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 (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-HMO Collaboratory Coordinating Center Limited Competition (U54)

Activity Code

U54 Specialized Center- Cooperative Agreements

Announcement Type

New

Related Notices

  • February 28, 2011 - See Notice NOT-RM-11-010 Notice of Technical Assistance Teleconference and Webinar for Applications to this RFA.

Funding Opportunity Announcement (FOA) Number

RFA-RM-11-003

Companion FOA

None

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 Cooperative Agreement (U54) award to develop and implement a Collaboratory Coordinating Center (CCC) as part of the HMO Collaboratory, supported through the NIH Common Fund. (See http://commonfund.nih.gov/hmocollaboratory/.) The long-term objective of this Common Fund project is to strengthen the capacity, capability and cost-effectiveness of conducting longitudinal large and multi-site studies using primary clinical data and samples in a distributed network of health care organizations. The overall goals of the CCC in the current FOA include: develop and expand infrastructure to support the long-term objectives of the project; develop appropriate governance structures; and evaluate the value of the infrastructure for possible larger-scale implementation. The work may include developing infrastructure and improving the methodology through the use of pilot projects to collect data from electronic databases containing demographic, administrative, clinical, and biospecimen information.  This methodology will ultimately assist in generating new evidence with which to evaluate healthcare interventions and will support research in personalized medicine, preventive strategies and population studies with community-based participation.  This work also will substantially enhance the Nation’s capability and capacity to systematically collect and curate prospective and retrospective data that will inform research in populations typically under-represented in randomized controlled clinical trials, such as patients with multiple co-morbidities, extremes of age, rural populations, and minorities.

Key Dates
Posted Date
Letter of Intent Due Date

April 27, 2011

Application Due Date(s)

May 27, 2011

AIDS Application Due Date(s)

Not Applicable

Scientific Merit Review

July, 2011

Advisory Council Review

August, 2011

Earliest Start Date(s)

September, 2011

Expiration Date

May 28, 2011

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.

Table of Contents

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

Part 2. Full Text of Announcement

Section I. Funding Opportunity Description

1. Background and Goals of the HMO Collaboratory

Three criteria that define the Collaboratory as a Common Fund program are that it should be transformative, cost effective, and collaborative. 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 rapid progress.

The goal of the HMO Collaboratory program, funded through the NIH Common Fund, is to leverage the scientific, data, and operational infrastructure within HMOs and potentially other health care delivery organizations to enable a range of transformative transdisciplinary research studies such as: large-scale and multi-site longitudinal studies that may include mega-epidemiology population-based studies; pragmatic clinical trials such as randomized group level community trials; longitudinal prospective cohort studies; and studies applying high-throughput methods to study human disease such as Genome-Wide Association Studies (GWAS).

Few programs support clinical or population science researchers irrespective of specialty or type of study. Fewer integrate the sharing and exchange of information from the routine health care environment with a focus on problems of high impact and interest to clinicians and patients.  In the last two decades, HMO research organizations have played valuable roles in a number of research projects and health surveillance activities funded by NIH institutes and centers (ICs) including the National Cancer Institute (NCI), the National Heart Lung and Blood Institute (NHLBI), the National Institute of Mental Health (NIMH), the National Institute on Drug Abuse (NIDA), and the National Center for Research Resources (NCRR), 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, these efforts have not been fully integrated, have provided limited central infrastructure support, and have not supplied the sustained investment necessary to optimize the substantial resources of HMOs for efficient clinical and health services research.

The HMO Collaboratory offers a unique opportunity for a collaboration of providers, patients, clinical researchers, informaticists, statisticians, economists, coordinators, ethicists, geneticists, and researchers from public and environmental health and social and behavioral science to develop solutions that could have a significant impact on the ability of research to advance treatment. Adoption of standards and best practices and a commitment to interoperability, as established through this initiative, could optimize collaborations and have a major impact.

This FOA solicits applications for the development of the HMO Collaboratory Coordinating Center (CCC) as part of the HMO Collaboratory program. The Collaboratory is expected to develop and test the capacity and capabilities of a distributed network of health care delivery organizations to conduct potentially transformative research using longitudinal data from large populations, including data from linked biospecimens. The Collaboratory program anticipates publishing separate funding announcements for demonstration research projects.  Data coordination activities for demonstration projects may take place at non-CCC sites but leverage infrastructure provided by the CCC.  Coordination activities for such projects will be funded under the demonstration research projects.

2. Research Objectives

The goal of this solicitation is to establish a Center that will provide clinical research teams and health care providers at HMOs and other health service delivery organizations with informatics and information technology (IT) processes and tools to enhance the collection and ensure the quality and security of research data and to enhance the research infrastructure from study concept through analysis, interpretation, and communication. These tools should focus on approaches for studies integrating data from high-throughput technologies, biorepositories, electronic health records (EHR) and registries and should have appropriate licenses to permit use by researchers inside and outside the Collaboratory program. Applicants are encouraged to partner with organizations with expertise in the integration of data.

One of the major problems in translating findings from basic research into clinical practice is lack of tools and robust processes for implementing single or multi-site studies at the level of community health care providers. The Collaboratory also may be well suited to measuring both the negative and positive health impacts of new treatments moving from tightly controlled randomized clinical trials (RCTs) into clinical practice.  Studies of the generalizability of RCT results, frequency of uncommon but severe adverse events, identification of which subpopulations benefit from new therapies, and relative value of new compared with old therapies require large numbers of patients to provide adequate power to reach conclusions.

Conducting clinical and translational research requires complex review and approval processes. Investigators frequently must interact with multiple institutional boards and committees prior to implementing research studies. After a study has received approval, researchers must frequently manually copy data from multiple electronic databases and note fields in hospital, clinic, and laboratory systems to spreadsheets or databases that may not be reproducible. The error rate for manual transfer is higher than for electronic transfer. While resources exist for some types of data transfer, the ability to integrate various sources of clinical, laboratory, and genetic data can be problematic for many small research teams and for persons involved in health care delivery. Collaboration across multiple sites also can be problematic for investigators who are not part of a large network. 

Currently, many projects that utilize health care network data have been implemented on a case-by-case basis in a manner that has not consistently resulted in reusable strategies for data extraction and well documented and maintained content. An investment in infrastructure through this solicitation is intended to build tools that will allow automated queries in order to speed health research and the evolution of health services, including support of current and future investigator initiated grants and to open the possibility of learning about the patient experience outside of trials using rigorous methods of observational data analysis, techniques of decision science, and other methods. For such an infrastructure to have maximal impact it must tie together individual sites and information not commonly part of the clinical research structure.

While large-scale specimen repositories exist, many studies lack access to well-documented, reliably collected biospecimens from large cohorts of well-characterized patients from a diversity of backgrounds.  There are numerous issues involved in a network biospecimen repository, including, protocols for collection and storage, distribution procedures, and information infrastructures to share existing genotype and phenotype data.  This solicitation is intended to develop an assessment of existing biospecimen resources, emerging methods for implementation of a biospecimen repository, and to assess barriers (and possible solutions) to participation in such a repository. 

Potential projects this infrastructure should be prepared to support in a cost-effective manner include but are not limited to:

3. Specific Areas of Research Interest

The CCC will function as the operational center of the Collaboratory, facilitating broad partnerships within and across participating entities. The Coordinating Center will oversee the development of an infrastructure intended to improve health research in a distributed network. In establishing the CCC, wherever possible, applicants should adopt or adapt resources of NIH supported or other national efforts in informatics including but not limited to the HMO Research Network (HMORN), the NIH Clinical Translational Sciences Awards (CTSA), REDCap, PROMIS®, NIH Toolbox, DEcIDE, eMERGE, CERTs, SHARP, Vaccine Safety Datalink, and the FDA Sentinel Initiative.  Applications should address the following goals, functions, and responsibilities:

3.1) IT and Infrastructure: Phased development of an efficient infrastructure to support efforts to facilitate health research in a distributed network of healthcare systems. Investigators are expected to use design and software engineering methods that are reusable, maintainable, simple, interoperable, and extensible.

3.2) Governance: Develop a governance structure that will promote collaboration across a network of distributed health care delivery systems members, multiple entities of the US Federal Government, healthcare experts, biomedical research experts, computer infrastructure experts, and other relevant parties. Applicants should provide adequate details of a governance plan for the Center oversight, especially on issues related to data and metadata standards, access, privacy, and confidentiality of patient information.  In addition, the governance plan should describe provisions for oversight and responsibility concerning operational issues and scientific and technical concerns related to study design, implementation, data analysis and communication of results. 

3.3) Clinical Study Support: Supply data coordination, study support and tools to improve efficiencies in diverse clinical studies, mega-epidemiological studies, and large-scale genomic studies such as GWAS conducted in a distributed network.

3.4) Biospecimen Repository Processes: Develop and evaluate processes and infrastructure to coordinate the collection, storage, and distribution of biospecimens at distributed or centralized locations and to build the information infrastructure to share genotype and phenotype information through authorized sites such as the VDW and dbGaP. This infrastructure should support large scale longitudinal studies.  Potential biospecimens should include but may not be limited to the use of discarded clinical samples (e.g. blood, plasma, serum, urine, tumors, other tissues) and the collection of samples obtained by consenting subjects at the time of a clinical interaction or after re-contact.

4. Distributed Network Critical Assessment and Evaluation Processes

4.1) Use Cases: Applicants should provide a description of a minimum of three Use Cases that are exemplars of the kinds of research that will be enabled by the Collaboratory and the proposed infrastructure and milestones. Preliminary data may include describing a similar project that may be on a smaller scale the applicant(s) and collaborators have participated in. This may include but is not limited to ongoing prospective longitudinal multi-institutional projects that make extensive use of the VDW, other curated data, or study design and implementation collaboration tools. Use Cases should be part of the planning of the proposed infrastructure and milestones and should be included in the Research Strategy under a separate subheading.

4.2) Evaluation: By the end of the first nine months of funding, the Coordinating Center is expected to provide the NIH with a detailed Distributed Network Critical Assessment (DNCA), described in detail below.  Throughout the grant period, the Coordinating Center will be asked to participate in regular milestone-driven evaluation and assessment of the HMO Collaboratory Program. The goal of these evaluations will be to monitor and assess the performance of the overall Collaboratory program and the Coordinating Center as a core component of the overall program. A major long-term goal of the HMO Collaboratory program is to assess the capacity of a distributed network of health care delivery organizations to improve on the cost-effectiveness of implementation of high quality large-scale studies. Applicants should provide a minimum half-page description as part of the Research Plan under a separate subheading describing what kinds of methods they will use to evaluate progress.

4.3) Milestones: This is a five year commitment with milestones. Preliminary yearly milestones for the Coordinating Center should be proposed in a one-page section at the end of the Research Strategy under a separate subheading. The DNCA will serve as a basis for negotiation with NIH program staff of detailed milestones for years 2-5.

4.4) DNCA: The NIH will use the DNCA to determine how well the HMO Collaboratory program is meeting programmatic priorities. In the DNCA it will be important to identify both research strengths and limitations of a distributed network. Areas to assess should relate back to the requirements listed for the IT and Infrastructure, Governance, Clinical Study Support, and Biospecimen Repository Processes sections of the application, and include but not be limited to:

The assessment should comment on the costs, feasibility, reusability, maintainability, simplicity, interoperability, and extensibility of the methods, structures, systems, and approaches assessed and whether they are consistent with ongoing national efforts to harmonize health IT standards.  The assessment should not be limited to the current HMORN and should include assessments of other potential research participants (e.g. other HMOs, health care organizations and delivery systems incorporating clinical information derived from EHRs). The assessment needs to make a statement about the IT support and system integration for clinical research and other large-scale biomedical research studies. Activities in support of the critical assessment may include appropriate technology acquisition, development and testing.

4.5) Transition Plan: The applicant should address how the proposed management of each specific objective 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 CCC.  Inclusion of approaches and activities that would facilitate the transition of the activities and infrastructure of the CCC, including content of the public website and collaboration site, at the end of the award period is required.

5. Additional Information

5.1) Minimum effort of personnel: The PD/PI must devote a minimum level of effort of 30% annually (3.6 calendar months) to the project.  A program manager/coordinator must devote a minimum level of effort of 50% annually (6 calendar months) to manage the project.  There must be an appropriate mix of time allocated for senior and junior scientists to ensure the successful conduct of the study.  Budgeted effort of other personnel must be appropriate to the needs of the project. 

5.2) Scientific Collaboration:  Applications must budget travel for several key persons (this number may be higher than 10) annually to an HMO Collaboratory program meeting, which may include multiple days of submeetings.  The staff to attend the meeting should include, at a minimum the project PD/PI(s), program manager/coordinator, lead informaticist and several VDW staff, lead biostatistician, lead epidemiologist, biospecimen lead, requisite staff for each of these parts, and based on project needs persons with backgrounds in environmental health sciences, health policy, economics, and social and behavioral sciences, and if applicable, PIs of main research projects and site PIs/coordinators.  

5.3) Organize meetings and regular conference calls of Collaboratory committees, sub-committees, annual business and program integration meetings, support the IT Advisory Panel and other committees as needed, organize periodic scientific meetings, as needed, to promote interactions, collaborations, project planning and analysis, and provide updates to NIH staff and affiliated research projects. 

5.4) Compile regular reports of accomplishments and roadblocks related to establishment of governance and effective operations, enhancement of data resources, and support for domain development and potential future research projects. Information is to be provided as requested by NIH staff on progress, budget, and projected plans to assist NIH staff in coordinating with the Collaboratory program. Updated reports will also be provided as necessary to the domain development and research study principal investigators.

5.5) Facilitate communications, data and information sharing, and development of collaborative manuscripts among HMO researchers and informaticists, NIH program staff, and non-HMO research principal investigators, as appropriate, involved in Coordinating Center activities including domain development projects and potential future research studies.

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, scientific or program staff will assist, guide, coordinate, or participate in project activities.

Application Types Allowed

New

The OER Glossary and the PHS398 Application Guide provide details on these application types.

Funds Available and Anticipated Number of Awards

The total amount of funds available for these awards is approximately $16 million for FY11-15, contingent upon receiving scientifically meritorious applications. One award is anticipated from this solicitation.

Award Budget

Total cost budget caps in each award year as follows: $4M in year 1, $3M in year 2, $3M in year 3, $3M in year 4, and $3M in year 5..

Award Project Period

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

Higher Education Institutions:

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

Nonprofits Other Than Institutions of Higher Education

For profit Organizations

Governments

Other

Non-domestic (non-U.S.) Entities (Foreign Organizations) are not eligible to apply. Foreign (non-U.S.) components of U.S. Organizations are not allowed.

The eligibility to apply in response to this FOA is limited to members of the HMO Research Network (HMORN). This limited competition will allow consortium agreement(s) with non-HMORN members..

Required Registrations

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.

All Program Directors/Principal Investigators (PD/PIs) 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 four (4) weeks prior to the application due date.

Eligible Individuals (Project Director/Principal Investigator)

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Project Director/Principal Investigator (PD/PI) 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 PHS398 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.

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.

Section IV. Application and Submission Information

1. Address to Request Application Package

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

2. Content and Form of Application Submission

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.

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 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

Application Submission

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 and all copies of the appendix material 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

Page Limitations

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

Research Plan

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

Organization of the Application 

The Research Strategy section should be organized to address the key elements of this funding opportunity.  The key elements are: IT and Infrastructure, Governance, Clinical Study Support, Biospecimen Repository Processes, Distributed Network Critical Assessment and Evaluation Processes (which includes Use Cases, Milestones, Evaluation Plan and Transition Plan).  The Research Strategy section should total 30 pages or less and include separate sections for each of the above elements.

Resource Sharing Plan

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:

Appendix

Do not use the appendix to circumvent page limits. Follow all instructions for the Appendix (please note all format requirements) as described in the PHS398 Application Guide, with the following modifications:

3. Submission Dates and Times

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.

4. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

5. 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.

6. Other Submission Requirements and Information

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.

Cooperative agreements: Awardees must agree to the "Cooperative Agreement Terms and Conditions of Award" in Section VI.2. "Award Administration Information". 

NIH considers the sharing of unique research resources developed through NIH-sponsored research an important means to enhance the value of, and advance research. When resources have been developed with NIH funds and the associated research findings published or provided to NIH, it is important that they be made readily available for research purposes to qualified individuals within the scientific community. If the final data/resources are not amenable to sharing, this must be explained in Resource Sharing section of the application. See http://grants.nih.gov/grants/policy/data_sharing/data_sharing_faqs.htm.

Data Sharing Plan: Regardless of the amount requested, applicants are expected to include a brief 1-paragraph description of how final data will be shared, or explain why data-sharing is not possible. Applicants are encouraged to discuss data-sharing plans with their NIH program contact. See Data-Sharing Policy or http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-032.html.

Plan for Sharing Software: A software dissemination plan, with appropriate timelines is expected to be included in the application in a separate heading in the Resource Sharing Plan(s) in the PHS398 Specific Research Plan Component. There is no particular software dissemination license required for this program, however reviewers will be asked to evaluate the dissemination plan based on its likely impact. A dissemination plan guided by the following principles is thought to promote the largest impact:

1.    The software should be freely available to biomedical researchers and educators in the non-profit sector, such as institutions of education, research institutions, and government laboratories. 

2.    The terms of software availability should include the ability of researchers outside the Center and its collaborating projects to modify the source code and to share modifications with other colleagues as well as with the Center. The terms should also permit the dissemination and commercialization of enhanced or customized versions of the software, or incorporation of the software or pieces of it into other software packages.

3.    To preserve utility to the community, the software should be transferable such that another individual or team can continue development in the event that the original investigators are unwilling or unable to do so.

4.    Applicants are asked to propose a plan to manage and disseminate the improvements or customizations of their tools and resources that are contributed by others. This proposal may include a plan to incorporate the enhancements into the “official” core software, may involve the creation of an infrastructure for plug-ins, or may describe some other solution.

The application is expected to include written statements from the officials responsible for intellectual property issues at all of the applicant institutions (including sub-contractors) to the effect that the institution supports and agrees to abide by software dissemination plans put forth in the application.  These letters should be clear expressions of commitment consistent with achieving the goals of the program.  A separate letter should be included from each institution or organization, including each subcontractor.   

The initial review group will comment on the appropriateness of the proposed plan for data sharing and the proposed plan for software sharing.    Program staff and advisors will also consider the adequacy of the dissemination plans as one of the criteria for award. The proposed sharing plans, after negotiation with the applicant when necessary, will be made a condition of the award. Evaluation of annual non-competing progress reports will include assessment of the responsiveness to NIH guidelines of data, materials, methods, and software dissemination practice by the grantee.

Post Submission Materials

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

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.

Overall Impact

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).

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 center that by its nature is not innovative may be essential to advance a field.

Significance

Does the center address important problems and critical barriers to progress in the field of clinical and translational research? If the aims of the center are achieved, how will scientific knowledge, technical capability, and clinical practice be improved? How will successful completion of the aims change the concepts, methods, and technologies used in large scale community-based clinical research? Will the proposed work achieve significant advances in the ability to perform large-scale and/or multi-site studies such as comparative effectiveness research, mega-epidemiology population-based studies, pragmatic clinical trials, randomized group level community trials?

Investigator(s)

Are the PD/PIs, collaborators, and other researchers well suited to the center? If Early Stage Investigators or New Investigators, or in the early stages of independent careers, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the center is collaborative or multi-PD/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the center? Do the PD/PIs and key personnel have the necessary expertise in statistics, data management, informatics, biospecimens, and study coordination to implement the proposed center and meet milestones and timelines? Have they demonstrated ongoing records of accomplishments in support of coordination, collaboration, and communication of large national-level consortia or networks?

Innovation

Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions? Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed. Does the application challenge and seek to impact current data management strategies by utilizing novel theoretical concepts, approaches or methodologies, or tools? Is a refinement, improvement, or new application of approaches 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 on-going basis? 

Approach

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the center? Are potential problems, alternative strategies, and benchmarks for success presented? If the center is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed?
If the center involves clinical research, are the plans for 1) protection of human subjects from research risks, and 2) inclusion of minorities and members of both sexes/genders, as well as the inclusion of children, justified in terms of the scientific goals and research strategy proposed?   

Environment

Will the scientific environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment and other physical resources available to the investigators adequate for the center proposed? Will the center benefit from unique features of the scientific environment, subject populations, or collaborative arrangements?

Additional Review Criteria

As applicable for the center 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.

Information Technology and Informatics

Does the application propose effective technologies and processes to track use of new tools and user feedback?  Does the proposed data structure promote interaction, data harmonization, data linkages, data fidelity, cost-effectiveness, integration of new sites, and safe-guarding of patient and provider confidentiality?  Is there effective use of existing informatics resources?  Are there appropriate approaches for making the software available to biomedical researchers and educators in the non-profit sector?  Are there appropriate approaches to manage and disseminate the improvements or customizations of their tools and resources that are contributed by others, consistent with achieving the program goals?

Governance

Does the application propose procedures to maximize research capacity, capability and collaborations across and within future research study sites?  Does the proposed governance structure promote constructive collaborations with NIH Program Director(s), NIH Project Scientist(s), NIH Working Group, IT Advisory Panel, and other committees and panels? Are there adequate plans relating to staff training, data collection, and multi-site management?  Are committee structures appropriate to the complexity of the work?

Clinical Study Support

Does the application propose effective processes for coordinated review of human subjects oversight issues, and practices and protocol templates for assuring human subjects protections?  Are there adequate plans to develop and disseminate clinical best practices?  Are there effective plans to assess Collaboratory infrastructure to support clinical studies?  Are there adequate plans to develop an extensible set of clinical study resources and tools? Are there effective procedures to enable collection and tracking of stakeholder input, and means to incorporate stakeholder input into the research process?

Biospecimen Repository Processes

Does the application adequately address the standardization/quality control of, and adherence to, the protocol and data collection and/or distribution guidelines?   Are there effective plans to develop best practices and models for protections with respect to ethical, legal, and social issues (ELSI)?  Are there effective plans to assess barriers to participation in the repository?

Distributed Network Critical Assessment, Use Cases, Milestones, Evaluation Plan and Transition Plan

Do the use cases demonstrate the kinds of research that could be conducted by the Collaboratory?  Are there adequate plans to document all activities, products, and procedures?  Are there adequate plans to perform a critical assessment of data architecture of the HMORN and potential research participants? Are there effective plans to identify the specific data and information components and needs for expansion of data resources to create a more effective and efficient research infrastructure?  Are there adequate methods to prioritize tasks needed for enhancement of data resources needed to support future projects?  Does the application provide adequate yearly milestones? Are there effective metrics and timelines?   Will the proposed approach and documentation facilitate transition of the content and activities of the coordinating center to a successor at the end of the project period?

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 center 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

The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following five points: 1) proposed use of the animals, and species, strains, ages, sex, and numbers to be used; 2) justifications for the use of animals and for the appropriateness of the species and numbers proposed; 3) adequacy of veterinary care; 4) procedures for limiting discomfort, distress, pain and injury to that which is unavoidable in the conduct of scientifically sound research including the use of analgesic, anesthetic, and tranquilizing drugs and/or comfortable restraining devices; and 5) methods of euthanasia and reason for selection if not consistent with the AVMA Guidelines on Euthanasia. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal Section.

Biohazards

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

Resubmissions

Not Applicable

Renewals

Not Applicable

Revisions

Not Applicable

Additional Review Considerations

As applicable for the center 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

Reviewers will assess the information provided in this section of the application, including 1) the Select Agent(s) to be used in the proposed research, 2) the registration status of all entities where Select Agent(s) will be used, 3) the procedures that will be used to monitor possession use and transfer of Select Agent(s), and 4) plans for appropriate biosafety, biocontainment, and security of the Select Agent(s).

Resource Sharing Plans

Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable: 1) Data Sharing Plan; 2) Sharing Model Organisms; and 3) 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.

2. Review and Selection Process

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 (assignments will be shown in the eRA Commons), in accordance with NIH peer review policy and procedures, using the stated review criteria.

As part of the scientific peer review, all applications:

Applications will be assigned on the basis of established PHS referral guidelines to the appropriate NIH Institute or Center and 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 (NACCAM). The following will be considered in making funding decisions:

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

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 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.

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.

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:

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

Areas of Joint Responsibility include:

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 Non-Competing Continuation Grant Progress Report (PHS 2590) annually and financial statements as required in the NIH Grants Policy Statement.

A final progress report, invention statement, and Financial Status Report are required when an award is relinquished when a recipient changes institutions or when an award is terminated.

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. 

Section VII. Agency Contacts

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

Application Submission Contacts

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Telephone 301-435-0714
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

Scientific/Research Contact(s)

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

Peer Review Contact(s)

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

Financial/Grants Management Contact(s)

George Tucker, MBA
National Center for Complementary and Alternative Medicine (NCCAM)
Telephone: 301-594-9102
Email: tuckerg@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 Parts 74 and 92.


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