National Institutes of Health (NIH)
National Center for Complementary and Integrative Health (NCCIH)
National Heart, Lung, and Blood Institute (NHLBI)
National Institute on Aging (NIA)
National Institute of Allergy and Infectious Diseases (NIAID)
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
National Institute of Nursing Research (NINR)
National Institute on Minority Health and Health Disparities (NIMHD)
National Cancer Institute (NCI)
All applications to this funding opportunity announcement should fall within the mission of the Institutes/Centers. The following NIH Offices may co-fund applications assigned to those Institutes/Centers.
Division of Program Coordination, Planning and Strategic Initiatives, Office of Disease Prevention (ODP)
Office of Behavioral and Social Sciences Research (OBSSR)
U24 Resource-Related Research Projects – Cooperative Agreements
None
The purpose of this FOA is to solicit applications for continuation of a Coordinating Center to provide national leadership for the NIH Health Care Systems (HCS) Research Collaboratory program. The Coordinating Center will 1) further develop, adapt, and adopt technical and policy guidelines and best practices for the effective conduct of research studies in partnership with health care systems; 2) work collaboratively with each Project team supported through the Collaboratory program, including their partnering HCS, to develop, test, and implement the proposed Projects while providing technical, design, and coordination support; 3) learn and disseminate the best strategies for engaging HCS as research partners to improve health and care delivery, with a particular focus on HCS with less historical involvement in research studies; and 4) learn, develop, and disseminate the best means of conducting pragmatic clinical trials in HCS to improve the scientific community’s ability to perform future pragmatic trials in a variety of healthcare contexts. The Coordinating Center will also serve as the central resource for the activities of the NIH HCS Research Collaboratory.
30 days prior to the 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 |
| Not Applicable | December 15, 2021 | Not Applicable | March 2022 | May 2022 | July 2022 |
All applications are due by 5:00 PM local time of applicant organization. All types of non-AIDS applications allowed for this funding opportunity announcement are due on the listed date(s).
Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date.
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 NIH Health Care Systems Research Collaboratory Program
The overall goal of the NIH Health Care Systems (HCS) Research Collaboratory program is to strengthen the national capacity to implement cost-effective large-scale research studies that engage health care delivery organizations and patients as research partners. The NIH HCS Research Collaboratory Program established a Collaboratory Coordinating Center (CCC) led by Duke University in 2012 (https://rethinkingclinicaltrials.org/) that has been providing national leadership and technical expertise for pragmatic clinical trials. Since 2012, the CCC has facilitated the successful planning and implementation of 21 full-scale Pragmatic Clinical Trials launched in the NIH HCS Research Collaboratory Program and HEAL Initiative PRISM Program.
The aim of the HCS Research Collaboratory program is to provide a framework of implementation methods and best practices that will enable the participation of many health care systems in pragmatic research, not to support a defined health care research network. Health care systems have interest in participating in studies that may potentially impact the care they deliver, including pragmatic clinical trials, longitudinal cohort studies, population-based studies and trials addressing the implementation of new or improved interventions or technologies into care. Research conducted in partnership with health care systems is essential to strengthen the relevance of research results to ‘real world’ health practice. Successful approaches and best practices established through this initiative for research partnerships with health care systems should have a major impact on clinical research in the US.
Although the importance of engaging health care delivery organizations for expanding informative biomedical research programs is clear, many challenges exist, both cultural and practical. Many ethical and regulatory issues must be addressed to perform research in the health care delivery setting. Technical challenges to accessing and aggregating data from health care systems in understandable ways are not trivial. Health care providers’ focus is on providing the best treatment based on current knowledge, whereas research studies have typically focused on studying which treatments work best in a precisely defined population. Research studies have also frequently used endpoints that are not part of the normal evaluation of patients during a routine visit and tested interventions that are impractical in most care delivery settings. Policy issues can arise due to conflicts between the mission of delivering health care and that of generating new knowledge. Education and engagement of providers and patients on the value of research in the care setting are urgently needed. The NIH HCS Research Collaboratory program created a broad framework to tackle some of these major challenges and will continue to further address these issues.
Although 20th century scientific and technological advances have improved the health and well-being of the U.S. population overall, racial and ethnic minorities, socioeconomically disadvantaged, underserved rural and sexual and gender minority populations continue to experience a disproportionate share of many acute or chronic diseases and adverse health outcomes, including the burden related to the recent COVID-19 disease outbreaks caused by the novel coronavirus (SARS-CoV-2) pandemic, and/or other pandemics, epidemics (e.g., dengue fever, zika, chikungunya) or public health emergencies. Several characteristics make addressing health disparities an especially challenging problem. The challenges lie in the interactions of influences at various levels (e.g., individual, interpersonal, family, community, societal), the diversity of the relevant mediators (e.g., exposures, risk and resilience factors), and the multiple interacting mechanisms involved (e.g., biological, behavioral, environmental, sociocultural, and healthcare system).
Pragmatic and implementation trials are needed to address many diseases and conditions that have predominantly impacted underserved patient populations, leading to increases in disease burden and unfavorable disease outcomes. Policies, clinical practice guidelines, tools and interventions require careful assessment within HCS to reduce or eliminate existing health inequities that continue to have negative health outcomes in populations with health disparities. Research is needed to study strategies to most effectively, equitably, and efficiently implement evidence-based interventions, and guidelines, if applicable, to further assess their effectiveness in “real world” settings for populations with health disparities.
Pragmatic and Implementation Trials (supported through other funding announcements) will be selected based both on the importance of the scientific questions and the potential to improve health care within health care delivery organizations. A high priority will be given to projects that address scientific questions to improve the care of populations with health disparities. The NIH anticipates funding numerous additional Pragmatic and Implementation Trials in response to a HCS Collaboratory funding opportunity or investigator-initiated applications to Institute or Center funding opportunities. New Pragmatic and Implementation Trials will utilize a phased award UG3/UH3 mechanism, with a one-year planning (UG3) and an up to four-year implementation (UH3) phase.
During the UG3 phase the Pragmatic and Implementation Trial teams in cooperation with the CCC 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.
A separate RFA will encourage applications for a set of Pragmatic and Implementation Trials that will be launched within the NIH HCS Research Collaboratory.
Collaboratory Coordinating Center Overview
The CCC will continue to provide overall national leadership for the NIH Health Care Systems (HCS) Research Collaboratory program. The Coordinating Center will 1) further develop, adapt, and adopt technical and policy guidelines and best practices for the effective conduct of research studies in partnership with health care systems; 2) work collaboratively with each Pragmatic or Implementation Project team supported through the Collaboratory program, including their partnering health care systems, to develop, test, and implement the proposed Pragmatic Projects while providing technical, design, and coordination support; 3) learn and disseminate the best strategies for engaging health care systems as research partners to improve health and care delivery, with a particular focus on HCS with less historical involvement in research studies; and 4) learn, develop, and disseminate the best means of conducting of pragmatic clinical trials in health care systems to improve the scientific community’s ability to perform future pragmatic trials in a variety of healthcare contexts. The Coordinating Center will also continue to serve as the central resource for the activities of the NIH HCS Research Collaboratory program, coordinating activities and providing administrative support for the Steering Committee and its subcommittees.
As the national leader for the NIH Health Care Systems Research Collaboratory program in cooperation with NIH, the Program Director/Principal Investigator(s) of the CCC 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 Coordinating Center must include individuals with broad experience (as detailed below) and ability to communicate clearly with all relevant stakeholders and work to find common ground.
The Coordinating Center is expected to have significant experience and knowledge in the following areas; .
- Research expertise
- Conduct of multisite research studies with participation by multiple health care delivery organizations, including engagement of systems that do not frequently participate in research
- 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
- Expertise in implementation science frameworks and methodology
- Study design and statistical expertise, particularly in novel study 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
- Extracting information from electronic health records and relevant clinical systems for research; experience with multiple health care systems and EHRs is preferred
- Working collaboratively with 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
- Reusable and sustainable models for incorporation of patient reported outcomes and patient reported assessments in health care EHRs and research study management tools, including electronic transfer of information from devices such as home glucose meters and blood pressure monitors, and use of smart phone or sensor data collection to enhance information available for pragmatic or implementation trials
- Health Disparity Research Expertise
- Pragmatic and implementation trial designs to improve health in populations with health disparities
- Recruiting diverse populations from health care system partners
- Knowledge of equity, diversity, and inclusion approaches and methods to assure that research addresses the health needs of all populations across the lifespan
- Knowledge of the latest regulatory requirements for conduct of research and for use of health care data for research and experience in conducting research that complies with the current and new regulations
- Experience with the ethical issues related to clinical research, clinical care, quality improvement, population health, implementation science, surveillance, and their boundaries
- Development of training materials about how to conduct pragmatic clinical trials and implementation trials for the scientific community.
- Creativity and innovation in solving technical and project challenges that respect and promote participation by all relevant communities
It is expected that the Coordinating Center will engage nationally with others working in similar areas and stay abreast of emerging experience, regulations, and technical advances that impact the ability of research to be conducted in health care settings. This could include NIH funded projects, such as NIA IMPACT Collaboratory, NIH/VA/DoD Pain Management Collaboratory, NIMH Mental Health Research Network, NCI Cancer Moonshot program, NIH HEAL Initiative, IDEA States Clinical Trials Network (ISPCTN), PROMIS and CTSAs; but also other federally and privately funded efforts, including the VA QUERI Program and other programs supported by the Office of the National Coordinator for Health Information Technology (ONC), PCORNet and PCORI.
Specific Objectives of this Coordinating Center
The specific objectives of the Coordinating Center are:
- further develop, adapt, and adopt technical and policy guidelines and best practices for the effective conduct of pragmatic clinical effectiveness and implementation trials in partnership with health care systems;
- work collaboratively with each Pragmatic or Implementation Trial team supported through the Collaboratory program, including their partnering health care systems, to develop, test, and implement the proposed study while providing technical, design, and coordination support;
- learn and disseminate the best strategies for engaging health care systems as research partners to improve health and care delivery, with a particular focus on HCS with less historical involvement in research studies; and
- learn, develop, and disseminate the best means of conducting pragmatic clinical trials in health care systems to improve the scientific community’s ability to perform future pragmatic trials in a variety of healthcare contexts.
This FOA will expand the NIH HCS Research Collaboratory Work Groups and allow the creation of new ones to achieve the collaborative activities of this program. The Work Groups will play a vital role in achieving the goals of the program. Activities to support the above four objectives could include, but are not limited:
- Identifying needs for new resources, best practices, or guidelines to enable pragmatic or implementation trials to be conducted across various health care systems to enable:
- Expanding the types of health care systems involved in research
- Encouraging pragmatic and implementation trials 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
- Updating resources that articulate basic requirements for health systems participation in various types of research (e.g. technical, policy, and workflow practices)
- Updating resources that describe the types of research that can be conducted in partnership with various health care systems
- 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 or refining a framework for the Collaboratory program to advance diversity, equity, and inclusion in pragmatic and implementation trials
- Refining and establishing resource tools to enable input from health care system leadership, patients, family members, providers, researchers, and staff on research questions and study conduct to ensure engagement and trial completion.
- Collaborating with related initiatives to share learnings and contribute to complementary efforts that support the conduct of pragmatic and implementation research with health care systems
- Identifying which resources to enhance or build upon to provide useful short training modules/materials about pragmatic and implementation trials conducted in health care systems; and methods and tools to widely disseminate Collaboratory endorsed policies, practices, and lessons learned. Identifying opportunities to extend the sharing of resources and tools at national conferences and seminars to research disciplines that are less engaged in pragmatic or implementation research.
- Developing training opportunities for cohorts of trainees from the pragmatic and implementation trials
- Refining and updating guidance and best practices about how to implement successful interventions from pragmatic clinical trials into other health care systems, and, when necessary, how to de-implement ineffective or harmful interventions.
- Further developing and updating tools and metrics that can be used to manage and track the quality and efficiencies of pragmatic or implementation trials
- Developing approaches and best practices to facilitate sharing of data and metadata to improve the quality of future secondary analyses of the data.
- Developing guidance for engaging a wide range of health care systems, patients, and clinicians in pragmatic clinical trials to assure that diverse patient populations are engaged in pragmatic or implementation trials.
The exact boundaries of the activities of the Coordinating Center, the Pragmatic and Implementation Trials, and NIH are not possible to predict at this time; and will depend in large part on the capacities and experience of the Pragmatic and Implementation Trial teams selected. The Coordinating Center will need to adapt to the needs of the program under the cooperative agreement structure.
The Coordinating Center will be responsible for facilitating harmonization and sharing of measures, tools, guidance documents, best practices, and approaches within and across Pragmatic and Implementation Trials in this collaborative program.
Administrative Support for HCS Research Collaboratory Program
Administrative activities of the CCC to support the HCS Research Collaboratory program could include but are not limited to:
- provision and maintenance of a public website for communication and sharing of activities, events, and resources of the program
- private collaboration space for the Pragmatic and Implementation Trials during the planning phase of their projects
- organizational and logistical support for facilitating the activities of the HCS Research Collaboratory Core Work Groups and Steering Committee,
- supporting standards and mechanisms for publicly sharing data, resources, phenotype definitions and algorithms, and code developed and utilized in HCS Research Collaboratory Pragmatic and Implementation Trials and by the Coordinating Center
- organizing and supporting the logistics of face to face meetings of the HCS Research Collaboratory Work Groups and Steering Committee in the Bethesda MD area to include a kickoff and one annual meeting for one and half days in the first year of the competing award and annual meetings of similar length in following years.
- organizing and supporting logistics of a face to face or virtual Kickoff Meeting for new Pragmatic or Implementation Trials as they join the HCS Research Collaboratory Program.
HCS Research Collaboratory 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 and with the awardees linked to the CCC resources from other FOAs will be required to accomplish the goals of this program. For a trial to be linked to the CCC resources, the administering NIH IC will be a partner in the HCS Collaboratory Program and the pragmatic or implementation trial application was submitted in response to a HCS Collaboratory RFA, an IC specific FOA, or a parent FOA. The linked trial will be of a pragmatic or implementation study design and conducted within the health care setting.
HCS Research Collaboratory Core Work Groups will be expanded and if needed new ones established or discontinued as the core collaborative activity of this program. 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 be established to cover the following topic areas: Ethics/Regulatory; Biostatistics and Study Design; Phenotype, Data Standards and Data Quality; Patient-Reported Outcomes; Healthcare Systems Interactions; Electronic Health Records; Stakeholder Engagement, particularly for populations with health disparities; and Implementation Science. One core work group could cover more than one topic area or topics that are cross-cutting could be woven through multiple Core Work Groups. Core Work Groups will be open to participation by individuals from all funded Pragmatic Studies, the Coordinating Center, and the NIH program staff representatives. Workgroups should capture solutions and disseminate their findings via appropriate means such as peer reviewed publications, the Living Textbook, or white papers.
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 HCS Research Collaboratory, 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 the Pragmatic or Implementation Trials, one representative from each Core Work Group, 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 vote of NIH membership may never exceed 1/3 of the total committee membership.
HCS Research Collaboratory Program Resources, Data, and Software Sharing
The HCS Research Collaboratory program encourages sharing of resources with broad availability of policies, practices, materials, and tools to facilitate collaboration, reuse, and replication. In addition, the HCS Research Collaboratory program encourages sharing of study data from Pragmatic Studies in a timely manner with appropriate privacy and confidentiality protections to facilitate further research, reuse of data, and replication. Thus, the HCS Research Collaboratory program expects grantees to implement a Resources and Data Sharing Plan consistent with these program goals.
In addition, the HCS Research Collaboratory program encourages sharing of software and code that are developed or modified to accomplish aims of this program. This may include, but is not limited to, software, tools, or code sets for extraction or definition of data from EHRs, clinical systems, and other health care data systems; implementation of new workflows for research studies; analytic and analysis programs; and tools for incorporation of patient input. The goals of software sharing under this program include 1) broad availability to biomedical researchers, health care delivery organizations, research institutions, and government health care systems and researchers; 2) terms that permit the dissemination and commercialization of enhanced or customized versions of the software, or incorporation of the software or components of it into other software packages; and 3) terms of software availability that include the ability of individuals outside the applicant institution and its collaborating organizations to modify the source code and to share modifications with others. 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 Pragmatic Studies, thus, grantees and their sub-contractors are expected to implement software sharing plans consistent with the goals of this program.
Coordinating Center Director Effort
The HCS Research Collaboratory Coordinating Center Director is the person(s) responsible for the overall management of the Coordinating Center and coordination with each of the Pragmatic Studies. The relationship between the Coordinating Center and the Pragmatic and 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 30% effort (3.6 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.
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Issuing IC and partner components intend to commit estimated total costs of a minimum of $1,525,000 and up to a maximum of $3,000,000 to fund one award.
Award budget of $1,525,000 total costs per year. The budget may increase to a maximum budget of up to $3,000,000 if additional trials are linked to the resources of the coordinating center, with an increase of $100,000 total costs for each extra trial an Institute or Center supports.
The maximum project period is 6 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
The eligibility to apply to this FOA is limited to the Renewal of the current Coordinating Center for the Health Care Systems Research Collaboratory (U24), which was supported under RFA-RM-16-018. This limited competition will allow consortium agreement(s) to bring in needed expertise and continue support for another wave of trials.
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.
- Dun and Bradstreet Universal Numbering System (DUNS) - All registrations require that applicants be issued a DUNS number. After obtaining a DUNS number, applicants can begin both SAM and eRA Commons registrations. The same DUNS number must be used for all registrations, as well as on the grant application.
- System for Award Management (SAM) – Applicants must complete and maintain an active registration, which requires renewal at least annually. The renewal process may require as much time as the initial registration. SAM registration includes the assignment of a Commercial and Government Entity (CAGE) Code for domestic organizations which have not already been assigned a CAGE Code.
- 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.
- eRA Commons - Applicants must have an active DUNS number to register in eRA Commons. Organizations can register with the eRA Commons as they are working through their SAM or Grants.gov registration, but all registrations must be in place by time of submission. eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to submit an application.
- Grants.gov – Applicants must have an active DUNS number and SAM registration in order to complete the Grants.gov registration.
Program Directors/Principal Investigators (PD(s)/PI(s))
All PD(s)/PI(s) must have an eRA Commons account. PD(s)/PI(s) should work with their organizational officials to either create a new account or to affiliate their existing account with the applicant organization in eRA Commons. If the PD/PI is also the organizational Signing Official, they must have two distinct eRA Commons accounts, one for each role. Obtaining an eRA Commons account can take up to 2 weeks.
Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with his/her organization to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support.
For institutions/organizations proposing multiple PDs/PIs, visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the SF424 (R&R) Application Guide.
2. Cost Sharing
This FOA does not require cost sharing as defined in the NIH Grants Policy Statement.
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:
Martina Schmidt, Ph.D.
Telephone: 301-594-3456
Email: schmidma@mail.nih.gov
Page Limitations
All page limitations described in the SF424 Application Guide and the Table of Page Limits must be followed.
For this specific FOA, the Research Strategy section is limited to 30 pages.
Instructions for Application Submission
The following section supplements the instructions found in the SF424 (R&R) Application Guide and should be used for preparing an application to this FOA.
SF424(R&R) Cover
All instructions in the SF424 (R&R) Application Guide must be followed.
SF424(R&R) Project/Performance Site Locations
All instructions in the SF424 (R&R) Application Guide must be followed.
SF424(R&R) Other Project Information
All instructions in the SF424 (R&R) Application Guide must be followed.
SF424(R&R) Senior/Key Person Profile
All instructions in the SF424 (R&R) Application Guide must be followed.
R&R Budget
All instructions in the SF424 (R&R) Application Guide must be followed.
The applicant must include funds for the Coordinating Center PD/PI and key personnel to attend two one and half days HCS Research Collaboratory program meetings in the first year and an annual meeting in subsequent years in the Bethesda MD area.
The Coordinating Center Director (or team of multiple PD/PIs) must devote at least 3.6 person months effort collectively to this program. The HCS Research Collaboratory Coordinating Center Director is the person responsible for the overall management of the Coordinating Center and coordination with each of the projects.
The budget should include funds for planning and hosting the face to face meetings of the Work Groups, Steering Committee, and any subcommittees. Two one and a half day meetings of the Steering Committee should be planned in the first and second year of the renewal award and an annual Steering Committee meeting in subsequent years.
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 partnering Institutes/Centers/Offices. The initial award will provide Coordinating Center support for a lower number of pragmatic and implementation trials and additional trials will be added in the out-years. The budget should describe how the minimum budget will be used to provide the base funding of the HCS Collaboratory program. As additional trials are added to the program the budget will increase at an amount of $100,000 total costs per year for each trial above the IC base number of trial support. The budget section should justify why additional resources are needed to increase the support for additional pragmatic and implementation trials (e.g., expansion of core work groups, increased staff requirements, onboarding costs for new trials, monitoring of recruitment and retention). Thus, the total budget will be determined by the number of trials linked to the CCC resources.
Budget should include funds to provide 3-4 virtual webinars or workshops per year for extramural researchers at NIH Institutes or Centers program partners. These training sessions will provide overview of embedded pragmatic trials and implementation trials to aid participants in identifying research questions appropriate for this design and developing an NIH application.
R&R Subaward Budget
All instructions in the SF424 (R&R) Application Guide must be followed.
PHS 398 Cover Page Supplement
All instructions in the SF424 (R&R) Application Guide must be followed.
PHS 398 Research Plan
All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions:
Research Strategy: 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 Harmonisation (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 Collaboratory Coordinating Center will be interacting with teams of Projects, the partner HCS and the NIH in this effort in working to develop and implement methods for projects across different HCS.
- The application must describe how the previous period of funding was used to meet the program objectives and provide a proposed plan for each specific objective and administrative support for the continuation of the HCS Research Collaboratory program.
- The application must provide information regarding the Coordinating Center activities, its staffing and the interactions with the Projects as they plan and implement the pragmatic clinical trials.
- The Coordinating Center will have five to seven Work Groups that will work with the Projects to assist with optimizing the design and conduct; 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 Projects; work with the 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.
- Applicants should describe processes through which the resources developed by the CCC will be made available to the community after the Common Fund period of support ends. The Health Care Systems Collaboratory Program is designed to establish best practices and resources to facilitate the establishment of pragmatic trials. Although centralized coordination will facilitate this process for the duration of this award, long term support for a central coordinating effort may or may not be required for future pragmatic trials. The software, hardware, licenses, standard operating procedures, best practices and other resources for pragmatic trial planning and management that will be developed through Common Fund support must be available to the community regardless of whether a centralized coordinating effort continues. Applications should describe plans to disseminate knowledge and expertise for pragmatic 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 FOAs for pragmatic or implementation trials and with the NIH in the development and design of research approaches, methods, processes, policies, and tools used in this program. Applicants should describe their prior experience working collaboratively in research consortia and other collaborative projects to accomplish shared goals.
Coordinating Center Transition Plan: Although centralized coordination will be available for the duration of this award, long term support for a central coordinating effort may or may not be required for future pragmatic and implementation trials. Applicants should address how the software, hardware, licenses, standard operating procedures, best practices and other resources for pragmatic trial planning and management that were developed through Common Fund support will be made available to the community regardless of whether a centralized coordinating effort continues. Applicants should describe processes through which these resources will be made available to the community.
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, should address a Data Sharing Plan.
The HCS Research Collaboratory program encourages sharing of resources with broad availability of policies, practices, materials, and tools to facilitate collaboration, reuse, and replication. In addition, the HCS Research Collaboratory program encourages sharing of study data from Projects in a timely manner with appropriate privacy and confidentiality protections to facilitate further research, reuse of data, and replication. Thus the HCS Research Collaboratory program expects grantees to address a Data a Sharing Plan consistent with achieving these program goals.
Appendix:
Only limited Appendix materials are allowed. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.
- No publications or other material, with the exception of blank questionnaires or blank surveys, may be included in the Appendix.
PHS Human Subjects and Clinical Trials Information
When involving human subjects research, clinical research, and/or NIH-defined clinical trials (and when applicable, clinical trials research experience) follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the SF424 (R&R) Application Guide, with the following additional instructions:
If you answered “Yes” to the question “Are Human Subjects Involved?” on the R&R Other Project Information form, you must include at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or Delayed Onset Study record.
Study Record: PHS Human Subjects and Clinical Trials Information
All instructions in the SF424 (R&R) Application Guide must be followed.
Delayed Onset Study
Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start).All instructions in the SF424 (R&R) Application Guide must be followed.
PHS Assignment Request Form
All instructions in the SF424 (R&R) Application Guide must be followed.
3. Unique Entity Identifier and System for Award Management (SAM)
See Part 1. Section III.1 for information regarding the requirement for obtaining a unique entity identifier and for completing and maintaining active registrations in System for Award Management (SAM), NATO Commercial and Government Entity (NCAGE) Code (if applicable), eRA Commons, and Grants.gov
4. Submission Dates and Times
Part I. Overview Information contains information about Key Dates and times. Applicants are encouraged to submit applications before the due date to ensure they have time to make any application corrections that might be necessary for successful submission. When a submission date falls on a weekend or Federal holiday, the application deadline is automatically extended to the next business day.
Organizations must submit applications to Grants.gov (the online portal to find and apply for grants across all Federal agencies). Applicants must then complete the submission process by tracking the status of the application in the eRA Commons, NIH’s electronic system for grants administration. NIH and Grants.gov systems check the application against many of the application instructions upon submission. Errors must be corrected and a changed/corrected application must be submitted to Grants.gov on or before the application due date and time. If a Changed/Corrected application is submitted after the deadline, the application will be considered late. Applications that miss the due date and time are subjected to the NIH Policy on Late Application Submission.
Applicants are responsible for viewing their application before the due date in the eRA Commons to ensure accurate and successful submission.
Information on the submission process and a definition of on-time submission are provided in the SF424 (R&R) Application Guide.
5. Intergovernmental Review (E.O. 12372)
This initiative is not subject to intergovernmental review.
6. Funding Restrictions
All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.
Pre-award costs are allowable only as described in the NIH Grants Policy Statement.
7. Other Submission Requirements and Information
Applications must be submitted electronically following the instructions described in the SF424 (R&R) Application Guide. Paper applications will not be accepted.
Applicants must complete all required registrations before the application due date. Section III. Eligibility Information contains information about registration.
For assistance with your electronic application or for more information on the electronic submission process, visit How to Apply – Application Guide. If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Dealing with System Issues guidance. For assistance with application submission, contact the Application Submission Contacts in Section VII.
Important reminders:
All PD(s)/PI(s) must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile Component of the SF424(R&R) Application Package. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to NIH. See Section III of this FOA for information on registration requirements.
The applicant organization must ensure that the DUNS number it provides on the application is the same number used in the organization’s profile in the eRA Commons and for the System for Award Management. Additional information may be found in the SF424 (R&R) Application Guide.
See more tips for avoiding common errors.
Upon receipt, applications will be evaluated for completeness and compliance with application instructions by the Center for Scientific Review . Applications that are incomplete, non-compliant and/or nonresponsive will not be reviewed.
In order to expedite review, applicants are requested to notify the NCCIH Referral Office by email at schmidma@mail.nih.gov when the application has been submitted. Please include the FOA number and title, PD/PI name, and title of the application.
Post Submission Materials
Applicants are required to follow the instructions for post-submission materials, as described in the policy. Any instructions provided here are in addition to the instructions in the policy.
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).
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 the prior research that serves as the key support for the proposed project rigorous? If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?
Specific to this FOA:
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?
Are the PD(s)/PI(s), collaborators, and other researchers well suited to the project? If Early Stage Investigators or those in the early stages of independent careers, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the project is collaborative or multi-PD/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project?
Specific to this FOA:
Do the personnel have the appropriate breadth of expertise and experience, 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 research studies, and experience in collaborative research with a variety of stakeholders? Are the proposed leadership approach, staffing, governance and organizational structure appropriate for the project? Do the investigators have experience the changing landscape of health care systems research and participant protection regulations?
:
Does the application challenge and seek to shift current research or clinical practice paradigms, national policies and practices, and enlarge participation in clinical research by utilizing novel theoretical concepts, approaches, methodologies, interventions, or tools? Does the application challenge and seek to impact current data management and research implementation strategies by utilizing novel theoretical concepts, approaches or methodologies, or tools? Is a refinement, improvement, or new application of approaches, concepts, or tools 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 included plans to address weaknesses in the rigor of prior research that serves as the key support for the proposed project? Have the investigators presented strategies to ensure a robust and unbiased approach, as appropriate for the work proposed? Are potential problems, alternative strategies, and benchmarks for success presented? If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed? Have the investigators presented adequate plans to address relevant biological variables, such as sex, for studies in vertebrate animals or human subjects?
If the project involves human subjects and/or NIH-defined clinical research, are the plans to address 1) the protection of human subjects from research risks, and 2) inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion or exclusion of individuals of all ages (including children and older adults), justified in terms of the scientific goals and research strategy proposed?
Specific to this FOA:
Will the proposed activities facilitate flexible, modular, and scalable policies, practices, algorithms, protocols, and tools to enable broad collaboration and participation? Will the proposed approach allow efficient management upkeep of a public website? Will the proposed approach allow for the Coordinating Center personnel and collaborative tools to enable speedy trialsand will it add to the productivity of the program? Has the applicant provided an appropriate plan for how they will take on the added work of more pragmatic and implementation trials and a justification for additional budget request for these extra activities?
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 categories of research that are exempt under 45 CFR Part 46, the committee will evaluate the justification for involvement of human subjects and the proposed protections from research risk relating to their participation according to the following five review criteria: 1) risk to subjects, 2) adequacy of protection against risks, 3) potential benefits to the subjects and others, 4) importance of the knowledge to be gained, and 5) data and safety monitoring for clinical trials.
For research that involves human subjects and meets the criteria for one or more of the categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials. For additional information on review of the Human Subjects section, please refer to the Guidelines for the Review of Human Subjects.
When the proposed project involves human subjects and/or NIH-defined clinical research, the committee will evaluate the proposed plans for the inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion (or exclusion) of individuals of all ages (including children and older adults) to determine if it is justified in terms of the scientific goals and research strategy proposed. For additional information on review of the Inclusion section, please refer to the Guidelines for the Review of Inclusion in Clinical Research.
The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following criteria: (1) description of proposed procedures involving animals, including species, strains, ages, sex, and total number to be used; (2) justifications for the use of animals versus alternative models and for the appropriateness of the species proposed; (3) interventions to minimize discomfort, distress, pain and injury; and (4) justification for euthanasia method if NOT consistent with the AVMA Guidelines for the Euthanasia of Animals. Reviewers will assess the use of chimpanzees as they would any other application proposing the use of vertebrate animals. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal Section.
Reviewers will assess whether materials or procedures proposed are potentially hazardous to research personnel and/or the environment, and if needed, determine whether adequate protection is proposed.
Not Applicable
For Renewals, the committee will consider the progress made in the last funding period.
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.
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).
Not Applicable
Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable: (1) Data Sharing Plan; (2) Sharing Model Organisms; and (3) Genomic Data Sharing Plan (GDS).
For 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.
2. Review and Selection Process
Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s) convened by NCCIH, in accordance with NIH peer review policy and procedures, using the stated review criteria. Assignment to a Scientific Review Group will be shown in the eRA Commons.
As part of the scientific peer review, all applications will receive a written critique.
Applications may undergo a selection process in which only those applications deemed to have the highest scientific and technical merit (generally the top half of applications under review) will be discussed and assigned an overall impact score.
Appeals of initial peer review will not be accepted for applications submitted in response to this FOA.
Applications will be assigned on the basis of established PHS referral guidelines to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications submitted in response to this FOA. Following initial peer review, recommended applications will receive a second level of review by the 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.6. Funding Restrictions. Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs.
Any application awarded in response to this FOA will be subject to terms and conditions found on the Award Conditions and Information for NIH Grants website. This includes any recent legislation and policy applicable to awards that is highlighted on this website.
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.
Recipients of federal financial assistance (FFA) from HHS must administer their programs in compliance with federal civil rights laws that prohibit discrimination on the basis of race, color, national origin, disability, age and, in some circumstances, religion, conscience, and sex. This includes ensuring programs are accessible to persons with limited English proficiency. The HHS Office for Civil Rights provides guidance on complying with civil rights laws enforced by HHS. Please see https://www.hhs.gov/civil-rights/for-providers/provider-obligations/index.html and http://www.hhs.gov/ocr/civilrights/understanding/section1557/index.html.
HHS recognizes that research projects are often limited in scope for many reasons that are nondiscriminatory, such as the principal investigator’s scientific interest, funding limitations, recruitment requirements, and other considerations. Thus, criteria in research protocols that target or exclude certain populations are warranted where nondiscriminatory justifications establish that such criteria are appropriate with respect to the health or safety of the subjects, the scientific study design, or the purpose of the research. For additional guidance regarding how the provisions apply to NIH grant programs, please contact the Scientific/Research Contact that is identified in Section VII under Agency Contacts of this FOA.
- Recipients of FFA must ensure that their programs are accessible to persons with limited English proficiency. HHS provides 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 https://www.hhs.gov/civil-rights/for-individuals/special-topics/limited-english-proficiency/fact-sheet-guidance/index.html and https://www.lep.gov. 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 https://minorityhealth.hhs.gov/omh/browse.aspx?lvl=2&lvlid=53.
- 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.
- HHS funded health and education programs must be administered in an environment free of sexual harassment. Please see https://www.hhs.gov/civil-rights/for-individuals/sex-discrimination/index.html; https://www2.ed.gov/about/offices/list/ocr/docs/shguide.html; and https://www.eeoc.gov/eeoc/publications/upload/fs-sex.pdf. 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.
- Recipients of FFA must also administer their programs in compliance with applicable federal religious nondiscrimination laws and applicable federal conscience protection and associated anti-discrimination laws. Collectively, these laws prohibit exclusion, adverse treatment, coercion, or other discrimination against persons or entities on the basis of their consciences, religious beliefs, or moral convictions. Please see https://www.hhs.gov/conscience/conscience-protections/index.html and https://www.hhs.gov/conscience/religious-freedom/index.html.
Please contact the HHS Office for Civil Rights for more information about obligations and prohibitions under federal civil rights laws at https://www.hhs.gov/ocr/about-us/contact-us/index.html or call 1-800-368-1019 or TDD 1-800-537-7697.
In accordance with the statutory provisions contained in Section 872 of the Duncan Hunter National Defense Authorization Act of Fiscal Year 2009 (Public Law 110-417), NIH awards will be subject to the Federal Awardee Performance and Integrity Information System (FAPIIS) requirements. FAPIIS requires Federal award making officials to review and consider information about an applicant in the designated integrity and performance system (currently FAPIIS) prior to making an award. An applicant, at its option, may review information in the designated integrity and performance systems accessible through FAPIIS and comment on any information about itself that a Federal agency previously entered and is currently in FAPIIS. The Federal awarding agency will consider any comments by the applicant, in addition to other information in FAPIIS, in making a judgement about the applicant’s integrity, business ethics, and record of performance under Federal awards when completing the review of risk posed by applicants as described in 45 CFR Part 75.205 and 2 CFR Part 200.206 “Federal awarding agency review of risk posed by applicants.” This provision will apply to all NIH grants and cooperative agreements except fellowships.
The following special terms of award are in addition to, and not in lieu of, otherwise applicable U.S. Office of Management and Budget (OMB) administrative guidelines, U.S. Department of Health and Human Services (DHHS) grant administration regulations at 45 CFR 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 setting project milestones, and implementing the project plan for the Coordinating Center
- Cooperating in sharing knowledge and experience with various tools and approaches utilized in conducting research in health care settings, including their strengths and weaknesses
- 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 Project recipients in the development and testing of implementation plans
- Collaborating with other recipients in harmonizing and sharing of tools, methods, and approaches within and between Demonstrating Projects
- 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
- Facilitating comparability across Projects when possible
- Providing integrative, organizational, and logistical support for the entire program, including tracking, scheduling, and facilitating workgroup meetings, committee meetings, and conference calls, preparing concise minutes or summaries of meetings for distribution
- Cooperating with other recipients in the publication and dissemination of program results and the eventual release to the scientific and healthcare communities of methods, tools, results, and other resources
- Providing high-quality documentation as needed, particularly of protocols or approaches that have broad applicability across the program that will be sufficient for outside users to understand and apply to their research projects with minimal assistance
- Providing expertise and leadership in addressing issues of broad applicability, such as informed consent, data sharing standards, analysis methodology, and dissemination
- Sharing resources, data, and software according to the goals for the HCS Research Collaboratory program and approved Plans
- Planning and hosting the face to face meetings of the Work Groups, Steering Committee, and any subcommittees
- Planning for the HCS Research Collaboratory Program External Advisory Panel meetings
- Developing short training modules/materials, methods, and tools to widely disseminate Collaboratory endorsed policies, practices, and lessons learned, to inform best practices for the conduct of pragmatic clinical trials. Including presentation of resources and tools at national conferences and seminars
- Agreeing to accept close coordination, cooperation, and management of the project with NIH, including those outlined under “NIH Responsibilities”
- Submitting periodic progress reports, in a standard format, as agreed upon by the Steering Committee and NIH.
- 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 Coordinator 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 Coordinator.
- The NIH Program Coordinator 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 Coordinator 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 NIH activities that may be relevant to the activities in the HCS Research Collaboratory 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 grantee 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 Director, NCCIH; other participating ICO Directors; and the National Advisory Council for Complementary and Integrative Health
- 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 HCS Research Collaboratory, 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 Projects, one representative from each Work Group, one representative from the Coordinating Center, the NIH Program Coordinator, and representatives from various NIH ICs. All members are expected to actively participate in all Steering Committee activities. The combined vote of NIH membership may never exceed 1/3 of the total committee membership.
- HCS Research Collaboratory Work Groups will be established as the core collaborative activity of this program. 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 be established to cover the following topic areas (one workgroup could cover more than one topic area): Ethics/Regulatory; Biostatistics and Study Design; Phenotype, Data Standards and Data Quality; Patient-Reported Outcomes; Healthcare Systems Interaction; Electronic Health Records; and Stakeholder Engagement. Work Groups will be open to participation by individuals from all funded Projects, the Coordinating Center, and the NIH.
- Establishment and adherence by each Project Team (Project grantee, Coordinating Center grantee, and NIH staff) to a written plan of engagement with timelines to ensure delineation of roles and timely delivery of the tested implementation plan
- Project grantees will work with the Coordinating Center and NIH, through all phases of their projects, including the trial conduct and closeout phase, to assure all resources, materials, protocols, data, best practices, and lessons learned, as well as software or sets of code, are disseminated broadly through the Coordinating Center with all HCS Research Collaboratory program resources
- All recipients and NIH will cooperate to ensure the timely and broad dissemination of all HCS Research Collaboratory program endorsed policies and practices and lessons learned in the program to inform researchers and health care systems engaged in research in health care settings
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 the threshold. See the NIH Grants Policy Statement for additional information on this reporting requirement.
In accordance with the regulatory requirements provided at 45 CFR 75.113 and 2 CFR Part 200.113 and Appendix XII to 45 CFR Part 75 and 2 CFR Part 200, recipients that have currently active Federal grants, cooperative agreements, and procurement contracts from all Federal awarding agencies with a cumulative total value greater than $10,000,000 for any period of time during the period of performance of a Federal award, must report and maintain the currency of information reported in the System for Award Management (SAM) about civil, criminal, and administrative proceedings in connection with the award or performance of a Federal award that reached final disposition within the most recent five-year period. The recipient must also make semiannual disclosures regarding such proceedings. Proceedings information will be made publicly available in the designated integrity and performance system (currently FAPIIS). This is a statutory requirement under section 872 of Public Law 110-417, as amended (41 U.S.C. 2313). As required by section 3010 of Public Law 111-212, all information posted in the designated integrity and performance system on or after April 15, 2011, except past performance reviews required for Federal procurement contracts, will be publicly available. Full reporting requirements and procedures are found in Appendix XII to 45 CFR Part 75 and 2 CFR Part 200 – Award Term and Condition for Recipient Integrity and Performance Matters.
We encourage inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants.
eRA Service Desk (Questions regarding ASSIST, eRA Commons, application errors and warnings, documenting system problems that threaten submission by the due date, and post-submission issues)
Finding Help Online: http://grants.nih.gov/support/ (preferred method of contact)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)
General Grants Information (Questions regarding application instructions, application processes, and NIH grant resources)
Email: GrantsInfo@nih.gov (preferred method of contact)
Telephone: 301-945-7573
Grants.gov Customer Support (Questions regarding Grants.gov registration and Workspace)
Contact Center Telephone: 800-518-4726
Email: support@grants.gov
Wendy Weber, N.D., Ph.D., M.P.H.
National Center for Complementary and Integrative Health (NCCIH)
Telephone: 301-402-1272
Email: weberwj@mail.nih.gov
David A Chambers
National Cancer Institute (NCI)
Phone: 240-276-5090
E-mail: none
National Institute of Nursing Research (NINR)
Telephone: 301-594-6152
Email: jmiller@mail.nih.gov
Charles H Washabaugh, PhD
National Institute Of Arthritis And Musculoskeletal And Skin Diseases (NIAMS)
Phone: 301-496-9568
E-mail: washabac@mail.nih.gov
Office of Disease Prevention (ODP)
Telephone: 301-827-5578
Email: Elizabeth.Neilson@nih.gov
Clayton Huntley, Ph.D.
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone: 240-627-3279
Email: chuntley@niaid.nih.gov
Lawrence J Fine
National Heart, Lung, And Blood Institute (NHLBI)
Phone: 301-435-0305
E-mail: Lawrence.Fine@NIH.gov
National Institute on Aging (NIA)
Phone: 301-496-6761
Email: marcel.salive@nih.gov
Larissa Aviles-Santa, MD, MPH
National Institute on Minority Health and Health Disparities (NIMHD)
Phone: 301-827-6924
E-mail: avilessantal@mail.nih.gov
Martina Schmidt, Ph.D.
National Center for Complementary and Integrative Health (NCCIH)
Telephone: 301-594-3456
Email: schmidma@mail.nih.gov
Shelley Headley
National Center for Complementary and Integrative Health (NCCIH)
Telephone: 301-594-3788
Email: shelley.headley@nih.gov
Crystal Wolfrey
National Cancer Institute (NCI)
Phone: (240) 276-6277
E-mail: none
Erik Edgerton
National Institute Of Arthritis And Musculoskeletal And Skin Diseases (NIAMS)
Phone: 301-594-7760
E-mail: erik.edgerton@nih.gov
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone: (301) 435-2860
Email: paula.acevedo@nih.gov
Lesa McQueen
National Institute on Aging (NIA)
Phone: 301-496-1472
Email: mcqueenl@mail.nih.gov
Priscilla Grant, JD
National Institute on Minority Health and Health Disparities (NIMHD)
Phone: 301-594-8412
E-mail: pg38h@nih.gov
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