and Human Services (HHS)
EXPIRED
ADVANCED CENTERS FOR MENTAL HEALTH DISPARITIES RESEARCH (ACMHDR) RELEASE DATE: February 6, 2004 PA NUMBER: PAR-04-060 (See Notice NOT-MH-06-120) (Requirement restated and contact info updated, see NOT-MH-05-006) EXPIRATION DATE: May 12, 2006, unless reissued. Department of Health and Human Services (DHHS) PARTICIPATING ORGANIZATION: National Institutes of Health (NIH) (http://www.nih.gov) COMPONENT OF PARTICIPATING ORGANIZATION: National Institute of Mental Health (NIMH) (http://www.nimh.nih.gov) CATALOG OF FEDERAL DOMESTIC ASSISTANCE NUMBER: 93.242 LETTER OF INTENT RECEIPT DATE: April 11 annually APPLICATION RECEIPT DATE: May 11, 2004; May 11, 2005; May 11, 2006 THIS PA CONTAINS THE FOLLOWING INFORMATION o Purpose of the PA o Research Objectives o Mechanism(s) of Support o Eligible Institutions o Individuals Eligible to Become Principal Investigators o Special Requirements o Where to Send Inquiries o Submitting an Application o Supplementary Instructions o Peer Review Process o Review Criteria o Award Criteria o Required Federal Citations PURPOSE OF THE PA This PA replaces PA-96-007. The purpose of this Advanced Centers for Mental Health Disparities Research (ACMHDR) initiative is to promote the enhancement of established research core infrastructures and investigator-initiated research aimed at understanding and ameliorating mental health disparities (defined below in next section). All research areas supported by NIMH that are relevant to mental health disparities are appropriate as the central focus for ACMHDR research. Research projects may include, but are not limited to, studies of mental health disparities of American Indians/Alaskan Natives, Asian Americans, African Americans, Hispanics, and Native Hawaiians and Pacific Islanders. Studies of ethnic subpopulations within these broad categories are also encouraged. RESEARCH OBJECTIVES The principal objective of this program is to assist in the maintenance of and strengthen a research environment in which state-of-the-art research methodologies may be applied to an interdependent set of research projects and pilot research projects relating to a single major focus in mental health disparities research. The NIH defines health disparities as differences in the incidence, prevalence, mortality, and burden of diseases and other adverse health conditions that exist among specific population groups in the United States (http://www.nih.gov/about/hd/strategicplan.pdf). Many disparities in mental health outcomes are highly associated with, but not necessarily limited to race, ethnicity, gender, and social conditions such as inadequate access to quality mental health care services. For example, a principal finding cited in Mental Health: Culture, Race, and Ethnicity -- A Supplement to Mental Health: A Report of the Surgeon General , is that racial and ethnic minorities bear a greater burden from unmet mental health needs and thus suffer a greater loss to their overall health and productivity. More is known about the existence of disparities in access to healthcare and mental health services, and the differential rates of mental health diagnoses among racial and ethnic groups and their significance, than the reasons for the occurrence of those disparities. The ACMHDR are specifically intended to support investigations of mental health disparities, with a strong emphasis on the reasons for the occurrence of those disparities, and are expected to produce findings that lead to outcomes that contribute to reducing the burden of mental health for all people. For further assistance in defining mental health disparities and/or the populations to be served by the Center, please contact Dr. Michael Sesma under WHERE TO SEND INQUIRIES. Further assistance in defining the research focus may be obtained by contacting the appropriate program official listed under WHERE TO SEND INQUIRIES. Each ACMHDR should provide an environment of scientific excellence that will ensure the highest quality research and leadership in its particular area of investigation. Through its research activities, the ACMHDR should demonstrate that it has a major impact on mental health disparities through (e.g.) publications, community involvement, and outreach efforts. As a result of support from this program, it is expected that research projects developed by the ACMHDR investigators will later be supported by other research and research training grants from NIMH, private foundations, and from other research grant awarding sectors of the Federal government. However, applicants who are seeking support for ACMHDR pilot projects are not expected to have current extensive additional research funding. MECHANISM OF SUPPORT This PA will use the NIH Specialized Center Grants (P50) award mechanism. As an applicant, you will be solely responsible for planning, directing, and executing the proposed center. This mechanism supports cores, research projects, and pilot research projects. Research projects are expected to be fully developed and designed to test a research hypotheses in a definitive manner, similar to an R01 in scope. Pilot research subprojects are for investigators who: (1) are new to the institution and have not had previous independent research support; (2) have academic responsibilities that have precluded pursuit of a research program; or (3) plan to make a change in their research direction that necessitates a fresh start in a new discipline relevant to mental health research. The pilot research project is intended for faculty without current research support. Therefore, investigators with significant current extramural support from other NIH mechanisms such as the R01 or research funding from another agency, are not eligible to submit pilot research projects. Support for these advanced centers may be requested for an initial period of up to 5 years, followed by a competitive renewal for an additional 5-year period. Once awarded and during the term of the award, centers are subject to administrative review for performance, and are not transferable to another institution. Applicants may request up to $600,000 in direct costs per year, plus Facility and Administrative (F&A) costs. Although the F&A costs associated with all contractual and consortium arrangements are considered as direct costs to the applicant organization, for the purposes of this program announcement, these will not count against the program direct costs cap of $600,000 per year. However, these costs should be indicated as instructed on Form 398, rev. 5/01. To qualify for support, a Center should consist of at least three research projects, which may include a pilot project(s) that are determined by expert review to be scientifically meritorious in relation to the career level of the project’s principal investigator. Pilot projects, although not specifically required, are strongly encouraged to assist in the career development of mental health researchers. Annual awards will be made subject to continued availability of funds and progress achieved. This PA uses just-in-time concepts, but it uses only non-modular budgeting formats (see http://grants.nih.gov/grants/funding/phs398/phs398.html. This program does not require cost sharing as defined in the current NIH Grants Policy Statement at http://grants.nih.gov/grants/policy/nihgps_2001/part_i_1.htm. ELIGIBLE INSTITUTIONS You may submit an application if your institution has any of the following characteristics: o For-profit or non-profit organizations o Public or private institutions, such as universities, colleges, hospitals, and laboratories o Units of state and local governments o Eligible agencies of the Federal government o Foreign institutions are not eligible for ACMHDR grants Applicant institutions should demonstrate the capacity to become an advanced center through evidence of previous commitment of institutional resources, development of, or access to, a critical mass of mental health and/or mental health disparities researchers, the presence of substantial recent topical peer-reviewed publications in the research area chosen, and partnerships/cooperative efforts with other institutions. Minority-Serving institutions such as (for example) Historically Black Colleges and Universities and Hispanic Serving Institutions are encouraged to apply. Advanced centers should be a major national scientific resource with the ability to impact practice and public mental health policy. They should demonstrate a capability to study questions among various populations in different community and practice settings. For the purpose of this PA, the NIMH will not support more than one ACMHDR grant (P50) from the same applicant institution. Institutions with similar or complementary active or pending support from other NIH sources are not precluded from applying for an ACMHDR. For example, programs such as Project Export or Research Infrastructure in Minority Institutions (National Center for Minority Health and Health Disparities), Minority Biomedical Research Support program (National Institute of General Medical Sciences), Research Centers in Minority Institutions (National Center for Research Resources), and/or other minority student/faculty support programs from private or public funding agencies may also apply for this program. INDIVIDUALS ELIGIBLE TO BECOME PRINCIPAL INVESTIGATORS 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 as an ACMHDR. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH programs. SPECIAL REQUIREMENTS An ACMHDR must have the following: (a) strong intellectual leadership, at the administrative level and in each of the individual research projects. This is characterized by a principal investigator and co-investigators who are able to demonstrate significant direct personal experience in a research project, clinical intervention, biomedical activity, public or private social service organizational function, or preventive intervention effort, with racial and ethnic minority groups, or other health disparity groups, in the related study area; (b) the availability of mental health researchers as co-investigators, especially members of racial and ethnic minority group(s) who have experience in mental health- relevant research for that referenced group; and (c) the availability of promising junior researchers who are either graduate students or junior faculty. The participation of minority investigators as consultants to the applicant institution will not be sufficient, in itself, to satisfy these requirements. An ACMHDR must include a central conceptual focus for the research and involve strong, collaborative, synergistic relationships among the investigators, which will form the basis for further research and research training activities. All activities must be interrelated to reflect an integrative ACMHDR rather than a loosely allied network of investigators. An ACMHDR must be interdisciplinary, including, as appropriate, investigators from biological sciences (e.g., neuroscience, molecular biology, genetics) and the social and behavioral sciences (e.g., health economics, sociology, public health, epidemiology, psychiatry, nursing, social work, psychology, statistics, anthropology, and demography). The principal investigator and investigators on research projects should be able to demonstrate competence in working with diverse populations and a history of working in the area of health disparities. The participation of minority investigators as consultants will not be sufficient, in itself, to satisfy these requirements. An effective evaluation plan, a required component of every ACMHDR program, should be able to demonstrate overall improvement of the institution’s research capacity. Therefore, the emphasis of evaluation activities is on self-study and on continual improvement of the institution's research capacity. In the evaluation plan, applicants are expected to identify their goals and objectives, and to set milestones appropriate to developing the institution's current research infrastructure and research capacity. The goals and specific objectives should relate to the overall goals of the ACMHDR program and to the institution's research development plans. The evaluation plan must describe the procedures and methods that will be used to collect and analyze the type of data needed to assess the extent to which the proposed goals and objectives have been achieved. The applicant should also provide information on the qualifications of the person(s) conducting the evaluation, the type of data to be collected, and the data collection schedule. Thereafter, the program requires that annually (in annual progress reports), each institution assess progress made toward its own goals and specific objectives including milestones for accomplishment. For an effective measure of progress by research project and pilot project investigators, the following data and information should be presented in subsequent annual progress reports for the former or current investigator; (1) name; (2) project title; (3) period of support; (4) number and type of competitive research support applications submitted; and (5) number and type of grants received. If the applicant plans to involve another corporate entity (e.g., research institute, medical school, local government, etc.) in the functions of the ACMHDR, the following must be included: (1) Description of the nature of the arrangements and lines of authority; (2) Letter(s) of agreement signed by the responsible officer of each associated organization stating that cooperation, research facilities, services, or other relevant assistance will be available on a continuing basis (Submit as an appendix to the application); and (3) Appropriate clearances from each associated organization that state that the proposed research meets that institution’s research review requirements (including Institutional Review Boards responsible for activities involving human subjects) An ACMHDR must have access to the target populations or subpopulations in sufficient numbers to accomplish its research goals. This access must be documented by letters of collaboration from relevant local and national groups. An ACMHDR with a clinical focus must provide access to and appropriate levels of administrative control over sufficient inpatient and/or outpatient facilities to ensure availability of patients/clients for specific research projects. Although funds from the ACMHDR grant may not be used to support formal research training activities, each ACMHDR should include a plan for providing opportunities for research training experiences in disciplines relevant to mental health. An ACMHDR may take advantage of the Ruth L. Kirschstein National Research Service Award (NRSA) Fellowships and Institutional Research Training Grants, Research Scientist Development Awards for support of appropriate developing scientists, and Supplements for Underrepresented Minorities in Biomedical and Behavioral Research. Information on these mechanisms can be found at http://grants.nih.gov/training/extramural.htm. The ACMHDR Director is encouraged to contact NIMH program staff regarding application for these support mechanisms. The ACMHDR will be required to submit detailed annual progress reports, including substantive information about research results to date, status of ongoing research, research plans for the next year, and any modification in long-term research plans. Presentation in scientific meetings and publication in refereed journals should be included. Also, inventions reporting, financial status reports, final reports, and other reports are required to be filed in accordance with PHS policy. Institutions with active or pending research infrastructure development support from other NIH sources such as Project Export or Research Infrastructure in Minority Institutions (National Center for Minority Health and Health Disparities), Minority Biomedical Research Support program (National Institute of General Medical Sciences, Research Centers in Minority Institutions (National Center for Research Resources, and/or other minority student/faculty support programs from private or public funding agencies may also apply for this program. However, within the Operational Plan for the Overall Center the applicant institution must describe how the funds from this proposed advanced center program will complement these other awards. Institutions must describe/explain any overlap in research aims/objectives. In particular, the applicant must describe how the research and research-related activities (goals and objectives) supported by different programs will complement each other. The application must also describe how administrative staff (secretarial assistance, administrative assistance) will be shared between this and other programs. WHERE TO SEND INQUIRIES We encourage your inquiries concerning this PA and welcome the opportunity to answer questions from potential applicants. Inquiries may fall into four areas: mental health disparities and populations to be served, scientific/research, peer review, and financial or grants management issues: o Direct your questions about mental health disparities and populations to be served to: Michael A. Sesma, Ph.D. Office for Special Populations National Institute of Mental Health 6001 Executive Boulevard, Room 8125, MSC 9659 Bethesda, MD 20892-9659 Telephone: (301) 443-2847 Email: [email protected] o Direct your questions about scientific/research issues to: Debra Babcock, Ph.D., M.D. Division of Neuroscience and Basic Behavioral Science National Institute of Mental Health 6001 Executive Boulevard, Room 7178, MSC 9639 Bethesda, MD 20892-9639 Telephone: (301) 443-1692 Email: [email protected] Ann Hohmann, Ph.D. Division of Services and Intervention Research National Institute of Mental Health 6001 Executive Boulevard, Room 7146, MSC 9631 Bethesda, MD 20892-9631 Telephone: (301) 443-4235 Email: [email protected] Emeline Otey, Ph.D. Division of Mental Disorders, Behavioral Research and AIDS National Institute of Mental Health 6001 Executive Boulevard, Room 6180, MSC 9625 Bethesda, MD 20892-9625 Telephone: (301) 443-1636 Email: [email protected] o Direct your questions about peer review issues to: Michael Kozak, Ph.D. Extramural Review Branch National Institute of Mental Health 6001 Executive Boulevard, Room 6138, MSC 9608 Bethesda, MD 20892-9608 Telephone: (301) 443-1340 Email: [email protected] o Direct your questions about financial or grants management matters to: Rebecca Claycamp Grants Management Branch National Institute of Mental Health 6001 Executive Boulevard, Room 6122, MS 9605 Bethesda, MD 20892-9605 Telephone: (301) 443-2811 Email: [email protected] LETTER OF INTENT Prospective applicants are asked to submit a letter of intent that includes the following information: o Descriptive title of the proposed research o Name, address, and telephone number of the Principal Investigator o Names of other key personnel o Participating institutions o Number and title of this PA 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 NIMH 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 should be sent to the appropriate program contact at the address listed under WHERE TO SEND INQUIRIES. SUBMITTING AN APPLICATION Applicants are strongly encouraged to contact the appropriate program contact listed under INQUIRIES with any questions regarding their proposed project and the goals of this PA. Applications must be prepared using the PHS 398 research grant application instructions and forms (rev. 5/2001). 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 DUNS number can be obtained by calling (866) 705-5711 or through the web site at http://www.dunandbradstreet.com/. The DUNS number should be entered on line 11 of the face page of the PHS 398 form. The PHS 398 is available at http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive format. For further assistance contact GrantsInfo, Telephone (301) 710-0267, Email: [email protected]. The title and number of this program announcement must be typed on line 2 of the face page of the application form and the YES box must be checked. SUPPLEMENTARY INSTRUCTIONS APPLICATION PAGE LIMITS: The description of the Operations Plan, Research and Statistics Methods Cores, and the Administrative Core is limited to a total of 30 pages; the research plans for the Research Projects are limited to 25 pages each; research plans for pilot projects are limited to 15 pages each. The application must use PHS Form 398 and include the following components in the specified order: Information for the Entire ACMHDR: o Face Page (noting this program announcement in Item 2) - Information provided here should pertain to the entire ACMHDR. o Description, Performance Sites, and Key Personnel (Form Page 2) - Information provided here should pertain to the entire ACMHDR. o Table of Contents (Form Page 3) o Budget Information (Form Pages 4 and 5) - Categorical figures should be provided to reflect the budget of the overall ACMHDR. Since detailed budget justification will be provided separately for each project and core (as described below), only items for which justification is not provided elsewhere should be presented in narrative of the budget information section. o Biographical Sketches of Key Personnel - Biographical sketches must be provided for key personnel of the entire ACMHDR, and arranged alphabetically based on the individual's surname. o Resources - Resources described here should be restricted to those not described separately for the individual projects and cores (as described below). o Introduction - For revised and resubmitted applications, a introduction of not more than three pages addressing the concerns of the previous review is required. Refer to the PHS 398 instructions for revised applications. o General Description of the Overall ACMHDR. This section should provide an overview of the entire proposed ACMHDR. This must include a description of the central hypothesis to be tested and goals to be achieved. This announcement requires an evaluation component for the ACMHDR. Towards this end, the general description section must identify the objectives of the overall ACMHDR, how these will be achieved, how the outcomes will be evaluated, and the timeline (milestones) for their achievement. This section must also specify the proposed contribution of each of the research projects in achieving the objectives of the ACMHDR and how these components relate to each other scientifically. o If previously supported by a Research On The Mental Health Of Minority Populations award, indicate the outcome (in less than 4 pages) of that specific activity as it relates to the application for the proposed ACMHDR support. o Operational Plan for Overall ACMHDR. The administrative and logistical arrangements, as well as the resource support necessary to implement the research, should be fully elaborated in the application. When multiple institutional sites are involved, a detailed description of the cooperative administrative arrangements must be included (documentation of these arrangements should be included in the "Letters of Support" section). Additionally, the expected distribution of the award to each institution by percent of effort and percent of funds must be explained. Also included in this section is the manner in which an external advisory board will advise the ACMHDR. Prospective board members should not be chosen or contacted prior to a funding decision and therefore should not be named. The plan for sharing data, biological material resources, and tools generated by the ACMHDR must also be included in this section. o Research Career Development and Outreach Plans. A description should be provided of the manner in which ACMHDR activities will provide research career advancement opportunities for developing investigators. An explanation should be provided of how the proposed Center relates to existing training programs of ACMHDR institutions. In addition, the plans for disseminating information to the public regarding the activities of the ACMHDR should be an element of the overall ACMHDR program description. The ACMHDR should enable investigators to conduct research and pilot studies and to formulate, develop, and test new hypotheses, methodologies, and data-gathering techniques. Models for organization of a ACMHDR may vary, but they all must contain the infrastructure for implementing an overarching research plan and a plan that includes sophisticated, multidisciplinary, integrated pilot research projects. This infrastructure must provide, at minimum, an administrative core and a methodology and statistics core, as described below. Administrative Core. An ACMHDR must have a scientifically and administratively well-qualified director who has primary responsibility for the scientific leadership and administration of the research program and a strong administrative structure. The description of the Administrative Core should include the following information: o Relationship to the applicant institution o Description of the administrative structure of the ACMHDR, including delineation of responsibilities and authorities of the ACMHDR Director and his/her assistants o Description of any committee whose role is advisory on specific aspects of the ACMHDR research program o Arrangements for planning, coordinating, facilitating, and evaluating the ACMHDR research projects and pilot research projects and development of Core resources o Procedures for coordinating and supervising the work of individual investigators o Procedures for coordinating specific studies conducted under the auspices of the ACMHDR o Personal Data (Biosketch) of the ACMHDR Director Methods and Statistics Core. Applicants should describe an organizational structure to provide on-site expertise in research design methodology, database management, psychometrics (if instrument development is to be included in the research activities), and statistical analysis to the investigators of the ACMHDR. Research Projects and Pilot/Feasibility Research Projects. A Center application must include at least three research projects, one or more of which may be pilot projects. For each proposed individual project, all of the sections of the PHS 398 application are required, including Specific Aims, Background and Significance, Preliminary Studies/Progress Report (if applicable), Research Design and Methods, Inclusion of Women and Minorities, and Children, and Protection of Human Subjects. An applicant must show the project is related to the central research focus of the ACMHDR. Early phases of major studies (feasibility studies) may be supported by the ACMHDR. Separate budgets and budget justifications for each research project are also required. Selection of the specific research focus of research projects and pilot research projects must be justified in terms of: o Their concordance with research areas of interest to NIMH o The state of scientific knowledge o The feasibility of performing the proposed research (e.g., availability of measurement instruments, populations to study) o Access to the target minority groups or subgroups in sufficient numbers for meaningful analysis o The potential impact of the research on understanding and improving the mental health of the minority populations under study The research plan should describe how the individual research projects and pilot research projects are linked to the central focus of the ACMHDR. Applicants should also describe the types of further programmatic steps that might be taken in future years to build upon early findings. In addition, a statement should be included describing relevant, current and planned research, training, and service grant support that will be available to the ACMHDR. The research plan for each project must include a description of the research design and methods. Description of the experimental design should outline the strategies proposed to accomplish the specific aims of the project and should include a discussion of the innovative aspects of the approach. Experimental procedures need not be spelled out in great detail if those procedures have already been extensively published and widely accepted by the scientific community; the methods to be used should be cited and referenced. Any new methodology, however, and its advantage over existing methodologies, should be fully described. Further, the feasibility of the proposed experiments, potential pitfalls, alternative approaches, if necessary, and relevance to ACMHDR goals should be discussed, as should plans for data sharing. o Human Subjects - For each individual activity or project and core involving human subjects, describe the plans for protection of subjects from research risks. Clinical research projects must also include a description of plans for the inclusion of women, minorities, and children, as described in the PHS 398 application instructions (rev. 5/2001). The plan should clearly describe any novel efforts designed to recruit and retain women, minorities, and children in the research project. o Vertebrate Animals - For each individual project and core involving vertebrate animals, provide a detailed description and justification for the use of animals as described in the PHS 398 application instructions (rev. 5/2001). Other Information: o Literature Cited - This section should include and compile literature cited throughout the application. o Letters of Support from Institutions and Collaborators - Also included in this section should be assurances from Institutional Animal Care and Use Committees and/or Institutional Review Boards (though the latter is not required for peer review). o Checklist Budget Budgets for the ACMHDR administrative core, methods and statistical core, and individual research projects and pilot research projects should be presented separately and each must be fully justified. In addition, the travel budget request should include funds for the ACMHDR Director and one other key professional staff member to attend an annual meeting with other ACMHDR directors and NIMH staff in the Washington, DC area. o Information should be presented on cash and in-kind support, if any, for the ACMHDR by the applicant institution. In-kind support may include such items as university supported faculty and graduate students who will participate in the program to supplement the core staff, funding of joint tenure-line appointments for ACMHDR staff, office space, supplies, and equipment. Allowable Costs Allowable costs include salaries of personnel responsible for the management of the ACMHDR, including the ACMHDR Director, support for resources shared across research projects and pilot research projects through the coordinating ACMHDR, such as equipment and personnel to provide research design and statistical consultation, data base management services, reference services, or scientific administrative services. Expenses clearly related and necessary to conduct the research projects, and support for individual pilot research projects at the developmental stage, which can include salaries, supplies, travel, special consultations, and publication costs, direct costs that can be specifically identified with the pilot research project. Only costs required by the research may be requested for research-related treatment, rehabilitation, or prevention services and programs In addition, funds can be used to support research participant recruitment and retention activities for all populations, especially activities to ensure appropriate participation by women, children and adolescents, elderly and other traditionally understudied populations, such as racial and ethnic minorities and people in rural areas. Those Centers that will conduct clinical trials may request funds to support the establishment of a Data and Safety Monitoring Board for those trials. Funds may also be used for travel, salaries, meeting expenses, subcontracts and paying consultants. 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. Grant funds may not be used for establishing, adding a component to, or operating a treatment, rehabilitation, or prevention/intervention service program or for formal research training activities. The ACMHDR grant is neither expected nor intended to cover all of the costs of a successful Center. NIMH expects and encourages the institution and personnel attracted to an ACMHDR to actively seek and compete for additional funding. APPLICATION RECEIPT DATES: Applications submitted in response to this program announcement will be accepted at the application receipt dates listed in the heading of this PA. SPECIFIC INSTRUCTIONS FOR APPLICATIONS REQUESTING $500,000 OR MORE PER YEAR: Applications requesting $500,000 or more in direct costs for any year must include a cover letter identifying the NIH staff member within one of NIH institutes or centers who has agreed to accept assignment of the application. SUBMITTING AN APPLICATION TO THE NIH: Submit a signed, typewritten original of the application, including the Checklist of the documents included, 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 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 20892-9663 Bethesda, MD 20817 (for courier/express service) APPLICATION PROCESSING: Applications must be received on or before the application receipt date listed in the heading of this PA. The CSR will not accept any application in response to this PA that is essentially the same as one currently pending initial review unless the applicant withdraws the pending application. The CSR 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 unfunded version of an application already reviewed, but such application must include an Introduction addressing the issues raised in the previous review. Although there is no immediate acknowledgement of the receipt of an application, applicants are generally notified of the review and funding assignment within 8 weeks. PEER REVIEW PROCESS Applications submitted for this PA will be assigned on the basis of established PHS referral guidelines. Appropriate scientific review groups convened in accordance with the standard NIH peer review procedures (http://www.csr.nih.gov/refrev.htm) will evaluate applications for scientific and technical merit. As part of the initial merit review, all applications will: o Undergo a selection process in which only those applications deemed to have the highest scientific merit, generally the top half of applications under review, will be discussed and assigned a priority score o Receive a written critique o Receive a second level review by the National Advisory Mental Health Council REVIEW CRITERIA 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 your application in order to judge the likelihood that the proposed research will have a substantial impact on the pursuit of these goals. The scientific review group will address and consider each of these criteria in assigning your application’s overall score, weighting them as appropriate for each application. o Significance o Approach o Innovation o Investigator o Environment Your application does not need to be strong in all categories to be judged likely to have major scientific impact and thus deserve a high priority score. For example, you may propose to carry out important work that by its nature is not innovative but is essential to move a field forward. REVIEW OF OVERALL ACMHDR In carrying out the scientific and technical merit review of the overall ACMHDR, the initial review group will take into account: SIGNIFICANCE: Does this ACMHDR and its associated research projects address an important mental health disparities topic? If the aims of the application are achieved, will scientific knowledge of mental health disparities be advanced? Will the effect of the center and its affiliated studies in addressing mental health disparities be significant? APPROACH: Is there adequate rationale to support the importance of a center approach as opposed to other mechanisms (e.g., individual R01, R21, R03 applications)? Does a conceptual and theoretical framework focused on a major topic in mental health disparities research inform the center organization and infrastructure development? Is the concept of a center on mental health disparities research fulfilled, including: (a) an integrated theme bringing together a multi- or interdisciplinary team of investigators in a common mission of studying mental health disparity topics, (b) development of a pooled, core database or access to research participants that can yield results beyond that accomplished with individual projects alone, (c) attraction of established investigators and development of collaboration among investigators with diverse backgrounds and areas of expertise, (d) a research mentorship component designed to guide new investigators through the pathways of research training and career development mechanisms, and (e) a process for stimulation and evaluation of new pilot study proposals for the investigation of mental health disparities? 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? Are the plans for evaluation of ACMHDR progress towards measurable objectives well conceived and appropriate? What is the feasibility and the likelihood of success of the application as defined by the stated goals, measurable objectives, anticipated milestones and/or outcomes, and the evaluation plan. INNOVATION: Does the center propose to develop novel concepts, approaches, measures or methods in the development and assessment of mental health disparities research? Are the aims original and innovative? Does the ACMHDR extend existing approaches or develop new methodologies or technologies that will facilitate development of focused research efforts? Does the ACMHDR propose to study populations/groups which have a paucity of data and information in comparison to other segments of the U.S. population? INVESTIGATOR: Are the ACMHDR director and other senior investigators at the forefront of their respective fields? Do they have the experience and authority necessary to organize, administer and direct the center? Is the investigator's research competence continuing to improve? 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? Is the center able to gain and sustain access to a representative range of people in a broad set of academic and community settings? Is there evidence of institutional support? Are the collaborating sites chosen for the center appropriate for addressing the research questions proposed? If applicable, does the distribution of the budget among multi-site institutions reflect a partnership between developed research institutions and developing research institutions? REVIEW OF RESEARCH PROJECTS AND PILOT RESEARCH PROJECTS The initial review group will take into account these factors when conducting the scientific and technical merit review of the research project and pilot research project applications: SIGNIFICANCE: o Does this study address an important problem in mental health disparities? o If the aims of the application are achieved, will scientific knowledge be advanced? o Will there be a significant impact of these studies on the concepts or methods that contribute to the reduction of health disparities? o For pilot subprojects: Is it likely that the research proposed in the pilot projects would yield data useful as the basis for a more sophisticated independent research support application (e.g., Career Development (K), Exploratory Research Grants (R34), Small Research Grant Program (R03), Exploratory/Developmental Research Grant (R21) (where applicable), a research project in an advanced center, or an R01)? APPROACH: o Are the conceptual framework, design, methods, and analyses of data adequately developed, well integrated, and appropriate to the aims of the project? o Does the applicant acknowledge potential problem areas and consider alternative methods/approaches? o Is the literature review critical and current, including identification of gaps in the knowledge? o For pilot projects: Are the proposed aims achievable and reasonable for a pilot project? INNOVATION: o Does the project employ novel concepts, approaches or methods and are the aims original and innovative? o Does the project challenge existing paradigms or develop new methodologies or technologies? INVESTIGATOR: o Is the investigator appropriately trained and well suited to carry out this work? o Is the work proposed appropriate to the experience level of the principal investigator and other researchers (if any)? o Has the investigator been productive in documenting his/her research findings in refereed-reviewed journals? o Has the investigator's productivity been commensurate with previous research support? Is the investigator's research competence continuing to improve? ENVIRONMENT: o Does the scientific environment in which the work will be done contribute to the probability of success? o Do the proposed experiments take advantage of unique features of the scientific environment or employ useful collaborative arrangements? o Is there evidence of institutional support? o If resources are not available, are there plans to acquire, or gain access to, the necessary resources to conduct the research? ADDITIONAL REVIEW CRITERIA: In addition to the above criteria, the following items will be considered in the determination of scientific merit and the priority score: Quality and appropriateness of the outreach and research career development components of the Center’s activities: Are approaches used to disseminate information regarding the Center’s activities as they relate to public understanding of science and mental health and illness adequate? Are approaches to attract and involve young investigators and students who show potential for significant future contributions and independent research careers in the work of the Center likely to be effective? 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 criteria included in the section on Federal Citations, below). http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm 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 Inclusion Criteria in the sections on Federal Citations, below). CARE AND USE OF VERTEBRATE ANIMALS IN RESEARCH: If vertebrate animals are to be used in the project, the five items described under Section f of the PHS 398 research grant application instructions (rev. 5/2001) will be assessed. ADDITIONAL CONSIDERATIONS SHARING RESEARCH DATA: Applicants requesting more than $500,000 in direct costs in any year of the proposed research are expected to include a data sharing plan in their application. 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 priority score. BUDGET: The reasonableness of the proposed budget and the requested period of support in relation to the proposed research. AWARD CRITERIA Applications submitted in response to a PA will compete for available funds with all other recommended applications. The following will be considered in making funding decisions: o Scientific merit of the proposed project as determined by peer review o Availability of funds o Relevance to program priorities 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). The establishment of data and safety monitoring boards (DSMBs) is required for multi-site clinical trials involving interventions that entail potential risk to the participants. (NIH Policy for Data and Safety Monitoring, NIH Guide for Grants and Contracts, June 12, 1998: http://grants.nih.gov/grants/guide/notice-files/not98-084.html). SHARING RESEARCH DATA: Starting with the October 1, 2003 receipt date, 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, 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 - Amended, October, 2001," published in the NIH Guide for Grants and Contracts on October 9, 2001 (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html); a complete copy of the updated Guidelines are 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 RESEARCH INVOLVING HUMAN SUBJECTS: The NIH maintains a policy that children (i.e., individuals under the age of 21) must be included in all human subjects research, conducted or supported by the NIH, unless there are scientific and ethical reasons not to include them. This policy applies to all initial (Type 1) applications submitted for receipt dates after October 1, 1998. 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 that is available at 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 proposals for research involving human subjects. You will find this policy announcement in the NIH Guide for Grants and Contracts Announcement, dated June 5, 2000, 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-02-005.html. Only research using hESC lines that are registered in the NIH Human Embryonic Stem Cell Registry will be eligible for Federal funding (see 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. Applications that do not provide this information will be returned without review. PUBLIC 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 public 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). Those who must comply with the Privacy Rule (classified under the Rule as covered entities ) must do so by April 14, 2003 (with the exception of small health plans which have an extra year to comply). 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.healthypeople.gov/. 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.
Weekly TOC for this Announcement
NIH Funding Opportunities and Notices
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