SOCIOBEHAVIORAL DATA ANALYSIS AND ARCHIVING IN AGING RELEASE DATE: July 7, 2004 PA NUMBER: PA-04-123 March 2, 2006 (NOT-OD-06-046) Effective with the June 1, 2006 submission date, all R03, R21, R33 and R34 applications must be submitted through Grants.gov using the electronic SF424 (R&R) application. Accordingly, this funding opportunity expires on the date indicated below. A replacement R03 (PA-06-102) funding opportunity announcement has been issued for the submission date of June 1, 2006 and submission dates thereafter. EXPIRATION DATE: March 2, 2006 Department of Health and Human Services (DHHS) PARTICIPATING ORGANIZATION: National Institutes of Health (NIH) COMPONENT OF PARTICIPATING ORGANIZATION: National Institute on Aging (NIA) (http://www.nih.gov/nia/) CATALOG OF FEDERAL DOMESTIC ASSISTANCE NUMBER: 93.866 THIS PA CONTAINS THE FOLLOWING INFORMATION o Purpose of this PA o Research Objectives o Mechanism of Support o Funds Available o Eligible Institutions o Individuals Eligible to Become Principal Investigators o Where to Send Inquiries o Submitting an Application o Peer Review Process o Review Criteria o Award Criteria o Required Federal Citations PURPOSE OF THIS PA The National Institute on Aging (NIA) is seeking small grant (R03) applications to: 1) stimulate and facilitate data archiving and secondary analyses of data related to caregiving, cognition, demography, economics, epidemiology, behavioral genetics and other behavioral research on aging; 2) provide support for preliminary projects using secondary analysis that could lead to subsequent applications for other research project grant award mechanisms; 3) provide support for rapid analyses of new databases and experimental modules for purposes such as informing the design and content of future study waves; 4) provide support for the development, enhancement and assembly of new databases from existing data; and 5) provide support for pilot research on under-utilized databases. This announcement updates and replaces a previous Program Announcement, Data Analysis and Archiving in Demography, Economics and Behavioral Research (PA-01-082, issued April 12, 2001). RESEARCH OBJECTIVES The NIA has supported the development of major data collection efforts in areas such as cognition, genetics, long term care, retirement and economic status, caregiving, behavioral medicine, and the dynamics of health and functional change in the very old. This Program Announcement encourages secondary analysis and archiving of these data sources. In February 2003 NIH reaffirmed its support for the concept of data sharing and stated that data should be made as widely and freely available as possible while safeguarding the privacy of participants, and protecting confidential and proprietary data (http://grants.nih.gov/grants/policy/data_sharing/index.htm). Many datasets have been assembled prior to the implementation of this policy and have not been made available to the research community. This Program Announcement provides the opportunity to archive such data to make the data available to the research community. Applications which are innovative and high risk with the likelihood for high impact are especially encouraged. See also NIH Small Research Grant Program which permits original data collection on several of the topics below. Examples of Areas of Investigation: A. Archiving The NIH supports making data publicly available to the research community. Research teams can request funds under this Program Announcement for data archiving of previously un-archived data. Additionally, many analyses can be conducted on sensitive datasets which cannot be made publicly available in their original form, because they include geographic information or data linked to administrative records. Such data can be made available as a synthetic dataset which can be useful for data exploration by researchers. Work on creating synthetic datasets can also be supported. B. Biodemography of Aging Biodemography of aging: including the demographic aspects of heritability and familial aggregation of disease and longevity and genetic variants; incorporation of genetic, biological, and disease variables into demographic models and age-specific mortality rates; the social roles of the elderly in nature; and biological mediators of the relationship between socio-economic status and health. Of particular interest are analyses of biological measures which have been included in social and behavioral data collections as recommended by Cells and Surveys: Should Biological Measures Be Included in Social Science Research? (Washington, DC: National Academy Press, 2001. Also available at http://www.nap.edu.) Analyses should target the correlates of these biomarkers with social and behavioral outcomes. C. Behavioral Genetics Ethical, legal, social, and economic implications of human genetic studies on aging. How would attrition rates be affected in longitudinal projects, how does collection of DNA influence willingness to participate in aging studies in general, and what are the larger factors (i.e, health insurance and privacy issues) that pose concern to study participants? Research assessing the role of demographic factors (e.g., age, sex, race/ethnicity) is also needed to understand cultural differences in perceptions of genetic research. D. Dementia Studies examining the impact of social relationships (e.g., social network structures, types, levels and quality of social support) on cognitive decline and dementia. Also, demography and economics of dementia and Alzheimer's Disease in older populations. E. Trends in Chronic Disease and Disability Investigation of the factors underlying the recent trend in declining disability in the older population. Determination and quantification of the causal factors underlying the trend (e.g. medical technological interventions, healthcare access and use, early life experiences, education, biomedical and social research advances, healthy lifestyle behaviors and public health measures). International comparative analyses of declining disability in countries with different institutional and family structures are encouraged. F. Living Arrangements Analysis of the factors that trigger movement of the elderly through various living arrangements, from independent living through the various forms of long- term care, and the functional and health-related outcomes associated with residential options available to older persons. G. Healthcare and Policy Stimulations Economic analyses of the impact of aging-related biomedical and social research and resulting new technologies and interventions. Estimation of the impact of medical interventions on future lifetime health care costs. Estimation of the impact of health (including links with geography and demography) on economic development, especially in developing countries. (See The World Health Report 1999: Making a Difference. World Health Organization. Also available at http://www.who.int/whr.). Estimation of the impact of changes in the functional status of the older population on Medicare and other health care costs. Evaluations and simulations of the impact of changes in DHHS and SSA policies (e.g. changing the age of eligibility for Medicare and Social Security benefits, and expanding coverage to include prescription drugs) on the health and functioning of the older population. H. Burden of Illness Measurement of the magnitude and socio-economic consequences of burden of illness in the older population. Improved analysis and methodology to allocate and impute burden of illness, given the importance of comorbidity in the older population. This may also include modeling risk factor trajectories and trends in non-communicable disease, disability and mortality in developed and developing countries, with emphasis on aging populations. Analyses and projections of the epidemiological transition in developing countries and research examining the demographic and economic impact of HIV/AIDS on population structure and the elderly, particularly in Africa and other developing countries. I. Health, Work and Retirement Implications of population aging for public and private retirement programs and for income security of future retirees; implications of women's life history (e.g., temporary exits from the labor force for child rearing and caregiving of older parents) on retirement income and savings adequacy; implications for late-life health and financial security of the timing of demographic events such as marriage, child-rearing, widowhood, etc.; determinants of retirement, family labor supply, and saving; consequences of retirement for health and functioning; comparative studies of labor force activity; effects of psychological factors (e.g. expectations, risk taking, personality, altruism, time preferences, etc.) and mental health characteristics (e.g. depression) on economic behaviors (e.g. savings and transfers); and economic and demographic analyses of employer- and organizational- level determinants of labor force participation at older ages. Research on the nature of work from the worker’s perspective is also encouraged. NIA cosponsored a report by the National Academy of Sciences titled the Health and Safety Needs of Older Workers. This report suggested areas that merit investigation in this field and research on work and on older workers can consult this report. Copies can be obtained at http://books.nap.edu/catalog/10884.html. J. Race, Ethnicity and Socioeconomic Status Interactions between health and socio-economic status (and their cumulative relationship) over time and across generations. Relationship among health, wealth and education; role of social cohesion as a mediating factor. Improved measures of socioeconomic position for aging populations; improved understanding of the mechanisms underlying associations between socio- economic status and health including the economic determinants of health promotion and disease prevention behaviors. Research to disentangle the effects of socio-economic status, social and environmental factors, health behaviors, and race and ethnicity on health. Studies of the health of diverse racial and ethnic older populations and the health of small geographic areas. Variables of interest include the effects of lifelong poverty, birth weight, access to and utilization of employer- provided health insurance, recency and circumstances of immigration; the strain of physically demanding work; occupation; wealth, income and early- life health status; and experiences of discrimination. Studies of the changing composition and conceptualization of race and ethnicity in the US and the effects on population health and health disparities; issues related to the development of racial and ethnic identity and to interactions among racial/ethnic identification and demographic, health, and other outcomes; and issues related to the measurement of race and ethnicity, including racial and ethnic self-identification. The National Academies of Science recently concluded a panel on Racial and Ethnic Differences in Health in Later Life in the United States. A report will be issued in June of 2004. Applicants are encouraged to consult the findings of the report (see http://www7.nationalacademies.org/cpop/Race_Ethnicity_Heatlh.html) K. General Demography General demographic analyses of population aging, including: cohort analyses of aging, including the baby boom cohort; implications of changing family structures on caregiving needs; historical demographic and epidemiological research on the aging process and on the determinants of health and mortality in older populations; forecasting life and active life expectancy, health, medical services and long term care usage; migration and immigration; the impact of state and small area characteristics on health; improved descriptive analyses of centenarian populations; macro and micro dynamics of intergenerational exchanges; use of public and private resources in the period before death; and comparative international analyses of population aging using Census and other data. L. Meta-analysis Linking data sets for the purpose of conducting analyses (i.e. meta- analyses, mega-analyses). Applications are encouraged that combine raw data from different data collections to be explored in new and innovative ways in order to achieve new research aims, and/or to permit more breadth, precision, and reliability than can be achieved by the analysis of data from an isolated research study. M. Caregiving Research on informal caregiving. Research is encouraged on the transitions between various phases of the caregiving role, especially research on changes as a consequence of acquiring the caregiving role (pre- and post-caregiving). Research is also encouraged on the dyadic relationship between caregiver and care recipient. Research is needed on the embedded nature of the caregiver in the community structure. Such multi-level analysis is especially important. N. Elder Mistreatment Research is encouraged using existing databases such as aggregated Adult Protective Service records or state-level data on incidence and prevalence of elder mistreatment. Where adequate and existing data permit, research on the social determinants or risk factors associated with differential types of elder mistreatment is also needed. O. Behavioral Medicine and Interventions Research is encouraged that examines the dynamic interrelationships among aging, health, and behavior processes and that emphasizes the influence of the socio-cultural environment on the development and maintenance of health and illness behaviors (e.g., healthy lifestyle practices, medical self management, and coping with chronic illnesses and disabilities). Preliminary analyses that could lead to social, behavioral and environmental interventions for health promotion, disease prevention, and disability postponement are especially encouraged. P. Cognitive Aging Research is encouraged that examines changes in cognitive functioning over the life course. Examples include studies that: examine the influence of contexts (behavioral, social, cultural, and technological) on the cognitive functioning and life performance of aging persons; investigate the effects of age-related changes in cognition on activities of daily living, social relationships, and health status; and develop strategies for improving everyday functioning through cognitive interventions. Research is also encouraged on higher-order cognitive processes (e.g., problem-solving, decision-making), social cognition, memory strategies, perceptual skills, and reading and speech comprehension. Research is also welcomed that explores the role of individual difference factors in cognitive functioning (e.g., motivation, self-efficacy, beliefs about aging, emotions, sensory limitations, experience and expertise). Q. Psychological Development and Integrative Science. Research is encouraged that combines diverse levels of analysis and examines reciprocal interactions among these levels, such as the effects of sociocultural, psychological (social, personality), biological, and genetic processes on behavioral and functional aging. R. Early Life Determinants of Late-Life Health Research is encouraged that examines the influence of early life characteristics (e.g. childhood health, SES or exposure to infectious disease) on morbidity and mortality in later life. Comparative and historical work in this area is also encouraged. Priority will be given to proposals undertaking secondary analysis of publicly available datasets that NIA has supported. Such datasets include: the Alameda County Health and Ways of Living Study 1965, 1974, 1994, 1995 Panel; Early Indicators of Later Work Levels, Disease, and Death; Health and Retirement Study; Hispanic EPESE; Human Mortality Database; Longitudinal Employe rHousehold Dynamics; Mexican Health and Aging Study; National Longitudinal Mortality Study; National Long-Term Care Survey;; Panel Study of Income Dynamics; 1990 Public-Use Microdata Sample for the Older Population and the Comparable Samples from ECE Countries (collected by the UN/ECE/PAU); Resources for Enhancing Alzheimer’s Caregiver Health (REACH); Social Environment and Biomarkers of Aging Study (SEBAS); Swedish Adoption/Twin Study of Aging (SATSA) and the Wisconsin Longitudinal Study (WLS). Information about these and other datasets that have been supported entirely or in part by the NIA, and instructions on how the data can be accessed, can be found in the Publicly Available Databases for Aging-Related Secondary Analyses in the Behavioral and Social Sciences, available in hard copy or on the web at http://www.nia.nih.gov/NR/rdonlyres/D2DC41DF- 3608-4785-A9BA-62B1138EB520/0/datasets.pdf. A number of NIA supported datasets are currently being developed and archived; research on these new data sources is encouraged. Information about new data sources can be found in the above-referenced document which is updated to include newly available data sources. Applicants are especially encouraged to refer to the Minority Aging and Health CD-Rom from the National Archive of Computerized Data on Aging (NACDA) offered to the research community through funding provided by NIA. A number of the datasets mentioned above are made available through NACDA at http://www.icpsr.umich.edu/NACDA/. Information on other initiatives supported by NIA may be found at the following Internet address: http://www.nia.nih.gov/ResearchInformation/ FundingAndTraining/CurrentFunding.htm MECHANISM OF SUPPORT Applicants responding to this PA will use the NIH Small Research Grant (R03) award mechanism. The applicant will be solely responsible for planning, directing, and executing the proposed project. A project period of up to two years and a budget for direct costs of up to two $25,000 modules or $50,000 per year may be requested. Some preference may be given to one year projects. It is expected that most of the analyses proposed in response to this announcement can be completed within a year. However, a few analyses, especially those that propose to link multiple datasets, involve restricted confidential data, or involve collaborations among several sites may take more than one year. For these reasons, up to two years of research may be supported. The particular reason or reasons for requesting the second year of support must be stated in the budget justification. This PA uses just-in-time concepts. It also uses the modular budgeting format. (see http://grants.nih.gov/grants/funding/modular/modular.htm). All applications submitted in response to this announcement must use the modular budget format. This program does not require cost sharing as defined in the current NIH Grants Policy Statement at http://grants.nih.gov/grants/policy/nihgps_2001/part_i_1.htm. Competing continuation applications will not be accepted. Small grant support may not be used for thesis or dissertation research. Only one revision of a previously reviewed small grant application may be submitted. ELIGIBLE INSTITUTIONS Application(s) may be submitted by institutions with any of the following characteristics: o For-profit or non-profit organizations o Public or private institutions, such as universities, colleges, hospitals, and laboratories o Units of State and local governments o Eligible agencies of the Federal government o Domestic or foreign institutions/organizations o Faith-based or community-based organizations A number of important datasets and archives are based in European and other countries (e.g., British birth cohorts, country-specific population registers). Many of these data sets offer unique insights into aging and are important aids in interpreting patterns of aging in the U.S. Domestic investigators are encouraged to collaborate with researchers at these foreign sites in order to access these datasets. Foreign-based investigators are also encouraged to apply for funding directly where it is clear that both the expertise and the data are at the foreign institution and of value to understanding aging in the U.S. 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 inquiries concerning this PA and welcome the opportunity to answer questions from potential applicants. Inquiries may fall into two areas: scientific/research and financial or grants management issues: o Direct your questions about scientific/research issues to: Elayne Heisler, Ph.D. Behavioral and Social Research Program National Institute on Aging 7201 Wisconsin Ave, Suite 533 Bethesda, MD 20892-9205 Telephone: (301) 496-3138 FAX : (301) 402-0051 Email: eh164f@nih.gov (e-mail correspondence is preferred) o Direct inquiries regarding financial or grants management matters to: Linda Whipp Grants and Contracts Management Office National Institute on Aging 7201 Wisconsin Avenue, Suite 2N212, MSC 9205 Bethesda, MD 20892 Telephone: (301) 496-1472 FAX: (301) 402-3672 Email: lw17m@nih.gov (e-mail correspondence is preferred) 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 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: GrantsInfo@nih.gov. The title and number of this program announcement must be typed on line of the face page of the application form and the YES box must be checked. APPLICATION RECEIPT DATES: Applications submitted in response to this Program Announcement will be accepted at the standard application deadlines, which are available at http://grants.nih.gov/grants/dates.htm. Application deadlines are also indicated in the PHS 398 application kit. SUPPLEMENTARY INSTRUCTIONS: All instructions for the PHS 398 (rev. 5/2001) must be followed, with these exceptions: o Research Plan Items a - d of the Research Plan (Specific Aims, Background and Significance, Preliminary Studies, and Research Design and Methods) may not exceed a total of 10 pages. Please note that a Progress Report is not needed; competing continuation applications for a small grant will be not accepted. o Appendix. The appendix may include original, glossy photographs or color images of gels, micrographs, etc. provided that a photocopy (may be reduced in size) is also included within the page limits of the research plan. No publications or other printed material, with the exception of pre-printed questionnaires or surveys, may be included in the appendix. SPECIFIC INSTRUCTIONS FOR MODULAR GRANT APPLICATIONS: All R03 applications must be submitted in a modular grant format. The modular grant format simplifies the preparation of the budget in these applications by limiting the level of budgetary detail. Applicants request direct costs in $25,000 modules. Section C of the research grant application instructions for the PHS 398 (rev. 5/2001) at http://grants.nih.gov/grants/funding/phs398/phs398.html includes step-by-step guidance for preparing modular grants. Additional information on modular grants is available at http://grants.nih.gov/grants/funding/modular/modular.htm. For the NIH Small Grant (R03), applicants may request direct costs in $25,000 modules, up to a total, annual direct cost request of $50,000 for project periods up to two years. SENDING AN APPLICATION TO THE NIH: Submit a signed, typewritten original of the application, including the checklist, and five 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) APPLICATION PROCESSING: Applications must be mailed on or before the receipt dates described at http://grants.nih.gov/grants/funding/submissionschedule.htm The CSR will not accept any application in response to this PA that is essentially the same as one currently pending initial review unless the applicant withdraws the pending application. The CSR will not accept any application that is essentially the same as one already reviewed. This does not preclude the submission of a substantial revision of an unfunded version of an application already reviewed, but such application must include an Introduction addressing the 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. Appropriate scientific review groups convened in accordance with the standard NIH peer review procedures (http://www.csr.nih.gov/refrev.htm) will evaluate applications for scientific and technical merit. As part of the initial merit review, all applications will: o Undergo a selection process in which only those applications deemed to have the highest scientific merit, generally the top half of applications under review, will be discussed and assigned a priority score o Receive a written critique o Receive a second level review by an appropriate national advisory council or board. REVIEW CRITERIA The NIH R03 small grant is a mechanism for supporting discrete, well-defined projects that realistically can be expected to be completed in two years and that require limited levels of funding. Because the research plan is restricted to 10 pages or less, a small grant application will not have the same level of detail or extensive discussion found in an R01 application. Accordingly, reviewers should evaluate the conceptual framework and general approach to the problem, placing less emphasis on methodological details and certain indicators traditionally used in evaluation the scientific merit of R01 applications including supportive preliminary data. Appropriate justification for the proposed work can be provided through literature citations, data from other sources, or from investigator-generated data. Preliminary data are not required, particularly in applications proposing pilot or feasibility studies. 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: 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, weighing 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. SIGNIFICANCE: Does this study address an important problem? If the aims of the application are achieved, how will scientific knowledge be advanced? What will be the effect of these studies on the concepts or methods that drive this field? APPROACH: Are the conceptual framework, design, methods, and analyses adequately developed, well-integrated, and appropriate to the aims of the project? Does the applicant acknowledge potential problem areas and consider alternative tactics? INNOVATION: Does the project employ novel concepts, approaches or methods? Are the aims original and innovative? Does the project challenge existing paradigms or develop new methodologies or technologies? INVESTIGATOR: Is the investigator appropriately trained and well suited to carry out this work? Is the work proposed appropriate to the experience level of the principal investigator and other researchers (if any)? ENVIRONMENT: Does the scientific environment in which the work will be done contribute to the probability of success? Do the proposed experiments take advantage of unique features of the scientific environment or employ useful collaborative arrangements? Is there evidence of institutional support? ADDITIONAL REVIEW CRITERIA: In addition to the above criteria, the following items will be considered in the determination of scientific merit and the priority score: PROTECTION OF HUMAN SUBJECTS FROM RESEARCH RISK: The involvement of human subjects and protections from research risk relating to their participation in the proposed research will be assessed. (See criteria included in the section on Federal Citations, below). http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm INCLUSION OF WOMEN 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 will be assessed. BUDGET: The reasonableness of the proposed budget and the requested period of support in relation to the proposed research. AWARD CRITERIA Applications submitted in response to a PA will compete for available funds with all other recommended applications. The following will be considered in making funding decisions: o Scientific merit of the proposed project as determined by peer review o Availability of funds o Relevance to program priorities REQUIRED FEDERAL CITATIONS HUMAN SUBJECTS PROTECTION: Federal regulations (45CFR46) require that applications and proposals involving human subjects must be evaluated with reference to the risks to the subjects, the adequacy of protection against these risks, the potential benefits of the research to the subjects and others, and the importance of the knowledge gained or to be gained. http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm 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. 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. 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. STANDARDS FOR PRIVACY OF INDIVIDUALLY IDENTIFIABLE HEALTH INFORMATION: The Department of Health and Human Services (DHHS) issued final modification to the Standards for Privacy of Individually Identifiable Health Information , the Privacy Rule, on August 14, 2002. The Privacy Rule is a federal regulation under the Health Insurance Portability and Accountability Act (HIPAA) of 1996 that governs the protection of individually identifiable health information, and is administered and enforced by the DHHS Office for Civil Rights (OCR). Decisions about applicability and implementation of the Privacy Rule reside with the researcher and his/her institution. The OCR website (http://www.hhs.gov/ocr/) provides information on the Privacy Rule, including a complete Regulation Text and a set of decision tools on Am I a covered entity? Information on the impact of the HIPAA Privacy Rule on NIH processes involving the review, funding, and progress monitoring of grants, cooperative agreements, and research contracts can be found at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-025.html. URLs IN NIH GRANT APPLICATIONS OR APPENDICES: All applications and proposals for NIH funding must be self-contained within specified page limitations. Unless otherwise specified in an NIH solicitation, Internet addresses (URLs) should not be used to provide information necessary to the review because reviewers are under no obligation to view the Internet sites. Furthermore, we caution reviewers that their anonymity may be compromised when they directly access an Internet site. HEALTHY PEOPLE 2010: The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2010," a PHS-led national activity for setting priority areas. This PA is related to one or more of the priority areas. Potential applicants may obtain a copy of "Healthy People 2010" at http://www.healthypeople.gov/. AUTHORITY AND REGULATIONS: This program is described in the Catalog of Federal Domestic Assistance at http://www.cfda.gov/ and is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284 and under Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement. The NIH Grants Policy Statement can be found at http://grants.nih.gov/grants/policy/policy.htm The PHS strongly encourages all grant recipients to provide a smoke-free workplace and discourage the use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routine education, library, day care, health care, or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people.


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