ROYBAL CENTERS FOR TRANSLATIONAL RESEARCH ON AGING RELEASE DATE: November 3, 2003 RFA Number: RFA-AG-04-007 June 11, 2008 - This RFA has been reissued as (RFA-AG-09-008). (see NOT-AG-04-001) Department of Health and Human Services (DHHS) PARTICIPATING ORGANIZATION: National Institutes of Health (NIH) (http://www.nih.gov/) COMPONENTS OF PARTICIPATING ORGANIZATIONS: National Institute on Aging (NIA) (http://www.nih.gov/nia/) CATALOG OF FEDERAL DOMESTIC ASSISTANT NUMBER: 93.866 LETTER OF INTENT RECEIPT DATE: December 22, 2003 APPLICATION RECEIPT DATE: January 22, 2004 THIS RFA CONTAINS THE FOLLOWING INFORMATION o Purpose of this RFA o Research Objectives o Mechanism 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 Supplementary Instructions 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. 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 from the basic behavioral and social sciences (including human factors) to practical outcomes, including new technologies, for the benefit of the aged, and 2) if possible also 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) Stimulate ideas for new program development in the area of translational research in the social and behavioral sciences; (2) Enhance the productivity of relevant basic research or existing projects through translation into viable new products or technologies; (3) Facilitate acceleration in the development of new products or technologies to enhance the health and quality of life of older Americans; (4) Recruit new researchers to the area of translational research; (5) Develop innovative networks of researchers with interests in translational research; (6) Assemble multidisciplinary teams to solve practical problems; (7) Facilitate public-private partnerships including increased interaction and collaboration among academic researchers, and commercial interests or Governmental bodies; (8) Facilitate and accelerate application through studies and analyses of the translational process itself. Given the limited funding available, successful Centers are expected to encourage researchers at their institutions and elsewhere 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, R21 and R03), and Small Business Innovative Research (SBIR) awards (R41, R43, R44). (SBIR/STTR applications would be submitted from small businesses.) 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 Behavioral and Social Research (BSR) Program has supported research at both (i) the population level, on the antecedents and impact of changing social, demographic, economic, and health characteristics of the older population, and (ii) 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. Feedback loops between basic and applied areas of social and behavioral science may accelerate the development of both. The underlying objective of this RFA is to strengthen the linkages (in both directions) between basic and applied research in order to accelerate the development of practical advances. It is anticipated that Center investigators will use the Center resources to develop and pilot new and innovative ideas, and will then submit applications for P01s, R01s, or SBIRs to more fully implement ideas developed and piloted in the Roybal Centers. Investigators who have already effectively piloted their ideas should consider applying through these mechanisms. A. Specific NIA Objectives The theme of a proposed Roybal Center for the study of middle-aged and older people 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 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, communications, transportation, retirement planning and saving, etc. The Center could also facilitate and accelerate application through studies and analyses of the translational process itself. Life-span approaches to translational issues could be appropriate. (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. It may be that some areas of basic research advance most rapidly when there are feedback loops and interactions involving application to real world problems. 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" 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 Below are examples of potential areas of concentration for proposed Centers. These ideas are intended to be 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, in the areas of individual and population aging. Applications are strongly encouraged to focus on a single topic. o Being able to adapt one’s behavior to a new context frequently determines whether one will or will not perform a given task successfully. By example, as adults grow older changes in speed of response to stimuli and increased length of time to learn new material are factors that could impinge on the ability to adapt. Likewise, 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 devices that can augment the adaptive and functional capacity of older adult users (NAS/NRC, 2000; see also NAS/NRC, 2003 “Panel on Adaptive Aging: From Technology to Gerontology” early November 2003). 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 With increasing age, adults face important decisions regarding their investments, retirement plans, mobility (e.g., motor vehicle operation), health, 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, Literacy and Decision Making." Research is needed to evaluate, and translate this research to practical interventions, how older adults read, comprehend and then possibly act on 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. 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 improved management of chronic diseases, and treatment of conditions such as diabetes, hypertension, or glaucoma -- that require the patient to strictly follow complicated regimens. o A Center could develop the design and piloting needed to establish the feasibility of a multi-level social and behavioral intervention designed to reduce disability in a set of target communities. Such a center might seek to find the most cost-effective ways of applying what is known (best practices) about maximizing functioning and reducing disability at both the individual and social structural levels (e.g., NAS/NRC New Horizons in Health 2001). Such a multi-factorial demonstration or feasibility study might also test the hypothesis that there are significant interactions between individual and social or economic levels. o Another Center could focus on behavioral medicine and analyze how genetic differences affect individual ability to modify behavior and how genes affect variation in responses to these behavioral changes. Questions of gene-environment covariation and age-related decrease in the ability to select stimulating and supportive environments are also relevant. o A Center could use new understanding of the psychological, economic, social and neurological underpinnings of well-being and life satisfaction to design improved measures of well-being and quality of life for use in clinical trials, surveys, or as outcomes in behavioral or policy interventions. Such a Center might even begin to lay groundwork for the development of an experimental system of National Wellbeing Accounts. o A Center might focus on the development and application of highly innovative models and methodologies from the behavioral and social sciences to the development of interventions and clinical trials, such as how best to increase compliance or show efficacy of pharmaceutical regimens, how to improve cognition and/or functional disability, or how to best define or track the cognitive and physical changes that result in a change in functional status. o A Center might focus on translating basic research on cognitive and social psychology to improve the validity or quality of large scale surveys or longitudinal studies of the adult population that rely heavily on self report. o Differing degrees of efficiency with which health systems are organized, financed, 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 might translate what has been learned about the geographic inefficiencies in the use of health care by the older population to improve the health of this population. o It is increasingly acknowledged that social and behavioral factors play a major role in the health of middle aged and older individuals. However, many attempts at carefully controlled interventions have either failed or met with only limited success. A Center in this area might attempt to evaluate and screen such interventions and develop new and highly innovative approaches. 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. o A Center might develop and apply new methods of forecasting health and health expenditures to the adult and older population in order to assess how medical and behavioral interventions might affect Medicare, Medicaid, out of pocket, and health insurance expenditures. D. Center Components Each Center Grant (P30) must consist of: (a) a management and administrative core and (b) a pilot core. Although the Center grant is primarily designed to support a research Center at a specific institution, some Centers may 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 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 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 maintaining any optional advisory committees that provide advice to the Principal Investigator on the overall direction and functioning of the Center, including the individual pilot projects. Members of the Advisory Committee should not be named in the application; instead areas of expertise should be listed. 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. o disseminating any practical outcomes generated by the Roybal Centers to the research community and general public (b) Pilot Core The Center application must request funds to initiate small-scale (in the range of $10,000 to $80,000 direct costs per year) 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 approximately three to five pilot projects will be funded annually. While pilot projects may be proposed for one to three years' duration, it is expected that most will be funded for one year. The Center application must include examples of three pilot projects, and the description of each example should not exceed 4 pages. In addition, the application must describe a plan to develop, identify, review and monitor pilot projects in a manner consistent with the overall goals of the Center. 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. This RFA is a one-time solicitation. Future unsolicited, competing-continuation applications based on this project will compete with all investigator-initiated applications and will be reviewed according to the customary peer review procedures. The anticipated award date is September 30, 2004. Applications that are not funded in the competition described in this RFA may be resubmitted as NEW investigator-initiated application using the standard receipt dates for NEW applications described in the instructions to the PHS 398 application. This RFA uses just-in-time concepts. It also uses the modular budgeting as well as the non-modular budgeting formats (see https://grants.nih.gov/grants/funding/modular/modular.htm). Specifically, if you are submitting an application with direct costs in each year of $250,000 or less, use the modular budget format. Otherwise follow the instructions for non-modular budget research grant applications. This program does not require cost sharing as defined in the current NIH Grants Policy Statement at https://grants.nih.gov/archive/grants/policy/nihgps_2001/part_i_1.htm. FUNDS AVAILABLE The NIA intends to commit up to approximately $1.6 million in total costs in FY 2004 to fund approximately 4-6 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 annual total costs are $360,000. A 3% per annum inflation increase is allowable in subsequent years. 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 be able to draw from a substantial base of relevant research. 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 Annual Meeting Roybal Center Principal Investigators and Core leaders will be required to attend annual meetings in the first, second and third years of the project 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 Principal Investigators 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. 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: Jeffrey W. Elias, 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: email@example.com 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: Jean Richelsen Grants and Contracts Management Office Gateway Building, Room 2N212 Bethesda, MD 20892-9205 Telephone: (301) 496-1472 E-mail: firstname.lastname@example.org 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). 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 document 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. SUPPLEMENTARY 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/ResearchInformation/FundingAndTraining/ ResearchSupport/P01Guidelines.htm . The following exceptions to these guidelines apply: no pre-application permission is required; the eligibility requirements do not apply; the application receipt date is January 22, 2004; 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 with the exception of the pilot core. The Pilot Core component of the application should include examples of three pilot projects, and each example should not exceed 4 pages. The pilot core is limited in total to 14 pages. In summary, there should be up to a 10 page introduction of the Center as a whole, plus up to 10 pages for the Management Core, and no more than 14 pages for the Pilot Core, to include description of the core and the pilot projects. Bio-sketches should not be repeated for pilot projects, but should be consolidated in the bio-sketch section. 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: Mary Nekola, Ph.D. Chief Scientific Review Office National Institute on Aging 7201 Wisconsin Avenue, Suite 2C212, MSC 9205 Bethesda, MD 20892-9205 Telephone: (301) 496-9666 E-mail: NekolaM@nia.nih.gov 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. 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. 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. However, when a previously unfunded application, originally submitted as an investigator-initiated application, is to be submitted in response to an RFA, it is to be prepared as a NEW application. That is, the application for the RFA must not include an Introduction describing the changes and improvements made, and the text must not be marked to indicate the changes from the previous unfunded version of the application. 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 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 written critique 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 evaluate the 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 the following criteria in assigning the application’s overall score, weighting them as appropriate for each application. 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 advance "use-inspired basic research"? o Considerable weight will be given to: (1) significant on-going research activity that is relevant to the theme of the proposed Center and (2) that demonstrate the ability to translate a body of basic research into significant practical outcomes. o Demonstrated potential to act as a conduit between basic behavioral and social science research and applied outcomes (in either or both directions). 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. Considerable weight will be given to the innovativeness of the approaches chosen. 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 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 The leadership ability, relevant experience, scientific stature and the appropriateness of the time committement of the P.I. A past history of applying basic behavioral and social research in a relevant area will be an important advantage. o The extent to which the scientific environment and proposed collaborative arrangements will lead to a successful interplay between basic and applied social and behavioral science. B. Management and Administrative Core 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. Whether the administrative structure maximizes the Center's capability to take advantage of research opportunities. C. Pilot Core o Quality, innovativeness and importance of the pilot studies . o Adequacy of the proposed process for developing, soliciting, reviewing, selecting, monitoring and evaluating pilot projects. o The qualifications, responsibilities and effectiveness of Pilot Core senior leaders. ADDITIONAL REVIEW CRITERIA: In addition to the above criteria, your application will also be reviewed with respect to the following: o 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). o INCLUSION OF WOMEN AND MINORITIES IN RESEARCH: 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). 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 REVIEW CONSIDERATIONS 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 22, 2003 Application Receipt Date: January 22, 2004 Peer Review Date: June 2004 Council Review: September 2004 Earliest Anticipated Start Date: September 30, 2004 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 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 SAFETY AND 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: 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. 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 https://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 https://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 https://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 RFA 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 https://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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