaiian Serving Institutions

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

Nonprofits Other Than Institutions of Higher Education

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

For-Profit Organizations

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

Governments

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

Other

  • Independent School Districts
  • Public Housing Authorities/Indian Housing Authorities
  • Native American Tribal Organizations (other than Federally
    recognized tribal governments)
  • Faith-based or Community-based Organizations
  • Regional Organizations
  • Non-domestic (non-U.S.) Entities (Foreign Institutions)

Foreign Institutions

Non-domestic (non-U.S.) Entities (Foreign Institutions) are  eligible to apply.


Non-domestic (non-U.S.) components of U.S. Organizations are  eligible
to apply.


Foreign components, as defined in
the NIH Grants Policy Statement
, are  allowed.

Applicant
Organizations

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

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

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

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

Eligible Individuals (Program Director/Principal
Investigator)

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

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

2. Cost Sharing

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

3. Additional Information on Eligibility

Number of Applications

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

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

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

Section IV. Application and Submission Information

1. Requesting an Application
Package

The application forms package specific to this opportunity
must be accessed through ASSIST, Grants.gov Workspace or an institutional
system-to-system solution. Links to apply using ASSIST or Grants.gov Workspace are
available in Part 1 of this
FOA. See your administrative office for instructions if you plan to use an
institutional system-to-system solution.

2. Content and Form of Application Submission

It is critical that applicants follow the Research (R) Instructions
in the SF424
(R&R) Application Guide
, except where instructed in this funding
opportunity announcement to do otherwise. Conformance to the requirements in
the Application Guide is required and strictly enforced. Applications that are
out of compliance with these instructions may be delayed or not accepted for
review.

Page Limitations

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

Instructions for Application Submission

The following section supplements the instructions found in
the SF424 (R&R) Application Guide and should be used for preparing an
application to this FOA.

SF424(R&R) Cover

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

SF424(R&R) Project/Performance Site Locations

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

SF424(R&R) Other Project Information

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

SF424(R&R) Senior/Key Person Profile

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

R&R or Modular Budget

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

R&R Subaward Budget

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

PHS 398 Cover Page Supplement

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

PHS 398 Research Plan

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

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

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

Appendix:

Only limited Appendix materials are allowed. Follow all
instructions for the Appendix as described in the SF424 (R&R) Application
Guide.

PHS Human Subjects and Clinical Trials Information

When involving NIH-defined human subjects research, clinical
research, and/or clinical trials (and when applicable, clinical trials research
experience) 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 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.

PHS Assignment Request Form

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

Foreign Institutions

Foreign (non-U.S.) institutions must follow policies
described in the NIH
Grants Policy Statement
, and procedures for foreign institutions.

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

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

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

5. Intergovernmental Review
(E.O. 12372)

This initiative is not subject to intergovernmental
review.

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

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

7. Other Submission
Requirements and Information

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

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) must include their eRA Commons ID in
the Credential field of the Senior/Key Person Profile Component of the
SF424(R&R) Application Package. Failure to register in the Commons
and to include a valid PD/PI Commons ID in the credential field will prevent
the successful submission of an electronic application to NIH. See Section III of this FOA for information on
registration requirements.

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

See more tips for avoiding common errors.

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

Common Data Elements

  • NINR encourages the use of common data elements (CDEs) in basic,
    clinical, and applied research, patient registries, and other human subject
    research to facilitate broader and more effective use of data and advance
    research across studies.
  • CDEs are data elements that have been identified and defined for
    use in multiple data sets across different studies. Use of CDEs can facilitate
    data sharing and standardization to improve data quality and enable data
    integration from multiple studies and sources, including electronic health
    records.
  • NIH ICs have identified CDEs for many clinical domains (e.g.,
    neurological disease), types of studies (e.g. genome-wide association studies
    (GWAS)), types of outcomes (e.g., patient-reported outcomes), and patient
    registries (e.g., the Global Rare Diseases Patient Registry and Data
    Repository).
  • NIH has established a “Common Data Element (CDE) Resource
    Portal” (http://cde.nih.gov/) to assist investigators in identifying
    NIH-supported CDEs when developing protocols, case report forms, and other
    instruments for data collection.
  • The Portal provides guidance about and access to NIH-supported CDE
    initiatives and other tools and resources for the appropriate use of CDEs and
    data standards in NIH-funded research.
  • Investigators are encouraged to consult the Portal and describe
    in their applications any use they will make of NIH-supported CDEs in their
    projects.

Post Submission Materials

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

Section V. Application Review Information

Only the review criteria described below will be considered
in the review process.

Applications submitted to the NIH in support of the NIH mission are evaluated for scientific and technical merit through the NIH peer review
system.

For this particular announcement, note the following:

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.

The R21 exploratory/developmental grant supports
investigation of novel scientific ideas or new model systems, tools, or
technologies that have the potential for significant impact on biomedical or
biobehavioral research. An R21 grant application need not have extensive
background material or preliminary information. Accordingly, reviewers will emphasize
the conceptual framework, the level of innovation, and the potential to
significantly advance our knowledge or understanding. Appropriate justification
for the proposed work can be provided through literature citations, data from
other sources, or, when available, from investigator-generated data.
Preliminary data are not required for R21 applications; however, they may be
included if available.

Overall Impact

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).

Scored Review Criteria

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? Does the proposed study
adhere to the World Health Organization definition of the age range for
Adolescents and Young Adults (12 – 24 years of age)? Is the study that the
investigators propose clearly focused on palliative care or end-of-life care?

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?

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?

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?

Do the investigators consider the developmental stage
of the proposed population for the study and address the ethical concerns
surrounding AYA involvement in family-centered palliative and/or end-of-life
care (as appropriate to the study)?  

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

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

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

For Resubmissions, the committee
will evaluate the application as now presented, taking into consideration the
responses to comments from the previous scientific review group and changes
made to the project.

Renewals

Not Applicable

Revisions

Not Applicable

Additional Review Considerations

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

Applications from Foreign
Organizations

Reviewers will assess whether the
project presents special opportunities for furthering research programs through
the use of unusual talent, resources, populations, or environmental conditions
that exist in other countries and either are not readily available in the
United States or augment existing U.S. resources.

Select Agent Research

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

Resource Sharing Plans

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

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 the Center for
Scientific Review, in accordance with NIH peer
review policy and procedures
, using the stated review
criteria
. Assignment to a Scientific Review Group will be shown in the eRA
Commons.

As part of the scientific peer review, all applications:

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

Applications will be assigned on the basis of established
PHS referral guidelines to the appropriate NIH Institute or Center. Applications
will compete for available funds with all other recommended applications . Following
initial peer review, recommended applications will receive a second level of
review by the appropriate national Advisory Council or Board. 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 his or her Summary Statement (written critique)
via the eRA
Commons
. Refer to Part 1 for dates for peer review, advisory council
review, and earliest start date.

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

Section VI. Award
Administration Information

1. Award Notices

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

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

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

Any application awarded in response to this FOA will be
subject to 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 of all trials whether required under the law or not.
For more information, see http://grants.nih.gov/ClinicalTrials_fdaaa/ 

Institutional Review Board or Independent Ethics Committee
Approval: Grantee institutions must ensure that the application as well as all
protocols are reviewed by their IRB or IEC. To help ensure the safety of
participants enrolled in NIH-funded studies, the awardee 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). 

2. Administrative and
National Policy Requirements

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

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

For additional guidance regarding how the provisions apply
to NIH grant programs, please contact the Scientific/Research Contact that is
identified in Section VII under Agency Contacts of this FOA. HHS provides
general guidance to recipients of FFA on meeting their legal obligation to take
reasonable steps to provide meaningful access to their programs by persons with
limited English proficiency. Please see https://www.hhs.gov/civil-rights/for-individuals/special-topics/limited-english-proficiency/index.html.
The HHS Office for Civil Rights also provides guidance on complying with civil
rights laws enforced by HHS. Please see https://www.hhs.gov/civil-rights/for-individuals/section-1557/index.html;
and https://www.hhs.gov/civil-rights/for-providers/laws-regulations-guidance/index.html.
 Recipients of FFA also have specific legal obligations for serving qualified
individuals with disabilities. Please see https://www.hhs.gov/civil-rights/for-individuals/disability/index.html.
Please contact the HHS Office for Civil Rights for more information about
obligations and prohibitions under federal civil rights laws at https://www.hhs.gov/ocr/about-us/contact-us/index.html or call 1-800-368-1019 or TDD 1-800-537-7697. Also note it is an HHS
Departmental goal to ensure access to quality, culturally competent care, including
long-term services and supports, for vulnerable populations. For further
guidance on providing culturally and linguistically appropriate services,
recipients should review the National Standards for Culturally and
Linguistically Appropriate Services in Health and Health Care at http://minorityhealth.hhs.gov/omh/browse.aspx?lvl=2&lvlid=53.

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

Cooperative Agreement Terms and Conditions of Award

Not Applicable

3. Reporting

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

A final 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
.

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

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

Section VII. Agency Contacts

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

Application Submission Contacts

eRA 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: http://grants.nih.gov/support/ (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: GrantsInfo@nih.gov (preferred
method of contact)


Telephone: 301-945-7573

Grants.gov Customer Support (Questions regarding
Grants.gov registration and Workspace)


Contact Center Telephone: 800-518-4726


Email: support@grants.gov

Scientific/Research Contact(s)

Lynn S. Adams, Ph.D.


National Institute of Nursing Research (NINR)


Telephone: 301-594-8911


Email: lynn.adams@nih.gov

Ashley Wilder Smith, Ph.D., M.P.H.



National Cancer Institute (NCI)


Telephone: 240-276-6714


Email: smithas@mail.nih.gov

Peer Review Contact(s)

Examine your eRA Commons account for review assignment and
contact information (information appears two weeks after the submission due
date).

Financial/Grants Management Contact(s)

Ron Wertz


National Institute of Nursing Research (NINR)


Telephone: 301-594-2807 


Email: wertzr@mail.nih.gov

Carol A. Perry


National Cancer Institute (NCI)


Telephone: 240-276-6282


Email: perryc@mail.nih.gov


 

Section VIII. Other
Information

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

Authority and Regulations

Awards are made under the authorization of Sections 301 and
405 of the Public Health Service Act as amended (42 USC 241 and 284) and under
Federal Regulations 42 CFR Part 52 and 45 CFR Part 75.

NIH… Turning Discovery Into Health®


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