Department of Health and Human Services

Part 1. Overview Information

Participating Organization(s)

National Institutes of Health (NIH)

Components of Participating Organizations

National Center for Complementary and Integrative Health (NCCIH)

National Institute of Neurological Disorders and Stroke (NINDS)

Funding Opportunity Title
Neural Mechanisms of Force-Based Manipulations: High Priority Research Networks (U24 Clinical Trial Optional)
Activity Code

U24 Resource-Related Research Projects – Cooperative Agreements

Announcement Type
New
Related Notices
  • April 23, 2021 - Notice of Pre-Application Technical Assistance Webinar for RFA-AT-21-006. See Notice NOT-AT-21-010.
Funding Opportunity Announcement (FOA) Number
RFA-AT-21-006
Companion Funding Opportunity
None
Assistance Listing Number(s)
93.213, 93.853
Funding Opportunity Purpose

This Funding Opportunity Announcement (FOA) solicits applications that focus on developing resources to refine and test key concepts that will advance and further support study on the neural mechanisms and biomechanics of force-based manipulations. This grant funding initiative will support resources and activities such as research network meetings, conferences, small-scale pilot research, multidisciplinary cross training (e.g., intensive workshops, summer institutes, or visiting scholar programs), and information dissemination to foster the growth and development of research on the neural mechanisms and biomechanics of force-based manipulations. Further details and a description of priority areas are provided in this FOA.

Key Dates

Posted Date
March 23, 2021
Open Date (Earliest Submission Date)
June 14, 2021
Letter of Intent Due Date(s)

June 14, 2021

Application Due Dates Review and Award Cycles
New Renewal / Resubmission / Revision (as allowed) AIDS Scientific Merit Review Advisory Council Review Earliest Start Date
July 14, 2021 Not Applicable Not Applicable November 2022 January 2022 April 2022

All applications are due by 5:00 PM local time of applicant organization. All types of non-AIDS applications allowed for this funding opportunity announcement are due on the listed date(s).

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

Expiration Date
July 15, 2021
Due Dates for E.O. 12372

Not Applicable

Required Application Instructions

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.

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

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

  3. Use Grants.gov Workspace to prepare and submit your application and eRA Commons to track your application.


  4. Table of Contents

Part 2. Full Text of Announcement

Section I. Funding Opportunity Description

Force-based manipulations refer to the passive application of mechanical force to the outside of the body with therapeutic intent, often as part of pain management care (e.g., low-back pain), rehabilitation care, or general wellness and disease prevention. Examples of force-based manipulations include, but are not limited to: light touch, pressure, mobilization, thrust, adjustment, and/or needling. The range of applied forces in manipulations is diverse. The forces applied in spinal manipulation are about 1,000 times greater than those in acupuncture needling, and the forces in massage are intermediate between these two. Tissues may respond to different forces—or more accurately, to the stresses and strains they induce. Currently, fundamental understanding of the mechanisms by which force-based manipulations exert their effects is underdeveloped. In the field of neuroscience, a large body of research has focused on understanding the neural systems involved in force-based mechanosensation. However, synergy between the fields of mechanosensation and manual therapies is largely unexplored.

In September 2019, the National Center for Complementary and Integrative Health (NCCIH), the Eunice Kennedy Shriver National Institute of Child Health and Human Development/National Center for Medical Rehabilitation Research, the National Institute of Neurological Disorders and Stroke, the National Institute on Aging, and the National Institute of Biomedical Imaging and Bioengineering sponsored a workshop to highlight current knowledge of biological mechanisms of force sensing and biomechanical force-based manipulations, with the following goals: (1) to identify research gaps and barriers in the field of force-based manipulations; (2) to discuss new research opportunities in this field; (3) to promote collaborations among neuroscientists, manual therapists (e.g., chiropractors, physiotherapists/physical therapists, osteopathic physicians, massage therapists), physiologists, mathematicians, and engineers to advance cutting-edge research related to force-based manipulations; and (4) to discuss the need for common terminology. A meeting report is available: https://files.nccih.nih.gov/force-workshop-summary-110920-508-updated.pdf

The workshop participants presented and discussed the following topics: defining the biomechanical force; peripheral neural and extraneural sensing of biomechanical force; spinal cord transmission of force sensation; central processing and modulation of biomechanical force; and technology advances for force-based manipulations.

Through workshop presentations and discussion, research gaps and opportunities were noted that included the need to: (1) characterize and quantify the types of mechanical forces; (2) develop reliable measures of force/stress/strain/stiffness; (3) identify metrics and biomarkers for short- and long-term therapeutic responses; (4) develop methodologies for applying and quantifying forces (e.g., robotics, simulation programs); (5) develop technologies for real-time recording and imaging of cells and tissues during force-based manipulations; (6) define and quantify psychosocial and expectation effects relevant to force-based manipulations; (7) link therapy to multiscale response, i.e., knowledge of the molecular, cellular, and circuit mechanisms that underlie the effects of various manual therapies; (8) develop opportunities to promote interdisciplinary teams (e.g., connecting neuroscientists, bioengineers, and clinician-scientists).

Scope

This FOA is intended to support the development of interdisciplinary research networks designed to advance research on the study of the neural mechanisms and biomechanics of force-based manipulations. The goal is to develop concepts and a framework and produce resources that will serve the field at large. Applications must propose high-impact activities to advance at least one (minimum) and up to three (maximum) of the high-priority research areas listed below. Applications must propose novel activities that are not feasible with existing resources.

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

(1) Terminology and measurement of force-based manipulations: Develop common terminology and metrics to characterize, uniformly define, and quantify the types of mechanical forces applied in various manual therapies. Develop and validate objective measures of force, stress, strain, stiffness, and the response to force at multiple levels of analysis (e.g., cellular, molecular, extraneural and neural, behavioral, psychological), their interrelations, and/or their variation ranging from childhood to older adults or in diverse population subgroups (e.g., chronic pain patients).

(2) Mechanistic multiscale (i.e., molecular, cellular, and circuit) research measuring the physiological response to force-based manipulations: Identify and examine neural and extraneural mechanisms of action involved in force-base manipulations in the context of human participants and/or animal models across the lifespan.

(3) Contextual effects of force-based manipulations: Determine and quantify how external influences such as psychosocial factors, affect/mood, and expectation modulate neural and physiological responses to force-based manipulations.

(4) Biomarkers of force-based manipulations: Identify biomarkers for short- and long-term therapeutic responses to force-based manipulations in human participants or in animal models of clinical conditions (e.g., low-back pain, myofascial pain syndrome) across the lifespan.

(5) Technology and methodology development for mechanistic studies: Identify/adapt/develop/validate methodologies for applying and quantifying forces (e.g., robotics, simulation programs, virtual reality, artificial intelligence [AI]). Develop technologies for real-time recording and imaging of cells and deep tissue during force-based manipulations. Develop computational mechanistic models of force-based manipulations that include a diversity of outcomes and factors beyond force itself that may influence those outcomes.

NINDS specific interests are limited to the following topics:

(1) Studies of cellular, molecular, extraneural, and neural mechanisms of sensory transduction in sensory afferent neurons and fibers and associated tissues

(2) Mechanistic research on the afferent neural pathways for mechanosensory transduction through spinal roots and ganglia and cranial nerves

(3) Mechanistic understanding of the neurological basis for the poorly understood psychosocial sense of “social touch”

(4) Novel methods of noninvasive and minimally invasive assessment of afferent neural activity for mechanosensory transduction

(5) Technology and methodology development for mechanistic studies including real-time recording and imaging of cells, nerve fibers, and deep tissue during mechanosensory transduction

(6) Computational approaches to mechanistic understanding of mechanosensory transduction and afferent neural processing.

Scope of Network Activities

Network support includes activities designed to bring together leading scientists, clinician-scientists, and clinicians (e.g., chiropractors, physiotherapists/physical therapists, osteopathic physicians, massage therapists) across disciplines and institutions to develop one or more priority areas on the neural mechanisms of force-based manipulations research. This program is intended to be flexible to support activities and develop unique resources as necessary to promote innovation in the field at large and to have a substantial impact on the progress and quality of research on the neural mechanisms and biomechanics of force-based manipulations.

The following are required activities:

  • 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/summaries; scientific publications; web resources; 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.
  • Pilot Projects: Applications must propose to support small-scale pilot projects to develop data, theoretical frameworks, or empirical methods, or support the development of novel or high-risk approaches requiring interdisciplinary collaboration. Network funding for pilot projects must either advance broad network goals or support 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 funding, and to evaluate the 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. Descriptions of actual pilot projects should not be included, however. Researchers associated with the network itself may be considered for pilot funding, but first priority should be given to researchers from other locations. 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.”
  • Collaboration: Applications must budget funds for attendance at an annual meeting of all networks funded under this announcement. These meetings will provide opportunities to share advances across networks, promote collaboration, and avoid duplication of efforts.
  • Articulation of Milestones and Progress Evaluation: Applications must articulate clear milestones and criteria for evaluating success of their dissemination, pilot research, and collaboration efforts.

Examples of network activities that can be proposed include, but are not limited to:

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

Network Structure

The networking, education, and infrastructure-building activities required for these efforts are rarely covered under an individual grant (e.g., R01, R21) 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 the emerging field. Instead, please describe the types of expertise that will be sought. Participation in network activities, including presentation 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 just 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 network applicants to support activities that will foster diversity of the scientific workforce.

Administration and Meetings

NIH, in collaboration with the awarded networks’ Program Directors PD(s)/Principal Investigators Pl(s), will establish post award a force-based manipulations 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. All funded investigators will be expected to attend.

Responsiveness Criteria

Responsive applications to this FOA must propose network activities (described above) in at least one (and up to three) of the five priority areas identified in the Purpose section (i.e., (1) terminology and measurement of force-based manipulations, (2) mechanistic multiscale (i.e., molecular, cellular, and circuit) research measuring the physiological response to force-based manipulations, (3) contextual effects of force-based manipulations, (4) biomarkers of force-based manipulations, (5) technology and methodology development for mechanistic studies). Specific foci within a priority area 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 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 propose activities that serve the field at large.

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 the pilot progression and outcome in line with network priorities. Applications must include details on eligibility criteria, evaluation, and assessment of the likelihood of the proposed pilot study leading 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.

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

Applications Not Responsive to This FOA:

  • Human research studies that include clinical trials designed to answer specific questions about 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, 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 manual therapies where the primary outcome(s) are clinical endpoints (e.g., pain and/or function).
  • Studies of acupuncture or needling of trigger points or putative acupuncture points.

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-18-403 “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.

Section II. Award Information

Funding Instrument

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.

Application Types Allowed
New

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.

Clinical Trial?

Optional: Accepting applications that either propose or do not propose clinical trial(s).

Need help determining whether you are doing a clinical trial?

Funds Available and Anticipated Number of Awards

The following NIH components intend to commit the following amounts in FY 2022:

NCCIH: $1,500,000

NINDS: $400,000

Together, the NIH components will support 3-4 awards.

Award Budget

Application budgets may not exceed $400,000 per year in direct costs excluding any consortium F&A costs and should reflect the actual needs of the proposed project.

Award Project Period

The scope of the proposed project should determine the project period. The maximum 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.

Section III. Eligibility Information

1. Eligible Applicants

Eligible Organizations

Higher Education Institutions

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

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

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

Nonprofits Other Than Institutions of Higher Education

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

For-Profit Organizations

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

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
Foreign Institutions

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. 

Required Registrations

Applicant organizations

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

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

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

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

Eligible Individuals (Program Director/Principal Investigator)

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

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

2. Cost Sharing

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

3. Additional Information on Eligibility

Number of Applications

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

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

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

Section IV. Application and Submission Information

1. Requesting an Application Package

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

2. Content and Form of Application Submission

It is critical that applicants follow the 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) 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 of all funded networks.

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:

Research Strategy: The application must address how the proposed project will have a substantial impact on the progress and quality of research relevant to force-based manipulations by virtue of the proposed activities. The application must address how the proposed networking activities will advance an emerging field of research relevant to force-based manipulations. The application must propose new high-impact activities that are not feasible with existing resources.

Networks are intended to serve the broader community of researchers engaged in force-based manipulations relevant research in the designated 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.

In the Approach section of the Research Strategy, the application must 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.

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 to evaluate the pilot progression and outcome in line with network priorities, in the Approach section. Applicants must describe the type and focus of potential pilot projects that would be solicited. A description of an actual pilot project should not be included, however.

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:

A Resource and Data Sharing Plan must be included in the application. Resource Sharing products can include (but are not limited to) meeting papers/summaries, scientific publications, web resources, tools or guides to support research or data enhancement, and 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.

  • All applications, regardless of the amount of direct costs requested for any one year, should address a Data Sharing Plan.
Appendix:
Only limited Appendix materials are allowed. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.
  • No publications or other material, with the exception of blank questionnaires or blank surveys, may be included in the Appendix.
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 Component of the SF424(R&R) Application Package. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to NIH. See Section III of this FOA for information on registration requirements.

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

See more tips for avoiding common errors.

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

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.

In addition, for applications involving clinical trials: 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.

Overall Impact

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

Scored Review Criteria

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

Significance

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

For this particular announcement, note the following

How well does the proposed project support the advancement of at least one (and up to three) of the five priority areas identified in the Purpose section (i.e., (1) terminology and measurement of force-based manipulations, (2) mechanistic multiscale (i.e., molecular, cellular, and circuit) research measuring the physiological response to force-based manipulations, (3) contextual effects of force-based manipulations, (4) biomarkers of force-based manipulations, and (5) technology and methodology development for mechanistic studies)? How well do the proposed activities promote progress and improve the quality of research in the designated field of force-based manipulations? How well will the resources produced serve the field at large and shape this emerging field? How well will the proposed activities advance the field to a point that network support will no longer be required to sustain growth? How well will the type and focus of potential pilot projects advance broad network goals or provide a basis for future research applications addressing network goals?

In addition, for applications involving clinical trials

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

Investigator(s)

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

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 force-based manipulations research? 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?

In addition, for applications involving clinical trials

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

Innovation

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

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 force-based manipulations and why these goals cannot be met through existing institutional programs or structures?

In addition, for applications involving clinical trials

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

Approach

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

If the project involves human subjects and/or NIH-defined clinical research, are the plans to address 1) the protection of human subjects from research risks, and 2) inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion or exclusion of individuals of all ages (including children and older adults), justified in terms of the scientific goals and research strategy proposed?

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?

Data Management and Statistical Analysis: Has appropriate consideration been given to utilizing the NINDS Common Data Elements?

In addition, for applications involving clinical trials

Does the application adequately address the following, if applicable

Study Design

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

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

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

Data Management and Statistical Analysis

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

Environment

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

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?

Additional Review Criteria

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

Study Timeline

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?

Resources and Data Sharing Plan

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.

Study Timeline

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

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

Protections for Human Subjects

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

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

Inclusion of Women, Minorities, and Individuals Across the Lifespan

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

Vertebrate Animals

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

Biohazards

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

Resubmissions

Not Applicable

Renewals

Not Applicable

Revisions

Not Applicable

Additional Review Considerations

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

Applications from Foreign Organizations

Not Applicable.

Select Agent Research

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

Authentication of Key Biological and/or Chemical Resources:

For projects involving key biological and/or chemical resources, reviewers will comment on the brief plans proposed for identifying and ensuring the validity of those resources.

Budget and Period of Support

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

2. Review and Selection Process

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s) convened by 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.

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

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.

Applications will be assigned on the basis of established PHS referral guidelines to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications submitted in response to this FOA. Following initial peer review, recommended applications will receive a second level of review by the appropriate national Advisory Council or Board. The following will be considered in making funding decisions:

  • Scientific and technical merit of the proposed project as determined by scientific peer review.
  • Availability of funds.
  • Relevance of the proposed project to program priorities.

3. Anticipated Announcement and Award Dates

After the peer review of the application is completed, the PD/PI will be able to access his or her Summary Statement (written critique) via the eRA Commons. 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.

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

Any application awarded in response to this FOA will be subject to terms and conditions found on the Award Conditions and Information for NIH Grants website.  This includes any recent legislation and policy applicable to awards that is highlighted on this website.

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

ClinicalTrials.gov: If an award provides for one or more clinical trials. By law (Title VIII, Section 801 of Public Law 110-85), the "responsible party" must register and submit results information for certain “applicable clinical trials” on the ClinicalTrials.gov Protocol Registration and Results System Information Website (https://register.clinicaltrials.gov). NIH expects registration 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 awardee must provide NIH copies of documents related to all major changes in the status of ongoing protocols.

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

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

2. Administrative and National Policy Requirements

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

Recipients of federal financial assistance (FFA) from HHS must administer their programs in compliance with federal civil rights laws that prohibit discrimination on the basis of race, color, national origin, disability, age and, in some circumstances, religion, conscience, and sex. This includes ensuring programs are accessible to persons with limited English proficiency. 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 http://www.hhs.gov/ocr/civilrights/understanding/section1557/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 “Federal awarding agency review of risk posed by applicants.” This provision will apply to all NIH grants and cooperative agreements except fellowships.

Cooperative Agreement Terms and Conditions of Award

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 awardees 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 awardees for the project as a whole, although specific tasks and activities may be shared among the awardees and NIH as defined below.

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

  • Developing objectives, approaches, and measurements of force-based manipulations (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.
  • Awardees 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 postaward 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. 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.
  • 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, awardees will be required to submit the Research Performance Progress Report (RPPR) annually and financial statements as required in the NIH Grants Policy Statement.

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

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

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

Section VII. Agency Contacts

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

Application Submission Contacts

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

Finding Help Online: http://grants.nih.gov/support/ (preferred method of contact)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)

General Grants Information (Questions regarding application instructions, application processes, and NIH grant resources)
Email: GrantsInfo@nih.gov (preferred method of contact)
Telephone: 301-945-7573

Grants.gov Customer Support (Questions regarding Grants.gov registration and Workspace)
Contact Center Telephone: 800-518-4726
Email: support@grants.gov

Scientific/Research Contact(s)

Merav Sabri, Ph.D.
National Center for Complementary and Integrative Health (NCCIH)
Telephone: 301-496-2583
Email: merav.sabri@.nih.gov

James Gnadt, Ph.D.
National Institute of Neurological Disorders and Stroke (NINDS)
Telephone: 301-496-9964
Email: gnadtjw@mail.nih.gov

Peer Review Contact(s)

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

Financial/Grants Management Contact(s)

Chief Grants Management Officer
National Institute of Neurological Disorders and Stroke (NINDS))
Email: ChiefGrantsManagementOfficer@ninds.nih.gov  

Shelley Carow
National Center for Complementary and Integrative Health (NCCIH)
Telephone: 301-594-3788
Email: carows@mail.nih.gov

Anna Taylor, Ph.D.
National Institute of Neurological Disorders and Stroke (NINDS)
Telephone: 301-496-4245
Email: anna.taylor@nih.gov

Section VIII. Other Information

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

Authority and Regulations

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


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