and Human Services (HHS)
EXPIRED
CENTERS PROGRAM FOR RESEARCH ON HIV/AIDS AND MENTAL HEALTH RELEASE DATE: June 20, 2003 PA NUMBER: PAR-03-142 (Reissued as PAR-08-009) (See Notice NOT-MH-06-127 The purpose of this notice is to extend the expiration date and change the eligibility. (Addendum: Budget cap increased, see NOT-MH-04-010) RECEIPT DATES: January 2, 2004; January 2, 2005; January 2, 2006 for all applications September 1, 2004; September 1, 2005; September 1, 2006 for competing renewal applications only EXPIRATION DATE: January 3, 2007 unless reissued. National Institute of Mental Health (NIMH) (http://www.nimh.nih.gov) CATALOG OF FEDERAL DOMESTIC ASSISTANCE NUMBER(S): 93.242 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 Where to Send Inquiries o Letter of Intent o Submitting an Application o Peer Review Process o Review Criteria o Award Criteria o Required Federal Citations PURPOSE OF THIS PA This program announcement replaces PAR-99-153, published in the guide on August 23, 1999. The Center for Mental Health Research on AIDS at the National Institute of Mental Health supports research Centers that provide Core support for multi-disciplinary research programs focused on mental health and HIV/AIDS. The purpose of this Centers Program is to improve and expand research by supporting infrastructure for administrative coordination; subject recruitment, tracking, and retention; quality control and assurance procedures; performing laboratory testing; performing statistical analyses; database management; sponsoring training and education; and organizational capacity, in order to provide leadership in the integration of multidisciplinary approaches to HIV/AIDS and mental health research, and to expand and develop information-sharing, expertise, technology, and technology transfer in the institutional and clinical communities. The support of this infrastructure will serve to enhance and extend the effectiveness and public health impact of research related to mental health and HIV/AIDS. RESEARCH OBJECTIVES The NIMH seeks to foster a synergistic approach to conducting research on mental health issues related to HIV infection. The goal of the NIMH AIDS Centers Program is to encourage the application of multiple scientific perspectives and approaches to stimulate inter-disciplinary collaboration and coordination. NIMH AIDS Centers should stimulate translational AIDS research activities at institutions that receive significant AIDS funding. NIMH AIDS Centers must have the potential to be broadly based investigative endeavors, encompassing or supporting research in a variety of areas including biological, biomedical, behavioral, neuroscience, prevention, clinical sciences, and services research. However, each successful NIMH AIDS Center should also demonstrate excellence and leadership in thematic areas that capitalizes on the experience and expertise of the Center investigators. The Center can then serve as a catalyst to spearhead activities related to this theme within the institution and surrounding communities. Some important specific research objectives that can be fostered by NIMH AIDS Centers are: 1) identification of mutable behavioral risk factors that put individuals at risk for HIV infection, and development of cost-effective interventions to change those behaviors; 2) development of methods and strategies to aid HIV-infected individuals and their families in coping with HIV infection and avoiding new sexually transmitted illnesses; 3) study of the effects of HIV infection of the CNS; 4) identification of the cellular and molecular mechanisms underlying HIV-induced CNS dysfunction; 5) development and testing of potential therapeutics to prevent or treat HIV/CNS disease; and 6) study of issues influencing adherence and non-adherence, and identification of methods to improve long-term adherence to drug therapy regimens and behavioral modification. The NIMH AIDS Centers will enable innovative, state-of-the-science research on HIV and mental health that could not or would not be conducted without the crucial support provided by them. The overall integrative theme of an NIMH AIDS Center should be clearly described, and the need for the Center Cores' support to facilitate the research projects should be justified. NIMH AIDS Centers are expected to serve as local, regional, national and international research resources for established and promising investigators, and to provide opportunities for research training, career development, and mentoring, with an emphasis on fostering the career development of minority scientists to become successful and productive HIV/AIDS researchers. NIMH AIDS Centers are encouraged to use a variety of strategies to achieve the research objectives of the award, including: addressing challenges to enrollment and retention of women, heterosexual men, and ethnic minorities in AIDS clinical and behavioral trials; and developing and expanding collaborations with: other research institutions, research networks funded by other NIH Institutes or Federal agencies or private organizations, international research programs, international and domestic community networks, and industry. Applicants are strongly encouraged to consult with NIMH program staff with regard to questions concerning program-specific requirements and research areas that are of highest priority. Although the specific structure and organization of individual NIMH AIDS Centers will vary, the following characteristics must be included in each application. Applicants should carefully review these characteristics because they are important factors in the evaluation and scoring of the application by peer reviewers. NIMH AIDS Center applications must describe in detail the essential function of each Core of the Center, how each Core will contribute to the overall theme and organization of the Center, and how each Core will be used by the participating research projects. NIMH AIDS Center Cores should provide resources to its institution's AIDS research efforts through support of activities that cannot effectively be provided by standard research grants. An example of such support is promoting translational research activities, i.e., studies bringing findings from the laboratory to the clinic, and vice versa. Specific aims of the proposed components of each of the Center Cores should be defined, and a time line for addressing each of those aims should be presented. A process for evaluating the progress of each Core should be developed, with identification of outcome measurements clearly defined. Accountability and progress measures for each Core can include process indicators (e.g., specific services and technologies offered and utilized); workload indicators (e.g., numbers of faculty users, specific research projects or grants supported, and numbers and types of conferences, symposia, and workshops); and success indicators (e.g., number and quality of publications and grants supported by the Center, especially those concerning interdisciplinary and translational research). Research Environment Each NIMH AIDS Center must provide an environment that promotes the conduct of the highest quality, state-of-the-science research, exhibiting leadership and innovation in its particular area(s) of investigation. Through its activities, the Center must demonstrate that it is a significant scientific research resource. Applicants should be very specific in describing the advantages of the overall Center structure, how the Center will be beneficial, and how the Center will contribute to advancing the field. The application of multiple scientific perspectives and a synergistic approach as well as thematic integration should be defining features of the Center. For competing continuations, applicants should identify original approved specific aims and clearly describe the progress made on each specific aim as well as provide evidence of relevant publications produced in the previous funding period. Competing continuation Centers should also include a description of how the presence of the Center has improved the conduct of research in the thematic area of expertise, as evidenced by broad dissemination of research products, citations by other published materials, or other indicators of scientific advancement. Specific examples of broad achievements should be detailed. Collaborations with community-based organizations (CBOs) should also included in descriptions of the research environment. Center Director The NIMH AIDS Center Director must be scientifically and administratively qualified to handle the complexity of the research objectives of the Center. A critical requirement is that the Center Director must be able to demonstrate leadership with regard to the scientific program and the team of individuals involved in that program. The director will have final responsibility for the scientific, administrative, and operational aspects of the Center. The Center Director is responsible for overall coordination of the Center and for the development of the Center as a significant local, regional, national, and international resource. Because the role of the Center Director is so crucial to the success of the Center, an individual should not serve as Director of more than one NIH Center grant. In addition, it is expected that the Center Director will make a significant and sustained justifiable commitment of time and effort to the Center, based on the breadth and complexity of the Center program and the effort needed to administer it, and foster the development of senior staff to ensure the Center is positioned to maintain its commitment to advancing HIV prevention well into the future. Training As a leader in its particular thematic areas of investigation, the NIMH AIDS Center should attract new investigators and provide for mentoring and career development. An important component of the Center and its research efforts is the training, career development and mentoring of new investigators who show potential for significant contributions and independent research careers. The applicant institution must therefore demonstrate that it has the capacity to train predoctoral and postdoctoral students for careers in HIV/mental health research, and the capacity to provide career development and mentoring opportunities for potential researchers. Center grant funds may not be used to pay stipends or other trainee costs; however, the Center staff may participate in the development of training programs, and Center resources may be made available for trainee use. In addition, as the Centers are considered to be local, regional, national, and international resources, Center applicants should also describe plans for facilitating the sharing of data with the scientific community, the mechanisms to be used for data-sharing, and the procedures for training staff in using those mechanisms. Evidence that training goals for new investigators have been met should be included in recompeting applications, and may include such indicators as recruitment and retention, scientific contributions (e.g., first authored publications), and small grant awards. Travel Limited support is available to cover travel of the Center Director and other investigators to scientific meetings that are justified as essential to the conduct of research supported by the Center. Travel of technical staff for training that is justified as essential to enhancing the quality of the research projects is also allowed. Organization NIMH AIDS Center applications are expected to be multi-disciplinary in scope, applying multiple scientific perspectives and approaches to foster inter - disciplinary collaboration and coordination, and are expected to include a depth of expertise and experience not ordinarily present in an individual research project application. The mechanisms that will foster interactions and collaborations among Center investigators should be described in detail in a well- organized plan that explains how these interactions and collaborations will result in enhanced quality, productivity and overall progress in research in the Center. An effective Center provides an environment that encourages cross-fertilization of ideas, provides an interactive research environment, and encourages creativity and innovation. The applicant should describe clearly how interactions and collaborations of participating investigators will enhance and expand the development and productivity of their research efforts, and how participating investigators will benefit from shared resources, formal and informal planning activities, and developmental or pilot support provided through the NIMH AIDS Center grant. NIMH AIDS Center must be organized to include the Cores listed below: o Administrative Core The Center must have an appropriate and adequate administrative structure with an internal organization capable of planning and evaluating Center activities. A strategic plan must be outlined which identifies the immediate and long-term goals of the Center. A process for implementing the activities to achieve the goals set by the Center should be clearly defined. For new Center applications, the highest priority goals should be identified with a detailed plan outlining the activities proposed to meet those goals for each year of the grant. Goals for each successive year should build on those identified for the first year of funding. Competing continuation Centers must provide information on how the Center has achieved the goals of the previous funding period and how the goals of the future years build on the past successes. A structure must be provided that has clear lines of authority to promote planning and evaluation activities as well as collaborations and interactions within, among and between programmatic elements of the Center in an efficient and cost-effective manner. A mechanism for internal review, decision-making, and priority-setting processes appropriate to conduct the activities of the Center must be defined. Appropriate criteria and review processes must be established and described to sustain investigator participation in the Center based on productivity, research direction, and overall contribution. The administrative structure must include a standing outside advisory committee(s) charged with providing appropriate and objective advice and evaluation as needed to the Center Director. The plan for meeting with the outside advisory committee(s) should be outlined, and a process for responding to recommendations of the committee(s) should be delineated. The Administrative Core may include a limited number of administrative and clerical personnel, with a detailed description of their responsibilities for the Center and strong justification for the level of support requested. However, salary and support for central administrative personnel usually paid from institutional overhead charges, such as budget officers, grants assistants, and building personnel, are not allowable. Administrative support services, including supplies, duplicating equipment, telephones, or maintenance contracts for equipment are allowed when not covered by institutional overhead charges. Salary and support for administrative activities such as public relations, fund-raising, or educational services unrelated to the research are not allowed. Rent may be allowed only in unusual and exceptional circumstances whereby the applicant institution has excellent researchers and potential for mental health-related HIV/AIDS research, but has documented insufficient on-site space. o Research Cores The structure of the NIMH AIDS Center will include the establishment of at least two Research Cores to support shared resources that are not easily funded through standard research funding mechanisms. The number and goals of the Research Cores should be reflective of the overall level of funding requested for the Center. Research Cores can be developed around any research activity that can provide resources to basic and clinical investigators. The Research Cores are expected to be used as shared resources and services and are intended to provide access to knowledge and technology that enhances the research productivity of the Center, scientific interaction within the Center and consultation being provided by the Center. These Research Cores also provide access to services that facilitate the research and strengthen the administrative and organizational cohesion of the Center. Research proposed to be conducted within the Research Core structure is allowed when directed toward improving and expanding the resource. Each Research Core should clearly describe a plan for identifying new or expanded services that it provides. In addition, each Research Core should clearly describe a plan for identifying potential users of the shared resources, and for providing the resources to investigators who may request them. The potential benefits of these resources and a mechanism to evaluate these benefits must be detailed in the description of the Research Core. The Research Core Director must be scientifically qualified to handle the nature and complexity of the research objectives of the Research Core. Each Core Director must be experienced in the scientific area in which the Core functions, and have demonstrated the ability to assume responsibility for the scientific, administrative, and operational aspects of the Research Core. The time commitment of the Core Director should be based on the breadth and complexity of the Core and the effort needed to administer it. o Developmental Core The NIMH AIDS Center structure must include a Developmental Core. Funds allocated to this Core are to provide start-up funds for new, innovative pilot projects by independent investigators. The intent of this Core is to support scientific studies for short periods of time to develop preliminary data for peer-reviewed research applications. Funds from this Core can be used to support pilot projects, feasibility studies, new or emerging research opportunities, and AIDS research activities of newly recruited faculty; restricted to these uses only. Generally, the total amount of money allocated to pilot projects should not exceed 10% of the Center grant's total annual direct costs (exceptions should be strongly justified). These projects should have the potential for developing into larger projects that could compete for funds on their own. The support of pilot projects or feasibility studies should be of relatively short duration (e.g., 1-2 years), depending upon the nature of the research. A process by which high-quality, innovative pilot proposals are identified by or solicited from investigators must be developed and clearly described. The mechanism for reviewing potential projects, making funding decisions and awards, and monitoring projects to ensure effective use of pilot project funds must be clearly described. As with all research to be conducted under the Center's auspices, pilot projects must comply with applicable NIH policies, and the necessary human subject and animal welfare assurances must be submitted. The Director of the Developmental Core must be scientifically qualified to direct the activities of the Core. This Core Director must be experienced in the scientific areas in which the core proposes to develop pilot projects and must have an understanding of the scientific process of developing ideas into applications. This Director should also demonstrate the ability to assume responsibility for the scientific, administrative, and operational aspects of the Developmental Core. Competing continuation Center applications should supply information about the progress, accomplishments and relevant publications of all projects supported by the Developmental Core of the previous funding period of the Center. This information should also include current funding status of completed pilot projects, whether data generated from pilot projects provided a basis for projects with independent funding, and whether investigators funded through this mechanism, particularly junior investigators, were successful at competing for independent funding. o Budgetary Items and Supportable Activities Allowable costs in NIH grants are governed by rules set forth in the NIH Grants Policy Statement and the NIH Guide for Grants and Contracts, unless otherwise stated on the Notice of Grant Award. Under these rules, the Center Director has flexibility to meet unexpected Center requirements by rebudgeting or requesting approval to rebudget among categories within the total direct cost budget of the Center (as shown on the Notice of Grant Award). The Center is intended to provide reasonable costs for any or all of those activities noted below which are clearly related to the specialized research needs of the Center and allowed by NIH policy. MECHANISM(S) OF SUPPORT This PA will use the NIH core center grant (P30) award mechanism. As an applicant you will be solely responsible for planning, directing, and executing the proposed project. NIMH will provide up to a maximum of $2,000,000 total costs per year for an AIDS Center grant. This PA uses just-in-time concepts. ELIGIBLE INSTITUTIONS You may submit (an) application(s) if your institution has any of the following characteristics: o Non-profit organizations o Public or private institutions, such as universities, colleges, hospitals, and laboratories o Domestic o Faith-based or community-based organizations Foreign institutions are not eligible to apply. In order to be eligible for an NIMH AIDS Center grant, applicants must demonstrate a minimum funded research base of four NIMH-funded research grants, and at least two more peer-reviewed AIDS and AIDS-related research awards at the time that the Center is funded and throughout the award period. The additional grants may be from other NIH Institutes or from peer-reviewed funding from alternate sources. This research base must demonstrate synergy and collaboration for AIDS-related behavior research or research investigating the neurological and neurobehavioral complications of HIV infection. The research base includes grants and contracts utilizing the following mechanisms: P01, R01, R03, R21, R35, R37, U01, U10, U19, and K series awards. 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. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH 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 three areas: scientific/research, peer review, and financial or grants management issues. o Direct your questions about scientific/research issues to: Dianne Rausch, Ph.D. Center for Mental Health Research on AIDS National Institute of Mental Health 6001 Executive Boulevard, Room 6212 Bethesda, MD 20892-9619 Telephone: (301) 443-7281 FAX: (301) 443-9719 Email: [email protected] o Direct your questions about peer review issues to: Michael Kozak, Ph.D. Division of Extramural Activities National Institute of Mental Health 6001 Executive Boulevard, Room 6138, MSC 9608 Bethesda, MD 20892-9608 Rockville, MD 20852-9608 (for express/courier service) Telephone: (301) 443-1340 FAX: (301) 443-4720 Email: [email protected] o Direct your questions about financial or grants management matters to: Brian Albertini Division of Mental Disorders, Behavioral Research, and AIDS National Institute of Mental Health 6001 Executive Boulevard, Room 6135, MSC 9605 Bethesda, MD 20852-9605 Telephone: (301) 443-0004 FAX: (301) 443-6885 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 sent by the date listed at the beginning of this document. The letter of intent should be sent to: Dianne Rausch, Ph.D. Center for Mental Health Research on AIDS National Institute of Mental Health 6001 Executive Boulevard, Room 6212 Bethesda, MD 20892-9619 Telephone: (301) 443-7281 FAX: (301) 443-9719 Email: [email protected] SUBMITTING AN APPLICATION Applications must be prepared using the PHS 398 research grant application instructions and forms (rev. 5/2001). 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]. APPLICATION RECEIPT DATES: Applications must be sent on or before the application receipt date listed in the heading of this PA. Revised applications of competitive renewals will be accepted on the September 1 following the first competitive renewal submission. This September 1 deadline is only applicable for revised competitive renewal applications. Applications received after the application receipt date will be returned to the applicant without review. SUPPLEMENTAL INSTRUCTIONS: To facilitate the review process, the application should be organized according to the outline described here. o Overview (not to exceed 10 pages) An overview should include: an overall description of the proposed Center, including objectives and integrating theme; justification of Center goals and proposed organization; evidence of the cohesiveness of the proposed Center; a brief description of background and responsibilities of the Center Director, key personnel, and participating investigators; and a diagram illustrating the organization and function of the programmatic and advisory structure of the Center. The overview should describe how the Center functions will develop and expand collaborations, bringing the thematic expertise to the local, regional, national and international scientific community. New Center applications should describe plans to develop these broad collaborations, delineating a process for evaluating progress. Competing continuation Center applications must describe past successes and new goals as well as provide convincing justification that continued support under this mechanism will continue to be highly productive. Both new and competing Center applications should describe the institutional commitment to the Center. A strong commitment of the parent institution can be demonstrated by providing sufficient resources and space to ensure organizational stability and fulfillment of Center objectives. The organizational status of the Center within the institution should be comparable to that of other similar organizational units within the institution. The parent institution should also provide assurance of its commitment to continuing support of the Center in the event of a change in Center directorship and have in place a well-defined plan for this situation. o Research Plan (not to exceed 25 pages) The research plan must include: a detailed description of the goals of the Center and how leadership and expertise will be provided as a resource for the scientific personnel and projects that form the Center; an action plan to achieve those goals, and a short- and long-term timeline for achieving those goals; the strengths of and opportunities provided by the proposed Center; strengths of the methods to be used; information about resources and facilities available to augment the Center's capabilities; policies and procedures for strategic planning, monitoring, and evaluating the Center activities; an overview of the core structure, including a justification for specific cores and a plan for how the cores will interact with and support the programmatic elements of the Center; and a description of how the Center will facilitate the existing science at the Institution. Competing continuation Centers should include some historical perspective describing the major successes of the previous funding periods and how continued funding will build on those successes. Competing continuation Centers also must provide evidence of leadership and expertise appropriate for the thematic areas of the Center. o Cores (not to exceed 10 pages for each core) A detailed description of each individual Core must include the aims and activities of the Core and a description of how the aims will be met; a justification and description of the personnel within each Core; the proposed users of the Center resources and the percent of time that they expect to use those resources; a plan for outreach to other potential users; a description of the core's resources and environment; and a plan for evaluating the activities of the Core. 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. Applicants requesting more than $500,000 must carry out the following steps: 1) Contact the IC program staff at least 6 weeks before submitting the application, i.e., as you are developing plans for the study; 2) Obtain agreement from the IC staff that the IC will accept your application for consideration for award; and, 3) Identify, in a cover letter sent with the application, the staff member and IC who agreed to accept assignment of the application. This policy applies to all investigator-initiated new (type 1), competing continuation (type 2), competing supplement, or any amended or revised version of these grant application types. Additional information on this policy is available in the NIH Guide for Grants and Contracts, October 19, 2001 at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-004.html. SENDING AN APPLICATION TO THE NIH: Submit a signed, typewritten original of the application, including the Checklist, and three signed photocopies in one package to: CENTER FOR SCIENTIFIC REVIEW NATIONAL INSTITUTES OF HEALTH 6701 ROCKLEDGE DRIVE, ROOM 1040, MSC 7710 BETHESDA, MD 20892-7710 BETHESDA, MD 20817 (for express/courier service) At the time of submission, two additional copies of the application must be sent to: Jean G. Noronha, Ph.D. NIMH Referral Liaison National Institute of Mental Health 6001 Executive Boulevard, Room 6154, MSC 9609 Bethesda, MD 20892-9609 Rockville, MD 20852 (for express/courier service) Telephone: (301) 443-3367 FAX: (301) 443-4720 Email: [email protected] APPLICATION PROCESSING: Applications must be mailed on or before the application receipt date listed in the heading of the PA. If an application is received after that date, it will be returned to the applicant without review. 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 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 8 weeks. PEER REVIEW PROCESS Applications submitted for this PA will be assigned on the basis of established PHS referral guidelines. An appropriate scientific review group will be convened by NIMH 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 Receive a written critique 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 second level review by the appropriate national advisory council or board 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 the application in order to judge the likelihood that the proposed research will have a substantial impact on the pursuit of these goals: o Significance o Approach o Innovation o Investigator o Environment The scientific review group will address and consider each of these criteria in assigning the application's overall score, weighting them as appropriate for each application. The 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, an investigator may propose to carry out important work that by its nature is not innovative but is essential to move a field forward. Applicants must ensure that their applications are responsive to the research goals of NIMH and to the essential organizational and administrative characteristics of a NIMH Center as described below. Review of re-competing Centers will include the necessity of strong accountability for past funding period. Changes in structure or focus that have taken place over the previous funding period that have been done to strengthen or broaden the efforts of the Center should be clearly described. Evidence for future Center success should be clearly stated. Overall Center Program Review Criteria SIGNIFICANCE: o Scientific significance of the proposed program to furthering research on mental health and HIV, expand research collaborations, and provide leadership in the thematic area of expertise o Evidence of thematic integration, synergy of approach, cohesiveness of objectives, and adequacy of evaluation plans to monitor progress o Multi-disciplinary scope, breadth, and overall quality of the Center's Program, and the core units, and provisions for coordinating and evaluating the resource provided to associated research projects o Re-competing Centers should provide a clear justification for the significance of continued support APPROACH: o Overall quality of the proposed administrative functions and infrastructure in relation to Center themes and research projects o Arrangements for internal quality control of ongoing functions, allocation of funds, day-to-day management, contractual agreements and internal communication and cooperation among investigators o Quality of plans for internal peer review of papers, chapters, and grant applications including procedures for determining authorship and other sensitive matters o Track record and quality of plans for mentoring and career development of promising investigators o Quality of the data analytic functions and procedures for database management, including quality assessment and control procedures, extent of use of the data for analysis, publication, and development of additional hypotheses o Re-competing Centers should include a description of how continued funding will build on the success of the previous funding period INNOVATION: o Unique strengths and contributions of the Center, including innovation, scientific productivity, and recognition, including publication record or participating investigators, new research grants, honors and awards o Extent of collaboration among investigators within the Center and with other research institutions, networks, programs, etc. o Quality and innovation of proposed pilot studies that would be anticipated, and quality of the procedures for selection and evaluation of new pilot study proposals o Re-competing Centers must include a justification for their ability to continue innovative efforts INVESTIGATOR: o Scientific and administrative qualifications of the Center Director, including evidence of scientific expertise and track record, strong leadership potential, administrative skills, and mentoring potential o Scientific qualifications and productivity of Center investigators, including quality and extent of the research expertise, degree of synergistic potential among the research groups o Quality of plans for personnel recruitment o Quality of plans for sponsoring workshops, seminars, and other educational activities for Center investigators and research staff o Track record of key personnel in mentoring and promoting career development of promising investigators, including summaries of training activities and new investigator accomplishments ENVIRONMENT: o Institutional commitment to the program, including availability and accessibility of appropriate research laboratories, equipment, and subjects o Academic and physical environment as it bears on the potential for interaction with scientists from other departments and institutions o Evidence of cost-effectiveness of Center structure and function, and document of quality control of core units o As appropriate, the adequacy of the means proposed for protecting against risks to human subjects, animals, and/or the environment o As appropriate, the adequate representation of women and minorities in study populations In addition, the proposed Center will be reviewed for the following: o Appropriateness of budget requested for the proposed structure and function o Appropriateness of the timeline for the proposed activities, and the quality of the proposed evaluation process for meeting the goals o Appropriateness of procedures for making allocations to core units and, reviewing and selecting pilot projects for support o Quality of plans to participate in scientific, professional, and public meetings and present research findings and, where concrete findings exist, plans for publishing the findings o Quality of plans for making data and methodologies available to the scientific community and for providing training in such methodologies o The quality of plans for participating in workshops and conferences, as well as disseminating information to non-researcher investigators and the local community when applicable 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). 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. 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. 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 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.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.
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NIH Funding Opportunities and Notices
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