and Human Services (HHS)
EXPIRED
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: Developing Centers for Intervention and/or Services Research (DCISR) (P20)
Announcement Type
This is
a reissue and modification of PAR-05-144, which was released on July 22, 2005
Program Announcement (PA) Number: PAR-08-087
Catalog of Federal Domestic Assistance Number(s)
93.242
Key Dates
Release/Posted
Date: February 4, 2008
Letters of Intent Receipt Date: May 21 annually
Application Receipt Date: June 24 annually
Peer Review Date: October/November annually
Council Review Date: January annually
Earliest Anticipated Start Date: April annually
Expiration Date: June 25, 2010
Due Dates for E.O. 12372
Not applicable
Additional Overview Content
Executive Summary
Table of Contents
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
4. Intergovernmental Review
5. Funding Restrictions
6. Other Submission Requirements
Section
V. Application Review Information
1. Criteria
2. Review and Selection Process
A. Additional Review Criteria
B. Additional Review Considerations
C. Resource Sharing Plan(s)
3. Anticipated Announcement and Award Dates
Section
VI. Award Administration Information
1. Award Notices
2. Administrative and National Policy Requirements
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
The public health importance of mental health treatment, prevention, and services research and the relevance of this research to the mission of the National Institute of Mental Health (NIMH) are highlighted in a series of reports by the National Advisory Mental Health Council (NAMHC). The report Bridging Science and Service (1998) underscores the need for expanding efficacy findings into effectiveness and services research. The report Priorities for Prevention Research at NIMH (1998) indicates the main areas of need in prevention research. The report Treatment Research in Mental Illness: Improving the Nations Public Mental Health Care through NIMH Funded Intervention Research (2005) reviews needs and opportunities in treatment research (http://www.nimh.nih.gov/about/advisory-boards-and-groups/namhc/reports/interventions-research.pdf); and the report The Road Ahead: Research Partnership to Transform Services (2006) provides an updated perspective on services research (http://www.nimh.nih.gov/about/advisory-boards-and-groups/namhc/reports/road-ahead.pdf).
The NIMH has funded a series of research centers focused on mental health intervention and services since the mid 1980s. These centers have served as national resources to advance the mission of NIMH to reduce the burden of mental disorders through research by developing more effective treatment and preventive interventions for mental illness and better delivery of services in various publicly and privately financed treatment settings. This Funding Opportunity Announcement (FOA) intends to continue the strong achievements of NIMH-funded research centers by providing opportunities to further advance the intervention and services research agenda.
This funding opportunity invites applications for grants to support infrastructure to conduct research to evaluate the effects and improve the effectiveness of treatment or preventive interventions and mental health services. Because this grant mechanism can be used to support a variety of research activities, it is incumbent on the applicants to clearly identify, explain, and justify the specific focus of the proposed center (e.g., prevention, treatment, or services). Based on the particular area of research, interest and background of the applicants, overlap among these broad areas of research can occur.
The type of intervention research to be supported under this initiative relates primarily to studying the effectiveness and clinical and/or community applications of treatment and preventive interventions. In this context, effectiveness research evaluates whether or not interventions that have been previously found to be efficacious in highly selected samples, can have clinically significant beneficial effects in samples and under conditions likely to be representative of usual community practice. Effectiveness research also includes research to optimize existing interventions through individualization of treatments, development and testing of treatment guidelines or algorithms, and other approaches. Thus, the main focus of this funding initiative is research to provide the scientific evidence needed for optimal decision making in the clinics or other community settings.
Services research to be supported under this initiative will emphasize research topics that are useful and practical for preventing or treating mental illness, as well as mental health-related issues relevant to persons living with mental illness, clinicians, purchasers of mental health services (including employers and private health insurance companies) and policy makers at the federal, state, and local levels. Mental health services research includes questions posed about inpatient, ambulatory, sub-acute, acute, community-based, rehabilitative and long-term care as well as mental health services delivered outside the specialty mental health system, like primary care, correctional and school systems.
Effectiveness and services research may require the development or adoption of novel methodological and organizational approaches, application of interdisciplinary efforts, and/or partnerships with entities such as community organizations, payers, or local officials. Applicants under this FOA can request support to achieve these goals. Research to foster innovation and integration across scientific disciplines and to expedite dissemination and implementation of new treatment approaches that foster recovery from mental disorders is encouraged. This may involve the formation of interdisciplinary teams of researchers from the social, economic, behavioral, and population sciences to investigate how social factors, financing systems, organizational structures and processes, health technologies, or personal behaviors affect access to mental health care, quality and cost of mental health care and ultimately the well-being of all people impacted by mental disorders.
Each applicant must choose, and justify, the primary focus of the proposed center along the continuum from evaluation of the effectiveness of preventive and/or treatment interventions to services, dissemination, and implementation research. Investigators whose main aim is to develop novel interventions by translating basic neuroscience findings into clinical applications, or to evaluate the initial efficacy of new interventions in highly selected samples and under tight experimental conditions, are referred to other research infrastructure funding mechanisms, such as PAR-07-159 - National Cooperative Drug Discovery Groups for the Treatment of Mental Disorders, Drug or Alcohol Addiction, PAR-06-053 - Interdisciplinary Developmental Science Centers for Mental Health (IDSC): Mature Centers (P50), or, for AIDS-related research, PAR-08-009 - Centers Program for Research on HIV/AIDS and Mental Health (P30).
Program Specifications
Grants awarded under this FOA will provide financial support for: (1) operations of the center, including data management and analysis; and (2) at least two specific developmental or exploratory research projects modeled on the NIMH R34 grant mechanism. In order to accommodate these areas of support all applications must describe an Operations Core, Research Methods Core, and a Principal Research Core.
The Principal Investigator should be an established independent researcher in the area of mental health intervention and/or services research, and will have a minimum commitment of 20 percent of time to the developing center.
See Section IV, Number 2 below for specific formatting issues.
Overview -- Development of Research Capacity
The Overview should provide an overall description of the DCISR rationale, mission, and goals. It should include a clear statement about the value added of this DCISR to the field and to the mission of NIMH (see http://www.nimh.nih.gov/strategic/strategicplanmenu.cfm).
An essential part of the application is to explain how the proposed research activities will be organized around a cohesive, overarching theme and likely to benefit from their inclusion in the center application rather than being proposed as stand alone grant applications. Thus, applicants must clearly define the value added that center support will provide and demonstrate how the center will be more than a collection of studies.
It is expected that applicants will already have ongoing relevant research activity at their institution, and will explain how research on mental health intervention and/or services can be expanded and enhanced by the support requested under this FOA.
The application should also describe how the DCISR will expand opportunities for junior investigators, particularly for underrepresented racial and ethnic groups, individuals with disabilities, and individuals from disadvantaged backgrounds. Established investigators, including clinicians, social scientists, and organizational researchers, willing to refocus their efforts on interventions and/or services research can also be included in these opportunities. The direct support of training efforts (e.g., stipends), however, should be sought through other NIH training and career development grant mechanisms.
Operations Core
The developing center must have a clearly articulated Operations Core that should serve to integrate the scientific and research capacity aims. This core includes administrative functions, data management and statistical analysis, and dissemination activities. If appropriate, community liaisons, particular stakeholders, clinical trials operations, and any specialized interdisciplinary components should be included in this core. The Operations Core should foster an environment of research excellence, support methodological innovation, facilitate multidisciplinary collaborations, coordinate efforts, and monitor progress according to an overall focused research agenda. The Operations Core should include a data management and statistical analysis component. These components may be located at a single institution or across multiple institutions. The developing center may consist of several collaborating sites that are not all located in a single institution or geographic region. The collaboration of multiple institutions and settings to create a virtual center must be specified and explained in the Operations Core section so the feasibility of such arrangements can be evaluated. If a clinical trial component is included in the Core, detailed subject recruitment and retention strategies should be described, particularly for underserved populations. Applicants are strongly encouraged to consult the NIH Outreach Notebook (http://orwh.od.nih.gov/inclusion/outreach.pdf) for guidance in developing appropriate strategies.
The Operations Core of the application should outline the scientific leadership for the proposed research activities. It should describe an administrative structure that maximizes efficiency through program planning and monitoring, a capacity development and maintenance plan, opportunities for investigators to do integrative work, and plans for accountability for the entire center. The Operations Core should also address knowledge and technology transfer and should enhance the availability of center accomplishments (e.g., data, methods, etc.) within and beyond the center.
Specialized Components of the Operations Core.
Depending on the research focus, applicants may describe particular specialized components of the Operations Core that are devoted to a particular topic and process. Previous program announcements for research centers promoted the inclusion of a community network core to encourage the field to engage with stakeholders (e.g., families, payers, community organizations). Under this FOA, a specialized network component in the Operations Core would follow from stated aims of the center where engagement with stakeholders addresses both content and process needs. Another example of a specialized component of the Operations Core could be an economics component, which may involve a team of investigators with specific expertise and devoted process and time to accomplish a particular aim of the center.
Research Methods Core
Each application should describe a process for building a Research Methods Core. The main purpose of this core function is to support testing of innovative approaches to research design, assessment methods, recruitment strategies, and analytic approaches needed for intervention and services research. Accordingly, the Research Methods Core is intended not only to serve as a support function for the Center investigators and their projects, but primarily to function as a national resource and research laboratory itself for developing and refining research methods.
There are a large number of potential areas of investigation that could be included in this core. The following are examples that are not meant to be comprehensive or exclusive of other topics:
Applicants are encouraged to focus on how this core will enhance the research activities chosen in the principal research core (see below). Optimally, the application should also address how the focus and activities of the Research Methods Core address one or more rate-limiting methodological challenges in the field and will advance intervention and/or services research, in general.
Principal Research Core
The developing center must have a clearly articulated plan to develop a set of scientific core activities that will enhance knowledge on how to prevent or treat mental illness, or on how to provide effective mental health services. Applicants may focus the research of the center anywhere along the continuum of public mental health-relevant research from effectiveness to services. Applicants should select a major, public health-relevant, mental health issue, though not necessarily within a single diagnostic category, as the focus of the research core, and propose studies to address it. The research area chosen should be the primary research focus of the center and all other cores should clearly relate to the efforts pursued in this core. A separate description must be provided for the Principal Research Core area, including potential research directions for future R01 applications, summary descriptions of exploratory and developmental research projects, and how these projects will relate to and support one another as well as projects in other cores. Applicants should describe how the Operations and Research Methods Cores are integrated in the service of this Principal Research Core and related research projects.
The following are some prevention and treatment examples of research that could fit into a Principal Research Core focusing on intervention research. This list is not meant to be comprehensive or exclusive of other topics:
The following are some examples of research that could fit into a Principal Research Core concentrating on services research. This list is not meant to be comprehensive or exclusive of other topics:
Specific Research Projects
At least two developmental research projects must be described in the application with enough detail to allow appropriate peer-review of their scientific merit and methodological soundness. For the purposes of this FOA, and because of the funding limitations, such projects are not expected to be major research proposals, able to test major experimental hypotheses in a definitive manner. Rather, these projects are intended to provide preliminary data to guide the design of future more definitive investigations. These projects are similar to the ones typically supported under PAR-06-248 - From Intervention Development To Services: Exploratory Research Grants (R34) or PA-06-181 - NIH Exploratory/Developmental Research Grant Program (R21). The focus of these research projects should be directly linked to the focus of the Principal Research Core and should have clear theoretical or conceptual bases. Innovative cross-disciplinary linkages and high-risk /high-pay-off projects designed to advance science are particularly encouraged.
Organization of Developing Centers
A developing center may be organized in a variety of ways and may include one institution or several. There is no single model for a developing center; the structure will depend upon the research questions and approaches selected. One type of center could adopt a Clinical Research Organization type approach, providing administrative, management, and operational support to a large set of ongoing and planned intervention or services studies in various community sites. Another type of center could adopt a decentralized, multi-site focus in which specialized activities are supported in different sites. A conceptual and theoretical rationale for the organizational structure should be discussed in the application. However, all applications must include the required cores outlined above.
1. Mechanism(s) of Support
This funding opportunity will use the NIH Exploratory Center Grant (P20) award mechanism. Support is limited to a maximum of 5 years and is not renewable. Grants are awarded directly to the applicant's institution and are not transferable to another institution. The applicant will be solely responsible for planning, directing, and executing the proposed project.
This funding opportunity uses the just-in-time budget concepts. It also uses the non-modular budget format described in the PHS 398 application instructions (see http://grants.nih.gov/grants/funding/phs398/phs398.html). A detailed categorical budget for the "Initial Budget Period" and the "Entire Proposed Period of Support" is to be submitted with the application.
2. Funds Available
Applicants may request up to $1,000,000 per year for total costs, including all negotiated Facilities and Administrative (F&A) costs. 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.
The earliest anticipated start date of funding is April 1 annually.
Section III. Eligibility Information
1. Eligible Applicants
1.A. Eligible Institutions
You may submit (an) application(s) if your organization has any of the following characteristics:
Foreign institutions are not eligible for support under this mechanism.
1.B. Eligible Individuals
Any individual with the skills, knowledge, and resources necessary to carry out the proposed research is invited to work with their institution to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support.
2. Cost Sharing or Matching
Not applicable
3. Other-Special Eligibility Criteria
A single institution may have more than one DCISR but they must address distinctly different research topics. If there are multiple NIMH centers at an institution, it is expected that there will be significant savings from sharing some infrastructure resources among the centers at the institution. Any NIMH applicant with at least four active NIH grants and/or contracts who intends to seek a fifth award should contact NIMH staff for guidance prior to applying (see http://www.nimh.nih.gov/research-funding/grants/nimh-policy-on-multiple-awards.shtml).
Institutions eligible under this FOA should have both ongoing research activity in the intervention or services area and a demonstrated need for support to expand their research efforts. The existence of research activity is evidenced by the presence of ongoing mental health research funded under PHS grants or equivalent sources of peer-reviewed support, and recent record of peer-reviewed scientific publications. This FOA is intended to support intervention and services research only. Those interested in basic neuroscience, basic behavioral science, HIV-related or treatment development research should consult other NIMH program announcements in those areas.
Section IV. Application and Submission Information
1. Address to Request Application Information
The 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
Applications must be prepared using the most current PHS 398 research grant application instructions and forms. Applications must have a Dun and Bradstreet (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 on line 2 of the face page of the application and the YES box must be checked. The application should also include the following components:
Materials Allowed in the Appendix:
Publications:
Other:
Format of Appendix Materials:
3. Submission Dates and Times
See Section
IV.3.A for details.
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 at the beginning of this document.
The letter of intent for applications to NIMH should be sent to:
Benedetto Vitiello, M.D.
Division of Services and Intervention Research
National Institute of Mental Health
6001 Executive Boulevard, Room 7147, MSC 9633
Bethesda, MD 20892-9633
Telephone: (301) 443-4283
FAX : (301) 443-4045
Email: [email protected]
3.B. Sending an Application to the NIH
Applications must be prepared using the PHS 398 research grant application instructions and forms as described above. 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
Bethesda, MD 20817 (for express/courier service)
At the time of submission, two additional copies of the application and all copies of 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)
Personal deliveries of applications are no longer permitted (see http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-040.html).
Applications must be received on or before the application receipt date(s) described above (Section IV.3.A.). If an application is received after that date, it will be returned to the applicant without review. Upon receipt, applications will be evaluated for completeness by CSR and responsiveness by the National Institute of Mental Health.
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. The NIH will not accept any application that is essentially the same as one already reviewed. This does not preclude the submission of a substantial revision of an application already reviewed, but such application must include an Introduction addressing the previous critique.
Although there is no immediate acknowledgement of the receipt of an application, applicants are generally notified of the review and funding assignment within eight (8) weeks.
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 http://grants.nih.gov/grants/policy/policy.htm.
Under this FOA, funds can be used to support research participant recruitment, community liaison personnel, and the formation of community advisory boards. The funds should target the recruitment and retention of traditionally understudied populations with the greatest public health need. These include racial and ethnic minorities and people in rural and inner city areas.
Those developing centers that will conduct clinical trials must establish a Data and Safety Monitoring Board; funds may be requested for that purpose. Funds may also be used for salaries, consultants, supplies, equipment, meeting expenses, travel, and subcontracts.
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 or competing continuation award if such costs: are necessary to conduct the project, and 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 or competing continuation 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
Resource Sharing Plan(s)
NIH considers the sharing of unique research resources developed through NIH-sponsored research an important means to enhance the value of, and advance, research. When resources have been developed with NIH funds and the associated research findings published or provided to NIH, it is important that they be made readily available for research purposes to qualified individuals within the scientific community. If the final data/resources are not amenable to sharing, this must be explained in Resource Sharing section of the application. See http://grants.nih.gov/grants/policy/data_sharing/data_sharing_faqs.htm.
(a) Data Sharing Plan: Investigators seeking $500,000 or more in direct costs in any year 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/.
Section V. Application Review Information
1. Criteria (Update: Enhanced review criteria have been issued for the evaluation of research applications received for potential FY2010 funding and thereafter - see NOT-OD-09-025).
Only the review criteria described below will be
considered in the review process.
2. Review and Selection 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 in accordance with the review criteria stated below.
As part of the initial merit review, all applications will:
The following will be considered in making funding decisions:
The goals of NIH-supported research are to advance our understanding of biological systems, improve the control of disease, and enhance health. In the written comments reviewers will be asked to discuss the following aspects of the application in order to judge the likelihood that the proposed research will have a substantial impact on the pursuit of these goals. Each of these criteria will be addressed and considered in assigning the overall score, weighting them as appropriate for each application. Note that the application does not need to be strong in all categories to be judged likely to have major scientific impact. For example, an investigator may propose to carry out important work that by its nature is not innovative but is essential to move a field forward.
Although the organizational structure of the DCISR is similar to that of the advanced center (e.g., specific cores), applicants to the DCISR are expected to be at an earlier phase of research development than typically the case for applicants to the advanced center. Thus, even if similar general review criteria apply to the DCISR and the advanced center mechanism, it is understood that these criteria are to be applied to reviewing research activities still at a developmental phase.
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 core review criteria, and additional review criteria (as applicable for the project proposed).
Core 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?
What will be the effect of
the developing center and its affiliated studies on care in community settings,
particularly for underserved populations? Does the plan for the developing
center indicate the potential for the center to serve as a research resource,
based on the infrastructure created or the development of new methodologies or
treatments?
Investigator(s): Are the PD/PIs, collaborators, and other researchers well suited to the project? If Early Stage Investigators or New Investigators, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? 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?
Are the developing center director and other senior investigators at the forefront of their respective fields? Have they devoted sufficient time to the center activities? Do they have the experience and authority necessary to organize, administer and direct the center? If a partnership with community organizations is proposed, have the applicants developed a plan that will draw community stakeholders to work with them in this developing center and promote their sustained involvement?
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?
Do the aims of the developing center grow from the current state of science in interventions and/or services research and from a clear and convincing theoretical or conceptual model? Do the projects challenge existing paradigms or provider practice; address innovative hypotheses or critical barriers to progress in the field?
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) Protections for Human Subjects, 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? For applications designating multiple
PDs/PIs, is the leadership approach, including the designated roles and
responsibilities, governance, and organizational structure, consistent with and
justified by the aims of the project and the expertise of each of the PDs/PIs?
Is there adequate rationale to support the importance of a developing center, as opposed to other mechanisms (e.g., individual R01 applications)? Does a conceptual and theoretical framework focused on a significant public-health topic in intervention and/or services research inform the developing center organization and research focus? If a narrow center focus is chosen, is it adequately justified based on the state of science and are the intervention outcomes sufficiently broad to make significant advances in science? Is the concept of a developing center articulated, including: (1) an integrated theme bringing together a multidisciplinary team of investigators in a common mission, (2) development of a pooled, core database that can yield results beyond that accomplished with individual projects alone, and (3) attraction of established investigators and development of collaboration among investigators with diverse backgrounds and areas of expertise.
In addition to the general criteria described above, there are specific review questions to be addressed within the Approach of each individual core:
Core-Specific Review Criteria:
Operations Core-General: Does the core clearly delineate procedures and plans for center administration, data management, analysis, and sharing? Where appropriate, does the core adequately describe community liaison, recruitment and retention of subjects, and information dissemination? Will the structure of the core foster multidisciplinary collaboration and research project oversight? If the application describes a virtual center that is geographically dispersed, does this core adequately describe how operations of the disparate parts will coalesce?
Operations Core-Specialized Components: If a specialized network component is included in the center, is there an appropriate plan for stakeholder engagement, and is the component designed to fit within the larger mission of the center? If a clinical trial component is included, is there adequately detailed description of subject recruitment and retention strategies, particularly for under-represented groups? If clinical trials are part of the research core, is there an adequate plan for data and safety monitoring (http://www.nimh.nih.gov/researchfunding/safetymonitoring.cfm)? For the data management and statistical analysis component, do elements of the structure described within this core create an appropriate structure and function to meet the needs of the research cores?
Research Methods Core: Do the projects in this core address significant problems in the field? Will the core's work enhance the research activities of the other parts of the developing center? Are there plans to secure additional funding for methodological research?
Principal Research Core and Projects: Is there a clearly articulated plan to develop a set of scientific core functions that will enhance and expand the center's ability to conduct research in the community? Are the research projects linked to the central focus of the center? Is there a conceptually tight rationale for the research, for future research directions, and for future applications to NIH? Are the Operations and Research Methods cores designed to ensure the success of the research core? The 5 standard criteria (significance, investigators, innovation, approach, and environment) should be applied to the research projects, but since they are developmental projects in nature, one would not expect the level of preliminary data, detail, or development as for an R01.
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?
Does the developing center take advantage of unique features of the scientific environment or employ useful collaborative arrangements? Does the developing center draw on the strengths of the institution? Are convincing letters of support and collaboration included? Is there evidence of institutional support? Are the collaborating sites chosen for the developing center the appropriate ones to address the research questions proposed?
Coordination and Cohesiveness: For the center as a whole, is the coordination among the operations and research cores adequately explained? Is the usefulness of the research cores and pilot studies magnified by their inclusion in a center? Is there synergistic potential among the centers research components? Is there justification for each research core and pilot/developmental studies in terms of the central theme and the overall research goals of the center? Does the center have the potential to achieve a whole greater than the sum of its parts? Are the plans for interactions with participating institutions and organizations adequately explained? Are the management plans and arrangements feasible? Are the plans and mechanisms to evaluate the centers progress explained?
2.A. Additional Review Criteria
As applicable for the project proposed, reviewers will consider the following additional items in the determination of scientific and technical merit, but will not give separate scores for these items.
Protections for Human Subjects. For research that involves human subjects but does not involve one of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate the justification for involvement of human subjects and the proposed protections from research risk relating to their participation according to the following five review criteria: 1) risk to subjects, 2) adequacy of protection against risks, 3) potential benefits to the subjects and others, 4) importance of the knowledge to be gained, and 5) data and safety monitoring for clinical trials.
For research that involves human subjects and meets the criteria for one or more of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials.
Inclusion of Women, Minorities, and Children. When the proposed project involves clinical research, the committee will evaluate the proposed plans for inclusion of minorities and members of both genders, as well as the inclusion of children.
Vertebrate Animals. The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following five points: 1) proposed use of the animals, and species, strains, ages, sex, and numbers to be used; 2) justifications for the use of animals and for the appropriateness of the species and numbers proposed; 3) adequacy of veterinary care; 4) procedures for limiting discomfort, distress, pain and injury to that which is unavoidable in the conduct of scientifically sound research including the use of analgesic, anesthetic, and tranquilizing drugs and/or comfortable restraining devices; and 5) methods of euthanasia and reason for selection if not consistent with the AVMA Guidelines on Euthanasia.
Resubmission Applications. When reviewing a Resubmission application (formerly called an amended application), the committee will evaluate the application as now presented, taking into consideration the responses to comments from the previous scientific review group and changes made to the project.
Renewal Applications. When reviewing a Renewal application (formerly called a competing continuation application), the committee will consider the progress made in the last funding period.
Revision Applications. When reviewing a Revision application (formerly called a competing supplement application), the committee will consider the appropriateness of the proposed expansion of the scope of the project. If the Revision application relates to a specific line of investigation presented in the original application that was not recommended for approval by the committee, then the committee will consider whether the responses to comments from the previous scientific review group are adequate and whether substantial changes are clearly evident.
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.
2.B. Additional Review Considerations
As applicable for the project proposed, reviewers will address each of the following items, but will not give scores for these items and should not consider them in providing an overall impact/priority score.
Budget and Period Support. Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.
Select Agents Research. Reviewers will assess the information provided in this section of the application, including 1) the Select Agent(s) to be used in the proposed research, 2) the registration status of all entities where Select Agent(s) will be used, 3) the procedures that will be used to monitor possession use and transfer of Select Agent(s), and 4) plans for appropriate biosafety, biocontainment, and security of the Select Agent(s).
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.
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).
2.C. Resource Sharing Plan(s)
When relevant, reviewers will be instructed to comment on the reasonableness of the following Resource Sharing Plans, or the rationale for not sharing the following types of resources. However, reviewers will not factor the proposed resource sharing plan(s) into the determination of scientific merit or impact/priority score, unless noted otherwise in the FOA. Program staff within the IC will be responsible for monitoring the resource sharing.
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 NIH 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 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 and Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Grantees, and Activities.
3. Reporting
When multiple years are involved, awardees will be required to submit the Non-Competing Grant Progress Report (PHS 2590) annually and financial statements as required in the NIH Grants Policy Statement.
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:
Direct inquiries regarding mental health services research to:
Agnes Rupp, Ph.D.
Division of Services and Intervention Research
National Institute of Mental Health
6001 Executive Boulevard, Room 7139, MSC 9631
Bethesda, MD 20892-9631
Telephone: (301) 443-6234
FAX: (301) 443-4045
Email: [email protected]
Direct inquiries regarding mental health interventions for children and adolescents to:
Benedetto Vitiello, M.D.
Child and Adolescent Treatment and Preventive Intervention Research Branch
Division of Services and Intervention Research
National Institute of Mental Health
6001 Executive Boulevard, Room 7147, MSC 9633
Bethesda, MD 20892-9633
Telephone: (301) 443-4283
FAX: (301) 443-4045
Email: [email protected]
Direct inquiries regarding mental health interventions for adults to:
Matthew Rudorfer, M.D.
Division of Services and Intervention Research
National Institute of Mental Health
6001 Executive Boulevard, Room 7160, MSC 9635
Bethesda, MD 20892-9635
Telephone: (301) 443-1185
FAX: (301) 443-4045
Email: [email protected]
Direct inquiries regarding mental health interventions for older (geriatric) adults to:
George Niederehe, Ph.D.
Geriatrics Research Branch
Division of Adult Translational Research and Treatment Development
National Institute of Mental Health
6001 Executive Boulevard, Room 7220, MSC 9634
Bethesda, MD 20892-9634
Telephone: (301) 443-9123
FAX: (301) 443-1424
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
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 20892-9605
Telephone: (301) 443-8811
FAX: (301) 443-6885
Email: [email protected]
Section VIII. Other Information
Required Federal Citations
Vertebrate Animals:
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 (45 CFR 46) 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:
Investigators submitting an NIH application seeking $500,000 or more in direct
costs in any single year are expected to include a plan for data sharing or
state why this is not possible (http://grants.nih.gov/grants/policy/data_sharing).
Investigators should seek guidance from their institutions, on issues related
to institutional policies and local IRB rules, as well as local, State and
Federal laws and regulations, including the Privacy Rule. Reviewers will
consider the data sharing plan but will not factor the plan into the
determination of the scientific merit or the impact/priority score.
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/.
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.
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.
Inclusion of Women, Minorities, and Children:
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 SF424 (R&R) application; 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, investigators funded by the NIH must submit or have
submitted for them to the National Library of Medicines PubMed Central (see http://www.pubmedcentral.nih.gov/), an
electronic version of their final, peer-reviewed manuscripts upon acceptance
for publication, to be made publicly available no later than 12 months after
the official date of publication. The NIH Public Access Policy is
available at (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-033.html). 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 (HHS) 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 HHS
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) or
PubMed Central (PMC) submission identification numbers must be used for
publicly accessible on-line journal articles. Publicly accessible on-line
journal articles or PMC articles/manuscripts accepted for publication that are
directly relevant to the project may be included only as URLs or PMC
submission identification numbers accompanying the full reference in either
the Bibliography & References Cited section, the Progress Report
Publication List section, or the Biographical Sketch section of the NIH grant
application. A URL or PMC submission identification number citation may be
repeated in each of these sections as appropriate. There is no limit to the
number of URLs or PMC submission identification numbers that can be cited.
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 or Health
Systems Agency review. Awards are made under the authorization of Sections 301
and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and
under Federal Regulations 42 CFR Part 52 and 45 CFR Parts 74 and 92. All awards
are subject to the terms and conditions, cost principles, and other
considerations described in the NIH Grants
Policy Statement.
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/.
Weekly TOC for this Announcement
NIH Funding Opportunities and Notices
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