Part I Overview Information

Department of Health and Human Services

Participating Organizations
National Institutes of Health (NIH), (http://www.nih.gov)

Components of Participating Organizations
National Institute of Mental Health (NIMH), (http://www.nimh.nih.gov)

Title: Leveraging Existing Health care Networks to Transform Effectiveness Research (U19)

Announcement Type

New

Request For Applications (RFA) Number:  RFA-MH-10-030

Catalog of Federal Domestic Assistance Number(s)
93.242

Key Dates
Release Date: November 9, 2009
Letters of Intent Receipt Date:  December 11, 2009
Application Receipt Date:  January 12, 2010
Peer Review Date:  March 2010
Council Review Date:  May 2010
Earliest Anticipated Start Date:  July 1, 2010 
Additional Information To Be Available Date (Url Activation Date): N/A
Expiration Date: January 13, 2010

Due Dates for E.O. 12372

Not Applicable

Additional Overview Content

Executive Summary

• Purpose.  This Funding Opportunity Announcement (FOA), issued by the National Institute of Mental Health (NIMH), solicits grant applications for a three-year cooperative agreement from researchers with experience conducting studies within large integrated health care delivery systems to develop and support a Mental Health Research Network (MHRN).  Respondents to the FOA will develop infrastructure that will leverage existing health care delivery systems to efficiently test the effectiveness of treatment, preventive and services interventions to improve care for people with mental disorders.  Applicants will propose a research infrastructure that demonstrates the ability to identify, recruit and enroll large patient populations into effectiveness trials, harmonize electronic medical record data across multiple integrated systems for research use, pool data for common analyses, and build capacity for the collection and storage of biologic material.  In addition, the MHRN program will conduct multi-site, collaborative, Mental Health research projects using integrated data systems, including at least one pilot intervention effectiveness study and perform short-term investigations of emerging mental health issues within health care systems,
• Mechanism of Support. This FOA will utilize the NIH Multi-Project Cooperative Agreement (U19) award mechanism
• Funds Available and Anticipated Number of Awards.  NIMH intends to commit approximately $3.0 million in FY 2010 to fund 1 new grant in response to this FOA. An award issued under this FOA is contingent upon the availability of funds and the receipt of a sufficient number of meritorious applications.
• Budget and Project Period.  Budgets for total costs of up to $3,000,000 per year and a total project period of up to three years may be requested for a maximum of $9,000,000 total costs over a three-year project period.
• Eligible Institutions/Organizations. Institutions/organizations listed in Section III.1.A. are eligible to apply.
• Eligible Project Directors/Principal Investigators (PDs/PIs). Individuals with the skills, knowledge, and resources necessary to carry out the proposed research are invited to work with their institution/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.
• Number of PDs/PIs. More than one PD/PI (i.e., multiple PDs/PIs) may be designated on the application.
• Number of Applications. Applicants may only submit one application in response to this FOA.
• Resubmissions. Resubmission applications are not permitted in response to this FOA. 
• Renewals. Renewal applications are not permitted in response to this FOA
• Special Date(s). This FOA uses non-standard due dates. See Receipt, Review and Anticipated Start Dates.
• Application Materials. See Section IV.1 for application materials.
• Hearing Impaired. Telecommunications for the hearing impaired are available at: TTY 301-451-5936. .

Table of Contents

Part I Overview Information

Part II Full Text of Announcement

Section I. Funding Opportunity Description
1. Research Objectives

Section II. Award Information
1. Mechanism(s) of Support
2. Funds Available

Section III. Eligibility Information
1. Eligible Applicants
    A. Eligible Institutions
    B. Eligible Individuals
2.Cost Sharing or Matching
3. Other - Special Eligibility Criteria

Section IV. Application and Submission Information
1. Address to Request Application Information
2. Content and Form of Application Submission
3. Submission Dates and Times
    A. Receipt, Review and Anticipated Start Dates
         1. Letter of Intent
    B. Sending an Application to the NIH
    C. Application Processing
   D.  Application Assignment
4. Intergovernmental Review
5. Funding Restrictions
6. Other Submission Requirements

Section V. Application Review Information
1. Criteria
2. Review and Selection Process
    A. Additional Review Criteria
    B. Additional Review Considerations
    C. Resource Sharing Plan(s)
3. Anticipated Announcement and Award Dates

Section VI. Award Administration Information
1. Award Notices
2. Administrative and National Policy Requirements
     A. Cooperative Agreement Terms and Conditions of Award
         1. Principal Investigator Rights and Responsibilities
         2. NIH Responsibilities
         3. Collaborative Responsibilities
         4. Arbitration Process
3. Reporting

Section VII. Agency Contact(s)
1. Scientific/Research Contact(s)
2. Peer Review Contact(s)
3. Financial/ Grants Management Contact(s)

Section VIII. Other Information - Required Federal Citations

Part II - Full Text of Announcement

Section I. Funding Opportunity Description

1. Research Objectives

Nature of the Funding Opportunity

Very large, well-characterized, and representative clinical samples are necessary to rapidly and cost-effectively pursue many mental health research questions, including studies of access, quality, and costs of existing treatment, preventive, and services interventions; tests of the effectiveness of new interventions within large patient populations, tests of the implementation of systemic interventions (e.g., collaborative care interventions) within large health care systems, and methods for delivering personalized care.  Integrated health care delivery system networks with searchable medical records offer potential platforms for recruiting appropriate samples of patients, clinicians, and health care clinics and conducting large-scale effectiveness trials of interventions targeted at the individual patient, provider, or system level.  Applicants will propose methods for linking existing health care databases and pilot projects that rapidly screen, recruit, and consent subjects for participation in intervention and services studies within these networks. 

The purpose of this Funding Opportunity Announcement (FOA) is to develop and test infrastructure to conduct mental health services and effectiveness research across large integrated health care systems, leading to the creation of a Mental Health Research Network across integrated health care delivery systems (MHRN).  The MHRN would be capable of identifying thousands of suitable case and control subjects for basic and applied investigations of mental illness in practice settings.  This initiative will allow for the initial development of a collaborative mental health effectiveness research platform among health care provider organizations that link primary, specialty, ambulatory and other care settings; have access to large, stable, and diverse patient populations; are able to take advantage of existing integrated databases; and can conduct efficient large-scale effectiveness studies testing treatment, preventive and services interventions to improve the mental health of large patient populations.  This initiative will also facilitate increased research collaboration between health care provider organizations and researchers affiliated with other academic institutions, as well as federal and state agencies.  For the purposes of this announcement, “integrated health care systems” and “health care provider organizations” refer to large health care delivery systems that can provide both general medical and mental health care services to tens of thousands of covered lives.

The ultimate purpose of the research funded by NIMH is to improve the impact of research on the public mental health of the US population. Therefore, it is appropriate that studies funded by this FOA focus on mental disorders of significant burden of disease across large populations. However, because of the potential to access millions of subjects, the MHRN may also be well suited for conducting research on less common disorders.

Need for the Research

Despite the capacity of many health care delivery systems to provide services to millions of patients with mental disorders, little information is available on the needs of these populations, the quality of services they receive, and the capacity of these systems to deliver effective interventions.  Furthermore, the cost of conducting large-scale effectiveness trials to answer important mental health research questions is prohibitive, without taking advantage of efficiencies within large-scale networks.  The trial enterprise, which requires identification of subjects, multiple strategies for recruitment, enrollment, randomization, data collection, and ongoing monitoring, limits the number of studies that can be launched anew within fixed research budgets.  The MHRN is intended to address this limitation.

With significant efforts needed to determine the relative effectiveness of beneficial treatments and their capacity for widespread implementation, studies will require large samples of patients, an abundance of practicing clinicians, integrated data systems to identify, assess, monitor, and follow-up patients, and capacity to conduct trials with rapidity, efficiency, safety and quality.  The MHRN would provide a platform to conduct a series of “comparative effectiveness” trials at costs far below a traditional effectiveness trial.

Scientific Objectives

The overall goal of the MHRN is to increase scientific knowledge on the effectiveness of treatment, preventive, and services interventions for mental disorders in the context of community-based health care delivery. Research funded by this FOA should demonstrate the capacity to take advantage of the large patient populations and diverse patient care settings, extend upon the integrated data systems, and the other complimentary research resources made available by the MHRN to achieve research objectives that would otherwise be infeasible or prohibitively expensive.

The overarching goals of the MHRN Initiative are to:

• develop and demonstrate viable methods for efficiently identifying, recruiting, and enrolling, with random assignment, well-phenotyped patients with mental disorders, clinicians, and health care clinics into mental health effectiveness trials;
• develop and demonstrate valid methods of integrating data from electronic medical records and patient care encounters on diagnosis, service use, quality of care, and outcomes for patients with mental disorders across multiple integrated health care systems;
• develop and demonstrate processes for creating a federated pooled clinical data across multiple integrated health care systems to analyze characteristics of patient populations, clinicians and health care settings;
• develop and demonstrate capacity for gathering, storing, and analyzing biologic material to study correlates of mental disorders and treatment response;
• develop and demonstrate the use of innovative technologies (e.g., patient web portals, handheld devices, secure messaging) to deliver interventions to improve outcomes for people with mental disorders; and
• create opportunities for interested non-network researchers to use MHRN study datasets for additional research studies.

These research objectives will be accomplished by several organizational units and individual research projects.  The specific units and research projects will be proposed by the applicant.

The following approaches are anticipated for meeting the objectives: (1) developing and applying innovative methods to efficiently collect and interpret data from automated data systems, conventional medical record systems, newly emerging electronic medical records, and web-based medical communication systems; (2) assembling large samples of patient data, including data for patients with specific mental disorders; (3) documenting patient demographic and chronic disease risk characteristics; (4) documenting longitudinal patterns of health care resource utilization and cost; (5) collecting and integrating complex data from patients, providers, and organizations to examine issues in health care delivery from multiple perspectives; and (6) conducting studies on patient and provider directed behavioral, pharmacologic, and systems-based interventions designed to improve the delivery of care in the realistic settings of community-based health care delivery systems.

A successful MHRN will accomplish the following tasks within the period of the award:

• Demonstrate the ability to identify subjects for low-base-rate conditions across multiple organizations within the network and determine “caseness” for inclusion in a prospective study.
• Demonstrate the ability to randomize subjects (e.g. patients, providers) into experimental and comparison conditions across multiple organizations within the network
• Collect, store, and analyze biologic data for subjects across multiple organizations within the network
• Launch at least one pilot trial of a mental health intervention across multiple organizations within the network
• Demonstrate the ability to use IT infrastructure to integrate research protocols and assessments within typical clinical visits.
• Demonstrate success at pooling data from multiple organizations for analysis

Types of Research Sought

The focus of this initiative is to develop a MHRN capable of conducting efficient research on the effectiveness of treatment, preventive, or services interventions.  Therefore, the primary types of research sought are those that contribute to the development of capacity for effectiveness research.  However, the network can also be used to support a wide range of research studies that address the priorities of the NIMH, as articulated within the recent Strategic Plan (http://www.nimh.nih.gov/about/strategic-planning-reports/index.shtml)

Primary research areas appropriate for support through this FOA include, but are not limited to:

• Studies of the effectiveness and cost‑effectiveness of efficacious mental health treatment, preventive, or services interventions.
• Studies of innovative treatment, preventive and services interventions targeted to specific populations in different organization settings, e.g., primary care, specialty care, emergency care, or community clinic.
• Studies of strategies to engage and retain patients into treatment, preventive and services interventions.
• Studies of the effectiveness of services interventions to improve access, quality and outcomes of care for mental disorders.
• Studies of the effectiveness of strategies to disseminate and/or implement evidence-based mental health treatment, preventive, screening, rehabilitation, and services interventions.
• Studies of the integration of mental health services within the Medical Home.

Secondary research areas appropriate to be conducted through this FOA include, but are not limited to:

1.  Clinical Epidemiology Studies

• Studies of the incidence, prevalence and developmental trajectories of mental disorders.
• Studies of service use, quality, and outcomes of specific services
• Studies of the long‑term risk of co-occurring medical and behavioral conditions.
• Methodological research to identify treatment response using health system data resources and informatics tools.
• Studies of factors influences the failure of patients to respond to psychopharmacologic treatment
• Studies of the prevalence of first-episode psychosis and their use of health care services
• Studies investigating history of mental illness as a risk factor for other disorders
  

2.  Evaluation and Methodological Studies Related to Clinical Trials

• Research on the costs and benefits to patient enrollees and health care provider institutions that result from participation in NIMH-sponsored trials or other trials. One purpose of this research is to identify strategies for increasing accrual to NIMH trials.
• Methodological research on the incorporation of quality‑of‑life, patient satisfaction, and economic endpoints in NIMH trials through direct clinical trial data collection or by other methods such as using modeling or other extrapolation methods to make it possible to use retrospective data to supplement the analysis of within‑trial data.
• Methodological research on incorporating quality-of-life, patient satisfaction and other measures into routine clinical care.

3.  Clinical Informatics Studies

• Studies of the feasibility, effectiveness, and cost of using clinical informatics systems to identify, recruit, and track organization members for targeted mental health treatment, preventive, and services interventions.
• Studies of the feasibility, effectiveness, and cost of using clinical informatics systems to aid patient/physician decision making for mental health screening, treatment, and prevention in clinical settings.
• Studies of the feasibility, effectiveness, and cost of using clinical informatics systems as an aid to multi‑disciplinary management of mental health care.
• Studies of the feasibility, effectiveness, and cost of using clinical informatics systems for provider feedback with the goal of improving the quality of care.
• Studies that develop and apply innovative standard-based informatics to bridge research and health care, including the development of methods of extracting data from electronic medical records and other clinical data sources to aid in identifying suitable patients for clinical trials and methods of ensuring continuity of care for patients when they return to community-based and other health care delivery systems from clinical research studies.

See Section VIII, Other Information - Required Federal Citations, for policies related to this announcement.

Section II. Award Information

1. Mechanism of Support

This funding opportunity will use the NIH Multi-Project Cooperative Agreement (U19) award mechanism(s).  The Project Director/Principal Investigator (PD/PI) will be solely responsible for planning, directing, and executing the proposed project.

This FOA uses “Just-in-Time” information concepts. It also uses non-modular budget formats described in the PHS 398 application instructions (see https://grants.nih.gov/grants/funding/phs398/phs398.html).

This is a cooperative agreement award mechanism.  In the cooperative agreement mechanism, the Project Director/Principal Investigator (PD/PI) retains the primary responsibility and dominant role for planning, directing, and executing the proposed project, with NIH staff being substantially involved as a partner with Principal Investigator, as described under Section VI.2, Administrative Requirements, “Cooperative Agreement terms and Conditions of Award.”

2. Funds Available

The NIMH intends to commit approximately $3.0 million in FY 2010 to fund 1 new grant in response to this FOA. An award issued under this FOA is contingent upon the availability of funds and the receipt of a sufficient number of meritorious applications. Budgets for total costs of up to $3,000,000 per year and a total project period of up to three years may be requested for a maximum of $9,000,000 total costs over a three-year project period.

Applications should contain three budget periods of 12 months each.  Applicants should provide adequate written budget justification and include all applicable direct and F&A costs. It is anticipated that approximately 55-65% of the three-year budget will be allocated to the two proposed research projects.  It is anticipated that no more than 30% of the budget should be allocated for infrastructure activities, including 5% or less of total costs for evaluation functions of the evaluation core. No more than 10% of the budget should be allocated for emerging research issues.  Applications must include estimates for travel costs for in-person Steering Committee meetings.  Travel cost estimates should include two in-person meetings each funding year.  Estimates should include two in-person Steering Committee meetings (one in Bethesda, MD, and one at the location of a national meeting).

Because the nature and scope of the proposed research will vary from application to application, it is anticipated that the size and duration of each award will also vary. Although the financial plans of the IC(s) provide support for this program, awards pursuant to this funding opportunity are contingent upon the availability of funds and the receipt of a sufficient number of meritorious applications.

Facilities and administrative costs requested by consortium participants are not included in the direct cost limitation, see NOT-OD-05-004.

NIH grants policies as described in the http://era.nih.gov/ElectronicReceipt/preparing.htm for instructions).

The decision of whether to apply for a grant with a single PD/PI or multiple PDs/PIs is the responsibility of the investigators and applicant organizations, and should be determined by the scientific goals of the project. Applications for grants with multiple PDs/PIs will require additional information, as outlined in the instructions below. When considering multiple PDs/PIs, please be aware that the structure and governance of the PD/PI leadership team as well as the knowledge, skills and experience of the individual PDs/PIs will be factored into the assessment of the overall scientific merit of the application.  Multiple PDs/PIs on a project share the authority and responsibility for leading and directing the project, intellectually and logistically. Each PD/PI is responsible and accountable to the grantee organization, or, as appropriate, to a collaborating organization, for the proper conduct of the project or program, including the submission of required reports. For further information on multiple PDs/PIs, please see https://grants.nih.gov/grants/multi_pi.

2. Cost Sharing or Matching

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

3. Other-Special Eligibility Criteria

Number of Applications.  An applicant may only submit one application under this announcement.

Resubmissions.  Resubmission applications are not permitted in response to this FOA.

Renewals.  Renewal applications are not permitted in response to this FOA.

Applications may be submitted by domestic for-profit and non-profit integrated (i.e. general medical and mental health) health care provider organizations (network members) acting jointly as a U.S. research network.  A domestic application may not include an international component.

Networks must include a sufficient number of health care organizations such that total patient enrollment is stable (i.e., the majority of patients can be followed for a combined retrospective and prospective period of five years) and is at least three million adults (ages 18 and over).  Also, network-covered populations should approximate the demographics of the general U.S. population, and must include diverse populations with respect to gender, race/ethnicity and, to the extent that it is practical, rural/urban populations and a range of geographic locations.

Applicants must demonstrate a shared commitment among all participating network members to working together on proposed research studies.  Applicants must show evidence of ability to access and organize data collection from all participating network members and to utilize an integrated system across all sites.  Applicants should also demonstrate linkage of electronic laboratory, pharmacy, outpatient, and hospitalization data at many network sites.  If these capabilities do not currently reside within one or more of the network members, the applicant must include details of plans to develop the necessary linkages and integration in all network members.  Applicants must demonstrate previous research productivity using the data resources available to their network.  Each network member must have access to a resource unit that supports research data management.

Section IV. Application and Submission Information

1. Address to Request Application Information

The PHS 398 application instructions are available at https://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive format. Applicants must use the currently approved version of the PHS 398. For further assistance contact GrantsInfo, Telephone (301) 710-0267, Email: GrantsInfo@nih.gov.

Telecommunications for the hearing impaired: TTY 301-451-5936.

2. Content and Form of Application Submission

Applications must be prepared using the most current PHS 398 research grant application instructions and forms. Applications must have a D&B Data Universal Numbering System (DUNS) number as the universal identifier when applying for Federal grants or cooperative agreements. The D&B number can be obtained by calling (866) 705-5711 or through the web site at http://www.dnb.com/us/. The D&B number should be entered on line 11 of the face page of the PHS 398 form.

The title and number of this funding opportunity must be typed in item (box) 2 only of the face page of the application form and the YES box must be checked.

SPECIAL INSTRUCTIONS

Applications with Multiple PDs/PIs

When multiple PD/PIs are proposed, use the Face Page-Continued page to provide items 3a – 3h for all PD/PIs. NIH requires one PD/PI be designated as the “contact PD/PI” for all communications between the PD/PIs and the agency. The contact PD/PI must meet all eligibility requirements for PD/PI status in the same way as other PD/PIs, but has no special roles or responsibilities within the project team beyond those mentioned above. The contact PD/PI may be changed during the project period. The contact PD/PI should be listed in block 3 of Form Page 1 (the Face Page), with all additional PD/PIs listed on Form Page 1-Continued. When inserting the name of the PD/PI in the header of each application page, use the name of the “Contact PD/PI, et. al.” The contact PD/PI must be from the applicant organization if PD/PIs are from more than one institution.

All individuals designated as PD/PI must be registered in the eRA Commons and must be assigned the PD/PI role in that system (other roles such as SO or IAR will not give the PD/PI the appropriate access to the application records). Each PD/PI must include their respective eRA Commons ID in the eRA Commons User Name field.

All projects proposing Multiple PDs/PIs will be required to include a new section describing the leadership plan approach for the proposed project.

Multiple PD/PI Leadership Plan: For applications designating multiple PDs/PIs, a new section of the research plan, entitled “Multiple PD/PI Leadership Plan” must be included. A rationale for choosing a multiple PD/PI approach should be described. The governance and organizational structure of the leadership team and the research project should be described, and should include communication plans, process for making decisions on scientific direction, and procedures for resolving conflicts.  The roles and administrative, technical, and scientific responsibilities for the project or program should be delineated for the PDs/PIs and other collaborators.

If budget allocation is planned, the distribution of resources to specific components of the project or the individual PDs/PIs should be delineated in the Leadership Plan. In the event of an award, the requested allocations may be reflected in a footnote on the Notice of Award.

Additional information is available in the PHS 398 grant application instructions.

3. Submission Dates and Times

Applications must be received on or before the receipt date described below (Section IV.3.A). Submission times N/A.

3.A. Receipt, Review and Anticipated Start Dates
Letters of Intent Receipt Date: December 11, 2009
Application Receipt Date: January 12, 2010
Peer Review Date: March 2010
Council Review Date: May 2010
Earliest Anticipated Start Date: July 1, 2010

3.A.1. Letter of Intent

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 Principal Investigator
• Names of other key personnel
• Participating institutions
• Number and title of this funding opportunity

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.

The letter of intent is to be sent by the date listed in Section IV.3.A.

The letter of intent should be sent to:

David Chambers, D.Phil
Division of Services and Interventions Research
National Institute of Mental Health
6001 Executive Boulevard, Room 7133, MSC 9631
Bethesda, MD 20892-9631
Telephone: (301) 443-3747
FAX: (301) 443-4045
Email: dchamber@mail.nih.gov

3.B. Sending an Application to the NIH

Applications must be prepared using the forms found in the PHS 398 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)

Personal deliveries of applications are no longer permitted (see https://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-040.html).

At the time of submission, two additional copies of the application and all copies of the appendix material must be sent to:

Shuang-Bao Hu, Ph.D.
Division of Extramural Activities
National Institute of Mental Health
6001 Executive Boulevard, Room 6156, MSC 9609
Bethesda, MD  20892-9609
Rockville, MD  20852 (for express/courier service)
Telephone:  (301) 443-5160
FAX:  (301) 594-0702
Email:  shuangbaohu@mail.nih.gov

3.C. Application Processing

Applications must be received on or before the application receipt date) described above (Section IV.3.A.). If an application is received after that date, the application may be delayed in the review process or not reviewed.  Upon receipt, applications will be evaluated for completeness by the CSR and for responsiveness by the reviewing Institute Incomplete and/or non-responsive applications will not be reviewed.

The NIH will not accept any application in response to this funding opportunity that is essentially the same as one currently pending initial review, unless the applicant withdraws the pending application. However, when a previously unfunded application, originally submitted as an investigator-initiated application, is to be submitted in response to a funding opportunity, it is to be prepared as a NEW application. That is, the application for the funding opportunity must not include an Introduction describing the changes and improvements made, and the text must not be marked to indicate the changes from the previous unfunded version of the application.

Information on the status of an application should be checked by the Principal Investigator in the eRA Commons at: https://commons.era.nih.gov/commons/.

4. Intergovernmental Review

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. The Grants Policy Statement can be found at NIH Grants Policy Statement.

Pre-award costs are allowable. A grantee may, at its own risk and without NIH prior approval, incur obligations and expenditures to cover costs up to 90 days before the beginning date of the initial budget period of a new award if such costs: 1) are necessary to conduct the project, and 2) would be allowable under the grant, if awarded, without NIH prior approval. If specific expenditures would otherwise require prior approval, the grantee must obtain NIH approval before incurring the cost. NIH prior approval is required for any costs to be incurred more than 90 days before the beginning date of the initial budget period of a new award.

The incurrence of pre-award costs in anticipation of a competing or non-competing award imposes no obligation on NIH either to make the award or to increase the amount of the approved budget if an award is made for less than the amount anticipated and is inadequate to cover the pre-award costs incurred. NIH expects the grantee to be fully aware that pre-award costs result in borrowing against future support and that such borrowing must not impair the grantee's ability to accomplish the project objectives in the approved time frame or in any way adversely affect the conduct of the project (see NIH Grants Policy Statement https://grants.nih.gov/archive/grants/policy/nihgps_2003/index.htm.)

6. Other Submission Requirements

Supplemental Instructions for the Preparation of Multi-Project Applications (U19)

The following section supplements the instructions found in Form PHS 398.  Additional instructions are required because the Form PHS 398 is designed primarily for individual, free-standing research project grant applications, and has no specific instructions for multi-project applications consisting of research network infrastructure development as well as research projects interrelated by a common theme.

The order of presentation should be as follows:

• PHS 398 Form pages  as described below:
  • Form Page 1 - Face Page, (please enter funding opportunity number and title)
  • Form Page 2 – Description/Performance Sites/etc.
  • Form Page 3 - Table of Contents
  • Form Pages 4 and 5 – Detailed Overall Budget for Initial Budget Period, and Detailed Overall Budget for the Entire Proposed Period of Support.  Budget information should be ordered with Forms 4 and 5 for the overall application first, followed by Forms 4 and 5 for each of the projects.
  • Biographical Sketches for Senior/Key Personnel and Other Significant Contributors
  • Resources Format Page – Resources for the Entire Application, followed by Resources for each individual Project
• Research Plan (as described below)
• Checklist
• Appendix

Research Plan Instructions

The Research Plan in the application must be organized in the following sections.  This organization replaces sections 2-17 in the PHS398 instructions.

A.    Overall Aims

B.    Background and Significance

C.    Governance and Operational Structure

D.    Research Infrastructure

E.    Individual Research Projects

F.    Emerging Research Issues

G.    Bibliography and References Cited

H.    Protection of Human Subjects

I.      Inclusion of Women and Minorities

J.     Targeted/Planned Enrollment Table (for each research project)

K.    Inclusion of Children

L.     Multiple PDs/PI Leadership Plan (required, if applicable)

M.   Consortium/Contractual Arrangements

N.    Letters of Support (e.g., Consultants) and/or Institutional Commitment

O.    Resource Sharing Plan(s)

Sections A-D must not exceed a 30-page limit.  Section E is limited to 10 pages per project. Section F should not exceed 3 pages.

A.    Overall Aims. The overall, broad objectives of the MHRN, including a description of what it intends to accomplish in this funding period, should be described in this section. The application must describe the structure of the MHRN, including an overview of the infrastructure, administrative structure and individual research projects.  The plans must also address how the proposed MHRN activities complement past or ongoing mental health research in the health care organizations, particularly research that has used available data resources and existing electronic data systems.

B.    Background and Significance. This section should briefly describe the health care organizations, including their size, diversity and stability of the patients, demographic composition of the patient population, and diversity of their geographic service areas; the potential significance of the MHRN in these organizations; and relevant research conducted to date in these organizations, including that which demonstrates productivity using available data resources and electronic data systems.

C.    Governance and Operational Structure. This section should describe the proposed administrative structure of the MHRN, e.g., PI, co-Investigators, Steering Committee, other committees, other research support resources, and how these entities would function to support and maintain the organizational structure and research projects of the MHRN.  The narrative should also address how communication and collaboration will be established and maintained between the research projects and the administrative units across participating MHRN health care organizations, participating federal agencies (i.e., NIMH/NIH), and other research collaborators.  Costs related to this section should include face-to-face Steering Committee meetings and other key administrative functions and should be appropriately described in the budget section in the beginning sections of the application. Appropriate structures to oversee quality control of the research (e.g., internal or external advisory committees) should be described in this section.

D.    Research Infrastructure. The infrastructure should be described in detail, and organized by units to perform administrative, data standardization and integration, and evaluation functions.  These units should support more than one research project.  In addition, full information on the performance sites, budget, key personnel, resources and environment for each unit should be provided in the initial sections of the application as described above for those sections.  Unit functions should include:

• Plans for how the standardization of data resources for mental health effectiveness research will be increased and any role in the development, or application, of mental health informatics resources and tools.
• Plans for additional infrastructure development to support the conduct of multiple treatment, preventive and services intervention effectiveness studies across multiple health care organizations within the network.
• Plans to encourage and create opportunities for research collaboration with interested non-network researchers and organizations for the use of MHRN study datasets. The core resources should be helpful to both network and non-network researchers in developing research proposals for extramural funding.
• Procedures for evaluating the administrative units, overall MHRN functioning, and progress of the individual research projects, as well as for implementing recommendations resulting from such evaluations. 
• Plans for participation in efforts, outside the applicant’s organization, to develop broader-ranging standards for representing mental health research data and information.

E.    Individual Research Projects. This section should provide details about how the HMRN resources will be used to complete at least two research projects.  The research should be consistent with the goals identified earlier in this RFA.  Each proposed research project should provide a narrative not to exceed 10 pages. The narrative should provide information on: (1) scientific background and the significance of the research project; (2) research question and specific aims; (3) preliminary results, including methodological investigations and pilot research data from any previous studies that form the basis for the proposed project; (4) research design and methodology; (5) data sources and data collection instrumentation and methods; and (6) statistical issues and analytical methods. In addition, information on the performance sites, budget, key personnel, resources and environment for each research project should be provided in the other sections of the application as described above.  Each research project should not exceed 10 pages in length.

F.    Emerging Research Issues. This section should describe the ability to perform a limited number of short-term investigations of emerging public health or effectiveness research issues concerning mental health.  These should be accomplished through the analyses of descriptive data, using available data resources of the network. Section F should not exceed three pages.

G.    Bibliography and References cited.

H.    Protection for Human Subjects.  This section should discuss the proposed protections from research risk related to both the overall network and the proposed research projects.  For the research infrastructure, applications should discuss efforts to ensure privacy and confidentiality of all data, and ensure that proposed activities include adequate attention to risk for all potential research subjects, including patients, providers, and administrators.  For the research projects, this section should include discussions of 1) risk to subjects, 2) adequacy of protection against risks, 3) potential benefits to the subjects and others, 3) importance of the knowledge to be gained, and 5) data and safety monitoring for clinical trials.

The following sections should follow PHS398 instructions for content and include:

I.      Inclusion of Women and Minorities;

J.     Targeted/Planned Enrollment Table (for each research project);

K.    Inclusion of Children;

L.     Multiple PDs/PI Leadership Plan (required, if applicable);

M.   Consortium/Contractual Arrangements;

N.    Letters of Support (e.g., Consultants) and/or Institutional Commitment; and

O.    Resource Sharing Plan(s) if appropriate.

Appendix Materials

All paper PHS 398 applications submitted must provide appendix material on CDs only. Include five identical CDs in the same package with the application. See https://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-031.html.

Do not use the Appendix to circumvent the page limitations. An application that does not observe the required page limitations may be delayed in the review process.

Resource Sharing Plan(s)

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 https://grants.nih.gov/grants/policy/data_sharing/data_sharing_faqs.htm.

(a) Data Sharing Plan: Regardless of the amount requested, investigators are expected to include a brief 1-paragraph description of how final research 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 https://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-032.html.

(b) Sharing Model Organisms: Regardless of the amount requested, all applications where the development of model organisms is anticipated are expected to include a description of a specific plan for sharing and distributing unique model organisms and related resources, or state appropriate reasons why such sharing is restricted or not possible. See Sharing Model Organisms Policy, and NIH Guide NOT-OD-04-042.

(c) Genome-Wide Association Studies (GWAS): Regardless of the amount requested, applicants seeking funding for a genome-wide association study are expected to provide a plan for submission of GWAS data to the NIH-designated GWAS data repository, or provide an appropriate explanation why submission to the repository is not possible.  A genome-wide association study is defined as any study of genetic variation across the entire genome that is designed to identify genetic associations with observable traits (such as blood pressure or weight) or the presence or absence of a disease or condition.  For further information see Policy for Sharing of Data Obtained in NIH Supported or Conducted Genome-Wide Association Studies, NIH Guide NOT-OD-07-088, and https://grants.nih.gov/grants/gwas/.

Section V. Application Review Information

1. Criteria

Only the review criteria described below will be considered in the review process.

2. Review and Selection Process

Review Process

Applications that are complete and responsive to the FOA will be evaluated for scientific and technical merit by an appropriate peer review group convened by NIMH and in accordance with NIH peer review procedures (http://grants1.nih.gov/grants/peer/), using the review criteria stated below.

As part of the scientific peer review, all applications will:

• 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 impact/priority score.
• Receive a written critique.
• Receive a second level of review by the National Advisory Mental Health Council (NAMHC)

The mission of the NIH is to support science in pursuit of knowledge about the biology and behavior of living systems and to apply that knowledge to extend healthy life and reduce the burdens of illness and disability.  As part of this mission, applications submitted to the NIH for grants or cooperative agreements to support biomedical and behavioral research are evaluated for scientific and technical merit through the NIH peer review system. 

Peer review emphasizes a synthesis of two major aspects of the U19 application: review of the merit of the overall network (including the organizational structure), and review of the specific research projects (and emerging research issues) compared to a standard of quality in a related, broad, scientific discipline.  This synthesis will result in a final review of the program as an integrated research effort designed to improve the quality and efficiency of mental health effectiveness research conducted in integrated health care systems. In arriving at an overall merit priority score for the U19, members of the review committee also will consider the likelihood that the proposed research program will have a substantial impact on the scientific field.

Overall Impact. Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following five core review criteria, and additional review criteria (as applicable for the project proposed).  In addition, the overall impact score should reflect the reviewer’s assessment of the likelihood that the application will meet the criteria for success identified in Part II, Section 1 under “Research Objectives.”

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

Review Criteria for the Overall Network

Significance.  Does the MHRN address important problems and critical barriers to conducting large-scale effectiveness studies in mental health?  If the aims of the network are achieved, how will effectiveness and services research, and/or clinical practice be improved?  How will successful completion of the aims change the landscape of mental health effectiveness research?  Will the MHRN make significant contributions to improving the conduct of mental health services and effectiveness research?  What is the potential of the overall MHRN program to advance knowledge that will impact the care of patients with mental disorders receiving care in integrated healthcare systems?

Investigator(s).  Are the PD/PIs, collaborators, and other researchers well suited to the project?  If Early Stage Investigators or New Investigators, do they have appropriate experience and training?  If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)?  As a collaborative network, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project? Do the qualifications of the PIs and other senior scientists to lead the U19 scientifically and coordinate all activities include:

• Demonstrated ability to provide effective scientific and administrative leadership, as exemplified by selection of individual projects for scientific excellence and thematic relatedness and by promotion of effective interactions and collaborations.
• The adequacy of the commitment (percent effort) of the PIs to the U19. There should be a specific commitment to both the scientific and administrative aspects of the U19. Though a common practice, it is not mandatory that the PIs be a project leader of an individual research project.

Innovation.  Does the application challenge and seek to shift current effectiveness 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 mental health effectiveness research or novel in a broad sense?  Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed?  To what degree does the overall program apply novel concepts and innovative approaches to mental health effectiveness research?  Does the application describe innovative mechanisms for identifying, recruiting, and enrolling subjects within effectiveness research studies and for conducting large-scale effectiveness trials?

Approach.  Are the overall organizational structure, proposed research infrastructure, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project?  Are potential problems, alternative strategies, and benchmarks for success presented?  Does the application detail an approach to establish the feasibility of conducting multiple large-scale effectiveness studies? Are the approaches proposed to fulfill the aims of the MHRN adequate, and is there indication that the approach to the organizational structure and overall design of the U19 is likely to be successful?  For applications designating multiple PIs, does the Leadership Plan ensure that there will be sufficient coordination and communication among the PIs?  Are the administrative plans for the management of the MHRN appropriate, including plans to resolving conflicts?  Does the MHRN effectively detail processes through which decisions about future MHRN directions/priorities will be taken?

Environment.  Will the scientific environment in which the work will be done enable a sustainable platform for conducting mental health effectiveness research? Are the institutional support, equipment and other physical resources available to the investigators adequate for the MHRN to fulfill all suggested infrastructure development and research project aims?  Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements? 

In addition to the above review criteria, the following criteria will be applied to applications in the determination of scientific merit and the impact/priority score. This sixth criterion will not receive a separate score but will be considered within the assignment of an overall score for the Network portion of the application.

Integration: Will the U19 show evidence of coordination, interrelationships, and synergy between meritorious research projects and core components as related to the primary theme of mental health effectiveness research?  Does the application describe advantages or value added that could be realized by conducting the proposed research as a U19 rather than through separate research efforts?   Does the application describe the presence and quality of mechanisms for regular communication and coordination among investigators? Does the proposed MHRN include mechanisms for quality control of the research (e.g., internal or external advisory committees)?

Review Criteria for Research Projects

Significance: Do the proposed studies address important problems related to mental health effectiveness or services research? If the aims of the research projects are achieved, how will scientific knowledge or clinical practice be advanced? What will be the effect of these studies on the concepts, methods, technologies, treatments, services, or preventive interventions that drive this field?  Are the emerging research issues included within the application likely to impact public health?

Investigators: Are the investigators appropriately trained and well suited to carry out this work? Is the work proposed appropriate to the experience level of the project leader and other researchers? Does the investigative team bring complementary and integrated expertise to the projects (if applicable)?  Do the projects involve sufficient network investigators to demonstrate feasibility of conducting efficient multi-site investigations?

Innovation: Are the projects original and innovative? For example: Do the projects challenge existing paradigms or clinical practice; address an innovative hypothesis or critical barrier to progress in conducting large-scale effectiveness research? Do the projects develop or employ novel concepts, approaches or methodologies, tools, or technologies for this area?  Do the emerging research issues represent necessary advances for the fields of services and effectiveness research?

Approach: Are the conceptual or clinical frameworks, designs, methods, and analyses adequately developed, well-integrated, and appropriate to the aims of the projects? Does the applicant acknowledge potential problem areas and consider alternative tactics?  Do the projects demonstrate efficient ability to identify, recruit, enroll, and track research subjects through common protocols across multiple network sites?

Environment: Does the scientific environment in which the work will be done contribute to the probability of success? Do the proposed experiments benefit from unique features of the scientific environment, or subject populations, or employ useful collaborative arrangements? Is there evidence of institutional support?   Does the environment include sufficient network membership to demonstrate ability to conduct studies across multiple geographical and organizational settings?

NOTE: Synergy and thematic relatedness between the projects and organizational structure, and their significance for the program as a whole, are not discussed when rating individual research projects. These characteristics are discussed and rated under the Integration review criterion when evaluating the Overall Network.

Additional Review Criteria

As applicable for the project proposed, reviewers will consider the following additional items in the determination of scientific and technical merit, but will not give separate scores for these items.

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

For research that involves human subjects  and meets the criteria for one or more of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials.

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.

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.

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.

Additional Review Considerations

As applicable for the project proposed, reviewers will address 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.

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

Select Agents 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 (http://grants.nih/gov/grants/policy/data_sharing/data_sharing_guidance.htm); 2) Sharing Model Organisms (https://grants.nih.gov/grants/guide/notice-files/NOT-OD-04-042.html); and 3) Genome Wide Association Studies (GWAS) (https://grants.nih.gov/grants/guide/notice-files/NOT-OD-07-088.html).

Selection Process

The following will be considered in making funding decisions:

• Scientific and technical merit of the proposed project as determined by peer review
• Availability of funds
• Relevance of the proposed project to program priorities

3. Anticipated Announcement and Award Dates

Not Applicable

Section VI. Award Administration Information

1. Award Notices

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.

If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant. For details, applicants may refer to the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General.

A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization. The NoA signed by the grants management officer is the authorizing document. Once all administrative and programmatic issues have been resolved, the Notice of Award will be generated via email notification from the awarding component to the grantee business official.

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. See Also Section IV.5. Funding Restrictions.

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 (https://grants.nih.gov/archive/grants/policy/nihgps_2003/index.htm) and Part II Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Grantees, and Activities (https://grants.nih.gov/archive/grants/policy/nihgps_2003/index.htm).

The following Terms and Conditions will be incorporated into the award statement and will be provided to the Principal Investigator as well as to the appropriate institutional official, at the time of award.

2.A. Cooperative Agreement Terms and Conditions of Award

The following special terms of award are in addition to, and not in lieu of, otherwise applicable OMB administrative guidelines, HHS 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.

2.A.1. Principal Investigator Rights and Responsibilities

The Principal Investigator (PD/PI) will have the primary responsibility for the MHRN effort as a whole, including research design and the actual performance of the MHRN effort, and preparation of publications. The PD/PI will attend all MHRN Steering Committee meetings, will annually document progress in written reports to the NIMH Program Director, and will provide periodic supplementary reports upon request.

To accommodate the changing environment resulting from improved technologies, the PD/PI is expected to make any necessary adjustments in the overall research strategies during the course of the project period. While joint research projects are strongly encouraged under this RFA, research projects within an application are also allowed to be conducted under the supervision of site-specific Project Leaders at individual MHRN member organizations otherwise contributing to meeting the goals and objectives of this RFA. Project Leaders of such single member organization studies within an application will have equivalent status with all other PIs in regard to participation on the MHRN Steering Committee and other MHRN committees. 

The awardee will retain custody of and have primary rights to the data developed under this award, subject to Government rights of access consistent with current HHS, PHS, and NIH policies. The awardee and NIMH will jointly develop appropriate confidentiality procedures for data collection, processing, storage and analysis to ensure the confidentiality of data on individual health care organization patients, health care providers and institutions involved in MHRN research projects. No identifying information of individual patients or providers should be available through aggregated MHRN research databases.  Encrypted study identification numbers will be used for all aggregated MHRN studies. The NIMH expects that limited access data will be released under this study.  Limited access data refers to study data, with certain deletions and recoding that are released to requesting institutions and investigators for specific purposes and with certain restrictions and conditions.

The PD/PI will be responsible for the timely submission for publication of manuscripts (co)authored by members of the grant and supported in part or in total under this Agreement.  All publications and presentation abstracts resulting from work done will be submitted to the Program Officer at least one week prior to journal submission for review, and within two weeks of acceptance for publication so that an up-to-date summary of the cooperative program accomplishments can be maintained and NIMH press releases can be prepared, if applicable.  Publications or oral presentations of work performed under this Agreement are the responsibility of the PD/PI and appropriate Project Leaders and require acknowledgement of NIMH support. Timely publication of major findings is encouraged

2.A.2. NIH Responsibilities

NIH/NIMH will assign one staff member to serve as the Project Scientist, who will also act as the coordinator. The Project Scientist will have substantial programmatic involvement that is above and beyond the normal stewardship role in awards, as described below:

• Substantial involvement in coordinating the activities of the awardee with the non-MHRN researchers, as necessary.
• Participation in the Steering Committee and subcommittees
• Serving as a resource with respect to other ongoing NIMH/NIH activities that may be relevant to this effort and providing expert advice to the awardee on specific scientific and/or analytic issues.
• Assisting, with the agreement of the PI, in the design, development, and coordination of the MHRN, its cores, and its studies.
• Reviewing study design and protocols, data abstraction and survey instruments, and analysis plans to ensure that they are within the scope of this effort and consistent with the results of peer review.

In addition to the Project Scientist, an NIMH Program Officer will be responsible for the normal scientific and programmatic stewardship of the award and will be named in the award notice.

The NIMH reserves the right to terminate or curtail the MHRN (or an individual component of the award) in the event of inadequate progress, data reporting, insufficient use of this resource, or safety issues.

The NIMH Program Officer will interact with the PI on a regular basis to monitor progress. Monitoring may include: regular communication with the PI and his/her staff, periodic site visits for discussion with the awardee research team, observation of field data collection and management techniques, fiscal reviews, and other relevant stewardship matters.

The NIMH Program Officer will also identify additional extramural staff from NIMH and other participating organizations that have appropriate experience and expertise to collaborate with MHRN in the development of research concepts, review of study designs and methods, participation in study analyses, and review of scientific reports and articles.  These additional staff may serve on various MHRN committees.  

2.A.3. Collaborative Responsibilities

During the course of the award period, the awardee will be invited to meet with the NIMH, other PIs, and/or other uninvolved experts in Bethesda, MD, to review scientific progress.

The MHRN Steering Committee will be the main oversight body for this cooperative agreement. The Steering Committee will coordinate the overall governance of the MHRN and establish and administer specific MHRN-wide policies. Membership of the Steering Committee will consist of the MHRN PD/PI, Project Leaders from each MHRN member organization, Project Leaders for each MHRN research project detailed in Research Plan Section E., and the Project Scientist from NIMH.  The chair of the Steering Committee will be selected by the Steering Committee members in consultation with the NIMH.  Each full member will have one vote.

The Steering Committee will periodically review the research agenda and specific research projects, review the evaluation of the overall operations of the MHRN, determine directions for future development and improvement, and share experiences in implementing the MHRN activities. It is expected that decisions made or actions taken by the Steering Committee will be by consensus, or majority vote when needed, and all network organizations will be expected to implement them.  Meetings of the Steering Committee will frequently be held by teleconference calls with in-person meetings usually held twice each year (see Section IV.6). Financial support for these meetings should be included in the MHRN application budget.

2.A.4. 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. The three members will be: 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 dispute resolution procedure does not alter the awardee's right to appeal an adverse action that is otherwise appealable in accordance with PHS regulations 42 CFR Part 50, Subpart D and HHS regulations 45 CFR Part 16.

3. Reporting

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.

Section VII. Agency Contacts

We encourage your inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants. Inquiries may fall into three areas: scientific/research, peer review, and financial or grants management issues:

1. Scientific/Research Contact(s):

David A. Chambers, D.Phil
Division of Services and Intervention Research
National Institute of Mental Health
6001 Executive Boulevard, Room 7133, MSC 9631
Bethesda, MD  20892-9631
Telephone:  (301) 443-3747
FAX:  (301) 443-4045
Email:  dchamber@mail.nih.gov

2. Peer Review Contact(s):

David Armstrong, Ph.D.
Division of Extramural Activities
National Institute of Mental Health
6001 Executive Boulevard, Room 6138, MSC 9606
Bethesda, MD 20892-9606
Telephone: (301) 443-3534
FAX:  (301) 443-4720
Email: armstrda@mail.nih.gov

3. Financial/Grants Management Contact(s):

Joy R. Knipple
Division of Extramural Activities
National Institute of Mental Health
6001 Executive Boulevard, Room 6131 MSC 9605
Bethesda, MD  20892-9605
Rockville, MD 20852 (for express/courier service)
Telephone:  (301) 443-8811
FAX:  (301) 443-6885
Email:  knipplej@mail.nih.gov

Section VIII. Other Information

Required Federal Citations

Use of Animals in Research:
Recipients of PHS support for activities involving live, vertebrate animals must comply with PHS Policy on Humane Care and Use of Laboratory Animals (https://grants.nih.gov/grants/olaw/references/PHSPolicyLabAnimals.pdf) as mandated by the Health Research Extension Act of 1985 (https://grants.nih.gov/grants/olaw/references/hrea1985.htm), and the USDA Animal Welfare Regulations (http://www.nal.usda.gov/awic/legislat/usdaleg1.htm) as applicable.

Human Subjects Protection:
Federal regulations (45CFR46) require that applications and proposals involving human subjects must be evaluated with reference to the risks to the subjects, the adequacy of protection against these risks, the potential benefits of the research to the subjects and others, and the importance of the knowledge gained or to be gained (http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm).

Data and Safety Monitoring Plan:
Data and safety monitoring is required for all types of clinical trials, including physiologic toxicity and dose-finding studies (phase I); efficacy studies (Phase II); efficacy, effectiveness and comparative trials (Phase III). Monitoring should be commensurate with risk. The establishment of data and safety monitoring boards (DSMBs) is required for multi-site clinical trials involving interventions that entail potential risks to the participants (NIH Policy for Data and Safety Monitoring, NIH Guide for Grants and Contracts, https://grants.nih.gov/grants/guide/notice-files/not98-084.html).

Sharing Research Data:
Investigators submitting an NIH application seeking $500,000 or more in direct costs in any single year are expected to include a plan for data sharing or state why this is not possible (https://grants.nih.gov/grants/policy/data_sharing).

Investigators should seek guidance from their institutions, on issues related to institutional policies and local IRB rules, as well as local, State and Federal laws and regulations, including the Privacy Rule.

Policy for Genome-Wide Association Studies (GWAS):
NIH is interested in advancing genome-wide association studies (GWAS) to identify common genetic factors that influence health and disease through a centralized GWAS data repository. For the purposes of this policy, a genome-wide association study is defined as any study of genetic variation across the entire human genome that is designed to identify genetic associations with observable traits (such as blood pressure or weight), or the presence or absence of a disease or condition. All applications, regardless of the amount requested, proposing a genome-wide association study are expected to provide a plan for submission of GWAS data to the NIH-designated GWAS data repository, or provide an appropriate explanation why submission to the repository is not possible. Data repository management (submission and access) is governed by the Policy for Sharing of Data Obtained in NIH Supported or Conducted Genome-Wide Association Studies, NIH Guide NOT-OD-07-088. For additional information, see https://grants.nih.gov/grants/gwas/.

Access to Research Data through the Freedom of Information Act:
The Office of Management and Budget (OMB) Circular A-110 has been revised to provide access to research data through the Freedom of Information Act (FOIA) under some circumstances. Data that are (1) first produced in a project that is supported in whole or in part with Federal funds and (2) cited publicly and officially by a Federal agency in support of an action that has the force and effect of law (i.e., a regulation) may be accessed through FOIA. It is important for applicants to understand the basic scope of this amendment. NIH has provided guidance at https://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm. Applicants may wish to place data collected under this funding opportunity in a public archive, which can provide protections for the data and manage the distribution for an indefinite period of time. If so, the application should include a description of the archiving plan in the study design and include information about this in the budget justification section of the application. In addition, applicants should think about how to structure informed consent statements and other human subjects procedures given the potential for wider use of data collected under this award.

Sharing of Model Organisms:
NIH is committed to support efforts that encourage sharing of important research resources including the sharing of model organisms for biomedical research (see https://grants.nih.gov/grants/policy/model_organism/index.htm). At the same time the NIH recognizes the rights of grantees and contractors to elect and retain title to subject inventions developed with Federal funding pursuant to the Bayh Dole Act (see the NIH Grants Policy Statement https://grants.nih.gov/archive/archive/grants/policy/nihgps_2003/index.htm). All investigators submitting an NIH application or contract proposal, beginning with the October 1, 2004 receipt date, are expected to include in the application/proposal a description of a specific plan for sharing and distributing unique model organism research resources generated using NIH funding or state why such sharing is restricted or not possible. This will permit other researchers to benefit from the resources developed with public funding. The inclusion of a model organism sharing plan is not subject to a cost threshold in any year and is expected to be included in all applications where the development of model organisms is anticipated.

Inclusion of Women And Minorities in Clinical Research:
It is the policy of the NIH that women and members of minority groups and their sub-populations must be included in all NIH-supported clinical research projects unless a clear and compelling justification is provided indicating that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43). All investigators proposing clinical research should read the "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research (https://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html); a complete copy of the updated Guidelines is available at https://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm. The amended policy incorporates: the use of an NIH definition of clinical research; updated racial and ethnic categories in compliance with the new OMB standards; clarification of language governing NIH-defined Phase III clinical trials consistent with the new PHS Form 398; and updated roles and responsibilities of NIH staff and the extramural community. The policy continues to require for all NIH-defined Phase III clinical trials that: a) all applications or proposals and/or protocols must provide a description of plans to conduct analyses, as appropriate, to address differences by sex/gender and/or racial/ethnic groups, including subgroups if applicable; and b) investigators must report annual accrual and progress in conducting analyses, as appropriate, by sex/gender and/or racial/ethnic group differences.

Inclusion of Children as Participants in Clinical Research:
The NIH maintains a policy that children (i.e., individuals under the age of 21) must be included in all clinical research, conducted or supported by the NIH, unless there are scientific and ethical reasons not to include them.

All investigators proposing research involving human subjects should read the "NIH Policy and Guidelines" on the inclusion of children as participants in research involving human subjects (https://grants.nih.gov/grants/funding/children/children.htm).

Required Education on the Protection of Human Subject Participants:
NIH policy requires education on the protection of human subject participants for all investigators submitting NIH applications for research involving human subjects and individuals designated as key personnel. The policy is available at https://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html.

Human Embryonic Stem Cells (hESC):
Criteria for federal funding of research on hESCs can be found at http://stemcells.nih.gov/index.asp and at https://grants.nih.gov/grants/guide/notice-files/NOT-OD-09-116.html. Only research using hESC lines that are registered in the NIH Human Embryonic Stem Cell Registry will be eligible for Federal funding (http://escr.nih.gov). It is the responsibility of the applicant to provide in the project description and elsewhere in the application as appropriate, the official NIH identifier(s) for the hESC line(s) to be used in the proposed research.

NIH Public Access Policy Requirement:
In accordance with the NIH Public Access Policy (https://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-033.html) investigators must submit or have submitted for them their final, peer-reviewed manuscripts that arise from NIH funds and are accepted for publication as of April 7, 2008 to PubMed Central (http://www.pubmedcentral.nih.gov/), to be made publicly available no later than 12 months after publication. As of May 27, 2008, investigators must include the PubMed Central reference number when citing an article in NIH applications, proposals, and progress reports that fall under the policy, and was authored or co-authored by the investigator or arose from the investigator’s NIH award.  For more information, see the Public Access webpage at http://publicaccess.nih.gov/.

Standards for Privacy of Individually Identifiable Health Information:
The Department of Health and Human Services (DHHS) issued final modification to the "Standards for Privacy of Individually Identifiable Health Information", the "Privacy Rule", on August 14, 2002. The Privacy Rule is a federal regulation under the Health Insurance Portability and Accountability Act (HIPAA) of 1996 that governs the protection of individually identifiable health information, and is administered and enforced by the DHHS Office for Civil Rights (OCR).

Decisions about applicability and implementation of the Privacy Rule reside with the researcher and his/her institution. The OCR website (http://www.hhs.gov/ocr/) provides information on the Privacy Rule, including a complete Regulation Text and a set of decision tools on "Am I a covered entity?" Information on the impact of the HIPAA Privacy Rule on NIH processes involving the review, funding, and progress monitoring of grants, cooperative agreements, and research contracts can be found at https://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-025.html.

URLs in NIH Grant Applications or Appendices:
All applications and proposals for NIH funding must be self-contained within specified page limitations. For publications listed in the appendix and/or Progress report, internet addresses (URLs) must be used for publicly accessible on-line journal articles.  Unless otherwise specified in this solicitation, Internet addresses (URLs) should not be used to provide any other information necessary for the review because reviewers are under no obligation to view the Internet sites. Furthermore, we caution reviewers that their anonymity may be compromised when they directly access an Internet site.

Healthy People 2010:
The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2010," a PHS-led national activity for setting priority areas. This FOA is related to one or more of the priority areas. Potential applicants may obtain a copy of "Healthy People 2010" at http://www.health.gov/healthypeople.

Authority and Regulations:
This program is described in the Catalog of Federal Domestic Assistance at http://www.cfda.gov/ and is not subject to the intergovernmental review requirements of Executive Order 12372. 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 52 and 45 CFR Parts 74 and 92. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement. The NIH Grants Policy Statement can be found at https://grants.nih.gov/grants/policy/policy.htm.

The PHS strongly encourages all grant recipients to provide a smoke-free workplace and discourage the use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routine education, library, day care, health care, or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people.

Loan Repayment Programs:
NIH encourages applications for educational loan repayment from qualified health professionals who have made a commitment to pursue a research career involving clinical, pediatric, contraception, infertility, and health disparities related areas. The LRP is an important component of NIH's efforts to recruit and retain the next generation of researchers by providing the means for developing a research career unfettered by the burden of student loan debt. Note that an NIH grant is not required for eligibility and concurrent career award and LRP applications are encouraged. The periods of career award and LRP award may overlap providing the LRP recipient with the required commitment of time and effort, as LRP awardees must commit at least 50% of their time (at least 20 hours per week based on a 40 hour week) for two years to the research. For further information, please see: http://www.lrp.nih.gov.