PA-04-121: UNDERSTANDING MECHANISMS OF HEALTH RISK BEHAVIOR CHANGE IN CHILDREN AND ADOLESCENTS

Department of Health
and Human Services (HHS)

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UNDERSTANDING MECHANISMS OF HEALTH RISK BEHAVIOR CHANGE IN CHILDREN AND ADOLESCENTS RELEASE DATE: July 6, 2004 PA NUMBER: PA-04-121 The R01 portion of this funding opportunity has been replaced by PA-07-148, which now uses the electronic SF424 (R&R) application for February 5, 2007 submission dates and beyond. March 2, 2006 (NOT-OD-06-046) Effective with the June 1, 2006 submission date, all R03, R21, R33 and R34 applications must be submitted through Grants.gov using the electronic SF424 (R&R) application. This announcement will stay active for only the May 1, 2006 AIDS and AIDS-related application submission date for these mechanisms. The non-AIDS portion of this funding opportunity for these mechanisms expires on the date indicated below. Other mechanisms relating to this announcement will continue to be accepted using paper PHS 398 applications until the stated expiration date below, or transition to electronic application submission. Replacement R21 (PA-06-298) funding opportunity announcement has been issued for the submission date of June 1, 2006 and submission dates for AIDS and non-AIDS applications thereafter. EXPIRATION DATE for R21 Non-AIDS Applications: March 2, 2006 EXPIRATION DATE for R21 AIDS and AIDS-Related Applications: May 2, 2006 Expiration Date for R01 Non-AIDS Applications: November 2, 2006 Expiration Date for R01 AIDS and AIDS-Related Applications: January 3, 2007 Department of Health and Human Services (DHHS) PARTICIPATING ORGANIZATIONS National Institutes of Health (http://www.nih.gov) COMPONENTS OF PARTICIPATING ORGANIZATION: National Institute of Child Health and Human Development (NICHD) (http://www.nichd.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 Alcohol Abuse and Alcoholism (NIAAA) (http://www.niaaa.nih.gov/) National Institute on Drug Abuse (NIDA) (http://www.nida.nih.gov/) National Institute of Nursing Research (NINR) (http://www.ninr.nih.gov) Office of Behavioral and Social Sciences Research (OBSSR) (http://obssr.od.nih.gov/) Office of Dietary Supplements (ODS) (http://dietary-supplements.info.nih.gov/) CATALOG OF FEDERAL DOMESTIC ASSISTANCE NUMBER(S): 93.865; 93.361; 93.399; 93.837; 93.273; 93.279 THIS PA CONTAINS THE FOLLOWING INFORMATION o Purpose of this PA o Research Objectives o Mechanisms of Support o Eligible Institutions o Individuals Eligible to Become Principal Investigators o Where to Send Inquiries o Submitting an Application o Peer Review Process o Review Criteria o Award Criteria o Required Federal Citations PURPOSE OF THIS PA The National Institute of Child Health and Human Development, the National Cancer Institute, the National Heart, Lung, and Blood Institute, the National Institute on Alcohol Abuse and Alcoholism, the National Institute on Drug Abuse, the Office of Behavioral and Social Sciences Research, and the Office of Dietary Supplements invite research grant applications that will enhance our understanding of the factors and mechanisms that determine changes in health risk behaviors during childhood and adolescence. The concept of health risk behavior change is used in this program announcement to encompass the evolution of specific health impairing behaviors. Of particular interest are factors and processes that influence the initiation, continuation, and/or cessation of one or more of the following health risk behaviors: (1) substance abuse, (2) inadequate exercise and poor dietary practices as they relate to being overweight or obese, and (3) intentional and unintentional injuries. The terms "health risk behaviors" and "risky behaviors" are used interchangeably in this PA. The goal of this PA is to promote optimal physical and mental health in children and adolescents. This may be accomplished by research to enhance our understanding of the origin, evolution, and termination of health risk behaviors and, ultimately, by the development of effective prevention and intervention strategies designed to maintain healthy behaviors and prevent health risk behaviors. Interdisciplinary research is sought to explore the biological, genetic, physiological, psychological, and social/environmental factors and mechanisms that influence health risk behavior change in children and adolescents. A better understanding of theory-driven, causal pathways and recognition of mediators and moderators will aid in the identification of the etiology of health risk behaviors, precursors of health risk behaviors, and associated risk and resilience factors. The research findings will have the potential to inform the development of more comprehensive and effective prevention and intervention strategies in the fields of substance abuse, obesity, and injuries. RESEARCH OBJECTIVES Background Many of the health risk behaviors of the 21st century result from voluntary behaviors such as unhealthy eating habits, the use of tobacco, alcohol or other drugs, and the failure to be physically active, maintain a healthy weight, or use safety equipment. Health risk behaviors, once considered the result of faulty decision-making, impulsive behavior, or characteristic of psychosocial development, are now recognized as dynamic conditions (some with genetic predispositions) evolving across the lifespan. Much research has been done to document various types of health risk behaviors, but little research has focused on understanding the mechanisms and contextual factors responsible for the process of behavior change. A biopsychosocial approach to the investigation of the mechanisms of health risk behavior change will explore the multiple spheres of influence provided by the individual, family, community, and society. Childhood and adolescence are times of tremendous biological, cognitive, and psychosocial growth and development, taking children on a whirlwind trajectory from early childhood to young adulthood. Childhood and adolescence represent challenging targets for research aimed at understanding how health risk behaviors form; how they differ by individual, by ethnicity, and by gender; and the importance of genotype, phenotype, and the environment. Childhood offers a window of opportunity for the development of health promoting behaviors, but also represents a period of vulnerability for the formation of health risk behaviors. Further, transition points between childhood and adolescence are marked by widespread developmental changes in emotional, social, and cognitive development that may contribute to the development of health related behaviors in important ways. Health risk behaviors involve both genders and all socioeconomic, ethnic, and racial groups. Limited research exists on isolating process variables and causal pathways involved in the initiation, treatment, and cessation of health risk behaviors. The development of effective prevention and intervention strategies for health risk behaviors should include theory-driven models and hypotheses, and the identification and evaluation of mediators and moderators involved in the behavior change process. The Healthy People 2010 objectives for the nation relate to improvements in the following leading health indicators: physical inactivity, overweight and obesity, tobacco and other substance abuse, and injury and violence. The goal of Healthy People 2010, with its focus on prevention, is to achieve longer and healthier lives for individuals and the general population. Accomplishing this goal will be facilitated by the development of effective prevention programs based on an understanding of the motivations and determinants of health risk behaviors throughout childhood and adolescence. Overview of Current Research and Theory Health risk behaviors such as tobacco, alcohol and other substance use, unhealthy dietary behaviors, and physical inactivity are evident in childhood and have far-reaching implications for individuals, families, and communities. Young people are trying illicit drugs at early ages, with almost one in three individuals having first experimented with alcohol (other than a few sips) before the age of 13 years. Alcohol consumption is a leading contributor to accidents, homicides, and suicides, the three leading causes of teen death. One in five youths has smoked a whole cigarette and one in ten youths has tried marijuana before turning 13 years of age. Cigarette smoking is the primary preventable cause of death in the United States. The majority of all American adult deaths results from cardiovascular disease and cancer, with many of the associated risk factors being initiated during adolescence. Substance abuse and the other health risk behaviors carry an enormous price tag in terms of the toll on life, quality of life, and economic costs. Health risk behaviors are monitored by surveys such as the Youth Risk Behavior Survey (YRBS), which in 2001 showed that 10.5 percent of high school students were overweight, 67.8 percent did not attend physical education class daily, 28.5 percent had smoked cigarettes, and 78.6 percent had not eaten five servings of fruits and vegetables daily in the week preceding the survey. During the 30 days preceding the survey, 14.1 percent of high school students had rarely or never worn a seat belt, 30.7 percent had ridden with a driver who had been drinking alcohol, 13.3 percent of students nationwide had driven a car or other vehicle one or more times after drinking alcohol, 47.1 percent had drunk alcohol, 17.4 percent had carried a weapon, and 23.9 percent had used marijuana. In the 2002 Monitoring the Future Survey, 11.3 percent of 12th graders were reported to have used illicit drugs other than marijuana in the month prior to the survey. The United States is facing an epidemic of childhood obesity, with poor dietary behaviors and high rates of physical inactivity contributing to this preventable health condition. In 1999 in the United States, 13 percent of children ages six to 11 years and 14 percent of adolescents ages 12 to 19 years were overweight. The prevalence of overweight has nearly tripled for adolescents in the past two decades. And, though rising rates of overweight and obesity affect all racial, ethnic, socioeconomic, and education-level groups, they have disproportionately affected African Americans, Hispanics, and individuals from lower-income and lower-education brackets. One potential complication of obesity is type II diabetes mellitus, a condition also increasing by epidemic proportion. Other complications likely to follow the increase in obesity and type II diabetes include increases in cardiovascular disease, kidney failure, and blindness. Besides type II diabetes, overweight and obese children and adolescents are at risk of becoming overweight adults with problems of coronary artery disease, hypertension, stroke, respiratory problems, gallbladder disease, osteoarthritis, sleep apnea, and some forms of cancer. Obese individuals also face decreased productivity, social stigmatization, high health care costs, and premature death. Each year, 300,000 deaths in the U.S. are associated with obesity. Physically inactive youth with low levels of cardiovascular fitness, high percentage of body fat, and large amounts of visceral adipose tissue have unfavorable cardiovascular risk profiles (e.g., low HDL, insulin resistance, and high triglycerides and LDL) which increase their risks of developing cardiovascular disease later in life. Although physical activity can help prevent excessive weight gain, more than a third of all middle and high school students do not get the recommended 30 minutes of moderate physical activity on most days of the week. Regular exercise and participation in sports or physical education classes can have positive effects such as building and maintaining strong muscles and bones, controlling weight, and providing positive psychological benefits. Physical activity declines as children transition from childhood through adolescence. Children of lower socioeconomic status are less active than children of higher socioeconomic status and girls are less active than boys during adolescence. Unintentional injuries are the leading cause of death for individuals from age one to 24 years. Motor vehicle crashes, fires, and poisonings injure and kill thousands of children each year, despite the fact that a number of effective preventive strategies exist. Understanding factors that influence children's decisions to wear seat belts and bike helmets, and identifying motivational aids to enhance their compliance with safety devices, will inform prevention and intervention strategies and subsequently reduce unintentional injuries and deaths. For years, researchers have been intrigued by health risk behaviors and have expended extensive effort to observe, describe, predict, and prevent risky behaviors. Many health risk behaviors co-occur and co-vary in segments of the population, although the basis of the covariance is frequently unknown. Research is needed that moves beyond measuring variance in search of a comprehensive understanding of the processes and factors responsible for health risk behavior change. Numerous intervention and prevention programs have been implemented for substance abuse, physical inactivity, obesity, violence and injury prevention, yet the effectiveness in many cases has been limited and the results have been short term. It is apparent that providing factual information concerning the dangers and negative consequences associated with health risk behaviors is not sufficient to deter all individuals from participating in high risk health behaviors. Understanding why some individuals are risk takers, the timing of their health risk behaviors, and the factors that influence their decisions and actions are all important in advancing the field of child and adolescent health risk behavior. Although a number of theories have been developed to explain adult behavior change, few have considered the multiple systems of influence and the complexity of their combined effects on behavior change in children and adolescents. Theoretical models relevant to health and risk behavior include the following: self-regulation theory (Kanfer, 1970), health belief model (Rosenstock, 1974), theory of reasoned action (Fishbein and Ajzen, 1975), subjective culture and interpersonal relations theory (Triandis, 1977), protection motivation theory (Maddux and Rogers, 1983), theory of planned behavior (Ajzen, 1985), self-determination theory (Deci & Ryan, 1985), transtheoretical model of behavior change (Prochaska, DiClemente, and Norcross, 1992), social cognitive theory (Bandura, 1994), and the ecological models (Sallis and Owen, 1999; Marshall and Biddle, 2001). Behavioral change theorists have identified a number of factors believed to play important roles including attitudes, intentions, skills, emotions, self- standards, self-efficacy, social norms, intrinsic and extrinsic motivation, and environment. Neuroscientists are discovering more about the complex changes in neurobehavioral systems with underpinnings that control behavior and emotion. This Program Announcement welcomes the behavioral, biobehavioral, and neuroscience communities to engage in the search for causal pathways to health risk behaviors. Research Scope The health risk behaviors of interest to this PA include: (1) substance abuse, (2) physical inactivity and poor dietary practices, and (3) intentional and unintentional injury. These topics were selected because each represents a significant risk to the health and well being of youth, with subsequent social and health implications during adulthood. These important health risk behaviors are amenable to short-term change in some cases and, at times, to long-term change. Additionally, these health risk behaviors have a high co- occurrence in individuals; it is important to understand factors that contribute to the development of each risky behavior independently, as well as the possible synergistic, additive, or dynamic interaction of these risk behaviors. Studies of interest may be observational, epidemiological, interventional, secondary data analyses (i.e., analysis of existing data), and cost/benefit analyses. A multidisciplinary approach is encouraged and research findings from fields such as developmental pediatrics, psychology, behavioral science, neuroscience, neuropsychology, business, education, public policy, and others will be considered. Health risk behaviors are influenced by a multitude of genetic, social, environmental, psychological, and physiological factors. Intrinsic factors such as genetic makeup, temperament, and memory of prior experiences combine with social and environmental factors to influence the physical, emotional, and intellectual development of an individual. Applicants are encouraged to expand upon current theories of behavior change and to consider techniques, strategies, and other models such as intrinsic and extrinsic motivation, motivational interviewing, feedback interventions, contingency management, social marketing, innovation diffusion, behavioral extinction, behavioral momentum/choice theory, contingency management techniques, behavioral economics, models of decision-making, and goal-directed behaviors. Numerous skills are involved in behavior change and should be considered for applications responding to this PA. These skills include self-monitoring (self-awareness), goal setting (realistic and specific), cognitive restructuring, stress management, mental imagery, relapse prevention skills, time management, conflict resolution, assertiveness skills, decision making skills, and substituting healthy behaviors for unhealthy behaviors. Identifying skills absent or ineffective in health risk behaviors and also those that are linked to healthy behaviors will be helpful. Both internal and external (contextual) factors contribute to an individual's propensity to engage in or refrain from health risk behaviors. What these factors are, how they interact, for whom, and when in the developmental trajectory, are all questions of importance in understanding health risk behaviors and behavior change. Examples of research questions designed to fill gaps in our understanding of mechanisms and factors responsible for substance abuse, physical inactivity and poor dietary practices, and intentional and unintentional injuries include, but are not limited to, the following: (1) Biological Influences on Substance Abuse, Physical Inactivity and Poor Dietary Practices, and Injuries o What are the basic biological factors and processes involved in the evolution of health risk behaviors? o What determines for whom and when in the developmental trajectory risk behaviors occur? o What neurochemical factors/processes and neuroanatomical circuits are involved in health risk behavior change and how do these systems evolve over time? o What can newer imaging techniques contribution to our understanding of the links between neuroscience (developing brain) and behavioral science (health risk behavior)? o What are the bi-directional influences of physiological contributions, (neurobiological, endocrine, and immune) to risk behaviors, and how do changes to the neural, endocrine, and immune systems over the developmental trajectory influence health-risk behaviors? o What explains the differences and similarities in risk taking behavior by age and gender? o What are the genetic predispositions to health risk behavior and how do resilience factors (such as parental attachment and school connectedness) attenuate genetic influences? o Does prenatal exposure to stress and/or teratogens (alcohol, tobacco, drugs of abuse) contribute to the offsprings' propensity to participate in health risk behaviors and, if so, how? o How do individuals identify, evaluate, differentiate, perceive, and internalize the inherent danger of health risk behaviors? o How do biological and experiential influences interact in the process of health risk behavior? How do these interactions change across childhood and by gender? o How does communication (parent/child or peer/peer) influence health risk behaviors? o What interactions occur between sensation, perception of risk, emotion, learning, and memory and how do these interactions influence risk behavior? o What roles do physiologic states and changes induced by pain, sleep deprivation, level of arousal, and exposure to drugs or hormones play in health risk behaviors? o What effect does stress have on health risk behavior? (2) Psychological Influences on Substance Abuse, Physical Inactivity and Poor Dietary Practices, and Injuries o What roles do metacognitive insight, risk perception, attention, beliefs, cognition, decision making, judgment, memory, self-regulation, sensation seeking, prosocial activity, goal setting, spirituality, and moral values play in risky behavior? o What is the role of prior experiences in current and future health risk behavior? o What are the roles of aggression, impulsivity, and antisocial behavior in risk behavior? o Can the developmental timeline for risk factors be shortened? o What is the role of emotion (including reactivity and regulation) and how does the goal to elicit positive emotions or to avoid negative emotions affect an individual's current state of mind and willingness to participate in risk behavior? o What is the role of orientation to present versus future in risk behavior? o How can researchers study risk behavior under real world social and emotional conditions? (3) Contextual Influences on Substance Abuse, Physical Inactivity and Poor Dietary Practices, and Injuries o What roles do contextual factors play in health risk behaviors? o How do parenting styles and behaviors, culture, and the socialization process influence children's health risk behavior? o What bi-directional effects on risky behavior occur as a result of the clash between parenting style and child's temperament? How are these conflicts between parenting style and child's temperament tempered by time and experience? o What impact do social and contextual factors have on biological factors that influence health risk behavior? o Which environmental groups (peer, family, and other social groups) influence health risk behavior and how? o How and why do resilience factors develop and can they be promoted at earlier ages? o What is the role of environmental feedback in risk behavior? o How do environmental opportunities (gangs, cliques, money, social capital) promote or prevent risk behaviors? How critical is timing and type of opportunity? o What is the role of the media in promoting health risk behavior and how can this be counteracted during childhood and adolescence? o What are the essential elements (content, delivery, deliverer, timing) in effective health promotion messages and programs? o How can health promotion messages be tailored effectively for younger children? What are the roles of reinforcement (booster) messages to prevent future risk behavior? (4) Co-occurring Health Behaviors o Which health risk behaviors co-occur and co-vary in youth and why? o What linkages exist between healthy and unhealthy behaviors during childhood and adolescence? o What are the connections between multiple unhealthy behaviors? o Which co-occurring mental health conditions are associated with health risk behaviors in youth and what is the relationship? o Are health risk behaviors more common in children with disorders of attention, emotion regulation, or learning and, if so, why? MECHANISM OF SUPPORT This PA will use the NIH Research Project Grant (R01) and Exploratory/Developmental Grant (R21) award mechanisms. As an applicant, you will be solely responsible for planning, directing, and executing the proposed project. The R01 should be used for full-scale research projects. The Exploratory/Developmental Grant (R21) is intended to encourage new exploratory and developmental research projects, including high risk research that may lead to a breakthrough in a particular area, or to the development of novel techniques, agents, methodologies, models or applications that could have major impact on biomedical, behavioral, or clinical research. Examples include feasibility testing for a novel area of investigation or a new experimental system with potential to enhance health-related research, and the unique and innovative use of an existing methodology to explore a new scientific area. For the R21 award, the applicant may request a project period of up to two years with a combined budget for direct costs of up $275,000 for the two-year period. For example, the applicant may request $100,000 in the first year and $175,000 in the second year. The request should be tailored to the needs of the project. Normally, no more than $200,000 may be requested in any single year. The NIH Exploratory/Developmental Award is explained in detail at http://grants.nih.gov/grants/guide/pa-files/PA-03-107.html. This PA uses just-in-time concepts. It also uses the modular as well as the non-modular budgeting formats (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 format. Otherwise follow the instructions for non- modular research grant applications. This program does not require cost sharing as defined in the current NIH Grants Policy Statement at http://grants.nih.gov/grants/policy/nihgps_2001/part_I_1.htm. 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 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 his/her institution to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH programs. WHERE TO SEND INQUIRIES We encourage your inquiries concerning this PA and welcome the opportunity answer questions from potential applicants. Inquiries may fall into two areas: scientific/research and financial or grants management issues: o Direct your questions about scientific/research issues to: Lynne Haverkos, M.D., M.P.H. Center for Research for Mothers and Children National Institute of Child Health and Human Development 6100 Executive Boulevard, 4B05, MSC 7510 Bethesda, MD 20892-7510 Telephone: (301) 435-6881 FAX: (301) 480-0230 Email: haverkol@mail.nih.gov Louise C. M sse, Ph.D. Division of Cancer Control and Population Sciences National Cancer Institute 6130 Executive Boulevard, Room 4076, MSC 7335 Bethesda, MD 20892-7335 Telephone: (301) 435-3961 FAX: (301) 480-2087 Email: massel@mail.nih.gov Charlotte Pratt, Ph.D., R.D. Division of Epidemiology and Clinical Applications National Heart, Lung and Blood Institute 6701 Rockledge Drive, Room 8134, MSC 7936 Bethesda, MD 20892-7936 Telephone: (301) 435-0382 FAX: (301) 480-1669 Email: prattc@nhlbi.nih.gov Cherry Lowman, Ph.D. Division of Treatment and Recovery Research National Institute on Alcohol Abuse and Alcoholism 5635 Fishers Lane, Room 2051, MSC 9304 Bethesda, MD 20892-9304 Telephone: (301) 443-0637 FAX: (301) 443-8774 Email: clowman@niaaa.nih.gov Kathleen Etz, Ph.D. Division of Epidemiology, Services, and Prevention Research National Institute on Drug Abuse 6001 Executive Boulevard, Room 5163, MSC 9589 Rockville, MD 20892-9589 Telephone: (301) 443-1514 FAX: (301) 443-2636 Email: etzk@mail.nih.gov Yvonne Bryan, Ph.D., R.N. Office of Extramural Programs National Institute of Nursing Research 6701 Democracy Boulevard, Room 710, MSC 4870 Bethesda, MD 20892-4870 Telephone: (301) 594-6908 FAX: (301) 480-8260 Email: bryany@mail.nih.gov o Direct your questions about financial or grants management matters to: Lisa Moeller Grants Management Branch National Institute of Child Health and Human Development 6100 Executive Boulevard, 8A17, MSC 7510 Bethesda, MD 20892-7510 Telephone: (301) 496-5482 FAX: (301) 402-0915 Email: moellerl2@mail.nih.gov Aida Vasquez Grants Administration Branch National Cancer Institute Executive Plaza South, Room 243, MSC 7150 Bethesda, MD 20892-7150 Telephone: (301) 496-2736 FAX: (301) 496-8601 Email: vasquez@mail.nih.gov Kieran Kelley Senior Grants Management Specialist National Heart, Lung and Blood Institute 6701 Rockledge Drive, Room 7170, MSC 7926 Bethesda, MD 20892-7926 Telephone: (301) 435-0154 FAX: (301) 480-3310 Email: kelleyk@nhlbi.nih.gov William Caputo Grants Management Branch National Institute on Alcohol Abuse and Alcoholism 5635 Fishers Lane, Room 3027, MSC 9304 Bethesda, MD 20892-9304 Telephone: (301) 443-2434 FAX: (301) 443-3891 Email: bcaputo@mail.nih.gov Gary Fleming Grants Management Branch National Institute on Drug Abuse 6101 Executive Boulevard, Suite 242, MSC 8403 Bethesda, MD 20892-8403 Telephone: (301) 443-6710 FAX: (301) 594-6849 Email: gf6s@nih.gov Lawrence Haller Office of Grants/Contract Management National Institute of Nursing Research 6701 Democracy Boulevard, Room 710, MSC 4870 Bethesda, MD 20892-4870 Telephone: (301) 402-1878 FAX: (301) 451-5652 Email: hallerl@mail.nih.gov SUBMITTING AN APPLICATION Applications must be prepared using the PHS 398 research grant application instructions and forms (rev. 5/2001). Applications must have a Dun and Bradstreet (D&B) Data Universal Numbering System (DUNS) number as the Universal Identifier when applying for Federal grants or cooperative agreements. The DUNS number can be obtained by calling (866) 705-5711 or through the web site at http://www.dunandbradstreet.com/. The DUNS number should be entered on line 11 of the face page of the PHS 398 form. The PHS 398 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: Instructions contained in the NIH Exploratory/Developmental Grant Program Announcement (http://grants.nih.gov/grants/guide/pa-files/PA-03-107.html) should be followed when submitting an R21 application. APPLICATION RECEIPT DATES: Applications submitted in response to this program announcement will be accepted at the standard application deadlines, which are available at http://grants.nih.gov/grants/dates.htm. Application deadlines are also indicated in the PHS 398 application kit. 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. 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 six 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 mailed on or before the receipt dates described at http://grants.nih.gov/grants/funding/submissionschedule.htm. The CSR will not accept any application in response to this PA that is essentially the same as one currently pending initial review unless the applicant withdraws the pending application. The CSR will not accept any application that is essentially the same as one already reviewed. This does not preclude the submission of a substantial revision of an 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 eight weeks. PEER REVIEW PROCESS Applications submitted for this PA will be assigned on the basis of established PHS referral guidelines. An appropriate scientific review group convened in accordance with the standard NIH peer review procedures (http://www.csr.nih.gov/refrev.htm) will evaluate applications for scientific and technical merit. As part of the initial merit review, all applications will: o Undergo a selection process in which only those applications deemed to have the highest scientific merit, generally the top half of applications under review, will be discussed and assigned a priority score o Receive a written critique o Receive a second level review by 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 (http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm). (See criteria included in the section on Federal Citations, below.) 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.) 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. BUDGET: The reasonableness of the proposed budget and the requested period of support in relation to the proposed research. AWARD CRITERIA Applications submitted in response to a PA will compete for available funds with all other recommended applications. The following will be considered in making funding decisions: o Scientific merit of the proposed project as determined by peer review o Availability of funds o Relevance to program priorities REQUIRED FEDERAL CITATIONS HUMAN SUBJECTS PROTECTION: Federal regulations (45CFR46) require that applications and proposals involving human subjects must be evaluated with reference to the risks to the subjects, the adequacy of protection against these risks, the potential benefits of the research to the subjects and others, and the importance of the knowledge gained or to be gained (http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm). 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 is 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. 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.health.gov/healthypeople. 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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