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 by the National Center for Complementary and Integrative Health (NCCIH) on behalf of the NIH.

Funding Opportunity Title

Limited Competition: NIH Health Care Systems Research Collaboratory - Coordinating Center (U24)

Activity Code

U24 Resource-Related Research Projects – Cooperative Agreements

Announcement Type

New

Related Notices

None

Funding Opportunity Announcement (FOA) Number

RFA-RM-16-018

Companion Funding Opportunity

RFA-RM-16-019, UG3/UH3 Exploratory/Developmental Phased Award Cooperative Agreement  

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

93.310  

Funding Opportunity Purpose

The purpose of this FOA is to solicit applications for continuation of a Coordinating Center to provide national leadership for the NIH Health Care Systems (HCS) Research Collaboratory program. The Coordinating Center will 1) further develop, adapt, and adopt technical and policy guidelines and best practices for the effective conduct of research studies in partnership with health care systems; 2) work collaboratively with each Demonstration Project team supported through the Collaboratory program, including their partnering health care systems, to develop, test, and implement the proposed Demonstration Projects while providing technical, design, and coordination support; 3) learn and disseminate the best strategies for engaging health care systems as research partners to improve health and care delivery; and 4) learn, develop, and disseminate the best means of conducting pragmatic clinical trials in health care systems to improve the scientific community’s ability to perform future pragmatic trials. The Coordinating Center will also serve as the central resource for the activities of the HCS Collaboratory.     

Key Dates
Posted Date

November 23, 2016

Open Date (Earliest Submission Date)

January 2, 2017

Letter of Intent Due Date(s)

30 days prior to the application due date

Application Due Date(s)

February 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)

February 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

June 2017  

Advisory Council Review

August 2017

Earliest Start Date

September 2017

Expiration Date

February 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

This initiative is funded through the NIH Common Fund, which supports cross-cutting programs that are expected to have exceptionally high impact. All Common Fund initiatives invite investigators to develop bold, innovative, and often risky approaches to address problems that may seem intractable or to seize new opportunities that offer the potential for transformation of research processes.

The overall goal of the NIH Health Care Systems (HCS) Research Collaboratory program is to strengthen the national capacity to implement cost-effective large-scale research studies that engage health care delivery organizations as research partners. Under the aegis of the NIH HCS Research Collaboratory Program, the NIH expects to:

1) establish a Coordinating Center that will provide national leadership and technical expertise in all aspects of research with HCS;

2) support the design and rapid execution of a set of high impact Demonstration Projects that will conduct research studies in partnership with health care delivery systems;

3) make available data, tools and resources from these and other 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 health care systems in clinical research, not to support a defined health care research network. Health care systems have interest in participating in studies that may potentially impact the care they deliver, including pragmatic clinical trials, longitudinal cohort studies, population-based studies and studies addressing the incorporation of new technologies into care. Research conducted in partnership with health care systems is essential to strengthen the relevance of research results to ‘real world’ health practice. Successful approaches and best practices established through this initiative for research partnerships with health care systems should have a major impact on clinical research in the US. (See http://commonfund.nih.gov/hcscollaboratory/).

Although the importance for biomedical research of 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 data from health care systems in understandable ways are not trivial. Health care providers’ focus is on providing the best treatment based on current knowledge whereas research studies have typically focused on studying which treatments work best in a precisely defined population. Research studies have frequently used endpoints that are not part of the normal evaluation of patients during a routine visit and interventions that are impractical in most care delivery settings. Policy issues can arise due to conflicts between the mission of delivering health care and that of generating new knowledge. Education and engagement of providers and patients on the value of research in the care setting are urgently needed. The NIH HCS Research Collaboratory program created a broad framework to tackle some of these major challenges and continued support will further address these issues.

Demonstration Projects will be selected based both on the importance of the scientific questions and the potential to address impediments to research with health care delivery organizations. The NIH anticipates funding an additional six-ten Demonstration Projects in addition to the ongoing Demonstration Projects. New Demonstration Projects will utilize a phased award UG3/UH3 mechanism, with a planning (UG3) and an implementation (UH3) phase.

During the UG3 phase the Demonstration Project team in cooperation with the Coordinating Center will develop detailed plans for site implementation; determine resource needs; test data extraction methods for patient identification and outcome assessment; review study design, statistical analytic plans, and study power; and develop plans for all aspects of ethical and regulatory oversight and protection of human subjects. All projects will be milestone-driven, and not all planning grants will necessarily move to the implementation phase.

The companion Common Fund FOA (RFA-RM-16-019), seeks applications for a third round of Pragmatic Clinical Trials Demonstration Projects.

Coordinating Center Overview

The Coordinating Center will continue to provide overall national leadership for the NIH Health Care Systems (HCS) Research Collaboratory program. The Coordinating Center will 1) further develop, adapt, and adopt technical and policy guidelines and best practices for the effective conduct of research studies in partnership with health care systems; 2) work collaboratively with each Demonstration Project team supported through the Collaboratory program, including their partnering health care systems, to develop, test, and implement the proposed Demonstration Projects while providing technical, design, and coordination support; 3) learn and disseminate the best strategies for engaging health care systems as research partners to improve health and care delivery; and 4) learn, develop, and disseminate the best means of conducting of pragmatic clinical trials in health care systems to improve the scientific community’s ability to perform future pragmatic trials. The Coordinating Center will also continue to serve as the central resource for the activities of the HCS Research Collaboratory program, coordinating activities and providing administrative support for the Steering Committee and its subcommittees.

As the national leader for the NIH Health Care Systems Research Collaboratory program in cooperation with NIH, the Program Director/Principal Investigator of the Coordinating Center is expected to have broad experience in working collaboratively with a variety of health care systems in extracting health care data for research and in managing the related regulatory, ethical, and policy issues. The ability to work collaboratively with multiple communities while providing strong leadership is a requirement.  In addition to a strong leader, the Coordinating Center must include individuals with broad experience (as detailed below) and ability to communicate clearly with all relevant stakeholders and work to find common ground.

The Coordinating Center is expected to have significant experience and knowledge in the following areas; the application should highlight the depth of experience and how it will be provided by the proposed team and structure.

  • Extracting information from electronic health records and relevant clinical systems for research; experience with multiple health care systems and EHRs is preferred
  • Knowledge of the latest regulatory requirements for conduct of research and for use of health care data for research and experience in conducting research that complies with the current and new regulations
  • Experience with the ethical issues related to clinical research, clinical care, quality improvement, population health, surveillance, and their boundaries
  • Conduct of multisite research studies with participation by multiple health care delivery organizations
  • Working collaboratively with others including patients, research participants, practitioners, researchers, hospital and research informatics and technical personnel, and senior managers of health care and research organizations
  • Workflows and practices of health care systems and their practitioners
  • Workflows and practices of research teams; experience in workflow for design and implementation of randomized studies should be highlighted
  • Knowledge, including an understanding of the strengths and weaknesses, of current data models, algorithms, and approaches used by various networks and studies to define clinical phenotypes, extract information, define endpoints, and discover errors in data from health care systems
  • Project management experience in taking a research question from idea through implementation to completion
  • Study design and statistical expertise, particularly in novel study designs and methods for pragmatic clinical trials
  • Creativity and innovation in solving technical and project challenges that respect and promote participation by all relevant communities
  • Reusable and sustainable models for incorporation of patient reported outcomes and patient reported assessments in health care EHRs and research study management tools, including electronic transfer of information from devices such as home glucose meters and blood pressure monitors, and use of smart phone or sensor data collection to enhance information available for pragmatic trials.
  • Development of training materials about how to conduct pragmatic clinical trials for the scientific community.

It is expected that the Coordinating Center will engage nationally with others working in similar areas and stay abreast of emerging experience, regulations, and technical advances that impact the ability of research to be conducted in health care settings. This could include NIH funded projects, such as eMERGE, PROMIS, and CTSAs, but also other federally and privately funded efforts, including Query Health and other programs supported by the Office of the National Coordinator for Health Information Technology (ONC), PCORNet and PCORI.

Specific Objectives of this Coordinating Center

The specific objectives of the Coordinating Center are:

1) further develop, adapt, and adopt technical and policy guidelines and best practices for the effective conduct of research studies in partnership with health care systems;

2) work collaboratively with each Demonstration Project team supported through the Collaboratory program, including their partnering health care systems, to develop, test, and implement the proposed Demonstration Projects while providing technical, design, and coordination support;

3) learn and disseminate the best strategies for engaging health care systems as research partners to improve health and care delivery; and

4) learn, develop, and disseminate the best means of conducting pragmatic clinical trials in health care systems to improve the scientific community’s ability to perform future pragmatic trials.

.  Activities to support the above four objectives could include, but are not limited to:

  • Building on the technical and policy experience of the many health care systems and researchers that have conducted studies that leverage electronic health record data and health care settings to address a variety of research questions 
  • Articulating basic requirements, including technical, policy, and workflow practices, for participation by health systems in research for a variety of types of research
  • Defining clearly the requirements for research that can be conducted in partnership with various health care systems so researchers better understand the types of research that can be done in these settings
  • Developing clear guidance and model agreements for addressing in uniform manner regulatory requirements for various types of studies conducted in single and multiple health care systems
  • Defining processes and best practices for ethical conduct of research in health care settings
  • Enabling input from health care system leadership, patients, family members, providers, researchers, and staff on research questions and study conduct to ensure feasibility.
  • Collaborating with related initiatives to share learnings and contribute to complementary efforts that support the conduct of research with health care systems
  • Developing short training modules/materials, methods and tools to widely disseminate Collaboratory endorsed policies, practices, and lessons learned, to inform best practices for the conduct of pragmatic clinical trials. Including presentation of resources and tools at national conferences and seminars.
  • Developing guidance and best practices about how to implement successful interventions from pragmatic clinical trials into other health care systems, and, when necessary, how to de-implement unsuccessful interventions.
  • Further developing tools and metrics that can be used to manage and track the quality and efficiencies of pragmatic clinical trials
  • Developing approaches to facilitate sharing of data and metadata (how the data are generated and coded) to improve the quality of analyses.
  • Developing guidance for engaging a wide range of health care systems, patients, and clinicians in pragmatic clinical trials

The exact boundaries of the activities of the Coordinating Center, the Demonstration Projects, and NIH are not possible to predict at this time, and will depend in large part on the capacities and experience of the Demonstration Project teams selected. 

The Coordinating Center will be responsible for facilitating harmonization and sharing of tools, guidance documents, best practices, and approaches within and across Demonstration Projects in this collaborative program. 

Administrative Support for HCS Research Collaboratory Program

Administrative activities of the CCC to support the HCS Research Collaboratory program could include but are not limited to:

  • provision of a public website for communication and sharing of activities, events, and resources of the program
  • private collaboration space for the demonstration projects during the planning phase of their projects
  • organizational and logistical support for facilitating the activities of the HCS Research Collaboratory Work Groups, and Steering Committee,
  • supporting standards and mechanisms for publicly sharing data, resources, phenotype definitions and algorithms, and code developed and utilized in HCS Research Collaboratory Demonstration Projects and by the Coordinating Center
  • organizing and supporting the logistics of face to face meetings of the HCS Research Collaboratory Work Groups and Steering Committee in the Bethesda MD area of a kick off and one annual meeting for one and half days in the first year of the competing award and annual meetings of similar length in following years.
HCS Research Collaboratory Program Governance

The awards funded under this FOA and the companion FOA will be cooperative agreements (see Section VI.2 Cooperative Agreement Terms and Conditions of Award). Close interaction with the NIH and with the awardees under the companion FOA will be required to accomplish the goals of this program.

HCS Research Collaboratory Work Groups will be established as the core collaborative activity of this program. The Work Groups will provide a forum for discussion of challenges and solutions across projects; harmonized and standardized policies and processes will be vetted in these groups.  Work Groups are expected to be established to cover the following topic areas (one work group could cover more than one topic area): Ethics/Regulatory; Biostatistics and Study Design; Phenotype, Data Standards and Data Quality; Patient-Reported Outcomes; Healthcare Systems Interaction; Electronic Health Records; and Stakeholder Engagement. Work Groups will be open to participation by individuals from all funded Demonstration Projects, the Coordinating Center, and the NIH. Workgroups should capture solutions and disseminate their findings via appropriate means such as peer reviewed publications, the Knowledge Repository, or white papers.

An HCS Research Collaboratory Steering Committee will be established to address issues that span all projects, provide input into the policies and processes of the HCS Research Collaboratory, and assist in dissemination of policies and processes that enable research in partnership with health care systems, their patients, and practitioners. At a minimum, the Steering Committee will be composed of one representative from each of the Demonstration Projects, one representative from each Work Group, one representative from the Coordinating Center, the NIH Program Coordinator, and representatives from various NIH ICs. All members are expected to actively participate in all Steering Committee activities. The combined vote of NIH membership may never exceed 1/3 of the total committee membership.

HCS Research Collaboratory Program External Advisory Panel (EAP)

An External Advisory Panel for the HCS Research Collaboratory program was established to review the progress of all components of the program and provide recommendations to the NIH. The members with relevant expertise were selected and invited by the NIH.  At the end of the third year of the program, the EAP recommended continuation of the program and the support of an additional round of pragmatic trials. The EAP will be convened again to make recommendations for the Program transition to other NIH Institutes and Centers at the midpoint of the next award period.

HCS Research Collaboratory Program Resources, Data, and Software Sharing

The HCS Research Collaboratory program encourages sharing of resources with broad availability of policies, practices, materials, and tools to facilitate collaboration, reuse, and replication.  In addition, the HCS Research Collaboratory program encourages sharing of study data from Demonstration Projects in a timely manner with appropriate privacy and confidentiality protections to facilitate further research, reuse of data, and replication.  Thus the HCS Research Collaboratory program expects grantees to implement a Resources and Data Sharing Plan consistent with these program goals.

In addition, the HCS Research Collaboratory program encourages sharing of software and code that are developed or modified to accomplish aims of this program.  This may include, but is not limited to, software, tools, or code sets for extraction or definition of data from EHRs, clinical systems, and other health care data systems; implementation of new workflows for research studies; analytic and analysis programs; and tools for incorporation of patient input.  The goals of software sharing under this program include 1) broad availability to biomedical researchers, health care delivery organizations, research institutions, and government health care systems and researchers; 2) terms that permit the dissemination and commercialization of enhanced or customized versions of the software, or incorporation of the software or components of it into other software packages; and 3)  terms of software availability that include the ability of individuals outside the applicant institution and its collaborating organizations to modify the source code and to share modifications with others.  While software development is not the primary goal of this program, it is expected that software or sets of code may be developed under this program by the Coordinating Center or the Demonstration projects, thus, grantees and their sub-contractors are expected to implement software sharing plans consistent with the goals of this program.

Coordinating Center Director Effort

The HCS Research Collaboratory Coordinating Center Director is the person(s) responsible for the overall management of the Coordinating Center and coordination with each of the Demonstration projects.  The relationship between the Coordinating Center and the Demonstration Projects should be one of equal partners in the planning phase. The Coordinating Center Director (or team of multiple PD/PIs) must devote at least 30% effort (3.6 person months) to this program.

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

Renewal

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

Funds Available and Anticipated Number of Awards

The NIH Common Fund intends to commit an estimated total of $1.5 to 2 million per year to fund 1 award.

Award Budget

Budget is limited to $2 million total costs per year.

Award Project Period

The maximum project period is 5 years.

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

Section III. Eligibility Information
1. Eligible Applicants
Eligible Organizations

The eligibility to apply to this FOA is limited to the Renewal of the current Coordinating Center for the Health Care Systems Research Collaboratory (U54). This limited competition will allow consortium agreement(s) to bring in needed expertise.

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.

2. Cost Sharing

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

3. Additional Information on Eligibility
Number of Applications

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

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

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

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:

Wendy Weber, N.D., Ph.D., M.P.H.
Telephone: 301-402-1272
Fax: 301-480-1587
Email:  weberwj@mail.nih.gov

Page Limitations

All page limitations described in the SF424 Application Guide and the Table of Page Limits must be followed.

For this specific FOA, the Research Strategy section is limited to 30 pages

Instructions for Application Submission

The following section supplements the instructions found in the SF424 (R&R) Application Guide and should be used for preparing an application to this FOA.

SF424(R&R) Cover

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

SF424(R&R) Project/Performance Site Locations

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

SF424(R&R) Other Project Information

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

SF424(R&R) Senior/Key Person Profile

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

R&R Budget

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

The applicant must include funds for the Coordinating Center PD/PI and key personnel to attend two one and half days HCS Research Collaboratory program meetings in the first year and an annual meeting in subsequent years in the Bethesda MD area.

The Coordinating Center Director (or team of multiple PD/PIs) must devote at least 3.6 person months effort to this program. The HCS Research Collaboratory Coordinating Center Director is the person responsible for the overall management of the Coordinating Center and coordination with each of the Demonstration projects. 

The budget should include funds for planning and hosting the face to face meetings of the Work Groups, Steering Committee, and any subcommittees.  Two one and a half day meetings of the Steering Committee should be planned in the first year of the renewal award and an annual Steering Committee meeting in subsequent years.  

R&R Subaward Budget

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

PHS 398 Cover Page Supplement

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

PHS 398 Research Plan

All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions: 

Research Strategy: Applicants should address how they will adhere to the NIH Policy on Good Clinical Practice Training. This policy establishes the expectation that all NIH-funded investigators and staff who are involved in the conduct, oversight, or management of clinical trials should be trained in Good Clinical Practice (GCP), consistent with principles of the International Conference on Harmonisation (ICH) E6 (R2). 

The principles of GCP help assure the safety, integrity, and quality of clinical trials. This Policy applies to NIH-funded investigators and clinical trial site staff who are responsible for the conduct, management and oversight of NIH-funded clinical trials (https://grants.nih.gov/grants/guide/notice-files/NOT-OD-16-148.html

The Collaboratory Coordinating Center will be interacting with teams of Demonstration Projects, the partner HCS and the NIH in this effort in working to develop and implement methods for projects across different HCS.

  • The application must describe how the previous period of funding was used to meet the program objectives and provide a proposed plan for each specific objective and administrative support for the continuation of the HCS Research Collaboratory program.
  • The application must provide information regarding the Coordinating Center activities, its staffing and the interactions with the Demonstration Projects as they plan and implement the pragmatic clinical trials. 
  • The Coordinating Center will have five to seven Work Groups that will work with the Demonstration Projects to assist with optimizing the design and implementation; gathering lessons learned across projects; and developing guidance and best practice documents. The application must provide details of the Work Groups including staffing, planned activities, and deliverables.  For example, the application must describe how Coordinating Center Work Groups will review the study design and biostatistical assumptions of the proposed Demonstration Projects; work with the Demonstration Project teams to develop detailed plans for site implementation, determine resource needs, test data extraction methods for patient identification and outcome assessment; and review plans for all aspects of ethical and regulatory oversight and protection of human subjects.
  • Applicants should describe processes through which the resources developed by the CCC will be made available to the community after the Common Fund period of support ends. The Health Care Systems Collaboratory Program is designed to establish best practices and resources to facilitate the establishment of pragmatic trials. Although centralized coordination will facilitate this process for the duration of this award, long term support for a central coordinating effort may or may not be required for future pragmatic trials. The software, hardware, licenses, standard operating procedures, best practices and other resources for pragmatic trial planning and management that will be developed through Common Fund support must be available to the community regardless of whether a centralized coordinating effort continues. Applications should describe plans to disseminate knowledge and expertise for pragmatic trial planning and oversight to the community. 
  • Applicants should describe their willingness to be flexible in determination of areas of responsibilities in this collaborative program. Applicants must indicate their willingness to cooperate with Demonstration Project teams supported in the companion FOAs and with the NIH in the development and design of research approaches, methods, processes, policies, and tools used in this program.  Applicants should describe their prior experience working collaboratively in research consortia and other collaborative projects to accomplish shared goals.

Coordinating Center Transition Plan: Although centralized coordination will be available for the duration of this award, long term support for a central coordinating effort may or may not be required for future pragmatic trials. Applicants should address how the software, hardware, licenses, standard operating procedures, best practices and other resources for pragmatic trial planning and management that were developed through Common Fund support will be made available to the community regardless of whether a centralized coordinating effort continues. Applicants should describe processes through which these resources will be made available to the community after the Common Fund period of support ends.

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:

The HCS Research Collaboratory program encourages sharing of resources with broad availability of policies, practices, materials, and tools to facilitate collaboration, reuse, and replication.  In addition, the HCS Research Collaboratory program encourages sharing of study data from Demonstration Projects in a timely manner with appropriate privacy and confidentiality protections to facilitate further research, reuse of data, and replication.  Thus the HCS Research Collaboratory program expects grantees to implement a Resources and Data Sharing Plan consistent with achieving these program goals. 

A Resources and Data Sharing Plan should be included in the application. 

Software Sharing Plan

The HCS Research Collaboratory program encourages sharing of software and code that are developed or modified to accomplish aims of this program.  This may include, but is not limited to, software, tools, or code sets for extraction or definition of data from EHRs, clinical systems, and other health care data systems; implementation of new workflows for research studies; analytic and analysis programs; and tools for incorporation of patient input.  While software development is not the primary goal of this program, it is expected that software or sets of code may be developed under this program by the Coordinating Center or the Demonstration Projects, thus, grantees and their sub-contractors are expected to implement a Software Sharing Plan consistent with achieving the goals of this program. 

A Software Sharing Plan, with appropriate timelines, is expected in the application.  There is no particular software dissemination license required for this program.  However, NIH does have goals for software sharing and reviewers will be instructed to evaluate the 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.

All applications, regardless of the amount of direct costs requested for any one year, should address a Data Sharing Plan.

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 Considerations on Resource and Data Sharing and Software Sharing which can be commented on by reviewers but are not 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 proposed Center address the needs of the research program that it will coordinate? Is the scope of activities proposed for the Center appropriate to meet those needs? Will successful completion of the aims bring unique advantages or capabilities to the research program?  

Specific to this FOA:

Will the Coordinating Center provide national leadership and engage all stakeholders in advancing policies and practices that enhance the broad participation of researchers and health care systems in research? If the aims of the center are achieved, how will clinical research, translation of research into practice, and participation by health care delivery organizations in research be improved? How will successful completion of the aims change the capability, methods, and technologies used in addressing research important to effect health improvement?

Investigator(s)

Are the PD(s)/PI(s) and other personnel well suited to their roles in the Center? Do they have appropriate experience and training, and have they demonstrated experience and an ongoing record of accomplishments in managing pragmatic trial research? Do the investigators demonstrate significant experience with coordinating collaborative clinical research? If the Center is multi-PD/PI, do the investigators have complementary and integrated expertise and skills; are their leadership approach, governance, plans for conflict resolution, and organizational structure appropriate for the Center? Does the applicant have experience overseeing selection and management of subawards, if needed?  

Specific to this FOA:

Do the personnel have the appropriate breadth of expertise and experience, including but not limited to, experience with data extraction in meaningful ways from EHRs and other clinical systems, experience with ethical issues related to research and care boundaries, experience in design, conduct, and analysis of research studies, and experience in collaborative research with a variety of stakeholders? Are the proposed leadership approach, staffing, governance and organizational structure appropriate for the project? Have they demonstrated an ongoing record of accomplishment in support of coordination, collaboration, and communication of large national-level inclusive networks or consortia? Are the investigators willing to collaborate with the NIH and Demonstration Project awardees to meet the goals and objectives of this program?  How well does the application describe how the investigative team is up to date on the changing landscape of health care systems research and participant protection regulations?

Innovation

Does the application propose novel organizational concepts or management strategies in coordinating the research program the Center will serve? Are the concepts, strategies, or instrumentation novel to one type of research program or applicable in a broad sense? Is a refinement, improvement, or new application of organizational concepts or management strategies proposed?   

Specific to this FOA:

Does the application challenge and seek to shift current research or clinical practice paradigms, national policies and practices, and enlarge participation in clinical research by utilizing novel theoretical concepts, approaches, methodologies, interventions, or tools? Does the application challenge and seek to impact current data management and research implementation strategies by utilizing novel theoretical concepts, approaches or methodologies, or tools? Is a refinement, improvement, or new application of approaches, concepts, or tools proposed? Does the application include mechanisms for leveraging novel collaboration and communication strategies? Does the application indicate creativity and flexibility to innovate on an ongoing basis?

Approach

Are the overall strategy, operational plan, and organizational structure well-reasoned and appropriate to accomplish the goals of the research program the Center will serve? Will the investigators promote strategies to ensure a robust and unbiased scientific approach across the program, as appropriate for the work proposed? Are potential problems, alternative strategies, and benchmarks for success presented? If the program is in the early stages of operation, does the proposed strategy adequately establish feasibility and manage the risks associated with the activities of the program? Are an appropriate plan for work-flow and a well-established timeline proposed?  Have the investigators presented adequate plans to ensure consideration of relevant biological variables, such as sex, for studies of vertebrate animals or human subjects?

Specific to this FOA:

Will the proposed activities facilitate flexible, modular, and scalable policies, practices, algorithms, protocols, and tools to enable broad collaboration and participation? Will the proposed approach allow efficient management upkeep of a public website? Will the proposed approach allow for the Coordinating Center personnel and collaborative tools to enable speedy Demonstration Project team planning and implementation? Is the plan for administrative support of the HCS Research Collaboratory program synergistic with the proposed plan for support of the Demonstration Projects and will it add to the productivity of the program?

Environment

Will the institutional environment in which the Center will operate contribute to the probability of success in facilitating the research program it serves? Are the institutional support, equipment and other physical resources available to the investigators adequate for the Center proposed? Will the Center benefit from unique features of the institutional environment, infrastructure, or personnel?  Are resources available within the scientific environment to support electronic information handling?

Additional Review Criteria

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

Protections for Human Subjects

For research that involves human subjects but does not involve one of the 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

For Renewals, the committee will consider the progress made in the last funding period.

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

Resource Sharing Plans

Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable: (1) Data Sharing Plan; (2) Sharing Model Organisms; and (3)  Genomic Data Sharing Plan (GDS). Additionally, Reviewers will evaluate the Software Sharing Plan relative to the following goals:

1.  The software should be freely available to biomedical researchers, health care delivery systems, research institutions, and government health care systems and researchers.

2.  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.

3.  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.

Authentication of Key Biological and/or Chemical Resources:

For programs 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:

  • Determining approaches, designing, and setting project milestones and implementing the project plan for the Coordinating Center
  • Cooperating in sharing knowledge and experience with various tools and approaches utilized in conducting research in health care settings, including their strengths and weaknesses
  • Cooperating in sharing issues related to data quality, data management, data biases and errors, query quality and sampling challenges, and pitfalls in utilization of health care data for research
  • Cooperating with each Demonstration Project awardees in the development and testing of implementation plans
  • Collaborating with other awardees in harmonizing and sharing of tools, methods, and approaches within and between Demonstrating Projects
  • Cooperating with others in sharing of study designs, methods, protocols, tools, and strategies
  • Participating in group activities, including program-wide Work Group and Steering Committee meetings
  • Facilitating comparability across Demonstration Projects when possible
  • Providing integrative, organizational, and logistical support for the entire program, including tracking, scheduling, and facilitating work group meetings, committee meetings, and conference calls, preparing concise minutes or summaries of meetings for distribution
  • Cooperating with other awardees in the publication and dissemination of program results and the eventual release to the scientific and healthcare communities of methods, tools, results, and other resources
  • Providing high-quality documentation as needed, particularly of protocols or approaches that have broad applicability across the program that will be sufficient for outside users to understand and apply to their research projects with minimal assistance
  • Providing expertise and leadership in addressing issues of broad applicability, such as informed consent, data sharing standards, analysis methodology, and dissemination
  • Sharing resources, data, and software according to the goals for the HCS Research Collaboratory program and approved Plans
  • Planning and hosting the face to face meetings of the Work Groups, Steering Committee, and any subcommittees
  • Planning for the HCS Research Collaboratory Program External Advisory Panel meetings
  • Developing short training modules/materials, methods and tools to widely disseminate Collaboratory endorsed policies, practices, and lessons learned, to inform best practices for the conduct of pragmatic clinical trials. Including presentation of resources and tools at national conferences and seminars
  • Agreeing to accept close coordination, cooperation, and management of the project with NIH, including those outlined under “NIH Responsibilities”
  • Submitting periodic progress reports, including materials for the mid-project EAP review at end of year 3, in a standard format, as agreed upon by the Steering Committee, the HCS RC Program External Advisory Panel (EAP), and the NIH.
  • 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 and goals of this program.

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

  • The NIH Program Coordinator will work with the CC Director (or team of co-PIs) and the Steering Committee to ensure the objectives of the program are being met.  The dominant role and prime responsibility for the program resides with the awardee, although specific tasks and activities will be shared among the awardee and the NIH Program Coordinator. 
  • The NIH Program Coordinator will provide technical assistance, advice, and coordination; however, the role of the NIH staff will be to facilitate and not to direct activities.  It is anticipated that decisions in all activities will be reached by consensus of the program and NIH staff will be given the opportunity to offer input to this process.
  • The NIH Program Coordinator serves as the contact point for addressing the program objectives with the awardee.
  • Serving as liaison between the Steering Committee and the NIH External Advisory Panel (EAP)
  • Additional NIH staff may participate in all work groups, implementation teams, and committees, including the Steering Committee, as appropriate. Participation by staff from other federal agencies may also be appropriate and advantageous to facilitate the activities of the program.
  • The NIH reserves the option to recommend withholding or reduction of support from activities that fail to achieve their goal or comply with the Terms and Conditions.
  • NIH staff may serve as resources for, or interface with, other ongoing NIH activities that may be relevant to the activities in the HSC Research Collaboratory to avoid duplication and facilitate collaboration and communication in overlapping areas.
  • Assist in development, design, and coordination of activities and projects
  • Responsibility for monitoring progress, which could include regular communications with grantee and coordinating center staff, periodic site visits, observation and review of demonstration project implementation plans and testing, and requests for additional reports or documentation
  • Attending the HCS Research Collaboratory Program External Advisory Panel (EAP) meetings and receiving a copy of the recommendations
  • Reporting periodically on progress of the program to the NIH Common Fund Executive Committee; Director, NCCIH; other interested IC Directors; and the National Advisory Council for Complementary and Integrative Health
  • An agency program official or IC program director will be responsible for the normal scientific and programmatic stewardship of the award and will be named in the award notice

Areas of Joint Responsibility include:

  • Awardee(s) agree to the governance through a Steering Committee.  An HCS Research Collaboratory Steering Committee will be established to address issues that span all projects, provide input into the policies and processes of the HCS Research Collaboratory, and assist in 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 Coordinating Center, the NIH Program Coordinator, and representatives from various NIH ICs.  All members are expected to actively participate in all Steering Committee activities.  The combined vote of NIH membership may never exceed 1/3 of the total committee membership.  
  • HCS Research Collaboratory Work Groups will be established as the core collaborative activity of this program. The Work Groups will provide a forum for discussion of challenges and solutions across projects; harmonized and standardized policies and processes will be vetted in these groups.  Work Groups are expected to be established to cover the following topic areas (one work group could cover more than one topic area): Ethics/Regulatory; Biostatistics and Study Design; Phenotype, Data Standards and Data Quality; Patient-Reported Outcomes; Healthcare Systems Interaction; Electronic Health Records; and Stakeholder Engagement.  Work Groups will be open to participation by individuals from all funded Demonstration Projects, the Coordinating Center, and the NIH. 
  • Establishment and adherence by each Demonstration Project Team (Demonstration Project grantee, Coordinating Center grantee, and NIH staff) to a written plan of engagement with timelines to ensure delineation of roles and timely delivery of the tested implementation plan
  • Demonstration Project grantees will work with the Coordinating Center and NIH, through all phase of their projects, including the implementation and close out phase, to assure all resources, materials, protocols, data, best practices, and lessons learned, as well as software or sets of code, are disseminated broadly through the Coordinating Center with all HCS Research Collaboratory program resources
  • All awardees and NIH will cooperate to ensure the timely and broad dissemination of all HCS Research Collaboratory program endorsed policies and practices and lessons learned in the program to inform researchers and health care systems engaged in research in health care settings

Dispute Resolution:

Any disagreements that may arise in scientific or programmatic matters (within the scope of the award) between award recipients and the NIH may be brought to Dispute Resolution. A Dispute Resolution Panel composed of three members will be convened. It will have three members: a designee of the Steering Committee chosen without NIH staff voting, one NIH designee, and a third designee with expertise in the relevant area who is chosen by the other two; in the case of individual disagreement, the first member may be chosen by the individual 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)

Wendy Weber, N.D., Ph.D., M.P.H.
National Center for Complementary and Integrative Health (NCCIH)
Telephone: 301-402-1272
Email: weberwj@mail.nih.gov

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

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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