Part 1. Overview Information

Key Dates

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

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

It is critical that applicants follow the instructions in 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 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.

Part 2. Full Text of Announcement

Section I. Funding Opportunity Description

Purpose

The purpose of this FOA is to support a collection of research networks that promote multidisciplinary mechanistic studies of music-based interventions (MBIs) for pain or Alzheimer’s disease and Alzheimer’s disease-related dementias (AD/ADRD). These networks are expected to develop compelling research frameworks that will effectively guide future clinical studies on MBIs in these health conditions; adopt consistent terminology and taxonomy; support interdisciplinary collaborations and initiate pilot projects to test novel mechanistic hypotheses; and identify strong mechanistic measures, outcomes, biomarkers, as well as relevant novel technologies and methodologies. To accomplish these objectives, applicants can propose activities such as meetings, workshops, conferences, research collaborations, exchange of ideas through visiting scientist arrangements or training opportunities. These activities will help identify unique research gaps that can be addressed through the networks in the form of pilot projects which will in turn generate the preliminary data needed for music and health investigators to compete for more substantial NIH grants. In addition, the networks should sustain their scientific impact through a variety of dissemination and outreach strategies, including publication of research frameworks, common terminologies, reviews, and other best practices.

Background

Music has the remarkable ability to enhance child development, improve adult function and well-being, and optimize quality of life during aging. Some studies have shown that music may also have the potential to ameliorate the symptoms of a broad range of diseases and disorders that occur throughout the lifespan. Recent scientific breakthroughs, including the development of new technologies, are providing the community with opportunities to understand the mechanisms through which music acts and to develop new music-based interventions (MBIs) for a variety of diseases, disorders, and conditions.

In 2017, the NIH, the John F. Kennedy Center for the Performing Arts (KC), and the National Endowment for the Arts (NEA) formed a collaborative partnership (Sound Health) and organized a workshop to evaluate the state of basic and applied music research across the lifespan (Music and the Brain). At this meeting, a diverse panel of experts generated a set of recommendations intended to highlight research opportunities and promote rigorous research in the field of music and health. These recommendations centered around four broad areas: 1) Basic and Mechanistic Research, 2) Translational and Clinical Research, 3) Methods and Outcomes, and 4) Capacity Building and Infrastructure.

A trans-NIH Music and Health working group was later formed to capitalize on these recommendations and promote their implementation. To address the first two goals of promoting basic and mechanistic and clinical research, NIH issued three FOAs in 2019 that fell into two categories. The first two FOAs (RFA-NS-19-008 and RFA-NS-19-009) supported R01 and R21 awards, respectively, for research related to the fundamentals and application of music in health. The third FOA (RFA-AT-19-001), utilized a phased R61/R33 mechanism to support research on music and health geared towards the development of music-based interventions. These RFAs were followed in 2020 by the publication of three program announcements with special reviews (PAR-20-266, PAR-21-100, and PAR-21-099) to continue NIH’s support for basic, mechanistic, translational, and clinical research on music and health. To address the recommendation on methods and outcomes, the NIH, in collaboration with the Foundation for the NIH (FNIH) and the Ren e Fleming Foundation, organized three workshops in 2021, focusing on Laying the Foundation: Defining the Building Blocks of Music-Based Interventions, Assessing and Measuring Target Engagement Mechanistic and Clinical Outcome Measures for Brain Disorders of Aging, and Relating Target Engagement to Clinical Benefit Biomarkers for Brain Disorders of Aging, respectively. This workshop series is summarized in a manuscript currently under review, titled The NIH Music-Based Interventions Toolkit.

This U24 FOA will address the 2017 workshop panel's fourth recommendation , which specifically called for multidisciplinary research networks and collaborative studies involving neuroscientists, music therapists, musicians, and biomedical, behavorial, or social scientists, to support multidisciplinary research, training, and establishment of evidence-based best practices. Pain and AD/ADRD are health conditions for which MBIs have been explored, however, when and how music may influence pain and AD/ADRD is unclear, and little is known about the hypothesized mechanisms underlying the potential effects of MBIs. Building multidisciplinary music research networks, each focusing on one of these health conditions, is critical to facilitate collaborations among neuroscientists, music therapists, musicians, and biomedical, behavioral, or social scientists and to support innovative pilot studies that may help investigators generate the necessary preliminary data to strengthen their future NIH applications for later stage studies on mechanisms through which music may have a positive impact on health.

Requirements and Scope

This FOA is intended to support the development of research networks designed to promote multidisciplinary mechanistic studies of music-based interventions (MBIs) for pain or AD/ADRD.

The scientific scope of the networks is limited to the following high-priority research areas:

Research Area One: Music-based Interventions

1) Definition and differentiation of different types of MBIs (e.g., passive listening vs. active engagement, self-management vs. therapist-based)

2) Identification and/or definition of various active components of music (e.g., melodies, chords, rhythms, musical expression) or MBIs (e.g. social interaction, expectation, attention, movement)

Research Area Two: Mechanisms and Biomarkers

1) Exploration of innovative neural mechanistic hypotheses of the systems involved in the therapeutic effect of music (e.g., sensory, motor, cognitive, emotional/affective, reward, interoceptive systems) in pain or AD/ADRD

2) Examination of non-neural physiological systems and novel measures (e.g., impact on related non-neural organs, biochemical and molecular signals, epigenetic modifications, etc.) relevant to music or MBIs for pain or AD/ADRD

3) Discovery of treatment response or predictive biomarkers or signatures/profiles for MBIs in the context of pain or AD/ADRD

Research Area Three: Technologies, Tools, & Models

1) Development of novel technologies to measure how MBIs impact various functions of the brain and body, or to monitor health-related responses for pain or AD/ADRD

2) Development and testing of innovative animal models to study mechanisms and biomarkers of MBIs in the context of pain or AD/ADRD

These proposed research network activities should be designed to bring together leading basic research scientists, including neuroscientists, music therapists and/or musicians, clinician-scientists, clinicians, behavioral scientists and/or social scientists across disciplines and institutions and develop research programs in one or more of the high-priority research areas described above related to MBIs for pain or AD/ADRD

NCCIH specific interests are limited to multidisciplinary research networks to advance the mechanistic understanding of music-based interventions in the context of pain.

NIA specific interests are limited to multidisciplinary research networks to advance the mechanistic understanding of music-based interventions in the context of AD/ADRD.

Required Network Activities to be included in the application:

1. Collaboration: Applications must budget funds for investigators to attend an annual meeting of all networks funded under this announcement. The annual meeting may sometimes be held in conjunction with an investigator meeting funded by other related initiatives. These meetings will provide opportunities to share advances across networks, promote collaboration, and avoid duplication of efforts. Additional meetings and collaborative efforts (e.g., working groups, collaborative visits) to develop research frameworks, common terminologies, taxonomy, and to identify gaps and opportunities or novel ideas, hypotheses, or technologies, methodologies, are also highly encouraged.

2. Pilot Projects: Applications must budget funds for small-scale pilot studies to develop data, theoretical frameworks, or empirical methods, or to support the development of novel or high-risk approaches requiring interdisciplinary collaboration. Network funding for pilot projects must either advance broad network goals or enable preliminary studies with potential to form the basis for subsequent independent research applications consistent with network goals. Applications must provide a formal plan to solicit, review, and select/prioritize requests for pilot project funding, and to evaluate pilot study progress and outcomes, in line with network priorities. Applicants must describe the type and focus of potential pilot projects that would be solicited; however, descriptions of actual pilot projects should not be included in the application. Researchers associated with the network itself may be considered for pilot funding, but priority should be given to researchers from a broader range of locations and institutions. The selection of subaward projects will be made in consultation with the NIH Project Scientist(s) and approved by the NIH Program Officer(s). The details of the full governance structure are provided in Section VI.2, Cooperative Agreement Terms and Conditions of Award."

For clinical trials, NIA utilizes the NIH Stage Model as a conceptual framework for behavioral intervention development and is especially interested in Stage I studies focused on testing the mechanisms through which music may achieve its effects, consistent with the NIH Science of Behavior Change emphasis on mechanisms of change.

Information about the NIH Stage Model for Behavioral Intervention Development can be found at: https://www.nia.nih.gov/research/dbsr/stage-model-behavioral-intervention-development.

Information regarding NIH’s Science of Behavior Change (SOBC) program can be found at: https://commonfund.nih.gov/behaviorchange.

3. Dissemination: Applications must propose dissemination activities to share network resources, products, and opportunities with the field at large. These resources can include but are not limited to meeting papers or summaries; scientific publications; web resources; training activities; tools or guides to support research or data enhancement; data sets, such as public access user-friendly research data, metadata, macro data, or other aggregations of data to support research; and harmonized versions of existing data or instruments.

4. Milestones and Progress Evaluation: Applications must clearly describe milestones and criteria for evaluating the success of their collaboration, research progress, and dissemination efforts.

Examples of network activities that can be proposed to promote multidisciplinary mechanistic understanding of MBIs for pain or AD/ADRD include, but are not limited to:

• Meetings to develop novel research areas and infrastructure
• Dissemination and outreach activities to draw researchers from relevant disciplines into the music and health field
• Educational activities such as intensive summer institutes, workshop series and related network activities, advanced seminars on methodology, or short-term residential opportunities
• Pilot projects to test novel hypotheses, refine hypotheses generated through other network activities, or test novel technologies or methods relevant to the high priority research areas

Network Structure

The networking, education, and infrastructure-building activities required for these efforts are rarely covered under an individual grant (e.g., R01, R21, R61/R33) and often do not fit the timelines for typical support mechanisms. In many instances the researchers who can support a successful network in an emerging area span multiple disciplines and are not located at a single institution. Therefore, this FOA is designed to provide research resources that create opportunities to shape the direction of an emerging field by addressing network and infrastructure development.

Applicants are strongly encouraged to limit the number of key personnel on network applications to avoid establishing conflicts of interest throughout this emerging field. Instead, applicants should describe the types of expertise that will be sought. Participation in network activities, including presenting at workshops, serving as faculty on summer institutes, or receiving pilot funding, will not constitute formal collaboration from the perspective of NIH, except for those key personnel listed on the application. Network activities are intended to advance the field at large. An important consideration in developing a network is the potential to grow the field substantially through recruitment of new investigators rather than simply sustaining the original team.

Applicants must propose how network activities will be coordinated across institutions and how the proposed activities will effectively engage with other relevant activities at participating institutions.

Potential applicants are encouraged to contact Scientific/Research staff listed in Section VII to discuss potential network development programs prior to submission of an application. All participating NIH institutes and centers (ICs) encourage applicants to support network activities that will foster diversity of the scientific workforce as described in the Notice of NIH’s Interest in Diversity (NOT-OD-20-031). Research shows that teams composed of scientists from diverse backgrounds and life experiences that value innovation and unique perspectives outperform homogenous teams.

Administration and Meetings

NIH, in collaboration with the awarded networks Program Directors PD(s)/Principal Investigators Pl(s), will establish post award an MBI Consortium Steering Committee. The Steering Committee will be composed of NIH Project Scientist(s) and additional designees of NIH, and each network’s PD(s)/PI(s) and coinvestigators as deemed necessary. NIH will appoint a Steering Committee Chair for the first award year. Thereafter, a Steering Committee Chair will be elected every 12 months from among the Steering Committee members by the committee. An individual may continue serving as Chair for more than one year if all committee members agree. NIH staff cannot serve as Steering Committee Chair. The Chair, together with the Steering Committee, will organize virtual meetings on a quarterly basis, or as needed, as well as an annual in-person meeting of all networks in the Washington, D.C. area or a different location designated by the NIH. All funded investigators will be expected to attend the annual meeting of funded networks.

Responsiveness Criteria

• Responsive applications to this FOA must propose all the required Network Activities (described above)

• Responsive applications must also address at least one (and up to three) of the high priority research areas identified in the Requirements and Scope section: (1) Music-based interventions, (2) Mechanisms and Biomarkers, and (3) Technologies, Tools, and Models.

• Proposed networks must focus on one of the two health conditions: pain or AD/ADRD. Specific foci within a priority area (i.e., Music-based Interventions, Mechanisms and Biomarkers, or Technologies, Tools, & Models (see above)) must be defined in the application and must reflect the intent of the FOA for developing research infrastructure in each area (as outlined in the Requirements and Scope section). Applications in other areas will not be deemed responsive to this announcement and will not be reviewed.

• Applications must span multiple disciplines.

• Applications must include a dissemination plan as well as a data and resource sharing plan for sharing network resources, products, and opportunities with the field at large.

• Applications must provide a formal plan to solicit, review, select/prioritize, and support small-scale pilot projects and to evaluate pilot progression and outcomes in line with network priorities. Applications must include details on eligibility criteria, evaluation, and assessment of the likelihood of the proposed pilot study to lead to a competitive NIH (or equivalent) research application. While examples of the focus of potential pilot projects are expected to be included in the application, describing an actual pilot is not encouraged.

• Applications must propose novel activities that are not feasible with existing resources and funding mechanisms for music-based interventions.

• Applications must describe milestones and criteria appropriate for assessing the ongoing value and success of the proposed activities.

Applications Not Responsive to This FOA:

• Human research studies that include clinical trials designed to answer specific questions about feasibility, acceptance, safety, tolerability, efficacy, and/or effectiveness of pharmacologic, behavioral, biologic, surgical, or device (invasive or noninvasive) interventions (e.g., phase 1, phase II, phase III, or pivotal clinical trials).
• Traditional investigator-initiated and highly focused research projects (best supported by the R01, R21, R61/R33, or P01 activity codes).
• Core (or related) services to supplement the budgets of existing R01-type efforts.
• Groups of investigators at the same institution who would normally interact and collaborate in the absence of a novel collaborative initiative.
• Clinical trials of music-based interventions where the primary outcome(s) are clinical endpoints (e.g., pain and/or function).
• Investigators seeking support for scientific meetings should use PA-18-648 NIH Support for Conferences and Scientific Meetings (Parent R13 Clinical Trial Not Allowed). Investigators seeking support for pre- and postdoctoral research training programs should use PA-20-142 Ruth L. Kirschstein National Research Service Award (NRSA) Institutional Research Training Grant (Parent T32). Investigators who only seek to create research education activities should use the R25 funding mechanism.

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

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

Section II. Award Information

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

Section III. Eligibility Information

1. Eligible Applicants

Higher Education Institutions

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

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

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

Nonprofits Other Than Institutions of Higher Education

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

For-Profit Organizations

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

Local Governments

• State Governments
• County Governments
• City or Township Governments
• Special District Governments
• Indian/Native American Tribal Governments (Federally Recognized)
• Indian/Native American Tribal Governments (Other than Federally Recognized)

Federal Governments

• Eligible Agencies of the Federal Government
• U.S. Territory or Possession

Other

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

Non-domestic (non-U.S.) Entities (Foreign Institutions) are not eligible to apply.

Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.

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

Applicant Organizations

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

• System for Award Management (SAM) Applicants must complete and maintain an active registration, which requires renewal at least annually. The renewal process may require as much time as the initial registration. SAM registration includes the assignment of a Commercial and Government Entity (CAGE) Code for domestic organizations which have not already been assigned a CAGE Code.
  • NATO Commercial and Government Entity (NCAGE) Code Foreign organizations must obtain an NCAGE code (in lieu of a CAGE code) in order to register in SAM.
  • Unique Entity Identifier (UEI)- A UEI is issued as part of the SAM.gov registration process. The same UEI must be used for all registrations, as well as on the grant application.
• eRA Commons - Once the unique organization identifier is established, organizations can register with eRA Commons in tandem with completing their full SAM and Grants.gov registrations; all registrations must be in place by time of submission. eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to submit an application.
• Grants.gov Applicants must have an active SAM registration in order to complete the Grants.gov registration.

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

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

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with his/her organization to develop an application for support. Individuals from diverse backgrounds, including underrepresented racial and ethnic groups, individuals with disabilities, and women are always encouraged to apply for NIH support. See, Reminder: Notice of NIH's Encouragement of Applications Supporting Individuals from Underrepresented Ethnic and Racial Groups as well as Individuals with Disabilities, NOT-OD-22-019.

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

2. Cost Sharing

This 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, per 2.3.7.4 Submission of Resubmission Application. This means that the NIH will not accept:

• A new (A0) application that is submitted before issuance of the summary statement from the review of an overlapping new (A0) or resubmission (A1) application.
• A resubmission (A1) application that is submitted before issuance of the summary statement from the review of the previous new (A0) application.
• An application that has substantial overlap with another application pending appeal of initial peer review (see 2.3.9.4 Similar, Essentially Identical, or Identical Applications).

Section IV. Application and Submission Information

1. Requesting an Application Package

The application forms package specific to this opportunity must be accessed through ASSIST, 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 instructions in 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.

Letter of Intent

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

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

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

The letter of intent should be sent to:

Martina Schmidt, Ph.D.
Telephone: 301-594-3456
Fax: 301-480-2419
Email: SchmidMa@mail.nih.gov

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) Project/Performance Site Locations

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

SF424(R&R) Cover

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 Budget

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

Applications must budget for study personnel to participate in an annual in-person meeting in the Washington, D.C. area or a location designated by the NIH of all funded networks.

No less than one third and up to half of the proposed direct costs may be budgeted for supporting one or more pilot studies. Generally, the pilot funds will be distributed in the form of subcontracts to the third-party researcher's institution.

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:

The application must address how the proposed research network will have a substantial impact on the progress and quality of research relevant to the mechanistic understanding of music-based interventions and the selected health condition (pain or AD/ADRD). The application must address how the proposed networking activities will advance an emerging field of research relevant to MBIs in the context of the selected health condition. The application must propose new high-impact activities that are not feasible with existing resources and funding opportunities.

Networks are intended to serve the broader community of researchers engaged in MBI relevant research in the designated health condition and scientific area and are consequently unlikely to be limited to a single institution. For network activities that span multiple institutions, applicants must explain how those activities will be coordinated across institutions and how the proposed activities will effectively engage with other relevant activities at participating institutions.

Networks must propose to support small-scale pilot projects. Network funding for pilot projects should either advance broad network goals or support preliminary studies with potential to form the basis for independent research applications consistent with network goals. Projects must include a formal plan to solicit, review, and select/prioritize requests for pilot funding, and evaluate pilot progression and outcomes in line with network priorities, in the Approach section. Applicants must describe the type and focus of potential pilot projects that would be solicited. However, a description of an actual pilot project should not be included.

The application must also address plans for dissemination and access to ensure that the network and its products will be appropriately targeted for the highest impact to potential participants. The application must describe how the proposed activities will have the potential to grow the field substantially through recruitment of new investigators rather than sustaining only the original team. Applications must describe milestones appropriate for assessing the ongoing value of the proposed activities. Applications must describe how the proposed activities will effectively engage with other relevant activities at participating institutions. For applications spanning multiple institutions, a plan for coordination across institutions must be clearly specified.

The application must identity which of the two health conditions the research will focus on: pain or AD/ADRD. The application must further specify how all three Network activities will be addressed. At least one (and up to three) of the high priority research areas from this list must be specified within the application:

1. Music-based interventions
2. Mechanisms and Biomarkers
3. Technologies, Tools, and Models

The specific high priority research area must align with the intent of the FOA for developing research infrastructure in each area as outlined in the Requirements and Scope section. The application must span multiple disciplines.

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.

The following modifications also apply:

All applications, regardless of the amount of direct costs requested for any one year, must 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 human subjects research, clinical research, and/or NIH-defined 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.

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.

6. Funding Restrictions

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

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

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 form. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to NIH. See Section III of this FOA for information on registration requirements.

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

See more tips for avoiding common errors.

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

In order to expedite review, applicants are requested to notify the NCCIH Referral Office by email at SchmidMa@mail.nih.gov when the application has been submitted. Please include the FOA number and title, PD/PI name, and title of the application.

Post Submission Materials

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

Section V. Application Review Information

1. Criteria

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

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

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

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

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.

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.

2. Review and Selection Process

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s) convened by NCCIH, 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 will receive a written critique.

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

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

• 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 recipient's business official.

Recipients must comply with any funding restrictions described in Section IV.6. Funding Restrictions. Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs.

Any application awarded in response to this 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 and results reporting of all trials whether required under the law or not. For more information, see https://grants.nih.gov/policy/clinical-trials/reporting/index.htm

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

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

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

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: Generaland Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Recipients, and Activities, including of note, but not limited to:

• Federalwide Research Terms and Conditions
• Prohibition on Certain Telecommunications and Video Surveillance Services or Equipment
• Acknowledgment of Federal Funding

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

Should the applicant organization successfully compete for an award, recipients of federal financial assistance (FFA) from HHS must administer their programs in compliance with federal civil rights laws that prohibit discrimination on the basis of race, color, national origin, disability, age and, in some circumstances, religion, conscience, and sex (including gender identity , sexual orientation, and pregnancy). This includes ensuring programs are accessible to persons with limited English proficiency and persons with disabilities. The HHS Office for Civil Rights provides guidance on complying with civil rights laws enforced by HHS. Please see https://www.hhs.gov/civil-rights/for-providers/provider-obligations/index.html and https://www.hhs.gov/civil-rights/for-individuals/nondiscrimination/index.html

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.

• Recipients of FFA must ensure that their programs are accessible to persons with limited English proficiency. For guidance on meeting the legal obligation to take reasonable steps to ensure meaningful access to programs or activities by limited English proficient individuals see https://www.hhs.gov/civil-rights/for-individuals/special-topics/limited-english-proficiency/fact-sheet-guidance/index.htmlandhttps://www.lep.gov.

• For information on an institution’s specific legal obligations for serving qualified individuals with disabilities, including reasonable accommodations and making services accessible to them, see http://www.hhs.gov/ocr/civilrights/understanding/disability/index.html.

• HHS funded health and education programs must be administered in an environment free of sexual harassment, see https://www.hhs.gov/civil-rights/for-individuals/sex-discrimination/index.html. For information about NIH's commitment to supporting a safe and respectful work environment, who to contact with questions or concerns, and what NIH's expectations are for institutions and the individuals supported on NIH-funded awards, please see https://grants.nih.gov/grants/policy/harassment.htm.
  
• For guidance on administering programs in compliance with applicable federal conscience protection and associated anti-discrimination laws see https://www.hhs.gov/conscience/conscience-protections/index.html and https://www.hhs.gov/conscience/religious-freedom/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.

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

The following special terms of award are in addition to, and not in lieu of, otherwise applicable U.S. Office of Management and Budget (OMB) administrative guidelines, U.S. Department of Health and Human Services (DHHS) grant administration regulations at 45 CFR Part 75, and other HHS, PHS, and NIH grant administration policies.

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

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

• Developing objectives, approaches, and measurements of music-based interventions as relevant to the selected health condition (including measures of mechanistic targets and outcomes).
• Designating investigators to serve as members on a Steering Committee and other subcommittees, as appropriate.
• Complying with Federal regulatory requirements, including but not limited to those relating to human subjects protections, informed consent, and reporting of adverse events.
• Attending quarterly (or as needed) virtual Steering Committee meetings.
• Agreeing to accept close coordination, cooperation, and management of the project with NIH, including those outlined below in the NIH Staff section. The PD(s)/PI(s) will be expected to maintain close communications with the NIH Project Scientist(s) and, where appropriate, the Program Officer(s). The Project Scientist(s) will have substantial scientific involvement that is above and beyond the normal stewardship role in awards.
• Cooperating in the reporting of the study progress and findings. Where warranted by appropriate participation, plans for joint publication with NIH of the results and conclusions are to be developed by the PD(s)/PI(s) or Steering Committee, as applicable.NIH policies governing possible coauthorship of publications with NIH staff will apply in all cases. In general, to warrant coauthorship, NIH staff must have contributed to the following areas: (a) design of the concepts or experiments being tested; (b) performance of significant portions of the activity; and (c) preparation and authorship of pertinent manuscripts.
• Overseeing the overall budget, activities, and performance of the cooperative agreement.
• Accepting the participatory and cooperative nature of the collaborative research process and complying with policies and practices of NIH.
• Sharing data, resources, and software as appropriate and consistent with achieving the goals of the program and the approved sharing policies for NIH.
• Attending an annual in-person meeting of all networks.
• Recipients will retain custody of and have primary rights to the data and software developed under these awards, subject to Government rights of access consistent with current DHHS, PHS, and NIH policies.

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

• NIH will appoint a Steering Committee Chair for the first award year.
• NIH will assign a Project Scientist(s) as the point of contact to work with the PD(s)/Pl(s) and participate in the Steering Committee to ensure the objectives of the program are being met. The primary responsibility for the program resides with the awardee, although specific tasks and activities will be shared among the awardee and the NIH Project Scientist(s). The Project Scientist(s) will review and make recommendations for the selection of pilot projects.
• NIH will assign a Program Officer(s) who will be responsible for retaining overall programmatic responsibility for the award and will clearly specify to the recipient the name(s) and role(s) of any additional individuals with substantial involvement in the project and the lines of reporting authority. The Program Officer(s) will approve the selection of pilot projects.
• NIH may designate additional staff to provide advice to the recipient on specific scientific and/or analytic issues. Such staff may include another Project Scientist(s) or Analyst, who will provide direct technical assistance to the recipients to optimize the conduct and/or analysis of the study or who may assist in the coordination of activities across multiple sites.
• NIH will serve as a resource with respect to other ongoing NIH activities that may be relevant to the protocol to facilitate compatibility and avoid unnecessary duplication of effort.
• NIH staff will interact with the PD(s)/Pl(s) on a regular basis to monitor progress. Monitoring may include regular communication with the PD(s)/Pl(s) and his/her staff.
• NIH staff will provide input, expert advice, and suggestions in the design, development, and coordination and implementation of the study objectives.
• NIH reserves the right to suspend and/or terminate or curtail the award (or an individual component of the award) in the event of inadequate progress or data reporting

Section_8.5.2.

• NIH staff will make recommendations for continued funding based on: a) overall study progress, including sufficient patient and/or data accrual; b) cooperation in carrying out the research (e.g., attendance at Steering Committee meetings, implementation of group decisions, compliance with the terms of award and reporting requirements); and/or c) maintenance of a high quality of research, which will allow comparisons across multiple cooperative agreement awards.
• Additionally, an agency program official or IC program director will be responsible for the normal scientific and programmatic stewardship of the award and will be named in the award notice.

Areas of Joint Responsibility include:

• Establishing a Steering Committee consisting of PD(s)/PI(s) and coinvestigators as deemed necessary, NIH Project Scientists, and additional designees of NIH for awards funded under this RFA to coordinate and manage collaborations among projects post award and to promote harmonization activities and reduce duplication of efforts. The NIH Program Officer(s) will serve as ex officio member(s) of the Steering Committee.
• Selecting a Steering Committee Chair. . A Steering Committee Chair will be elected every 12 months from among the Steering Committee members by the committee. An individual may continue serving as Chair for more than one year if all committee members agree. NIH staff cannot serve as Steering Committee Chair.
• Organizing and participating in quarterly (or as needed) virtual Steering Committee meetings as well as an annual in-person meeting of all networks.
• Ensuring that sites and investigators as well as NIH and other research partners fully comply with Federal regulatory requirements. This includes but is not limited to those relating to human subjects protections, informed consent, and reporting of adverse events.

Dispute Resolution:

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

3. Reporting

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

A final RPPR, invention statement, and the expenditure data portion of the Federal Financial Report are required for closeout of an award, as described in the NIH Grants Policy Statement. NIH FOAs outline intended research goals and objectives. Post award, NIH will review and measure performance based on the details and outcomes that are shared within the RPPR, as described at 45 CFR Part 75.301 and 2 CFR Part 200.301.

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

In accordance with the regulatory requirements provided at 45 CFR 75.113 and 2 CFR Part 200.113 and Appendix XII to 45 CFR Part 75 and 2 CFR Part 200, recipients that have currently active Federal grants, cooperative agreements, and procurement contracts from all Federal awarding agencies with a cumulative total value greater than $10,000,000 for any period of time during the period of performance of a Federal award, must report and maintain the currency of information reported in the System for Award Management (SAM) about civil, criminal, and administrative proceedings in connection with the award or performance of a Federal award that reached final disposition within the most recent five-year period. The recipient must also make semiannual disclosures regarding such proceedings. Proceedings information will be made publicly available in the designated integrity and performance system (currently FAPIIS). This is a statutory requirement under section 872 of Public Law 110-417, as amended (41 U.S.C. 2313). As required by section 3010 of Public Law 111-212, all information posted in the designated integrity and performance system on or after April 15, 2011, except past performance reviews required for Federal procurement contracts, will be publicly available. Full reporting requirements and procedures are found in Appendix XII to 45 CFR Part 75 and 2 CFR Part 200 Award Term and Condition for Recipient Integrity and Performance Matters.

Section VII. Agency Contacts

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

eRA Service Desk (Questions regarding ASSIST, eRA Commons, application errors and warnings, documenting system problems that threaten submission by the due date, and post-submission issues)

Finding Help Online: 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

Wen G. Chen, MMSc., PhD
National Center for Complementary and Integrative Health (NCCIH)
Telephone: 301-451-3989
Email: chenw@mail.nih.gov

Coryse St. Hillaire-Clarke, Ph.D.
National Institute on Aging (NIA)
Division of Neuroscience (DN)
Phone: 301-496-9350
E-mail: sthillaireclacn@mail.nih.gov

Lisa Onken, Ph.D.
National Institute on Aging (NIA)
Division of Behavioral and Social Research (DBSR)
Phone: (301) 496-3131
E-mail: lisa_onken@nih.gov

Martina Schmidt, Ph.D.
National Center for Complementary and Integrative Health (NCCIH)
Telephone: 301-594-3456
Email: SchmidMa@mail.nih.gov

Debbie Chen
National Center for Complementary and Integrative Health (NCCIH)
Phone: 301-594-3788
Email: debbie.chen@nih.gov

Robin Laney
National Institute on Aging (NIA)
Phone: 301-496-1472
E-mail: laneyr@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.

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 and 2 CFR Part 200.