EPIDEMIOLOGY OF DRUG ABUSE RELEASE DATE: May 3, 2004 PA NUMBER: PA-04-100 December 8, 2006 - The R01 portion of this funding opportunity has been replaced by PA-07-118, which now uses the electronic SF424 (R&R) application for February 5, 2007 submission dates and beyond.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 R03 (PA-06-330) and R21 (PA-06-329) funding opportunity announcements have been issued for the submission date of June 1, 2006 and submission dates for AIDS and non-AIDS applications thereafter. Expiration Date for R03 and R21 Non-AIDS Applications: March 2, 2006 Expiration Date for R03 and 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 ORGANIZATION: National Institutes of Health (NIH) (http://www.nih.gov) COMPONENT OF PARTICIPATING ORGANIZATION: National Institute on Drug Abuse (NIDA) (http://www.nida.nih.gov) CATALOG OF FEDERAL DOMESTIC ASSISTANCE NUMBER: 93.279 THIS PROGRAM ANNOUNCEMENT (PA) CONTAINS THE FOLLOWING INFORMATION o Purpose of the 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 Supplementary Instructions o Peer Review Process o Review Criteria o Award Criteria o Required Federal Citations PURPOSE OF THIS PA This program announcement (PA) replaces PA-99-002, Epidemiologic Research on Drug Abuse, published in the NIH Guide, October 2, 1998; PA-99-113, Drug Use and Related Adverse Behavioral and Social Consequences, published in the NIH Guide, June 18, 1999; and PAR-99-168, Research on the Origins and Pathways to Drug Abuse. This new PA encourages a broad range of epidemiologic research on drug use, abuse, and dependence. It highlights new areas for research that emphasize the vital public health role of epidemiologic research in drug abuse. The major goal of this PA is to stimulate innovative investigations that enhance our understanding of: (1) drug use patterns and trends within and across populations; (2) interplay of social interactions, social environment, structural context with individual behavioral characteristics and genetic vulnerability; (3) the phenotypic heterogeneity of drug abuse; (4) causal mechanisms leading to onset, maintenance, and remittance of drug abuse, as well as protective mechanisms that reduce the risk of drug abuse; and (5) drug abuse over the life course, including developmental processes that influence drug use trajectories and behavioral, health, and social consequences of drug abuse. In addition, research is encouraged to develop methodologies to improve the accuracy, efficiency, scope, timeliness, and analytic yield of drug abuse epidemiologic data. Because of the breadth of epidemiology research, applications are anticipated to reflect diverse and multidisciplinary putative approaches and multiple levels of causation. To take advantage of the strength of specific research fields in an efficient manner, and to maximize the generalizability of findings, researchers are encouraged to develop and/or incorporate innovations in epidemiologic study design. Such designs may include nesting of biological and/or basic research, contextual analysis, and contemporary longitudinal analyses. RESEARCH OBJECTIVES Background Drug abuse epidemiologic research focuses on understanding the nature, extent, consequences, and etiology of drug abuse across individuals, families, age groups, gender, communities, and population groups. Epidemiologic research plays a critical public health role by providing an estimate of the magnitude, impact, and risk of drug abuse on a population, and by laying the foundation for developing strategies to prevent drug abuse, plan and evaluate drug abuse services, and suggest new areas for basic, clinical, and treatment research. The natural history of drug abuse can be observed most validly in epidemiologic studies and the population-based approach provides specific advantages over research relying on samples of convenience, such as clinical samples, by reducing the potential for selection bias in observed associations while enhancing generalizability. There are, however, limitations to epidemiologic research. Large sample sizes can pose difficulties in terms of time and cost to obtain intensive and detailed measures, particularly over extended periods of time. Also, the observational nature of much epidemiologic drug abuse research limits experimental control and manipulation of variables under study. However, underutilized applications in epidemiologic study design, such as nested case control studies, enable integration of focused intensive measurement in the context of epidemiologic research. It is also possible to draw epidemiologically informative samples, based on specific characteristics, for recruitment into laboratory-based research. Although collaboration between laboratory-based and epidemiologic research is becoming more widespread in other areas of health research, it is less common in the field of drug abuse research. This PA encourages innovative research that incorporates the strengths of epidemiologic and laboratory-based designs. Recent advances in health science research have connected biological and genetic factors across the spectrum of diseases including drug abuse and addiction. For diseases with a substantial environmental component, however, biology and genetics are not sufficient to explain or predict disease patterns. In order to better understand the epidemiology of drug abuse and its consequences within and across populations, research is encouraged on the influence of social and cultural factors on the initiation and progression of drug use among population groups. Novel conceptualization and measurement of social and cultural contexts within theoretically grounded research are important to the advancement of drug abuse research. Increased understanding of how genetic, biological, social, and contextual phenomena interact to influence behavior will inform prevention and treatment for individuals at risk for drug abuse. Crosscutting Issues Research indicates that there are significant gender-specific differences in biological factors in drug abuse, antecedents and consequences of drug abuse, and responses to prevention and treatment. Investigators should, wherever germane, include adequate numbers of both male and female subjects in their studies in order to make meaningful gender comparisons. Researchers are also encouraged to design studies to explore gender differences in the nature and extent of drug-using behaviors, in the pathways and determinants of initiation, progression and maintenance of drug abuse, and the behavioral and social consequences of drug abuse. For more information on research on this topic, see the Women, Gender Differences and Drug Abuse PA http://grants.nih.gov/grants/guide/pa-files/PA-03-139.html. HIV/AIDS and drug abuse are frequently referred to as twin epidemics, and whenever possible, it is essential that epidemiologic studies address this interrelationship. Investigators are encouraged to incorporate appropriate measures and analyses of factors critical to understanding the transmission of HIV/AIDS and other sexually transmitted diseases (STDs), Hepatitis (HCV and HCB), and Tuberculosis (TB), as well as related disparities across different population groups. The aim is to promote integrated approaches to understanding and addressing interactions between individuals and environments that contribute to the continuum of problems related to drug abuse, including HIV/AIDS. For more information on research on this topic, see http://hiv.drugabuse.gov and http://www.drugabuse.gov/MeetSum/HIVworkshop.html. Research shows that minority groups, particularly Blacks and Hispanics, are in some instances less likely to use licit or illicit drugs, but that such groups tend to be over-represented among those who suffer from adverse health, behavioral, and social consequences related to drug use (e.g., HIV/AIDS, premature births, intentional and unintentional injuries, violence, crime, etc.). Epidemiologic research is clearly needed to inform prevention and intervention strategies aimed at reducing and eliminating drug-related health disparities, as well as services research on access, utilization, and retention of racial and ethnic minority populations in drug abuse treatment. This announcement therefore encourages research that focuses on identifying risk factors and consequences that are unique to or more prevalent in subpopulations in socioeconomically disadvantaged (i.e., low education level, poverty) and medically underserved rural and urban communities. For more on NIDA’s interest in this topic, see http://www.drugabuse.gov/StrategicPlan/HealthStratPlan.html. Advances in the field of drug abuse epidemiology will require innovations in statistical, epidemiologic, sociologic, and genetic epidemiologic designs to meet challenges in the rapidly evolving drug abuse field. This announcement encourages methodological innovations that address transitions in stages and trajectories of drug abuse, intergenerational transmission of drug abuse, and heterogeneous pathways to and consequences of drug abuse. Especially encouraged are approaches that facilitate: (a) nested case-control and case- cohort designs that efficiently combine the advantages of epidemiologic samples with more intensive laboratory-based and biological measures, (b) innovations in measurement such as real-time measures of drug abuse through the use of handheld devices, and (c) secondary analyses of existing epidemiologic data sets that contain high-quality information about drug abuse. For more information on research using secondary analyses, particularly research on psychopathology vulnerability for drug abuse, see the Risk Factors for Psychopathology using Secondary Data Sets PA http://grants.nih.gov/grants/guide/pa-files/PA-03-044.html. Major Program Areas The epidemiologic drug abuse research program is further organized into major program areas that are described below. It is important to note that the crosscutting issues of gender, HIV/AIDS, health disparities, and methodological innovations apply across all of these topics. Examples of the types of research topics include, but are not limited to, the following: o Emerging and current trends o Social epidemiology of drug abuse o Familial/genetic liability and phenotypic heterogeneity o Drug abuse psychopathology: comorbidity and vulnerability o Human development in adolescence and adulthood o Developmental consequences of drug abuse o Social and behavioral consequences of street drugs o Drug markets and behavior economics Emerging and current trends Research directed at examining drug abuse trends is particularly important in the contemporary context where a variety of new substances are available to increasingly diverse populations and in an expanding range of settings. Changing availability and changing social and cultural trends influence patterns of use. Research continues to reveal new drug use trends and issues warranting further exploration such as the high level of abuse of prescription drugs, patterns of use of drugs in combination, and the association between non-injection drug use and HIV-risk behaviors in some contexts. This program of research encourages: (a) studies that develop more effective and timely ways to identify the nature, extent, and changes of new trends at an early stage within local, national and international contexts, and to identify associated health, social and behavioral consequences; (b) theory-driven research models for understanding the diffusion of drug trends into new populations including the impact of cultural factors, social networks, drug distribution mechanisms and media; (c) exploratory descriptive hypothesis-generating ethnographic studies as well as analytic studies that examine factors impacting initiation, continuation, progression and cessation of use of novel drugs; (d) studies that examine the relation between the use of novel drugs and HIV-risk behaviors; (e) research into whether users of these new substances experience substance use disorders; and (f) innovative studies to improve methods for characterizing drug use behaviors such as, for example, the use of different substances strategically in combination or in sequence within specified periods of time. Social epidemiology of drug abuse Drug abuse research has focused largely on individual risk factors, while the universe of determinants includes individual, familial, neighborhood, community, population-specific, and societal factors. There is urgent need to extend drug abuse research to incorporate the concept of interactivity (individual susceptibility interacting with social environment, genetic environment, neighborhood environment) and cumulative history (how these determinants differentially impose risk across time, generations, and the life course). This program specifically encourages: (a) studies that examine the interaction of individual and social environmental factors on drug use/abuse/dependence; (b) studies that consider both immediate and cumulative (life-course and trans- generational) effects of interactions among drug abusing behaviors, environments, and genes; (c) studies that draw upon current research on the effects of social environmental factors on health and disease in general; (d) research that identifies whether and how the environment as culture can be meaningfully disaggregated into measurable components and tested for effects on drug abuse; (e) studies that inform the debate on which aspects or dimensions of the social environment (e.g., society, social institution, small group, dyad) also should be included, when they should be included, and how they should be measured; (f) investigations of the collective impact of neighborhood factors such as residential stability/instability, collective efficacy, social cohesion or other aspects of locally shared environments on drug abuse among different groups; and (g) studies of how social and cultural factors influence or predict drug use/abuse and its consequences. Familial/genetic liability and phenotypic heterogeneity Numerous genetic epidemiologic studies confirm that drug abuse "runs" in families, and that such transmission is due in part to genetic factors. These findings have been tremendously important, and have set the stage for additional research to specify drug abuse phenotype(s) and gene-by-environment interactions inherent to complex disorders such as drug abuse. Indeed, untangling the complicated pathways from genotypes to phenotypes is one of the biggest challenges in the drug abuse field. The objective of this program area is to further explicate the transmissibility of drug abuse phenotypes and to explicate individual differences, familial processes, and social/environmental factors that confer and/or protect against the expression of genetic liability. This program area encourages research on the following topics: (a) the refinement of drug abuse phenotypes and nosology to inform prevention, services, and molecular genetic research; (b) identification of key individual and environmental characteristics that affect genetic vulnerability and/or the course of drug abuse, including psychopathological conditions; (c) clarification of gene-environment interactions for fine-tuning preventive interventions with high-risk populations; (d) studies that inform the debate on the general liability versus specificity of genetic risk for drug abuse; (e) genetically- informative assessments that are nested within epidemiologic-based studies; (f) development of statistical and analytic approaches to model complex disorders and traits. Drug abuse psychopathology: comorbidity and vulnerability Cross-sectional and longitudinal studies of adolescents and adults in both clinical and general populations have found high rates of co-occurrence between drug abuse and psychiatric disorders, particularly the conduct/antisocial disorders and the mood disorders. Far fewer studies have examined the temporal order or causal relationships, including potentially common pathways, for specific psychiatric disorders and drug abuse. Thus, the nature of the association among psychiatric and drug use disorders remains unclear. Understanding the relations between precursor and comorbid psychiatric disorders and drug abuse is the focus of this program and has important prevention and treatment implications. Specifically, this program of research encourages studies that focuses on: (a) child psychiatric precursors to drug abuse, with a particular emphasis on attentional, externalizing, and internalizing disorders; (b) the impact of mental health interventions on drug abuse risk; (c) moderating and mediating factors that can inform the association between psychiatric disorders and drug abuse; (e) temperament and personality, particularly behavioral disinhibition, as stand-alone etiologic or potential mediating factors; and (f) dynamic relations between the timing and course of psychiatric illness and the timing and course of drug abuse, including drug use initiation, maintenance, escalation, and remittance. Towards this end, research approaches of particular interest to this program include: epidemiologic (population-based) cross-sectional and longitudinal studies, genetic epidemiologic and other studies of familial risk, clinical prospective and clinical follow-up studies, innovative designs that characterize the interactions between individual psychiatric and genetic factors with the environment, nested studies, and secondary data analyses. For additional information related to psychopathology vulnerability for drug abuse, see http://www.drugabuse.gov/Meetings/Childhood. Human development in adolescence and adulthood This program focuses on three key adolescent developmental issues that have relevance for drug abuse: timing, transitions, and biologic maturation. The developmental stage when drugs are introduced has implications for drug abuse, as evidenced by recent research showing that initiation during early developmental periods is associated with greater subsequent use. Similarly, developmental transitions (e.g., pubertal, cognitive, social, and achievement related), and individual variation in the timing of these, are also likely to influence trajectories of use. Studies of particular interest under this program include, but are not limited to, those that assess: (a) how developmental timing and the timing of drug use act and interact to influence the course of drug using behavior and related outcomes; (b) the implications of emerging cognitive, emotional, and social capacities across developmental periods for drug abuse; (c) the impact of the adoption of stage-specific roles on drug abuse and the impact of drug abuse on the adoption of such roles; (d) the creation of new or implementation of existing methodologic approaches that adequately capture the developmental nature of individual change; (e) real-time assessment methodologies to capture the capricious and context-dependent nature of drug using behaviors over developmental periods; and (f) translational research including epidemiologic studies that incorporate lab-based findings on adolescent brain development, measures of shifts in emotional and cognitive processes, and assessments of biological changes associated with puberty. Developmental consequences of drug abuse This program focuses on the effects of parental drug abuse and its consequences (e.g., family violence, child maltreatment) on child development. Parent drug abuse may influence children’s development through direct and indirect pathways. Direct pathways include genetic transmission of vulnerability to substance use disorders and prenatal exposure to drugs. Parent substance abuse can also indirectly impact development through its effect on children’s environments. Longitudinal, prospective, and multidisciplinary studies are needed to investigate the independent and combined contributions of biologic/genetic, psychosocial, and contextual factors that influence the development of children. Child populations at heightened risk for drug abuse (e.g., homeless youth, children in foster care) are of particular interest. This program of research encourages studies that focus on factors related to parent drug abuse, as they relate to children’s drug abuse and other developmental outcomes as well as the processes by which these factors influence child development. This program of research specifically encourages: (a) independent and combined effects of parental drug abuse, family violence and child maltreatment; (b) effects of exposure to lifestyles associated with illicit drug activities; (c) effects of forced parent-child separations due to parental drug related illness, death or imprisonment; (d) post-traumatic stress disorder (PTSD) affecting the child and parental drug abuse, family violence, and/or child maltreatment; and (e) child characteristics and family dynamics that contribute to associations between parental drug abuse and child maltreatment and between parental drug abuse, family violence and/or child maltreatment and related child outcomes. Social and behavioral consequences of street drugs This program examines the range of behavioral and social consequences arising from street-level drug abuse. Behavioral consequences include educational and occupational problems, crime and violence, and comorbid conditions (overdose, suicide, cognitive impairment). Social consequences include drug trafficking and distribution, gang activities, family disruption, and neighborhood dysfunction. Little attention has been given to how abuse of particular drugs and combinations of drugs affects these consequences. Understanding retail street drug activity and consumption patterns is key to understanding drug distribution networks and drug price/purity and availability. Data are available on the frequency of drug use, but better estimates of drug price/purity, and a better understanding of the quantity of drug used are sorely needed. Specifically, the street-level drugs program encourages research on: (a) what, how much, and how often drugs are actually consumed by drug users; (b) which adulterants, diluents, and contaminants are present in retail drugs; (c) the patterns of use of different drugs, including teasing apart patterns of polydrug use; (d) economic analyses to understand issues such as price/purity, consumption, and cross-elasticities; (e) small-scale epidemiologic studies could characterize price, demand, and consequences at the level of a city or other small geographic area; and (f) ethnographic studies to describe price and availability effects on behavior of those who use, abuse, or are dependent to explore whether elasticity of demand varies with severity of drug use. Drug markets and behavior economics Research increasingly points to the importance of studying drug abuse as the behavior of individuals in their environments. While the immediate (proximal) environments of drug abusers have received considerable research attention, the context of broader and more distal environmental influences have received less consideration. Principles of behavior derived from more macro-environmental disciplines, particularly economics, have great potential for expanding understanding of the full set of influences on drug abuse. It is important to examine the intersection of psychological, economic and environmental concepts and findings and their relevance to drug abuse etiology, continuation, relapse and hopefully, more effective preventive and treatment interventions. By applying the research and perspectives of behavioral economics, marketing research, drug availability market factors, the psychology of decision making and other related areas, important but understudied pieces of the drug abuse puzzle will be investigated. The following issues are of particular interest: (a) nested case control studies within larger epidemiologic studies that enable laboratory-based behavioral economic analysis of defined populations; (b) research on the influence of environmental factors on behavioral economic measures such as delayed discounting functions or impulsivity and risk taking; and (c) interactions among broad social forces (e.g., neighborhood quality and socioeconomic status), racial and ethnic health disparities, and drug abuse trajectories and consequences. MECHANISMS OF SUPPORT This PA will use the NIH research grant (R01) award mechanism, NIH small grant award (R03), and the NIH exploratory/developmental award (R21). The applicant will be solely responsible for planning, directing, and executing the proposed project. This PA uses just-in-time concepts. It also uses the modular budgeting 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 budget format. Otherwise follow the instructions for non-modular budget research grant applications. This program does not require cost sharing as defined in the current NIH Grants Policy Statement at http://grants.nih.gov/grants/policy/nihgps_2001/part_i_1.htm. ELIGIBLE INSTITUTIONS You may submit (an) application(s) if your institution has any of the following characteristics: o For-profit or non-profit organizations o Public or private institutions, such as universities, colleges, hospitals, and laboratories o Units of State and local governments o Eligible agencies of the Federal government o Domestic or foreign institutions/organizations o Faith-based or community-based organizations INDIVIDUALS ELIGIBLE TO BECOME PRINCIPAL INVESTIGATORS Any individual with the skills, knowledge, and resources necessary to carry out the proposed research is invited to work with their institution to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH programs. 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 two areas: scientific/research and financial or grants management issues: o Direct your questions about scientific/research issues to: Yonette Thomas, Ph.D. Division of Epidemiology, Prevention, and Services Research National Institute on Drug Abuse/NIH/DHHS 6001 Executive Boulevard, Room 5169, MSC 9589 Bethesda, MD 20892-9589 Rockville, MD 20852 (for express/courier service) Telephone: 301-402-1910 Fax: (301) 480-2543 Email: yuthomas@mail.nih.gov o Direct your questions about financial or grants management matters to: Gary Fleming, J.D. National Institute on Drug Abuse/NIH/DHHS 6101 Executive Boulevard, Room 270, MSC 8403 Bethesda, MD 20892-9605 Rockville, MD 20852 (for express/courier service) Telephone: (301) 443-6710 FAX: (301) 594-6849 Email: gfleming@nida.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. 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 BUDGET GRANT APPLICATIONS: Applications requesting up to $250,000 per year in direct costs must be submitted in a modular budget grant format. The modular budget grant format simplifies the preparation of the budget in these applications by limiting the level of budgetary detail. Applicants request direct costs in $25,000 modules. Section C of the research grant application instructions for the PHS 398 (rev. 5/2001) at http://grants.nih.gov/grants/funding/phs398/phs398.html includes step-by-step guidance for preparing modular grants. Additional information on modular grants is available at http://grants.nih.gov/grants/funding/modular/modular.htm. SPECIFIC INSTRUCTIONS FOR APPLICATIONS 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 IC program staff at least 6 weeks before submitting the application, i.e., as you are developing plans for the study; 2) Obtain agreement from IC staff that IC will accept your application for consideration for award; and, 3) Identify, in a cover letter sent with the application, the staff member at NIDA 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 unfunded version of an application already reviewed, but such application must include an Introduction addressing the previous critique. Although there is no immediate acknowledgement of the receipt of an application, applicants are generally notified of the review and funding assignment within 8 weeks. PEER REVIEW PROCESS Applications submitted for this PA will be assigned on the basis of established PHS referral guidelines. Appropriate scientific review groups convened in accordance with the standard NIH peer review procedures (http://www.csr.nih.gov/refrev.htm) will evaluate applications for scientific and technical merit. As part of the initial merit review, all applications will: o Undergo a selection process in which only those applications deemed to have the highest scientific merit, generally the top half of applications under review, will be discussed and assigned a priority score o Receive a written critique o Receive a second level review by an appropriate national advisory council or board. REVIEW CRITERIA The goals of NIH-supported research are to advance our understanding of biological systems, improve the control of disease, and enhance health. In the written comments, reviewers will be asked to evaluate application in order to judge the likelihood that the proposed research will have a substantial impact on the pursuit of these goals. The scientific review group will address and consider each of the following criteria in assigning the application’s overall score, weighting them as appropriate for each application. o Significance o Approach o Innovation o Investigator o Environment The application does not need to be strong in all categories to be judged likely to have major scientific impact and thus deserve a high priority score. For example, an investigator may propose to carry out important work that by its nature is not innovative but is essential to move a field forward. SIGNIFICANCE: Does this study address an important problem? If the aims of the application are achieved, how will scientific knowledge be advanced? What will be the effect of these studies on the concepts or methods that drive this field? APPROACH: Are the conceptual framework, design, methods, and analyses adequately developed, well-integrated, and appropriate to the aims of the project? Does the applicant acknowledge potential problem areas and consider alternative tactics? INNOVATION: Does the project employ novel concepts, approaches or methods? Are the aims original and innovative? Does the project challenge existing paradigms or develop new methodologies or technologies? INVESTIGATOR: Is the investigator appropriately trained and well suited to carry out this work? Is the work proposed appropriate to the experience level of the principal investigator and other researchers (if any)? ENVIRONMENT: Does the scientific environment in which the work will be done contribute to the probability of success? Do the proposed experiments take advantage of unique features of the scientific environment or employ useful collaborative arrangements? Is there evidence of institutional support? ADDITIONAL REVIEW CRITERIA: In addition to the above criteria, the following items will be considered in the determination of scientific merit and the priority score: PROTECTION OF HUMAN SUBJECTS FROM RESEARCH RISK: The involvement of human subjects and protections from research risk relating to their participation in the proposed research will be assessed. (See criteria included in the section on Federal Citations, below). http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm INCLUSION OF WOMEN, MINORITIES AND CHILDREN IN RESEARCH: The adequacy of plans to include subjects from both genders, all racial and ethnic groups (and subgroups), and children as appropriate for the scientific goals of the research will be assessed. Plans for the recruitment and retention of subjects will also be evaluated. (See Inclusion Criteria in the sections on Federal Citations, below). CARE AND USE OF VERTEBRATE ANIMALS IN RESEARCH: If vertebrate animals are to be used in the project, the five items described under Section f of the PHS 398 research grant application instructions (rev. 5/2001) will be assessed. ADDITIONAL REVIEW CONSIDERATIONS Sharing Research Data Applicants requesting more than $500,000 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 are available at http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm. The amended policy incorporates: the use of an NIH definition of clinical research; updated racial and ethnic categories in compliance with the new OMB standards; clarification of language governing NIH-defined Phase III clinical trials consistent with the new PHS Form 398; and updated roles and responsibilities of NIH staff and the extramural community. The policy continues to require for all NIH-defined Phase III clinical trials that: a) all applications or proposals and/or protocols must provide a description of plans to conduct analyses, as appropriate, to address differences by sex/gender and/or racial/ethnic groups, including subgroups if applicable; and b) investigators must report annual accrual and progress in conducting analyses, as appropriate, by sex/gender and/or racial/ethnic group differences. INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS: The NIH maintains a policy that children (i.e., individuals under the age of 21) must be included in all human subjects research, conducted or supported by the NIH, unless there are scientific and ethical reasons not to include them. All investigators proposing research involving human subjects should read the "NIH Policy and Guidelines" on the inclusion of children as participants in research involving human subjects that is available at http://grants.nih.gov/grants/funding/children/children.htm. REQUIRED EDUCATION ON THE PROTECTION OF HUMAN SUBJECT PARTICIPANTS: NIH policy requires education on the protection of human subject participants for all investigators submitting NIH proposals for research involving human subjects. You will find this policy announcement in the NIH Guide for Grants and Contracts Announcement, dated June 5, 2000, at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html. HUMAN EMBRYONIC STEM CELLS (hESC): Criteria for federal funding of research on hESCs can be found at http://stemcells.nih.gov/index.asp and at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-005.html. Only research using hESC lines that are registered in the NIH Human Embryonic Stem Cell Registry will be eligible for Federal funding (see http://escr.nih.gov). It is the responsibility of the applicant to provide, in the project description and elsewhere in the application as appropriate, the official NIH identifier(s)for the hESC line(s)to be used in the proposed research. Applications that do not provide this information will be returned without review. NATIONAL ADVISORY COUNCIL ON DRUG ABUSE RECOMMENDED GUIDELINES FOR THE ADMINISTRATION OF DRUGS TO HUMAN SUBJECTS: The National Advisory Council on Drug Abuse recognizes the importance of research involving the administration of drugs to human subjects and has developed guidelines relevant to such research. Potential applicants are encouraged to obtain and review these recommendations of Council before submitting an application that will administer compounds to human subjects. The guidelines are available on NIDA's Home Page at http://www.nida.nih.gov under the Funding, or may be obtained by calling (301) 443-2755. HIV/AIDS COUNSELING AND TESTING POLICY FOR THE NATIONAL INSTITUTE ON DRUG ABUSE: Researchers funded by NIDA who are conducting research in community outreach settings, clinical, hospital settings, or clinical laboratories and have ongoing contact with clients at risk for HIV infection, are strongly encouraged to provide HIV risk reduction education and counseling. HIV counseling should include offering HIV testing available on-site or by referral to other HIV testing service for persons at risk for HIV infection including injecting drug users, crack cocaine users, and sexually active drug users and their sexual partners. For more information see http://grants.nih.gov/grants/guide/notice-files/NOT-DA-01-001.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.healthypeople.gov/. AUTHORITY AND REGULATIONS: This program is described in the Catalog of Federal Domestic Assistance at http://www.cfda.gov/ and is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement. The NIH Grants Policy Statement can be found at http://grants.nih.gov/grants/policy/policy.htm. The PHS strongly encourages all grant recipients to provide a smoke-free workplace and discourage the use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routine education, library, day care, health care, or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people.

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