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Part II - Full Text of Announcement

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: Collaborative Hubs for International Research on Mental Health (U19)

Announcement Type

New

Update: The following update relating to this announcement has been issued:

Request For Applications (RFA) Number: RFA-MH-11-070

Catalog of Federal Domestic Assistance Number(s)
93.242

Key Dates
Release Date: September 15, 2010
Letters of Intent Receipt Date(s): December 21, 2010
Application Receipt Dates(s): January 21, 2011
Peer Review Date(s): April-May 2011
Council Review Date(s): August 2011
Earliest Anticipated Start Date: September 2011
Additional Information To Be Available Date (Url Activation Date):
Expiration Date: January 22, 2011

PRE-APPLICATION TELECONFERENCE

NIMH will hold a pre-application teleconference on Monday, November 1, 2010, from 9:00 a.m.-11:00 a.m. (EST) to which all prospective applicants are invited. This is a technical assistance teleconference conducted by NIMH staff involved in managing this program to explain the goals and objectives of this initiative and answer questions from the attendees. Participating in the teleconference is neither required nor necessary for a successful application. It is intended to be an opportunity to clarify the objectives of the initiative. Potential applicants are encouraged to submit their questions or comments to [email protected] in advance of the call. Applicants interested in participating in the technical assistance call should email [email protected] to obtain a dial-in number. A set of questions and answers from the teleconference will be posted after the session to a site-to-be-determined and announced.

Due Dates for E.O. 12372

Not Applicable

Additional Overview Content

Executive Summary

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
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. Dispute Resolution 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

Purpose

The National Institute of Mental Health invites applications to establish Collaborative Hubs for International Research on Mental Health (CHIRMH). This program aims to establish three regional hubs to increase the research base for mental health interventions in World Bank designated low- and middle-income countries (LMICs) through integration of findings from translational, clinical, epidemiological and/or policy research. Each regional hub is to conduct research and provide capacity-building opportunities in one of six geographical regions (i.e., East Asia and the Pacific; Europe and Central Asia; Latin America and the Caribbean; Middle East and North Africa; South Asia; Sub-Saharan Africa). The purpose of the CHIRMH program is to expand research activities in LMICs with the goal of providing the necessary knowledge, tools, and sustainable research-based strategies for use by government agencies, non-governmental organizations, and health care institutions to reduce the mental health treatment gap. The mental health treatment gap refers to the proportion of persons who need, but do not receive care. As a group, awardees will constitute a collaborative network of regional hubs for mental health research in LMICs with capabilities for answering research questions (within and across regions) aimed at improving mental health outcomes for men, women, and children.

The treatment gap for mental disorders across the world is large and leads to chronic disability and increased mortality for those affected. Research is needed to identify effective treatment and prevention strategies to close this gap. Mental health research that ultimately enables effective services to preempt, prevent, and treat mental disorders requires both infrastructure and partnerships. Tackling the urgent challenges of the treatment gap demands effective collaborations among researchers, mental health service users, mental health service providers, and government agencies that will implement and sustain services. Therefore, a goal of this FOA is to support research partnerships and activities in LMIC settings that will stimulate research to address the prevention and treatment of mental disorders and ultimately increase the evidence base for mental health interventions.

Background

The prevalence of mental disorders worldwide is approximately 30% (Demyttenaere et al., 2004). In addition, mental disorders account for 37% of healthy years lost from disease (Wang et al., 2007), and are the leading cause of disability worldwide (Lopez et al., 2006). Despite this dramatic need, only a fraction of those with mental disorders receive effective treatment, even in well-resourced settings like the United States. According to a recent report from the World Health Organization (WHO) World Mental Health Survey, disorder severity was associated with service use, yet service availability was directly proportional to a country s Gross Domestic Product (Wang et al., 2007). Moreover, among patients who initiated treatment in settings with impoverished resources and infrastructure, few received treatment meeting minimum standards for adequacy or follow-up care (Wang et al., 2007).

The mental health treatment gap is exacerbated by the dearth of health care workers available to provide evidence-based mental health services that meet minimum standards. While a growing evidence base exists for higher income countries like the United States, far less research has been conducted regarding the treatment gap in LMICs, which face special human resource challenges. For example, the WHO Africa region has the fewest psychiatrists per capita with approximately four psychiatrists for every 10,000,000 people (WHO Mental Health Atlas, 2005b). Across South East Asia, there is, on average, one psychiatric nurse for every million people, compared with 248 per million persons in Europe (WHO, 2005b). These limitations also apply to other mental health specialists.

The challenges of too few mental health professionals in LMICs have strengthened the argument that mental health care should be integrated into primary care, enabling access to these services in the community. This example of task shifting, defined as the rational redistribution of tasks among health workforce teams, involves the appropriate transfer of specific tasks from specialists to those with abbreviated training (WHO, 2007). Task shifting permits judicious use of valuable human resources by engaging qualified health workers in the community. In the context of mental health services where systems lack specialists, primary care providers (i.e., doctors, nurses, community health workers, etc.) may offer much-needed care for mental disorders in the community. A sizable and growing body of research demonstrates that task shifting in both high-income countries and LMICs can be efficient, cost-effective, and sustainable for the delivery of HIV services, improving tuberculosis treatment outcomes, and a wide range of maternal and child health interventions (Lewin, et al., 2010; Lehmann, Van Damme, Barten, & Sanders, 2009; WHO, 2007; Samb et al., 2007). Recent recommendations from the WHO address areas of task shifting in the delivery of HIV services that may be relevant to the strategic delivery of other health services, including mental health interventions (WHO, 2007). While a small, but growing evidence base on the use of non-specialist mental health workers is emerging from LMICs, many empirical questions remain.

An expanded mental health evidence base in LMICs is needed; studies from these countries are underrepresented in scientific literature. Notable gaps in research exist in the domains of health policy and systems, cost-effectiveness of interventions, and scale-up of evidence-based services. A range of factors contributes to the dearth of mental health research in these settings, from limited access to relevant literature to the lack of collaborative networks of investigators of all experience levels. Enhancing resources and improving capacity have been identified as priorities in enriching mental health research in LMICs (Wang et al., 2007).

Research partnerships are key to enhancing resources and improving capacity for mental health research in LMICs. A partnership model of research, in which LMIC nationals lead research projects with any needed technical support from colleagues in more developed countries, can lead to ownership, sustainability, and the development of local and national research capacity (Costello & Zumla, 2000). Cultural and national influences play a large role in the interpretation and application of research findings (Costello et al., 2000). Similarly, local and national researchers in LMICs have critical knowledge of the cultural and national influences regarding health problems and treatment issues. Thus, in mental health research conducted in LMICs, local and national researchers should engage in partnerships, as needed, to provide technical assistance, enhance resources, and build capacity.

Research Scope and Objectives

The objective of this FOA is to establish regional hubs in LMICs that will conduct innovative public health-relevant mental health research, build research infrastructure, and develop research capacity. The work supported under this FOA is expected to: (1) develop and strengthen regional collaborations, including partnerships among governmental and non-governmental organizations, research institutions, and mental health service user advocacy groups; (2) facilitate the conduct of high quality, state-of-the-science mental health services and/or policy research, taking advantage of health system and socio-cultural diversity; (3) support research capacity building; and (4) generate collaborations with local communities on the research process and the interpretation of study outcomes.

The majority of each regional hub’s capacity-building and research activities must be conducted within LMICs and must provide for significant involvement of local/regional LMIC researchers in study design, development, implementation, and interpretation. The CHIRMH program is not intended to support research that can be conducted primarily in and/or by U.S. or other high income country institutions. In addition, each regional hub must develop and collaborate with local/regional government agencies and established institutions in the region to: (1) ensure necessary coordination of research activities with existing policy, clinical service demands, and community priorities; (2) facilitate access to and involvement of locally-identified high priority study populations and treatment centers; and (3) ensure dissemination of study findings to key stakeholders.

Hubs: A hub is defined as a multidisciplinary research group of investigators and their collaborators focused on a common research topic. Hubs are expected to serve as a focal point for all research, research capacity-building, and collaborative activities supported under this FOA.

Applicants must describe existing or planned research collaborations in the region of interest (eligible regions defined below) and relevant areas of methodological expertise. Collaborative teams should minimally include experts in behavioral and social science, epidemiology, mental health policy, and mental health services research. Applicants should partner with existing global health research programs with established infrastructure. Each regional hub must have an existing on-site administrative structure in its respective region along with scientific and mentoring capacity to perform the research activities proposed in the application at the time of award.

Regions: Research must be conducted in World Bank designated LMICs in one of the following geographic regions:

Partnerships: To be considered responsive, applications should describe partnerships within the hub’s selected geographic region with:

Applications considered responsive to this FOA must demonstrate that a research partnership currently exists (or can be developed and maintained) between the applicant and the partnership entities listed above via official documentation of the partnership (i.e., letter of support). The partnership is intended to ensure that the viewpoints of multiple stakeholders (i.e., investigators, service providers, service users, and policymakers) contribute to the development and conduct of the research and research capacity-building efforts, thereby increasing the likelihood of public health-relevant research findings, and ultimately, the uptake of research findings by service systems. Partnerships are expected to be integral to the conduct of the research proposed in the application and the application should describe the activities and responsibilities of each of the partners.

CHIRMH PROGRAM COMPONENTS

Responsive applications will address each of the following components:

1. Hub Overview;

2. Research Component focused on task shifting for delivery of mental health intervention;

3. Research Capacity-Building Component;

4. Shared Projects Component;

5. Administrative Core

1. Hub Overview

Each application must include an overview that provides a synopsis of the applicant’s plan to develop a program in the designated LMIC(s) that will increase opportunities and capacity for conducting mental health research in the region. The applicant should articulate how the aims of the proposed research, research capacity-building, and shared project components intersect to achieve this end. Similarly, the activities of the administrative core that will support these components should be summarized. This section should include a description of existing partnerships with governmental and non-governmental organizations, as well as research collaborations, that will strengthen the likelihood of uptake of the hub research activities by public health agencies in the region.

2. Research Component

Each application must include a research project on task shifting for delivery of mental health interventions. Research topics might include, but are not limited to, the following:

NOTE: This FOA will NOT support:

3. Research Capacity-Building Component

One goal of the CHIRMH program is to establish resources and infrastructure for research that will benefit the hub s region. Hubs should provide opportunities for capacity-building and use regional collaborations to take advantage of scientific opportunities that will ultimately work to decrease the mental health treatment gap. Applicants must articulate a plan for outreach, engagement, and collaboration with regional partners in capacity-building. As different regions may have different levels of research capacity-building and readiness for research participation, a hub s capacity-building component should clearly describe a principled approach to engagement and subsequent activities.

Each hub shall develop and implement a research capacity-building component for regional investigators to increase the number of qualified scientific and technical personnel capable of conducting mental health research. Applicants shall articulate a plan for sustained research capacity-building suited to the needs of the region, which will significantly enhance the future capacity for mental health research in the region by the end of the project period.

Applicants are encouraged to develop innovative models of mentoring, career development, and research training. Capacity-building programs may focus on the development of independent researchers by providing mentorship and supporting career development projects for graduate students, advanced post-doctoral candidates, junior faculty, or established investigators who wish to refocus their careers on mental health research. Applicants may also direct career development and training activities to groups of individuals; for example, a regional hub may establish research training programs for community health workers, graduate students, clinicians and staff of regional mental health non-governmental organizations, or other technical personnel to learn specialized skills. Applicants should provide a description of the career development and training activities that may be made available through this FOA. Funds may not be used to support an academic degree program.

Where training activities are directed toward graduate students, post-doctoral candidates or other investigators seeking independent research careers, the plan for the Research Capacity-Building Component should include and describe the process for solicitation, submission, review, and award of career development projects. Each trainee must have a mentor and trainees must devote at least 50% of full-time professional effort to the hub research project. The Research Capacity-Building Component should support the salary and costs of candidates with outstanding potential, as well as other reasonable costs for career development and training activities. Do not submit descriptions of individual candidate career development projects in the application.

Funds for the Research Capacity-Building Component, not to exceed $50,000 in direct costs per year, should be included in the overall budget of the application. All trainees should be from the hub’s geographic region.

4. Shared Projects Component

Starting in the third year of the award, each hub must set aside up to a total of $50,000 per year in direct costs to support a shared research project to be determined by the network of funded regional hubs. Each applicant must propose a shared research project that: (a) has the potential for significant public health and/or public policy impact across geographic regions; (b) takes advantage of health system and sociocultural diversity; and (c) utilizes shared assessments or analytic approaches to arrive at comparable findings. Examples of shared projects include, but are not limited to:

5. Administrative Core

Each application must include an Administrative Core headed by the PD/PI. The Administrative Core is responsible for the overall administration, coordination, and management of the entire range of regional hub activities, including monitoring progress and ensuring that the project milestones are being met and implemented effectively within the proposed timeline. A well-developed administrative plan is integral to the success of the hub and must be clearly defined in the application. The administrative plan should include a discussion of the structure of the core, roles of administrative staff within the core, and lines of authority within the core. This description should also include the training and experience of proposed staff and the functions to be performed, as well as a discussion of how the regional hub will ensure effective and timely communications between regional hub partners and NIMH staff. The Administrative Core must provide both an organizational and administrative structure that is conducive to ensuring collaborative efforts and interaction among the hub and its partners, and appropriate integration of regional scientists into the research project.

The Administrative Core should clearly identify personnel and resources needed to oversee the Hub and must provide a clear and explicit discussion of how fiscal and other resources will be prioritized, allocated, and managed. Each hub must have a well delineated organizational structure and administrative mechanisms that foster interactions among investigators, accelerate the pace of research, enable translation of research findings to clinical applications, and ensure a productive research effort. The PD/PI is responsible for ensuring that shared scientific resources are utilized to the maximum extent possible and that procedures are developed to ensure that such resources are available to members of the research team in a timely manner. The Administrative Core should also have a research administrator who is responsible for daily administration and fiscal management.

NOTE: Applications without each of the above required five sections will be considered non-responsive and will be returned to the applicant without review.

Steering Committee

A Steering Committee will be established to direct the collaborative work of the hubs. All major scientific and budgetary decisions will be made by the majority of the voting members of the Steering Committee. The PI of each CHIRMH U19 or, in the case of a Multiple PI award, a designated representative will be members of the Steering Committee. See Section VI.2.A.3. for a full description of Steering Committee responsibilities.

Network Scientific Advisory Group

The NIMH will appoint, in consultation with the PIs of the awardee hubs, a Network Scientific Advisory Group (NSAG). This group will comprise no more than seven Federal and non-Federal experts who will provide scientific advice for the activities of the awarded projects. See Section VI.2.A.2. for a full description of the NSAG.

References

Costello, A., & Zumla, A. (2000). Moving to research partnerships in developing countries. BMJ, 321, 827-829.

Demyttenaere, K., et al., (2004). Prevalence, severity, and unmet need for treatment of mental disorders in the World Health Organization World Mental Health Surveys. JAMA, 291(21), 2581-2590.

Lehmann, U., Van Damme, W., Barten, F., & Sanders, D. (2009). Task shifting: the answer to the human resources crisis in Africa? Human Resources for Health, 7, 49. doi: 10.1186/1478-4491-7-49

Lewin, S., Mubabi-Babigumira, S., Glenton, C., Daniels, K., Bosch-Capblanch, X, van Wyk, B.E., Odgaard-Jensen, J., Johansen, M., Aja, G.N., Zwarenstein, M., Scheel, I.B. (2010). Lay health workers in primary and community health care for maternal and child health and the management of infectious diseases. Cochrane Database of Systematic Reviews, Issue 3. Art. No.: CD004015. doi: 10.1002/14651858.CD004015.pub3.

Lopez, A. D., Mathers, C.D., Ezzati, M., Jamison, D.T., & Murray, C.J.L. (Eds; 2006). Global burden of disease and risk factors. Washington, DC: World Bank.

Samb, B., et al. (2007). Task shifting: An emergency response to the health workforce crisis in the era of HIV. Lessons from the past, current practice and thinking. New England Journal of Medicine, 357, 24.

Wang, P.S., et al. (2007). Use of mental health surveys for anxiety, mood, and substance disorders in 17 countries in the WHO world mental health surveys. Lancet, 370, 841-850.

World Health Organization (2005a). Preventing chronic diseases: A vital investment: WHO global report. Geneva, Switzerland: World Health Organization.

World Health Organization (2005b). Mental health atlas: 2005. Geneva, Switzerland: World Health Organization.

World Health Organization (2007). Task shifting: Rational redistribution of tasks among health workforce teams: Global recommendations and guidelines. Geneva, Switzerland: World Health Organization.

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

Section II. Award Information

1. Mechanism of Support

This FOA will utilize the Multi-Project Cooperative Agreement (U19) award mechanism. 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 http://grants.nih.gov/grants/funding/phs398/phs398.html).

This funding opportunity will use 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 the Principal Investigator, as described under the Section VI. 2. Administrative Requirements, "Cooperative Agreement Terms and Conditions of Award."

At this time, the NIMH has not determined whether or how this solicitation will be continued beyond the present FOA.

2. Funds Available

The NIMH intends to commit approximately $2,000,000 in total costs for fiscal year 2011 to fund up to three new grants in response to this FOA. An applicant may request a project period of up to 5 years. An applicant may request up to $500,000 direct costs per year. Future year amounts will depend on annual appropriations.

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 NIMH 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 NIH Grants Policy Statement will apply to the applications submitted and awards made in response to this FOA.

Section III. Eligibility Information

1. Eligible Applicants

1.A. Eligible Institutions

The following organizations/institutions are eligible to apply:

1.B. Eligible Individuals

Any individual with the skills, knowledge, and resources necessary to carry out the proposed research as the PD/PI is invited to work with his/her institution to develop an application for support. Individuals from underrepresented racial and ethnic groups, individuals with disabilities, and foreign institutions in low- and middle-income countries are encouraged to apply for NIH program support.

More than one PD/PI, or multiple PDs/PIs, may be designated on the application for projects that require a team science approach and therefore clearly do not fit the single-PD/PI model. Additional information on the implementation plans, policies, and procedures to formally allow more than one PD/PI on individual research projects is available at http://grants.nih.gov/grants/multi_pi. All PDs/PIs must be registered in the NIH eRA Commons prior to the submission of the application (see http://grants.nih.gov/grants/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 http://grants.nih.gov/grants/multi_pi.

PDs/PIs must commit a minimum of 3 person months (25% of full time professional effort) conducting research and related activities specified in the application on-site where the research is based. In the case of multiple PDs/PIs, the PDs/PIs combined full time professional effort must be a minimum of 3 person months (25% of full-time professional effort).

Applicants may submit more than one application, provided each application is scientifically distinct.

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

An NIH Intramural scientist may not serve as the PD/PI of a CHIRMH, but may participate as a collaborator or consultant. However, an intramural scientist may not receive salary, equipment, supplies, or other remuneration from this FOA. The intramural scientist must obtain written approval of his/her NIH Institute Scientific Director for the amount of resources that may be allocated to the project; this amount must be specified in the letter, and cannot exceed $200,000 in direct costs of intramural resources. The approval must also specify that the conduct of the project will comply with the DHHS regulations for research involving human subjects (if applicable) and with the PHS policy on vertebrate animal research (if applicable). The participation of an intramural scientist is independent of and unrelated to the role of the NIH Project Collaborator as described in the Terms and Conditions of Award. For CHIRMH applications that include NIH intramural components, the involvement of intramural scientists needs to be consistent with NIH policy http://www1.od.nih.gov/oir/sourcebook/ethic-conduct/ethical-conduct-toc.htm.

Number of Applications. Applicants may submit more than one application in response to this FOA, provided each application is scientifically distinct.

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

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

Section IV. Application and Submission Information

1. Address to Request Application Information

The current PHS 398 application instructions are available at http://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: [email protected].

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

2. Content and Form of Application Submission

Prepare all applications using the PHS 398 application forms in accordance with the PHS 398 Application Guide (http://grants.nih.gov/grants/funding/phs398/phs398.html).

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.

Foreign Organizations (Non-domestic (non-U.S.) Entity)

NIH policies concerning grants to foreign (non-U.S.) organizations can be found in the NIH Grants Policy Statement at: http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part12.htm#_Toc54600260.

Applications from foreign organizations must:

In addition, for applications from foreign organizations:

Proposed research should provide special opportunities for furthering research programs through the use of unusual talent, resources, populations, or environmental conditions in other countries that are not readily available in the United States or that augment existing U.S. resources.

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.

Multiple PD/PI Leadership Plan: For applications designating multiple PDs/PIs, the section of the Research Plan entitled, Multiple PD/PI Leadership Plan , must be included in the Overall Research Objectives and Strategic Plan section of the Program Overview. 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 (NoA).

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).

3.A. Receipt, Review and Anticipated Start Dates
Letter of Intent Receipt Date(s): December 21, 2010
Application Receipt Date(s): January 21, 2011
Peer Review Date(s): April-May 2011
Council Review Date(s): August 2011
Earliest Anticipated Start Date(s): September 2011

3.A.1. Letter of Intent

Prospective applicants are asked to submit a letter of intent that includes the following information:

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:

LeShawndra N. Price, Ph.D.
Office for Research on Disparities and Global Mental Health
National Institute of Mental Health
6001 Executive Boulevard, Room 8130, MSC 9659
Bethesda, MD 20892-9659
Rockville, MD 20852 (for express/courier service)
Telephone: (301) 443-2847
FAX: (301) 443-8552
Email: [email protected]

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 http://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:

Jean G. Noronha Ph.D.
Division of Extramural Activities
National Institute of Mental Health
6001 Executive Boulevard, Room. 6154, MSC 9609
Bethesda, MD 20892-9609
Rockville, MD 20852 (for express/courier service)
Telephone: (301) 443-3367
FAX: (301) 443-4720
Email: [email protected]

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 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 http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part6.htm).

6. Other Submission Requirements

Cooperative Agreement

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

Start Up Meeting

In the first year of the award, requested budgets in the Administrative Core must include funds for travel by the PD/PI and two additional Key Personnel (e.g., Project Leaders) to participate in a start-up meeting in Johannesburg, South Africa at a location determined by NIMH staff.

Annual Meetings

Each regional hub will be responsible for hosting up to two annual meetings and attending the remainder during the life of the grant that will have the participation of 3 key staff from each of the awardee hubs, selected experts, and the Network Scientific Advisory Group (defined in the Terms and Conditions, see Section VI.2.A.3), and appropriate NIMH staff. These meetings are intended to identify areas of collaboration among hubs. The focus of the meetings will include determining how the expertise, facilities, and other resources of the hubs can contribute to ongoing or new projects; sharing of data; and identifying opportunities for research involving participating hubs. Investigators will also be expected to present their scientific progress and future plans.

For planning purposes, applicants should request funds to host two annual meetings and to attend this meeting in the other 3 years. Therefore support is requested yearly for this meeting either as a host or for attendance. Each applicant should also budget for travel costs for the PD/PI and key staff (up to three persons) to attend annual workshops in the years in which they are not hosting the workshop. At the time of award, budgets may be reduced to reflect the number of awardee sites and the funds needed to host annual meetings.

Presentation of the Application

The order of presentation should be as follows in accordance with the Special Instructions for Multi-Component Applications:

7.a. Specific Aims 1 page

7.b. Overall Research Objectives & Strategic Plan 12 pages

8.a. Research Component Cover Page (see special instructions, below)

8.b. Research Component Summary & Key Personnel (PHS 398 Form Page 2)

8.c. Research Component Table of Contents (PHS 398 Form Page 3)

8.d. Research Component Budget Pages (PHS 398 Form Pages 4 and 5); with budget justifications

8.e. Research Component Specific Aims 1 page

8.f. Research Component Research Strategy 6 pages

8.g. Research Component Resources

9.a. Research Capacity-Building Cover Page (see special instructions, below)

9.b. Research Capacity-Building Summary & Key Personnel (PHS 398 Form Page 2)

9.c. Research Capacity-Building Table of Contents (PHS 398 Form Page 3)

9.d. Research Capacity-Building Budget Pages (PHS 398 Form Pages 4 and 5); with budget justifications

9.e. Research Capacity-Building Specific Aims 1 page

9.f. Research Capacity-Building Research Strategy 6 pages

9.g. Research Capacity-Building Resources

10.a. Shared Research Project Cover Page (see special instructions, below)

10.b. Shared Research Project Summary & Key Personnel (PHS 398 Form Page 2)

10.c. Shared Research Project Table of Contents (PHS 398 Form Page 3)

10.d. Shared Research Project Budget Pages (PHS Form Pages 4 and 5); with budget justifications

10.e. Shared Research Project Specific Aims 1 page

10.f. Shared Research Project Research Strategy 6 pages

10.g. Shared Research Project Resources

11.a. Administrative Core Cover Page (see special instructions, below)

11.b. Administrative Core Summary & Key Personnel (PHS 398 Form Page 2)

11.c. Administrative Core Table of Contents (PHS Form Page 3)

11.d. Administrative Core Budget Pages (PHS Form Pages 4 and 5); with budget justifications

11.e. Administrative Core Management Strategy 6 pages

11.f. Administrative Core Resources

Special Instructions for Multi-Component Applications

The following section supplements the instructions found in the PHS Form 398 for preparing the multi-project grant application (U19). Additional instructions are required because the PHS398 application Form 398 is designed primarily for the traditional individual, free-standing research project grant (R01) application and several sections have to be modified and expanded so that the form can be used to provide the information needed for a multi-component project grant application.

The supplemental instructions for multi-project applications below are divided as follows:

A. General Instructions Addresses collaborative efforts among research projects, the administrative and organizational structure as well as the overall facilities and environment, and the overall budget.

B. Specific Instructions for the Research, Research Capacity-Building, and Shared Research Project Components Describes modifications to PHS Form 398 instructions on selected items to address the collaborative or interactive role of the project.

C. Specific Instructions for the Administrative Core Describes modifications to PHS Form 398 instructions on selected items to address the collaborative or interactive role of the project.

A. General Instructions

All applications must be submitted on PHS Form 398. The multi-project grant application should be assembled and paginated as one complete document.

1. Form Page 1 Face Page

Items 1-14: Complete these items as instructed. This should be the first page of the entire application and all succeeding pages should be numbered consecutively.

When multiple PDs/PIs are proposed, use the Face Page-Continued page to provide items 3a-3h for all PDs/PIs. The Contact PI should be listed on block 3 of Form Page 1-Face Page, with additional PDs/PIs listed on the Face Page-Continued.

2. Form Page 2

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.

List the performance sites where the research will be conducted.

Under Key Personnel, list the PDs/PIs of the multi-project application, followed by the Project and Core Leaders of the component research projects and cores, and other key personnel and then other significant contributors.

3. Form Page 3 Table of Contents

Do not use Form Page 3 of the PHS 398; a more comprehensive table of contents is needed for a multi-project application.

Bearing in mind that the application will be scientifically reviewed project by project and core by core, prepare a detailed Table of Contents that will enable reviewers to readily locate specific information pertinent to the overall application as well as to each component research project and core. A page reference should be included for the budget for each project component and each core. Further, each research project should be identified by number (e.g., Project 1), title, and responsible Project Leader, and the Core should be identified by letter (e.g., Core A) and title. The page location of a COMPOSITE BUDGET should be indicated in the Table of Contents.

4. Composite Budget

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 projects and core).

SAMPLE: Consolidated Direct Cost Budget for All Proposed Years of Support

Component

Year 1

Year 2

Year 3

Year 4

Year 5

All Years

Project 1. Research Component

249,998

249,998

249,998

225,000

198,782

1,173,776

Project 2. Research Capacity-Building Component

50,000

50,000

50,000

50,000

50,000

250,000

Project 3. Shared Projects Component

50,000

50,000

50,000

150,000

Core A. Admin. Core.

200,000

200,000

150,000

174,999

200,000

924,999

Totals

499,998

499,998

499,998

499,999

498,782

2,498,775


5. Form Page 5

Complete the Total Direct Cost line entries for all requested budget periods (years) and the Total Direct Cost for Entire Period of Support entry. Detailed budgets are required within the descriptions of each project and core (see below). If the FOA allows for budget requests beyond 5 years, use a second Form Page 5 to reflect the additional budget years requested.

6. Biographical Sketch Format Page

Biographical sketches of all professional personnel for all components should be placed at the end of the application with the PDs/PIs first, followed by those of other key personnel in alphabetical order.

7. Resources Format Page

Do not complete. Essential information is to be presented in the individual research project and core sections of the application.

8. Hub Overview

Specific Aims (Limited to 1 page)

List in priority order, the broad, long-range objectives and goals of the proposed project. Concisely and realistically describe the hypothesis or hypotheses to be tested. In addition, state the overall project’s multi-program goals and how it relates to the individual projects and core.

Research Objectives and Strategic Plan (12 pages)

This narrative section summarizes the overall research plan for the multi-project application and is limited to 12 pages. The multi-project application should be viewed as a confederation of interrelated research projects, each capable of standing on its own scientific merit, but complementary to one another. This is an important section for it provides the group of investigators an opportunity to give conceptual wholeness to the overall program by giving a statement of the general problem area and by laying out a broad strategy for attacking the problems. As the strategy develops, each project and core should be cited briefly as to its place in the overall scheme. Summarize the special features in the environment and/or resources that make this application strong or unique.

Organize the Research Strategy in the specified order as stated in the PHS398 Instructions, Section 5.5. Make sure to start each section with the appropriate section heading in order, Significance, Innovation, Approach, and include the appropriate information. Experimental details should be cited using the Bibliography and Reference Cited section and need not be detailed in the Research Strategy.

9. Leadership Plan for Multiple PDs/PIs (required if applicable)

Applications designating multiple PDs/PIs for the overall Program must include a new section, entitled Multiple PD/PI Leadership Plan. As part of the Program Overview. This plan must describe: a rationale for choosing a multiple PD/PI approach; the governance and organizational structure of the leadership team and the research projects and cores; communication plans, processes for making decisions on scientific direction, and procedures for resolving conflicts; the administrative, technical, and scientific roles and responsibilities 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 also be delineated. In the event of an award, the requested allocation may be reflected in a footnote on the Notice of Award.

10. Checklist

One checklist, placed at the end of the application, is to be submitted for the entire application.

11. Appendix Materials

Refer to Section IV.6. Appendix Materials below, for instructions on submitting appendix materials. For each project or core in the multi-project application, 3 publications plus other approved material are allowed.

12. Resource Sharing Plan. One resource sharing plan, placed at the end of the application, is to be submitted for the entire application.

B. Specific Instructions for the Research, Research Capacity-Building, and Shared Research Project Components

Except for the requirements below, follow the PHS Form 398 Specific Instructions found at http://grants1.nih.gov/grants/funding/phs398/phs398.doc#_Toc130797900 in preparing the research project.

For the Research, Research Capacity-Building, and Shared Research Project Components include:

Cover page (See special instructions, below)

Description & Key personnel (PHS 398 Form Page 2)

Table of Contents (PHS 398 Form Page 3)

Budget pages (PHS 398 Form Pages 4 and 5); with budget justifications

Research Strategy

Resources

1. Cover Page

The Face Page of the 398 Form should not be used as a cover page for individual research projects within a multi-project application. Instead, use the PHS 398 continuation page to create a Cover Page containing selected data about the research project. This Cover Page will demarcate each research component (i.e., Research, Research Capacity-Building, Shared Research Project)) and should contain the following information items (these are a subset of the information provided on a PHS 398 Face Page):

Project Number and Title (e.g., 1. Preclinical Evaluation of HIV Microbicides)

Name of Project Leader (e.g., Jones, Roberta A.)

Human Subjects (Yes or No)

If Yes: Exemption number, -or- IRB approval Date (e.g., 12/13/2006, or Pending , and Federal-wide Assurance (FWA) number

Vertebrate Animals: (Yes or No)

If Yes: IACUC Approval Date (e.g., 11/17/2006, or Pending) and Animal welfare assurance number

Proposed Period of Support:

From (mmddyyyy - e.g., 07/01/2007)

To (mmddyyyy - e.g., 06/30/2112)

Costs Requested for Initial Budget Period (e.g., 07/01/2007-06/30/2008)

Direct Costs (e.g., $150,000)

Total Costs (e.g., $162,000)

Costs Requested for the Entire Budget Period: (e.g., 07/01/2007-06/30/2012)

Direct Costs (e.g., $700,000)

Applicant Organization (full address)

2. Form Page 2

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

List the performance sites where the research or research component activities will be conducted.

Under Key personnel list the Project Leader followed by other key project personnel and then other significant contributors.

3. Form Page 3

Prepare a Table of Contents for the research project using Form Page 3 of the PHS 398.

4. Budget Pages (PHS 398 Form Pages 4 and 5)

Prepare a detailed budget and justification for the research project or component using Form Pages 4 and 5 of the PHS 398.

5. Research Plan

Specific Aims (Limited to 1 page)

List in priority order, the broad, long-range objectives and goals of the individual research component (i.e., Research, Research Capacity Building, Shared Research Project). Concisely and realistically describe the hypothesis or hypotheses to be tested. In addition, state the individual component’s relationship to the multi-project program goals and how it relates to other components or the Administrative core.

Research Strategy

The Research Strategy section for the Research, Research Capacity-Building, and Shared Research Project components may not exceed 6 pages, including tables, graphs, figures, diagrams, and charts. Use this section to describe how the proposed research will contribute to meeting the program’s goals and objectives and explain the rationale for selecting the methods to accomplish the specific aims. In addition to stating the biological significance of the research, indicate the project’s relevance to the primary theme of the application.

Organize the Research Strategy in the specified order as stated in the PHS 398 Instructions, Section 5.5. Make sure to start each section with the appropriate section heading in order, Significance, Innovation, Approach, and include the appropriate information. Experimental details should be cited using the Bibliography and Reference Cited section and need not be detailed in the Research Strategy.

Milestones for the Research, Research Capacity-Building, and Regional Outreach Components

Each regional hub must propose milestones to measure the progress of the individual projects, as well as the hub as a whole. Milestones should identify partnership strengthening activities, research, and research capacity-building outcomes by providing measures of success within specified timelines and across project years. In addition to providing quantifiable program outcomes, milestones will facilitate tracking progress toward each hub s proposed aims and objectives. For the Research, Research Capacity-Building, and Shared Research Project Components, applicants must provide well-described, quantifiable, and scientifically justified milestones for all study activities, including protocol development, development of Standard Operating Procedures, goals for data collection and analysis, obtaining clearances from in-country human subject review boards, partnership strengthening activities, capacity building, study completion, and analysis of final study data.

Milestones should be presented via a Gantt chart or equivalent, with associated timelines and identified outcomes. Milestones must specify the outcome(s) for each activity. Milestones should be integrated with the overall goals of the proposed program. Applicants should include plans for periodically revisiting and revising milestones and timelines, if needed, as new information becomes available, challenges to the proposed development path are encountered, and research outside the Hub goals modifies the science proposed.

Milestones and timelines should be placed at the end of the Research Strategy for each individual component and fall within the page limitations for the section.

Correspondence from Partners and Collaborators

A letter of collaboration or support from each partner’s participating investigators should be included in the Appendix of the submitted applications and co-signed by the institutional official responsible for binding the organization to such an agreement. Participating investigators who will serve as consultants should not be contacted or named in the application.

6. Resources

Provide information on resources available for the individual component. Describe how the scientific environment in which the research will be done contributes to the probability of success (e.g., institutional support, physical resources, and intellectual rapport.) For Early Stage Investigators, describe institutional investment in the success of the investigator. If there are multiple performance sites, describe the resources available at each site. Describe any special facilities used for working with biohazards or other potentially dangerous substances.

7. Biographical Sketches

Do not repeat the biographical sketches of participating investigators since this information will be included at the end of the overall application (and therefore will be referenced in the Overall Table of Contents).

C. Specific Instructions for the Administrative Core

Except for the requirements below, follow the PHS 398 Specific Instructions found at http://grants1.nih.gov/grants/funding/phs398/phs398.doc#_Toc130797900 in preparing each proposed core.

For the Administrative Core, include:

Cover page (see special instructions, below)

Description & Key personnel (PHS 398 Form Page 2)

Table of Contents (PHS 398 Form Page 3)

Budget Pages (PHS 398 Form Pages 4 and 5); with budget justifications

Management Strategy

Resources Format Page

1. Cover Page

The Face Page of the 398 Form should not be used as a cover page for cores within a multi-project application. Instead, use the 398 continuation page to create a "Cover Page" containing selected data about the administrative core. This Cover Page will demarcate the core and should contain the following information items (which are a subset of the information provided on a Face Page - see PHS 398):

Core Letter and Core Title: (e.g., A. Monoclonal Antibody Production Core)

Name of Core Leader: (e.g., Smith, Robert A.)

Human Subjects (Yes or No)

If Yes, Exemption Number, -or- IRB Approval Date (e.g., 5/14/06, or Pending), and Federal-wide

Assurance (FWA) number

Vertebrate Animals (Yes or No)

If Yes, IACUC Approval Date (e.g., 4/15/07, or Pending), and Animal welfare assurance number

Proposed Period of Support

From: (mmddyyyy, e.g., 07/01/2007)

To: (mmddyyyy, e.g., 06/30/2012)

Costs Requested for Initial Budget Period

Direct Costs (e.g. $50,000)

Total Costs (e.g. $70,000)

Costs Requested for the Entire Budget Period

Direct Costs (e.g. $212,323)

Total Costs (e.g. $297,252)

Applicant Organization (ABC University; 111 Main Street; Anywhere, Else 99999)

The following are specific instructions for sections of the PHS 398 application form that are to be completed differently than usual. For all other items in the core application, follow the usual PHS 398 instructions.

2. Form Page

Provide a Description (abstract) of the core activities and services according to the instructions on Form Page 2 of the PHS 398. In addition, the abstract should contain a brief description of how the core services will contribute towards attainment of the multi-project program objectives.

List the performance sites where the core activities and services will be conducted.

Under "Key Personnel", list the Core Leader, followed by other key core personnel, and then other significant contributors.

3. Form Page 3

Prepare a Table of Contents for the core using page 3 of Form PHS 398.

4. Budget Pages (PHS 398 Form Pages 4 and 5)

Prepare a detailed budget and justification for the core using Form Pages 4 and 5 of the PHS 398.

Funding for the overall administrative efforts, including administrative services, expenses for publications demonstrating collaborative efforts, communication expenses, and expenses associated with hosting and travel related to the annual meeting should be requested in the administrative core budget. The application should also include a budget and plan for how research related travel and training will be organized and managed. All travel should follow NIH travel guidelines.

5. Research Plan

Administrative Core (Limited to 6 pages)

Each application must include an Administrative Core and must describe the overall management, coordination and supervision of the regional hub. Provide an administrative plan discussing the structure and roles of administrative staff, including the training and experience of proposed staff and the functions they will perform; how fiscal and other resources will be prioritized, allocated and managed; how communications will be facilitated; and how research-related travel and training will be budgeted. Funding for the overall administrative efforts, including administrative services, expenses for publications demonstrating collaborative efforts, communication expenses, etc., should be requested here. Use this section to describe how the proposed core activities will contribute to meeting the hub's goals and objectives and explain the rationale for selection of the general methods and approaches proposed to accomplish the hub’s specific aims. In addition, this section should indicate the relevance of the administrative core to the primary theme of the multi-project application.

6. Resources

Provide information on resources available for the core. Describe how the scientific environment in which the research will be done contributes to the probability of success (e.g., institutional support, physical resources, and intellectual rapport.) For Early Stage Investigators, describe institutional investment in the success of the investigator. If there are multiple performance sites, describe the resources available at each site. Describe any special facilities used for working with biohazards or other potentially dangerous substances.

7. Biographical Sketches

Do not repeat the biographical sketches of participating investigators since this information will be included at the end of the overall application (and therefore will be referenced in the Overall Table of Contents).

PHS398 Research Plan Sections

All application instructions outlined in the PHS398 Application Instructions are to be followed, with the following additional requirements:

Budget

This FOA uses non-modular budget formats described in the PHS 398 application instructions (see http://grants.nih.gov/grants/funding/phs398/phs398.html).

All foreign applicants must complete and submit budget requests using the Research & Related Budget component found in the application package for this FOA. See NOT-OD-06-096.

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 http://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 should be explained in Resource Sharing section of the application. See http://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 http://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 http://grants.nih.gov/grants/gwas/.

Specific Instructions for Foreign Applications

All foreign applicants must complete and submit budget requests using the Research & Related Budget component found in the application package for this FOA. See NOT-OD-06-096.

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:

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.

Overall Impact

Reviewers will provide an overall impact/priority 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 scored review criteria, and additional review criteria (as applicable for the project proposed).

Scored Review Criteria

Reviewers will consider each of the five review criteria below in the determination of scientific and technical 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 project address an important problem or a critical barrier to progress in the field? If the aims of the project 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? Is the proposed research relevant and important to the foreign [non-U.S.] countries or region? How will the work inform the public health system or mental health policy of the foreign country?

Investigator(s). Are the PD/PIs, collaborators, and other researchers well suited to the project? 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? Does the PD/PI have experience leading a multidisciplinary team and demonstrate the ability to manage administrative functions in the region and countries in which the research will be based? Is there substantial and appropriate integration of partner investigators into the research plan? Do the investigators commit adequate effort to successfully fulfill the proposed projects needs? Does the research team include a representative from the appropriate government agency that can ensure uptake of research findings and ensure public health relevance for that setting?

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?

Approach. Are the overall strategy, 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? If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed?

If the project 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 applicant’s overall approaches to overcoming obstacles and limitations sound and feasible? Are the overarching Hub milestones applicable to the overall program, feasible within the proposed timeframes, and integrated with the milestones for individual projects and cores? Do the milestones present quantifiable measures for the achievement of intended outcomes for the program as a whole in a timely manner?

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? Are the sites and/or facilities where research will be conducted within the region appropriate for the research? Is there a process to identify, evaluate the capabilities of, and add new research sites based on the emerging needs within the geographic region?

Additional Review Criteria for Evaluating the Overall U19 Application

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

Review Criteria for an Administrative Core

Additional Review Criteria

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.

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.

Resubmission Applications. Resubmission applications are not applicable to this FOA.

Renewal Applications. Renewal applications are not applicable to this FOA.

Revision Applications. Revision applications are not applicable to this FOA.

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.

Applications from Foreign Organizations. Reviewers will assess whether the project presents special opportunities for furthering research programs through the use of unusual talent, resources, populations, or environmental conditions that exist in other countries and either are not readily available in the United States or augment existing U.S. resources.

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 (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-04-042.html); and 3) Genome Wide Association Studies (GWAS) (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-07-088.html).

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.

Selection Process

The following will be considered in making funding decisions:

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 NoA 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 (http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part4.htm) and Part II Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Grantees, and Activities (http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_part9.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’s 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. Awardee and Principal Investigator Rights and Responsibilities

The PDs/PIs of the CHIRMH will have the primary responsibility for defining the research objectives, approaches, and details of the projects and core within the guidelines of the FOA and retain primary responsibility for the performance of all U19 supported research activities. The PD/PI will be responsible for:

All awardees are required to perform the duties of organizer and host of an annual meeting to be attended by all awardee PD/PIs, Project Leaders, key personnel, and NIMH staff.

PDs/PIs agree to participate in the cooperative research program, including serving on the Steering Committee, participating in Steering Committee meetings and teleconferences, adhering to Steering Committee policies and decisions, and accepting the participation and assistance of NIMH staff in accordance with the guidelines described in Section VI.2.A. Cooperative Agreement Terms and Conditions of Award: NIH Responsibilities.

All awardees proposing clinical research must comply with Federal, State, and Local regulations regarding clinical research and monitoring of clinical trials, and oversee that all training requirements for the protection of human subjects are in compliance. All clinical research performed outside of the U.S. must, in addition to U.S. Federal regulations, comply with the host country regulations for protection of human subjects and conduct of clinical research.

The PD/PI will ensure that on-site administrative structure, scientific capacity, and training are available to enable the research team, including local research investigators and partners, to perform the research activities proposed in this grant.

The PD/PI will ensure that research and research capacity building activities conducted under this cooperative agreement employ an approach that integrates findings from translational, clinical, epidemiological and/or policy research to increase the research base for mental health interventions in LMICs. The PDs/PIs will provide a process for assessing ongoing research and research capacity building projects and modifying, redirecting, and/or curtailing ongoing research activities to reflect local changes/shifts based on emerging needs or changing epidemiological conditions within the geographic regions. PDs/PIs will ensure the development of research-based strategies for use by government agencies, non-governmental organizations, and health care institutions to reduce the treatment gap for mental disorders.

The PD/PI will be responsible for the timely submission of all abstracts, manuscripts and reviews (co)authored by members of the grant and supported in part or in total under this Cooperative Agreement. Manuscripts shall be submitted to the NIH Program Official within two weeks of acceptance for publication and must comply with the NIH Public Access Policy (see http://publicaccess.nih.gov/). Publications or oral presentations of work performed under this Cooperative Agreement will require appropriate acknowledgement of NIMH support. Timely publication of major findings is encouraged.

Awardees will retain custody of and have primary rights to the data and software developed under these awards, subject to Government rights of access consistent with current DHHS, PHS, and NIH policies.

2.A.2. NIH Responsibilities

An NIMH Project Scientist will have substantial programmatic involvement that is above and beyond the normal stewardship role in awards, as described below. The role of the NIMH Project Scientist will be to facilitate and not to direct the activities. It is anticipated that the NIMH Project Scientist will offer advisory input. The NIMH Project Scientist will facilitate liaison activities for partnerships, and provide assistance with access to NIH-supported resources and services. Other appropriate NIMH Program staff assistance will be coordinated by the NIMH Project Scientist, which may include Medical Officer(s), clinical operations and regulatory staff and other expertise as required. The NIMH Project Scientist, with support of the appropriate staff and expertise, may provide coordination and assistance to the awardees to meet the requirements for clinical protocol content and conduct. The NIMH Project Scientist with substantial programmatic involvement may:

A Network Scientific Advisory Group (NSAG) will be appointed and supported by the NIMH to review the progress and provide scientific advice for the intersecting and joint activities of all grants that receive funding under this FOA. The NSAG will be comprised of no more than seven Federal and non-Federal experts selected by the NIMH to participate in NSAG activities in an advisory capacity when appropriate. The NSAG will meet annually at the annual meeting of the Network of awardee hubs.

Additionally, an agency Program Official or IC Program Director will be responsible for the normal scientific and programmatic stewardship of the award and will be named in the award notice.

2.A.3. Collaborative Responsibilities

A Steering Committee will serve as the governing board for CHIRMH awardees. All participants in the CHIRMH program are bound by the policies and procedures developed by the Steering Committee; adoption of such policies and procedures requires a majority vote. Awardees under this FOA will be required to accept and implement policies approved by the Steering Committee.

Membership in the Steering Committee will include the PI of each CHIRMH U19 award, or a designated representative in the case of Multiple PI award. Each member will have one vote. The NIMH Project Collaborator will be a non-voting member of the Steering Committee.

The chair will be chosen by a majority vote of the Steering Committee, with years of service as chair determined by the committee. The chair is responsible for preparing meeting agendas, for scheduling and chairing meetings, and for preparing concise minutes which will be delivered to steering committee members within 30 days of the meeting. Virtual meetings are appropriate. The NIMH Project Collaborator may not serve as the Chair of the Steering Committee.

Steering Committee responsibilities will include:

NIMH will arrange regular Steering Committee meetings via teleconferences, and annual Steering Committee meetings in conjunction with the annual CHIRMH meeting. The annual meeting is a forum for members to provide the latest update on their research, exchange ideas and information, and discuss collaborations among members of the CHIRMH. Meeting participants will identify the group’s tangible resources, capabilities, and needs to advance the CHIRMH’s overall goals. The PI of each CHIRMH (or a designated representative for multiple PI awards) is required to make an oral presentation on current and planned activities and projects at each annual meeting. Each hub will be responsible for hosting at least two annual workshops during the life of the grant.

2.A.4. Dispute Resolution Process

Any disagreements that may arise in scientific or programmatic matters (within the scope of the award) between award recipients and the NIH may be brought to Dispute Resolution. A Dispute Resolution Panel composed of three members will be convened. It will have three members: a designee of the Steering Committee chosen without NIH staff voting, one NIH designee, and a third designee with expertise in the relevant area who is chosen by the other two; in the case of individual disagreement, the first member may be chosen by the individual awardee. This special dispute resolution procedure does not alter the awardee's right to appeal an adverse action that is otherwise appealable in accordance with PHS 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 Contacts:

Pamela Y. Collins, MD, MPH
Office for Research on Disparities and Global Mental Health
National Institute of Mental Health
6001 Executive Boulevard, Room 8125, MSC 9659
Bethesda, MD 20892-9689
Rockville, MD 20852 (for express/courier service)
Telephone: (301) 443-2847
FAX: (301) 443-8552
Email: [email protected]

LeShawndra N. Price, Ph.D.
Office for Research on Disparities and Global Mental Health
National Institute of Mental Health
6001 Executive Boulevard, Room 8130, MSC 9659
Bethesda, MD 20892-9659
Rockville, MD 20852 (for express/courier service)
Telephone: (301) 443-2847
FAX: (301) 443-8552
Email: [email protected]

2. Peer Review Contacts:

David Armstrong, Ph.D.
Division of Extramural Activities
National Institute of Mental Health
6001 Executive Boulevard, Room 6138, MSC 9606
Bethesda, MD 20892-9606
Rockville, MD 20852 (for express/courier service)
Telephone: (301) 443-3534
FAX: (301) 443-4720
Email: [email protected]

3. Financial or Grants Management Contacts:

Joy R. Knipple
Division of Extramural Activities
National Institute of Mental Health
6001 Executive Boulevard, Room 6115, MSC 9605
Bethesda, MD 20892-9689
Rockville, MD 20852 (for express/courier service)
Telephone: (301) 443-8811
FAX: (301) 443-6885
Email: [email protected]

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 (http://grants.nih.gov/grants/olaw/references/PHSPolicyLabAnimals.pdf) as mandated by the Health Research Extension Act of 1985 (http://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, http://grants.nih.gov/grants/guide/notice-files/not98-084.html).

Sharing Research Data:
Regardless of the total dollars requested, investigators are expected to include a brief 1-paragraph description of how final research data will be shared. Applicants are encouraged to discuss data-sharing plans with their NIMH program contact. See Data-Sharing Policy or http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-032.html.

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 http://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 http://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 http://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 http://grants.nih.gov/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 (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html); a complete copy of the updated Guidelines is available at http://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 (http://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 http://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 http://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 (http://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 http://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 http://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.

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