Department of Health and Human Services
Part 1. Overview Information
Participating Organization(s)

National Institutes of Health (NIH)

Components of Participating Organizations

This Funding Opportunity Announcement (FOA) is developed as a Common Fund initiative (http://commonfund.nih.gov/) through the NIH Office of the NIH Director, Office of Strategic Coordination (https://dpcpsi.nih.gov/).  The FOA will be administered on behalf of the NIH by one of the following Institutes, Centers, or Offices:

National Heart, Lung, and Blood Institute (NHLBI)
National Institute on Aging (NIA)
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
National Institute of Dental and Craniofacial Research (NIDCR)
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
National Institute on Drug Abuse (NIDA)
National Institute of Neurological Disorders and Stroke (NINDS)
National Institute of Nursing Research (NINR)
National Center for Complementary and Integrative Health (NCCIH)
Division of Program Coordination, Planning and Strategic Initiatives, Office of Disease Prevention (ODP)
Division of Program Coordination, Planning and Strategic Initiatives, Office of Strategic Coordination (Common Fund)

Funding Opportunity Title

NIH Health Care Systems Research Collaboratory - Demonstration Projects for Pragmatic Clinical Trials (UG3/UH3)

Activity Code

UG3/UH3 Exploratory/Developmental Phased Award Cooperative Agreement

Announcement Type

New

Related Notices
Funding Opportunity Announcement (FOA) Number

RFA-RM-16-019

Companion Funding Opportunity

RFA-RM-16-018, U24 Resource-Related Research Projects – Cooperative Agreements

Catalog of Federal Domestic Assistance (CFDA) Number(s)

93.310, 93.866, 93.279, 93.121, 93.840, 93.233, 93.839, 93.838, 93.837, 93.853, 93.846, 93.865, 93.847, 93.213, 93.361   

Funding Opportunity Purpose

The purpose of this FOA is to solicit applications to support Demonstration Projects that include an efficient, large-scale pragmatic clinical trial. Trials must be conducted across two or more health care systems (HCS) and must be conducted as part of the NIH HCS Research Collaboratory supported through the NIH Common Fund. (See https://commonfund.nih.gov/hcscollaboratory). Awards made through this FOA will initially support a one-year milestone-driven planning phase (UG3), with possible rapid transition to the second implementation phase (UH3) for a pragmatic trial Demonstration Project. UH3s will be awarded after administrative review of eligible UG3s that have met the scientific milestone and feasibility requirements necessary for the UH3 implementation phase, depending on the availability of funds. The UG3/UH3 application must be submitted as a single application, and applicants should note specific instructions for each phase in this FOA. 

The overall goal of the NIH HCS Research Collaboratory program is to strengthen the national capacity to implement cost-effective, large-scale research studies that engage health care delivery organizations as research partners. The NIH HCS Research Collaboratory Program has established a Collaboratory Coordinating Center (CCC) that is providing national leadership and technical expertise in all aspects of research with HCS.  After awards are made by NIH, the CCC (https://www.nihcollaboratory.org/Pages/default.aspx) and the NIH will work with successful awardees from this FOA to facilitate the planning and rapid execution of high impact Demonstration Projects that conduct research studies in partnerships with health care delivery systems, ultimately making available data, tools and resources from Collaboratory research projects to develop a broadened base of research partnerships with HCS.

Key Dates
Posted Date

November 23, 2016

Open Date (Earliest Submission Date)

May 2, 2017

Letter of Intent Due Date(s)

30 days prior to the application due date

Application Due Date(s)

June 2, 2017, by 5:00 PM local time of applicant organization. All types of non-AIDS applications allowed for this funding opportunity announcement are due on this date.

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

AIDS Application Due Date(s)

June 2, 2017, by 5:00 PM local time of applicant organization. All types of AIDS and AIDS-related applications allowed for this funding opportunity announcement are due on this date.

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

Scientific Merit Review

October-November 2017

Advisory Council Review

January 2018

Earliest Start Date

March 2018

Expiration Date

June 3, 2017

Due Dates for E.O. 12372

Not Applicable

Required Application Instructions

It is critical that applicants follow the Research (R) Instructions in the SF424 (R&R) Application Guide, except where instructed to do otherwise (in this FOA or in a Notice from the NIH Guide for Grants and Contracts). Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions. Applications that do not comply with these instructions may be delayed or not accepted for review.


Table of Contents

Part 1. Overview Information
Part 2. Full Text of the Announcement

Section I. Funding Opportunity Description
Section II. Award Information
Section III. Eligibility Information
Section IV. Application and Submission Information
Section V. Application Review Information
Section VI. Award Administration Information
Section VII. Agency Contacts
Section VIII. Other Information

Part 2. Full Text of Announcement
Section I. Funding Opportunity Description

The overall goal of the NIH Common Fund 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://www.nihcollaboratory.org/Pages/default.aspx) that is providing national leadership and technical expertise.  Since 2012, the CCC has facilitated the successful planning and implementation of nine full-scale Demonstration Project Pragmatic Clinical Trials supported by a previous FOA (http://grants.nih.gov/grants/guide/rfa-files/RFA-RM-12-002.html and  http://grants.nih.gov/grants/guide/rfa-files/RFA-RM-13-012.html).  Similarly, successful awardees from this FOA will work with the NIH and CCC for both the planning and implementation of their Demonstration Project pragmatic clinical trial.  All Demonstration Projects must conduct research studies in partnership with health care delivery systems, and work with the NIH and the CCC to ultimately make available data, tools, resources and lessons learned from Collaboratory research projects to facilitate a broadened base of research partnerships with HCS.

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 HCS in pragmatic research, not to support a defined health care research network. Demonstration Projects will be expected to provide innovative approaches to address and overcome important barriers to research in the setting of HCS partnerships. HCS have interest in participating in studies that may potentially impact the care they deliver, including pragmatic clinical trials (http://www.bmj.com/content/350/bmj.h2147), longitudinal cohort studies, population-based studies and studies addressing the incorporation of new technologies into care. Research conducted in partnership with HCS 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. (See http://commonfund.nih.gov/hcscollaboratory/).

The increased adoption of health information technology tools is not only changing how care is delivered but also providing opportunities for expanded participation of health care delivery organizations in research. Equally, the potential to conduct research studies in real world settings on large numbers of participants allows questions to be addressed that researchers could not feasibly address with paper records. In the last two decades, health care delivery organizations have played valuable roles in a number of research projects and health surveillance activities funded by NIH institutes and centers (ICs) and by other U.S. Department of Health and Human Services agencies including the Agency for Healthcare Research and Quality, the Centers for Disease Control and Prevention, and the Food and Drug Administration, as well as the Veterans Health Administration. However, although most scientific work has utilized health data, until recently, many studies have not required active engagement of patients or their practitioners as research partners.

Although the importance for biomedical research and strengthened partnerships with organizations that deliver health care 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 quality-controlled data from health care systems in understandable ways are not trivial. Research studies frequently use endpoints that are not part of the normal evaluation of patients during a routine visit or monitor the fidelity of intervention delivery in ways that are difficult in most care delivery settings, which may limit external validity. Education and engagement of providers and patients on the value of research in the care setting, and of researchers on the relevance of their work to health systems, are urgently needed for optimizing the care in all people. The NIH HCS Research Collaboratory program has created a broad framework to tackle some of these major challenges, and has launched nine full-scale Demonstration Projects in a variety of clinical settings to develop methods and best practices for future pragmatic trials (https://www.nihcollaboratory.org/Pages/default.aspx). 

The purpose of this FOA is to solicit applications for UG3/UH3 cooperative agreements to support Demonstration Projects that include an efficient, large-scale pragmatic clinical trial, to be conducted as part of the NIH HCS Research Collaboratory. We define pragmatic trials as trials “primarily designed to determine the effects of an intervention under the usual conditions in which it will be applied”, which is in contrast with explanatory trials that “are primarily designed to determine the effects of an intervention under ideal circumstances” (http://www.bmj.com/content/350/bmj.h2147). The Collaboratory is well-suited to measuring both the negative and positive health impacts, as well as resource implications, of treatments delivered in real world settings. The Collaboratory is also well-suited for testing how readily practice guidelines can be implemented in HCS, and for assessing outcomes of implementation across a broad range of patient sub-groups.  The Collaboratory could also leverage existing efforts, such as those of the US Preventive Services Task Force (http://www.uspreventiveservicestaskforce.org/BrowseRec/Index/browse-recommendations), for generating evidence regarding screenings, counseling services and preventive medications to improve the health of Americans. 

The CCC and NIH have worked with previously awarded Collaboratory Pragmatic Clinical Trial Demonstration Projects to 1) develop, adapt, and adopt technical guidelines and best practices for the effective conduct of research studies in partnership with health care systems; 2) work collaboratively with each Demonstration Project team, including their partnering HCS, to develop and test an implementation plan for the proposed Demonstration Projects while providing technical, design, and coordination guidance; and 3) disseminate widely Collaboratory endorsed policies, practices and lessons learned in the Demonstration Projects to inform best practices for broad participation of HCS and their patients, practitioners, and staff in research studies to improve health and care delivery. The CCC also serves as the central resource for the activities of the HCS Research Collaboratory program, including providing administrative support for the Steering Committee and its Work Groups and subcommittees. This FOA will leverage these resources and experiences of the Collaboratory program to facilitate planning and implementation of Demonstration Projects supported by this FOA.

HCS Research Collaboratory Work Groups have been established by the CCC and the NIH as the core collaborative activity of this program. The Work Groups 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 have been established in the following areas: Electronic Health Records, Regulatory /Ethics, Biostatistics & Study Design, Health Provider-Systems Interactions, Stakeholder Engagement, Phenotype & Data Standards, and Patient Reported Outcomes (https://www.nihcollaboratory.org/cores/Pages/default.aspx). Additional Work Groups may be identified as the HCS Research Collaboratory expands with new projects. Work Groups are open to participation by individuals from all funded Demonstration Projects, the CCC, and the NIH.

During the UG3 phase the Demonstration Project team, in cooperation with the CCC and NIH, will develop detailed plans for site implementation, determine resource needs, test data extraction methods for patient identification and outcome assessment, and develop plans for all aspects of ethical and regulatory oversight and protection of human subjects (e.g., collect feasibility or pilot data). The CCC and Collaboratory Work Groups will provide pragmatic trial expertise and guidance to help finalize plans for implementation for the UG3 phase of these awards, which will generally be one year in duration. All projects will be milestone-driven, and all planning grants will need to meet all milestones to have an opportunity to move to the implementation phase (UH3), if sufficient funds are available.

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 requires sharing of study data from Demonstration Projects in a timely manner with appropriate privacy and confidentiality protections, in accordance with the Data Sharing Policy developed by the HCS Research Collaboratory Steering Committee (https://www.nihcollaboratory.org/Pages/KnowledgeRepositoryTabs.aspx?Paged=TRUE&p_SortBehavior=0&p_Created=20140715%2016%3a32%3a51&p_ID=71&PageFirstRow=61&&View={F028E1AA-0D11-4E13-BC09-CE77694521B8}). Thus the HCS Research Collaboratory program requires awardees to implement a Resources and Data Sharing Plan consistent with achieving these program goals.  In addition, the HCS Research Collaboratory program requires sharing of software and code that are developed or modified to accomplish aims of this program, if sharing of this information will be useful to the scientific community to more efficiently conduct pragmatic trials in the future. This may include, but is not limited to, software, tools, or code sets for extraction or definition of data from electronic health records, 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 (such as the NIH PROMIS tool, http://www.nihpromis.org). 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, thus, awardees and their sub-contractors are expected to implement a Software Sharing Plan consistent with achieving the goals of this program.

Research Objectives

This FOA solicits applications for UG3/UH3 Phased Innovation cooperative agreements for Demonstration Projects for large-scale pragmatic trials to be implemented through HCS. The design of the proposed pragmatic trial should maximize external validity of the study, by testing generalizability, feasibility and sustainability of findings across distinct health care settings, and diverse staff and patient populations.

The proposed pragmatic trials must meet the following criteria:

  • The pragmatic trial must test an intervention, or coordinate several interventions (which can be treatments, preventive actions, or organizational changes) that are robust, apply broadly to patient populations and are suitable for use in multiple health systems, with the broad goal of determining whether the intervention(s) improves health outcomes, and adds value to the utilization of the nation’s health care resources.
  • The question must be of public health importance.
  • The intervention(s) must be well-characterized and available such that it could be reliably delivered by clinical providers and/or HCS. If an intervention includes a drug, biologic or device, it must be a legally-marketed drug, biologic or medical device in the US, and used as approved/cleared for use by the Food and Drug Administration.
  • The intervention(s) must be reasonably simple and not require a complex structure for implementation or monitoring. System level interventions may be particularly suitable.
  • As in routine practice, the pragmatic trial must allow for interventions to be implemented with maximal flexibility and by all appropriate practitioners (not just those with high levels of training or competence).
  • The trial must leverage opportunities made available by the nature of integrated health care systems, and use of outcomes that can be captured by passive follow-up by electronic health records, and with minimal need for adjudication.
  • The trial outcome measure(s) must be clinically meaningful and important to stakeholders including patients and policy makers. Additional outcome measures such as use of health care services and other resources may be included. Outcome measures must provide useful information to medical decision makers, whether patients, care providers, health care systems or payers.
  • The trial design must incorporate rigorous controls, prospectively identified, preferably by randomization. The design may incorporate novel randomization approaches, such as by cluster or timing of implementation. If another method is used to generate the comparison group, perhaps by staged assignment or staged implementation of the intervention, it should provide comparable rigor.
  • Proposed analytic plans for projects that proposed cluster-randomized trials must address adequacy of sample size and study power, and employ analytic strategies relevant for such pragmatic trial designs.  Applicants are strongly encouraged to consult Collaboratory Biostatistical Guidance documents (http://sites.duke.edu/rethinkingclinicaltrials/biostatistical-guidance-documents/) when developing pragmatic trial analytic plans.
  • The study must address, and potentially overcome, important barriers to research in the setting of HCS partnerships.
  • The trial must enroll patients based on broad eligibility criteria to maximize diversity, and minimize intentional or unintentional exclusions based on risk, age, health literacy, demographics, or expected adherence.

Partnerships with health care delivery organizations will be critical in implementing this work. It is anticipated that the Demonstration Projects will generally 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, which may include inpatient, outpatient, imaging, clinical laboratory, pharmacy and community data. Applicants, who may be from academic institutions or other organizations, must demonstrate experience in successful conduct of clinical research in partnerships with HCS. In general, applicants must identify at least three HCS as partners for the proposed Demonstration Project. If an applicant identifies less than three HCS as partners for the proposed Demonstration Project, they must provide a strong scientific rationale for limiting this aspect of the project and address generalizability and adequacy of sampling for the Project. 

These projects will be funded as phased awards with a one-year planning phase (UG3) and a two to four year implementation phase (UH3). Activities in both phases will depend on the specific study (e.g. disease domains, type of interventions, experimental design, randomization strategy and proposed outcome measures).

During the UG3 or planning phase activities will generally include, but are not limited to:

  • Identify project staff that will participate in the Collaboratory Work Groups (see Section I.5 Additional Information https://www.nihcollaboratory.org/cores/Pages/default.aspx), which will develop guidelines and practices to be implemented across Collaboratory projects.
  • Work with the Collaboratory to implement approved guidelines and practices for electronic data extraction and quality control methods and tools, as well as for electronic data sharing. In the planning phase, this will include developing and validating all electronic data methods and tools within the HCS needed for the Demonstration Project (e.g. electronic health records, electronic methods for patient identification and outcomes assessment, patient reported data, biospecimens, images, high-throughput genomic data, family history data, data abstraction and survey instruments) and complete quality control testing at all sites. 
  • Assess adequacy and finalize clinically relevant outcome measures with other Collaboratory investigators. It is anticipated that successful applicants will work with other Collaboratory investigators and NIH to identify common outcome measures (such as measures of quality of life, physical function, pain or fatigue). It is also anticipated that successful applicants will work with the Collaboratory Coordinating Center and NIH to develop metrics for resource utilization for planning and implementing Collaboratory pragmatic trials.  If an award is made, NIH and CCC staff will work with the Program Directors/Principal Investigators to facilitate this aspect across Demonstration Projects.
  • Refine estimates of requirements with guidance from NIH and the CCC, for sample size, numbers of sites, site to site heterogeneity, and implementation timetable based on data derived from the partnering HCS.
  • In general, all studies must use at least three HCS for implementation, unless a specific rationale for limiting this aspect of the project is provided.
  • Develop detailed plans for site implementation, including site staff, method of identification, randomization (as applicable) and participant recruitment and acquisition and administration/implementation of the intervention if applicable.
  • Address all ethical issues and issues related to human subject safety oversight for the Demonstration Project, including development of informed consent documents or opt-out consent if applicable, and finalizing site of IRB review. Applicants must propose a consolidated or centralized IRB approach for trial oversight, to facilitate both appropriate and timely study implementation.
  • Address all potential regulatory elements of the proposed trial (if applicable).
  • Develop a detailed budget for conduct and completion of the Demonstration Project, including preparation of a final study report.
  • Finalize detailed plans for data coordination and quality control for the UH3 phase. It is not anticipated that the CCC will provide these functions for individual Demonstration Projects. Data coordinating activities for individual Demonstration Projects must be separately budgeted as part of the UH3 budget.

Demonstration Project Implementation Phase (UH3): The objective of the two to four year UH3 implementation phase is to actually conduct the Demonstration Project within the NIH HCS Research Collaboratory, in accordance with activities planned in the UG3 phase. Implementation activities will depend upon the study, but in general the following goals should be achieved:

  • Each Demonstration Project is expected to implement all aspects of the proposed pragmatic trial – including the identification and recruitment of proposed sample sizes of patients, practice sites, and clinicians, the execution of the intervention and its implementation, and the assessment of outcomes.
  • Each project is expected to provide complete assessment of all issues related to patient, clinician and site identification, and EHR tools used in these steps.
  • Each project is expected to provide definitive information about the execution of the intervention at all sites.
  • Each project is to provide detailed and definitive testing of the validity of methods used for monitoring and outcome assessment.
Research Areas

For each participating NIH IC, examples of potential research questions that could be addressed by Demonstration Projects, and would be responsive to this FOA are outlined below.  Potential applicants are urged to contact NIH IC Scientific/Research Staff to ensure that proposed studies are responsive to this FOA.

National Heart, Lung, and Blood Institute (NHLBI)

Examples of research topics for pragmatic clinical trials that are of interest to NHLBI include, but are not limited to:

  • Assessments of parameters that drive sustainable delivery of evidenced-based treatments that lower risk for heart, lung, and blood diseases and sleep disorders (HLBS).
  • Effectiveness of approaches to improve the management of all types of heart failure.
  • Effectiveness of strategies to reduce cardiovascular risk in young or middle age adults.
  • Translation or implementation of the lower systolic hypertension goals into practice settings.
  • Effectiveness of approaches to prevent and manage obesity in primary care settings.
  • Assessments of referral models that promote appropriate utilization of technology (e.g., implantable cardioverter-defibrillator placement).
  • Assessments of the utilization of personalized health records or other methods to capture patient reported outcomes for cardiovascular disease prevention and management.
  • Effectiveness of strategies to reduce the risk of stroke in patients with atrial fibrillation.
  • Pragmatic strategies to improve the diagnosis and treatment of sleep disorders in routine care to reduce risk of cardiovascular disease.
  • Effectiveness of approaches to reduce HLBS risk among populations with health disparities.
  • Effectiveness of alternative models for cardiac and pulmonary rehabilitation for increasing participation and adherence in these programs.
  • Effectiveness of intervention in the treatment of asymptomatic severe aortic stenosis.
  • Effectiveness of hydration protocols to manage acute sickle cell disease events in the emergency room.
  • Effectiveness of health promotion and education for hemophilia patients to promote adopting and sustaining health behaviors that optimize physical functioning.
  • Effectiveness of blood banking policies and procedures to prevent adverse outcomes related to transfusions.
  • Effectiveness of patient education to prevent deep vein thrombosis.
  • Effectiveness of pulmonary rehabilitation to reduce hospital readmissions in COPD patients.
  • Comparative effectiveness of alternative provider incentives to use evidence-based practices to reduce acute care visits (emergency room or unscheduled appointments) for asthma.
  • Effectiveness of pre-operative screening and treatment of sleep apnea on surgical morbidity, mortality, and re-hospitalization. 
  • Effectiveness of antibiotic treatment for the prevention of ARDS in at-risk patients.
  • Evaluation of the use of technologies to guide chronic lung disease self-management.
  • Assessments of health system characteristics associated with successful implementation of any protocol-based treatment strategy for HLBS.        
  • Tests of sustainable implementation strategies for HLBS guidelines across various health care systems that employ implementation research primary outcome metrics (i.e. measures of acceptability, adoption, appropriateness, costs, fidelity, penetration, and sustainability).

National Institute on Aging (NIA)
Examples of research topic areas that may be relevant to this FOA include, but are not limited to:

  • Evaluation of beneficial and adverse outcomes from differing management strategies for multiple chronic conditions, testing an intervention, or coordinating several interventions.
  • Incorporation of specific palliative care services (e.g., symptom management, establishment of care goals consistent with patient and family preferences, discontinuation of potentially unnecessary treatments) into care of older adults within and/or across specific settings.
  • Development and validation of effective strategies to reconcile medication type and dose across care setting transitions (e.g., hospital to home, home to hospital including intermediate care such as between inpatient units, rehabilitation facilities and nursing homes).
  • Effectiveness of incorporating an automated notification system into an electronic pharmacy ordering system that alerts providers to the potential for drug-drug interactions or adverse drug effects in individual patients meeting specific age-associated clinical parameters (e.g., creatinine clearance: body surface area).
  • Effectiveness of an automated electronic health record notification system that identifies older patients at increased risk of major bleeding based on hematologic/coagulation factors, medications, renal function, anthropomorphic and/or other variables.
  • Effectiveness of incorporating geriatric assessment (i.e., systematic assessment of functional, cognitive, medical, and other parameters) into care of older adults referred for invasive medical or surgical procedures.
  • Effectiveness of anticoagulation strategies for non-valvular atrial fibrillation in patients older than 80 years, including those with multiple chronic conditions and/or renal dysfunction.
  • Evaluation of the long-term benefits and harms of bisphosphonate medication for low bone density or osteoporosis, comparing continued use of pharmacotherapy with an alternative of discontinuation. 
  • Evaluation of benefits and harms of screening for cognitive impairment in community-dwelling older adults in primary care–relevant settings, and effect on decision-making, patient, family or caregiver, and/or societal outcomes.
  • Evaluation of benefits and harms of interventions for mild cognitive impairment or mild to moderate dementia in older adults in terms of decision-making, patient, family or caregiver, and/or societal outcomes.
  • Behavioral economics-based interventions which change choice architectures to improve health care of older adults.
  • Effectiveness of simple, scalable incentive-based interventions to improve health-promoting behavior in midlife and/or older adults in one or more of the following settings: workplaces, community, nursing homes, assisted living facilities, rehabilitation facilities.
  • Technology-based interventions to improve affect regulation and emotional well-being of midlife and/or older adults with chronic health conditions, or of their caregivers.
  • Assessment of new organizational and delivery models, which include innovations and care coordination in home health care and adult day services for the frail older adults.

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Study topics for pragmatic trials of interest to NIAMS include:

  • Approaches to improve the management of chronic rheumatic, musculoskeletal, and/or skin diseases in adults and children, particularly through testing the use of different regimens to optimize outcomes and reduce known risks.

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
NICHD includes the National Center for Medical Rehabilitation Research (NCMRR) which has as its mission to enhance the health, productivity, independence, and quality-of-life of people with physical disabilities through basic, behavioral, translational, and clinical research. NICHD will only accept projects related to rehabilitation for this FOA. Relevant topics include, but are not limited to:

  • Trials of specific, scalable, interventions to reduce limitations in upper or lower extremity function and methods by which these can be effectively integrated into routine clinical practice
  • Test standardized practice models for specific impairments or conditions that integrate both approaches to care and standardized outcome measurement for monitoring
  • Comparison of surgical and non-surgical interventions or combinations of interventions to address physical disabilities (i.e., tendon release vs. physical therapy for contracture)
  • Programs to integrate rehabilitation care into standard medical practice (general practice, internal medicine, pediatrics, geriatrics) with the intent of preventing secondary conditions, facilitating maintenance of rehabilitation gains post-discharge, or identifying functional decline and intervening early
  • Effectiveness of self-monitoring systems to prevent secondary complications in chronic conditions, or to encourage health and wellness interventions to maintain health

National Institute of Dental and Craniofacial Research (NIDCR

NIDCR supports interventional research designed to improve oral health, including reducing the burden of untreated dental diseases and oral and pharyngeal cancer, and to improve oral health – related quality of life.  In addition, NIDCR supports research to determine if provision of oral health care to medically-complex patients improves other clinical outcomes. Topics that would be appropriate to the NIDCR include, but are not limited to:

  • Studies of effective methods to disseminate evidence-based practices to prevent oral diseases in adults, especially those with multiple chronic conditions.
  • Studies to improve the receipt of dental care for adult populations with multiple chronic conditions.
  • Studies to improve the management of oral diseases in those with oral and pharyngeal cancers.
  • Studies determining if provision of dental care or supervised oral hygiene improves clinical outcomes, including patient-centered outcomes, in hospitalized patients or individuals living in long-term care facilities.

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Study topics for pragmatic trials of interest to NIDDK include:

  • Diseases of the kidney and urologic system.
  • Glycemic control of diabetes, including: comparison of risks and benefits of approaches to glycemic control and/or strategies to individualize glucose lowering therapy; management of hyperglycemia in hospitalized patients; approaches to mitigating hypoglycemia in the elderly and other vulnerable populations and use of continuous glucose monitoring in individuals with type 1 diabetes or with type 2 diabetes on intensive insulin regimens.
  • Approaches to improve diabetes prevention and management delivered in routine care settings, including: incorporation of diabetes educators or community health workers to provide self-management support; shared decision making; improved care coordination; telemedicine; identifying common diabetes co-morbidities such as depression, cognitive impairment and dementia or obstructive sleep apnea and incorporating the treatment of those comorbidities into treatment approaches to improve diabetes outcomes; diagnosis and management of prediabetes or diabetes in women after a pregnancy complicated by gestational diabetes.
  • Long term effects of bariatric surgery on glycemic outcomes in individuals with prediabetes or type 2 diabetes, including overall risk and benefit, comparison of different procedures and delineation of results in specific subgroups (e.g. overweight vs obese; duration of diabetes)
  • Prevention and management of diabetic foot ulcers including:  approaches to prevent primary or recurrent diabetic foot ulcers in high risk populations; treatment approaches for diabetic foot ulcers, including the use of surgery and anti-microbial therapies; and comparison of prevention or treatment strategies. 
  • Assessment and management of subclinical hypothyroidism, thyroid nodules, and hyperparathyroidism. 
  • Diseases of the digestive system, including esophageal reflux, peptic ulcer disease, celiac disease, inflammatory bowel disease, functional GI disorders such as irritable bowel syndrome and gastroparesis, fecal incontinence, diverticulitis, appendicitis; liver diseases including non-alcoholic steatohepatitis and viral hepatitis, sclerosing cholangitis, gallstones, exocrine pancreatic diseases, particularly chronic pancreatitis.  Pragmatic studies are of particular interest for uncommon or rare diseases where randomized trials are not easily performed, such as Hirschprung’s disease, pseudoobstruction, intestinal failure, short-gut syndrome, genetic liver and metabolic diseases, acute liver failure and transplantation.  Pragmatic trials are also of particular interest for approaches that have not historically been supported by extensive NIDDK funding, such as surgical and endoscopic treatments.
  • Obesity treatment and prevention.

National Institute on Drug Abuse (NIDA)

The mission of the National Institute on Drug Abuse (NIDA) is to advance science on the causes and consequences of drug use and addiction and to apply that knowledge to improve individual and public health. 

A number of interventions scientifically proven to prevent substance use and its consequences, and to identify and treat substance use disorders, are available. However, they are not used to their fullest potential. NIDA seeks pragmatic trials that can rigorously test the effects of deploying these effective interventions broadly within health care systems on health outcomes and on the utilization of health care resources. Studies specifically addressing substance use outcomes are especially welcome, particularly those that examine the utility of embedding available instruments such as the PROMIS substance use item bank in EHRs or other clinically-relevant computerized systems for eliciting patient-reported outcomes. Relevant health care systems include any that provide medical, mental health, or substance use disorder treatment and that can meet the criteria for responsiveness of this FOA. 

Studies focused on alcohol only will not be considered by NIDA, but those focused on other substances combined with alcohol will be considered.

The intervention studied must be one that could reasonably be implemented and sustained in practice in the health care systems in which the study is being conducted and other similar systems. Examples of effective interventions that might be deployed include, but are not limited to, the following:

  • FDA-approved medications for the treatment of drug use disorders including methadone, buprenorphine, buprenorphine/naloxone, and naltrexone
  • Interim approaches for providing FDA-approved medications for the treatment of drug use disorders
  • Treatment of pregnant women with opioid and other substance use disorders to optimize neonatal and maternal outcomes
  • Behavioral treatment interventions, including those delivered electronically, as well as interventions that combine behavioral and pharmaceutical approaches
  • Recovery management interventions
  • Naloxone for the treatment of opioid overdoses
  • Validated screening approaches
  • Parent- and family-based drug use prevention interventions that reduce the risk for drug use and related behavioral health problems for delivery in primary care, both those that need further testing in primary care and those that are effective in other settings but could be implemented in primary care. 

In addition to assessing health and utilization outcomes associated with implementing effective interventions, studies are encouraged to address implementation, delivery, and sustainability issues.  The following examples are based on the parent- and family-based substance use prevention interventions, but similar and related studies might be undertaken for other effective interventions: 

  • Studies examining how to optimize existing integrated behavioral health models within health care systems to support implementation of evidence-based parenting interventions (EBIs) that address key components of implementation, such as determining fit of EBIs within HCS; engagement of families; training and support for staff; tracking behavioral health outcomes  within the infrastructure of HCS; identifying mechanisms for sustainability of family-based behavioral health interventions for substance use prevention within HCS. 
  • Studies on modifying HCS to utilize co-location of services, integrated behavioral health models, or other service delivery models (e.g., community benefit opportunities through health reform) that include implementation of evidence-based parenting and family-based interventions within (or through) the HCS.

National Institute of Neurological Disorders and Stroke (NINDS)
The National Institute of Neurological Disorders and Stroke is interested in applications that are relevant to the mission (http://www.ninds.nih.gov/about_ninds/mission.htm) of the NINDS.  Relevant mission disease areas include stroke and stroke risk factors, chronic pain, epilepsy, neurodegenerative disease, peripheral neuropathy, neurological disparities, as well as other neurological diseases and disorders.

National Institute of Nursing Research (NINR)

NINR supports clinical, basic, and translational research to build the scientific foundation for clinical practice, prevent disease and disability, manage and eliminate symptoms caused by illness, enhance palliative and end-of-life care, and train the next generation of scientists. Study topics of interest to NINR include:

  • Symptom Science research to develop improved, personalized strategies to treat and prevent the adverse symptoms of illness across diverse populations and settings.
  • Wellness to promote health and prevent illness across health conditions, settings, the lifespan, and in minority and underserved populations.
  • Self-Management strategies to help individuals with chronic conditions and their caregivers better understand and manage their illness and improve their health behaviors.
  • End-of-Life and Palliative Care to assist individuals, families, and health care professionals in managing the symptoms of life limiting conditions and planning for end-of-life decisions

National Center for Complementary and Integrative Health (NCCIH

NCCIH is identifying targeted areas of investigation for complementary health. Applications will be considered of high programmatic priority if they propose projects that study a mind and body or integrated approach for one of the following high priority topic areas: symptom management, particularly for chronic pain syndromes; reduction of prescription drug (opioid) use or abuse in patients with chronic pain; medication adherence; post-traumatic stress (disorder); traumatic brain injury; sleep disorders or disturbances; anxiety; depression; promotion of psychological resilience; weight loss and weight loss maintenance; smoking cessation; and promotion of healthy eating and physical activity. Applications that propose trials of regulated products (dietary supplements, devices or biologics) for indications that have not been approved or cleared by the US Food and Drug Administration are not responsive to this FOA.

Division of Program Coordination, Planning and Strategic Initiatives, Office of Disease Prevention

(ODP)

The Office of Disease Prevention (ODP) is interested in co-funding applications for pragmatic trials within the context of primary care that address clinical preventive services research gaps identified within the Insufficient Evidence statements of the US Preventive Services Task Force.  These research gaps cover topics across the life span.  More information about these research gaps can be found on the ODP website at https://prevention.nih.gov/resources-for-researchers/prevention-research-needs-gaps/uspstf-i-statements and at the Agency for Health Care Research and Quality at http://www.uspreventiveservicestaskforce.org/BrowseRec/Index/browse-recommendations.

Milestones and UG3/UH3 Transition

The application must propose a well-defined set of milestones for the planning phase (UG3) and annual milestones for the implementation phase (UH3).   It is understood that the proposed milestones for the UH3 phase will be revised as activities during the UG3 planning phase. In the event of an award, the PD/PI and NIH staff will negotiate a list of milestones for each year of support.

At the completion of the UG3 planning phase, the applicant will be required to submit a detailed transition request for the UH3 Demonstration Project implementation phase. UH3 transition requests will undergo an administrative review to determine whether the milestones have been met. It is anticipated that not all funded UG3 projects will transition to the UH3 phase.

Prospective applicants should note that funding of UG3 /UH3 Phased Innovation cooperative agreement does not guarantee support of the UH3 Demonstration Project implementation phase.  Transition to the UH3 phase of the project will occur only if an administrative review process recommends that the UG3 planning activities have been successful, the Demonstration Project can proceed with confidence of success, and if funds are available.

Additional Information

In preparing applications, applicants should note the following:

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 CCC will be required to accomplish the goals of this program. An HCS Research Collaboratory Steering Committee has been established by the CCC 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 healthcare systems, their patients, and practitioners. The Steering Committee is composed of one representative from each of the Demonstration Projects, one representative from each Work Group, one representative from the CCC, the NIH Program Coordinator, and representatives from various NIH ICs and the Common Fund. 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.

NIH oversight of the HCS Research Collaboratory activities includes an External Advisory Panel (EAP) to review the progress of all components of this program, and to make recommendations to the NIH. The EAP provides recommendations to the NIH Common Fund for the continuation or termination of the program, including options for sustainability.

See Section VIII. Other Information for award authorities and regulations.

Section II. Award Information
Funding Instrument

Cooperative Agreement: A support mechanism used when there will be substantial Federal scientific or programmatic involvement. Substantial involvement means that, after award, NIH scientific or program staff will assist, guide, coordinate, or participate in project activities. See Section VI.2 for additional information about the substantial involvement for this FOA.

Application Types Allowed

New

The OER Glossary and the SF424 (R&R) Application Guide provide details on these application types.

Funds Available and Anticipated Number of Awards

Issuing IC and partner components intend to commit an estimated total of $4,000,000 to fund 7-10 UG3 planning awards in FY 2018.

Award Budget

The application budget for the one-year UG3 phase is limited to $500,000 in direct costs.  Costs for each year of the UH3 phase are limited to $1 million in direct costs.

Award Project Period

The maximum period of funding for the UG3 phase is one year and the maximum period of funding of the UH3 phase is four years, for a total of five years for the entire UG3/UH3 award. 

NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made in response to this FOA.

Section III. Eligibility Information
1. Eligible Applicants
Eligible Organizations

Higher Education Institutions

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

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

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

Nonprofits Other Than Institutions of Higher Education

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

For-Profit Organizations

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

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)
  • Eligible Agencies of the Federal Government
  • U.S. Territory or Possession

Other

  • Independent School Districts
  • Public Housing Authorities/Indian Housing Authorities
  • Native American Tribal Organizations (other than Federally recognized tribal governments)
  • Faith-based or Community-based Organizations
  • Regional Organizations
Foreign Institutions

Non-domestic (non-U.S.) Entities (Foreign Institutions) are not eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.
Foreign components, as defined in the NIH Grants Policy Statement, are not allowed.

Required Registrations

Applicant Organizations

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

  • Dun and Bradstreet Universal Numbering System (DUNS) - All registrations require that applicants be issued a DUNS number. After obtaining a DUNS number, applicants can begin both SAM and eRA Commons registrations. The same DUNS number must be used for all registrations, as well as on the grant application.
  • System for Award Management (SAM) (formerly CCR) – 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 and SAM registration in order to complete the eRA Commons registration. Organizations can register with the eRA Commons as they are working through their SAM or Grants.gov registration. eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to submit an application.
  • Grants.gov – Applicants must have an active DUNS number and SAM registration in order to complete the Grants.gov registration.

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

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

Eligible Individuals (Program Director/Principal Investigator)

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

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

Personnel of the NIH HCS Research Collaboratory Coordinating Center must not be named as personnel on applications submitted in response to this FOA.

2. Cost Sharing

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

3. Additional Information on Eligibility
Number of Applications

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

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

  • A new (A0) application that is submitted before issuance of the summary statement from the review of an overlapping new (A0) or resubmission (A1) application.
  • A resubmission (A1) application that is submitted before issuance of the summary statement from the review of the previous new (A0) application.
Section IV. Application and Submission Information
1. Requesting an Application Package

Buttons to access the online ASSIST system or to download application forms are available in Part 1 of this FOA. See your administrative office for instructions if you plan to use an institutional system-to-system solution.

2. Content and Form of Application Submission

It is critical that applicants follow the Research (R) Instructions in the SF424 (R&R) Application Guide, including Supplemental Grant Application Instructions except where instructed in this funding opportunity announcement to do otherwise. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.

For information on Application Submission and Receipt, visit Frequently Asked Questions – Application Guide, Electronic Submission of Grant Applications.

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, PhD
Chief, Office of Scientific Review
National Center for Complementary and Integrative Health
6707 Democracy Blvd, Suite 401
Bethesda, MD 20892 (Express Mail Zip: 20817)
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, with the following exceptions or additional requirements:

For this specific FOA, the Research Strategy section is limited to 30 pages, divided between the UG3 and UH3 phases of the project.

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. 

Biosketches should reflect the PD(s)/PI(s) and key personnel's expertise in design and implementation of large-scale clinical studies within multiple HCS including using electronic health records for recruitment and outcomes assessment. The experience of the investigative team with successful recruitment and retention of participants should be described.

R&R Budget

All instructions in the SF424 (R&R) Application Guide must be followed.

Application budgets must include a minimum effort for the PD/PI of 2.4 person months to the project. If a project includes multiple PDs/PIs, the total annual PD/PI effort must be at least 2.4 person months.

Application must be an appropriate mix of time allocated for senior and junior scientists to ensure the successful conduct of the study. Budgeted effort of other personnel must be appropriate to the needs of the project.

The budget must include personnel at all partnering HCS with expertise relevant to the project, which might include informaticists, clinical investigators and staff with expertise in the administrative aspects of clinical trials oversight.

Applications must budget to travel several key persons (at a minimum the project PD(s)/PI(s), program manager/coordinator, lead informaticist, lead biostatistician and research methodologist) to attend two separate, one and a half day meetings of the HCS Research Collaboratory program steering committee in the first year and an annual meeting in subsequent years in the Bethesda MD area. Based on project needs, interdisciplinary team members (persons with backgrounds in environmental health sciences, health policy, economics, and social and behavioral sciences, and, if applicable, PDs/PIs of main research projects and site PDs/PIs/coordinators), must also travel to NIH HCS Research Collaboratory program meetings. Travel for additional meeting (s) in the Planning Phase may be required. 

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: 

To clearly distinguish between the two phases, applicants should specify separate UG3 and UH3 information in each subsection (Specific Aims and Research Strategy) of the PHS 398 Research Plan as appropriate. Activities in both phases will depend on the specific study (e.g. disease domains, type of interventions, experimental design, randomization strategy and proposed outcome measures).

In preparing the application, investigators should consider the fact that applications will be assigned a single impact score for both UG3 and UH3 phases.

Specific Aims: Applicants should address the scientific questions to be answered, what specifically will be done during the proposed funding periods and the impact of addressing the research question on public health. Specific aims should be scientifically appropriate for the distinct phases of the project. Include separate aims, within the designated page limit, for both the UG3 and UG3 phase, and clearly label them as UG3 specific aims and UH3 specific aims.

Research Strategy: Within the Research Strategy, applicants should first describe the UG3 Phase and then the UH3 Phase. The Research Strategy section should have a clear demarcation of the UG3 and UH3 phases of the application. It is not necessary to repeat background information or details of methods in the UH3 portion that were provided in the UG3 portion. The UH3 Phase must be described in sufficient detail to permit reviewers to assess significance and innovation of the proposed work and the strength of the experimental design. Address how the research question serves the goals of the overall Collaboratory program and addresses a major public health issue. Applications should describe details for the proposed pragmatic trial including projections for recruitment, attrition and effect size estimations.  Investigators are encouraged to describe how the approaches, measures, design and outcomes proposed are pragmatic.

The application should describe the health care system partners and the investigative team's experience conducting pragmatic trials within health care systems. In general, all studies must use at least three HCS for implementation, unless a specific rationale for limiting this aspect of the project is provided, which must be identified in the application. The application must provide a rationale for the HCS selected for the Demonstration Project and provide a description of the infrastructure and expertise to implement the proposed pragmatic trial within all proposed HCS.

Both the UG3 and the UH3 phases of the Research Strategy must have a section of proposed milestones, which should be well described, quantifiable, and scientifically justified to allow an assessment of progress. For UG3 milestones, applicants should delineate what they propose to achieve in order to proceed to the UH3 phase. The milestones should also include a timeline, a discussion of the suitability of the milestones for assessing success in the UG3 Phase, and a discussion of the implications of successful completion of these milestones for the proposed UH3 Phase. Annual milestones for the Demonstration Project implementation (UH3) phase should also be included in the application, although it is understood that timelines and milestones for implementation in the UH3 phase that are proposed in the application will evolve as activities in the UG3 phase progress, if an Award is made.

Collaboratory Work Groups are open to participation by individuals from all funded Demonstration Projects, the CCC, and the NIH. Applicants should describe how project personnel would participate in the Collaboratory Work Groups (Electronic Health Records, Regulatory /Ethics, Biostatistics & Study Design, Health Provider-Systems Interactions, Stakeholder Engagement, Phenotype & Data Standards, and Patient Reported Outcomes). https://www.nihcollaboratory.org/cores/Pages/default.aspx.

Applicants must describe their willingness to comply with policies, guidelines and practices developed by the Work Groups, and to work with the CCC in providing relevant information and materials.

Applicants must not propose work that duplicates efforts already funded or underway. Although novel theoretical approaches and methodologies may be needed,  when possible applicants should leverage, adopt or adapt resources from ongoing NIH-supported efforts in informatics as well as other national efforts including but not limited to the many federal investments in the HMO Research Network, the CTSAs, REDCap, PROMIS, NIH Toolbox, Health Care Innovation Awards, DEcIDE, eMERGE, other networks, CERTs, SHARP, Vaccine Safety Datalink, the Sentinel Initiative.

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

Letters of Support: Applications must include a strong letter of support from each of the HCS partners that relate their commitment to the proposed research and outlines how the project fits with organizational priorities, the quality of the proposed EHR and data systems and the commitment of their IT staff to the project. The letter must provide a description of how the project would directly impact delivery of healthcare within their organization and indicate level of intention to sustain the intervention(s) based upon results. The application is expected to include letters from the officials responsible for intellectual property issues at the applicant institutions (including sub-contractor institutions) stating that the institution supports and agrees to abide by the Resources and Data Sharing Plan and the Software Sharing Plan put forth in the application. These letters should be clear expressions of commitment consistent with achieving the goals of the program.

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, with the following modification:

All applications, regardless of the amount of direct costs requested for any one year, must include a Data Sharing Plan. Applicants must provide a description of the resources that will be made broadly available including policies, practices, materials, and tools to facilitate collaboration, reuse, and replication of the project.  Applications should provide descriptions of how privacy and confidentiality will be maintained.  The plan must be include a description of how data will be shared to allow for transparency and reproducibility of study findings (e.g. access to data, data enclave, or data repository).

Software Sharing Plan

A Software Sharing Plan, with appropriate timelines, must be included in the application. Applicants should describe what software will be generated by the award and how they will determine which software is potentially useful to the scientific community and how it will be shared.  There is no particular software dissemination license required for this program. However, NIH does have goals for software sharing applicants should keep in mind  the following goals:

  • The software should be freely available to biomedical researchers, health care delivery systems, research institutions, and government health care systems and researchers.
  • The terms should also 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.
  • The terms of software availability should include the ability of individuals outside the applicant institution and its collaborating organizations to modify the source code and to share modifications with other colleagues.

Appendix:

 Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

PHS Inclusion Enrollment Report

When conducting clinical research, follow all instructions for completing PHS Inclusion Enrollment Report as described in the SF424 (R&R) Application Guide.

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 Applying Electronically. If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Guidelines for Applicants Experiencing System Issues. For assistance with application submission, contact the Application Submission Contacts in Section VII.

Important reminders:

All PD(s)/PI(s) must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile Component of the SF424(R&R) Application Package. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to NIH. See Section III of this FOA for information on registration requirements.

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

See more tips for avoiding common errors.

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

In order to expedite review, applicants are requested to notify the NCCIH Referral Office by email at schmidma@mail.nih.gov when the application has been submitted. Please include the FOA number and title, PD/PI name, and title of the application.

Applications Involving the NIH Intramural Research Program

The requests by NIH intramural scientists will be limited to the incremental costs required for participation.   As such, these requests will not include any salary and related fringe benefits for career, career conditional or other Federal employees (civilian or uniformed service) with permanent appointments under existing position ceilings or any costs related to administrative or facilities support (equivalent to Facilities and Administrative or F&A costs).  These costs may include salary for staff to be specifically hired under a temporary appointment for the project, consultant costs, equipment, supplies, travel, and other items typically listed under Other Expenses.  Applicants should indicate the number of person-months devoted to the project, even if no funds are requested for salary and fringe benefits. 

If selected, appropriate funding will be provided by the NIH Intramural Program.  NIH intramural scientists will participate in this program as PDs/PIs in accord with the Terms and Conditions provided in this FOA.  Intellectual property will be managed in accord with established policy of the NIH in compliance with Executive Order 10096, as amended, 45 CFR Part 7; patent rights for inventions developed in NIH facilities are NIH property unless NIH waives its rights. 

Should an extramural application include the collaboration with an intramural scientist, no funds for the support of the intramural scientist may be requested in the application.  The intramural scientist may submit a separate request for intramural funding as described above.  

Post Submission Materials

Applicants are required to follow the instructions for post-submission materials, as described in the policy.

Section V. Application Review Information
1. Criteria

Only the review criteria described below will be considered in the review process. As part of the NIH mission, all applications submitted to the NIH in support of biomedical and behavioral research are evaluated for scientific and technical merit through the NIH peer review system.

For this particular announcement, note the following:

This FOA includes Additional Review Criteria on Milestones and Resource and Data Sharing and Software Sharing which require comment by reviewers and which are to be considered when determining the overall impact score.

Overall Impact

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

Scored Review Criteria

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

Significance

Does the project address an important problem or a critical barrier to progress in the field? Is there a strong scientific premise for the project? If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field? Will addressing the research question realistically serve the goals of the overall Collaboratory program and strengthen the capacity, capability and cost-effectiveness of conducting large multi-site studies within health care delivery organizations? Is the proposed project a pragmatic trial addressing a major public health issue? Will the completion of the proposed pragmatic trial change the concepts, methods and technologies used in large scale community-based clinical research? Will the UG3 planning activities and subsequent Demonstration Project implementation in the UH3 phase achieve important advances in the ability to perform large-scale pragmatic clinical trials?  Does it inform how HCS can work together effectively and efficiently?

Investigator(s)

Are the PD(s)/PI(s), collaborators, and other researchers well suited to the project? If Early Stage Investigators or New Investigators, or in the early stages of independent careers, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the project is collaborative or multi-PD/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project? Do the PD(s)/PI(s) and key personnel have the necessary expertise in design and implementation of large-scale clinical studies within multiple HCS (including using electronic health records for recruitment and outcomes assessment)? Do the PD(s)/PI(s) have extensive experience in performing proposed Planning Phase activities, and do they have a track record of successful recruitment and retention in prior studies, investigative collaborations or partnerships with (within) health delivery organizations in conducting clinical studies within a HCS?   

Innovation

Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions? Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed? Does the application challenge and seek to impact current conventional approaches by utilizing novel approaches or methodologies for a pragmatic trial? Is the comparison condition(s) proposed informative given the state of the science in this area? Is a refinement, improvement or new strategy of approaches proposed? Does the application include mechanisms for leveraging novel collaboration and study oversight strategies?

Approach

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

If the project involves human subjects and/or NIH-defined clinical research, are the plans to address 1) the protection of human subjects from research risks, and 2) inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion or exclusion of children, justified in terms of the scientific goals and research strategy proposed? Are the projections for recruitment, ongoing engagement, attrition and effect size estimations based on data in the proposed HCS or similar settings? Are the approaches, measures, design and outcomes proposed pragmatic? And generalizable? Will the results provide relevant information and adequate data for other potential adopting HCS settings to determine applicability? Will proposed planning activities (including plans for identifying a sufficiently large target patient population), and proposed milestones, allow for implementing the Demonstration Project?  

Environment

Will the scientific environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment and other physical resources available to the investigators adequate for the project proposed? Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements? Does the application provide sufficient quantitative information and rationale for the HCS selected for the Demonstration Project? Have the HCS partners successfully conducted clinical studies, such that there are sufficient infrastructure and expertise (e.g. clinical investigators, informaticists) to implement the proposed pragmatic trial within all proposed HCS? Does the application include documentation from the HCS partner organizations that outline strong commitment to the project planning and implementation?  

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.

Milestones

Are the steps and milestones clearly defined? Are the milestones feasible, well developed and quantifiable with regard to specific goals and accomplishments? Are adequate criteria provided for the UG3 phase that will be utilized in determining milestone completion before proceeding to the next phase of the project? Are the UH3 milestones appropriate for the next phase of the project?

Resources and Data Sharing Plan

The reviewers will comment on the appropriateness and adequacy of the proposed Resources and Data Sharing Plan to meet the goals of the HCS Research Collaboratory program and factor their evaluation into the determination of the overall impact score.

Software Sharing Plan

Reviewers will evaluate the appropriateness and adequacy of the proposed Software Sharing Plan relative to the following goals:

  • The software should be freely available to biomedical researchers, health care delivery systems, research institutions, and government health care systems and researchers.
  • The terms should also 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.
  • The terms of software availability should include the ability of individuals outside the applicant institution and its collaborating organizations to modify the source code and to share modifications with other colleagues.
Protections for Human Subjects

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

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

Inclusion of Women, Minorities, and Children 

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

Vertebrate Animals

Not Applicable

Biohazards

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

Resubmissions

Not Applicable

Renewals

Not Applicable

Revisions

Not Applicable

Additional Review Considerations

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

Applications from Foreign Organizations

Not Applicable

Select Agent Research

Not Applicable

Authentication of Key Biological and/or Chemical Resources:

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

Budget and Period of Support

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

2. Review and Selection Process

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s) convened by National Center for Complementary and Integrative Health, 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:

  • 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.
  • Will receive a written critique.

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.

Section VI. Award Administration Information
1. Award Notices

If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant as described in the NIH Grants Policy Statement.

A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization for successful applications. The NoA signed by the grants management officer is the authorizing document and will be sent via email to the grantee’s business official.

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

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

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, Grantees, and Activities. More information is provided at Award Conditions and Information for NIH Grants.

Recipients of federal financial assistance (FFA) from HHS must administer their programs in compliance with federal civil rights law. This means that recipients of HHS funds must ensure equal access to their programs without regard to a person’s race, color, national origin, disability, age and, in some circumstances, sex and religion. This includes ensuring your programs are accessible to persons with limited English proficiency.  HHS recognizes that research projects are often limited in scope for many reasons that are nondiscriminatory, such as the principal investigator’s scientific interest, funding limitations, recruitment requirements, and other considerations. Thus, criteria in research protocols that target or exclude certain populations are warranted where nondiscriminatory justifications establish that such criteria are appropriate with respect to the health or safety of the subjects, the scientific study design, or the purpose of the research.

For additional guidance regarding how the provisions apply to NIH grant programs, please contact the Scientific/Research Contact that is identified in Section VII under Agency Contacts of this FOA. HHS provides general guidance to recipients of FFA on meeting their legal obligation to take reasonable steps to provide meaningful access to their programs by persons with limited English proficiency. Please see http://www.hhs.gov/ocr/civilrights/resources/laws/revisedlep.html. The HHS Office for Civil Rights also provides guidance on complying with civil rights laws enforced by HHS. Please see http://www.hhs.gov/ocr/civilrights/understanding/section1557/index.html; and http://www.hhs.gov/ocr/civilrights/understanding/index.html. Recipients of FFA also have specific legal obligations for serving qualified individuals with disabilities. Please see http://www.hhs.gov/ocr/civilrights/understanding/disability/index.html. Please contact the HHS Office for Civil Rights for more information about obligations and prohibitions under federal civil rights laws at http://www.hhs.gov/ocr/office/about/rgn-hqaddresses.html or call 1-800-368-1019 or TDD 1-800-537-7697. Also note it is an HHS Departmental goal to ensure access to quality, culturally competent care, including long-term services and supports, for vulnerable populations. For further guidance on providing culturally and linguistically appropriate services, recipients should review the National Standards for Culturally and Linguistically Appropriate Services in Health and Health Care at http://minorityhealth.hhs.gov/omh/browse.aspx?lvl=2&lvlid=53.

In accordance with the statutory provisions contained in Section 872 of the Duncan Hunter National Defense Authorization Act of Fiscal Year 2009 (Public Law 110-417), NIH awards will be subject to the Federal Awardee Performance and Integrity Information System (FAPIIS) requirements.  FAPIIS requires Federal award making officials to review and consider information about an applicant in the designated integrity and performance system (currently FAPIIS) prior to making an award.  An applicant, at its option, may review information in the designated integrity and performance systems accessible through FAPIIS and comment on any information about itself that a Federal agency previously entered and is currently in FAPIIS.  The Federal awarding agency will consider any comments by the applicant, in addition to other information in FAPIIS, in making a judgement about the applicant’s integrity, business ethics, and record of performance under Federal awards when completing the review of risk posed by applicants as described in 45 CFR Part 75.205 “Federal awarding agency review of risk posed by applicants.”  This provision will apply to all NIH grants and cooperative agreements except fellowships.

Cooperative Agreement Terms and Conditions of Award

The following special terms of award are in addition to, and not in lieu of, otherwise applicable U.S. Office of Management and Budget (OMB) administrative guidelines, U.S. Department of Health and Human Services (DHHS) grant administration regulations at 45 CFR Parts 74 and 92 (Part 92 is applicable when State and local Governments are eligible to apply), and other HHS, PHS, and NIH grant administration policies.

The administrative and funding instrument used for this program will be the cooperative agreement, an "assistance" mechanism (rather than an "acquisition" mechanism), in which substantial NIH programmatic involvement with the awardees is anticipated during the performance of the activities. Under the cooperative agreement, the NIH purpose is to support and stimulate the recipients' activities by involvement in and otherwise working jointly with the award recipients in a partnership role; it is not to assume direction, prime responsibility, or a dominant role in the activities. Consistent with this concept, the dominant role and prime responsibility resides with the awardees for the project as a whole, although specific tasks and activities may be shared among the awardees and the NIH as defined below.

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

  • Overseeing the overall budget, activities and performance of the Demonstration Project. The PD(s)/PI(s) must devote a minimum level of effort of 20% annually (2.4 calendar months) to the project. If a project includes multiple PIs, the total annual PI effort must be at least 20%.  The institution must obtain appropriate prior approval for any change in PI effort.
  • Accepting the participatory and cooperative nature of the collaborative research process and complying with policies and practices developed by the NIH HCS Research Collaboratory governing structure.
  • Sharing data, resources and software according to the approved sharing policies for the NIH HCS Research Collaboratory program.
  • Participating in all meetings of the HCS Research Collaboratory Steering Committee. Identifying study team members with relevant expertise to participate in program-wide Work Groups and sub-committees (as appropriate).
  • Cooperating with the NIH HCS Research Collaboratory Steering Committee, Collaboratory Coordinating Center, research partners, and NIH staff in the design and conduct of protocols, analysis of data, and reporting of results of research.
  • Agreeing to accept close coordination, cooperation and management of the project with NIH, including those outlined below under "NIH Responsibilities."
  • Submitting materials to the NIH Program Director, Coordinating Center, Steering Committee, and/or External Advisory Panel (EAP) as requested.  This will include regular reports of accomplishments and roadblocks, conference and meeting summaries, and other reports as requested.
  • Materials submitted will meet all subject and formatting requirements.
  • Awardees will submit a detailed transition request for the UH3 Demonstration Project implementation phase, outlining UG3 progress, how negotiated UG3 Milestones have been met, as well as detailed plans, budget and annual milestones for the UH3 implementation phase.  Note that, funding of the UG3 Demonstration Project planning phase cooperative agreement does not guarantee support of the UH3 Demonstration Project implementation phase.
  • Any of the above function may be performed by the applicant organization or by subcontract to the applicant organization.
  • Awardees will retain custody of and have primary rights to the data and software developed under these awards, subject to Government rights of access consistent with current DHHS, PHS, and NIH policies!

NIH staff has substantial programmatic involvement that is above and beyond the normal stewardship role in awards, as described below:

  • The NIH Project Scientist will work with the PD(s)/PI(s) and the Steering Committee to ensure the objectives of the program are being met.  The primary responsibility for the program resides with the awardee, although specific tasks and activities will be shared among the awardee and the NIH Project Scientist.
  • NIH staff will interact with the PD(s)/PI(s) on a regular basis to monitor progress. Monitoring may include: regular communication with the PD(s)/PI(S) and his/her staff, periodic site visits for discussion with the awardees’ research team, observation of field data collection and management techniques, fiscal reviews, and other relevant stewardship activities.
  • The NIH reserves the right to terminate or curtail the award (or an individual component of the award) in the event of inadequate progress or data reporting.
  • Additional NIH staff may participate in all Work Groups, implementation teams and committees, including the Steering Committee, as appropriate. NIH may designate staff from other federal agencies to participate, if advantageous to facilitate the activities of the program.
  • NIH staff will act as a resource and facilitator for activities of the awardee with non-NIH HCS researchers and other NIH, DHHS, or other federally-sponsored research networks that may be relevant to this effort.
  • NIH staff will provide input, expert advice, and suggestions in the design, development, and coordination of the infrastructure development and implementation efforts.
  • NIH staff will report periodically on progress of the program to the NIH Common Fund Executive Committee and interested IC Directors.
  • NIH will establish an EAP to review the progress of all components of this program, and to make recommendations to the NIH. The EAP will provide recommendations to the NIH Common Fund for the continuation or termination of the program, including options for sustainability, if continuation is recommended.
  •  NIH staff will conduct an administrative review of the UH3 transition request to determine whether the Demonstration Project will transition to UH3 funding and be implemented.  Criteria for transition to the UH3 phase used in the NIH administrative review include: successful achievement of the UG3 milestones, potential for successfully meeting the UH3 implementation phase plans and milestones, demonstrated ability of the team to work within the consortium arrangement, and the availability of funds.
  • Additionally, an agency program official or IC program director will be responsible for the normal scientific and programmatic stewardship of the award and will be named in the award notice.

Areas of Joint Responsibility include:

  • Ensuring that NIH HCS sites and investigators as well as NIH and other research partners fully comply with federal regulatory requirements.  This includes, but is not limited to those relating to human subjects protections, informed consent, and reporting of adverse events.
  • Jointly developing appropriate confidentiality procedures for data collection, processing, storage and analysis to ensure the confidentiality of data on individual health care provider organization patients, health care providers and other institutions involved in any Collaboratory research projects.
  • Participating in the HCS Research Collaboratory Steering Committee 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 Demonstration Projects, one representative from each Work Group, one representative from the CCC, the NIH Program Coordinator, and representatives from various NIH ICs and the Common Fund.  The combined vote of NIH membership may never exceed 1/3 of the total committee membership.
  • Participating in the HCS Research Collaboratory Work Groups that have been established as the core collaborative activity of this program. The Work Groups 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 have been established in the following areas: Electronic Health Records, Regulatory /Ethics, Biostatistics & Study Design, Health Provider-Systems Interactions, Stakeholder Engagement, Phenotype & Data Standards, and Patient Reported Outcomes (https://www.nihcollaboratory.org/cores/Pages/default.aspx). Additional Work Groups may be identified as the HCS Research Collaboratory expands with new projects. Work Groups are open to participation by individuals from all funded Demonstration Projects, the CCC, and the NIH.
  • Awardees will work with other Collaboratory investigators and NIH to identify common clinical outcome measures (such as measures of quality of life, physical function, pain or fatigue). NIH and CCC staff will work with the Principal Investigators to facilitate this aspect of Demonstration Projects.
  • Establishing and adherence by each Demonstration Project Team (Demonstration Project grantee, CCC grantee, and NIH staff) to a written plan of engagement, with timelines, to ensure timely delivery of the tested implementation plan. 
  • Working together with the CCC through all phases of the projects, including the implementation and close out, to assure all resources, materials, protocols, data, best practices, program policies, and lessons learned, as well as software or sets of code, are disseminated broadly through the CCC, 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 awardee. This special dispute resolution procedure does not alter the awardee's right to appeal an adverse action that is otherwise appealable in accordance with PHS regulation 42 CFR Part 50, Subpart D and DHHS regulation 45 CFR Part 16.

3. Reporting

When multiple years are involved, awardees will be required to submit the Research Performance Progress Report (RPPR) annually and financial statements as required in the NIH Grants Policy Statement.

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

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

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

Section VII. Agency Contacts

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

Application Submission Contacts

eRA Service Desk (Questions regarding ASSIST, eRA Commons registration, submitting and tracking an application, documenting system problems that threaten submission by the due date, post submission issues)
Finding Help Online: http://grants.nih.gov/support/ (preferred method of contact)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)

Grants.gov Customer Support (Questions regarding Grants.gov registration and submission, downloading forms and application packages)
Contact Center Telephone: 800-518-4726
Email: support@grants.gov

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Email: GrantsInfo@nih.gov (preferred method of contact)
Telephone: 301-710-0267

Scientific/Research Contact(s)

Robin Boineau, M.D.
National Center for Complementary and Integrative Health (NCCIH)
Telephone: 301-443-8206
Email: Robin.Boineau@nih.gov

Barbara Wells, Ph.D.
National Heart, Lung and Blood Institute (NHLBI)
Telephone: 301-435-0417
Email: barbara.wells@nih.gov

Andrew Narva, M.D., FACP, FASN
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Telephone: 301-594-8864
Email: narvaa@niddk.nih.gov

Sarah Duffy, Ph.D.
National Institute on Drug Abuse (NIDA)
Telephone: 301-443-6504
Email: duffys@nida.nih.gov

Peter Gilbert, Sc.M.
National Institute of Neurological Disorders and Stroke (NINDS)
Telephone: 301-496-9135
Email: Gilbertp@ninds.nih.gov

Robin Conwit, MD
National Institute of Neurological Disorders and Stroke (NINDS)
Telephone:301-496-9135
Email: Robin.conwit@nih.gov

Sue Marden, Ph.D.
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), which includes the National Center for Medical Rehabilitation Research (NCMRR)
Telephone: 301-435-7767
Email: mardens@mail.nih.gov

Jeri Miller, Ph.D.
National Institute of Nursing Research (NINR)
Telephone: 301-594-6152
Email: jmiller@mail.nih.gov

Marcel Salive, M.D., M.P.H.
National Institute on Aging (NIA)
Telephone:301-496-5278
Email: marcel.salive@nih.gov

Chuck Washabaugh, Ph.D.
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Telephone 301-594-5055
Email: charles.washabaugh@nih.gov

Jane Atkinson, D.D.S.
National Institute of Dental and Craniofacial Research (NIDCR)
Telephone: 301- 435-7908
Email: jatkinso@mail.nih.gov

Rachel Ballard, M.D., M.P.H.
Division of Program Coordination, Planning and Strategic Initiatives, Office of Disease Prevention (ODP)
Telephone: 301-827-5559 
Email: rachel.ballard@nih.gov

Peer Review Contact(s)

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

Financial/Grants Management Contact(s)

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

Tracee Foster
National Heart, Lung, and Blood Institute (NHLBI)
Telephone: 301-435-0166
Tracee.foster@nih.gov

Tammi Simpson
National Heart, Lung, and Blood Institute (NHLBI)
Telephone: 301-435-0166
Tammi.simpson@nih.gov

Charlette Kenley
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Telephone: 301-594-8847
Email: kenleyc@extra.niddk.nih.gov 

Ericka Wells
National Institute on Drug Abuse (NIDA)
Telephone: 301-827-6705
Email: wellse2@nida.nih.gov

Tijuanna DeCoster, MPA, PhD
National Institute of Neurological Disorders and Stroke (NINDS)
Telephone: 301-496-9231
Email: decostert@ninds.nih.gov

Bryan S. Clark, MBA
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Telephone: 301-435-6975
Email: clarkb1@mail.nih.gov

Ron Wertz
National Institute of Nursing Research (NINR)
Telephone: 301-594-2807 
Email: wertzr@mail.nih.gov

Lesa McQueen
National Institute on Aging (NIA)
Telephone: 301-496-1472
Email: McQueenL@nia.nih.gov

Mark Langer
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Telephone: 301-451-8216
Email: langerm@mail.nih.gov

Diana Rutberg, MBA
National Institute of Dental and Craniofacial Research (NIDCR)
Telephone: 301-594-4798
Email: rutbergd@mail.nih.gov

Section VIII. Other Information

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

Authority and Regulations

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

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