EXPIRED
National Institutes of Health (NIH)
U24 Resource-Related Research Projects Cooperative Agreements
December 16, 2022 - This RFA has been reissued as RFA-AT-23-009
December 16, 2022 - Notice of Need to Expire and Reissue RFA-AT-23-008 Research Networks to Promote Multidisciplinary Mechanistic Studies on Music-Based Interventions for Pain/Alzheimers Disease/AD Related Dementias (U24 Clinical Trial Optional) to Correct Review Criteria. See Notice NOT-AT-23-006
NOT-OD-22-195 New NIH "FORMS-H" Grant Application Forms and Instructions Coming for Due Dates on or after January 25, 2023
NOT-OD-22-189 Implementation Details for the NIH Data Management and Sharing Policy
NOT-OD-22-198 Implementation Changes for Genomic Data Sharing Plans Included with Applications Due on or after January 25, 2023
NOT-OD-23-012 Reminder: FORMS-H Grant Application Forms & Instructions Must be Used for Due Dates On or After January 25, 2023 - New Grant Application Instructions Now Available
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 studieson MBIs in these health conditions; adopt consistent terminology and taxonomy; support interdisciplinary collaborations andinitiate 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 shall sustain their scientific impact through a variety of dissemination and outreach strategies, including publication of research frameworks, common terminologies, reviews, and other best practices.
December 10, 2022
Application Due Dates | Review and Award Cycles | ||||
---|---|---|---|---|---|
New | Renewal / Resubmission / Revision (as allowed) | AIDS | Scientific Merit Review | Advisory Council Review | Earliest Start Date |
January 10, 2023 | Not Applicable | Not Applicable | March 2023 | May 2023 | July 2023 |
All applications are due by 5:00 PM local time of applicant organization.
Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date.
No late applications will be accepted for this Funding Opportunity Announcement.
Not Applicable
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.
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:
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.
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:
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
Applications Not Responsive to This FOA:
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.
Cooperative Agreement: A support mechanism used when there will be substantial Federal scientific or programmatic involvement. Substantial involvement means that, after award, NIH scientific or program staff will assist, guide, coordinate, or participate in project activities. See Section VI.2 for additional information about the substantial involvement for this FOA.
The OER Glossary and the SF424 (R&R) Application Guide provide details on these application types. Only those application types listed here are allowed for this FOA.
Optional: Accepting applications that either propose or do not propose clinical trial(s).
The following NIH components intend to commit the following amounts in FY2023:
NCCIH: $1,000,000 in total cost and will support 2 awards, focusing on pain.
NIA: $500,000 in total cost and will support 1 award focusing on Alzheimer’s disease and Alzheimer’s disease-related dementias (AD/ADRD).
Application budgets are limited to $300,000 in direct costs per year.
The scope of the proposed project should determine the project period. The maximum project period is 5 years
NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made from this FOA.
1. Eligible Applicants
Higher Education Institutions
The following types of Higher Education Institutions are always encouraged to apply for NIH support as Public or Private Institutions of Higher Education:
Nonprofits Other Than Institutions of Higher Education
For-Profit Organizations
Local Governments
Federal Governments
Other
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.
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:
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:
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.
The following section supplements the instructions found in the SF424 (R&R) Application Guide and should be used for preparing an application to this FOA.
SF424(R&R) Cover
All instructions in the SF424 (R&R) Application Guide must be followed.
SF424(R&R) Project/Performance Site Locations
All instructions in the SF424 (R&R) Application Guide must be followed.
SF424(R&R) Other Project Information
All instructions in the SF424 (R&R) Application Guide must be followed.
SF424(R&R) Senior/Key Person Profile
All instructions in the SF424 (R&R) Application Guide must be followed.
R&R 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:
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:
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
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.
Note: Effective for due dates on or after January 25, 2023, the Data Sharing Plan and Genomic Data Sharing Plan (GDS) will not be evaluated at time of review.
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.
Does the proposed ?
In addition, for applications involving clinical trials
Are the scientific rationale and need for a clinical trial to test the proposed hypothesis or intervention well supported by preliminary data, clinical and/or preclinical studies, or information in the literature or knowledge of biological mechanisms? For trials focusing on clinical or public health endpoints, is this clinical trial necessary for testing the safety, efficacy or effectiveness of an intervention that could lead to a change in clinical practice, community behaviors or health care policy? For trials focusing on mechanistic, behavioral, physiological, biochemical, or other biomedical endpoints, is this trial needed to advance scientific understanding?
For this particular announcement, note the following:
Are the PD(s)/PI(s) and other personnel well suited to their roles in the Research Network? Does the applicant have experience overseeing selection and management of subawards, if needed?
In addition, for applications involving clinical trials
With regard to the proposed leadership for the project, do the PD/PI(s) and key personnel have the expertise, experience, and ability to organize, manage and implement the proposed clinical trial and meet milestones and timelines? Do they have appropriate expertise in study coordination, data management and statistics? For a multicenter trial, is the organizational structure appropriate and does the application identify a core of potential center investigators and staffing for a coordinating center?
For this particular announcement, note the following:
Has a team of leading scientists across disciplines and institutions been assembled and as a team do they have the expertise needed to develop one or more priority areas of music based intervention, pain or Alzheimer’s disease? Does the multidisciplinary group of investigators assembled have the appropriate expertise needed to grow this field? Are they well positioned to support the activities of the proposed network and to integrate their efforts with broader strategic interests of potential network participants on a larger scale?
Does the application propose novel proposed?
In addition, for applications involving clinical trials
Does the design/research plan include innovative elements, as appropriate, that enhance its sensitivity, potential for information or potential to advance scientific knowledge or clinical practice?
For this particular announcement, note the following:
Does the application explain how the proposed networking activities will advance an emerging field of research relevant to music-based interventions and why these goals cannot be met through existing institutional programs or structures?
Are the overall strategy, operational plan, and organizational structure well-reasoned and appropriate to accomplish the goals of the research ? Are an appropriate plan for work-flow and a well-established timeline proposed? Have the investigators presented adequate plans to ensure consideration of relevant biological variables, such as sex, for studies of vertebrate animals or human subjects?
In addition, for applications involving clinical trials
Does the application adequately address the following, if applicable
Study Design
Is the study design justified and appropriate to address primary and secondary outcome variable(s)/endpoints that will be clear, informative and relevant to the hypothesis being tested? Is the scientific rationale/premise of the study based on previously well-designed preclinical and/or clinical research? Given the methods used to assign participants and deliver interventions, is the study design adequately powered to answer the research question(s), test the proposed hypothesis/hypotheses, and provide interpretable results? Is the trial appropriately designed to conduct the research efficiently? Are the study populations (size, gender, age, demographic group), proposed intervention arms/dose, and duration of the trial, appropriate and well justified?
Are potential ethical issues adequately addressed? Is the process for obtaining informed consent or assent appropriate? Is the eligible population available? Are the plans for recruitment outreach, enrollment, retention, handling dropouts, missed visits, and losses to follow-up appropriate to ensure robust data collection? Are the planned recruitment timelines feasible and is the plan to monitor accrual adequate? Has the need for randomization (or not), masking (if appropriate), controls, and inclusion/exclusion criteria been addressed? Are differences addressed, if applicable, in the intervention effect due to sex/gender and race/ethnicity?
Are the plans to standardize, assure quality of, and monitor adherence to, the trial protocol and data collection or distribution guidelines appropriate? Is there a plan to obtain required study agent(s)? Does the application propose to use existing available resources, as applicable?
Data Management and Statistical Analysis
Are planned analyses and statistical approach appropriate for the proposed study design and methods used to assign participants and deliver interventions? Are the procedures for data management and quality control of data adequate at clinical site(s) or at center laboratories, as applicable? Have the methods for standardization of procedures for data management to assess the effect of the intervention and quality control been addressed? Is there a plan to complete data analysis within the proposed period of the award?
For this particular announcement, note the following:
How effectively will the dissemination plan allow for sharing of network resources, products, and opportunities with the field at large?
Do the plans for dissemination and access ensure that the network and its products will be appropriately targeted for the highest impact to potential participants? Is there an adequate plan to solicit, review, prioritize, and support small-scale pilot project(s)? Is there an adequate description of eligibility criteria, evaluation, and assessment of the likelihood of the proposed pilot project(s) to lead to a competitive NIH (or equivalent) research application? Is there an adequate description of the type and focus of potential pilot projects?
Will the institutional environment in which the benefit from unique features of the institutional environment, infrastructure, or personnel? Are resources available within the scientific environment to support electronic information handling?
In addition, for applications involving clinical trials
If proposed, are the administrative, data coordinating, enrollment and laboratory/testing centers, appropriate for the trial proposed?
Does the application adequately address the capability and ability to conduct the trial at the proposed site(s) or centers? Are the plans to add or drop enrollment centers, as needed, appropriate?
If international site(s) is/are proposed, does the application adequately address the complexity of executing the clinical trial?
If multi-sites/centers, is there evidence of the ability of the individual site or center to: (1) enroll the proposed numbers; (2) adhere to the protocol; (3) collect and transmit data in an accurate and timely fashion; and, (4) operate within the proposed organizational structure?
For this particular announcement, note the following:
How well will network activities be coordinated across institutions and how will they effectively engage with other relevant, already ongoing activities at the participating institutions? Is a clear plan for coordination across multiple institutions specified?
In addition, for applications involving clinical trials
If proposed, are the administrative, data coordinating, enrollment and laboratory/testing centers, appropriate for the trial proposed?
Does the application adequately address the capability and ability to conduct the trial at the proposed site(s) or centers? Are the plans to add or drop enrollment centers, as needed, appropriate?
If international site(s) is/are proposed, does the application adequately address the complexity of executing the clinical trial?
If multi-sites/centers, is there evidence of the ability of the individual site or center to: (1) enroll the proposed numbers; (2) adhere to the protocol; (3) collect and transmit data in an accurate and timely fashion; and, (4) operate within the proposed organizational structure?
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.
Specific to applications involving clinical trials
Is the study timeline described in detail, taking into account start-up activities, the anticipated rate of enrollment, and planned follow-up assessment? Is the projected timeline feasible and well justified? Does the project incorporate efficiencies and utilize existing resources (e.g., CTSAs, practice-based research networks, electronic medical records, administrative database, or patient registries) to increase the efficiency of participant enrollment and data collection, as appropriate?
Are potential challenges and corresponding solutions discussed (e.g., strategies that can be implemented in the event of enrollment shortfalls)?
Milestones
Are the proposed milestones feasible, well developed, and quantifiable regarding the specific goals and accomplishments of the resource network? Are they appropriate for assessing the ongoing value of the proposed activities? Are appropriate criteria specified to evaluate the network’s progress in advancing the field to a point where network support is no longer needed for sustained growth?
For research that involves human subjects but does not involve one of the categories of research that are exempt under 45 CFR Part 46, the committee will evaluate the justification for involvement of human subjects and the proposed protections from research risk relating to their participation according to the following five review criteria: 1) risk to subjects, 2) adequacy of protection against risks, 3) potential benefits to the subjects and others, 4) importance of the knowledge to be gained, and 5) data and safety monitoring for clinical trials.
For research that involves human subjects and meets the criteria for one or more of the categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials. For additional information on review of the Human Subjects section, please refer to the Guidelines for the Review of Human Subjects.
When the proposed project involves human subjects and/or NIH-defined clinical research, the committee will evaluate the proposed plans for the inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion (or exclusion) of individuals of all ages (including children and older adults) to determine if it is justified in terms of the scientific goals and research strategy proposed. For additional information on review of the Inclusion section, please refer to the Guidelines for the Review of Inclusion in Clinical Research.
The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following criteria: (1) description of proposed procedures involving animals, including species, strains, ages, sex, and total number to be used; (2) justifications for the use of animals versus alternative models and for the appropriateness of the species proposed; (3) interventions to minimize discomfort, distress, pain and injury; and (4) justification for euthanasia method if NOT consistent with the AVMA Guidelines for the Euthanasia of Animals. Reviewers will assess the use of chimpanzees as they would any other application proposing the use of vertebrate animals. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal Section.
Reviewers will assess whether materials or procedures proposed are potentially hazardous to research personnel and/or the environment, and if needed, determine whether adequate protection is proposed.
Not applicable
Not applicable
Not applicable
Reviewers will comment on the appropriateness and adequacy of the proposed sharing of network resources, products, and opportunities with the field at large to meet the goals of this initiative.
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.
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.
Not applicable
Reviewers will assess the information provided in this section of the application, including 1) the Select Agent(s) to be used in the proposed research, 2) the registration status of all entities where Select Agent(s) will be used, 3) the procedures that will be used to monitor possession use and transfer of Select Agent(s), and 4) plans for appropriate biosafety, biocontainment, and security of the Select Agent(s).
Note: Effective for due dates on or after January 25, 2023, the Data Sharing Plan and Genomic Data Sharing Plan (GDS) will not be evaluated at time of review.
Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable: (1) Data Sharing Plan; (2) Sharing Model Organisms; and (3) Genomic Data Sharing Plan (GDS).
For involving key biological and/or chemical resources, reviewers will comment on the brief plans proposed for identifying and ensuring the validity of those resources.
Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.
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.
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:
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.
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:
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.
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:
NIH staff have substantial programmatic involvement that is above and beyond the normal stewardship role in awards, as described below:
Areas of Joint Responsibility include:
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. Data Management and Sharing
Note: The NIH Policy for Data Management and Sharing is effective for due dates on or after January 25, 2023.
Consistent with the NIH Policy for Data Management and Sharing, when data management and sharing is applicable to the award, recipients will be required to adhere to the Data Management and Sharing requirements as outlined in the NIH Grants Policy Statement. Upon the approval of a Data Management and Sharing Plan, it is required for recipients to implement the plan as described.
4. 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.
We encourage inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants.
eRA Service Desk (Questions regarding ASSIST, eRA Commons, application errors and warnings, documenting system problems that threaten submission by the due date, and post-submission issues)
Finding Help Online: https://www.era.nih.gov/need-help (preferred method of contact)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)
General Grants Information (Questions regarding application instructions, application processes, and NIH grant resources)
Email: GrantsInfo@nih.gov (preferred method of contact)
Telephone: 301-480-7075
Grants.gov Customer Support (Questions regarding Grants.gov registration and Workspace)
Contact Center Telephone: 800-518-4726
Email: 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
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.