MAINTENANCE OF LONG TERM BEHAVIORAL CHANGE RELEASE DATE: January 15, 2003 (see NOT-OB-03-002) RFA NUMBER: OB-03-003 Office of Behavioral and Social Sciences Research (OBSSR) (http://obssr.od.nih.gov/) Office of Disease Prevention (ODP) (http://odp.od.nih.gov/) National Cancer Institute (NCI) (http://www.nci.nih.gov/) National Eye Institute (NEI) (http://www.nei.nih.gov/) National Institute on Aging (NIA) (http://www.nia.nih.gov/) National Institute on Alcohol Abuse and Alcoholism (NIAAA) (http://www.niaaa.nih.gov/) National Institute of Child Health and Human Development (NICHD) (http://www.nichd.nih.gov/) National Institute on Drug Abuse (NIDA) (http://www.nida.nih.gov/) National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) (http://www.niddk.nih.gov/) National Institute of Mental Health (NIMH) (http://www.nimh.nih.gov/) National Institute of Nursing Research (NINR) (http://www.ninr.nih.gov/) LETTER OF INTENT RECEIPT DATE: March 11, 2003 APPLICATION RECEIPT DATE: April 11, 2003 THIS RFA CONTAINS THE FOLLOWING INFORMATION o Purpose of this RFA o Research Objectives o Mechanism(s) of Support o Funds Available o Eligible Institutions o Individuals Eligible to Become Principal Investigators o Special Requirements o Where to Send Inquiries o Submitting an Application o Peer Review Process o Review Criteria o Receipt and Review Schedule o Award Criteria o Required Federal Citations PURPOSE OF THIS RFA The above named organizations invites applications for research projects that (a) examine biopsychosocial processes and test interventions designed to achieve long-term health behavior change and (b) a Resource Center to provide coordination for this set of research projects. Past research has typically focused on short term behavioral change, yielding little information on how change, once achieved, is maintained over the long term. This Request for Applications (RFA) encourages investigators to expand on the current theoretical base of change processes and intervention models, as well as to consider new conceptualizations from basic research in the social and behavioral sciences. Applications must focus on important health-related behaviors already demonstrated amenable to short-term change, such as tobacco use, exercise, eating habits, alcohol and drug use, inoculation obtainment, disease screening, stress reduction, adherence to health care regimens,human immunodeficiency virus (HIV)or sexually transmitted infection (STI) risk practices, bullying and abuse of others, sun exposure, and failure to use safety equipment. RESEARCH OBJECTIVES Background This Request for Applications follows on a 1997 RFA focusing on "Innovative Approaches to Disease Prevention Through Behavior Change." The goal of the 1997 RFA was to stimulate investigation of innovative strategies designed to achieve healthy behavior change by focusing on tobacco use, sedentary lifestyle, poor diet, and alcohol abuse. The RFA solicited intervention studies aimed at either a comparison of theoretical approaches to behavior change or assessment of the utility of specific behavior change theory in a multibehavioral framework. Although programs funded through that and other NIH efforts have been successful in achieving change during and immediately following the intervention phase, little empirical attention has been given to understanding factors that sustain and support behavior change after risk practices are identified, appropriate interventions implemented, and initial outcomes assessed. Indeed, other research indicates that relapse rates for addictive behaviors such as substance abuse and tobacco use are very high. For example, most individuals who stop smoking cigarettes relapse within six months. Adherence to exercise, diet and other health regimens is no better, despite the fact that initial success rates for various behavior change programs are very high. Thus long term maintenance of behavior change is as challenging, if not more so, than the initiation of behavior change. NIH believes that progress in this area may be accelerated by a more thorough examination of behavioral change processes that address factors influencing the initiation, maintenance, and resumption of behavior change at multiple levels. In 1998 the National Heart, Lung, and Blood Institute held a conference on "Maintenance of Behavior Change in Cardiorespiratory Risk Reduction." Cross- cutting themes and research recommendations that emerged from this conference included the need for (a) new models of population health behavior change and maintenance that integrate individual-level with broader environmental and macro-level policy influences; (b) a fuller model, which views maintenance more as a process than as a destination; and (c) more theory-based and interdisciplinary research on the maintenance process and on strategies for assisting special populations and addressing more than one behavioral risk at a time. Participants suggested that researchers should focus on understanding those who are successful at long-term maintenance, and on developing new approaches that can be used to help those who are not. The National Research Council 2001 report, "New Horizons in Health: An Integrative Approach", suggested that behavioral and social interventions have traditionally emphasized acute change. These interventions assume that the individual, group, community, or population has an adverse influence on health that could be corrected by a brief program of change. In its report, the committee recognized the need for new models of behavior change that address sustaining change in the face of constantly shifting personal, social and environmental circumstances ( p.157). Similarly, the Institute of Medicine (IOM) 2001 report, "Health and Behavior: The Interplay of Biological, Behavioral, and Societal Influences", noted that most studies, while demonstrating the ability to alter behavior, either do not test, or when tested do not demonstrate, sustained behavior change (p.334). The IOM committee indicated that interventions are most likely to be effective when they address the context in which behavior occurs. In their recommendations, they suggested the need to study both longer duration efforts, and concurrent interventions at the multiple levels that influence behavior: individual (physiological, psychological), family, social networks, organization, community, and society. Research Goals and Topics This RFA seeks to stimulate studies of biopsychosocial processes and interventions that target long-term maintenance of behavioral change. Investigators are encouraged to expand on the current theoretical base of change theories and intervention models to include relevant areas, such as motivational interviewing, contingency management, goal setting, social marketing, and innovation diffusion, as well as to consider new conceptualizations from basic research in the social and behavioral sciences, including behavioral extinction, behavioral momentum/choice theory, behavioral economics, models of decision-making, and goal-directed behaviors. Applications must focus on important health behaviors previously shown to be amenable to short-term change, such as such as tobacco use, exercise, eating habits, alcohol and drug use, immunization, disease screening, stress reduction, adherence to health care regimens, HIV/STI risk practices, bullying and abuse of others, sun exposure, or use of safety equipment. Multi-level (individual, interpersonal, community and/or societal) approaches to the understanding of behavior and intervention are encouraged, as is an interdisciplinary perspective. Studies are welcome that expand upon currently funded projects to ascertain influences on participants' failure to maintain behavior change following intervention. Also, encouraged are studies that explore interpersonal or social contexts that may interfere with maintenance of behavior change. Studies may be observations, experiments, epidemiological surveys, intervention trials, or examinations of archival data. Cost/benefit analyses are also encouraged. The examples listed below are not exhaustive; it is expected that additional important strategies and topics will be identified by investigators who respond to this RFA. Studies in these areas can include: 1) Research on factors affecting maintenance of behavior change, including: Studies of risk and protective factors operating and interacting at different levels: individual level (isolation, genetics, poverty, lack of confidence, personality, stage of readiness to change, personal history of behavior change, coping skills, changing neurobiological substrates); interpersonal level (caregiving, peer pressure, friends and partners who smoke or drink, social support); community level (norms, stigma, community support, enforcement of laws, exposure to negative cues, neighborhood resources, safety); and/or societal level (food labels, changing policies, taxes, media, environmental determinants) Studies examining whether different neurobiological, social/psychological, cultural, and other processes are involved in adopting a new behavior (short term change) versus sustaining a behavior over time (long term change), including tests of the underlying assumptions of various maintenance theories Research examining maintenance of behavior change in persons with multiple risk behaviors (e.g., comparing long term intervention response of people who engage in multiple risk or problem behaviors to those who engage in a single risk behavior; and analyzing possible transfer of behavior skills from one behavior to another). Research examining the factors associated with maintenance of behavior change in those who achieved change themselves versus those who participated in formal interventions programs; or in those whose participation is voluntary versus court-mandated. Investigations of the extent to which social contexts sustain and support behavior change after behaviors are targeted, an intervention is implemented, and initial outcomes of intervention are determined. These factors may include continuation of cues and supports, and maintenance of reinforcement schedules supporting change. Studies that ascertain how social environments may be modified to provide greater reinforcing value or that increase the cost or delay of rewards associated with targeted health risk behaviors. Research that explores ways to sustain skills that are newly acquired or enhanced through intervention but that decay over time due to lack of opportunity to practice or mastery experiences. 2) Research on intervention, including studies of: Intervention target: Investigations of various underserved or high- risk/special need populations across the life-course, with respect to the effectiveness of different maintenance interventions for different and potentially vulnerable population groups (e.g., psychiatrically high-risk populations, ethnic or minority populations; economically disadvantaged populations; children, adolescents, elderly; injecting drug users and their sexual partners). Also studies that describe how people lapse or relapse after behavioral proficiency is demonstrated in the context of intervention; studies examining the "match" between the intervention type and delivery style to individual or target population Intervention type and delivery channel: Studies of factors associated with intervention success or failure (e.g., therapeutic relationship, continuous care/ contact; tailored messages; self-help; dual behavior programs; partner support programs; relapse prevention training; varying learning contexts; providing retrieval cues; financial incentives; use of multiple media; pharmacotherapy; program intensity; integration into lifestyle, consistency of community enforcement programs) Intervention setting: Studies of factors associated with the environment in which the intervention is delivered (e.g.,home, community centers, community task forces, social institutions such as schools and law enforcement, mass media) that either enhance or undermine successful maintenance Intervention timing, duration, intensity: Studies that compare initiation and maintenance phases of behavioral change efforts, to determine how best to structure interventions designed to maintain behaviors (e.g., is it best to structure interventions so that they are initially intensive, then decreasing in intensity during maintenance, or should less intensive interventions be used for longer periods of time, or intensity maintained at high levels throughout?) Also included are studies that test the sustainability of various interventions over time, with and without "reintervening" or the use of "boosters" following some initial shorter follow-up period. In this regard, studies that have demonstrated short-term, positive impact are encouraged to apply for funding to demonstrate longer-term sustainability. The initial grant in which short-term outcomes were found does not necessarily have to be NIH funded. Intervention level: Studies that compare single level interventions with programs that either intervene or coordinate at more that one level (individual, family, organizational, community, and/or societal); studies that capitalize on naturally occurring community or societal changes as these affect the success of structured interventions in maintaining changes in behavior; studies that identify how to make maintenance interventions self-sustaining after research funding ends Active elements: Research that identifies the mechanisms of action or active components of behavioral, institutional, and community interventions that promote the maintenance of behavioral change, and how these may differ from active elements in interventions successful in producing acute change effects. These studies may focus on testing the underlying assumptions of various maintenance theories. 3) Other topics/special issues, including: Studies that develop, adapt, or assess new technologies for either studying the natural history of behavior or delivering interventions designed to maintain behaviors over the long term (e.g., examining whether internet-based programs can facilitate behavior maintenance or function in place of direct therapist support) Interdisciplinary research that links biomedical, behavioral, sociological, anthropological, and policy perspectives to gain a more comprehensive understanding of maintenance as a process involving the interaction of multiple influences (e.g., metabolic, developmental, socioeconomic, physiological, psychosocial, and cultural influences on dietary patterns) Studies that examine the role of different financing factors and mechanisms (e.g., health plan parity benefits, managed care practices, other cost control measures, public vs. private insurance) in enhancing or undermining the effectiveness of behavioral, institutional, and community interventions designed to promote the maintenance of behavioral change. MECHANISM(S) OF SUPPORT This RFA will use the National Institutes of Health (NIH) research project (R01) award mechanism. The total project period for an R01 application submitted in response to this RFA may not exceed 5 years. As an applicant you will be solely responsible for planning, directing, and executing the proposed project. The anticipated award date is October 2003. This RFA uses just-in-time concepts. It also uses the modular budgeting format. (see http://grants.nih.gov/grants/funding/modular/modular.htm). FUNDS AVAILABLE The co-sponsors intend to commit approximately $6,150,000 in 2003 to fund between 16-19 awards. The total cost of the Resource Center (see below)is not to exceed $200,000 annually. Studies of complex intervention trials are not to exceed $750,000 in annual total cost per individual grant. Studies of pyschosocial processes are expected to cost significantly less. Administrative adjustments in project period or amount of support may be required at the time of the award. Since a variety of approaches would represent valid responses to this RFA, it is anticipated that there will be a range of costs among the grants awarded. The usual NIH policies governing grants administration and management will apply. Although this program is provided for in the financial plans of the sponsoring Institutes and Offices, awards pursuant to this RFA are contingent upon the availability of funds for this purpose and the receipt of a sufficient number of applications of high scientific merit. ELIGIBLE INSTITUTIONS You may submit an application if your institution has any of the following characteristics: o For-profit or non-profit organizations o Public or private institutions, such as universities, colleges, hospitals,and laboratories o Units of State and local governments o Eligible agencies of the federal government o Domestic or foreign 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 It is anticipated that a successful grant application will contain the following key elements: Research Sites Process studies Studies of behavior and social processes may involve either the examination of archival data or the collection of new data. Preference will be given to studies that are guided by conceptualizations that expand on the current base of change theories to include relevant areas, such as motivational interviewing, contingency management, goal setting, social marketing, and methodology of innovation diffusion. Also receiving preferencial consideration will be studies that examine new conceptualizations from basic research in the social and behavioral sciences, including behavioral extinction, behavioral momentum theory, behavioral economics, models of decision-making, and goal- directed behaviors. Applicants are expected to show the relevance of their previous work to the current effort. Interventions Interventions should be maintenance effectiveness trials in real world settings (e.g., home, clinic, workplace, club, church). Community-level interventions (e.g., studies of community-based regulatory or policy changes) will also be supported under this initiative. When appropriate, the nature of the proposed intervention should be specified in terms of, for example, its intensity, duration, and frequency of contact. Plans for assuring treatment fidelity and implementation must also be specified. Applications must explain how the design will handle external factors that can affect intervention implementation and success. Involvement of a community advisory panel and/or partnership with a non-academic community or health organization may be helpful in devising strategies to enhance intervention design, implementation, outreach, and interpretation of findings. Preference will be given to those with data demonstrating the efficacy of affecting shorter-term change on the same study cohort and behavior(s) of interest as the proposed study. Resource Center Applications are also requested for one Resource Center (CC)to interact with the selected grant Sites and the NIH program administrators on a variety of topics ranging from seeking and compiling information, to providing technical assistance, to assisting in cross-site analyses, to disseminating outcomes via mechanisms such as a website. Because the behaviors, samples, and objectives may vary considerably across projects, the CC's first task will be to help the sites assess the potential for cross-study analyses and common measures. It is likely that commonalities will be found in subgroups of grantees rather than in the cohort as a whole. In consultation with the Sites and NIH, the CC will facilitate and coordinate selection of any common instruments (e.g., compiling the listing of proposed common measures; reviewing the literature and assessing the advantages and disadvantages of different measures for common study variables). Additionally, the CC will be responsible for tracking recruitment and retention across the different Sites, and advising the Sites on strategies for enhancing recruitment/retention, especially in minority or ethnic populations. The CC will work with projects to maximize the potential for cross-site comparability of data. While different sites may take the lead on different cross-study projects, including application for supplemental funding, the CC staff will collect and store shared data generated by the Sites, and have the option of participating with other awardees as co-authors in preparing manuscripts that report results from the common data sets. In addition, the CC will perform a variety of functions, such as, maintaining a directory of investigators and co-investigators; arranging all conference calls and meetings, and ad-hoc meetings of project directors; and facilitating information exchange among the Sites and NIH, and between the NIH and the general research community. Along these lines, the Resource Center will be responsible for planning the agendas and handling the logistics for the semi-annual meetings of the Research Sites, to be held in the Washington DC area. The CC will post minutes of the conference calls and meetings on a website that it will establish and maintain. The CC will post discussions of progress, problems, and accomplishments of the individual Sites and working groups that are formed to address topics of common concern (e.g., recruitment and retention, common measures, social support, common behaviors). The latter role will also include compiling specific reports and developing and implementing common formats across Sites for all reports, protocols and descriptions. The CC will also devise plans for the dissemination of information resulting from these studies, including the preparation of slides for presentation of study objectives, methods, and findings. Up to $20,000 per year for cross-site consultants and small working group sessions should also be budgeted. Two completely separate applications from different applicant-investigators must be filed if an institution seeks selection as both a Research Site and the Resource Center. New Research Sites may be added in subsequent years. Bi-Annual Meetings and Collaboration All prospective awardees should describe strategies for the establishment of collaborative arrangements with other awardees. Applicants must plan for conference calls four times a year among grantees supported as a result of the RFA, to discuss new developments, review research progress and difficulties, coordinate ongoing research and plan future research. In addition, application budgets must include funds to attend two collaborative meetings to be held in the Washington DC area, for three investigators from each site per year. The first collaborative meeting will occur shortly after grant award, and will focus on research designs, objectives, and possible collaborative arrangements that might foster increased productivity or efficiency in addressing the objectives proposed by the applicants. Where feasible, it will be desirable to achieve some uniformity in measurement of key behaviors across the different funded sites. Applicants should include a statement about their willingness to participate in such activities. The Resource Center will assist grantees with collaborative activities, such as conference calls, meeting logistics, and the development of common measures and methods. Data from any shared data sets will be submitted to the Resource Center on a regular basis, where it will made available for cross-site analyses and archived for public use within two years after the end of the initial award period. The CC, Sites and NIH program representatives will jointly define rules regarding publication of findings from analysis of the shared data sets. It is hoped that the spirit of collaboration which spawned this initiative will carry forward throughout the project and beyond. Toward this end, researchers are encouraged, after a reasonable period of time for primary analyses and publication, to make the data collected as a result of this RFA readily available to future researchers wishing to use this data at their own research site. This availability may be achieved by either archiving the data and related documentation at any recognized data archive, placing the data and documentation on a publicly available file server maintained by the grantee organization, or supplying the data and documentation at cost upon request. 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: Direct your questions about scientific/research issues to: Linda Nebeling, PH.D., MPH, RD, FADA ,Chief Health Promotion Research Branch Behavioral Research Program Division of Cancer Control and Population Sciences National Cancer Institute 6130 Executive Blvd, EPN 4080 MSC 7335 Bethesda, MD 20892-7335 (Rockville, MD 20852 for express mail) Telephone: (301) 451-9530 Fax: (301) 480-2087 Email: nebelinl@mail.nih.gov Maryann Redford, D.D.S, M.P.H. Division of Extramural Research National Eye Institute Building EPS, Room 350 6120 Executive Blvd, MSC 7164 Bethesda, MD 20892-7164 Telephone: (301) 451-2020 FAX: (301) 402-0528 Email: maryann.redford@nei.nih.gov Sidney M. Stahl, Ph.D. Behavioral and Social Research Program National Institute on Aging 7201 Wisconsin Avenue, Suite 533/Gateway Bethesda, MD 20892-9205 Telephone: (301) 402-4156 Fax: (301) 402-0051 Email: StahlS@nia.nih.gov Jan Howard, Ph.D., Chief Prevention Research Branch Division of Clinical and Prevention Research National Institute on Alcohol Abuse and Alcoholism (NIAAA) 6000 Executive Blvd. Suite 505 Bethesda, MD 20892 Telephone: (301) 443-1678 Fax: (301) 443-8774 E-mail: jhoward@niaaa.nih.gov Lynne M. Haverkos, MD, MPH Behavioral Pediatrics and Health Promotion Research Program National Institute of Child Health and Human Development 6100 Executive Blvd., Rm 4B05, MSC 7510 Bethesda, MD 20892-7510 (Rockville, Md 20852 for Fed Ex or UPS) Phone: (301) 435-6881 Fax: (301) 480-0230 E-mail: haverkol@mail.nih.gov Minda R. Lynch, Ph.D. Behavioral and Cognitive Sciences Research Branch National Institute on Drug Abuse/NIH/DHHS 6001 Executive Blvd., Rm. 4282 Bethesda, Maryland 20892 Phone: (301) 435-1322 Fax: (301) 594-6043 E-mail: mlynch1@nida.nih.gov Robert J. Kuczmarski, Dr. P.H. Division of Digestive Diseases and Nutrition National Institute of Diabetes and Digestive and Kidney Diseases 6707 Democracy Blvd., Room 673 (MSC 5450) Bethesda, MD 20892-5450 (for express mail, use 20817) Telephone: (301) 451-8354 FAX: (301) 480-8300 E-mail: RK191R@NIH.GOV Andrew D. Forsyth, Ph.D. Division of Mental Disorders, Behavioral Research, and AIDS National Institute of Mental Health 6001 Executive Blvd, MSC 9619 Bethesda, MD 20892 Telephone: (301) 443-8403 FAX: (301) 443-9719 Email: aforsyth@mail.nih.gov Janice Phillips, PhD, RN, FAAN National Institute of Nursing Research 6701 Democracy Blvd., Suite 710 One Democracy Plaza Bethesda, MD 20892-4870 (Express Mail Zip Code - 20817) Telephone: (301) 594-6152 FAX: (301) 480-826o Email: phillipsj@nih.gov Direct your questions about peer review issues to: Michael Micklin, Ph.D. Risk, Prevention, & Health Behavior Integrated Review Group Center for Scientific Review National Institutes of Health 6701 Rockledge Drive, Rm. 3178 MSC 7848 Bethesda, MD 20814-9692 Telephone: (301) 435-1258 Fax: (301) 480-3962 Email: micklinm@csr.nih.gov Direct your questions about financial or grants management matters to: Crystal Wolfrey Grants Administration Branch National Cancer Institute 6120 Executive Boulevard, Suite 243 Bethesda, MD 20892-7340 Rockville, MD 20852 (for express/courier service) Telephone: (301) 496-8634 E-mail: crystal.wolfrey@nih.gov William W. Darby Grants Management Officer National Eye Institute Building EPS, Room 350 6120 Executive Blvd, MSC 7164 Bethesda, MD 20892-7164 Telephone: (301) 451-2020 FAX: (301) 496-9997 Email: wwd@nei.nih.gov Linda Whipp Grants and Contracts Management Officer National Institute on Aging Gateway Building, Suite 2N212 7201 Wisconsin Avenue, MSC 9205 Bethesda, MD 20892-9205 Telephone: (301) 496-1472 FAX: (301) 402-3672 Email: whippl@nia.nih.gov Judy Fox Chief, Grants Management Branch Office of Planning and Resource Management National Institute on Alcohol Abuse and Alcoholism 6000 Executive Blvd. Suite 504 Bethesda, MD. 20892-7003 Phone: (301) 443-4704 Fax: (301) 443-3891 Email: jsimons @niaaa.nih.gov Dianna N. Bailey Grants Management Specialist National Institute of Child Health and Human Development 6100 Executive Blvd., Rm 8A01, MSC 7510 Bethesda, Md 20892-7510 (Rockville, Md 20852 for Fed Ex or UPS) Phone: (301) 435-6978 Fax: (301) 480-4783 Email: db405m@nih.gov Gary Fleming, J.D., M.A. Grants Management Branch National Institute on Drug Abuse/NIH/DHHS 6001 Executive Boulevard, Room 3131 Bethesda, MD 20892-9541 Telephone: (301) 443-6710 FAX: (301) 594-6849 E-mail: gf6s@nih.gov Teresa Farris Marquette Grants Management Branch National Institute of Diabetes and Digestive and Kidney Diseases 6707 Democracy Blvd., Room 728 Bethesda, MD 20892-5450 Telephone: (301-594-7682) FAX: (301) 480-3504 E-mail: Marquettet@extra.niddk.nih.gov Diana S. Trunnell Grants Management Branch National Institute of Mental Health 6001 Executive Blvd, MSC 9605 Bethesda, MD 20892 Telephone: (301) 443-2805 Fax: (301) 443-6885 Email: diana_trunnell@nih.gov Tara Mowery Grants Management Specialist National Institute of Nursing Research 6701 Democracy Blvd., Suite 710 One Democracy Plaza Bethesda, MD 20892-4870 (Express Mail Zip Code - 20817) Telephone: (301) 594-5979 Fax: (301) 451-5650 Email: tara_mowery@nih.gov LETTER OF INTENT Prospective applicants are asked to submit a letter of intent that includes the following information: o Descriptive title of the proposed research o Name, address, and telephone number of the Principal Investigator o Names of other key personnel o Participating institutions o Number and title of this RFA Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows IC staff to estimate the potential review workload and plan the review. The letter of intent is to be sent by the date listed at the beginning of this document. The letter of intent should be sent to: Susan D. Solomon, PhD Senior Advisor Office for Behavioral and Social Sciences Research National Institutes of Health One Center Drive, Room 256 Bethesda, MD 20892 E-mail (preferred): ssolomon@nih.gov Phone: (301) 496-0979 Fax: (301) 402-1150 SUBMITTING AN APPLICATION Applications must be prepared using the PHS 398 research grant application instructions and forms (rev. 5/2001). The PHS 398 is available at http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive format. For further assistance contact GrantsInfo, Telephone (301) 435-0714, Email: GrantsInfo@nih.gov. SPECIFIC INSTRUCTIONS FOR MODULAR GRANT APPLICATIONS: Applications requesting up to $250,000 per year in direct costs 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. USING THE RFA LABEL: The RFA label available in the PHS 398 (rev. 5/2001) application form must be affixed to the bottom of the face page of the application. Type the RFA number on the label. Failure to use this label could result in delayed processing of the application such that it may not reach the review committee in time for review. In addition, the RFA title, number, and type of application: "Site," or "Resource Center," must be typed on line 2a of the face page of the application form and the YES box must be checked. The RFA label is also available at: http://grants.nih.gov/grants/funding/phs398/label-bk.pdf. SENDING AN APPLICATION TO THE NIH: Submit a signed, typewritten original of the application, including the checklist, and 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 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 application already reviewed, but such application must include an Introduction addressing the previous critique. PEER REVIEW PROCESS Upon receipt, applications will be reviewed for completeness by the CSR. Incomplete applications will be returned to the applicant without further consideration. Applications that are complete will be evaluated for scientific and technical merit by an appropriate scientific review group convened by CSR in accordance with the review criteria stated below. As part of the initial merit review, all applications will: o Receive a written critique o Undergo a selection process in which only those applications deemed to have the highest scientific merit, generally the top half of applications under review, will be discussed and assigned a priority score o Receive a second level review by the appropriate national advisory council or board REVIEW CRITERIA FOR THE RESEARCH SITES The goals of NIH-supported research are to advance our understanding of biopsychosocial systems, improve the control of disease, and enhance health. In the written comments, reviewers will be asked to discuss the following aspects of Research Site applications 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 your application's overall score, weighting them as appropriate for each application. Your 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, you may propose to carry out important work that by its nature is not innovative but is essential to move a field forward. (1) SIGNIFICANCE: Does your study address an important problem? If the aims of your application are achieved, how do they advance scientific knowledge? What will be the effect of these studies on the concepts or methods that drive this field? (2) APPROACH: Are the conceptual framework, design, methods, and analyses adequately developed, well integrated, and appropriate to the aims of the project? Do you acknowledge potential problem areas and consider alternative tactics? If an intervention is proposed, are the conceptual models well integrated into the design and testing of the proposed intervention? Will the intervention take place in a real world setting? Has sufficient detail about the intervention been provided to understand the intervention processes and mechanisms of change? Have provisions been made for extended follow-up, including methods capable of assessing maintenance of change and confounding variables? (3) INNOVATION: Does your project employ novel concepts, approaches, or methods? Are the aims original and innovative? Does your project challenge existing paradigms or develop new methodologies or technologies? (4) INVESTIGATOR: Are you appropriately trained and well suited to carry out this work? Is the work proposed appropriate to your experience level as the PI and to that of other researchers (if any)? If an intervention has been proposed, has there been provision for partnerships between behavior change experts, intervention specialists, and appropriate health professionals or community leaders? (5) ENVIRONMENT: Does the scientific environment in which your 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, your application will also be reviewed with respect to the following: PROTECTIONS: The adequacy of the proposed protection for humans, animals, or the environment, to the extent they may be adversely affected by the project proposed in the application. INCLUSION: 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. Plans for the recruitment and retention of subjects will also be evaluated. (See Inclusion Criteria included in the section on Federal Citations, below) DATA SHARING: The adequacy of the proposed plan to share data. BUDGET: The reasonableness of the proposed budget and the requested period of support in relation to the proposed research. REVIEW CRITERIA FOR THE RESOURCE CENTER The scientific review group will address and consider each of these criteria in assigning your application's overall score, weighting them as appropriate for each application. Your application does not need to be strong in all categories to be judged deserving of a high priority score. (1) CROSS SITE STUDY COORDINATION: Prior experience of the Principal Investigator and other key personnel in functioning as a Resource Center in a multi-site study, including coordination of both substantive and administrative aspects of multi-site studies (2) METHODS AND MEASURES: Previous experience in instrument selection and development (3) CONTENT: Substantive familiarity with issues related to maintenance of behavioral change (4) DISSEMINATION: Experience with communication and dissemination of information, including the preparation of slides and reports; establishing and maintaining a multi-site website; facilitating information exchange among the Sites, the NIH, and the general research community. (5) BUDGET: The reasonableness of the proposed budget and the requested period of support in relation to the proposed set of activities. RECEIPT AND REVIEW SCHEDULE Letter of Intent Receipt Date: March 11, 2003 Application Receipt Date: April 11, 2003 Peer Review Date: June/July 2003 Council Review: September 2003 Earliest Anticipated Start Date: November 2003 AWARD CRITERIA Award criteria that will be used to make award decisions include: o Scientific merit of the proposed project as determined by peer review o Availability of funds o Relevance to program priorities o Content area balance o Practice relevance REQUIRED FEDERAL CITATIONS MONITORING PLAN AND DATA SAFETY AND MONITORING BOARD: Research components involving Phase I and II clinical trials must include provisions for assessment of patient eligibility and status, rigorous data management, quality assurance, and auditing procedures. In addition, it is NIH policy that all clinical trials require data and safety monitoring, with the method and degree of monitoring being commensurate with the risks (NIH Policy for Data Safety and Monitoring, NIH Guide for Grants and Contracts, June 12,1998: http://grants.nih.gov/grants/guide/notice-files/not98-084.html). INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH: It is the policy of the NIH that women and members of minority groups and their sub-populations must be included in all NIH-supported clinical research projects unless a clear and compelling justification is provided indicating that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43). All investigators proposing clinical research should read the AMENDMENT "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research - Amended, October, 2001," published in the NIH Guide for Grants and Contracts on October 9, 2001 (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html); a complete copy of the updated Guidelines are available at http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_ 2001.htm. The amended policy incorporates: the use of an NIH definition of clinical research; updated racial and ethnic categories in compliance with the new OMB standards; clarification of language governing NIH-defined Phase III clinical trials consistent with the new PHS Form 398; and updated roles and responsibilities of NIH staff and the extramural community. The policy continues to require for all NIH-defined Phase III clinical trials that: a) all applications or proposals and/or protocols must provide a description of plans to conduct analyses, as appropriate, to address differences by sex/gender and/or racial/ethnic groups, including subgroups if applicable; and b) investigators must report annual accrual and progress in conducting analyses, as appropriate, by sex/gender and/or racial/ethnic group differences. INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS: The NIH maintains a policy that children (i.e., individuals under the age of 21) must be included in all human subjects research, conducted or supported by the NIH, unless there are scientific and ethical reasons not to include them. This policy applies to all initial (Type 1) applications submitted for receipt dates after October 1, 1998. All investigators proposing research involving human subjects should read the IH 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://grants.nih.gov/grants/stem_cells.htm and at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-005.html. Only research using hESC lines that are registered in the NIH Human Embryonic Stem Cell Registry will be eligible for Federal funding (see http://escr.nih.gov). It is the responsibility of the applicant to provide the official NIH identifier(s)for the hESC line(s)to be used in the proposed research. Applications that do not provide this information will be returned without review. PUBLIC ACCESS TO RESEARCH DATA THROUGH THE FREEDOM OF INFORMATION ACT: The Office of Management and Budget (OMB) Circular A-110 has been revised to provide public access to research data through the Freedom of Information Act(FOIA) under some circumstances. Data that are (1) first produced in a project that is supported in whole or in part with Federal funds and (2) cited publicly and officially by a Federal agency in support of an action that has the force and effect of law (i.e., a regulation) may be accessed through FOIA. It is important for applicants to understand the basic scope of this amendment. NIH has provided guidance at http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm. Applicants may wish to place data collected under this RFA 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. URLs IN NIH GRANT APPLICATIONS OR APPENDICES: All applications and proposals for NIH funding must be self-contained within specified page limitations. Unless otherwise specified in an NIH solicitation, Internet addresses (URLs) should not be used to provide information necessary to the review because reviewers are under no obligation to view the Internet sites. Furthermore, we caution reviewers that their anonymity may be compromised when they directly access an Internet site. HEALTHY PEOPLE 2010: The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2010," a PHS-led national activity for setting priority areas. This PA is related to one or more of the priority areas. Potential applicants may obtain a copy of "Healthy People 2010" at http://www.health.gov/healthypeople. AUTHORITY AND REGULATIONS: This program is described in the Catalog of Federal Domestic Assistance Numbers 93.395 (NCI), 93.867(NEI), 93.886 (NIA), 93.273 (NIAAA), 93.865 (NICHD),93.279(NIDA), 93.242 (NIMH), and 93.361(NINR), and is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. Awards are made under authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and administered under NIH grants policies described at http://grants.nih.gov/grants/policy/policy.htm and under Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92. The PHS strongly encourages all grant recipients to provide a smoke-free workplace and 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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