EDWARD R. ROYBAL CENTERS FOR TRANSLATIONAL RESEARCH IN THE BEHAVIORAL AND SOCIAL SCIENCES RELEASE DATE: October 28, 2002 RFA: AG-03-002 National Institute on Aging (NIA) (http://www.nia.nih.gov/) LETTER OF INTENT RECEIPT DATE: December 27, 2002 APPLICATION RECEIPT DATE: January 21, 2003 THIS RFA CONTAINS THE FOLLOWING INFORMATION o Purpose of this RFA o Research Objectives o Mechanism(s) of Support o Funds Available o Eligible Institutions o Individuals Eligible to Become Principal Investigators o Special Requirements o Where to Send Inquiries o Letter of Intent o Submitting an Application o Peer Review Process o Review Criteria o Receipt and Review Schedule o Award Criteria o Required Federal Citations PURPOSE OF THIS RFA The National Institute on Aging (NIA) invites applications from qualified institutions for Edward R. Roybal Centers for Translational Research in the Behavioral and Social Sciences. NIA invites both new teams of investigators and continuing centers (funded under AG-97-005) to apply. The long-range objectives of the Roybal Centers are to improve the health, quality of life, and productivity of middle-aged and older people, through: (1) facilitating the translation of what we have learned about aging processes from the basic behavioral and social sciences (including human factors) to practical outcomes, including new technologies, for the benefit of the aged, and 2) stimulating new "use-inspired" basic research in the behavioral and social sciences. By making research resources more accessible, a Roybal Center grant will provide the research infrastructure to: (1) Enhance the productivity of relevant research, including the promotion of translational research into existing projects. (2) Stimulate ideas for new program development in the area of translational research in the social and behavioral sciences. Successful Centers are expected to encourage researchers at their institutions to pursue additional funding to further develop, test, and implement ideas piloted within these Centers. Mechanisms for additional funding through NIH would include program projects (P01), research grants (R01), and Small Business Innovative Research (SBIR ) awards (R43, R44). (3) Facilitate acceleration in the development of new products or technologies to enhance the health and quality of life of older Americans. (4) Facilitate and accelerate application through studies and analyses of the translational process itself. (5) Recruit new researchers to the area of translational research. (6) Facilitate interaction and collaboration among academic researchers, and commercial interests or Governmental bodies. (7) Develop innovative networks of researchers with interests in translational research. RESEARCH OBJECTIVES Background NIA has long been the primary sponsor of research in the basic social and behavioral sciences on the processes of aging at both the individual and societal levels. This long-term investment in research has generated a large body of knowledge about how people change over the adult life course (both physically and in such areas as cognition, motivation, personality, and memory), on the inter-relationships between older people and social institutions, and on the societal and economic impact of the changing age- composition of the population. The BSR Program has supported research and training both (i) at the population level, on the antecedents and impact of changing social, demographic, economic, and health characteristics of the older population, and (ii) at the individual level, on the bio-psychosocial processes linking health and behavior, cognitive functioning, human factors, and integrative approaches to the study of social, psychological, contextual/environmental, genetic, and physiological influences on health and well-being over the life course. As recent years have seen an explosion of fundamental insights in the basic social and behavioral sciences, translating this knowledge into practical advances to benefit the health and well being of older Americans has increasingly become a priority for the NIA. The underlying objective of this RFA is to fund research Centers to accelerate the process of translation to address that need. Beyond Center funding, it is anticipated that investigators will develop and submit applications for P01s, R01s, or SBIRs to implement ideas developed in the Roybal Centers. A. Specific NIA Objectives The theme of a proposed Roybal Center may be organized to examine: (a) Acceleration in the process of translating basic behavioral and social science research theories, methodologies, and findings about aging processes into practical outcomes and new technologies that would improve the lives of later middle-aged and older people. The end-point could be improvement in some indicator or indicators of functioning or well-being in different environments, whether in the home, at work, or in spheres as diverse as health care, communications, transportation, retirement planning and saving, etc. The Center could also facilitate and accelerate application through studies and analyses of the translational process itself. (b) New "use-inspired basic research" as defined by Stokes (Pasteur's Quadrant: Basic Science and Technological Innovation, 1997). Using the work of Pasteur as an example, Stokes argued that the most beneficial research is frequently motivated by considerations of use while simultaneously advancing basic understanding. Such "use-inspired basic research" is distinguished from those studies that serve as theoretical exercises designed mainly to further the body of knowledge on a particular topic and from those that are "strictly applied research" that may be undertaken to solve a particular problem but not necessarily concerned with the advancement of scientific knowledge per se. The focus on investigating a practical problem will require applicants to show familiarity with the practical domain or environment being investigated as well as with relevant aspects of aging research. Such familiarity may be achieved by collaboration with specialists in the domain or community, or by prior experience in applying aging research successfully to this domain. Because practical problems will likely benefit from cross-disciplinary attention, applications that reflect broad-based expertise are particularly encouraged. B. NIA's Behavioral and Social Research (BSR) Program's "Areas of Emphasis" With an underlying crosscutting principle of "translation and application of findings", the BSR Program is particularly interested in, but does not require, applications that address one or more of the "areas of emphasis." BSR's areas of emphasis include: (a) Aging Minds (b) Increasing Health Expectancy (c) Health, Work, and Retirement (d) Intervention and Behavior Change (e) The Burden of Illness and the Efficiency of Health Systems (f) Health Disparities (g) Genetics, Behavior, and the Social Environment C. Examples of Areas of Concentration The following section provides examples of potential areas of concentration for proposed Centers in a number of different practical domains. These ideas are intended to be non-exhaustive and illustrative only, as applications are welcome from all domains that would increase our understanding of the processes of technological innovation and translation of basic research to practical outcomes, as related to individual and population aging. Applications are strongly encouraged to focus on one topic. o With increasing age, adults face important decisions regarding their investments, retirement plans, mobility (e.g., motor vehicle operation), health care, and living arrangements. A "Center for Applied Decision-Making" could extrapolate existing knowledge, conceptual models, and research paradigms to the study of older adults' decision-making skills and their effect on instrumental activities of daily living. Related to this, another example might be a "Center for Health Communication and Literacy." Research is needed to evaluate, and translate this research to practical interventions, how older adults read and comprehend health-related information pertaining to long-term care and health insurance, media reports of medical research, treatment benefits and risks, and other medical or genetic risk information. In addition, studies might be supported that examine how adults seek and evaluate health information sources (i.e., credibility of source), the nature and style of information presented via various types of health-related media, and the development and testing of health education curricula. o Being able to adapt your behavior frequently determines whether you will or will not perform a given task successfully. As adults grow older, we respond more slowly to simple stimuli and take longer to learn new material, thus potentially decreasing our ability to adapt. Vision, speech and hearing can become impaired. In addition, older adults often exhibit larger temporal variations in sensory, motor, and more abstract cognitive abilities than do younger and middle-aged adults. Advances in technology provide the opportunity to construct technology that can augment greatly the adaptivity and functionality of older adult users (NRC, 2000). This line of research includes developing and testing various devices (e.g., miniaturized computers) to aid perception and processing of environmental information for activities such as walking, driving, and reading and viewing of computerized or electromechanical displays, so improving quality of life among the elderly. The Center might also focus research on personalized and interactive interfaces. Such a Center should integrate the social and behavioral sciences with engineering as well as contribute to theory building for broader applications. Alternatively, a Center could focus on enhancing health outcomes by means of enhanced caregiver interaction technologies, such as through mobile patient monitoring systems that alert healthcare providers or caregivers to problematic or changed patient status. Auto regulatory systems, that is, devices that alert the user to change or adjust their behavior to maximize or enhance their health and functioning, could also be a Center focus. o A Center could stimulate research on various topics aimed at translating our basic understanding of the theories and principles of economics, psychology, and other behavioral and social science disciplines to improved interventions for older persons in the areas of work and retirement. For example, a Center might focus on using behavioral economics and basic cognitive science to improve retirement planning, such as increasing the savings rate for retirement, whether through 401k plans or personal savings, or increasing participation in long term care insurance programs. The influence of employer/corporate behavior on such interventions might also be examined. o A Center focusing on maintaining and accelerating the decline in disability in the older population might encourage research on adapting the principles of behavior change to design or modify health promotion programs or to address specific conditions affecting older people's functional status in terms of the activities of daily living. Topics might include the encouragement of increased exercise, improved management of chronic diseases, and treatment of conditions such as diabetes, hypertension, or glaucoma -- that require the patient to strictly follow complicated regimens. Another Center could explore the genetics of behavioral medicine that analyze how genetic differences affect individual ability to modify behavior and how genes affect variation in responses to these behavioral changes. Another example might be to develop and apply models and methodologies from the behavioral and social sciences to the development of interventions and clinical trials, such as how best to increase compliance to pharmaceutical regimens or how to improve cognitive IADLs. Such a Center would also identify underlying factors that could be used to enable "best practices" targeted interventions with defined populations (e.g., employed and married versus retired and living alone adults). Other Centers could design improved measures of well-being and quality of life for use in clinical trials and other interventions or could design multi-level social and behavioral interventions. o Differing degrees of efficiency with which health systems organize and finance themselves, and react to the needs of their populations, explain part of the widening gap in death rates between the rich and the poor, in nations and between countries, around the world (WHO, 2000). Such health system inefficiencies and consequent under- utilization of resources have resulted in a high degree of inequality in the provision of services and in preventable disability. A "Center on the Efficiency of Health Systems" could stimulate basic research to document how middle-aged and older adults are affected by these trends, linked with pilot projects to address how best to offer a safety net for those groups who are disproportionately affected by health system inefficiencies. A related area would be to translate what has been learned about the strengths and weaknesses of various health financing (insurance) schemes to practical programs for the delivery of health care services for the older population. o Large differences in health outcomes by socioeconomic status (SES) – less education and lower income and wealth -- have long been identified, but cannot be explained fully by traditional arguments, such as access to health care or poor health behaviors. Recent research by Goldman and Smith (2002) examined differences in treatment adherence among patients with two illnesses, diabetes and HIV, and found, after controlling for other factors, more educated patients are more likely to adhere to therapy, and this adherence makes them experience improvements in their self-reported general health. The ability to maintain a better health regimen is an important independent determinant of subsequent health outcomes. Differences associated with less education could be effectively overcome, resulting in improved compliance and improved health outcomes. A Center in this area might develop a theory of SES differences in health-related risks and test the theory through multi-level practical interventions among lower SES patients. D. Center Components Each Center Grant (P30) must consist of: (a) a management and administrative core and (b) a pilot core. In addition, a dissemination core may be included at the discretion of the Principal Investigator. Although the Center grant is primarily designed to support a research Center at a specific institution, some Centers may also wish to make research resources available to the larger scientific community or galvanize scientists at several academic institutions. Consortium arrangements are permissible, provided that the applicant institution meets the eligibility requirements. Centers are also encouraged to collaborate with other NIA- funded Centers, including the Resource Centers and Coordinating Center for Minority Aging Research (RCMAR) and the Demography Centers. Information about these Centers is available from the program staff listed under INQUIRIES. (a). Management and Administrative Core (MANDATORY) The Management and Administrative Core is central to each Center. Activities of the core should include: o developing a strategic vision for the Center, coordinating all Center activities that fall within the Center's tactical framework; o ensuring overall management of the Center and compliance with NIH and NIA policies; o monitoring pilot projects that are part of the Center, assessing their progress, and reassigning resources as needed during the course of the award; o encouraging and facilitating the development of networks among researchers, commercial interests, community interests, and Governmental entities; o encouraging the pursuit of additional financial and/or material resources to support and expand Center research, for example through collaborating with commercial interests and submitting small business and traditional research applications to NIH; pursuing additional resources for non- research support services to, for example, promote dissemination, marketing, and/or corporate sponsorship of product development; o creating and maintaining an Advisory Committee that oversees the functioning of the Center, including the individual pilot projects. See SPECIAL REQUIREMENTS for further details; o initiating and maintaining interactions with relevant community groups (e.g., community boards, businesses, health care facilities) in order to facilitate the conduct of the Center's pilot research projects. The PI of the Center will coordinate the day-to-day running of the management and administrative core. (b). Pilot Core (MANDATORY) The Center application must request funds to initiate small-scale (in the range of $15,000 to $50,000 direct costs) pilot research that is consistent with the theme of the Center grant. Such pilots could be implemented by both junior and established investigators at the Center institutions or at outside institutions or in association with academic and/or corporate partners. It is expected that two to four pilot projects will be funded annually. While pilot projects may be proposed for one or two years' duration, it is expected that most will be funded for one year. The Center application must include examples of two, and only two, of the pilot projects, and each example should not exceed 2 pages. In addition, the application must describe a plan to develop, identify, review, and monitor pilot projects. (c). Dissemination Core (OPTIONAL) The practical outcomes generated by the Roybal Centers should be widely disseminated to the research community and general public so that others can implement them. Therefore, each Center could optionally participate in a program of dissemination of research results. If a dissemination core is included, the applicant should address how research dissemination activities will be included, such as newsletter publication, presentations at scientific conferences, publication in scientific and popular press outlets, web sites that allow outcome and/or data access, marketing, and interface with community agencies and programs. MECHANISM OF SUPPORT This RFA will use the NIH Research and Development Core Center Grant (P30) award mechanism. P30 grants support shared resources and facilities for a multidisciplinary research team or group of investigators focusing on a common research topic. As an applicant you will be solely responsible for planning, directing, and executing the proposed project. The anticipated award date is September 30, 2003. FUNDS AVAILABLE The NIA intends to commit approximately $3.0 million in total costs in FY 2003 to fund 8-10 new 5-year grants in response to this RFA. NIA expects to fund Centers of different sizes. Although this program is provided for in the financial plans of the NIA, awards are contingent upon the availability of funds for this purpose and the receipt of a sufficient number of applications of outstanding scientific and technical merit. Maximum allowable total costs are $350,000. A 3% per annum inflation increase is allowable in subsequent years. At this time it is not known whether the RFA will be reissued. The NIA appreciates the value of complementary funding from other public and private sources, including foundations and commercial and industrial concerns, for activities that will complement and expand those supported by the NIA. 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 or local governments o Eligible agencies of the Federal government o Faith-based or community-based organizations Note that foreign organizations are not eligible to apply for P30 grants. An Edward R. Roybal Center Grant (P30) requires relevant pre-existing research activity at the institution. Ideally, applicant institutions will have a substantial base of relevant research. A minimum of one peer-reviewed and externally funded research project in the behavioral or social sciences is required. The project should be active at the time of application and the Principal Investigator (PI) of the Roybal Center application should be PI of the active project. 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. SPECIAL REQUIREMENTS Advisory Committee The Management and Administrative Core should include an Advisory Committee that oversees the functioning of the Core and the individual pilot projects. The Advisory Committee should consist of at least five members drawn from diverse expertise. The PI of the Center should be the chair of the Advisory Committee. During the first year of the Center, the Advisory Committee should meet at least twice (one of these meetings may be a conference call, but at least one meeting must be in person) to review the research plans and status of current projects. During the out-years of the Center, the Advisory Committee should meet at least once per year, either in person or by conference call. Minutes of these meetings should be prepared and provided to the NIA Program Official. The Administrative Core budget should reflect the costs associated with communicating with and convening the Advisory Committee. Members of the Advisory Committee should not be named in the application; instead areas of expertise should be listed. Annual Meeting Roybal Center Principal Investigators and Core leaders will be required to attend an annual meeting and the travel budget should therefore reflect appropriate allocation for this activity. The meetings will be held at the NIH in Bethesda, MD, or at another site agreed to by the PIs and the NIA. The purpose of the meetings is to have investigators working in the same general area share information about translational research methods and findings. Applicants should include a statement in the application indicating a willingness to participate in such meetings and to cooperate with other researchers in the exchange of data, materials, and ideas. Approval of Pilot Projects NIA policy requires that the specific aims of any pilot project, in addition to the pilot project budget and Curriculum Vitae of the pilot investigator, must be submitted to the NIA Program Official for approval before funds may be expended. WHERE TO SEND INQUIRIES We encourage inquiries concerning this RFA 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: Sidney S. Stahl, Ph.D. Behavioral and Social Research Program National Institute on Aging Gateway Building, Suite 533 Bethesda, MD 20892-9205 Telephone: (301) 402-4156 E-mail: StahlS@nia.nih.gov o Direct your questions about peer review issues to: Mary Nekola, Ph.D., Chief Scientific Review Office Gateway Building, Room 2C212 Bethesda, MD 20892-9205 Telephone: (301) 496-9666 E-mail: NekolaM@nia.nih.gov o Direct your questions about financial or grants management matters to: Linda Whipp, Chief Grants and Contracts Management Office Gateway Building, Room 2N212 Bethesda, MD 20892-9205 Telephone: (301) 496-1472 E-mail: WhippL@nia.nih.gov 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 RFA Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows IC staff to estimate the potential review workload and plan the review. The letter of intent is to be sent by the date listed at the beginning of this document. The letter of intent should be sent to: Dr. Mary Nekola Scientific Review Office National Institute on Aging 7201 Wisconsin Avenue, Suite 2C212, MSC 9205 Bethesda, MD 20892-9205 Telephone: (301) 496-9666 FAX: (301) 402-0066 Email: NekolaM@nia.nih.gov 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 https://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive format. For further assistance contact GrantsInfo, Telephone (301) 710-0267, Email: GrantsInfo@nih.gov. SUPPLEMENTAL INSTRUCTIONS: Center applications must follow the application format and page limitations described in the NIA Program Project Guidelines available on the NIA Webpage at http://www.nia.nih.gov/GrantsAndTraining/Policies/ProgramProjectPoliciesandGuidelines.htm. The following exceptions to these guidelines apply: no pre-application permission is required; the eligibility requirements do not apply; the submission date is January 21, 2003; the instructions for amended and supplemental applications do not apply; and the applicable review criteria are listed in the RFA. The Center application must follow the organization format described in the Guidelines. To summarize: Cores are limited to 10 pages for sections a-d and there should be up to a ten-page introduction of the Center as a whole. Regarding the Pilot Core, as part of the 10 pages allotted, the application should include examples of two pilot projects, and each example should not exceed 2 pages. For current ROYBAL Centers being funded under AG-97-005, a progress report of no more than 2 pages should be included as part of the 10-page introduction. USING THE RFA LABEL: The RFA label available in the PHS 398 (rev. 5/2001) application form must be affixed to the bottom of the face page of the application. Type the RFA number on the label. Failure to use this label could result in delayed processing of the application such that it may not reach the review committee in time for review. In addition, the RFA title and number must be typed on line 2 of the face page of the application form and the YES box must be marked. The RFA label is also available at: https://grants.nih.gov/grants/funding/phs398/label-bk.pdf. 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 7701 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: Chief of Review Scientific Review Office National Institute on Aging 7201 Wisconsin Avenue, Suite 2C212, MSC 9205 Bethesda, MD 20892-9205 APPLICATION PROCESSING: Applications must be received by the application receipt date listed in the heading of this RFA. If an application is received after that date, it will be returned to the applicant without review. The Center for Scientific Review (CSR) will not accept any application in response to this RFA 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 substantial revisions of applications already reviewed, but such applications must include an Introduction addressing the previous critique. PEER REVIEW PROCESS Upon receipt, applications will be reviewed for completeness by the CSR and responsiveness by NIA staff. Incomplete and/or non-responsive applications will be returned to the applicant without further consideration. Applications that are complete and responsive to the RFA will be evaluated for scientific and technical merit by an appropriate peer review group convened by the NIA in accordance with the review criteria stated below. As part of the initial merit review, all applications will: o Receive a written critique o May undergo a process in which only those applications deemed to have the highest scientific merit, generally the top half of the applications under review, will be discussed and assigned a priority score o Receive a second level review by the National Advisory Council on Aging 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. A. Overall Center o Significance of the proposed mission or theme of the Center. If the aims are achieved, how do they advance the translation of behavioral and social science research into practical advances to benefit the health and well being of older Americans or forward "use-inspired basic research"? o Although one peer-reviewed, externally funded, currently active grant in the behavioral and social sciences is the minimum requirement, considerable weight will be given to: (1) significant on-going research activity that is relevant to the theme of the proposed Center or (2) that demonstrate the ability to translate a body of research previously funded by BSR to significant practical outcomes. o Demonstrated potential to act as a conduit between basic behavioral and social science research and applied outcomes. This will be judged by evidence of past involvement in related research and the specific plans for seeking applied outcomes as described in the application. o The theoretically and empirically supported rationale for the particular approach to extending basic behavioral and social science research into applied areas, and the degree to which the proposed approach is innovative and employs novel concepts, approaches or methods. o Commitment as stated in the application to collaborate with commercial, non-profit or governmental interests to support and expand Center research. Such commitment should be demonstrated by letters of support regarding new collaborations and/or evidence of past partnerships. Proposed collaborative activities must increase the opportunities for research and translation. o Quality of plans to ensure that the outcomes of the translational research will directly improve the quality of life of older Americans. o Evidence of institutional support, such as commitment from the host institution to the research activity and availability of appropriate facilities for the research activities proposed. o Appropriateness of the budget for the Center. o Leadership ability, relevant experience in appropriate areas, and scientific stature of the PI. The time commitment of the Center PI must be sufficient to show substantial personal supervision of the various activities of the Center. A past history of applying basic behavioral and social research in a relevant area will be an important advantage. o The likelihood that the scientific environment and proposed collaborative arrangements will lead to the probability of success. B. Management and Administrative Core o Whether the lines of authority and the administrative structure are designed for effective Center management. Whether the administrative structure maximizes the Center's capability to take advantage of research opportunities. o The qualifications, responsibilities and effectiveness of senior leaders. Appropriateness of percent effort of senior leaders. o Appropriateness of the duties and percent efforts of administrative staff of the Center in terms of their qualifications and contributions to the specialized needs and conduct of the Center's theme. o The effectiveness of the Center's internal planning activities and the Advisory Committee as described. C. Pilot Core o Adequacy of the proposed process for developing, soliciting, reviewing, selecting, monitoring and evaluating pilot projects. o Quality, innovativeness and importance to the theme of the Center. o Relevance of the proposed pilot projects to the theme of the Center; o Degree to which pilot project funds will be used to stimulate projects that will promote the theme of the Center; o The qualifications, responsibilities and effectiveness of Pilot Core senior leaders. Appropriateness of percent effort of senior leaders. D. Dissemination Core (where applicable) o Quality of the plans for dissemination activities, such as newsletters, web sites, publications and presentations, interface with community agencies and programs, interviews with electronic media, and planned strategies for translating research findings into practical programs or services. o Scientific value and public good that might result from any proposed dissemination activities. o The qualifications, responsibilities and effectiveness of Dissemination Core senior leaders. Appropriateness of percent effort of senior leaders. ADDITIONAL REVIEW CRITERIA: In addition to the above criteria, your application will also be reviewed with respect to the following: o PROTECTIONS: The adequacy of the proposed protection for humans, animals, or the environment, to the extent they may be adversely affected by the project proposed in the application. o INCLUSION: The adequacy of plans to include subjects from both genders and all racial and ethnic groups (and subgroups), as appropriate for the scientific goals of the research. Plans for the recruitment and retention of subjects will also be evaluated. (See Inclusion Criteria included in the section on Federal Citations, below). o DATA SHARING: The adequacy of the proposed plan to share data. o BUDGET: The reasonableness of the proposed budget and the requested period of support in relation to the proposed research. RECEIPT AND REVIEW SCHEDULE Letter of Intent Receipt Date: December 27, 2002 Application Receipt Date: January 21, 2003 Peer Review Date: June 2003 Council Review: September 23-24, 2003 Earliest Anticipated Start Date: September 30, 2003 AWARD CRITERIA Award criteria that will be used to make award decisions include: o Scientific merit (as determined by peer review) o Availability of funds o Programmatic priorities REQUIRED FEDERAL CITATIONS MONITORING PLAN AND DATA SAFETY AND MONITORING BOARD: Research components involving Phase I and II clinical trials must include provisions for assessment of patient eligibility and status, rigorous data management, quality assurance, and auditing procedures. In addition, it is NIH policy that all clinical trials require data and safety monitoring, with the method and degree of monitoring being commensurate with the risks (NIH Policy for Data Safety and Monitoring, NIH Guide for Grants and Contracts, June 12, 1998: https://grants.nih.gov/grants/guide/notice-files/not98-084.html). 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 AMENDMENT "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 (https://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html); a complete copy of the updated Guidelines are available at https://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. 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 https://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html. 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 https://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm. Applicants may wish to place data collected under this RFA in a public archive, which can provide protections for the data and manage the distribution for an indefinite period of time. Is 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. 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 RFA 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, Number 93.866, and is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. Awards that are made under authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and administered under NIH grants policies described at https://grants.nih.gov/grants/policy/policy.htm and under Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92. The PHS strongly encourages all grant recipients to provide a smoke-free workplace and to 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. REFERENCES 1. Goldman, Dana P and James P. Smith, 2002. Can patient self-management help explain the SES health gradient? Proc. Natl. Acad. Sci. Vol. 99, Issue 16, 10929-10934. 2. Behavioral and Social Research Program, National Institute on Aging, National Institutes of Health. Website: http://www.nia.nih.gov/ResearchInformation/ExtramuralPrograms/BehavioralAndSocialResearch/ 3. National Research Council, 2001. New Horizons in Health: An Integrated Approach. Committee on Future Directions for Behavioral and Social Sciences Research at the National Institutes of Health. Burton H. Singer and Carol D. Ryff, editors. Commission on Behavioral and Social Sciences and Education. Washington, DC: National Academy Press. 4. National Research Council, 2000. The Aging Mind: Opportunities in Cognitive Research. Committee on Future Directions for Cognitive Research on Aging. Paul C. Stern and Laura L. Carstensen, editors. Commission on Behavioral and Aging Sciences and Education. Washington, DC: National Academy Press. 5. Stokes, Donald E. (1997). Pasteur's Quadrant: Basic Science and Technological Innovation. Washington, DC: Brookings Institution Press. 6. World Health Organization (2000). The World Health Report: 2000. Health Systems: Improving Performance. Geneva: WHO. Center

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