EXPIRED
National Institutes of Health (NIH)
NIH-DoD-VA Pain Management Collaboratory - Coordinating Center (U24)
U24 Resource-Related Research Projects Cooperative Agreements
New
RFA-AT-17-002
RFA-AT-17-001, UG3/UH3 Exploratory/Developmental Phased Award Cooperative Agreement
93.213, 93.279; 93.313; 93.273
The purpose of this FOA is to solicit applications for a Coordinating Center (CC) to provide national leadership for the NIH-DoD-VA Health Care Systems (HCS) Research Collaboratory program on non-pharmacological approaches to pain management and comorbidities in U.S. military personnel, veterans and their families. For brevity, this initiative will be referred to as the NIH-DoD-VA Pain Management Collaboratory. Coordinating Center applicants will need to: 1) develop, adapt, and adopt technical and policy guidelines and best practices for the effective conduct of research in partnership with health care systems focused on military personnel, veterans, and their families; 2) work collaboratively with and provide technical, design, and other support to Demonstration Project teams, to develop and implement a pragmatic trial protocol; and 3) disseminate widely Collaboratory-endorsed policies and best practices and lessons learned in the Demonstration Projects for implementing research within health care settings. The Coordinating Center will also serve as the central resource for the activities of the NIH-DoD-VA Pain Management Collaboratory program, including providing administrative support for a Steering Committee and its subcommittees.
December 12, 2016
February 3, 2017
30 days prior to the application due date
March 3, 2017, by 5:00 PM local time of applicant organization. All types of non-AIDS applications allowed for this funding opportunity announcement are due on this date.
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.
Not Applicable
November 15, 2017
March 4, 2017
Not Applicable
It is critical that applicants follow the Research (R) Instructions in the SF424 (R&R) Application Guide, except where instructed to do otherwise (in this FOA or in a Notice from the NIH Guide for Grants and Contracts). Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions. Applications that do not comply with these instructions may be delayed or not accepted for review.
Part 1. Overview Information
Part 2. Full Text of the Announcement
Section
I. Funding Opportunity Description
Section II. Award Information
Section III. Eligibility Information
Section IV. Application and Submission
Information
Section V. Application Review Information
Section VI. Award Administration Information
Section VII. Agency Contacts
Section VIII. Other Information
Since 2001, more than 2.5 million U.S. troops have been deployed for Operation New Dawn, Operations Enduring Freedom (OEF) in Afghanistan, and Iraqi Freedom (OIF) in Iraq. The all-volunteer military experienced multiple redeployments to the war zone, extensive use of the reserve components of the military and National Guard, that also involved the deployment of women and parents of young children. Many of these deployed service members sustained severe injuries that in previous wars would have resulted in death. Significant and continuing improvements in outer tactical vests (body armor) and helmets saved lives. However, despite these improvements, many service members returning from these operations, and from other military operations, experienced pain, traumatic brain injuries (TBIs), symptoms of post-traumatic stress disorder (PTSD), suicidal thoughts or behaviors, substance abuse, and/or related comorbidities. Studies report nearly 45% of soldiers and 50% of veterans experience pain on a regular basis and there is significant overlap between chronic pain, PTSD, and persistent post-concussive symptoms. There is an ongoing problem with pain among military and veteran populations and an incomplete evidence base for effective pain management. Opioid medications are often prescribed for the treatment of chronic pain, but chronic use is associated with the potential for misuse, abuse, and dependence and often fails to adequately control pain. As a result, there is a need for non-pharmacological approaches to complement pharmacological strategies for pain management and to reduce the needs and hazards of excessive reliance on opioids.
The NIH, DoD, and VA have been working individually and collaboratively to develop and improve pain management approaches for military personnel, veterans and their families by adopting changes in clinical protocols, and implementing research initiatives. Some of these efforts include: 1) increasing availability of non-pharmacological approaches for pain management in some VA and DoD medical facilities; 2) DoD funding of studies on comparative effectiveness of integrative approaches for chronic pain and co-morbid conditions; 3) VA funding of studies examining the efficacy of yoga therapy for chronic pain, including low back pain, and for PTSD; 4) funding of the Defense and Veterans Center for Integrative Pain Management; and 5) a 2014 NIH-VA joint funding initiative resulting in the support of 13 research projects focused on the development and testing of non-pharmacological approaches to pain management.
In a separate but related effort, the 2010 Patient Protection and Affordable Care Act required the Department of Health and Human Services (HHS) to enlist the Institute of Medicine (IOM) in examining pain as a public health problem. In June, 2011, the Institute of Medicine (IOM) released a Consensus Report on "Relieving Pain in America: A Blueprint for Transforming Prevention, Care, Education, and Research (http://iom.edu/Reports/2011/Relieving-Pain-in-America-A-Blueprint-for-Transforming-Prevention-Care-Education-Research.aspx). The report notes that chronic pain affects an estimated 116 million American adults more than the total affected by heart disease, cancer, and diabetes combined. Pain also costs the nation up to $635 billion each year in medical treatment and lost productivity. The report notes that ideally, most patients with severe persistent pain would obtain pain care from an interdisciplinary team using an integrated approach that would target multiple dimensions of the chronic pain experience including disease management, reduction in pain severity, and improved functioning, emotional well-being and health-related quality of life.
In the last two decades, health care delivery organizations have played valuable roles in research projects and health surveillance activities funded by NIH institutes and centers (ICs), other U.S. Department of Health and Human Services agencies, the DoD, and the VA. The increased adoption of health information technology tools contributes to the increased feasibility for researchers, in partnership with health care delivery organizations, to conduct studies in real world settings with large numbers of participants.
Although there is a recognized and compelling need for research to identify effective complementary non-pharmacological approaches for pain management and other comorbid conditions in military and veteran populations, many challenges exist. Ethical and regulatory issues must be addressed to perform research in health care delivery settings. Health care providers focus on providing the best treatment, based on current knowledge, whereas research typically focuses on studying which treatments work best in a precisely defined population. Further, research studies have frequently used endpoints that are not part of routine patient assessment or care, and may propose interventions that are challenging to implement in many health care delivery settings. Bridging the gap between research and practice is an important step in the direction of providing increased benefits to the patients. Education and engagement of providers and patients on the value of research in health care settings are urgently needed. This NIH-DoD-VA Pain Management Collaboratory will create a broad framework to address and overcome these challenges.
The overall goal of this initiative, jointly supported by the NIH, DoD, and VA, is to develop the capacity to implement cost-effective large-scale pragmatic clinical research in military and veteran health care delivery organizations focusing on non-pharmacological approaches to pain management and other comorbid conditions. Types of non-pharmacological approaches to study could include, but are not limited to, mindfulness/meditative (e.g., mindfulness based stress reduction, meditation), and movement (e.g. structured exercise, tai chi, yoga) interventions, manual (e.g. spinal manipulation, massage, acupuncture) therapies, neuromodulation (e.g., electrical stimulation), and psychological and behavioral interventions (e.g., cognitive behavioral therapy), or an integrative approach that involves more than one intervention. Of special interest are integrated models of multi-modal care that are delivered in different settings (e.g. pain care that could include collaborative care, care management, care delivered through tele-care, peer-coaches, or informal caregivers etc.)
The NIH-DoD-VA Pain Management Collaboratory Initiative, will:
Demonstration Projects, solicited under a separate companion FOA (RFA-AT-17-001), will be selected based on the importance of the scientific questions and the potential to address impediments to research on non-pharmacological approaches to pain management and other comorbid conditions in health care delivery organizations serving military personnel, veterans and their families. Demonstration Projects will need to collaborate with the coordinating center to develop, initiate and implement a research protocol, which includes ethical and regulatory oversight. Demonstration projects will be phased awards with an initial planning (UG3) phase followed by an implementation (UH3) phase. During the UG3 phase the Demonstration Project teams, in cooperation with the Coordinating Center, will determine resource needs, pilot test data extraction methods for patient identification and outcome assessment, and protection of human subjects. Those demonstration projects meeting milestones during the UG3 planning phase will be approved to move to the implementation phase (UH3).
The Coordinating Center is expected to provide leadership for the NIH-DoD-VA Pain Management Collaboratory program. The Coordinating Center will need to:
1) develop, adapt, and adopt technical and policy guidelines and best practices
for the effective conduct of pragmatic clinical trials in partnership with
health care systems focused on military personnel, veterans, and their
families;
2) work collaboratively with, and provide technical, design, and other support to Demonstration Project teams, to develop and implement a research protocol; and
3) widely disseminate NIH-DoD-VA Pain Management Collaboratory -endorsed
policies and best practices and lessons learned for implementing research within
health care settings that deliver health care to U.S. military personnel,
veterans, and their families.
The Coordinating Center will also serve as the central resource for the activities of the NIH-DoD-VA Pain Management Collaboratory program, including providing administrative support to a Steering Committee and its work groups. The coordinating center will be responsible for facilitating harmonization and sharing of tools and approaches within, and across Demonstration Projects.
Program Governance will be accomplished using the NIH cooperative agreement mechanism (see Section VI.2 Cooperative Agreement Terms and Conditions of Award). Close interaction with the NIH, DoD and VA and Demonstration Project awardees will be required under this program.
Work Groups will be established and managed by the coordinating center as a core collaborative activity. The Work Groups will provide a forum for discussion of challenges and solutions across projects; harmonized and standardized policies and processes will be vetted in these groups. Work Groups are expected to address, at a minimum, the following areas: Stakeholder Engagement, Ethical/Regulatory, Study Design/Biostatistics, Phenotype/Outcomes, Electronic Health Records (EHR), and Data Sharing. Work Groups will be chaired by Coordinating Center staff and include individuals from the Demonstration Projects, and staff from the NIH, DoD, and VA.
A Steering Committee will address issues that span all projects, provide input into the policies and processes of the NIH-DoD-VA Pain Management Collaboratory, provide guidance to the Coordinating Center and demonstration projects, and assist in dissemination of policies and processes that enable research in health care systems that serve U.S. military personnel, veterans, and their families. At a minimum, the Steering Committee will be chaired by the PD/PI of the Coordinating Center and have representation from the following groups: one representative from each of the Demonstration Projects; one representative from each Work Group; Program Coordinators from the NIH, DoD, and VA, and other representatives as appropriate from various NIH, DoD, and VA programs; and NIH/VA/DoD program officers/project scientists for each award made as part of the initiative. All members are expected to actively participate in all Steering Committee activities. NIH, DoD, and VA representation may not exceed 40 percent of the committee membership.
It is also expected that the Coordinating Center will engage with groups and organizations (e.g., NIH, DOD, VA, private organizations) working in similar areas, and will stay abreast of extant and emerging information and efforts (e.g., PROMIS, CTSAs, The Interagency Pain Research Coordinating Committee), regulations, and technical advances that could facilitate research on non-pharmacological approaches to pain management and other comorbid conditions.
The Coordinating Center is expected to have at a minimum significant knowledge in the following areas:
Coordinating Center Director Effort
The NIH-DoD-VA Pain Management Collaboratory program Coordinating Center Director will be the individual responsible for the overall management of the Coordinating Center including coordination with each of the Demonstration project teams. The relationship between the Coordinating Center and the Demonstration Projects should be a partnership in the planning phase.
Administrative support for NIH-DoD-VA Pain Management Collaboratory Program
Administrative support for the activities of the NIH-DoD-VA Pain Management Collaboratory program, should include, but not be limited to:
NIH-DoD-VA Pain Management Collaboratory Program Resources, Data, and Software Sharing
The NIH-DoD-VA Pain Management Collaboratory program encourages sharing of data, resources policies, best practices, materials, and tools to facilitate collaboration, use, and replication of results. In addition, the NIH-DoD-VA Pain Management Collaboratory program encourages sharing of data from Demonstration Projects; data sharing should be done in a timely manner with appropriate privacy and confidentiality protections. Thus, the NIH-DoD-VA Pain Management Collaboratory program expects grantees to implement a Resources and Data Sharing Plan consistent with these program goals.
While software development is not the primary goal of this program, it is expected that software or sets of code may be developed under this program by the Coordinating Center or the Demonstration projects. The NIH-DoD-VA Pain Management Collaboratory program, therefore, encouragessharing of software and code that is developed under this program. Grantees and their sub-contractors are expected to implement software sharing plans consistent with the goals of this program, if sharing of this information will be useful to the scientific community to more efficiently conduct pragmatic trials in the future. This may include, but is not limited to, software, tools, or code sets for extraction of or for defining data in EHRs, clinical systems, and other health care data systems; software developed for implementation of new workflows for research studies; analytic and analysis programs; or tools for incorporation of patient input. Sharing software under this program, will broaden its availability to researchers, health care delivery organizations, research institutions, and government health care systems. The conditions for sharing should include terms that permit the dissemination and commercialization of enhanced or customized versions of the software, or incorporation into other packages. The software should be available to and modifiable by individuals outside the applicant institution and its collaborating organizations.
See Section VIII. Other Information for award authorities and regulations.
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.
New
The OER Glossary and the SF424 (R&R) Application Guide provide details on these application types.
NIH ($1,650,000 from NCCIH, $ 250,000 from NIDA and $100,000 from ORWH) intends to commit $2 million in FY 2017 to fund 1 award.
Direct costs requested for the first three years may not exceed $1.3 million per year; direct costs for years 4 to 6 may not exceed $1.0 million per year.
The total project period for an application submitted in response to this FOA may not exceed 6 years.
NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made in response to this FOA.
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
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 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 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.
In terms of experience and expertise, in addition to a strong experienced leader, the Coordinating Center PD/PI should have the following qualities:
This FOA does not require cost sharing as defined in the NIH Grants Policy Statement.
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:
Buttons to access the online ASSIST system or to download application forms 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.
It is critical that applicants follow the Research (R) Instructions in the SF424 (R&R) Application Guide, including Supplemental Grant Application Instructions except where instructed in this funding opportunity announcement to do otherwise. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.
For information on Application Submission and Receipt, visit Frequently Asked Questions Application Guide, Electronic Submission of Grant Applications.
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
National Center for Complementary and Integrative
Health (NCCIH)
6707 Democracy Blvd.
Suite 401, MSC 5475
Bethesda, MD 20892-5475 (For FedEx, etc., use 20817)
Telephone: 301-594-3456
Email: SchmidMa@mail.nih.gov
All page limitations described in the SF424 Application Guide and the Table of Page Limits must be followed, with the following exceptions or additional requirements:
For this specific FOA, the Research Strategy section is limited to 30 pages.
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.
All instructions in the SF424 (R&R) Application Guide must be followed.
All instructions in the SF424 (R&R) Application Guide must be followed.
All instructions in the SF424 (R&R) Application Guide must be followed.
All instructions in the SF424 (R&R) Application Guide must be followed.
Biographical Sketches should reflect how the investigator team, collaborators, and other personnel are well suited to the project. The team should include expertise and experience in non-pharmacological approaches to pain management and comorbidities in U.S. military personnel, veterans and their families, including but not limited to, experience with data extraction in meaningful ways from EHRs and other clinical systems, experience with ethical issues related to research and care boundaries, experience in design, conduct, and analysis of pragmatic clinical trials, and experience in collaborative research with a variety of stakeholders.
All instructions in the SF424 (R&R) Application Guide must be followed.
The Coordinating Center Director must be able to devote at least 30% effort (3.6 person months) to this program.
The applicant must include funds for the Coordinating Center PD/PI and key personnel to support and attend two one and half day NIH-DoD-VA Pain Management Collaboratory program meetings in the first year and an annual one-and-half-day meeting in subsequent years in the greater Washington D.C. area. Funds need to be included for the coordinating center to host the meeting, including the meeting room and all other expenses. Demonstration project staff will travel their own people on their budgets.
All instructions in the SF424 (R&R) Application Guide must be followed.
All instructions in the SF424 (R&R) Application Guide must be followed.
All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions:
Research Strategy: Coordinating center applicants must indicate their willingness to cooperate with Demonstration Project teams, the NIH, DoD and VA in the development and design of research approaches, methods, processes, policies, and tools used in this program.
The Coordinating Center will have five to seven Work Groups that will work with the Demonstration Projects to assist with optimizing the design and implementation; gathering lessons learned across projects; and developing guidance and best practice documents. The application must provide details of the Work Groups including staffing, planned activities, and deliverables. For example, the application must describe how Coordinating Center Work Groups will review the study design and biostatistical assumptions of the proposed Demonstration Projects; work with the Demonstration Project teams to develop detailed plans for site implementation, determine resource needs, test data extraction methods for patient identification and outcome assessment; and review plans for all aspects of ethical and regulatory oversight and protection of human subjects.
To meet the needs and responsibilities of the Coordinating Center, applicants should describe their group expertise and prior experience working collaboratively in research consortia and other collaborative projects to accomplish shared goals for the team as a whole, without repeating information on individual biosketches. Additionally, applications should describe the team's experience conducting pragmatic trials in both military and veteran health care settings such that they can provide technical expertise to other investigators proposing to do pragmatic trials in these settings. A description of the team's ongoing record of accomplishment in support of coordination, collaboration, and communication of large national-level inclusive networks or consortia should be provided.
The applicant should also describe the specific tasks and accomplishments needed to meet the objectives of the NIH-DoD-VA Pain Management Collaboratory Coordinating Center, which could include, but are not limited to:
Coordinating Center Transition Plan
Although it is unknown whether the Coordinating Center will be renewed, the applicant should provide an administrative support plan describing how it would facilitate the transition of activities to a potential successor at the end of the period. This should include describing the transition of any software, hardware, and licenses, as well as standard operating procedures, best practices, content of the public website and collaboration site and other documentation for management of the coordinating center period. Applicants should describe processes through which these resources will be made available to the community after the NIH-DoD-VA Pain Management Collaboratory period of support ends.
Resource Sharing Plan: Individuals are expected to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide, with the following modification:
All applications, regardless of the amount of direct costs requested for any one year, should address a Data Sharing Plan. Applicants are expected to provide a description of the resources that will be made broadly available including policies, practices, materials, and tools to facilitate collaboration, reuse, and replication of the project. Applications should provide descriptions of how privacy and confidentiality will be maintained. The plan must include a description of how data will be shared to allow for transparency and reproducibility of study findings (e.g. access to data, data enclave, or data repository). The Data Sharing Plan should describe how information will be shared in a timely manner with appropriate privacy and confidentiality protections to facilitate further research, reuse of data, and replication.
Software Sharing Plan
A Software Sharing Plan, with appropriate timelines, is expected to be included in the application. Applicants should describe what software will be generated by the award and how they will determine which software is potentially useful to the scientific community and how it will be shared. There is no particular software dissemination license required for this program. However, NIH does have goals for software sharing applicants should keep in mind the following goals:
Appendix: Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.
When conducting clinical research, follow all instructions for completing PHS Inclusion Enrollment Report as described in the SF424 (R&R) Application Guide.
All instructions in the SF424 (R&R) Application Guide must be followed.
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
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.
This initiative is not subject to intergovernmental review.
All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.
Pre-award costs are allowable only as described in the NIH Grants Policy Statement.
Applications must be submitted electronically following the instructions described in the SF424 (R&R) Application Guide. Paper applications will not be accepted.
Applicants must complete all required registrations before the application due date. Section III. Eligibility Information contains information about registration.
For assistance with your electronic application or for more information on the electronic submission process, visit Applying Electronically. If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Guidelines for Applicants Experiencing System Issues. 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, 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.
Applicants are required to follow the instructions for post-submission materials, as described in the policy.
Only the review criteria described below will be considered in the review process. As part of the NIH mission, all applications submitted to the NIH in support of biomedical and behavioral research are evaluated for scientific and technical merit through the NIH peer review system.
For this particular announcement, note the following: This FOA includes Additional Review Considerations on Resource and Data Sharing and Software Sharing which will be considered by reviewers but will not be scored individually or influence the overall impact score.
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 project address an important problem or a critical barrier to progress in the field? Is there a strong scientific premise for the project? 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?
Will the Coordinating Center provide national leadership and engage all stakeholders in advancing policies and practices that enhance the broad participation of researchers and health care systems in research focused on non-pharmacological approaches to pain management and comorbidities in U.S. military personnel, veterans and their families? If the aims of the center are achieved, how will clinical research, translation of research into practice, and participation by relevant health care delivery organizations in research be improved? How will successful completion of the aims change the capability, methods, and technologies used in addressing research important to effect health improvement regarding non-pharmacological pain management and comorbidities in U.S. military personnel, veterans and their families?
Are the PD(s)/PI(s), collaborators, and other researchers well suited to the project? If Early Stage Investigators or New Investigators, or in the early stages of independent careers, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the project is collaborative or multi-PD/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project?
Are the PD(s)/PI(s), collaborators, and other personnel well suited to the project? Do the personnel have the appropriate breadth of expertise and experience in non-pharmacological approaches to pain management and comorbidities in U.S. military personnel, veterans and their families, including but not limited to, experience with data extraction in meaningful ways from EHRs and other clinical systems, experience with ethical issues related to research and care boundaries, experience in design, conduct, and analysis of pragmatic clinical trials, and experience in collaborative research with a variety of stakeholders? Do the PD(s)/PI(s) and collaborators have experience conducting pragmatic trials in both military and veteran health care settings such that they can provide technical expertise to other investigators proposing to do pragmatic trials in these settings? Have they demonstrated an ongoing record of accomplishment in support of coordination, collaboration, and communication of large national-level inclusive networks or consortia? Are the investigators willing to collaborate with the NIH, DoD, and VA, and Demonstration Project awardees to meet the goals objectives of this program?
Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions? Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed?
Does the application include mechanisms for leveraging novel collaboration and communication strategies? Does the application indicate creativity and flexibility to innovate on an ongoing basis?
Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the 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 children, justified in terms of the scientific goals and research strategy proposed?
Will the proposed approach allow for rapid deployment of Coordinating Center personnel and collaborative tools to enable speedy Demonstration Project team planning and testing? Is the plan for administrative support of the NIH-DoD-VA Pain Management Collaboratory program facilitative of the proposed plan for support of the Demonstration Projects and will it add to the productivity of the program?
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?
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.
For research that involves human subjects but does not involve one of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate the justification for involvement of human subjects and the proposed protections from research risk relating to their participation according to the following five review criteria: 1) risk to subjects, 2) adequacy of protection against risks, 3) potential benefits to the subjects and others, 4) importance of the knowledge to be gained, and 5) data and safety monitoring for clinical trials.
For research that involves human subjects and meets the criteria for one or more of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials. For additional information on review of the Human Subjects section, please refer to the Guidelines for the Review of Human Subjects.
When the proposed project involves human subjects and/or NIH-defined clinical research, the committee will evaluate the proposed plans for the inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion (or exclusion) of children to determine if it is justified in terms of the scientific goals and research strategy proposed. For additional information on review of the Inclusion section, please refer to the Guidelines for the Review of Inclusion in Clinical Research.
Not Applicable
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
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.
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).
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; (3) Genomic Data Sharing Plan (GDS); and Software Sharing Plan.
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.
Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.
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. Because the DoD, VA, and several NIH ICOs (NCCIH, NINDS, NIDA, NIAAA, NICHD, NINR, ORWH) are participating in this FOA even though they are not contributing funds and they are participating in the companion FOA, they will be allowed to provide recommendations for reviewers and attend the review of the applications for this FOA. Assignment to a Scientific Review Group will be shown in the eRA Commons.
As part of the scientific peer review, all applications:
Appeals of initial peer review will not be accepted for applications submitted in response to this FOA.
Applications will be assigned to the National Center for Complementary and Integrative Health (NCCIH). Applications will compete for available funds with all other recommended applications . Following initial peer review, recommended applications will receive a second level of review by the National Advisory Council for Complementary and Integrative Health. The following will be considered in making funding decisions:
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.
If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant as described in the NIH Grants Policy Statement.
A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization for successful applications. The NoA signed by the grants management officer is the authorizing document and will be sent via email to the grantee’s business official.
Awardees must comply with any funding restrictions described in Section IV.5. Funding Restrictions. Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs.
Any application awarded in response to this FOA will be subject to terms and conditions found on the Award Conditions and Information for NIH Grants website. This includes any recent legislation and policy applicable to awards that is highlighted on this website.
All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General and Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Grantees, and Activities. More information is provided at Award Conditions and Information for NIH Grants.
Recipients of federal financial assistance (FFA) from HHS must administer their programs in compliance with federal civil rights law. This means that recipients of HHS funds must ensure equal access to their programs without regard to a person’s race, color, national origin, disability, age and, in some circumstances, sex and religion. This includes ensuring your programs are accessible to persons with limited English proficiency. HHS recognizes that research projects are often limited in scope for many reasons that are nondiscriminatory, such as the principal investigator’s scientific interest, funding limitations, recruitment requirements, and other considerations. Thus, criteria in research protocols that target or exclude certain populations are warranted where nondiscriminatory justifications establish that such criteria are appropriate with respect to the health or safety of the subjects, the scientific study design, or the purpose of the research.
For additional guidance regarding how the provisions apply to NIH grant programs, please contact the Scientific/Research Contact that is identified in Section VII under Agency Contacts of this FOA. HHS provides general guidance to recipients of FFA on meeting their legal obligation to take reasonable steps to provide meaningful access to their programs by persons with limited English proficiency. Please see http://www.hhs.gov/ocr/civilrights/resources/laws/revisedlep.html. The HHS Office for Civil Rights also provides guidance on complying with civil rights laws enforced by HHS. Please see http://www.hhs.gov/ocr/civilrights/understanding/section1557/index.html; and http://www.hhs.gov/ocr/civilrights/understanding/index.html. Recipients of FFA also have specific legal obligations for serving qualified individuals with disabilities. Please see http://www.hhs.gov/ocr/civilrights/understanding/disability/index.html. Please contact the HHS Office for Civil Rights for more information about obligations and prohibitions under federal civil rights laws at http://www.hhs.gov/ocr/office/about/rgn-hqaddresses.html or call 1-800-368-1019 or TDD 1-800-537-7697. Also note it is an HHS Departmental goal to ensure access to quality, culturally competent care, including long-term services and supports, for vulnerable populations. For further guidance on providing culturally and linguistically appropriate services, recipients should review the National Standards for Culturally and Linguistically Appropriate Services in Health and Health Care at http://minorityhealth.hhs.gov/omh/browse.aspx?lvl=2&lvlid=53.
In accordance with the statutory provisions contained in Section 872 of the Duncan Hunter National Defense Authorization Act of Fiscal Year 2009 (Public Law 110-417), NIH awards will be subject to the Federal Awardee Performance and Integrity Information System (FAPIIS) requirements. FAPIIS requires Federal award making officials to review and consider information about an applicant in the designated integrity and performance system (currently FAPIIS) prior to making an award. An applicant, at its option, may review information in the designated integrity and performance systems accessible through FAPIIS and comment on any information about itself that a Federal agency previously entered and is currently in FAPIIS. The Federal awarding agency will consider any comments by the applicant, in addition to other information in FAPIIS, in making a judgement about the applicant’s integrity, business ethics, and record of performance under Federal awards when completing the review of risk posed by applicants as described in 45 CFR Part 75.205 Federal awarding agency review of risk posed by applicants. This provision will apply to all NIH grants and cooperative agreements except fellowships.
Cooperative Agreement Terms and Conditions of Award
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
resides with the awardees for the project as a whole, although specific tasks
and activities may be shared among the awardees and the NIH, DoD, and the VA as
defined below.
The PD(s)/PI(s) will have the primary responsibility for:
The NIH, DoD, and VA 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 the 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 PO or Project Scientist 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.
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 progress report, invention statement, and the expenditure data portion of the Federal Financial Report are required for closeout of an award, as described in the NIH Grants Policy Statement.
The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for awardees of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later. All awardees of applicable NIH grants and cooperative agreements are required to report to the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over $25,000. See the NIH Grants Policy Statement for additional information on this reporting requirement.
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.
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
registration, submitting and tracking an application, documenting system
problems that threaten submission by the due date, 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)
Grants.gov
Customer Support (Questions
regarding Grants.gov registration and submission, downloading forms and
application packages)
Contact Center Telephone: 800-518-4726
Email: support@grants.gov
GrantsInfo
(Questions regarding application instructions and process, finding NIH grant
resources)
Email: GrantsInfo@nih.gov (preferred method of contact)
Telephone: 301-710-0267
Eve E. Reider, Ph.D.
National Center for Complementary & Integrative Health (NCCIH)
Telephone: 301-443-8374
Email: ereider@mail.nih.gov
Will M. Aklin, Ph.D.
National Institute on Drug Abuse (NIDA)
Telephone: 301-443-1428
Email: aklinwm@mail.nih.gov
Lisa Begg, Dr.P.H., R.N.
Office of Research on Women’s Health (ORWH)
Telephone: 301-496-3975
Email: beggl@od.nih.gov
Martina Schmidt, Ph.D.
National Center for Complementary & Integrative Health (NCCIH)
Telephone: 301-594-3456
Email: SchmidMa@mail.nih.gov
Shelley Carow
National Center for Complementary & Integrative Health (NCCIH)
Telephone: 301-594-3788
Email: CarowS@mail.nih.gov
Pamela G. Fleming
National Institute on Drug Abuse (NIDA)
Telephone: 301-253-8729
Email: pfleming@nida.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.