National Institutes of Health (NIH)
National Institute of Neurological Disorders and Stroke (NINDS)
National Institute on Aging (NIA)
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
National Center for Complementary and Integrative Health (NCCIH)
U24 Resource-Related Research Projects – Cooperative Agreements
NOT-OD-22-190 - Adjustments to NIH and AHRQ Grant Application Due Dates Between September 22 and September 30, 2022
The purpose of this FOA is to solicit applications for a Coordinating Center to provide leadership for the HEAL Coordinated Approaches to Pain Care in Health Care Systems Program. The Coordinating Center will 1) work collaboratively with each Project team supported through the Collaboratory program, including their partnering health care system (HCS), to develop, test, and implement the proposed Projects while providing technical, design, and coordination support; 2) provide centralized resources (e.g., electronic health records expertise, study design and statistical expertise for implementation trials, bioethics and regulatory expertise) for coordination and integration of the research effort across all projects; and 3) centralize the engagement of patients, care providers, health care systems, payors, and policy makers to inform the activities of the program of research, with a particular focus on HCS with less historical involvement in research studies. The Coordinating Center also will serve as the central administrative resource for the activities of the Coordinated Approaches to Pain Care Program.
30 days prior to application due date.
| Application Due Dates | Review and Award Cycles | ||||
|---|---|---|---|---|---|
| New | Renewal / Resubmission / Revision (as allowed) | AIDS | Scientific Merit Review | Advisory Council Review | Earliest Start Date |
| November 04, 2022 | Not Applicable | Not Applicable | March 2023 | May 2023 | July 2023 |
All applications are due by 5:00 PM local time of applicant organization.
Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date.
Not Applicable
It is critical that applicants follow the instructions in the Research (R) Instructions in the SF424 (R&R) Application Guide, except where instructed to do otherwise (in this FOA or in a Notice from NIH Guide for Grants and Contracts).
Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions.
Applications that do not comply with these instructions may be delayed or not accepted for review.
The HEAL Coordinated Approaches to Pain Care in Health Care Systems Research Program
The overall goal of the HEAL Coordinated Approaches to Pain Care in Health Care Systems Research Program is to provide additional evidence to enhance the ability of health care delivery organizations to implement coordinated and personalized care to manage complex pain conditions.
The biopsychosocial model of pain highlights the need for coordinated and personalized care to manage complex pain conditions. Pain care is too often delivered as single modality through one setting, providing inadequate pain management, and resulting in poor outcomes. Coordinated personalized care should optimize use of effective medications, procedures, physical function and/or psychological therapies, patient self-management strategies, and complementary approaches to manage pain. The care plan should be centered on patient goals and can be achieved by leveraging existing HCS resources delivered though a coordinated approach and supported by payor policies and guidelines. An integrated (AHRQ) coordinated care approach would provide support for primary care providers to interact with related care teams to enhance evidence-based coordinated care through referral to specialty care as needed. A comprehensive (AHRQ) coordinated care approach would provide appropriate components of coordinated pain care in a specialty clinic or rehabilitation setting in consultation with primary care.
This program will have two main components:
A Coordinating Center (CC) solicited by this funding opportunity announcement (FOA) that will: 1) provide leadership for the program and further develop, adapt, and adopt technical and policy guidelines and best practices for the efficient conduct of research on coordinated models of pain care; 2) work collaboratively with each team supported through the HEAL Coordinated Approaches to Pain Care Program by providing technical, design, and coordination support for the trials; and 3) identify and disseminate the best strategies for engaging health care systems as research partners to implement coordinated pain care programs. The Coordinating Center also will serve as the central administrative resource for organizing the activities of the Coordinated Approaches to Pain Care Program.
The coordinating center will:
• Establish a steering committee to oversee the awarded Individual Implementation Research Projects.
• Create a consortium to coordinate and integrate research across all study teams.
• Establish working groups led by experts from the CC and populated by representatives from each research project to enhance study designs, optimize patient engagement, provide biostatistical expertise, assist with creating plans and testing use of data from the electronic health records, facilitate interactions with the health care systems, address bioethics and regulatory issues of the trials, and inform augmentation of electronic health record data to capture patient reported outcomes if appropriate.
• Support centralized resources across all studies: e.g., patient/community engagement strategies; assist individual teams with their efforts to diversify and retain the research workforce and patient population; data collection, sharing, and harmonization of common measures; and engagement with payers, policy makers, and health care systems.
Individual Implementation Research Projects (5 to 6), will be awarded through a related funding announcement RFA-NS-22-053, to a variety of HCSs where coordinated care does not exist or has limited uptake by patients. The goal of the research projects is to rigorously assess and embed implementation strategiesfor evidenced based coordinated care approaches into partner HCS, one with research resources and one with limited research resources and expertise The collective goal of this program is to answer the question of how best to deliver effective coordinated pain care in a variety of HCS in accord with their available resources for health care delivery.
HCSs of interest include:
- Private or Nonprofit HCSs with infrastructure and resources for delivery and coverage of coordinated care components through specialty care centers to provide comprehensive care.
- Private or Nonprofit HCSs with coverage for services provided in part through primary care and in part through referral to other specialty services within the HCS for integrated care.
- Public HCSs with capability for delivery of services in part through primary care and in part through referrals to other specialty services for integrated care (e.g., FQHCs)
- Disability programs for patients with work related injury or on short-term disability receive coverage for medical services that may be done via primary care and referrals or a coordinated pain care program in specialty setting.
Research areas of interest include:
- Research studies to evaluate the effectiveness of implementation strategies to embed evidence-based approaches for coordinated pain care (integrated or comprehensive care) into a HCS.
- Evaluation of strategies that enhance, increase the uptake of, or access to existing coordinated care pain programs for underserved populations.
- Trials to assess and embed innovative approaches to optimize existing coordinated pain care models in an HCS: e.g., improve access to coordinated care, expand available services, enhance stakeholder engagement in developing care plans, or extend community partnerships.
- Hybrid trials which test the effectiveness of different models of coordinated pain care AND implementation of the effective models.
Essential items for the Coordinated Approaches to Pain Care Program Implementation Research Projects:
- A proposed coordinated care approach that includes at a minimum a multidisciplinary set of treatments, including as appropriate medication management program, psychological approaches and physical interventions. Additional interventions such as, but not limited to, procedures and complementary interventions may be included.
- Partnership between two HCS, one with research resources and expertise and one which has little or no history of not participation in research.
- It is anticipated that the Projects will be performed with high volume electronically supported integrated HCS to establish efficiencies. The HCS partnership must facilitate access to all data sources relevant to the project.
- Utilization of rigorous methods and study design for an implementation trial.
- An implementation plan for embedding evidence-based models of coordinated pain care. A plan for service coverage within the HCS (leverage proposed CMS rule change for codes and coverage of comprehensive or integrated pain care programs).
- Inclusion of patients, providers, payors and policy makers as stakeholders in study strategic planning, design, implementation, and evaluation.
- A plan for sustainability of the pain care model in the participating HCSs after study completion.
- A plan to address the NIH inlcusion policies.
- A plan to integrate primary care and specialty care.
- A plan for collaboration across awarded projects and contribution to the coordinating center activities.
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Inclusion of primary care providers in either a comprehensive or integrated care strategy to deliver coordinated care.
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Priority will be given to projects that address scientific questions to improve the care of NIH-designated populations that experience health disparities.
- Inclusion of stakeholders: At minimum the following: Primary care providers, specialty pain care providers, patients, payors, and policy makers.
- A strategy to coordinate pain care planning, service delivery, and outcomes assessment between primary care and existing specialty pain care services within each of the partner HCS.
- .Research strategy to implement the evidence-based care model into partner HCS
- Plans to retain successful study practices beyond the duration of the award.
It is anticipated that the Research Projects will be performed with high volume electronically supported integrated HCS to establish efficiencies. The HCS partnership must facilitate access to all data sources relevant to the project. Research Project awards will utilize a phased award UG3/UH3 mechanism, with a one-year planning (UG3) and an up to four-year implementation (UH3) phase.
The Coordinating Center is expected to have significant experience and knowledge in the following areas;
- Research expertise in;
- Conduct of multisite research studies with participation by multiple health care delivery organizations, including engagement of systems that do not frequently participate in research
- Regulatory processes and compliance
- Workflows and practices of research teams; experience in workflow for design and conduct of randomized studies should be highlighted
- Project management experience in taking a research question from an idea through implementation to completion by assisting study teams that will be performing the trials.
- Expertise in implementation science frameworks and methodology
- Study design and statistical expertise, particularly in designs and methods for pragmatic clinical and implementation trials
- Health Care Systems expertise;
- Knowledge of current data models, algorithms, and approaches used by various networks and studies to define clinical phenotypes, extract information, define endpoints, and discover errors in data from health care systems
- Extraction of information from electronic health records and relevant clinical systems for research; experience with multiple health care systems and EHRs is preferred
- Collaboration across diverse stakeholders including patients, research participants, practitioners, researchers, hospital and research informatics and technical personnel, and senior managers of health care and research organizations
- Knowledge of payment policies, workflows and practices of a variety of types of health care systems and their practitioners
Methodology to incorporate patient reported outcomes and patient reported assessments in health care EHRs and research study management tools Health Disparity Research Expertise in:
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- Methods to recruit NIH-designated populations that experience health disparities from health care system partners
- Equity, diversity, and inclusion approaches and methods to ensure that research addresses the health needs of all populations across the lifespan
- Regulatory requirements for conduct and compliance of research and for use of health care data
- Ethical issues related to clinical research, clinical care, quality improvement, population health, and implementation science.
During the UG3 Individual Implementation Research Project phase the individual study teams in cooperation with the CC will develop detailed plans for site implementation; determine resource needs; test data extraction methods for patient identification and outcome assessment; test methods for outcome assessment augmentation beyond the EHR; review study design, statistical analytic plans, and study power; and develop plans for all aspects of ethical and regulatory oversight and protection of human subjects. All projects will be milestone-driven, and not all planning awards will necessarily move to the trial conduct phase.
The Program Director/Principal Investigator(s) of the CC is expected to have broad experience in working collaboratively with a variety of health care systems, in extracting health care data for research and in managing the related regulatory, ethical, and policy issues. The ability to work collaboratively with multiple communities while providing strong leadership is a requirement. In addition to strong leadership, the CC must include individuals with broad experience (as detailed below) and ability to communicate clearly with all relevant stakeholders and work to find common ground.
Specific Objectives of this Coordinating Center
The specific objectives of the Coordinating Center are:
- Work collaboratively with each study partner HCS team in the program to develop, test, and perform the proposed study while providing technical, design, and coordination support
- Provide expertise to each team to enhance recruitment of diverse populations
- Learn and disseminate the best strategies for engaging health care systems as research partners to improve coordinated pain care delivery, with a focus on HCS with less historical involvement in research studies
- Provide support across all study partner teams to promote collaboration towards harmonizing efforts, share lessons learned, and assist with challenges in implementation of services in a broad range of HCs
The Coordinating Center will support the establishment and activities of Work Groups that will help investigators meet the goals of the program. Activities the Work Groups could support include but are not limited to:
- Identifying needs for new resources, best practices, or guidelines to enable implementation trials to be conducted across various health care systems
- Expanding the types of health care systems involved in research
- Encouraging strategies to address health disparities
- Building on the technical and policy experience of health care systems and researchers that have conducted studies that leverage electronic health record data
- Refining guidance and model agreements for addressing regulatory requirements for studies conducted in health care systems
- Refining and building upon processes and best practices for ethical conduct of pragmatic and implementation research in health care settings
- Developing training opportunities for young investigators associated with the Coordinated Approaches to Pain Care Program trials
- Refining and updating guidance and best practices about how to implement successful interventions from the program’s trials into other HCS, and if appropriate how to de-implement ineffective or harmful interventions
- Developing approaches and best practices, to facilitate sharing of data and metadata to improve the quality of future secondary analyses of the data
- Facilitating sharing of data across trials to the NIH HEAL data ecosystem.
The CC will be responsible for facilitating harmonization and sharing of the HEAL Pain Common Data Elements for use in the individual trials,best practices, and approaches within and across the trials in this collaborative program.
The CC’s role may be further defined to align with needs and resources of the implementation teams ls after awards are made. The cooperative agreement structure allows for such refinement.
Administrative Support for HCS Research Collaboratory Program
Administrative activities of the CC to support the HCS Research Collaboratory program could include but are not limited to:
- provision and maintenance of a public website for each trial.
- collaboration support- time, space, administration,-for the individual trials during the duration of the program.
- organizational and logistical support for facilitating the activities of the Work Groups and Steering Committee,
- supporting standards and mechanisms for publicly sharing data, resources, phenotype definitions and algorithms, and codes developed in the Coordinated Approaches to Pain Care Program.
- organizing and supporting the logistics of meetings of the Steering Committee in the Bethesda MD area to include a kickoff and one annual meeting in the first year of the competing award and annual meetings of similar length in following years.
Program Governance
The awards funded under this FOA will be cooperative agreements (see Section VI.2 Cooperative Agreement Terms and Conditions of Award). Close interaction with the NIH, the recipients of the individual program trials, and the CC investigators will be required to accomplish the goals of this program. Trials selected for the Coordinated Approaches to Pain Care will have administering NIH IC officials who will be partners in the Coordinated Approaches to Pain Care Program.
A Coordinated Approaches to Pain Care Steering Committee will be established to address issues that span all projects, provide input into the policies and processes of the Coordinated Approaches to Pain Care Program, and assist in dissemination of policies and processes that enable research in partnership with health care systems, their patients, and practitioners. At a minimum, the Steering Committee will be composed of one representative from each of Implementation Trial teams, one representative from the Coordinating Center, the NIH Program Coordinator, and representatives from NIH staff. All members are expected to actively participate in all Steering Committee activities. The combined NIH membership may not exceed 1/3 of the total committee membership. The NIH HEAL Initiative requires a high level of coordination and sharing between investigators. It is expected that NIH HEAL Initiative recipients will cooperate and coordinate their activities after awards are made by participating in Program Director/Principal Investigator (PD/PI) meetings, including an annual HEAL Investigators Meeting, as well as other activities.
HEAL Diversity
In addition to scientific diversity, applicants should strive to incorporate diversity in their team development plan. Research shows that diverse teams working together and capitalizing on innovative ideas and distinct perspectives out-perform homogenous teams. Scientists and trainees from diverse backgrounds and life experiences bring different perspectives, creativity, and individual enterprise to address complex scientific problems. There are many benefits that flow from a diverse NIH-supported scientific workforce, including: fostering scientific innovation, enhancing global competitiveness, contributing to robust learning environments, improving the quality of the research, advancing the likelihood that underserved or health disparity populations participate in, and benefit from health research, and enhancing public trust. Please refer to Notice of NIH's Interest in Diversity NOT-OD-20-031 for more details.
HEAL Data Sharing
NIH intends to maximize the impact of HEAL Initiative-supported projects through broad and rapid data sharing. Consistent with the HEAL Initiative Public Access and Data Sharing Policy (https://heal.nih.gov/about/public-access-data), all applications, regardless of the amount of direct costs requested for any one year, are required to include a Data Management and Sharing Plan outlining how scientific data and any accompanying metadata will be managed and shared.
https://www.heal.nih.gov/data/public-access-data
Coordinating Center Director Effort
The Coordinated Approaches to Pain Care Coordinating Center Director is responsible for the overall management of the Coordinating Center and coordination with each of the studies. The relationship between the Coordinating Center and the Implementation Trials should be one of equal partners in the planning phase. The Coordinating Center Director (or team of multiple PD/PIs) must devote at least 25% effort (3.0 person months) collectively to this program.
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.
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.
Not Allowed: Only accepting applications that do not propose clinical trials.
The NIH HEALinitiative intends to commit $3,750,000 across 5 years to fund one award.
Budgets cannot exceed $700,000 in direct costs in any year.
The maximum project period is 5 years.
NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made from this FOA.
1. Eligible Applicants
Higher Education Institutions
- 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 Government
- Eligible Agencies of the Federal Government
- U.S. Territory or Possession
Other
- Independent School Districts
- Public Housing Authorities/Indian Housing Authorities
- Native American Tribal Organizations (other than Federally recognized tribal governments)
- Faith-based or Community-based Organizations
- Regional Organizations
Non-domestic (non-U.S.) Entities (Foreign Institutions) are not eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.
Foreign components, as defined in the NIH Grants Policy Statement, are not allowed.
Applicant Organizations
Applicant organizations must complete and maintain the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award. All registrations must be completed prior to the application being submitted. Registration can take 6 weeks or more, so applicants should begin the registration process as soon as possible. The NIH Policy on Late Submission of Grant Applications states that failure to complete registrations in advance of a due date is not a valid reason for a late submission.
- System for Award Management (SAM)– Applicants must complete and maintain an active registration, which requires renewal at least annually. The renewal process may require as much time as the initial registration. SAM registration includes the assignment of a Commercial and Government Entity (CAGE) Code for domestic organizations which have not already been assigned a CAGE Code.
- NATO Commercial and Government Entity (NCAGE) Code – Foreign organizations must obtain an NCAGE code (in lieu of a CAGE code) in order to register in SAM.
- Unique Entity Identifier (UEI)- A UEI is issued as part of the SAM.gov registration process. The same UEI must be used for all registrations, as well as on the grant application.
- eRA Commons - Once the unique organization identifier is established, organizations can register with eRA Commons in tandem with completing their full SAM and Grants.gov registrations; all registrations must be in place by time of submission. eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to submit an application.
- Grants.gov – Applicants must have an active SAM registration in order to complete the Grants.gov registration.
Program Directors/Principal Investigators (PD(s)/PI(s))
All PD(s)/PI(s) must have an eRA Commons account. PD(s)/PI(s) should work with their organizational officials to either create a new account or to affiliate their existing account with the applicant organization in eRA Commons. If the PD/PI is also the organizational Signing Official, they must have two distinct eRA Commons accounts, one for each role. Obtaining an eRA Commons account can take up to 2 weeks.
Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with his/her organization to develop an application for support. Individuals from diverse backgrounds, including underrepresented racial and ethnic groups, individuals with disabilities, and women are always encouraged to apply for NIH support. See, Reminder: Notice of NIH's Encouragement of Applications Supporting Individuals from Underrepresented Ethnic and Racial Groups as well as Individuals with Disabilities, NOT-OD-22-019.
For institutions/organizations proposing multiple PDs/PIs, visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the SF424 (R&R) Application Guide.
2. Cost Sharing
This FOA does not require cost sharing as defined in the NIH Grants Policy Statement.
Applicant organizations may submit more than one application, provided that each application is scientifically distinct.
The NIH will not accept duplicate or highly overlapping applications under review at the same time, per 2.3.7.4 Submission of Resubmission Application. This means that the NIH will not accept:
- A new (A0) application that is submitted before issuance of the summary statement from the review of an overlapping new (A0) or resubmission (A1) application.
- A resubmission (A1) application that is submitted before issuance of the summary statement from the review of the previous new (A0) application.
- An application that has substantial overlap with another application pending appeal of initial peer review (see 2.3.9.4 Similar, Essentially Identical, or Identical Applications)
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:
Linda Porter, PhD
National Institute of Neurological Disorders and Stroke (NINDS)
Telephone: 301-346-3266
Email:[email protected]
All page limitations described in the SF424 Application Guide and the Table of Page Limits must be followed.
The following section supplements the instructions found in the SF424 (R&R) Application Guide and should be used for preparing an application to this FOA.
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.
The Biosketches should provide evidence for the appropriate breadth of expertise and experience, including but not limited to, experience with support and coordination of large complex projects, meaningful data extraction from Electronic Health Records and other clinical systems, experience with ethical issues related to research and care boundaries, experience in design, conduct, and analysis of research studies, and experience in collaborative research with a variety of stakeholders.
R&R Budget
All instructions in the SF424 (R&R) Application Guide must be followed.
The applicant must include funds for the Coordinating Center PD/PI and key personnel to attend one Coordinated Approaches to Pain Care program meeting in the first year and an annual meeting in subsequent years in the Bethesda MD area and one face-to-face NIH HEAL Investigator meeting to be held in the Bethesda, Maryland or Washington, DC general geographic area,
The Coordinating Center Director (or team of multiple PD/PIs) must devote at least 3.0 person months effort collectively to this program.
The budget should be structured to allow for the scaling of activities of the Coordinating Center based on the number of pragmatic or implementation trials that are supported by the program. It is anticipated five to six trials will be selected by NIH HEAL partnering Institutes/Centers/Offices.
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:
- Applicants should address how they will adhere to the NIH Policy on Good Clinical Practice Training. This policy establishes the expectation that all NIH-funded investigators and staff who are involved in the conduct, oversight, or management of clinical trials should be trained in Good Clinical Practice (GCP), consistent with principles of the International Conference on Harmonization (ICH) E6 (R2).The principles of GCP help assure the safety, integrity, and quality of clinical trials. This Policy applies to NIH-funded investigators and clinical trial site staff who are responsible for the conduct, management and oversight of NIH-funded clinical trials (https://grants.nih.gov/grants/guide/notice-files/NOT-OD-16-148.html).
The CC will be interacting with study teams awarded in the partner Health Care Systems and the NIH in this effort.
- The application must provide information regarding the CC activities, its staffing and the interactions with the individual trial investigators as they plan and implement their studies.
- The application must provide details of how the CC will review the study design and biostatistical assumptions of the trials during their planning phase, work with the investigator 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.
- Applicants should describe processes through which the resources developed by the CC will be made available to the community after the period of support ends. Applications should describe plans to disseminate knowledge and expertise for implementation trial planning and oversight to the community.
- Applicants should describe their willingness to be flexible in determination of areas of responsibilities in this collaborative program. Applicants must indicate their willingness to cooperate with Project teams supported by HEAL FOAs for implementation trials. Applicants should describe their prior experience working collaboratively in research consortia and other collaborative projects to accomplish shared goals.
Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide.
The following modifications also apply:
- All applications, regardless of the amount of direct costs requested for any one year, must include a Resources and Data Sharing Plan.
HEAL Data Sharing
NIH intends to maximize the impact of HEAL Initiative-supported projects through broad and rapid data sharing.Consistent with the HEAL Initiative Public Access and Data Sharing Policy (https://heal.nih.gov/about/public-access-data), and in line with the new NIH Policy for Data Management and Sharing (https://grants.nih.gov/grants/guide/notice-files/NOT-OD-21-013.html), all applications, regardless of the amount of direct costs requested for any one year, are required to include a Data Management and Sharing Plan outlining how scientific data and any accompanying metadata will be managed and shared. The plan should describe data types, file formats, submission timelines, and standards used in collecting or processing the data. It is expected that data generated by HEAL Initiative-funded projects will be submitted to study-appropriate domain-specific or generalist repositories in consultation with the HEAL Data Stewardship Group to ensure the data is accessible via the HEAL Initiative Data Ecosystem.
To maximize discoverability and value of HEAL datasets and studies, and facilitate data integration and collaboration, applications submitted in response to this FOA are strongly encouraged to incorporate standards and resources where applicable:
- Applicants are encouraged to ensure that data collected by the study conform to Findable, Accessible, Interoperable, and Reusable (FAIR) principles.
- Applicants are specifically encouraged to incorporate into their planning, an alignment with the guidelines, principles and recommendations developed by the HEAL Data Ecosystem, including but not limited to preparing data to store in selected specified repositories, applying minimal metadata standards, use of core HEAL Clinical Data Elements (CDEs, https://heal.nih.gov/data/common-data-elements), and other necessary requirements to prepare data to connect to the HEAL Data Ecosystem.
- All new HEAL clinical pain studies are required to submit their case-report forms/questionnaires to the HEAL Clinical Data Elements (CDE) Program. The program will create the CDE files containing standardized variable names, responses, coding, and other information. The program will also format the case-report forms in a standardized way that is compliant with accessibility standards under Section 508 of the Rehabilitation Act of 1973 (29 U.S.C § 794 (d)), which “require[s] Federal agencies to make their electronic and information technology accessible to people with disabilities.” HEAL Initiative clinical studies that are using copyrighted questionaries are required to obtain licenses for use prior to initiating data collection. Licenses must be shared with the HEAL CDE team and the program officer prior to use of copyrighted materials. For additional information, visit the HEAL CDE Program.
The NIH notices referenced below provide additional NIH guidance that should be considered in developing a strong data management and sharing plan. The list is instructive but not comprehensive.
- Elements of an NIH Data Management and Sharing Plan (NOT-OD-21-014)
- NIH has provided guidance around selecting a repository for data generated by NIH-supported research and has developed desirable characteristics for all data repositories (NOT-OD-21-016).
- NIH encourages the use of data standards including the PhenX Toolkit (www.phenxtoolkit.org) (for example, see NOT-DA-12-008, NOT-MH-15-009)
- NIH encourages researchers to explore the use of the HL7 FHIR® (Fast Healthcare Interoperability Resources) standard to capture, integrate, and exchange clinical data for research purposes and to enhance capabilities to share research data (NOT-OD-19-122). The FHIR® standard may be particularly useful in facilitating the flow of data with EHR-based datasets, tools, and applications.
- NIH encourages clinical research programs and researchers to adopt and use the standardized set of data classes, data elements, and associated vocabulary standards specified in the United States Core Data for Interoperability (USCDI) standards, as they are applicable (NOT-OD-20-146). Use of the USCDI can complement the FHIR® standard and enable researchers to leverage structured EHR data for research and enable discovery.
Awardees conducting research that includes collection of genomic data should incorporate requirements under the NIH Genomic Data Sharing Policy (NOT-OD-14-124, NOT-OD-15-086).
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.
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.
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.
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 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 fieldof the Senior/Key Person Profile form. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to NIH. See Section III of this FOA for information on registration requirements.
The applicant organization must ensure that the unique entity identifier provided on the application is the same identifier used in the organization’s profile in the eRA Commons and for the System for Award Management. Additional information may be found in the SF424 (R&R) Application Guide.
See more tips for avoiding common errors.
Upon receipt, applications will be evaluated for completeness and compliance with application instructions by the Center for Scientific Review and responsiveness by components of participating organizations, NIH. Applications that are incomplete, non-compliant and/or nonresponsive will not be reviewed.
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.
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.
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 proposed Center address the needs of the research projects/consortium that it will coordinate? Is the scope of activities proposed for the Center appropriate to meet those needs? Will successful completion of the aims bring unique advantages or capabilities to the research projects/consortium?
Specific to this FOA:
Is sufficient evidence provided that the proposed Coordinating Center has the potential to engage stakeholders to provide the infrastructure and leadership needed evidence that will enhance the broad adoption of trial outcomes by health care systems?
Investigator(s)
Are the PD(s)/PI(s) and other personnel well suited to their roles in the Center? Do they have appropriate experience and training, and have they demonstrated experience and an ongoing record of accomplishments in managing implementation research? Do the investigators demonstrate significant experience with coordinating collaborative clinical research? If the Center is multi-PD/PI, do the investigators have complementary and integrated expertise and skills; are their leadership approach, governance, plans for conflict resolution, and organizational structure appropriate for the Center? Does the applicant have experience overseeing selection and management of subawards, if needed?
Specific to this FOA:
Do the personnel have the appropriate breadth of expertise and experience, including but not limited to, experience with support and coordination of large complex projects, meaningful data extractionfrom Electronic Health Records and other clinical systems, experience with ethical issues related to research and care boundaries, experience in design, conduct, and analysis of research studies, and experience in collaborative research with a variety of stakeholders?
Innovation
Does the application propose novel organizational concepts management strategies in coordinating the research projects/consortium the Center will serve? Are the concepts, strategies, or instrumentation novel to one type of research program or applicable in a broad sense? Is a refinement, improvement, or new application of organizational concepts or management strategies proposed?
Specific to this FOA:
Are the approaches to support partner HCS with different resources novel? Will the approaches promote implementation of best practices that align with resources in the HCS?
Approach
Are the overall strategy, operational plan, and organizational structure well-reasoned and appropriate to accomplish the goals of the research projects/consortium the Center will serve? Will the investigators promote strategies to ensure a robust and unbiased scientific approach across the projects/consortium, as appropriate for the work proposed? Are potential problems, alternative strategies, and benchmarks for success presented? If the projects/consortium is in the early stages of operation, does the proposed strategy adequately establish feasibility and manage the risks associated with the activities of the projects/consortium? Are an appropriate plan for work-flow and a well-established timeline proposed? Have the investigators presented adequate plans to ensure consideration of relevant biological variables, such as sex, for studies of vertebrate animals or human subjects?
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?
Specific to this FOA:
Will the proposed approach allow for the Coordinating Center personnel and collaborative tools to enable speedy trials and will it add to the productivity of the program? Does the data sharing plan describe how data will be shared and how privacy and confidentiality will be maintained? Will the approaches promote implementation of best practices that are relevant to the partner HCS and align with resources in the HCS?
Does the resource sharing plan sufficiently describe what tools, polices, materials, or other resources will be made broadly available as well as how they will be disseminated? Does the data sharing plan describe how data will be shared and how privacy and confidentiality will be maintained?
Are the proposed leadership approach, staffing, governance and organizational structure appropriate for the project?
Are there plans for the proposed CC to review the study design and biostatistical assumptions of the trials during their planning phase, to work with the investigator teams to develop detailed plans for site implementation, to determine resource needs, to test data extraction methods for patient identification and outcome assessment; and to review plans for all aspects of ethical and regulatory oversight and protection of human subjects?
Environment
Will the institutional environment in which the Center will operate contribute to the probability of success in facilitating the research projects/consortium it serves? Are the institutional support, equipment and other physical resources available to the investigators adequate for the Center proposed? Will the Center benefit from unique features of the institutional environment, infrastructure, or personnel? Are resources available within the scientific environment to support electronic information handling?
Additional Review Criteria
As applicable for the project proposed, reviewers will evaluate the following additional items while determining scientific and technical merit, and in providing an overall impact score, but will not give separate scores for these items.
Protections for Human Subjects
For research that involves human subjects but does not involve one of the 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.
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).
Resource Sharing Plans
Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable:(1) Sharing Model Organisms; and (2) Genomic Data Sharing Plan (GDS).
Authentication of Key Biological and/or Chemical Resources:
For projects/consortia 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.
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 National Advisory Council for Complementary and Integrative Health. 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.
1. Award Notices
If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant as described in the NIH Grants Policy Statement.
A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization for successful applications. The NoA signed by the grants management officer is the authorizing document and will be sent via email to the recipient's business official.
Recipients must comply with any funding restrictions described in Section IV.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.
Institutional Review Board or Independent Ethics Committee Approval: Recipient institutions must ensure that protocols are reviewed by their IRB or IEC. To help ensure the safety of participants enrolled in NIH-funded studies, the recipient must provide NIH copies of documents related to all major changes in the status of ongoing protocols.
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, including of note, but not limited to:
- Federalwide Research Terms and Conditions
- Prohibition on Certain Telecommunications and Video Surveillance Services or Equipment
- Acknowledgment of Federal Funding
If a recipient is successful and receives a Notice of Award, in accepting the award, the recipient agrees that any activities under the award are subject to all provisions currently in effect or implemented during the period of the award, other Department regulations and policies in effect at the time of the award, and applicable statutory provisions.
Should the applicant organization successfully compete for an award, recipients of federal financial assistance (FFA) from HHS must administer their programs in compliance with federal civil rights laws that prohibit discrimination on the basis of race, color, national origin, disability, age and, in some circumstances, religion, conscience, and sex (including gender identity, sexual orientation, and pregnancy). This includes ensuring programs are accessible to persons with limited English proficiency and persons with disabilities. The HHS Office for Civil Rights provides guidance on complying with civil rights laws enforced by HHS. Please see https://www.hhs.gov/civil-rights/for-providers/provider-obligations/index.html and https://www.hhs.gov/civil-rights/for-individuals/nondiscrimination/index.html
HHS recognizes that research projects are often limited in scope for many reasons that are nondiscriminatory, such as the principal investigator’s scientific interest, funding limitations, recruitment requirements, and other considerations. Thus, criteria in research protocols that target or exclude certain populations are warranted where nondiscriminatory justifications establish that such criteria are appropriate with respect to the health or safety of the subjects, the scientific study design, or the purpose of the research. For additional guidance regarding how the provisions apply to NIH grant programs, please contact the Scientific/Research Contact that is identified in Section VII under Agency Contacts of this FOA.
- Recipients of FFA must ensure that their programs are accessible to persons with limited English proficiency. For guidance on meeting the legal obligation to take reasonable steps to ensure meaningful access to programs or activities by limited English proficient individuals see https://www.hhs.gov/civil-rights/for-individuals/special-topics/limited-english-proficiency/fact-sheet-guidance/index.html and https://www.lep.gov.
- For information on an institution’s specific legal obligations for serving qualified individuals with disabilities, including reasonable accommodations and making services accessible to them, see http://www.hhs.gov/ocr/civilrights/understanding/disability/index.html.
- HHS funded health and education programs must be administered in an environment free of sexual harassment, see https://www.hhs.gov/civil-rights/for-individuals/sex-discrimination/index.html. For information about NIH's commitment to supporting a safe and respectful work environment, who to contact with questions or concerns, and what NIH's expectations are for institutions and the individuals supported on NIH-funded awards, please see https://grants.nih.gov/grants/policy/harassment.htm.
- For guidance on administering programs in compliance with applicable federal conscience protection and associated anti-discrimination laws see https://www.hhs.gov/conscience/conscience-protections/index.html and https://www.hhs.gov/conscience/religious-freedom/index.html.
Please contact the HHS Office for Civil Rights for more information about obligations and prohibitions under federal civil rights laws at https://www.hhs.gov/ocr/about-us/contact-us/index.html or call 1-800-368-1019 or TDD 1-800-537-7697.
In accordance with the statutory provisions contained in Section 872 of the Duncan Hunter National Defense Authorization Act of Fiscal Year 2009 (Public Law 110-417), NIH awards will be subject to the Federal Awardee Performance and Integrity Information System (FAPIIS) requirements. FAPIIS requires Federal award making officials to review and consider information about an applicant in the designated integrity and performance system (currently FAPIIS) prior to making an award. An applicant, at its option, may review information in the designated integrity and performance systems accessible through FAPIIS and comment on any information about itself that a Federal agency previously entered and is currently in FAPIIS. The Federal awarding agency will consider any comments by the applicant, in addition to other information in FAPIIS, in making a judgement about the applicant’s integrity, business ethics, and record of performance under Federal awards when completing the review of risk posed by applicants as described in 45 CFR Part 75.205 and 2 CFR Part 200.206 “Federal awarding agency review of risk posed by applicants.” This provision will apply to all NIH grants and cooperative agreements except fellowships.
NIH 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 Parts 75, 2 CFR Part 200, and other HHS, PHS, and NIH grant administration policies.
The administrative and funding instrument used for this program will be the cooperative agreement, an "assistance" mechanism (rather than an "acquisition" mechanism), in which substantial NIH programmatic involvement with the recipients is anticipated during the performance of the activities. Under the cooperative agreement, the NIH purpose is to support and stimulate the recipients' activities by involvement in and otherwise working jointly with the award recipients in a partnership role; it is not to assume direction, prime responsibility, or a dominant role in the activities. Consistent with this concept, the dominant role and prime responsibility resides with the recipients for the project as a whole, although specific tasks and activities may be shared among the recipients and the NIH as defined below.
The PD(s)/PI(s) will have the primary responsibility for:
- Determining approaches, designing, and meeting CC project milestones, and implementing the project plan for the Coordinating Center
- Cooperating in sharing issues related to data quality, data management, data biases and errors, query quality and sampling challenges, and pitfalls in the utilization of health care data for research
- Cooperating with each trial PD(s)/PI(s) in the development and testing of implementation plans
- Cooperating with others in sharing of study designs, methods, protocols, tools, and strategies
- Participating in group activities, including program-wide Work Group and Steering Committee meetings
- Providing integrative, organizational, and logistical support for the entire program, including tracking, scheduling, and facilitating workgroup meetings, and conference calls, preparing concise minutes or summaries of meetings for distribution
- Assessing and disseminating data and methods developed for or derived from the Coordinated Approaches to Pain Care Program within and outside the Consortium.
- Adhering to policies regarding data sharing and publication established by the NIH and the HEAL Coordinated Approaches to Pain Care Program.
- Abiding by common definitions, protocols, and procedures, as determined in collaboration with the Program Steering Committee.
- Providing expertise and leadership in addressing issues of broad applicability, such as informed consent, data sharing standards, analysis methodology, and dissemination
- Agreeing to accept close coordination, cooperation, and management of the project with NIH, including those outlined under “NIH Responsibilities”
- Recipients will retain custody of and have primary rights to the data and software developed under these awards, subject to Government rights of access consistent with current DHHS, PHS, and NIH policies and goals of this program.
NIH staff has substantial programmatic involvement that is above and beyond the normal stewardship role in awards, as described below:
- The NIH Program Officer will work with the CC Director (or team of co-PIs) and the Steering Committee to ensure the objectives of the program are being met. The dominant role and prime responsibility for the program reside with the recipient, although specific tasks and activities will be shared among the recipient and the NIH Program Officer.
- The NIH Program Officer will provide technical assistance, advice, and coordination; however, the role of the NIH staff will be to facilitate and not to direct activities. It is anticipated that decisions in all activities will be reached by consensus of the program and NIH staff will be given the opportunity to offer input to this process.
- The NIH Program Officer serves as the contact point for addressing the program objectives with the recipient.
- Additional NIH staff may participate in all work groups, implementation teams, and committees, including the Steering Committee, as appropriate. Participation by staff from other federal agencies may also be appropriate and advantageous to facilitate the activities of the program.
- The NIH reserves the option to recommend withholding or reduction of support from activities that fail to achieve their goal or comply with the Terms and Conditions.
- NIH staff may serve as resources for, or interface with, other ongoing HEAL activities that may be relevant to the activities in the Coordinated Approaches to Pain Care Program to avoid duplication and facilitate collaboration and communication in overlapping areas.
- Assist in development, design, and coordination of activities and projects
- Responsibility for monitoring progress, which could include regular communications with recipient and coordinating center staff, periodic site visits, observation and review of project implementation plans and testing, and requests for additional reports or documentation
- Reporting periodically on the progress of the program to the NIH HEAL Executive Committee, the NIH HEAL Director, and other participating ICO Directors;
- 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:
- Recipient(s) agree to the governance through a Steering Committee. An HCS Research Collaboratory Steering Committee will be established to address issues that span all projects, provide input into the policies and processes of the Coordinated Approaches to Pain Care Program , and assist in the dissemination of policies and processes that enable research in partnership with health care systems, their patients, and practitioners. At a minimum, the Steering Committee will be composed of one representative from each of the trials/studies within the Coordinated Approaches to Pain Care Program, one representative from the Coordinating Center, the NIH Program Coordinator, and representatives from various NIH ICs that are administering individual trials/studies. All members are expected to actively participate in all Steering Committee activities. The combined NIH membership may never exceed 1/3 of the total committee membership. NIH Program Officials will be non voting member son the steering committee.
- Establishment and adherence by each trial team (PDs/PIs, Coordinating Center recipient, and NIH staff) to a written plan of engagement with timelines to ensure delineation of roles and timely delivery of the tested implementation plan
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 composed of three members 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 recipient. This special dispute resolution procedure does not alter the recipient's right to appeal an adverse action that is otherwise appealable in accordance with PHS regulation 42 CFR Part 50, Subpart D and DHHS regulation 45 CFR Part 16.
3. Reporting
When multiple years are involved, recipients will be required to submit the Research Performance Progress Report (RPPR) annually and financial statements as required in the NIH Grants Policy Statement.
A final RPPR, invention statement, and the expenditure data portion of the Federal Financial Report are required for closeout of an award, as described in the NIH Grants Policy Statement. NIH FOAs outline intended research goals and objectives. Post award, NIH will review and measure performance based on the details and outcomes that are shared within the RPPR, as described at 45 CFR Part 75.301 and 2 CFR Part 200.301.
The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for recipients of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later. All recipients of applicable NIH grants and cooperative agreements are required to report to the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over $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, 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: [email protected] (preferred method of contact)
Telephone: 301-480-7075
Grants.gov Customer Support (Questions regarding Grants.gov registration and Workspace)
Contact Center Telephone: 800-518-4726
Email: [email protected]
Linda Porter, PhD
National Institute for Neurological Disorders and Stroke (NINDS)
Telephone: 301-451-4460
Email: [email protected]
Marlene Peters Lawerence , PhD
National Institute for Neurological Disorders and Stroke (NINDS)
Telephone: 301-480-9636
Email: [email protected]
Laura Elizabeth Kwako
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Phone: 301-451-8507
E-mail: [email protected]
Wendy Weber, N.D., Ph.D., M.P.H.
National Center for Complementary and Integrative Health (NCCIH)
Telephone: 301-402-1272
Email: [email protected]
Karen C. Lee, MD, MPH
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Telephone: 301-827-3973
Email: [email protected]
Devon Oskvig, Ph.D.
National Institute on Aging (NIA)
Phone: (301) 496-9350
E-mail: [email protected]
Center for Scientific Review (CSR)
Email:[email protected]
Shellie Willburn
National Institute of Neurological Disorders and Stroke (NINDS)
Phone: 301.496.9231
E-mail:[email protected]
Judy Fox
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Phone: (301) 443-4704
E-mail: [email protected]
Debbie Chen
National Center for Complementary and Integrative Health (NCCIH)
Phone: 301-594-3788
Email: [email protected]
Margaret Young
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Telephone: 301-642-4552
Email: [email protected]
Jeni Smits
National Institute on Aging (NIA)
Phone: none
E-mail: [email protected]
Recently issued trans-NIH policy notices may affect your application submission. A full list of policy notices published by NIH is provided in the NIH Guide for Grants and Contracts. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.
Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and 45 CFR Part 75.
and Human Services (HHS)
