Department of Health and Human Services

Part 1. Overview Information
Participating Organization(s)

National Institutes of Health (NIH)

Components of Participating Organizations

National Center for Complementary and Alternative Medicine (NCCAM)
National Institute of Nursing Research (NINR)
Office of Behavioral and Social Sciences Research (OBSSR)
Office of Research on Women’s Health (ORWH)

Funding Opportunity Title

Arts-Based Approaches in Palliative Care for Symptom Management (R01)

Activity Code

R01 Research Project Grant

Announcement Type

New

Related Notices

None

Funding Opportunity Announcement (FOA) Number

PAR-14-294

Companion Funding Opportunity

None

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

93.361, 93.213, 93.313

Funding Opportunity Purpose

The purpose of this funding opportunity announcement (FOA) is to support mechanistic clinical studies aimed at understanding the impact of arts-based approaches in palliative care for symptom management. This FOA is intended to support mechanistic clinical studies to provide an evidence base for the use of the arts in palliative care for symptom management. The objective is to understand the biological, physiological, neurological, psychological, and/or sociological mechanisms by which the arts exert their effects on symptom management during and throughout the palliative care continuum. The goal is for the research supported under this FOA to develop an evidence-base that could be used as a basis for the uptake of arts-based therapies in palliative care settings, among individuals across the lifespan, with a wide variety of serious chronic conditions and their accompanying symptoms. This FOA is not intended to determine efficacy or the comparative effectiveness of interventions, or to assess interventions designed to treat the underlying cause of a particular disease state.

Key Dates
Posted Date

July 24, 2014

Open Date (Earliest Submission Date)

September 5, 2014

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.

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.

Scientific Merit Review
Advisory Council Review
Earliest Start Date
Expiration Date

September 8, 2017

Due Dates for E.O. 12372

Not Applicable

Required Application Instructions

It is critical that applicants follow the 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.


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Table of Contents

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

Part 2. Full Text of Announcement
Section I. Funding Opportunity Description

This FOA is intended to foster research on the potential for arts-based approaches to enhance palliative care for individuals living with multiple symptoms related to serious chronic or terminal illness. The objective is to encourage research to determine how the specific arts intervention might be working mechanistically in managing or ameliorating patients’ serious chronic symptoms related to quality of life (QoL). Mechanism refers to the biological, physiological, neurological, psychological, and/or sociological manner by which the arts exert its purported effect(s) on selected outcomes. Also of interest is the comparison of differences in mechanisms in male and female sample populations. The term “arts” refers not only to artistic activities, but also to creative activities, such as literature, rituals, oral histories, storytelling, etc. The intent of palliative care is multifaceted and includes relieving the myriad of disease-related symptoms (such as pain), mitigating the impact of co-morbidities, and enabling a positive influence on the course of illness. Palliative care integrates and coordinates the emotional, psychological, social, and physical aspects of care with a focus on enhanced QoL. Throughout the course of illness, a team approach composed of a variety of practitioners is used to achieve this end – to prevent suffering by managing stressful clinical complications and improving the patient’s sense of well-being. On January 2014, the World Health Organization (WHO) Executive Board considered a report by the WHO secretariat on palliative care and adopted the resolution entitled “Strengthening of palliative care as a component of integrated treatment through the life course.” The document emphasized the need to integrate evidence-based palliative services into the continuum of care, at all levels, of chronic life-threatening conditions, with an emphasis on primary care, and community- and home-based care. (Report from the Secretariat, Strengthening of palliative care as a component of integrated treatment through the life course. World Health Organization. Executive Board, 134th Session, December 20, 2013.)

The report further described a range of conditions in which palliative care may be needed, including: serious and chronic illnesses such as cancer, cardiovascular disease, chronic obstructive pulmonary diseases, kidney failure, chronic liver disease, Alzheimer’s disease and other dementias, neurological diseases, and infectious diseases such as HIV/AIDS, among others.

Background

The participating NIH institutes, centers, or offices (ICO) are interested in fostering complementary and integrative practices and settings that reduce symptom burden and optimize QoL (NCCAM), the science of palliative care across the lifespan (NINR), the applicability of palliative care specifically to women (ORWH), and the psychological, emotional, social, and behavioral aspects (OBSSR) of this research. Each ICO is interested in determining how the arts might enhance palliative care to manage symptoms broadly defined in individuals with serious illness and provide care for serious chronic conditions across the lifespan, including those from diverse populations. The NCCAM provides research support for a broad spectrum of complementary health approaches, with the goal of developing foundational evidence to form the basis of further research. Complementary and integrative arts-based approaches have shown some promise in relieving symptoms, and may prove beneficial in enhancing palliative care for individuals living with serious chronic or terminal illness. NINR conducts and supports research in areas that explore strategies to prevent, reduce, or comfort the symptoms of advanced illness across the lifespan, particularly developing and testing strategies to minimize the physical and psychological burdens on individuals and their caregivers. NINR recognizes palliative care as a critical component of high-quality, evidence-based health care that extends to symptom management encompassing emotional, social, spiritual, and informed decision-making support. The ORWH ensures that research conducted and supported by the NIH adequately addresses issues regarding women's health. This FOA is very pertinent to ORWH’s mission because ORWH acknowledges that women suffer disproportionately from serious chronic conditions and palliative care for family members often falls upon women caregivers. The OBSSR mission is to stimulate behavioral and social sciences research throughout NIH and to integrate these areas of research more fully into others of the NIH health research enterprise, and as such is committed to developing funding initiatives to further areas that lend themselves to this mission. This initiative will encourage research to elucidate the mechanism of arts-based approaches to enhance palliative care in individuals with a wide variety of serious chronic conditions and their accompanying symptoms.

This FOA is responding, in part, to two recent workshops. The first was held in March 2011, in which the National Endowment for the Arts (NEA) joined the National Institute on Aging (NIA), OBSSR, and NCCAM at NIH as part of a federal interagency task force on the arts and human development to request that the National Academy of Sciences (NAS) convene a public workshop to focus on research challenges and opportunities in exploring the relationship of the arts to health and well-being in older adults. The NEA is an independent federal agency that funds and promotes artistic excellence, creativity, and innovation for the benefit of individuals and communities. As a core function, the NEA has great interest in supporting research into the value and impact of the arts. Palliative care may hold promise for integrating arts-based approaches into overall care, since it focuses on reducing symptoms, alleviating pain, and improving QoL rather than curing disease. The current initiative seeks to further develop these approaches and findings discussed at the workshop, linking arts participation with improved QoL by extending research on arts-based approaches to the area of palliative care. The second workshop, “The Science of Compassion:  Future Directions in End-of-Life and Palliative Care,” was held in August 2011, and hosted by the NINR, with support from numerous NIH partners (NCCAM, NIA, Office of Rare Diseases Research (ORDR), ORWH, Clinical Center). The summit examined the state of end-of-life and palliative care research, particularly in relation to clinical practice and called for substantial research efforts to develop and test effective and optimal models of end-of-life and palliative care interventions. Among the issues discussed were management of pain and other symptoms, creation of effective models of health service, challenges of study design, and metrics to evaluate improvements in care. The integration of mind and body practices was identified as understudied among the issues in palliative care. In both chronic debilitating conditions and at the end-of-life, palliative care was considered a comprehensive approach to provide the best possible QoL for patients and their families. Integrative therapy was suggested as an effective model for palliative care because of the potential advantage of non-pharmacological options, in addition to pharmacologic agents, for reducing pain. Therefore, studies that examine the mechanism by which arts-based approaches (in addition to usual care), as a component of complementary care, enhance palliative care for symptom management, are the focus of this FOA.

Although additional research is needed in this area, a few studies have yielded promising results in examining the potential of music engagement, visual arts therapy, movement-based arts therapy (e.g., dance, theater), or expressive writing to ameliorate physical and/or psychological symptoms in patients with serious chronic illness. Such studies typically have investigated the impact of arts interventions on patients with cancer (various types), coronary artery disease, chronic psychiatric conditions, fibromyalgia, or other illnesses in a range of palliative care settings. Other studies have reported positive psychosocial outcomes associated with caregivers who are included in arts interventions. While there may not be ideal solutions for managing the complex array of symptoms that accompany serious chronic illness, patient participation in arts interventions has been linked to reduced levels of pain, stress, anxiety, and fatigue, and to improved psychosocial and QoL outcome measures. However, across the arts spectrum, the literature is lacking information on the mechanism by which arts-based approaches purportedly enhance palliative care for symptom management. Thus, not only is there a clear need to build a stronger evidence base for the role of the arts in palliative care for symptom management, but also to elucidate the underlying mechanisms by which the arts might be working to alleviate symptoms. Given the potential of the arts to prevent, ameliorate, relieve, or help treat symptoms and health-related conditions, research is needed to understand their role and mechanism in enhancing and optimizing palliative care.

Research Scope

Appropriate compelling mechanistic clinical studies with clear rationale could include, but are not limited to, the following research areas:

  • Develop methodologies that allow the elucidation of the underlying mechanism by which arts-based intervention may be operating, as part of integrative practices in palliative care;
  • Assess which components of arts-based integrative palliative care interventions exert an effect on QoL and functioning, for various severities and trajectories of symptom management in serious chronic conditions;
  • Examine how arts-based interventions actually optimize palliative care and impact QoL by mitigating common symptoms and/or symptom clusters (such as pain, dyspnea, fatigue, stiffness, mobility disability, distress, etc.) associated with a number of serious chronic conditions;
  • Examine patient-related factors (e.g., age, sex, illness, ethno-culture, etc.) that account for individual variation in responsiveness to arts-based interventions for symptomatic relief;
  • Examine approaches that integrate the arts within palliative care among children, adults, and their caregivers to reduce, eliminate, or ameliorate symptoms throughout illness trajectories and determine when and how these interventions are working.
  • Examine interdisciplinary intervention-based protocols that explore the mechanistic relationship between engagement with the arts and purported health-promoting and symptom-reducing outcomes within care settings.

NIH encourages applications to this FOA that also address health disparities, symptom management in patients with HIV/AIDS, evaluate the use of the arts in under-represented individuals/groups, focus on the caregivers of individuals who receive palliative care, and utilize special populations such as older adults, children, women, individuals in the military, or veterans. Also of interest is the comparison of male and female sample populations with respect to mechanistic outcomes. Of particular interest is research which will increase the understanding of sex and gender differences, as well as sex and gender factors in health and disease, to support implementation of the NIH Strategic Plan for Women’s Health Research (http://orwh.od.nih.gov/research/strategicplan/index.asp).

This FOA will not support studies of experimental models of disease or animal studies, or fully-powered randomized clinical trials designed to test efficacy or effectiveness. Randomization may be employed as a methodological approach to elucidate the mechanism of arts-based approaches and to meet other goals of this FOA. Applications proposing research in topics not identified above as high programmatic priority will be considered of low programmatic priority, which will reduce the likelihood of funding.

Consultation with NCCAM and NINR

Applicants are encouraged to consult with NCCAM and NINR staff as your team develops plans for an application (see Section VII, Agency Contacts). This early contact will provide an opportunity to clarify NCCAM and NINR policies and guidelines for this FOA.

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
Revision

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

Applicants may request up to $300,000 in direct costs per year.

Award Project Period

The maximum project period is 3 years.

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

Section III. Eligibility Information
1. Eligible Applicants
Eligible Organizations

Higher Education Institutions

  • 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)

Governments

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

Other

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

Required Registrations

Applicant Organizations

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

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

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

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

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).

In addition, the NIH will not accept a resubmission (A1) application that is submitted later than 37 months after submission of the new (A0) application that it follows.  The NIH will accept submission:

  • To an RFA of an application that was submitted previously as an investigator-initiated application but not paid;
  • Of an investigator-initiated application that was originally submitted to an RFA but not paid; or
  • Of an application with a changed grant activity code.
Section IV. Application and Submission Information
1. Requesting an Application Package

Applicants must download the SF424 (R&R) application package associated with this funding opportunity using the “Apply for Grant Electronically” button in this FOA or following the directions provided at Grants.gov.

2. Content and Form of Application Submission

It is critical that applicants follow the instructions in the SF424 (R&R) Application Guide, including Supplemental Grant Application Instructions 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.

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

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. , with the following additional instructions:

Facilities & Other Resources:  Applicants are encouraged to provide strong evidence of the availability of appropriate institutional resources, and suitable patient populations. Documentation of availability of eligible subjects at clinic sites, presented in tabular format should be provided. The application should include relevant information that addresses the feasibility of recruiting participants who are eligible for the clinical study. Specifically, applicants must provide evidence that the recruiting center in the study has access to a sufficient number of study participants who meet the eligibility criteria as defined in the submitted protocol.

SF424(R&R) Senior/Key Person Profile

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

Applicants are encouraged to provide strong evidence of the study team's qualifications and ability to conduct the proposed research, as well as those of the experienced investigative team members, and previous investigative experience in related clinical research, including the successful recruitment of study population. Provide specific evidence of necessary experience and expertise with the arts intervention, the study population, and the research methods to be employed. Demonstrate that the investigative team has a track record of publishing the results of research previously completed.

Biographical Sketches:  Documentation of the PD/PI's experience in leading clinical studies and expertise in the content area of the research. Biographical sketches for all key study personnel must be provided. Even mechanistic clinical research requires a multidisciplinary team (clinician, biostatistician, data manager, study coordinator, etc.) and the application should reflect their hands-on involvement in the design and implementation of the study protocol.

R&R or Modular Budget

All instructions in the SF424 (R&R) Application Guide must be followed. Applicants should budget for the services of appropriate safety monitoring, e.g. Medical Safety Monitor, Independent Medical Monitor, or Safety Monitoring Committee, as indicated (see http://nccam.nih.gov/grants/policies/data-safety-monitoring).

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:

Specific Aims: The specific aims of the mechanistic clinical studies must be clearly and concisely presented. The primary and major secondary hypotheses to be evaluated must be clearly stated.

Research Strategy: Clinical Significance and Biological Relevance: The clinical significance and biological relevance of the proposed mechanistic clinical study must be clearly stated to provide the theoretical framework for the proposed hypotheses. In particular, investigators should discuss how the study will test the primary hypothesis, how the research results (positive or negative) will advance the field, and overall potential impact of the proposed research.

Innovation

Indicate how the proposed study has the potential to advance the field (e.g., by breaking ground for future studies in this area) even if (a) the proposed study design, methods, and intervention are not innovative, and/or (b) the results of the study indicate that further clinical development of the arts intervention is unwarranted.

Prior Studies and Rationale for Development: The major findings of the preclinical and clinical studies that led to the proposed mechanistic clinical study should be described. Pilot studies that demonstrate the need for the study should be discussed. Provide evidence that the proposed project is likely to yield clear answers to proceed to the next step of the therapeutic development of the arts intervention. Study conceptualization and planning must be at a stage sufficient to allow an assessment of the likelihood of success.

Applications should address the reasons for consideration of the intervention. This may include public health impact if subsequent efficacy trials are conducted and positive; ethical dimensions; and patient perspectives on acceptability of the proposed intervention. Characteristics of any preliminary research results provided in support of the proposed project, whether conducted by the applicant or others, should be described in the application so that peer review may evaluate the strength of the supporting evidence. The applicant should also discuss the limitations of those data.

Study Design: A summary of the study protocol should be presented in the Research Strategy section and must include the following items:

  • Description of the study design and the rationale for this choice.
  • Description of the arts intervention to be tested and how it will be administered.
  • Description of the target population, and why it is an appropriate group to address the proposed hypotheses and how the results will be generalizable to the population as a whole.
  • List of participant eligibility criteria (inclusion & exclusion).
  • Participant recruitment and retention plans, including a discussion of the availability of participants for the proposed study and the ability of enrollment site to recruit and retain the proposed number of participants, particularly women and minority participants. Data supporting recruitment and retention estimates must be provided.
  • Description of all assessments including clinical, laboratory, physiological, behavioral, patient-centered, or other outcomes addressing the primary and secondary research questions. Use of patient reported outcomes, including those available through PROMIS, NIH Toolbox, and NeuroQoL, as well as non-traditional data collection approaches (e.g., telephone, mobile devices, or web-based systems) should be considered.
  • Statistical Methods:  Statistical methods should be proposed that are appropriately matched to the study design. Discussion of sample size justification; study outcome measures; plans for interim and final analyses; methods of bias control in allocation of participants to treatment and in assessment of outcomes; and methods for handling missing data.
  • Data Management and Quality Control:  Details of efficient data management and methods for monitoring quality; methods for monitoring the quality and consistency of intervention administration; and methods for ensuring participant confidentiality.
  • Discussion of the challenges expected in implementing the study and how these might be overcome.
  • Timeline:  Applicants should include a proposed timeline for reaching important study milestones such as:  (a) obtaining regulatory approval of the final protocol; (b) establishing agreements with participating industry partners, if indicated; (c) finalizing the study procedures and training participating clinical site staff; (e) enrolling 25%, 50%, 75%, and 100% of the targeted sample size; and (f) completing all subject follow-up and data collection activities.
  • Descriptions of the organization of the study and how the research will be managed.
  • If an administrative period is proposed, a timeline and milestones during this period should be provided.

Human Subjects Protections: Applicants must include a Data and Safety Monitoring (DSM) Plan that is commensurate with the risk level of the proposed clinical study (see http://grants.nih.gov/grants/guide/notice-files/not98-084.html). The DSM Plan must provide a general description of the monitoring plan, policies, procedures, responsible parties, and procedures for identifying, managing, and reporting “reportable events” (i.e., serious adverse events and unanticipated problems) to the applicable regulatory agencies [e.g., Institutional Review Boards (IRBs), the NCCAM, the NINR, the NIH Office of Biotechnology Activities, the Office for Human Research Protections (OHRP), the Food and Drug Administration (FDA), and the Data and Safety Monitoring Board (DSMB) or other study monitoring authority]. Therefore, the DSM Plan must address the following areas:

  • Who will perform the monitoring?
  • What will be monitored?
  • When will monitoring be performed?
  • How and to whom information on serious adverse events and other reportable events will be conveyed, and what actions will be taken?

Letters of Support: Applicants are encouraged to include documentation of the commitment of any subcontractors and consultants, as well as service agreements for personnel or facilities. Letters of commitment must be co-signed by the business official of the collaborating center.

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans (Data Sharing Plan, Sharing Model Organisms, and Genome Wide Association Studies (GWAS)) as provided in the SF424 (R&R) Application Guide, with the following modification:

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

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

Planned Enrollment Report

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

PHS 398 Cumulative Inclusion Enrollment Report

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

Foreign Institutions

Foreign (non-U.S.) institutions must follow policies described in the NIH Grants Policy Statement, and procedures for foreign institutions described throughout the SF424 (R&R) Application Guide. For more information, see NCCAM's statement on International Interventional Clinical Studies:  NCCAM Special Considerations (http://nccam.nih.gov/grants/internationalclinicaltrials).

3. Submission Dates and Times

Part I. Overview Information contains information about Key Dates. 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.

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.  If a Changed/Corrected application is submitted after the deadline, the application will be considered late.

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.

4. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

5. Funding Restrictions

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

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

6. Other Submission Requirements and Information

Applications must be 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 Applying Electronically.

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 by the Center for Scientific Review, NIH. Applications that are incomplete will not be reviewed.

Post Submission Materials

Applicants are required to follow the instructions for post-submission materials, as described in NOT-OD-13-030.

Section V. Application Review Information
1. Criteria

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

Overall Impact

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? 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?

Is there a sufficient body of preclinical or clinical research of high scientific rigor to support the study rationale? Is it clear why the proposed mechanistic study is essential to advance the field of arts-based approaches in palliative care for symptom management? Is the proposed project likely to yield clear answers needed to proceed to the next step of the therapeutic development of the arts intervention as proposed in this application?

Investigator(s)   

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

Does the application provide strong evidence of necessary experience and expertise with the arts intervention, the study population, and the research methods to be employed? Does the investigative team have a track record of publishing the results of research previously completed? Has the investigative team successfully recruited the study population in previous clinical studies?

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?

Does the proposed study have the potential to advance the field (e.g., by breaking ground for future studies in this area) even if (a) the proposed study design, methods, and intervention are not innovative, and/or (b) the results of the study indicate that further clinical development of the arts intervention is unwarranted?

Approach

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

If the project involves 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 children, justified in terms of the scientific goals and research strategy proposed?

Are the mechanistic hypotheses based on a sound theoretical framework? Does the applicant describe how the proposed study relates to a larger strategy for research and development on the arts intervention, and will it provide mechanistic data needed to advance that strategy?

Does the application demonstrate the feasibility of methods for developing tools for data management and study oversight, finalizing protocol documents and manuals, as well as addressing appropriate regulatory requirements (IND, IRB)? Are the outcome measures, dose/duration of study, appropriateness of inclusion/exclusion criteria, sample size, and power calculations clearly justified and explained in the application?

Is the proposed design feasible and adequate to provide interpretable results? Is the proposed timeline feasible and appropriate for the timely completion of the study (particularly regarding participant accrual goals)?

Are the plans for recruitment outreach and are follow-up procedures to ensure data collection at stated intervals appropriate? Are the retention plans and practices described?

Environment

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

Does the information provided in the application provide reasonable assurance that the target sample size can be enrolled in the timeframe proposed? Does the application document the availability of the requisite eligible subject pool in the proposed clinical center(s)? Is there documentation of the commitment of any subcontractors and consultants, as well as service agreements for personnel and facilities?

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.

Protections for Human Subjects

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

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

Inclusion of Women, Minorities, and Children 

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 children to determine if it is justified in terms of the scientific goals and research strategy proposed. For additional information on review of the Inclusion section, please refer to the Guidelines for the Review of Inclusion in Clinical Research.

Vertebrate Animals

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

Biohazards

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

Resubmissions

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

For Revisions, the committee will consider the appropriateness of the proposed expansion of the scope of the project. If the Revision application relates to a specific line of investigation presented in the original application that was not recommended for approval by the committee, then the committee will consider whether the responses to comments from the previous scientific review group are adequate and whether substantial changes are clearly evident.

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) Genome Wide Association Studies (GWAS).

Budget and Period of Support

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

2. Review and Selection Process

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s) convened by CSR, 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 submitted in response to this FOA. 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

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.

2. Administrative and National Policy Requirements

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

Cooperative Agreement Terms and Conditions of Award

Not Applicable

3. Reporting

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

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

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

Section VII. Agency Contacts

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

Application Submission Contacts

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

Grants.gov Customer Support (Questions regarding Grants.gov registration and submission, downloading forms and application packages)
Contact CenterTelephone: 800-518-4726
Web ticketing system: https://grants-portal.psc.gov/ContactUs.aspx
Email: support@grants.gov

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

Scientific/Research Contact(s)

D. Lee Alekel, PhD
National Center for Complementary and Alternative Medicine (NCCAM)
Telephone:  301-443-8374
Email:  Lee.Alekel@nih.gov

Lynn Adams, PhD
National Institute of Nursing Research (NINR)
Telephone:  301-594-8911
Email:  lynn.adams@nih.gov

William N. Elwood, PhD
Office of Behavioral and Social Sciences Research (OBSSR)
Telephone:  301-402-0116
Email: william.elwood@nih.gov

Amy C. Mistretta, MPH
Office of Research on Women's Health (ORWH)
Telephone:  301-496-9200
Email:  amy.mistretta@nih.gov

Peer Review Contact(s)

Gabriel Fosu, PhD
Center for Scientific Review (CSR)
Telephone: 301-435-3562
Email: fosug@csr.nih.gov

Financial/Grants Management Contact(s)

George A. Tucker, MBA, CGMS
National Center for Complementary and Alternative Medicine (NCCAM)
Telephone:  301-594-9102
Email:  tuckerg@mail.nih.gov

Ron Wertz, GMS
National Institute of Nursing Research (NINR)
Telephone:  301-594-2807
Email:  wertzr@mail.nih.gov

Section VIII. Other Information

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

Authority and Regulations

Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and 45 CFR Parts 74 and 92.

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