UNDERSTANDING AND PROMOTING HEALTH LITERACY (R01) RELEASE DATE: June 22, 2004 PA NUMBER: PAR-04-116 EXPIRATION DATE: October 14, 2006, unless reissued. November 21, 2006 - The R01 portion of this funding opportunity has been replaced by PAR-07-020, which now uses the electronic SF424 (R&R) application for February 5, 2007 submission dates and beyond. Department of Health and Human Services (DHHS) PARTICIPATING ORGANIZATIONS: Agency for Healthcare Research and Quality (AHRQ) (http://www.ahrq.gov/) National Institutes of Health (NIH) (http://www.nih.gov) COMPONENTS OF PARTICIPATING ORGANIZATIONS: Office of Behavioral and Social Sciences Research (OBSSR) (http://obssr.od.nih.gov/) National Cancer Institute (NCI) (http://www.nci.nih.gov/) National Heart, Lung, and Blood Institute (NHLBI) (http://www.nhlbi.nih.gov/) National Institute on Aging (NIA) (http://www.nia.nih.gov/) National Institute for Biomedical Imaging and Bioengineering (NIBIB) (http://www.nibib.nih.gov/) National Institute of Child Health and Human Development (NICHD) (http://www.nichd.nih.gov/) National Institute on Deafness and Other Communication Disorders (NIDCD) (http://www.nidcd.nih.gov) National Institute of Dental and Craniofacial Research (NIDCR) (http://www.nidcr.nih.gov) National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) (http://www.niddk.nih.gov/) National Institute on Drug Abuse (NIDA) (http://www.nida.nih.gov/) National Institute of Environmental Health Sciences (NIEHS) (http://www.niehs.nih.gov/) National Institute of Mental Health (NIMH) (http://www.nimh.nih.gov/) National Library of Medicine (NLM) (http://www.nlm.nih.gov/) Note: The policies, guidelines, terms, and conditions stated in this announcement may differ from those used by the NIH. CATALOG OF FEDERAL DOMESTIC ASSISTANCE NUMBERS: 93.113, 93.121, 93.173, 93.242, 93.279, 93.286, 93.393, 93.837, 93.847, 93.865, 93.866, 93.879 LETTER OF INTENT RECEIPT DATE: September 13, 2004; September 13, 2005; September 13, 2006 APPLICATION RECEIPT DATE: October 13, 2004; October 13, 2005; October 13, 2006 THIS PA CONTAINS THE FOLLOWING INFORMATION o Purpose of the PA o Research Objectives o Mechanism(s) of Support o Eligible Institutions o Individuals Eligible to Become Principal Investigators o Special Requirements o Where to Send Inquiries o Submitting an Application o Supplementary Instructions o Peer Review Process o Review Criteria o Award Criteria o Required Federal Citations PURPOSE OF THIS PA The participating Institutes, Centers and Offices of the National Institutes of Health (NIH) and the Agency for Healthcare Research and Quality (AHRQ) invite investigators to submit R01 research grant applications on health literacy. The goal of this Program Announcement is to increase scientific understanding of the nature of health literacy and its relationship to healthy behaviors, illness prevention and treatment, chronic disease management, health disparities, risk assessment of environmental factors, and health outcomes including mental and oral health. Increased scientific knowledge of interventions that can strengthen health literacy and improve the positive health impacts of communications between healthcare and public health professionals (including dentists, healthcare delivery organizations, and public health entities), and consumer or patient audiences that vary in health literacy, is needed. Such knowledge will help enable healthcare and public health systems serve individuals and populations more effectively, and employ strategies that reduce health disparities in the population. Healthy People 2010 defines health literacy as the degree to which individuals have the capacity to obtain, process and understand basic health information and services needed to make appropriate health decisions (U.S. Department of Health and Human Services, 2000). Many factors affect individuals ability to comprehend, and in turn use or act on, health information and communication. Proficiency in reading, writing, listening, interpreting, oral communication, and visual analysis is necessary as the modern health system typically relies on a variety of interpersonal, textual, and electronic media to present health information. Individuals and families both must be able to: communicate with health professionals; understand the health information in mass communication; understand how to use health- related print, audiovisual, graphical and electronic materials; understand basic health concepts (e.g., many health problems can be prevented or minimized) and vocabulary (e.g., about the body, diseases, medical treatments, etc.); and connect this health-related knowledge to health decision-making and action-taking. Access to and understanding of health information and services is a reciprocal process among health professionals, communication professionals and patients. For instance, these professionals must use science-based strategies and tactics, develop resources and materials, and understand communication interactions between providers and patients. Research on health literacy should assist NIH in its mission of communicating scientifically-based health information to the public and to the health care providers and related professionals who serve the public. The application of scientific knowledge from health literacy research may also strengthen the health information knowledge and communication skills of the public, and further one of the national goals of Healthy People 2010, to improve health literacy by the decade’s end. RESEARCH OBJECTIVES Background Health literacy is a complex phenomenon that involves individuals, families, communities and systems. For instance, consumers, patients, caregivers, or other laypersons may vary with respect to: o Access (e.g., to audience-appropriate information, media or professionals); o Skills (e.g., to gather and comprehend health information; to speak and share personal information about health history and symptoms; to act on information by initiating appropriate follow-up visits and conveying understanding back to the information source; to make decisions about basic healthy behaviors, such as healthy eating and exercise; to engage in self- care and chronic disease management); o Knowledge (e.g., of health and medical vocabulary, concepts such as risk , the organization and functioning of healthcare systems); o Disabilities (e.g., sensory, communication, cognitive or physical challenges or limitations); o The features of their health care providers and the public health systems in which these providers practice (e.g., the communication skills of health professionals, platforms employed for patient education, built environments and signage); o Other important characteristics including developmental or life stage, cultural, linguistic or educational differences that affect health beliefs, knowledge and communication. Too often people with the greatest health burdens have limited access to relevant health information. In part, this is due to the complex and cumbersome ways health information often is presented, and due to individuals limited abilities to fully interpret and understand complex health terminology and instructions, and to make personal decisions related to risk avoidance or risk reduction strategies. For instance, to follow health care instructions, patients need to be able to comprehend written and oral prescription instructions, directions for self-care, and plans for follow-up tests and appointments. In addition, health care providers may not communicate effectively with individuals with limited levels of literacy. For instance, achieving informed consent for treatment is difficult when health care personnel cannot explain biological processes or treatment procedures in simplified language and patients cannot interpret health information. These situations hamper the effectiveness of health professionals efforts to prevent, diagnose and treat medical conditions, and limit many health care consumers abilities to make important health care decisions. Low health literacy is a wide spread problem, affecting more than 90 million adults in the United States (Kirsch, Jungeblut, Jenkins & Kolstad, 1993). Low health literacy results in patients inadequate engagement in, and benefit from, health care advances as well as medical errors. Low health literacy is likely to be a major contributor of adverse health outcomes (AMA, 1999; Baker, Gazmararian, Williams, Scott, Parker, Green, Ren, & Peel, 2002; Baker, Parker, Williams, & Clark, 1998). Research has linked low or limited health literacy with such adverse outcomes as poorer self-management of chronic diseases, less healthy behaviors, higher rates of hospitalizations, and overall poorer health (Gazmararian, Baker, Williams, Parker, Scott, Green, Fehrenbach, Ren, & Koplan, 1999; Schillinger, Grumbach, Piette, Wang, Osmond, Daher, Palacios, Sullivan, & Bindman, 2002; Williams, Parker, Baker, Pitkin, Coates, & Nurss, 1995). Specific Objectives This Program Announcement invites applications to develop research on health literacy in general areas that include, but are not limited to, the following: o Modeling and measuring the nature and scope of health literacy; o Variation in health literacy over the life course or among native and non- native speakers of English; o Mediators and moderators of low health literacy; o The impact of low health literacy on health outcomes, diseases, behaviors and treatments, including the contribution of health literacy to informed decision-making, adherence to preventative or therapeutic regimens, utilization of health care services, risk avoidance strategies, and other consumer health-care related actions; o The identification of effective preventive and other interventions to improve health literacy among populations and to enable the healthcare and public health systems to communicate effectively across different health literacy levels; and o The development of effective methods and new technologies in health literacy research. Applications should be relevant to both the objectives of the PA and to at least one of the participating institute’s general research interests. Prior to preparing an application, researchers are strongly encouraged to both review the general research interests of the participating institutes, and to contact program staff of the relevant institutes to discuss the proposed research. 1. Nature and Scope o Assess the prevalence and causes of low health literacy; o Identify the nature of the mix of abilities and skills required to be functionally health literate (e.g., including media and health care system navigation skills, etc.), and the roles of basic literacy (i.e., reading, writing, speaking, listening, visual interpretation skills) and mathematics abilities (e.g., graphical interpretation and other quantitative skills) in health literacy. o Explore the magnitude and variation, by socioeconomic and/or other group characteristics, in accessing, seeking, evaluating, interpreting, and using health information from a variety of sources. o Examine the problems and factors involved in the presentation and interpretation of quantitative information (e.g., graphic interpretation, risk or probability statistics, the influence of information context and information formats, etc.) from either the provider or user perspective, or investigate how specific health referents, such as basic genetics and/or environmental risk concepts, are best understood and conveyed. o Create a conceptual model of health literacy or the skill sets that influence the comprehension of relevant health information (e.g., visual information comprehension skills that permit understanding of such visual messages as color-coding, representation of risk, or disease processes). o Evaluate the different strategies and channels available, including the role of information technologies, that enable consumers to seek, access, and interpret relevant health information effectively, and how these may differ by cultural and health literacy backgrounds (e.g., research on the information seeking or service utilization characteristics among health consumers with different levels of health literacy). 2. Lifespan and Cultural Differences Applications addressing health literacy as an age-differentiated phenomenon might explore the developmental precursors of low health literacy and the age-related changes in reading and other cognitive skills throughout the life course that may contribute to these difficulties. Research might include, but is not limited to: o Identify the reading and oral language comprehension skills crucial for the satisfactory acquisition and understanding of basic health information by children, adolescents, and adults of various ages. o Determining how intuitive or everyday notions of germs, contagion, environmental exposures, disease, drugs, bodily processes and other health- related concepts influence health literacy and consequent illness-prevention behaviors across the life-course, and identifying age-appropriate intervention techniques that can be used to mitigate these problems. o Examine the role of social and cultural factors in the development of health literacy. For example, how do children acquire health-related knowledge (e.g., through the media, family socialization) as they age, especially those children in households where their parents speak limited English and the children serve as interpreters? o Explore how the quantity and quality of structured interactions with adult caregivers affects the health literacy of the child from birth to age three. o Examine the effect of current age-related differences in media use (e.g., children versus elderly) on health literacy. 3. Mediators and Moderators of Health Literacy: Protective and Risk Factors o Describe how patients information seeking abilities and health information interpretation mediates or moderates the effects of provider practices on health literacy. o Examine bi-directional communication processes between providers and patients/clients in the health care/health promotion system that affect health literacy, including systemic and cultural barriers that help create and sustain health literacy problems, as well as adaptation strategies used by providers and consumers to minimize health literacy problems. How does patients use of print and electronic health information mediate or moderate their communication with providers? o Examine how physicians or dentists nonverbal communication influences patients comprehension and implementation of health-related information. o Examine the influence of social, contextual, and environmental factors (e.g., urban versus rural, housing types, workplace features, social support and social network members, etc.) on health literacy outcomes. o Examine the media (including TV, radio, movies, newspapers, the Internet, and interactive systems) as a socializing agent of health literacy. For example, determine how newspaper articles, TV drug advertising, soap operas, and medical dramas affect health literacy. How can different media be used to communicate more effectively with consumers varying in health literacy levels? o Examine the factors that influence the desire for, or processing of, health literacy information. For example, how does self-efficacy in decision making and/or financial planning, time perspectives as presented in socio-emotional selectivity theory, ease of cognitive access via intuitive and reasoning processes, and coping and anxiety reduction behaviors influence the use of, or desire to access, health-care knowledge? 4. Impacts and Consequences of Low Health Literacy o Examine the relationship between health literacy and health disparities. o Analyze the role of health literacy in the prevention and treatment of chronic diseases. o Identify the relationship between health literacy variation and the ability to engage in informed decision making for a variety of health issues, such as chronic disease management or participation in clinical trials. o Evaluate the magnitude of the problems caused by low levels of health literacy, or by professionals lack of effective communication skills for adapting to the communication needs of consumers with differing levels of literacy. o Assess the role of health literacy as a mediator or moderator of health- care access across adulthood. 5. Preventative Interventions: Education and Training o Explore the role of K-12 education systems in increasing levels of health literacy and improving health communication skills. For example, researchers might examine the treatment of health literacy in K-12 health education and biology or general science classes, and assess the effectiveness of such coursework, curricula, and pedagogy on improving health literacy among school-age children, or evaluate the effectiveness of arts-based interventions on children’s development of health literacy. o Assess the role of K-12 education (e.g., in basic literacy skills such as reading, writing, comprehension, speaking, and listening skills, or in mathematics) on health literacy. o Determine the specific content and components of undergraduate, graduate and in-service training experiences needed to adequately prepare provider groups (e.g., pharmacists, social workers, nurses, dentists, etc.) in communications with low literate patient populations (e.g., assess cultural competence’s effect on provider communication skills, or assess training innovative approaches that allow providers to help patients deal with shame over low health literacy and facilitate negotiating the modern health care system). Examine policies that support the development, implementation and effectiveness of such training experiences. Evaluate the roles of information technology in training to improve health literacy. 6. Other Health Literacy Interventions o Evaluate the effectiveness of health literacy interventions directed at the general public, different audience segments, patients, providers, or the health care or public health systems. For instance, how can health care systems be designed to better support the information needs of consumers with different levels of health literacy? How effective are interventions within the healthcare system that are designed to increase the access of intended audiences to relevant health information and appropriate materials (e.g., print or audiovisual materials, Internet-based information, translators, library information resources and services, and patient advocates)? o Examine the development and dissemination of effective information sources and materials for audiences with different levels of health literacy (e.g., how should prevention campaigns be designed to effectively communicate with audiences with differing levels of health literacy?). o Design and evaluate health literacy diagnostic and/or communication tools to help health care professionals identify, and communicate more effectively with, consumers with different levels of health literacy. For instance, develop and pilot tools and/or strategies to help make complex quantitative health information more understandable (e.g., technology tools for automatically converting health information to a variety of appropriate levels). o Identify innovative strategies, practices and policies currently in use that can be disseminated immediately to promote health literacy across the various participants in the health care systems. o Conduct cost/effectiveness analyses of various health literacy interventions. o Further multi-level health literacy intervention approaches, for instance, by developing paradigms and/or statistical models to test the interaction of such variables as knowledge, prior education, cognitive status, social support, community influence, technology, and health-care access on health- care decisions. 7. Methodology and Research Technology Development o Assess the efficacy of current methods of health literacy assessment; develop, as needed, audience-appropriate methodologies to understand the prevalence of low health literacy in different populations, the interaction of low health literacy with other demographic and social factors, and the contribution of low health literacy to healthcare costs and health outcomes. o Identify effective approaches of combining qualitative and quantitative methods to further knowledge of health literacy. o Identify a core set of constructs, variables, and quantitative measures for conducting health literacy research. o Develop and pilot new tools and technologies to identify health literacy barriers (e.g., an assessment to distinguish, among persons with low literacy skills, those who have learning disabilities or communication disorders such as auditory processing, aphasia, or hearing loss). o In the context of understanding and promoting health literacy: develop technologies related to data reduction, data mining, and knowledge extraction; develop tools for meta-databases and integrative services to enhance the utility of existing databases; develop new methods or technologies for timely, appropriate communication of pertinent health information and knowledge (e.g., as seen through the creation of telemedicine, or to enhance patient, doctor, or administrator decision-making regarding health literacy, etc.). Approaches A wide variety of research approaches are encouraged under this Program Announcement: basic research that investigates or describes the nature of health literacy and the magnitude of health literacy problems, and applied research addressing issues pertinent to health literacy practices (e.g., systems level interventions) and research-in-practice (e.g., active potential end users participate as supportive research partners). Applications also may develop theoretical models, refine research constructs, improve methods and measurements, and establish causal relationships (e.g., between low health literacy and lack of effective health promotion). Researchers also may address the effectiveness of interventions, or adapt and test existing programs (including those that are not research-based) to reduce low health literacy and its adverse consequences (e.g., interventions implemented by health care systems and systems outside of health care such as systems of public education). The research must involve either: a) health literacy, or one of its many components, as a key outcome, b) health literacy as a key explanatory variable for some other outcome, c) methodological or technological improvement to strengthen research on health literacy, or d) health literacy- focused preventions and interventions. Studies to develop, or evaluate, the readability or utility of specific materials that are intended for single uses or single audiences are not responsive to this program announcement unless these investigations are integral to testing a significant research hypothesis related to health literacy. Projects may employ any one or combination of study designs, research approaches, and data collection techniques. Secondary analyses of existing datasets as well as meta-analytic studies are also suitable for this announcement. Multilevel, multidisciplinary, and interdisciplinary research is also encouraged, especially studies that incorporate individual, family, community and societal mediators of health literacy in childhood and adulthood, or state-of-the-art health communication theory and knowledge. Researchers are encouraged to address ongoing investigations of prevention, healthy living, chronic disease management, patient-based health care, cultural competence, and health disparities to inform the research on health literacy. Research questions can focus on consumers, patients, clients or other population groups; the strategies and tactics used by providers of medical and health information/communication to enable them to effectively reach literacy challenged population; or the influences of health literacy upon interactions between consumers, patients, clients, providers, and organizations or systems. Additional Resources: Federally Qualified Health Centers (FQHCs) may provide a valuable resource to applicants interested in responding to this PA, particularly those that have an active collaboration with colleges and universities. These FQHCs include Community Health Centers and Migrant Health Centers across the country. Information may be found at the DHHS Health Resources and Services Administration website for the Bureau of Primary Health Care: http://pubs.niaaa.nih.gov/publications/datasys.htm The Indian Health Service (IHS) through its direct federal programs, Tribal programs and urban programs serves more than 1.6 million American Indian and Alaska Native people. These programs may also be of interest to applicants. Information can be found at the IHS website at: www.ihs.gov In addition to this PA, the NIH has published another PA titled Understanding and Promoting Health Literacy (R03) , [PAR-04-117]. That Program announcement (with special review) covers the same research objectives and has the same receipt dates, but it is an announcement specifically designed for R03 applications. NHLBI and NIDCD do not participate in the PA for R03 applications. Reference Report: The Institute of Medicine’s recent report, Health Literacy: A Prescription to End Confusion (2004) reviews the current body of knowledge about health literacy, and identifies actions for the promotion of health literacy in society. Potential applicants are encouraged to consult this report as a general reference: Health Literacy: A Prescription to End Confusion. (2004). L. Nielsen-Bohlman, A. M. Panzer, and D. A. Kindig, Editors. Committee on Health Literacy, Board on Neuroscience and Behavioral Health, Institute of Medicine. (Available at http://www.iom.edu/report.asp?id=19723) MECHANISM(S) OF SUPPORT This PA will use the NIH R01 award mechanism. As an applicant, you will be solely responsible for planning, directing, and executing the proposed project. This PA uses just-in-time concepts. It also uses the modular budgeting format. (see http://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. This program does not require cost sharing as defined in the current NIH Grants Policy Statement at http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part2.htm. ELIGIBLE INSTITUTIONS You may submit (an) application(s) if your institution has any of the following characteristics: o For-profit or non-profit organizations o Public or private institutions, such as universities, colleges, hospitals, and laboratories o Units of State and local governments o Eligible agencies of the Federal government o Domestic or foreign institutions/organizations o Faith-based or community-based organizations 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 The research must involve either: a) health literacy, or one of its many components, as a key outcome, b) health literacy as a key explanatory variable for some other outcome, c) methodological or technological improvement to strengthen research on health literacy, or d) health literacy- focused preventions and interventions. WHERE TO SEND INQUIRIES We encourage your inquiries concerning this PA and welcome the opportunity to answer questions from potential applicants. Inquiries may fall into three areas: scientific/research, peer review, and financial or grants management issues: o Direct your questions about scientific/research issues to: Rosaly Correa-de-Araujo, MD, MSc, PhD Senior Advisor on Women's Health Agency for Healthcare Research and Quality John M. Eisenberg Building 540 Gaither Road Rockville, Maryland 20850 Phone (301) 427-1550 Fax (301) 427-1562 Email: rcorrea@ahrq.gov Sabra Woolley, Ph.D. Health Promotion Research Branch Division of Cancer Control and Population Sciences National Cancer Institute 6130 Executive Boulevard, Room 4078 Bethesda, Maryland 20892 Telephone: 301-435-4589 Email: woolleys@mail.nih.gov Gary L. Kreps, Ph.D. Division of Cancer Control and Population Sciences National Cancer Institute Building EPN, Room 4084 Bethesda, MD 20892-7365 Telephone: (301) 496-7984 FAX: (301) 480-2198 Email: Gary.Kreps@nih.gov Dr. Peter Kaufmann Division of Epidemiology and Clinical Applications, Clinical Applications and Prevention Program National Heart, Lung, and Blood Institute Building RK2, Room 8118 Bethesda, MD 20817 Telephone: 301-435-0404 Email: kaufmanp@nhlbi.nih.gov Dr. Jeffrey Elias Behavioral and Social Research Program National Institute of Aging Gateway/533 Bethesda, MD 20892 Telephone: 301-402-4156 Email: eliasj@nia.nih.gov Peter M. Lyster, Ph.D. Division of Discovery Science & Technology National Institute of Biomedical Imaging and Bioengineering 6707 Democracy Bvd. Suite 200 Bethesda, MD 20892-5469 Telephone: (301)402-1337 FAX: (301)480-1614 Email: lysterp@mail.nih.gov Daniel B. Berch, Ph.D. Child Development and Behavior Branch National Institute of Child Health and Human Development 6100 Executive Blvd., Room 4B05 Bethesda, MD 20892-7510 Tel: (301) 402-0699 FAX: (301) 480-0230 Email: berchd2@mail.nih.gov Marin P. Allen, Ph.D. Office of Health Communication and Public Liaison National Institute on Deafness and Other Communication Disorders 31 Center Drive, Room 3C-35 Bethesda, MD 20892-2320 Tel: 301-496-7243 FAX: 301-402-0018 Email: allenma@nidcd.nih.gov Patricia S. Bryant, Ph.D. Division of Clinical Research National Institute of Dental and Craniofacial Research Bldg. 45 Rm. 4AS-43A Bethesda, MD 20892-6401 Telephone: (301) 594-2095 FAX: (301) 480-8322 Email: Patricia.Bryant@nih.gov (Note: Appropriate NIDCR contact if application emphasizes behavioral or social science methods and issues) Lonnie L. Lisle Office of Health Communication and Public Liaison National Institute of Deafness and Other Communication Disorders 31 Center Drive, MSC 2320 Bldg. 31, Rm. 3C-35 Bethesda, MD 20892-2320 301-496-9682 lislel@nidcd.nih.gov Ruth Nowjack-Raymer, MPH, PhD Clinical Research Branch National Institute of Dental and Craniofacial Research Bldg. 45 Rm. 4AS-43J Bethesda, MD 20892-6401 Telephone: 301-594-5394 FAX: 301-480-8322 Email: ruth.nowjack-raymer@nih.gov (Note: Appropriate NIDCR contact if application emphasizes health disparities) Dr. Sanford Garfield Biometry and Behavioral Research Program Division of Diabetes, Endocrinology, and Metabolic Diseases (DDEMD) National Institute of Diabetes and Digestive and Kidney Diseases 2 Democracy Plaza, Room 685 6707 Democracy Blvd Bethesda, MD 20892-5460 Telephone: 301-594-8803 Email: sg50o@nih.gov Susan Martin, Ph.D. Prevention Research Branch Division of Epidemiology, Services and Prevention Research (DESPR) National Institute on Drug Abuse 6001 Executive Blvd, Room 5163 Rockville, MD 20892 Telephone: 301-443-1514 Email: smartin@mail.nih.gov Shobha Srinivasan, Ph.D. Susceptibility and Population Health Branch Division of Extramural Research and Training National Institute of Environmental Health Sciences MD EC-21 111 Alexander Drive P.O. Box 12233 Research Triangle Park, NC 27709 Telephone: 919-541-2506 Fax: 919-316-4606 Email: sriniva2@niehs.nih.gov Emeline Otey, Ph.D. Adult Psychopathology and Prevention Research Branch Division of Mental Disorders, Behavioral Research National Institute of Mental Health 6001 Executive Blvd, Room 6180 Bethesda, MD 20892 Telephone: 301- 443-1636 Email: eotey@mail.nih.gov (Note: Appropriate NIMH contact for applicants interested in promoting health literacy about the causes, risk for, and diagnosis of mental disorders or in health literacy about HIV/AIDS.) Carmen Moten, Ph.D. Services Research and Clinical Epidemiology Research Branch Division of Services and Intervention Research National Institute of Mental Health 6001 Executive Blvd, Room 7146, MSC 9631 Bethesda, MD, 20892 Telephone: 301-443-3364 Email: cmotem@mail.nih.gov (Note: Appropriate NIMH contact for applicants interested in promoting health literacy in the context of mental health services.) Valerie Florance, Ph.D. NLM Extramural Programs National Library of Medicine Rockledge 1, Suite 301 6705 Rockledge Drive Bethesda, MD 20892 Telephone: 301.594.4882 FAX: 301.402.2952 Email: floranv@mail.nih.gov Dr. Lawrence Fine Office of Behavioral and Social Sciences Research National Institutes of Health Building 1, Room 256 Bethesda, MD 20892 Telephone: (301) 435-6780 FAX: (301) 402-1150 Email: finel@od.nih.gov o Direct your questions about peer review issues to: Michael Micklin, Ph.D. Chief Risk, Prevention, & Health Behavior Integrated Review Group SRA for SPIP Study Section Center for Scientific Review National Institutes of Health 6701 Rockledge Drive, Rm. 3136 MSC 7759 Bethesda, MD 20892 (20817 for overnight mail) Tel: 301-435-1258 FAX: 301-594-6363 Email: micklinm@csr.nih.gov o Direct your questions about financial or grants management matters to: Crystal Wolfrey Grants Administration Branch National Cancer Institute Building EPS, Room 243 Rockville, MD 20852 Tel: 301-496-8634 FAX: 301-496-8601 Email: crystal.wolfrey@nih.gov Angelos Bacas Grants Management Branch National Institute of Child Health and Human Development 6100 Executive Boulevard, Room 8A07F 6100 Executive Boulevard, MSC 7510 Bethesda, Maryland 20892-7510 Tel: (301) 435-6976 FAX: (301) 480-4783 Email: ab329b@nih.gov Sara Stone Grants Management National Institute on Deafness and Other Communication Disorders Executive Plaza South, Room 400B 6120 Executive Boulevard, MSC 7180 Rockville, Maryland 20892-7180 Tel: 301-402-0909 Email: stones@nidcd.nih.gov Mr. Brian Albertini Grants Management Branch National Institute of Mental Health 6001 Executive boulevard, Room 6115 Bethesda, MD 20892 Telephone: (301) 443-0004 Fax: (301) 443-0219 Email: albertib2@mail.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 numbers of the Principal Investigator o Names of other key personnel o Name and address of participating institutions o Number and title of this PAR 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 CSR staff to estimate the potential review workload and plan the review. The letter of intent should be sent by the date listed on the first page. The letter of intent should be sent to: Lawrence Fine, M.D., Dr.P.H. Office of Behavioral and Social Sciences Research National Institutes of Health Building 1, Room 256 1 Center Drive Bethesda, MD 20892 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 2 of the face page of the application form and the YES box must be checked. SUPPLEMENTARY INSTRUCTIONS APPLICATION RECEIPT DATES: Applications submitted in response to this program announcement will be accepted at the following receipt dates: October 13, 2004, October 13, 2005, and October 13, 2006. SPECIFIC INSTRUCTIONS FOR MODULAR BUDGET GRANT APPLICATIONS: Applications requesting up to $250,000 per year in direct costs must be submitted in a modular budget grant format. The modular budget 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. SPECIFIC INSTRUCTIONS FOR APPLICATIONS INCLUDING RANDOMIZED CLINICAL TRIALS: Applicants are encouraged to contact the relevant IC’s prior to submission to obtain IC-specific guidelines for applications proposing a randomized clinical trial. SPECIFIC INSTRUCTIONS FOR APPLICATIONS REQUESTING $500,000 OR MORE PER YEAR: Applications requesting $500,000 or more in direct costs for any year must include a cover letter identifying the NIH staff member within one of NIH institutes or centers who has agreed to accept assignment of the application. Applicants requesting more than $500,000 must carry out the following steps: 1) Contact the IC program staff at least 6 weeks before submitting the application, i.e., as you are developing plans for the study; 2) Obtain agreement from the IC staff that the IC will accept your application for consideration for award; and, 3) Identify, in a cover letter sent with the application, the staff member and IC who agreed to accept assignment of the application. This policy applies to all investigator-initiated new (type 1), competing continuation (type 2), competing supplement, or any amended or revised version of these grant application types. Additional information on this policy is available in the NIH Guide for Grants and Contracts, October 19, 2001 at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-004.html. SENDING AN APPLICATION TO THE NIH: Submit a signed, typewritten original of the application, including the checklist, and 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 received by the receipt dates listed on the first page of the PAR. The CSR will not accept any application in response to this PAR 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 and specific program interests. Upon receipt, applications will be reviewed for completeness by the Center for Scientific Review (CSR) and responsiveness by the participating institutes. Incomplete and/or non-responsive applications will be returned to the applicant without further consideration. An appropriate special scientific review group convened by the CSR in accordance with the standard NIH peer review procedures (http://www.csr.nih.gov/refrev.htm) will evaluate applications for scientific and technical merit. As part of the initial merit review, all applications will: o Undergo a selection process in which only those applications deemed to have the highest scientific merit, generally the top half of applications under review, will be discussed and assigned a priority score o Receive a written critique o Receive a second level review by the appropriate national advisory council or board REVIEW CRITERIA The goals of NIH-supported research are to advance our understanding of biological systems, improve the control of disease, and enhance health. In the written comments, reviewers will be asked to evaluate 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. o Significance o Approach o Innovation o Investigator o Environment 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, MINORITIES AND CHILDREN IN RESEARCH: The adequacy of plans to include subjects from both genders, all racial and ethnic groups (and subgroups), and children as appropriate for the scientific goals of the research will be assessed. Plans for the recruitment and retention of subjects will also be evaluated. (See Inclusion Criteria in the sections on Federal Citations, below). CARE AND USE OF VERTEBRATE ANIMALS IN RESEARCH: If vertebrate animals are to be used in the project, the five items described under Section f of the PHS 398 research grant application instructions (rev. 5/2001) will be assessed. ADDITIONAL REVIEW CONSIDERATIONS Sharing Research Data Applicants requesting $500,000 or more in direct costs in any year of the proposed research are expected to include a data sharing plan in their application. The reasonableness of the data sharing plan or the rationale for not sharing research data will be assessed by the reviewers. However, reviewers will not factor the proposed data sharing plan into the determination of scientific merit or priority score. Applicants are encouraged to discuss their data sharing plan with their program contact at the time they negotiate an agreement with the Institute/Center (IC) staff to accept assignment of their application as described at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-004.html. Applicants are reminded that agreement to accept assignment of applications over $500,000 must be obtained at least six weeks in advance of the anticipated submission date. Program staff will be responsible for overseeing the data sharing policy and for assessing the appropriateness and adequacy of the proposed data-sharing plan. For more information see the Final NIH Statement on Sharing Research Data (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-032.html). 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 ANIMAL WELFARE PROTECTION: Recipients of PHS support for activities involving live, vertebrate animals must comply with PHS Policy on Humane Care and Use of Laboratory Animals (http://grants.nih.gov/grants/olaw/references/PHSPolicyLabAnimals.pdf), as mandated by the Health Research Extension Act of 1985 (http://grants.nih.gov/grants/olaw/references/hrea1985.htm), and the USDA Animal Welfare Regulations (http://www.nal.usda.gov/awic/legislat/usdaleg1.htm), as applicable. HUMAN SUBJECTS PROTECTION: Federal regulations (45CFR46) require that applications and proposals involving human subjects must be evaluated with reference to the risks to the subjects, the adequacy of protection against these risks, the potential benefits of the research to the subjects and others, and the importance of the knowledge gained or to be gained. http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm DATA AND SAFETY MONITORING PLAN: Data and safety monitoring is required for all types of clinical trials, including physiologic, toxicity, and dose- finding studies (phase I); efficacy studies (phase II), efficacy, effectiveness and comparative trials (phase III). The establishment of data and safety monitoring boards (DSMBs) is required for multi-site clinical trials involving interventions that entail potential risk to the participants. (NIH Policy for Data and Safety Monitoring, NIH Guide for Grants and Contracts, June 12, 1998: http://grants.nih.gov/grants/guide/notice-files/not98-084.html). SHARING RESEARCH DATA: Investigators submitting an NIH application seeking $500,000 or more in direct costs in any single year are expected to include a plan for data sharing or state why this is not possible. http://grants.nih.gov/grants/policy/data_sharing Investigators should seek guidance from their institutions, on issues related to institutional policies, local IRB rules, as well as local, state and Federal laws and regulations, including the Privacy Rule. Reviewers will consider the data sharing plan but will not factor the plan into the determination of the scientific merit or the priority score. INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH: It is the policy of the NIH that women and members of minority groups and their sub-populations must be included in all NIH-supported clinical research projects unless a clear and compelling justification is provided indicating that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43). All investigators proposing clinical research should read the "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research - Amended, October, 2001," published in the NIH Guide for Grants and Contracts on October 9, 2001 (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html); a complete copy of the updated Guidelines are available at http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm. The amended policy incorporates: the use of an NIH definition of clinical research; updated racial and ethnic categories in compliance with the new OMB standards; clarification of language governing NIH-defined Phase III clinical trials consistent with the new PHS Form 398; and updated roles and responsibilities of NIH staff and the extramural community. The policy continues to require for all NIH-defined Phase III clinical trials that: a) all applications or proposals and/or protocols must provide a description of plans to conduct analyses, as appropriate, to address differences by sex/gender and/or racial/ethnic groups, including subgroups if applicable; and b) investigators must report annual accrual and progress in conducting analyses, as appropriate, by sex/gender and/or racial/ethnic group differences. INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS: The NIH maintains a policy that children (i.e., individuals under the age of 21) must be included in all human subjects research, conducted or supported by the NIH, unless there are scientific and ethical reasons not to include them. All investigators proposing research involving human subjects should read the "NIH Policy and Guidelines" on the inclusion of children as participants in research involving human subjects that is available at http://grants.nih.gov/grants/funding/children/children.htm. REQUIRED EDUCATION ON THE PROTECTION OF HUMAN SUBJECT PARTICIPANTS: NIH policy requires education on the protection of human subject participants for all investigators submitting NIH proposals for research involving human subjects. You will find this policy announcement in the NIH Guide for Grants and Contracts Announcement, dated June 5, 2000, at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html. HUMAN EMBRYONIC STEM CELLS (hESC): Criteria for federal funding of research on hESCs can be found at http://stemcells.nih.gov/index.asp and at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-005.html. Only research using hESC lines that are registered in the NIH Human Embryonic Stem Cell Registry will be eligible for Federal funding (see http://escr.nih.gov). It is the responsibility of the applicant to provide, in the project description and elsewhere in the application as appropriate, the official NIH identifier(s)for the hESC line(s)to be used in the proposed research. Applications that do not provide this information will be returned without review. PUBLIC ACCESS TO RESEARCH DATA THROUGH THE FREEDOM OF INFORMATION ACT: The Office of Management and Budget (OMB) Circular A-110 has been revised to provide public access to research data through the Freedom of Information Act (FOIA) under some circumstances. Data that are (1) first produced in a project that is supported in whole or in part with Federal funds and (2) cited publicly and officially by a Federal agency in support of an action that has the force and effect of law (i.e., a regulation) may be accessed through FOIA. It is important for applicants to understand the basic scope of this amendment. NIH has provided guidance at http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm. Applicants may wish to place data collected under this PA in a public archive, which can provide protections for the data and manage the distribution for an indefinite period of time. If so, the application should include a description of the archiving plan in the study design and include information about this in the budget justification section of the application. In addition, applicants should think about how to structure informed consent statements and other human subjects procedures given the potential for wider use of data collected under this award. STANDARDS FOR PRIVACY OF INDIVIDUALLY IDENTIFIABLE HEALTH INFORMATION: The Department of Health and Human Services (DHHS) issued final modification to the Standards for Privacy of Individually Identifiable Health Information , the Privacy Rule, on August 14, 2002. The Privacy Rule is a federal regulation under the Health Insurance Portability and Accountability Act (HIPAA) of 1996 that governs the protection of individually identifiable health information, and is administered and enforced by the DHHS Office for Civil Rights (OCR). 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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