Participating Organization(s)	National Institutes of Health (NIH)
Components of Participating Organizations	National Institute of Mental Health (NIMH)
Funding Opportunity Title	Limited Competition: Mental Health Research Network II (U19)
Activity Code	U19 Research Program Cooperative Agreements
Announcement Type	New
Related Notices	None
Funding Opportunity Announcement (FOA) Number	RFA-MH-14-110
Companion Funding Opportunity	None
Number of Applications	Only one application per institution is allowed, as defined in Section III. 3. Additional Information on Eligibility.
Catalog of Federal Domestic Assistance (CFDA) Number(s)	93.242
Funding Opportunity Purpose	This Funding Opportunity Announcement (FOA) is to support the Mental Health Research Network (MHRN), a research resource consortium within several non-profit integrated health care delivery systems. Originally, the MHRN was created to develop infrastructure that would demonstrate 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. This FOA is intended to provide targeted expansion of the network to 1) develop capacity to perform trials involving pharmacotherapy, 2) develop procedures for deploying large-scale mental health IT interventions, and 3) conduct a signature project of large population impact on an area of high priority to the field. It is expected that the MHRN will continue to implement appropriate procedures to collaborate with outside investigators on a variety of applicable studies, will use the virtual data warehouse (VDW) on a range of studies including policy impact, practice variation, and signal detection, and will effectively disseminate the outcomes of research projects within the large health care delivery systems to which the MHRN is connected.

Posted Date	May 8, 2013
Letter of Intent Due Date(s)	June 22, 2013
Application Due Date(s)	July 22, 2013
AIDS Application Due Date(s)	Not Applicable
Scientific Merit Review	October 2013
Advisory Council Review	January 2014
Earliest Start Date	April 1, 2014
Expiration Date	July 23, 2013
Due Dates for E.O. 12372	Not Applicable

Required Application Instructions

It is critical that applicants follow the instructions in the PHS 398 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.

Looking ahead: NIH is committed to transitioning all grant programs to electronic submission using the SF424 Research and Related (R&R) format and is currently investigating solutions that will accommodate NIH’s multi-project programs. NIH will announce plans to transition the remaining programs in the NIH Guide to Grants and Contracts and on NIH’s Applying Electronically website.

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

The purpose of this Funding Opportunity Announcement (FOA) is to support the Mental Health Research Network (MHRN), a research resource consortium within eleven non-profit integrated health care delivery systems. This FOA is a limited competition solicitation only open to institutions who are members of the current MHRN consortium funded by an NIMH U19 cooperative agreement award.

Originally, the MHRN was created to develop infrastructure that would demonstrate 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. Within the initial three-year funding period, the MHRN has effectively demonstrated each of these capacities through the execution of a set of infrastructure development projects.

This FOA is intended to provide targeted expansion of the network through pilot studies and core activities to 1) develop capacity to perform trials involving pharmacotherapy, 2) develop procedures for deploying large-scale mental health IT interventions, and 3) conduct a signature project of large population impact on an area of high priority to the field. It is expected that the MHRN will continue to implement appropriate procedures to collaborate with outside investigators on a variety of applicable studies, will use the virtual data warehouse (VDW) on a range of studies including policy impact, practice variation, and signal detection, and will effectively disseminate the outcomes of research projects within the large health care delivery systems to which the MHRN is connected and beyond.

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 extent to which these systems 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 clinical research 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 treatment, preventive and services interventions 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 will extend upon a platform to conduct a series of effectiveness trials at costs far below a traditional effectiveness trial.

MHRN Environment. Currently, the MHRN consists of 11 research sites at member institutions (research divisions) affiliated with non-profit integrated health care delivery systems. All these MHRN Member institutions belong to a consortium of 16 health care delivery organizations with integrated research divisions, known as the HMO Research Network (HMORN). In addition to MHRN, HMORN has attracted other NIH-funded research programs including the Cancer Research Network, and the Cardiovascular Research Network, as well as several programs funded by the Agency for Health care Research and Quality (AHRQ). The MHRN is thus well positioned to collaborate with experts in other clinical areas to improve the overall health of people with mental disorders.

The parent HMOs for MHRN Members provide care for approximately 11 million individuals. These HMOs offer substantial resources that are potentially useful for the conduct of mental health effectiveness and services research. These resources include data for: large, well-defined, and diverse patient populations; long-established administrative and medical records; physician and patient web portals; biospecimen resources; linkages to other data systems such as population-based patient registries; and capacity for rapid identification and accrual of subjects to longitudinal retrospective and prospective cohorts for observational studies or clinical trials.

Original MHRN Goals. When the original MHRN FOA was issued, a successful network was defined as one accomplishing the following tasks:

• Demonstrate the ability to identify subjects and determine caseness for inclusion in a prospective study;
• Demonstrate the ability to randomize subjects 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, and pool data from multiple organizations for analysis.

Existing MHRN Infrastructure. In response to this set of challenges, MHRN investigators have completed the following activities:

• Enhanced the Virtual Data Warehouse (VDW) to harmonize mental health diagnosis and treatment data across all sites of the MHRN, establishing standard definitions for key exposures and mental health outcomes, and developed procedures for distributing standard programs and aggregating data across sites.
• Conducted observational studies using the VDW to analyze practice variation across multiple sites, as well as organizing patient-reported outcome data (PHQ-9 scores) across sites within the MHRN.
• Developed and implemented a centralized online platform for administration of standardized clinical measures across multiple sites, as well as procedures for online electronic informed consent, protection of personally identifiable information and transfer of sensitive data. In addition, procedures have been established for multi-site collection of biological specimens, including consent, and specimen collection and use. These functions were created in the context of a patient registry.
• Developed and executed a psychotherapeutic pilot trial, involving recruitment, enrollment and efficient, centralized, longitudinal outcome assessment of patients.

Potential and Need for further improvements. In the initial project period, the MHRN made substantial progress in demonstrating the viability of the members to identify, recruit and enroll patients into psychotherapy trials, in utilizing the VDW to assess practice variation and the impact of policies on suicidal behavior, in developing patient registries for trials on autism spectrum disorders, and in enhancing processes for collaboration with outside investigators. For these tasks, the MHRN no longer requires direct support. However, NIMH sees key targeted areas in which limited resources may further enhance the MHRN’s capabilities of efficiently housing a number of high priority research studies in effectiveness and services research. These areas include, but are not limited to: 1) developing and testing procedures for conduct of pharmacotherapy trials within network sites, 2) developing and testing procedures for trials using technology-driven interventions for prevention, treatment, or services, and 3) enhancing signal detection of unexpected positive results from off-label use of therapies. Limited funds are also available for network oversight and coordination, and for dissemination of information on the use of MHRN as a platform for the field to conduct effectiveness and services research.

This FOA is structured around supporting these targeted activities, through pilot projects, as well as providing funds for a Signature Project, detailed below, whose findings will have a substantial impact on the mental health of a large population.

MHRN is expected to continue to function as a resource to the broad mental health research community mainly through the following activities:

• Maintaining accessibility to relevant data for patient populations and their providers served by the parent HMOs of MHRN Member institutions for use by MHRN-affiliated and non-affiliated investigators in research studies;
• Facilitating and coordinating access to these data for research conducted by MHRN-affiliated and non-affiliated investigators using approaches and solutions that optimize the use of the MHRN and are conducive to collaborative efforts;
• Maintaining high level of expertise and competency in scientific areas relevant to MHRN and of potential interest to non-MHRN-affiliated collaborators;
• Sharing this expertise with other (non-MHRN-affiliated) mental health researchers with the goal to facilitate interactions and research collaborations among mental health researchers who might benefit from these data;
• Increasing participation of MHRN-affiliated and non-affiliated investigators in independently funded research relevant to these areas of expertise, including efforts to increase the number, scope, and scientific impact of research projects conducted by external investigators in collaboration with MHRN;
• Conduct a Signature Project (described below), a large-scale pragmatic trial to answer a research question of high impact to improve the care of people with mental disorders.
• Conducting pilot projects (directly funded by MHRN) that will allow MHRN and external investigators to develop competitive applications for funding of full research projects. It is expected that by the end of the proposed MHRN funding period, investigators involved in MHRN-sponsored pilot projects (including outside collaborators) will have submitted at least 5 investigator-initiated applications for other funding (based on the data from pilot projects).

Overall structure of the Network

To ensure efficient conduct of the activities outlined above, the proposed MHRN structure will be encompassed within the Administrative Core, and is encouraged to include the following organizational and functional units, as well as any other units or working groups key to achieving the aims of the MHRN:

• Organizational Unit must be established to coordinate MHRN administrative functions, including but not limited to mediating and coordinating administratively interactions among MHRN Members and providing organizational support for joint Network activities (e.g., organizing meetings, teleconferences, etc.).
• Informatics Unit is the key component for the MHRN resource function. This Unit should be organized to support MHRN informatics infrastructure, notably including the VDW, and to continue improvements in data development, informatics tools, etc. The Informatics Unit should coordinate informatics-related efforts at individual MHRN Member sites as well as interact with other Units and Projects (see below) to support their functions.
• Outreach and External Collaboration Unit should work to increase the usage of the MHRN by external investigators, as well as to support the implementation of MHRN findings within the partnering health systems. This Unit is expected to take actions popularizing MHRN as a resource and facilitate access to external, non-MHRN-affiliated investigators. Importantly, this Unit must provide a liaison function to help connect non-MHRN-affiliated investigators with those MHRN investigators who would be most appropriate as experts and/or potential collaborators. This Unit must also establish an efficient system and operating procedures for (1) receiving and managing an influx of requests for access to data, ideas for collaborations, and applications for research projects from the scientific community and channeling them to relevant MHRN components or researchers, as well as (2) developing procedures for supporting training experiences for junior investigators interested in conducting research within MHRN sites. Finally, this Unit must develop procedures to improve the connectivity of MHRN findings to member and external health system operations, both in identifying new research topics for study and to foster population impact of scientific findings.

Signature Project

The Signature Project should target a significant problem in the prevention, treatment, and/or management of a large population of people with mental disorders served by the health systems affiliated with the network. It should be designed as a pragmatic trial, meeting the following criteria:

• The pragmatic trial should test an intervention, or compare several interventions (which can be treatments, preventive actions, policies or organizational changes) that are robust, apply broadly to patient populations and are suitable for use in multiple health systems, with the broad goal of determining whether the intervention improves health and adds value to the utilization of the nation’s health care resources.
• The question should be of major importance to the health of people with mental disorders and in which tested interventions are hypothesized to result in dramatic functional and/or systemic improvements in the health of the population and the care that they receive.
• The intervention(s) should be able to be reliably delivered by clinical providers typically found in the health care setting and/or health care systems or self-administered through computer-based technology with appropriate assessments of quality.
• The intervention(s) should be reasonably simple, easily incorporated into the care setting and not
• require a complex structure for implementation or monitoring.
• The trial should exploit opportunities made available by the nature of the MHRN; for example, the use of primary endpoint events can be easily captured by passive follow-up, such as electronic health records, or efficient active data collection, and, ideally, objectively quantified (e.g. hospitalization, sick days). Furthermore, the costs of conducting the trial should be a fraction of the historic costs of completing similar trials.
• The trial design should incorporate rigorous and robust comparison conditions, prospectively identified, and feasible to be implemented within health care systems. The design may incorporate novel randomization approaches, such as by cluster or timing of implementation. The design should also maximize external validity of the study, by testing generalizability of findings across distinct health care settings, and diverse staff and patient populations.
• The trial should enroll hundreds of patients based on broad eligibility criteria to maximize diversity, with minimum exclusions on risk, age, health literacy, comorbidities, or expected adherence.
• As in routine practice, the pragmatic trial should allow for interventions to be implemented with maximal flexibility and by all appropriate practitioners (not just those with exceptional levels of training or competence).

Example Topics for Signature Project Consideration

Below are example topics of high impact for consideration as a theme for the Signature Project. Each example is intended to define an opportunity to make significant improvements on the outcomes of large populations served by the MHRN. The list below is intended to be suggestive, not exhaustive; other research areas of equivalent or higher impact should be considered.

• Data suggest the high use of antipsychotic treatments for non-psychotic conditions in children and adolescents. The resulting risk of metabolic adverse effects is unnaturally high, and has severe impacts on the healthy development and well-being of thousands. Approaches to reduce the use of antipsychotics in child and adolescent populations could dramatically improve health and mental health outcomes across the country.
• People with severe mental illness are at high risk for multiple comorbid medical illnesses, including cardiovascular disease and diabetes, exacerbated by the known metabolic side effects of commonly used medications. The development and testing of algorithms for antipsychotic treatment to minimize medical consequences of mental health treatment could substantially improve health of people with SMI and ultimately improve life expectancy.
• Depression continues to confer high cost and burden of illness across the US population. While treatment of depression has yielded significant gains, more impact may be realized through prevention of depression in individuals at risk due to persistent anxiety, subsyndromal depression, family history, and critical periods of risk. The development and testing of strategies to reduce incidence of depression in large populations could dramatically improve health and reduce burden on care systems.

Pilot Projects

The Pilot Projects are designed to test the feasibility of conducting additional trials to those already accomplished within the MHRN. They should be designed to pilot test identification, recruitment, and enrollment protocols for patients, clinicians and health care organizations, and should be of two basic types:

(1) projects that demonstrate additional capability for conducting a range of impactful trials not previously conducted on the network (e.g. pharmacotherapy; clinical algorithms; large-scale health IT trials) and

(2) resource improvement/methodological research projects, which build new efficiencies in the conduct of high-impact effectiveness and services research.

It is expected that these projects will result in studies conducted below historic study costs by an order of magnitude. Both types of projects should involve MHRN-affiliated as well as non-affiliated investigators wherever possible.

MHRN-affiliated investigators are encouraged to plan for their engagement in both types of projects. Non-MHRN-affiliated researchers may be more inclined to engage in the second type of projects. These pilot projects should be similar to traditional NIH exploratory/developmental (R21) projects in terms of emphasis on exploration of new ideas, generating preliminary data, testing the feasibility of a bigger study, etc. Projects of this type are expected to serve as a main channel for research collaborations between external investigators and MHRN experts.

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

• Extend the capacity of the network to conduct prospective trials via the successful completion of multiple pilot studies of types of interventions not yet studied across multiple network sites (e.g. pharmacotherapy, large-scale delivery of IT interventions, clinical algorithms).
• Successfully complete a Signature Project of high impact on the mental health of a large population.
• Develop and submit at least 5 investigator-initiated applications involving outside investigators conducted within MHRN sites.
• Benchmark the costs of conducting a range of studies on the network compared to historical norms, and progress toward network-involved trials to be completed with costs at an order of magnitude below prior norms.
• Expand tools to create efficiency in the conduct of effectiveness and services research studies on the network.
• Successfully disseminate trial results to health system partners resulting in change of policy and/or practice.

Funding Instrument	Cooperative Agreement: A support mechanism used when there will be substantial Federal scientific or programmatic involvement. Substantial involvement means that, after award, NIH staff will assist, guide, coordinate, or participate in project activities.
Application Types Allowed	Renewal The OER Glossary and the PHS 398 Application Guide provide details on these application types.
Funds Available and Anticipated Number of Awards	NIMH intends to commit $2,000,000 in FY 2014 to fund one award.
Award Budget	Application budgets are limited to $2,000,000 per year in total costs for up to five years, and need to reflect actual needs of the proposed project.
Award Project Period	The total project period may not exceed five 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.

As this FOA is a limited competition opportunity, only the institutions that are the principal employers of the PD(s)/PI(s) of the current Mental Health Research Network (MHRN) are eligible to apply to this FOA.

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

Applicant organizations must complete the following registrations as described in the PHS 398 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.

• System for Award Management (SAM) must maintain an active entity registration (formerly CCR registration), to be renewed at least annually. Use the Sam.gov Manage Entity function to manage your entity registrations. See the Grants Registration User Guide at SAM.gov for additional information.
• eRA Commons

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

All registrations must be completed by the application due date. Applicant organizations are strongly encouraged to start the registration process at least6 weeks prior to the application due date.

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

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 PHS 398 Application Guide.

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

Only one application per institution (normally identified by having a unique DUNS number or NIH IPF number) is allowed.

NIH will not accept any application that is essentially the same as one already reviewed within the past thirty-seven months (as described in the NIH Grants Policy Statement), except for submission:

1. To an RFA of an application that was submitted previously as an investigator-initiated application but not paid;
2. Of an investigator-initiated application that was originally submitted to an RFA but not paid; or
3. Of an application with a changed grant activity code.

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

It is critical that applicants follow the instructions in the PHS 398 Application Guide, except where instructed in this funding opportunity announcement to do otherwise. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.

Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows IC staff to estimate the potential review workload and plan the review.

By the date listed in Part 1. Overview Information, prospective applicants are asked to submit a letter of intent that includes the following information:

• Descriptive title of proposed activity
• Name(s), address(es), and telephone number(s) of the PD(s)/PI(s)
• Names of other key personnel
• Participating institution(s)
• Number and title of this funding opportunity

The letter of intent should be sent to:

David Chambers, DPhil
Division of Services and Intervention Research
National Institute of Mental Health
6001 Executive Boulevard, Room 7144, MSC 9631
Bethesda MD, 20892-9631
Rockville, MD 20852 (for express/courier service)
Telephone: 301-443-3747
Email: [email protected]

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 files must be sent to:

Shuang-Bao Hu, Ph.D.
Division of Extramural Activities
National Institute of Mental Health
6001 Executive Blvd, Room 6156, MSC 9609
Bethesda, MD 20892-9609
Rockville, MD 20852 (for express/courier service)
Telephone: 301-443-5160
FAX: 301-443-4720
Email: [email protected]

All page limitations described below in the PHS 398 Application Guide and the Table of Page Limits must be followed, with the following requirements:

MHRN Application Components Research Strategy Page Limits

• Overall - 12 pages
• Administraive Core (including all units and workgroups) - 12 pages
• Signature Project - 12 pages
• Each Pilot Project - 6 pages

The following section supplements the instructions found in the PHS398 Application Guide, and should be used for preparing a multi-component application.

The application should consist of the following required components:

• Overall
• Administrative Core
• Signature Project
• Pilot Projects: minimum of 3 required

All instructions in the PHS398 Application Guide must be followed, with the following additional instructions, as noted.

Face Page (Overall)

All instructions in the PHS 398 Application Guide must be followed.

Description, Project/Performance Sites, Senior/Key Personnel, Other Significant Contributors, Human Embryonic Stem Cells (Overall)

All instructions in the PHS 398 Application Guide must be followed, with the following additions:

Description: Using Page 2 of Form 398; provide a succinct but accurate description (abstract) of the overall multi-project application addressing the major, common theme of the program.  Do not exceed the space provided.

Project/Performance Sites: List the performance sites where the research will be conducted.

The Network 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.

Senior/Key Personnel: List only the PD(s)/PI(s) of the multi-project application.

Table of Contents (Overall)

All instructions in the PHS 398 Application Guide must be followed.

Detailed Budget for Initial Budget Period (Overall)

No detailed budget information should be provided in the Overall component for the initial budget period. Budgets for the Administrative core,

The PI(s)/PD(s) of the MHRN funded under this FOA are expected to devote at least 3.6 person/months overall, based on a 12-month calendar (equivalent to a total of 30% of his/her time and effort) to the project.

Budget for Entire Proposed Period of Support (Overall)

All instructions in the PHS 398 Application Guide must be followed.

Do not use Form Page 4 of PHS Form 398.  Instead, using the suggested format presented below, prepare a Composite Budget for All Proposed Years of Support. (Justification for budget elements should not be presented here but in the individual budgets of the network infrastructure and research projects.)

SAMPLE: Consolidated Direct Cost Budget for All Proposed Years of Support. Add other Projects and Cores as appropriate to the FOA.

Component	Year 1	Year 2	Year 3	Year 4	Year 5	All Years
Administrative Core	$550,000	$550,000	$550,000	$5505,000	$550,000	$2,750,000
Signature Project	$450,000	$450,000	$450,000	$450,000	$450,000	$2,250,000
Pilot Project A	$125,000	$125,000	$125,000	$0	$0	$375,000
Pilot Project B	$0	$125,000	$125,000	$125,000	$0	$375,000
Pilot Project C	$0	$0	$125,000	$125,000	$125,000	$375,000
Totals	$1,125,000	$1,250,000	$1,375,000	$1,250,000	$1,250000	$6,250,000

 

 

 

 

 

 

 

Biographical Sketch (Overall)

All instructions in the PHS 398 Application Guide must be followed.

Resources (Overall)

All instructions in the PHS 398 Application Guide must be followed, with the following additional instruction:

The resources section should include descriptions of shared resources across the Administrative Core, Signature Project and Pilot Projects.

Research Plan (Overall)

All instructions in the PHS 398 Application Guide must be followed, with the following additional instructions:

Introduction to Application: This section should provide details on progress made in the first three years of the MHRN, including brief descriptions of (1) infrastructure developed and (2) results from pilot investigations.

Specific 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..

Research Strategy:

Background and Significance. Focusing on the network as a whole, this section should address (i) the importance of the problem or critical barrier to progress that the proposed network will address, (ii) how past activities of the MHRN have contributed to a solution to the problem or barriers to progress, (iii) how the structure of the MHRN and research studies to be conducted will facilitate improvements in scientific knowledge, research capacity, and/or clinical practice, and (iv) how the activities of the MHRN will change the field if the proposed aims are achieved.

This section should also 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.

Innovation. This section should describe the new directions that the MHRN will take in the next project period, and how the overall program of research and structure will advance the field above and beyond work already completed.

Approach. This section should describe the overall structure of the MHRN, including a discussion of how the administrative core and individual research projects (including the signature project and pilots) will collectively accomplish the aims of the network.This section should show how the MHRN as a whole will 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. This section should also 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 any relevant research conducted to date in these organizations, including that which demonstrates improved efficiency over typical research study execution.

Protection for Human Subjects: This section should discuss the proposed protections from research risk related to the overall network. 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. Specific descriptions of efforts to increase efficiency in recruitment and enrollment of research participants while maximizing necessary protections should be included in this section. Specific protections from research risk related to the Administrative Core, Signature project and pilot studies should be included within the relevant sections below. 

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 PHS 398 Application Guide, with the following modification:

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

All instructions in the PHS398 Application Guide must be followed, with the following additional instructions, as noted.

Face Page (Administrative Core)

All instructions in the PHS 398 Application Guide must be followed.

Description, Project/Performance Sites, Senior/Key Personnel, Other Significant Contributors, Human Embryonic Stem Cells (Administrative Core)

All instructions in the PHS 398 Application Guide must be followed, with the following additional instructions:

Description: Using Page 2 of Form 398; provide a succinct but accurate description (abstract) of the Administrative Core, including the structure of the core, briefly explaining the roles of units and workgroups.  Do not exceed the space provided.

Project/Performance Sites: List the performance sites that apply to the Administrative Core.

Senior/Key Personnel: List the PD/PI of the Administrative Core, leadership of the units and workgroups, other key personnel, and other significant contributors.

Table of Contents (Administrative Core)

All instructions in the PHS 398 Application Guide must be followed.

Detailed Budget for Initial Budget Period (Administrative Core)

All instructions in the PHS 398 Application Guide must be followed, with the following additional insructions:

Applications should include a budget for the overall governance structure of the Administrative Core, along with a budget justification.

Costs for organizing an annual meeting in Bethesda, MD, should be included in the budget, including support for meeting attendance by the PD/PI, the Project Leaders and Cores leaders, and other key personnel.

Budget for Entire Proposed Period of Support (Administrative Core)

All instructions in the PHS 398 Application Guide must be followed, with the following additional instruction:

List the units and workgroups of the Administrative Core with associated costs across all proposed years of support.

Biographical Sketch (Administrative Core)

All instructions in the PHS 398 Application Guide must be followed.

Resources (Administrative Core)

All instructions in the PHS 398 Application Guide must be followed, with the following additional instruction:

The resources section should include descriptions of facilities and resources at all participating network sites.

Research Plan (Administrative Core)

All instructions in the PHS 398 Application Guide must be followed, with the following additional instructions:

Specific Aims: Clearly state how the core will contribute to the overall goals of the MHRN and outline interactions of the core with the Signature Project and Pilot Projects.

Research Strategy:

Governance and Operational Structure. This section should provide an overview of the proposed Administrative Core of the MHRN, describing the functional units (e.g., Organizational, Informatics, and Outreach and External Collaboration), and any other committees/workgroups, and how these entities would function to support and maintain the structure and research projects of the MHRN. 

Research Infrastructure. The infrastructure should be described in detail, and organized by units to perform administrative, data standardization and integration, and evaluation functions.  The application should have separate sections for each of the three required units, and any additional units and workgroups to be included. These units should support the signature project and pilot studies. 

Organizational Unit. This section should provide information on the structure and process of the MHRN, including PD/PI, key investigators, Steering Committee, and the detailed plans for the oversight of the units, workgroups, and research projects of the MHRN. The narrative should 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.  Appropriate structures to oversee quality control of the research (e.g., internal or external advisory committees) should be described in this section, as well as 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. 

Informatics Unit. This section should provide information on how the data infrastructure and resources of the MHRN, including the VDW, will be managed and improved over time. Unit functions should include plans for how the standardization of data resources for mental health effectiveness research will be increased and the role of the unit in the development, or application, of mental health informatics resources and tools. The core resources should be designed to be helpful to both network and non-network researchers in developing research applications for extramural funding.

Outreach and external Collaboration Unit. This section should provide information on the structure and process of the MHRN's efforts to enhance 1) collaboration on research studies with health care organizations within and outside MHRN, and network and non-network researchers and organizations, and 2) dissemination of research findings within the partnering health systems. The application should also describe plans to encourage and create opportunities for research collaboration with interested non-network researchers and organizations for the use of MHRN study datasets. Detailed information on procedures for reviewing and initiating new research and practice collaborations should be included in this section

Additional Units and Workgroups. This section should provide information on additional administrative or thematic units and workgroups that will serve to advance the mission of the MHRN, detailing the structure and process of each of these units, defined purpose, and intended outcomes.

This section should also include information on the planning of an annual in-person meeting of the MHRN steering group in Bethesda, MD.

Protection for Human Subjects: This section should discuss any procedures within the Administrative Core to manage efforts around the protections from research risk related to the MHRN research projects.

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 PHS 398 Application Guide.

Each application should propose a Signature Project, as described below, and at least three Pilot Projects that are aimed at extending the current capacity of the network to conduct a range of effectiveness and services research studies.

All instructions in the PHS398 Application Guide must be followed, with the following additional instructions, as noted.

Face Page (Research Projects)

All instructions in the PHS 398 Application Guide must be followed.

Description, Project/Performance Sites, Senior/Key Personnel, Other Significant Contributors, Human Embryonic Stem Cells (Research Projects)

All instructions in the PHS 398 Application Guide must be followed, with the following additional instructions:

Description: Provide a Description (abstract) of the research proposed in the individual research project according to the instructions on Form Page 2 of PHS Form 398.  In addition, the abstract should contain a brief description of how the individual research project will contribute towards attainment of the multi-project objectives.

Project/Performance Sites: List the performance sites where the research will be conducted.

Key Personnel: List the Project Leader, followed by other key project personnel, and then other significant contributors.

Table of Contents (Research Projects)

All instructions in the PHS 398 Application Guide must be followed.

Detailed Budget for Initial Budget Period (Research Projects)

All instructions in the PHS 398 Application Guide must be followed for each research project (Signature and Pilot).

Budget for Entire Proposed Period of Support (Research Projects)

All instructions in the PHS 398 Application Guide must be followed for each research project (Signature and Pilot).

Biographical Sketch (Research Projects)

All instructions in the PHS 398 Application Guide must be followed for each research project (Signature and Pilot).

Resources (Research Projects)

All instructions in the PHS 398 Application Guide must be followed for each research project (Signature and Pilot), including descriptions of facilities and resources at the sites involved within the specific project. This may include non-MHRN research and clinical sites.

Research Plan (Research Projects)

All instructions in the PHS 398 Application Guide must be followed for each research project (Signature and Pilot), with the following additional instructions:

Specific Aims: List, in priority order, the objectives and goals of the proposed Research Project. This applies to both the Signature Project and all Pilot Projects. Concisely and realistically describe the hypothesis or hypotheses to be tested. In addition, state the individual research project's relationship to the overall MHRN goals and if it relates to other projects or to specific activities of the Administrative Core.

Research Strategy:

Signature Project: This section should provide details about how the MHRN resources will be used to complete a high impact Signature project, as detailed in Part 2, Section 1.  The Signature Project should be consistent with the goals identified earlier in this FOA. The narrative should provide information on: (1) Significance, (2) Innovation, and (3) Approach, as detailed in the "Research Strategy" section of the PHS 398 instructions. Applicants should explain how the proposed Signature Project will demonstrate the network's capacity to perform an efficient, large-scale trial at a significantly lower cost than historical comparisons, in an area of high public health importance, as described above.

Pilot Projects:

This section should provide details about how the MHRN resources will be used to complete at least three pilot projects, each described separately. The research should be consistent with the goals identified earlier in this FOA.  The narrative should provide information on: (1) Significance, (2) Innovation, and (3) Approach, as detailed in the "Research Strategy" section of the PHS 398 instructions. Applicants should demonstrate how the pilot projects are synergistic and show the potential for the network to expand its capacity to conduct a range of prospective trials. Applicants must provide milestones and timelines for each research project.

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 PHS 398 Application Guide.

Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix (please note all format requirements) as described in the PHS 398 Application Guide.

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 PHS 398 Application Guide.

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

This initiative is not subject to intergovernmental review.

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

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

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

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

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

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

For this particular announcement, note the following:

Peer review emphasizes a synthesis of three major aspects of the U19 application: (1) review of the merit of the overall network (including the organizational structure), (2) review of the Signature Project, and (3) review of the additional pilot projects 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 and services research conducted in integrated health care systems.

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

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

Significance

Does the MHRN address an important problem or a critical barrier to progress in the field? If the aims of the MHRN are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field? What is the potential of the overall MHRN program to advance knowledge that will improve outcomes of patients with mental disorders receiving care in integrated healthcare systems? Do the proposed activities of the MHRN have a high likelihood of significantly advancing mental health services and intervention research, above and beyond prior accomplishments of the network? Do the proposed activities appear to improve the efficiency of large-scale prospective studies to be conducted, at significantly reduced costs as compared to historical norms?

Investigator(s)

Are the PD(s)/PI(s), collaborators, and other researchers well suited to the goals of the MHRN? If Early Stage Investigators or New Investigators, or in the early stages of independent careers, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the project is collaborative or multi-PD/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project? Do the qualifications of the PD/PI and other senior scientists to lead the MHRN scientifically and coordinate all activities include demonstrated ability to provide effective scientific and administrative leadership, particularly in the engagement of researchers from outside the MHRN and health system participants within and outside the MHRN? In addition, do the qualifications of the PD/PI and other key personnel include adequate expertise in the areas in which the MHRN is designed to expand (e.g. health IT, pharmacology trials, methods)?

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? To what degree does the overall program apply novel concepts and innovative approaches to the efficient conduct of pragmatic mental health effectiveness and services research? Does the application describe innovative and efficient mechanisms for identifying, recruiting, enrolling, and monitoring subjects within effective research studies and for conducting large-scale prospective trials?

Approach

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the MHRN? Are potential problems, alternative strategies, and benchmarks for success presented? If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed? 

If the MHRN 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? Are the administrative plans for the management of the MHRN appropriate, including plans to resolve 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 contribute to the probability of success? Are the institutional support, equipment and other physical resources available to the investigators adequate for the project proposed? Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements? Is there clear evidence of the support and collaboration of the health systems within which the MHRN sites exist? Is there an appropriate environment and plan for the engagement of external institutions and investigators in collaboration with the MHRN?

Reviewers will provide an overall impact score to reflect their assessment of the likelihood (1) for the Signature Project to have ultimate impact on the clinical practice and the health of the public, as well as to exert a sustained, powerful influence on the research field, in consideration of the following review criteria and additional review criteria (as applicable for the project proposed).

Reviewers will consider each of the five review criteria below for the Signature Project, in the determination of scientific and technical merit, and give separate scores for each.  Questions listed should be answered for the proposed Signature Project.

Significance

Does the Signature Project address important problems related to mental health effectiveness or services research? If the aims of the research project is achieved, how will scientific knowledge or clinical practice be advanced? What will be the effect of this study on the concepts, methods, technologies, treatments, services, or preventive interventions that drive this field?   Does the Signature Project address a high-impact research topic, with the possibility of dramatically improving outcomes for people with mental disorders?

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 project?  Does the project involve sufficient network investigators to demonstrate feasibility of conducting efficient multi-site investigations? Does the research project include investigators from within the MHRN and external investigators as part of the study team?

Innovation

Is the project original and innovative for the MHRN? For example: Does the project challenge existing paradigms or clinical practice; address an innovative hypothesis or critical barrier to progress in conducting large-scale effectiveness research? Does the project 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 mental health services and effectiveness research, above and beyond the prior work of the network? Does the Signature Project break new ground in the efficient conduct of large-scale pragmatic trials?

Approach

Are the conceptual or clinical frameworks, designs, methods, and analyses adequately developed, well-integrated, and appropriate to the aims of the project? Does the applicant acknowledge potential problem areas and consider alternative tactics?  Does the project demonstrate ability to efficiently identify, recruit, enroll, and track research subjects through common protocols across multiple network sites? Does the research design show optimal use of network research infrastructure, resulting in higher efficiency in the conduct of research projects to historical norms?

If the project(s) 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

Does the scientific environment in which the work will be done contribute to the probability of success? Does the proposed experiment benefit from unique features of the scientific environment, or subject populations, or employ useful collaborative arrangements? Is there evidence of institutional support among the health care delivery systems?   Does the environment include sufficient network membership to demonstrate ability to conduct the study 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 the Signature Project (as well as the set of pilot projects). These characteristics are discussed and rated under the Impact score review criterion when evaluating the Overall MHRN.

Review Criteria - Pilot Projects

Reviewers should consider the set of pilot projects collectively when assessing their merit and give a single score to reflect this assessment. Reviewers should consider the following questions in determining the overall scientific and technical merit of the pilot projects:

Do the set of pilot projects address important problems related to mental health effectiveness or services research? If the aims of the pilot projects are achieved, how will scientific knowledge or clinical practice be advanced? Are the pilot projects demontrate expansion of the MHRN's research capacity to conduct new types of studies than those previously carried out across the network? Do the projects involve investigators outside of the MHRN, with complementary expertise to the current investigators within the network? Do the projects use and extend the capacity of the network to efficiently identify, recruit, enroll and track research subjects through common protocols across multiple network sites?

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

Protections for Human Subjects

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

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

Inclusion of Women, Minorities, and Children 

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

Vertebrate Animals

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

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

Revisions

Not Applicable.

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

Applications from Foreign Organizations

Not Applicable

Select Agent Research

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.

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s) convened by the NIMH, in accordance with NIH peer review policy and procedures, using the stated review criteria. Assignment to a Scientific Review Group will be shown in the eRA Commons.

As part of the scientific peer review, all applications:

• Will receive a written critique.

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

Applications will be assigned 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 Mental Health Council. The following will be considered in making funding decisions:

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

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.

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

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

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

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

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

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.

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

The PD(s)/PI(s) 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(s)/PI(s) 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(s)/PI(s) is expected to make any necessary adjustments in the overall research strategies during the course of the project period. Although joint research projects are strongly encouraged under this FOA, 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 FOA. Project Leaders of such single member organization studies within an application will have equivalent status with all other PD(s)/PI(s) 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(s)/PI(s) 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(s)/PI(s) and appropriate Project Leaders and require acknowledgement of NIMH support. Timely publication of major findings is encouraged

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

NIH/NIMH will assign one staff member to serve as the Project Scientist. 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 PD/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 PD(s)/PI(s) 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 may 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.

Areas of Joint Responsibility include:

During the course of the award period, the awardee will be invited to meet with the NIMH, other PDs/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.

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.

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

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

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

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

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Telephone 301-710-0267
TTY 301-451-5936
Email: [email protected]

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: [email protected]

David A. Chambers, D.Phil.
National Institute of Mental Health (NIMH)
Telephone:  301-443-3747
Email:  [email protected]

David Armstrong, Ph.D.
National Institute of Mental Health (NIMH)
Telephone: 301-443-3534
Email: [email protected]

Tamara Kees
National Institute of Mental Health (NIMH)
Telephone: 301-443-8811
Email: [email protected]

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

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