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 (http://dpcpsi.nih.gov/osc/). The FOA will be administered by the National Center for Complementary and Alternative Medicine (NCCAM) on behalf of the NIH.
Funding Opportunity Title	NIH Health Care Systems Research Collaboratory - Coordinating Center (U54)
Activity Code	U54 Specialized Center- Cooperative Agreements
Announcement Type	New
Related Notices	Janaury 26, 2012 - See Notice NOT-RM-12-012. The purpose of this notice is to inform the research community that a technical assistance videocast will be conducted.
Funding Opportunity Announcement (FOA) Number	RFA-RM-11-021
Companion FOA	RFA-RM-12-002, UH2/UH3 Phase Innovation Awards Cooperative Agreement
Number of Applications	See Section III. 3. Additional Information on Eligibility.
Catalog of Federal Domestic Assistance (CFDA) Number(s)	93.310
FOA Purpose	The purpose of this FOA is to solicit applications for a Coordinating Center to provide national leadership for the NIH Health Care Systems (HCS) Research Collaboratory program. The Coordinating Center will 1) 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, including their partnering health care systems, to develop and test an implementation plan for the proposed Demonstration Projects while providing technical, design, and coordination support; and 3) disseminate widely Collaboratory endorsed policies and practices and lessons learned in the Demonstration Projects to inform best practices for broad participation of health care systems and their patients, practitioners, and staff in research studies to improve health and care delivery. The Coordinating Center will also serve as the central resource for the activities of the HCS Research Collaboratory program, including providing administrative support for the Steering Committee and its subcommittees.

Posted Date	January 24, 2012
Open Date (Earliest Submission Date)	March 27, 2012
Letter of Intent Due Date	March 27, 2012
Application Due Date(s)	April 27, 2012
AIDS Application Due Date(s)	Not Applicable
Scientific Merit Review	June, July 2012
Advisory Council Review	August, 2012
Earliest Start Date(s)	September, 2012
Expiration Date	April 28, 2012
Due Dates for E.O. 12372	Not Applicable

Required Application Instructions

It is critical that applicants follow the instructions in the PHS398 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. While some links are provided, applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions. Applications that do not comply with these instructions may be delayed or not accepted for review.

Part 1. Overview Information
Part 2. Full Text of 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

Nature of the Health Care Systems Research Collaboratory Program

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:

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

ii. 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;

iii. 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/).

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 (AHRQ), the Centers for Disease Control and Prevention (CDC), and the Food and Drug Administration (FDA). However, most studies have utilized health care data, but have not conducted studies that require active engagement of patients or their practitioners as research participants or researchers. Moreover, these efforts have generally focused on the needs of specific studies and not on the overall process for engaging health care systems as partners.

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 is urgently needed. This NIH HCS Research Collaboratory program will create a broad framework to tackle some of these major challenges.

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 approximately six Demonstration Projects each year for the first three years of the funding period of this program. Demonstration Projects will utilize a phased award UH2/UH3 mechanism, with a planning (UH2) and an implementation (UH3) phase. The Coordinating Center will be responsible for providing support for the UH2 phase of these awards which will generally be one year in duration. Coordinating functions for the second (UH3) phase will be developed and negotiated separately. During the UH2 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, 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 be selected to move to the implementation phase.

The first companion solicitation, Common Fund FOA (RFA-RM-12-002), seeks applications for Pragmatic Clinical Trials Demonstration Projects.

Coordinating Center Overview

The Coordinating Center will provide overall national leadership for the NIH Health Care Systems (HCS) Research Collaboratory program. The Coordinating Center will 1) 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, including their partnering health care systems, to develop and test an implementation plan for the proposed Demonstration Projects while providing technical, design, and coordination support; and 3) disseminate widely Collaboratory endorsed policies and practices and lessons learned in the Demonstration Projects to inform best practices for broad participation of health care systems and their patients, practitioners, and staff in research studies to improve health and care delivery. The Coordinating Center will also serve as the central resource for the activities of the HCS Research Collaboratory program, including 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 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 is preferred
• Knowledge of the regulatory requirements for conduct of research and for use of health care data for research and experience in conducting research that complies with the 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 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
• 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

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 the Beacon Communities Program supported by the Office of the National Coordinator for Health Information Technology (ONC).

Specific Objectives of this Coordinating Center

The specific objectives of the Coordinating Center are:

1) 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, including their partnering health care systems, to develop and test an implementation plan for the proposed Demonstration Projects while providing technical, design, and coordination support;

3) disseminate widely Collaboratory endorsed policies and practices and lessons learned in the Demonstration Projects to inform best practices for broad participation of health care systems and their patients, practitioners, and staff in research studies to improve health and care delivery.

The applicant should describe their plans for accomplishing each of the above three objectives. Such activities 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
• Incorporating best practices from various EHR-research and surveillance networks and the experience in data exchange for health care and quality measurement
• Implementing a flexible model that allows reuse or extension of phenotypes, protocols, and algorithms developed in prior studies and in other programs to address new 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
• Providing a template or mechanism for sharing modular descriptions of phenotypes, outcomes, workflows, etc. that can be shared, reused, and extended by others and contributed back to enrich the resources and framework for future studies in partnership with health care systems
• 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.

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 responsibilities will need to be negotiated once the program is funded and started. Applicants should describe their willingness to be flexible in determination of areas of responsibilities in this collaborative program.

The Coordinating Center will be responsible for facilitating harmonization and sharing of tools and approaches within and across Demonstration Projects 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.

Administrative Support for HCS Research Collaboratory Program

Applicants should also describe their plans for providing administrative support for the activities of the HCS Research Collaboratory program, including but 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, Steering Committee, and HCS Research Collaboratory External Advisory Panel (EAP) (see below)
• supporting standards and mechanisms for publically sharing data, resources, and code developed and utilized in HCS Research Collaboratory Demonstration Projects and by the Coordinating Center
• organizing and supporting the logistics of two face to face meetings of the HCS Research Collaboratory Work Groups and Steering Committee in the Bethesda MD area of approximately one and half days in the first year and annual meetings of similar length in following years.

HCS Research Collaboratory Program Governance

The awards funded under this FOA and the companion FOAs 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 FOAs 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 in the following areas, at a minimum: Technical/Data, Ethical/Regulatory, Design/Statistical, and Phenotype/Outcome Description. Work Groups will be open to participation by individuals from all funded Demonstration Projects, the Coordinating Center, and the NIH.

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 40 percent.

HCS Research Collaboratory Program External Advisory Panel (EAP)

An External Advisory Panel for the HCS Research Collaboratory program will be established to review the progress of all components of the program and provide recommendations to the NIH. The members with relevant expertise will be selected and invited by the NIH. It is expected to have 6-8 permanent members; however, the membership may be enlarged permanently or on an ad hoc basis as needed. The EAP will meet twice a year, one in person meeting and one telephone conference. At least once a year, there will be a joint meeting with the Steering Committee to allow members of both the EAP and the Steering Committee to interact directly. Twice a year the EAP will make recommendations in writing regarding progress of the program to NIH, including changes, if any, which would benefit the program. At the end of year 3, the EAP will provide recommendations for the continuation or termination of the program, including possible models for sustainability, if continuation is recommended. 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 HSC 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 relationship between the Coordinating Center and the Demonstration Projects should be one of equal partners in the planning phase. The Coordinating Center Director must devote at least 30% effort (3.6 person months) to this program.

Coordinating Center Support for Work Group and Steering Committee Meetings

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

Coordinating Center Transition Plan

The application should address how the proposed plan for each specific objective and administrative support of the HCS Research Collaboratory program would facilitate the transition of those activities to a potential successor at the end of the five-year project period. This should include ongoing documentation of required software, hardware, and licenses, as well as ongoing maintenance of standard operating procedures, best practices, and other documentation for management of the CC. Inclusion of approaches and activities that will facilitate the transition of the activities and infrastructure of the CC, including content of the public website and collaboration site, at the end of the award period is required. Continuation of the Coordinating Center beyond five years is unknown at this time.

Funding Instrument	Cooperative Agreement
Application Types Allowed	New
Funds Available and Anticipated Number of Awards	The total amount of funds available for these awards is approximately $2 million for fiscal year 2012 contingent upon receiving scientifically meritorious proposals. One award is anticipated from this solicitation.
Award Budget	Total costs requested for the first three years may not exceed $2 million per year; total costs for years 4 and 5 may not exceed $1.5 million per year.
Award Project Period	The total project period for an application submitted in response to this FOA may not exceed 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.

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

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)

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

Applicant organizations must complete the following registrations as described in the PHS398 Application Guide to be eligible to apply for or receive an award. Applicants must have a valid Dun and Bradstreet Universal Numbering System (DUNS) number in order to begin each of the following registrations.

• Central Contractor Registration (CCR) must maintain an active registration, to be renewed at least annually
• eRA Commons

All Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) must also work with their institutional officials to register with the eRA Commons or ensure their existing eRA Commons account is affiliated with the eRA Commons account of the applicant organization.

All registrations must be completed by the application due date. Applicant organizations are strongly encouraged to start the registration process at least 4-6 weeks prior to the application due date.

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.

Multiple PD(s)/PI(s) are not allowed in response to this FOA.

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

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

NIH will not accept any application in response to this FOA that is essentially the same as one currently pending initial peer review unless the applicant withdraws the pending application. NIH will not accept any application that is essentially the same as one already reviewed.

Applicants are required to prepare applications according to the current PHS 398 application forms in accordance with the PHS 398 Application Guide.

It is critical that applicants follow the instructions in the PHS398 Application Guide, except where instructed in this funding opportunity announcement to do otherwise. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.

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 research
• Name, address, and telephone number of the PD(s)/PI(s)
• Names of other key personnel
• Participating institutions
• Number and title of this funding opportunity

The letter of intent should be sent to:

Laura Lee Johnson, Ph.D.
National Center for Complementary and Alternative Medicine (NCCAM)
6707 Democracy Blvd.
Suite 401, MSC 5475
Bethesda, MD 20892-5475 (For FedEx, etc., use 20817)
Telephone: 301-435-2591
Email: johnslau@mail.nih.gov

Applications must be prepared using the PHS 398 research grant application forms and instructions for preparing a research grant application. Submit a signed, typewritten original of the application, including the checklist, and three signed photocopies in one package to:

Center for Scientific Review
National Institutes of Health
6701 Rockledge Drive, Room 1040, MSC 7710
Bethesda, MD 20892-7710 (U.S. Postal Service Express or regular mail)
Bethesda, MD 20817 (for express/courier service; non-USPS service)

At the time of submission, two additional paper copies of the application must be sent to:

Dale Birkle Dreer, Ph.D.
National Center for Complementary and Alternative Medicine (NCCAM)
6707 Democracy Blvd.
Suite 401, MSC 5475
Bethesda, MD 20892-5475 (For FedEx, etc., use 20817)
Telephone: 301-451-6570
Email: birkled@mail.nih.gov

All page limitations described in the PHS398 Application Guide and the Table of Page Limits must be followed, with the following exceptions or additional requirements:

• Research Strategy section is limited to 30 pages.

All instructions in the PHS398 Application Guide must be followed, with the following additional instructions:

1. Specific Aims is limited to one page.

2. Research Strategy, including tables, graphs, figures, diagrams, and charts, is limited to 30 pages.

Organization of the Application: The Research Strategy section should be organized to address the three specific objectives of this funding opportunity (development of technical and policy guidelines and best practices, development and testing of implementation plans for demonstration projects, and dissemination of policies and practices) and the proposed plan for coordination and administrative support of the HCS Research Collaboratory program. The Research Strategy section should total 30 pages or less and include separate sections for each of the above components, including highlighting expected experience and knowledge.

Ensure the application addresses all Other Submission Requirements as outlined in Section IV.6 and addresses all Review Criteria as detailed in Section V.1. Include letters of support from participating institutions and organizations who must agree to adopt and implement the proposed Resources and Data Sharing Plan and Software Sharing Plan. However, do not include letters of support from anyone not specifically needed to carry out the project. Organization, clarity, and completeness are encouraged.

Sharing Plans

Individuals are required to comply with the instructions for the Resource Sharing Plans (Data Sharing Plan, Sharing Model Organisms, and Genome Wide Association Studies (GWAS)) as provided in the PHS398 Application Guide, with the following modifications:

NIH considers the sharing of unique research resources developed through NIH-sponsored research an important means to enhance the value of, and advance research. If the final data/resources are not amenable to sharing, this must be explained in the proposed Sharing Plans.

Resources and Data Sharing Plan

The HCS Research Collaboratory program encourages sharing of resources with broad availability of policies, practices, materials, and tools to facilitate collaboration, reuse, and replication. In addition, the HCS Research Collaboratory program encourages sharing of study data from 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 is expected to be included in the application. The initial review group will comment on the appropriateness and adequacy of the proposed Resources and Data Sharing Plan. These comments will be factored into the determination of the overall score. Program staff and advisors will also consider the adequacy of the proposed plan as one criterion for award. The proposed Resources and Data Sharing Plan, after negotiation with the applicant when necessary, will be made a condition of award. Evaluation of the annual non-competing progress reports will include assessment of the responsiveness to the Resources and Data Sharing Plan included in the Notice of Award.

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 to be included 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:

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.

The review group will comment on the appropriateness and adequacy of the proposed Software Sharing Plan to meet the goals of the NIH in this program and factor their review into the determination of the overall score. Program staff and advisors will also consider the adequacy of the proposed plan as one of the criteria for award. The proposed Software Sharing Plan, after negotiation with the applicant when necessary, will be made a condition of the award. Evaluation of the annual non-competing progress reports will include assessment of the responsiveness to the Software Sharing Plan included in Notice of Award.

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.

Appendix

No Appendix Materials are allowed.

Part I. Overview Information contains information about Key Dates.

Information on the process of receipt and determining if your application is considered on-time is described in detail in the PHS398 Application Guide.

Applicants may track the status of the application in the eRA Commons, NIH’s electronic system for grants administration.

This initiative is not subject to intergovernmental review.

All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.

Pre-award costs are allowable only as described in the NIH Grants Policy Statement.

Applications must be received on or before the due dates in Part I. Overview Information. If an application is received after that date, it will not be reviewed.

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

Special Requirements that must be addressed in the application.

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

The application should address how the proposed plan for each specific objective and administrative support of the HCS Research Collaboratory program would facilitate the transition of those activities to a potential successor at the end of the five-year project period. This should include ongoing documentation of required software, hardware, and licenses, as well as ongoing maintenance of standard operating procedures, best practices, and other documentation for management of the CC. Inclusion of approaches and activities that will facilitate the transition of the activities and infrastructure of the CC, including content of the public website and collaboration site, at the end of the award period is required. Continuation of the Coordinating Center beyond five years is unknown at this time.

The HSC 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 relationship between the Coordinating Center and the Demonstration Projects should be one of equal partners in the planning phase. The Coordinating Center Director must devote at least 30% effort (3.6 person months) to this program.

Cooperative agreements: Awardees must agree to the "Cooperative Agreement Terms and Conditions of Award" in Section VI.2. "Administrative and National Policy Requirements".

Applicants are required to follow the instructions for post-submission materials, as described in NOT-OD-10-115.

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 Resource and Data Sharing and Software Sharing which require comment by reviewers and which are to be considered when determining the overall impact score.

Reviewers will provide an overall impact/priority score to reflect their assessment of the likelihood for the center 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 center proposed).

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

Significance

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), collaborators, and other personnel well suited to the project? 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 objectives of this program?

Innovation

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, approach, and implementation well-reasoned and appropriate to accomplish the stated specific objectives of the project? Are potential problems, alternative strategies, and benchmarks for success presented? 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 rapid deployment and management of a public website? Will the proposed approach allow for rapid deployment of Coordinating Center personnel and collaborative tools to enable speedy Demonstration Project team planning and testing? Is the plan for administrative support of the 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

Does the environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment and other physical resources available and adequate to ensure a rapid start and continuing support for the center? Will the project benefit from unique features of the institutional environment, workforce, or collaborative arrangements?

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

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 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.

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 Human Subjects Protection and Inclusion Guidelines.

Inclusion of Women, Minorities, and Children

When the proposed project involves clinical research, the committee will evaluate the proposed plans for inclusion of minorities and members of both genders, as well as the inclusion of children. For additional information on review of the Inclusion section, please refer to the Human Subjects Protection and Inclusion Guidelines.

Vertebrate Animals

Generally not applicable. Reviewers should bring concerns to the attention of the SRO.

Biohazards

Generally not applicable. Reviewers should bring concerns to the attention of the SRO.

Resubmissions

Not Applicable.

Renewals

Not Applicable.

Revisions

Not Applicable.

As applicable for the project proposed, reviewers will consider each of the following items, but will not give scores for these items, and should not consider them in providing an overall impact/priority 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) Sharing Model Organisms; and 2) Genome Wide Association Studies (GWAS).

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.

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s) convened by the National Center for Complementary and Alternative Medicine, in accordance with NIH peer review policy and procedures, using the stated review criteria. Review assignments 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/priority score.
• Will receive a written critique.

Appeals of initial peer review will not be accepted for applications submitted response to this FOA.

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 Alternative Medicine. 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.
• Policies consistent with goals for resources and data sharing and sharing of software.
• Complementarity to and synergy with other funded projects.

Additional criteria for award will include:

• Willingness of PD(s)/PI(s) to collaborate with the NIH and with other investigative groups participating in the program.

After the peer review of the application is completed, the PD(s)/PI(s) will be able to access his or her Summary Statement (written critique) via the eRA Commons.

Information regarding the disposition of applications is available in the NIH Grants Policy Statement.

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

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

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

Any application awarded in response to this FOA will be subject to the DUNS, CCR Registration, and Transparency Act requirements as noted on the Award Conditions and Information for NIH Grants website.

All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement.as part of the NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General and Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Grantees, and Activities. More information is provided at Award Conditions and Information for NIH Grants.

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 and hosting the HCS Research Collaboratory Program External Advisory Panel meetings
• 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 Principal Investigator 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, NCCAM; other interested IC Directors; and the National Advisory Council for Complementary and Alternative Medicine
• 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 40 percent.
• 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 in the following areas, at a minimum: Technical/Data, Ethical/Regulatory, Design/Statistical, and Phenotype/Outcome Description. 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.

When multiple years are involved, awardees will be required to submit the Non-Competing Continuation Grant Progress Report (PHS 2590) annually and financial statements as required in the NIH Grants Policy Statement.

Additionally, awardees will be required to submit quarterly reports that describe the status and progress of all components of the project. The quarterly reports will be used as a management tool for the NIH. Reporting on cost will also be required.

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.

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

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Telephone 301-710-0267
TTY 301-451-5936
Email: GrantsInfo@nih.gov

eRA Commons Help Desk(Questions regarding eRA Commons registration, tracking application status, post submission issues)
Phone: 301-402-7469 or 866-504-9552 (Toll Free)
TTY: 301-451-5939
Email: commons@od.nih.gov

Laura Lee Johnson, Ph.D.
National Center for Complementary and Alternative Medicine (NCCAM)
Telephone: 301-435-2591
Email: johnslau@mail.nih.gov

Elaine Collier, M.D.
National Center for Advancing Translational Sciences (NCATS)
Telephone: 301-435-0794
Email: ec5x@nih.gov

Dale Birkle Dreer, Ph.D.
National Center for Complementary and Alternative Medicine (NCCAM)
Telephone: 301-451-6570
Email: birkled@mail.nih.gov

George Tucker, MBA
National Center for Complementary and Alternative Medicine (NCCAM)
Telephone: 301-594-9102
Email: tuckerg@mail.nih.gov

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

Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and 45 CFR Parts 74 and 92.