Part I Overview Information

Department of Health and Human Services

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

Components of Participating Organizations
National Institute of Mental Health (NIMH), (http://www.nimh.nih.gov/)
National Institute of Alcohol Abuse and Alcoholism (NIAAA), (http://www.niaaa.nih.gov/)

Title: Developing Centers for Innovation in Services and Intervention Research (DCISIR)

Announcement Type
This is a reissue of PAR-01-090, which was previously released May 7, 2001.

Updates: The following updates relating to this announcement have been issued:

Program Announcement (PA) Number: PAR-05-144

Catalog of Federal Domestic Assistance Number(s)
93.242, 93.273

Key Dates
Release Date: July 22, 2005
Letters of Intent Receipt Date(s): October 1, 2005; May 1 annually thereafter
Application Receipt Date(s): November 1, 2005; June 1 annually thereafter
AIDS-related application Receipt Date(s): see NOT-MH-06-115
Peer Review Date(s): March 2006, October annually thereafter
Council Review Date(s): May 2006, January annually thereafter
Earliest Anticipated Start Date: July 2006; April 1 annually thereafter
Expiration Date: July 2, 2007

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
   4. Intergovernmental Review
   5. Funding Restrictions

 Section V. Application Review Information
   1. Criteria
   2. Review and Selection Process
     A. Additional Review Criteria
     B. Additional Review Considerations
     C. Sharing Research Data
     D. Sharing Research Resources
   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 need to increase the public health relevance, value, and utility of clinical research for clinicians, policy makers and consumers has long been recognized and has been highlighted in reports by the National Advisory Mental Health Council: (http://www.nimh.nih.gov/publicat/nimhbridge.pdf), (http://www.nimh.nih.gov/publicat/nimhtranslating.pdf), (http://www.nimh.nih.gov/publicat/nimhpriorrpt.pdf) and in recommendations by the National Advisory Council on Alcohol Abuse and Alcoholism: (http://www.niaaa.nih.gov/publications/exsum.htm).

Clinical research trials that provide the information needed for decision making in clinical and health policy settings have recently been termed “pragmatic clinical trials” or “practical clinical trials” (PCTs). Traditional trials are not designed to provide information for targeted decision making 1. They have typically focused on testing the short-term efficacy of one intervention versus a competing intervention in relieving specific symptoms of illness or reducing rehospitalization. These studies, most often conducted with homogeneous samples of research subjects at tertiary academic referral sites, have provided essential information. But they represent only the first step in a longer process of research if we are to produce information necessary for clinical and policy decision making.

Traditional efficacy studies identify, for a restricted population, which intervention is superior overall. Typically though, they do not identify why the intervention is successful when it is, for whom it is most appropriate and acceptable, who is most likely to accept and stay with particular interventions, and why the intervention that was not superior worked for those people for whom it did. Because of the limited focus of these efficacy studies, front-line clinicians lack the information they need for decision making with specific patients. This may be one reason why the results of these trials have had little impact on the behavior of clinicians in community practice settings. This PA is designed to help researchers develop the capacity necessary to test the effectiveness of interventions in community settings (e.g., primary care, criminal justice, schools) and develop effective strategies for disseminating research findings among providers and consumers of care. In addition, this PA is intended to support research within existing community settings that can provide information for later research on access, use, quality of care, and dissemination of successful programs.

However, some intervention research is still in the early stages of development or an intervention developed for one circumstance holds promise in another. It is appropriate for applicants to include these more focused studies, without extensive linkages to community settings, among the projects in the methods and research cores. Applicants who propose to include studies with a limited focus should justify how the areas of research they intend to undertake are best served by such arrangements.

Aims

The services and intervention research that is needed to provide pragmatic information for clinical and policy decision making, improve current community practice, and ultimately reduce the burden of mental illness and of alcohol-related problems requires (a) the creation and adoption of novel methodological and organizational approaches, (b) the use of behavioral, social, economic, and/or political theories to transport interventions into community settings, (c) the creation of sustainable community partnerships, and (d) the creation of sustainable multidisciplinary research teams that can work cooperatively and creatively. This PA is intended as a mechanism to build capacity at qualified institutions to achieve these goals and those of the NIH Roadmap initiative. Each applicant may choose, but must also justify, the mix of services and intervention research proposed, based on the environment and the experience and interests of the research team.

Program Specifications

Grants awarded under this PA will provide financial support for two types of activities: (1) general development of research capacity and (2) funding of at least two specific developmental or exploratory research projects. All the activities will be under the overall direction and supervision of the Principal Investigator, who will function as director of the Developing Center for Innovation in Services and Intervention Research. The Principal Investigator should be an established independent researcher in the area of mental health interventions and/or services research and will have a minimum time commitment of 30 percent to the developing center. All applications must have an Operations Core, Research Methods Core, and Principal Research Core. The Research Plan for applications submitted in response to this PA is limited to 35 pages total. No more than five pages should be dedicated to a justification for the need for and goals of the DCISIR, 10-12 pages dedicated to the Operations Core, and the remaining pages to the Research Methods and Principal Research Cores. All applications must clearly define the value added that center support will provide and demonstrate how the center is more than a collection of studies.

Development of Research Capacity

It is expected that the applicants will have current research activities at their institution and will explain how research on mental health interventions and services can be expanded and enhanced by the support requested under this PA.

The application should also describe how the DCISIR will expand opportunities for junior investigators, particularly for underrepresented racial and ethnic groups and individuals with disabilities. Established investigators, including clinicians, social scientists, and organizational researchers, willing to refocus their efforts on interventions and 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, dissemination activities, community liaison, clinical trials operations, if appropriate, and any specialized interdisciplinary components. 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. Applicants are strongly encouraged to include within this core a component focusing on the engagement of community stakeholders, such as individuals with mental illness and of alcohol-related problems and their families, mental health care providers, community organizations and institutions (e.g., schools, churches, group homes, and extended care facilities), public and private purchasers of mental health care and/or alcohol treatment services, and insurers and managed care organizations.

The Operations Core should include a data management and statistical analysis component as well as a clinical trials operations component, when relevant. These components may be located at a single institution or across multiple institutions. The DCISIR 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. It is essential that the trials component of the Core detail subject recruitment and retention strategies, particularly for underserved populations. Applicants are strongly encouraged to consult the NIH Outreach Notebook (http://orwh.od.nih.gov/pubs/outreach.pdf) for guidance in developing appropriate strategies. Depending on the research focus, other specialized components might also be included in the Operations Core (e.g., economics component).

The Operations Core of the application should outline the scientific leadership for all anticipated research. 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. 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. Each center should be able to become a vital resource for decision makers and researchers.

Research Methods Core

Each application should describe a process for building a Research Methods Core. The 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. Applicants should seek funding through traditional mechanisms (R01, R21, R34, R03) for specific projects.

There are a large number of potential areas of investigation that could be included in this core. The following are examples. The examples are not meant to be comprehensive, nor are the examples meant to be exclusive of other topics. Further examples can be found in the NIMH Design, Measurement, and Statistics in Community Mental Health Research program announcement (http://grants.nih.gov/grants/guide/pa-files/PA-04-150.html).

Applicants are encouraged to focus on how this core will enhance the research activities chosen in the principal research core (see below).

Principal Research Core

The developing center must have a clearly articulated plan to develop a set of scientific core functions that will enhance and expand capacity to move mental health and/or alcohol interventions into community settings. Applicants may focus the research of the center anywhere along the continuum of public health-relevant, mental health research and/or research on alcohol-related problems. The continuum ranges from testing intervention effects and understanding mechanisms of action to research on the adaptation and dissemination of interventions in community settings.

Applicants should select a major, public health-relevant, mental health and/or alcohol-related problem, 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.

Intervention testing research should seek to build capacity to facilitate the testing of preventive, treatment or rehabilitative interventions with direct applicability to community settings. Support can be used to:

As with the Methods Core examples, this is only a very small list of examples. Applicants are encouraged to use their knowledge of research and the state of science combined with their understanding of public health need to determine which questions should be the focus of their Principal Research Core.

A DCISIR may choose to have a Principal Research Core that focuses on services research, with foci ranging from clinical epidemiology, quality of care, systems of care, organizational factors affecting care and prevention efforts, financing of care, and dissemination of successful strategies to improve the provision of care and prevention efforts and improve the lives of consumers and their families.

The following are some examples of research that could fit into a Principal Research Core focusing on services research. These are not meant to be comprehensive, nor are the examples meant to be exclusive of other topics.

While applicants can choose to design their developing center to reflect one end or the other of the continuum of research, it is hoped that applicants will allow the nature of the problem focus chosen and the state of the scientific knowledge in this area determine where along the continuum the center efforts should focus.

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. Due to the purposes of this PA and its funding limitations, such projects are not expected to be major research proposals, able to test major experimental hypotheses in a definitive manner. Rather, such projects are intended to provide preliminary data to be utilized in guiding the design of future more definitive investigations. These projects are similar to the ones typically supported under the NIMH developing grant mechanism: From Intervention Development To Services: Exploratory Research Grants (R34) (http://grants.nih.gov/grants/guide/pa-files/PAR-03-078.html) or the NIH Exploratory/Developmental Research Grant Award R21 (http://grants.nih.gov/grants/guide/pa-files/PA-03-107.html). 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 push science forward or in new directions, are particularly encouraged.

Organization of 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, they must include the required cores outlined above.

Section II. Award Information

1. Mechanism(s) of Support

This funding opportunity will use the National Institutes of Health (NIH) Exploratory Center Grant award mechanism (P20). This mechanism supports planning for new programs, expansion or modification of existing resources, and feasibility studies to explore various approaches to the development of interdisciplinary programs that offer potential solutions to problems of special significance to the mission of NIH. 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. Under this PA, applicants can request up to $400,000 per year for direct costs, plus negotiated Facilities and Administrative Costs (formerly known as indirect costs). As an applicant, you 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

Under this PA, applicants can request up to $400,000 per year for direct costs, plus negotiated Facilities and Administrative Costs (formerly known as indirect 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 IC(s) provide support for this program, awards pursuant to this funding opportunity are contingent upon the availability of funds.

Facilities and administrative costs requested by consortium participants are not included in the direct cost limitation, see NOT-OD-05-004 (see http://grants.nih.gov/grants/guide/notice-files/NOT-OD-05-004.html).

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:

Institutions eligible under this PA should have both ongoing research activity in the intervention or services area and a demonstrated need for support to take full advantage of their research potential. 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 PA 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.

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 programs.

2. Cost Sharing or Matching
Not applicable

3. Other-Special Eligibility Criteria

A single institution may have more than one DCISIR but they must address distinctly different research topics. No institution may have more than three center grants from the Division of Services and Intervention Research at NIMH. 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. No investigator may have more than four NIMH grants on which s/he is Principal Investigator.

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) 435-0714, Email: GrantsInfo@nih.gov.

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

2. Content and Form of Application Submission

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

The title and number of this funding opportunity must be typed 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:

3. Submission Dates and Times
See Section IV.3.A for details.

3.A. Receipt, Review and Anticipated Start Dates

Letters of Intent Receipt Date(s): October 1, 2005; May 1 annually thereafter
Application Receipt Dates(s): November 1, 2005; June 1 annually thereafter
Peer Review Date(s): March 2006, October annually thereafter
Council Review Date(s): May 2006, January annually thereafter
Earliest Anticipated Start Date: July 2006; April 1 annually thereafter

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 : bvitiell@mail.nih.gov

The letter of intent for applications to NIAAA should be sent to:

Harold I. Perl, Ph.D.
Division of Treatment and Recovery Research
National Institute on Alcohol Abuse and Alcoholism
5635 Fishers Lane, Room 2039, MSC 9304
Bethesda, MD 20892-9304
Telephone: (301) 443-0788
Email: hperl@mail.nih.gov

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 (U.S. Postal Service Express or regular mail)
Bethesda, MD 20817 (for express/courier service; non-USPS service)

At the time of submission, two additional copies of the application 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 courier/express service)

Applications must be received by the application receipt date indicated in the heading of this PA. If an application is received after that date it will be returned to the applicant without review.

3.C. Application Processing

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 PA, 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.

Applicants are referred to the General Clinical Research Center program at the NIH/National Center for Research Resources (http://www.ncrr.nih.gov/clinical/cr_gcrc.asp) as a potential resource for inpatient and outpatient facility costs.

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/archive/grants/policy/nihgps_2003/index.htm.

6. Other Submission Requirements
Not applicable

Plan for Sharing Research Data

The precise content of the data-sharing plan will vary, depending on the data being collected and how the investigator is planning to share the data. Applicants who are planning to share data may wish to describe briefly the expected schedule for data sharing, the format of the final dataset, the documentation to be provided, whether or not any analytic tools also will be provided, whether or not a data-sharing agreement will be required and, if so, a brief description of such an agreement (including the criteria for deciding who can receive the data and whether or not any conditions will be placed on their use), and the mode of data sharing (e.g., under their own auspices by mailing a disk or posting data on their institutional or personal website, through a data archive or enclave). Investigators choosing to share under their own auspices may wish to enter into a data-sharing agreement. References to data sharing may also be appropriate in other sections of the application.

All applicants must include a plan for sharing research data in their application. The data sharing policy is available at http://grants.nih.gov/grants/policy/data_sharing. All investigators responding to this funding opportunity should include a description of how final research data will be shared, or explain why data sharing is not possible.

The reasonableness of the data sharing plan or the rationale for not sharing research data will be assessed by the reviewers. However, reviewers will not factor the proposed data sharing plan into the determination of scientific merit or the priority score.

Sharing Research Resources

NIH policy requires that grant awardee recipients make unique research resources readily available for research purposes to qualified individuals within the scientific community after publication (NIH Grants Policy Statement http://grants.nih.gov/archive/archive/grants/policy/nihgps_2003/index.htm and http://grants.nih.gov/archive/grants/policy/nihgps_2003/index.htm#_Toc54600131). Investigators responding to this funding opportunity should include a plan for sharing research resources addressing how unique research resources will be shared or explain why sharing is not possible.

The adequacy of the resources sharing plan and any related data sharing plans will be considered by Program staff of the funding organization when making recommendations about funding applications. The effectiveness of the resource sharing will be evaluated as part of the administrative review of each non-competing Grant Progress Report (PHS 2590, http://grants.nih.gov/grants/funding/2590/2590.htm). See Section VI.3. Reporting.

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

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.

What follows are general review criteria for the entire DCISIR application:

1. Public Health Significance: Do the center and its associated research projects address an important public health problem? If the aims of the application are achieved, how will scientific knowledge of intervention and/or services research be advanced? What will be the effect of the center and its affiliated studies on care in community settings, particularly for underserved populations?

2. Innovation: Does the center propose to develop novel concepts, approaches, measures or methods in the assessment of interventions and/or services research? Are the aims original and innovative? Do they grow from the current state of science and from a clear and convincing theoretical or conceptual model? Does the center extend existing approaches or develop new methodologies or technologies that will significantly advance the field? Do the projects challenge existing paradigms or clinical practice; address innovative hypotheses or critical barriers to progress in the field?

3. Approach: Is there adequate rationale to support the importance of a 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 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 center fulfilled, 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, (3) attraction of established investigators and development of collaboration among investigators with diverse backgrounds and areas of expertise, (4) a research mentorship component for new investigators through research training and career development mechanisms, and (5) a process for stimulation and evaluation of new pilot study proposals? Is the approach for the center adequately developed, well integrated, and appropriate to the general aims of the center? Does the applicant acknowledge potential problem areas and consider alternative tactics? Are collaborations across sites well justified and reasonable to carry out the research activities?

4. Leadership: Are the center director and other senior investigators at the forefront of their respective fields? Have they devoted sufficient time to the center research and to mentoring activities, particularly for ethnic or racial minority investigators? Do they have the experience and authority necessary to organize, administer and direct the center? Have they developed a plan that will draw community stakeholders to work with them in this center and promote their sustained involvement?

5. Environment: Does the scientific environment of the center contribute to the probability of success? Does the center take advantage of unique features of the scientific environment or employ useful collaborative arrangements? Does the center draw on the strengths of the institution in all areas (e.g., collaborating with faculty in a school of arts and sciences, IT faculty and staff, other scientifically relevant NIH centers, other researchers who have already made community contacts)? Is the center able to gain and sustain access to the community, including all the research-relevant stakeholders (e.g., teachers, parents, self help groups, director of a community mental health center)? Are convincing letters of support and collaboration included? Is there evidence of institutional support? Are the collaborating sites chosen for the center the appropriate ones to address the research questions proposed?

Specific criteria for each core include:

Operations Core. Does the core clearly delineate procedures and plans for center administration, data management and analysis, community liaison, recruitment and retention of subjects (particularly minorities), and information dissemination? Will the structure of the core foster multidisciplinary collaboration and research project oversight? Does the core reflect a partnership with community agencies or practices, including consumers of these agencies? 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)? Is the data management and statistics plan strong enough to be able to address the challenges inherent in the research projects? Will this center structure and focus lead to a center that will be a sustainable and vital resource for the field and for policy makers?

Research Methods Core. Are the projects in this core truly innovative? Will they help advance research in community settings? Will the core's work enhance the research activities of the other parts of the center? Are there plans to secure additional funding for methodological research? Is the balance of quantitative and qualitative expertise appropriate for the aims of this core and the overall center?

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, approach, innovation, investigators, 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.

2.A. Additional Review Criteria:

In addition to the above criteria, the following items will continue to be considered in the determination of scientific merit and the priority score:

Protection of Human Subjects from Research Risk: The involvement of human subjects and protections from research risk relating to their participation in the proposed research will be assessed (see the Research Plan, Section E on Human Subjects in the PHS Form 398).

Inclusion of Women, Minorities and Children in Research: The adequacy of plans to include subjects from both genders, all racial and ethnic groups (and subgroups), and children as appropriate for the scientific goals of the research will be assessed. Plans for the recruitment and retention of subjects will also be evaluated (see the Research Plan, Section E on Human Subjects in the PHS Form 398).

2.B. Additional Review Considerations

Budget: The reasonableness of the proposed budget and the requested period of support in relation to the proposed research. The priority score should not be affected by the evaluation of the budget.

2.C. Sharing Research Data

Data Sharing Plan: The reasonableness of the data sharing plan or the rationale for not sharing research data will be assessed by the reviewers. However, reviewers will not factor the proposed data sharing plan into the determination of scientific merit or the priority score. The presence of a data sharing plan will be part of the terms and conditions of the award. The funding organization will be responsible for monitoring the data sharing policy.

2.D. Sharing Research Resources

NIH policy requires that grant awardee recipients make unique research resources readily available for research purposes to qualified individuals within the scientific community after publication (See the NIH Grants Policy Statement http://grants.nih.gov/archive/grants/policy/nihgps/part_ii_5.htm#availofrr and http://www.ott.nih.gov/policy/rt_guide_final.html). Investigators responding to this funding opportunity should include a sharing research resources plan addressing how unique research resources will be shared or explain why sharing is not possible.

The adequacy of the resources sharing plan will be considered by Program staff of the funding organization when making recommendations about funding applications. Program staff may negotiate modifications of the data and resource sharing plans with the awardee before recommending funding of an application. The final version of the data and resource sharing plans negotiated by both will become a condition of the award of the grant. The effectiveness of the resource sharing will be evaluated as part of the administrative review of each non-competing Grant Progress Report (PHS 2590). See Section VI.3. Reporting.

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 Principal Investigator will also receive a written critique called a Summary Statement.

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 (http://grants.nih.gov/archive/grants/policy/nihgps_2003/index.htm).

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 (designated in item 14 on the Application Face Page). If a grantee is not email enabled, a hard copy of the NoA will be mailed to the 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 notice of grant award. 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/archive/grants/policy/nihgps_2003/index.htm) and Part II Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Grantees, and Activities (http://grants.nih.gov/archive/grants/policy/nihgps_2003/index.htm).

3. Reporting

Awardees will be required to submit the PHS Non-Competing Grant Progress Report, Form 2590 annually (http://grants.nih.gov/grants/funding/2590/2590.htm) and financial statements as required in the NIH Grants Policy Statement.

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:

Direct inquiries regarding programmatic issues about mental health services research to:

Agnes Rupp, Ph.D.
Division of Services and Interventions 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:  arupp@mail.nih.gov

Direct inquiries regarding programmatic issues about 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: bvitiell@mail.nih.gov

Direct inquiries regarding programmatic issues about 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: mrudorfe@mail.nih.gov

Direct inquiries regarding programmatic issues about 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: gniedere@mail.nih.gov

Direct inquiries regarding programmatic issues about alcohol-related research to:

Harold I. Perl, Ph.D.
Division of Treatment and Recovery Research
National Institute on Alcohol Abuse and Alcoholism
5635 Fishers Lane, Room 2039, MSC 9304
Bethesda, MD 20892-9304
Telephone: (301) 443-0788
Email: hperl@mail.nih.gov

2. Peer Review Contacts:

Review Chief
Division of Extramural Activities
National Institute of Mental Health
6001 Executive Boulevard, Room 6154, MSC 9609
Bethesda, MD 20892
Telephone: (301) 443-3367
FAX: (301) 443-4720

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: knipplej@mail.nih.gov

Judy Fox
Chief, Grants Management Office
National Institute on Alcohol Abuse and Alcoholism
5635 Fishers Lane, Room 3023, MSC 9304
Bethesda, MD 20892-9304
Telephone: (301) 443-4704
Email: jfox@mail.nih.gov

Section VIII. Other Information

Required Federal Citations

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:
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 priority score.

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.

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 PA 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.

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. Unless otherwise specified in an NIH solicitation, Internet addresses (URLs) should not be used to provide information necessary to 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 PA 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 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/.

Footnote

Tunis SR, Stryer DB, Clancy CM. Practical clinical trials: increasing the value of clinical research for decision making in clinical and health policy. JAMA 2003; 290;12: 1624-32.


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