PA-01-096: BEHAVIORAL, SOCIAL, MENTAL HEALTH, AND SUBSTANCE ABUSE RESEARCH WITH DIVERSE POPULATIONS

Department of Health
and Human Services (HHS)

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This Program Announcement expires on June 1, 2004, unless reissued. BEHAVIORAL, SOCIAL, MENTAL HEALTH, AND SUBSTANCE ABUSE RESEARCH WITH DIVERSE POPULATIONS Release Date: May 21, 2001 PA NUMBER: PA-01-096 (Reissued as PA-06-218) National Institute of Mental Health (http://www.nimh.nih.gov/) National Institute on Drug Abuse (http://www.nida.nih.gov/) National Institute of Child Health and Human Development (http://www.nichd.nih.gov/) Office of Behavioral and Social Sciences Research (http://obssr.od.nih.gov/) Office of Research on Women"s Health (http://www4.od.nih.gov/orwh/) THIS PA USES "MODULAR GRANT" AND "JUST-IN-TIME" CONCEPTS. THIS PA INCLUDES DETAILED MODIFICATIONS TO STANDARD APPLICATION INSTRUCTIONS THAT MUST BE USED WHEN PREPARING AN APPLICATION IN RESPONSE TO THIS PA. PURPOSE The National Institutes of Health (NIH) is committed to supporting research that will increase scientific understanding of the health status of various population groups and lead to more effective health interventions and services for individuals within those groups. High priority is placed on research with groups that appear to have distinctive health risk profiles but thus far have received insufficient attention from investigators. This Program Announcement (PA) highlights a particular set of such groups: lesbian, gay, bisexual, transgendered, and related populations (designated here as LGBT populations). The National Institute of Mental Health (NIMH), National Institute on Drug Abuse (NIDA), and National Institute of Child Health and Human Development (NICHD) invite submission of grant applications for behavioral, social, mental health, and substance abuse research with LGBT populations. The Office of Behavioral and Social Sciences Research (OBSSR) joins this PA as part of its effort to promote research on the behavioral and social aspects of health and illness, and the Office of Research on Women"s Health (ORWH) joins this PA as part of its effort to promote research that will lead to improved health for women. However, only NIMH, NIDA, and NICHD will provide direct grant support under this PA. Studies relevant to the missions of the three sponsoring Institutes may be proposed within the areas of basic, clinical, intervention, practice, and services research. Projects should make use of the most rigorous current methodologies and, where needed, engage in development and evaluation of new methodologies. This PA was developed in response to recommendations produced at a workshop on New Approaches to Research on Sexual Orientation, Mental Health, and Substance Abuse, which took place on September 27-28, 1999, under the co- sponsorship of NIMH, NIDA, OBSSR, and ORWH. 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, LGBT Populations: Behavioral, Social, Mental Health, and Substance Abuse Research, is related to the priority areas of Mental Health and Mental Disorders and of Substance Abuse. Potential applicants may obtain a copy of "Healthy People 2010" at http://www.health.gov/healthypeople/. ELIGIBILITY REQUIREMENTS Applications may be submitted by domestic and foreign, for-profit and non- profit organizations, public and private, such as universities, colleges, hospitals, laboratories, units of State and local governments, and eligible agencies of the Federal government. Racial/ethnic minority individuals, women, and persons with disabilities are encouraged to apply as principal investigators. MECHANISM OF SUPPORT This PA will use the National Institutes of Health (NIH) research project grant (R01) award mechanism. Responsibility for the planning, direction, and execution of the proposed project will be solely that of the applicant. The total project period for an application submitted in response to this PA may not exceed 5 years. Specific application instructions have been modified to reflect MODULAR GRANT and JUST-IN-TIME streamlining efforts being examined by the NIH. Complete and detailed information on modular grant applications can be found at: http://grants.nih.gov/grants/funding/modular/modular.htm. Potential applicants interested in other award mechanisms are strongly encouraged to consult with program staff at the appropriate Institute or Office listed under INQUIRIES below. RESEARCH OBJECTIVES Background The primary focus of this program announcement is behavioral, social, mental health, and substance abuse research with lesbian, gay, bisexual, transgendered, and related populations. These populations may be characterized as encompassing 2 broad, partially overlapping clusters: o People whose sexual orientation--as manifested in behaviors, attractions, cognitions, or identity--is directed towards the same gender or both genders. This cluster includes, but is not limited to, individuals who describe themselves by terms such as lesbian, gay, and bisexual. o People whose gender-related identity, roles, expression, or behavior or whose reproductive system structure or function are atypical or nonconforming to conventional standards. This cluster includes, among others, people who are transgendered, transsexual, crossdressing, and intersexed. Following recent usage, the term LGBT is adopted here as a general designation for these diverse populations as well as for individuals within these populations. However, grant applicants may adopt other classification frameworks and terminologies as appropriate for their proposed research. Current scientific evidence clearly indicates that the majority of LGBT people do not suffer from clinical disorders. However, recent data from both national health surveys and targeted studies suggest that prevalence rates of affective disorders, tobacco addiction, alcohol abuse, certain forms of drug abuse, and possibly other dysfunctions are higher for LGBT populations (or particular segments of those populations) than for the general population. The data also suggest that LGBTs are more likely than the general population to seek mental health and substance abuse services. But LGBT clients may often fail to receive appropriate and effective services, because many service providers have limited knowledge of or experience in working with LGBTs. Further research is required to clarify the nature, extent, and determinants of mental disorder and substance abuse among LGBTs. Also needed is research that will lead to improved forms of prevention, treatment, counseling, and service delivery for LGBTs. Most LGBT people are exposed to negative stereotyping and other forms of stigmatization, and many also experience overt discrimination, harassment, threats of violence, and actual violence. Even when not leading to clinical disorder or involving bodily injury, these stressful conditions often produce significant psychological discomfort, and may, some evidence suggests, be associated with physical health problems. For some LGBT people, these conditions may also have the effect of restricting opportunities and progress in social, educational, and occupational domains. LGBTs adopt various behavioral and psychological strategies in response to stigmatization and hostility. These strategies range from concealment and inhibition to elaboration of a public identity organized around LGBT status. Such strategies can have multiple consequences, both positive and negative, for the LGBT person’s mental and physical health and subsequent development, and may affect the well-being of others in the person’s family and social environment as well. Further research is needed to better understand how stressful conditions arise in the various contexts of LGBT people’s daily lives and how LGBTs interpret and react to these conditions. Such work must carefully consider the social and cultural structures that LGBTs participate in and are exposed to. Research in this area can guide the development of individual-, group-, and community-level interventions to reduce the occurrence and adverse impacts of threats directed toward LGBTs. The research may also lead to new insights into how people who face stigmatization due to LGBT status (and perhaps other characteristics) can develop and maintain successful coping processes and constructive forms of identity and behavior. In other research areas as well, LGBT populations present behavioral and social scientists with opportunities for developing new hypotheses, models, and approaches. Considerations of the ways in which LGBTs depart from or conform to conventional standards of sexuality and gender, and of how their behaviors and relationships are constrained by current legal and institutional arrangements, can lead to novel perspectives in such areas as: psychological development and individual differences across the lifespan, dynamics of interpersonal relationships, family structure and function, organization and influences of subcultures, demographic patterns, and health- related behaviors. Findings from studies of LGBTs in these areas are likely to have significant implications for general theory and research on behavioral and social processes. They may also suggest new directions for research on mental health and substance abuse in both LGBTs and non-LGBTs. It is important to recognize that LGBT people are highly diverse, varying not only in their specific sexual orientation and gender-related characteristics but also on many other dimensions, including: age, generational cohort, geography, ethnicity/race, culture, family structure, language, socioeconomic class, education, occupation, and physical and mental capacities. All such variations are potentially relevant for the planning, conduct, and interpretation of behavioral, social, mental health, and substance abuse research. Thus, LGBT samples (as well as any non-LGBT comparison samples) should be carefully selected and described, attempts to generalize to other segments of LGBT populations or to other groups should be undertaken cautiously, and methods should be designed and implemented in ways that are scientifically and ethically appropriate for all participants. It is often useful for researchers to consult with knowledgeable members of the particular population groups being investigated, such consultants can provide valuable assistance in framing research issues, designing studies, interpreting results, and ensuring that instruments and procedures are sensitive to the experiences and concerns of the participants. Although this PA refers to LGBT populations broadly, it is appropriate (and often preferable) for investigators to focus on one or a few well-defined segments of those populations. For some topics, studies designed around comparisons among specific LGBT groups are useful. It is not required that all studies engage in comparisons of LGBT with non-LGBT samples. Research is invited in the areas described below. Specific topics and questions may be formulated at the biological, psychological, social, and cultural levels. Studies may employ experimental, observational, survey, clinical, ethnographic, epidemiologic, demographic, modeling, and related methods, as well as methods for ethical, policy, and institutional analysis. While the primary domain is LGBTs in the United States, research with non- U.S. populations is acceptable if the work promises to contribute to scientific understanding of LGBTs in the U.S. Investigators are also referred to other NIH program announcements that address issues related to gender and sexuality, including: PA-00-074, Women"s Mental Health and Gender Differences Research (http://grants.nih.gov/grants/guide/pa-files/PA-00-074.html), PA-00-071, Affiliative Behaviors and HIV/STD Prevention (http://grants.nih.gov/grants/guide/pa-files/PA-00-071.html), and, PAS-00- 136, Demographic Research on Sexual Behaviors Related to HIV (http://grants.nih.gov/grants/guide/pa-files/PAS-00-136.html). Other NIH program announcements and requests for applications can be found in the NIH Guide for Grants and Contracts at: http://grants.nih.gov/grants/guide/index.html. Basic Research Basic research on the behavioral and social characteristics of LGBT people at all stages of the lifespan is invited. Research may also address non-LGBTs who are members of LGBT persons" families, households, and communities or who otherwise have contact with or influence upon LGBTs. Examples of basic research include, but are not limited to: o Studies of the nature and development of sexual orientation and of gender- related identity, roles, expression, body-image, and behavior. o Studies of the influences of sexual orientation and gender identity on personality, affective, communicative, and cognitive processes. o Interpersonal relationships and social networks: Studies of the nature, course, and consequences of LGBT persons" relationships with others (both LGBT and non-LGBT), including friendships, romantic relationships, family relationships, caregiving relationships, and relationships at workplaces, schools, and other institutions. Both supportive and non-supportive (including conflictual) forms of relationships may be examined. Relationship dissolution may also be investigated. In addition, studies of the organization and dynamics of LGBT social networks and how they influence members" individual and social behavior. Investigations may consider the impact of broader cultural and technological influences (e.g., Internet) on the formation and development of relationships and networks. o Families and households that are headed by or include LGBT persons: Studies of their formation, structure, function, internal dynamics, and long- term development, their interactions with extended family, community, and institutions, and the psychological and social development of child and adult members. o Adult development: Studies of LGBT persons expectations, planning, decision-making, and evaluations concerning major conditions and transitions of their adult lives (e.g., education, work, retirement, residence, family, health, bereavement) and of related issues surrounding development of personality, identity, and social roles in adulthood. Research may focus on the content and consequences of LGBTs" conceptions of how their options and status differ from those of members of other groups, as well as consider emerging norms and ideals within particular segments of LGBT populations. o Demographic and socioeconomic characteristics of LGBT populations: Studies of population composition and distribution (in terms of age, geography, ethnicity, and other demographic characteristics), migration (within and across national boundaries), residential patterns, family and household characteristics, reproductive patterns (including fertility, contraceptive use, alternative insemination, and adoption), morbidity and mortality, health care access and usage, educational attainment, employment and retirement patterns, economic status, usage of social services (public and private), interactions with criminal justice system, and related topics. o Multiple minority status: Studies of self-concepts, identity management, and acculturation processes in LGBT persons who also belong to other minority or marginalized groups. o Concealment and disclosure of LGBT status: Studies of the psychological and social processes that determine whether and how individuals conceal or disclose their LGBT status and related information (to various others and across contexts), also, studies of the effects of concealment or disclosure upon other aspects of behavior, identity, experience, and well-being. o Beliefs and attitudes concerning LGBT groups and individuals: Studies of their content, expression, manifestation, determinants, and modifiability, in both LGBTs and non-LGBTs. Investigations may consider the influence of representations of sexual orientation and gender in the mass media and popular culture. o Stigmatization, discrimination, violence, and abuse toward persons perceived to be LGBTs: Studies of the determinants of perpetrators" motivations, behaviors, and self-perceptions, studies of the factors influencing victims" interpretations, responses, and outcomes, and studies of the effects on others who relate to or identify with victims. Investigations may consider how social, cultural, institutional, and legal contexts influence the form of abusive behavior and its aftermath. Mental Health and Substance Abuse: Clinical and Intervention Research Investigations of the characteristics and underlying processes of mental disorder and substance abuse in LGBT people are invited, including studies concerning incidence, prevalence, risk and protective factors, classification, diagnosis, features, course, etiology, outcomes, and recurrence. Also invited is research that will lead to more efficacious preventive, treatment, rehabilitative, and counseling interventions for LGBT people. Examples of relevant research include but are not limited to: o Studies of disorders and dysfunctions that have been hypothesized to be more prevalent among LGBTs or particular sub-groups of LGBTs, including mood, anxiety, personality, conduct, eating, and body dysmorphic disorders, suicidality, and the abuse of tobacco, alcohol, cocaine, anabolic steroids, and club drugs such as methamphetamine, MDMA, ketamine, and GHB/GBL. o Studies of protective and resiliency factors and of coping processes in LGBT people. Potential areas of investigation include: social supports within the family and within LGBT communities, willingness to seek counseling and therapy, and involvement with spirituality or religion. Research may aim to identify disorders or conditions for which LGBTs (or sub-groups) have reduced risk. o Stress and subclinical distress related to LGBT status: Studies of specific causes, manifestations, consequences, and moderating factors. o Studies of the nature, prevalence, and consequences of physical and sexual abuse of LGBT people, during childhood, adolescence, and adulthood. o Studies of current and emerging patterns of substance use and abuse in LGBT communities. Investigations may address: supply and distribution networks, social mechanisms underlying diffusion of particular forms of substance use, and contexts of substance use. o Studies of patterns and determinants of comorbidity among mental disorders, substance abuse, and neurological and physical disorders in LGBT populations. o Studies of mental health and substance abuse issues related to HIV/AIDS and other infectious diseases in LGBT populations. o Development and evaluation of preventive, treatment, and rehabilitative interventions for mental disorders and substance abuse in LGBT people. Interventions may involve behavioral, psychosocial, pharmacological, or other modalities (or combinations), and may be designed for implementation at the individual, group, family, school, or community levels. Efforts may be directed either to developing novel interventions or to adapting existing approaches. o Development of effective support, self-help, counseling, and therapeutic approaches for people in the process of examining, adopting, disclosing, and integrating their LGBT status ("coming out") and for members of their families. o Transsexual persons: Development and evaluation of approaches to psychosocial assessment and counseling for people who are considering, are undergoing, or have completed hormonal or surgical interventions to alter gender-related appearance and function, also, development and evaluation of counseling approaches for family members and partners. Work in this area should be sensitive to ethical issues (e.g., rights and responsibilities of people seeking interventions, criteria for informed consent to interventions) and to the wide range of assumptions and values within contemporary culture regarding gender variability and body modification. o Intersexed persons: Developmental and longitudinal studies of gender status and mental health of persons with congenital or acquired ambiguities of genitalia or internal reproductive organs, including research aimed at clarifying influences of biological, psychological, and social factors, follow-up studies of children and adults who have received hormonal or surgical interventions, studies of ethical issues surrounding hormonal and surgical interventions, including criteria for informed consent, development and evaluation of approaches to psychosocial assessment and counseling for intersexed persons and their families. o Analyses of the validity and utility of such diagnostic categories as gender dysphoria and gender identity disorder, and of proposals for their revision or replacement. o Studies of the efficacy and ethics of interventions aimed at altering sexual orientation or gender identity. Mental Health and Substance Abuse: Practice and Services Research Research is invited that will lead to improved implementation and delivery of preventive, treatment, rehabilitative, and counseling interventions and related services for LGBT people. Studies may address services provided or supervised by any type of professional mental health or substance abuse service provider (including psychiatrists, psychologists, primary care physicians, nurses, counselors, and social workers) and in any type of setting (including hospitals, residential treatment facilities, outpatient clinics, nursing homes, retirement facilities, community centers, schools, workplaces, juvenile facilities, prisons, hotlines, and peer support groups). Strongly encouraged is research concerned with those portions of LGBT populations that tend to have limited access to or choice of mental health and substance abuse services, including those who are lower-income, uninsured, homeless, and incarcerated, as well as adolescents, aging people, ethnic minorities, immigrants and refugees, and people in rural areas. Examples of relevant research include, but are not limited to: o Studies of service providers" knowledge, attitudes, and competence regarding the experiences and concerns commonly reported by LGBT people, development and evaluation of training and knowledge dissemination programs for service providers on LGBT topics. o Studies of the influence of clients" LGBT status on service providers" diagnostic, treatment, and referral decisions. o Studies of patterns and determinants of service utilization and satisfaction by LGBT people. o Studies of the contents and determinants of LGBT people"s beliefs and attitudes about mental disorders and substance abuse and about the nature, effectiveness, and accessibility of various forms of treatment. o Studies of the patterns and quality of communications between service providers and LGBT clients and how communications can be improved. o Studies of accessibility and quality of LGBT-competent services within managed care systems, public health agencies, community health centers, private clinics, and other delivery and financing systems. o Studies to determine factors associated with quality and outcome of services for LGBTs. Factors to be investigated may include: training and experience of providers, client expectations and compliance, household and social supports for client, service delivery setting, specialization of services, coordination with other services, and financing systems. o Development and evaluation of individual-, group-, and community-level interventions aimed at reducing stigmatization and abuse of LGBT people. o Studies of the roles of mental health service providers in treatment planning for transsexual and intersexed persons, including analyses of the appropriate role of mental health providers in recommending and approving hormonal and surgical interventions. o Studies of the impacts on youth and families of policies and practices related to: involuntary hospitalization of LGBT youth by parents/guardians, removal of LGBT youth from parents/guardians custody by child welfare agencies, and removal of youth from custody of LGBT parents/guardians or from households containing LGBT members by child welfare agencies. Methodology Development Development of innovative methodologies for behavioral, social, mental health, and substance abuse research on LGBT topics is strongly encouraged. In general, methodology development should be incorporated into projects focused on substantive research questions, such as outlined in the preceding sections. However, grant applications for projects that have methodology development as their primary aim will be considered if the intended product is likely to have an especially significant and broad impact on research practice. Such projects should include a component in which the new methodology is implemented in an actual study and evaluated for effectiveness, rigor, and practicality. Areas for methodology development include, but are not limited to: o Improved approaches to defining, classifying, operationalizing, and measuring sexual orientation and gender identity. o Improved approaches for involving and maximizing the contributions of LGBT persons in the design and performance of studies conducted within their own communities. o Improved approaches to research design and statistical analysis for studies of LGBTs and other groups that comprise a small proportion of the overall population or are difficult to access. o Improved methods for sampling and obtaining participation from LGBTs (or sub-groups) and appropriate comparison populations in research studies. o Improved methods for defining and assessing informed consent to participate in research and interventions relating to sexual orientation and gender identity. o Improved methods for engaging participants in research involving sensitive and personal topics, obtaining accurate and complete information from them, ensuring privacy and confidentiality, increasing comfort, and detecting and alleviating any distress that arises during and following participation. INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS 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 biomedical and behavioral research projects involving human subjects, unless a clear and compelling rationale and justification are 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 research involving human subjects should read the UPDATED "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research," published in the NIH Guide for Grants and Contracts on August 2, 2000 (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-048.html), a complete copy of the updated Guidelines are available at http://grants.nih.gov/grants/funding/women_min/guidelines_update.htm. The revisions relate to NIH defined Phase III clinical trials and require: a) all applications or proposals and/or protocols to 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) all investigators to report accrual, and to conduct and report analyses, as appropriate, by sex/gender and/or racial/ethnic group differences. INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS It is the policy of NIH that children (i.e., individuals under the age of 21) must be included in all human subjects research, conducted or supported by the NIH, unless there are scientific and ethical reasons not to include them. This policy applies to all initial (Type 1) applications submitted for receipt dates after October 1, 1998. All investigators proposing research involving human subjects should read the "NIH Policy and Guidelines on the Inclusion of Children as Participants in Research Involving Human Subjects" that was published in the NIH Guide for Grants and Contracts, March 6, 1998, and is available at the following URL address: http://grants.nih.gov/grants/guide/notice-files/not98-024.html Investigators also may obtain copies of these policies from the program staff listed under INQUIRIES. Program staff may also provide additional relevant information concerning the policy. NIH GRANTS POLICY STATEMENT The NIH Grants Policy Statement (NIHGPS) has been revised and reissued. The provisions of the revised NIHGPS are effective for all funded NIH grants and cooperative agreements with budget periods beginning on or after March 1, 2001. The revised NIHGPS is available at: http://grants.nih.gov/grants/policy/nihgps_2001. 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. Reviewers are cautioned that their anonymity may be compromised when they directly access an Internet site. APPLICATION PROCEDURES Applicants are strongly encouraged to contact the program contacts listed under INQUIRIES with any questions regarding their proposed project and the goals of this PA. Applications are to be submitted on the grant application form PHS 398 (rev. 4/98) and will be accepted at the standard application deadlines as indicated in the application kit. Application kits are available at most institutional offices of sponsored research and from the Division of Extramural Outreach and Information Resources, National Institutes of Health, 6701 Rockledge Drive, MSC 7910, Bethesda, MD 20892-7910, telephone (301) 710-0267, Email: GrantsInfo@nih.gov. Applications are also available on the World Wide Web at: http://grants.nih.gov/grants/forms.htm. SPECIFIC APPLICATION INSTRUCTIONS FOR MODULAR GRANTS The modular grant concept establishes specific modules in which direct costs may be requested as well as a maximum level for requested budgets. Only limited budgetary information is required under this approach. The just-in-time concept allows applicants to submit certain information only when there is a possibility for an award. It is anticipated that these changes will reduce the administrative burden for the applicants, reviewers and Institute staff. The research grant application form PHS 398 (rev. 4/98) is to be used in applying for these grants, with the modifications noted below. BUDGET INSTRUCTIONS Modular Grant applications will request direct costs in $25,000 modules, up to a total direct cost request of $250,000 per year. (Applications that request more than $250,000 direct costs in any year must follow the traditional PHS 398 application instructions.) The total direct costs must be requested in accordance with the program guidelines and the modifications made to the standard PHS 398 application instructions described below: PHS 398 o FACE PAGE: Items 7a and 7b should be completed, indicating Direct Costs (in $25,000 increments up to a maximum of $250,000) and Total Costs [Modular Total Direct plus Facilities and Administrative (F&A) costs] for the initial budget period. Items 8a and 8b should be completed indicating the Direct and Total Costs for the entire proposed period of support. o DETAILED BUDGET FOR THE INITIAL BUDGET PERIOD - Do not complete Form Page 4 of the PHS 398. It is not required and will not be accepted with the application. o BUDGET FOR THE ENTIRE PROPOSED PERIOD OF SUPPORT - Do not complete the categorical budget table on Form Page 5 of the PHS 398. It is not required and will not be accepted with the application. o NARRATIVE BUDGET JUSTIFICATION - Prepare a Modular Grant Budget Narrative page. (See http://grants.nih.gov/grants/funding/modular/modular.htm for sample pages.) At the top of the page, enter the total direct costs requested for each year. This is not a Form page. o Under Personnel, list all project personnel, including their names, percent of effort, and roles on the project. No individual salary information should be provided. However, the applicant should use the NIH appropriation language salary cap and the NIH policy for graduate student compensation in developing the budget request. For Consortium/Contractual costs, provide an estimate of total costs (direct plus facilities and administrative) for each year, each rounded to the nearest $1,000. List the individuals/organizations with whom consortium or contractual arrangements have been made, the percent effort of all personnel, and the role on the project. Indicate whether the collaborating institution is foreign or domestic. The total cost for a consortium/contractual arrangement is included in the overall requested modular direct cost amount. Include the Letter of Intent to establish a consortium. Provide an additional narrative budget justification for any variation in the number of modules requested. o BIOGRAPHICAL SKETCH - The Biographical Sketch provides information used by reviewers in the assessment of each individual"s qualifications for a specific role in the proposed project, as well as to evaluate the overall qualifications of the research team. A biographical sketch is required for all key personnel, following the instructions below. No more than three pages may be used for each person. A sample biographical sketch may be viewed at: http://grants.nih.gov/grants/funding/modular/modular.htm - Complete the educational block at the top of the form page, - List position(s) and any honors, - Provide information, including overall goals and responsibilities, on research projects ongoing or completed during the last 3 years, - List selected peer-reviewed publications, with full citations. o CHECKLIST - This page should be completed and submitted with the application. If the F&A rate agreement has been established, indicate the type of agreement and the date. All appropriate exclusions must be applied in the calculation of the F&A costs for the initial budget period and all future budget years. o The applicant should provide the name and phone number of the individual to contact concerning fiscal and administrative issues if additional information is necessary following the initial review. Applicants planning to submit an investigator-initiated new (Type 1), competing continuation (Type 2), competing supplement, or any amended/revised version of the preceding grant application types requesting $500,000 or more in direct costs for any year are advised that he or she must contact the Institute program staff before submitting the application, i.e., as plans for the study are being developed. Furthermore, the application must obtain agreement from the Institute staff that the Institute will accept the application for consideration for award. Finally, the applicant must identify, in a cover letter sent with the application, the staff member and Institute who agreed to accept assignment of the application. This policy requires an applicant to obtain agreement for acceptance of both any such application and any such subsequent amendment. Refer to the NIH Guide for Grants and Contracts, March 20, 1998 at http://grants.nih.gov/grants/guide/notice-files/not98-030.html Any application subject to this policy that does not contain the required information in a cover letter sent with the application will be returned to the applicant without review. The title and number of the program announcement must be typed on line 2 of the face page of the application form and the YES box must be marked. Submit a signed, typewritten original of the application, including the Checklist, and 5 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) REVIEW CONSIDERATIONS Applications will be assigned on the basis of established PHS referral guidelines. Applications will be evaluated for scientific and technical merit by an appropriate scientific review group convened in accordance with the standard NIH peer review procedures. As part of the initial merit review, all applications will receive a written critique and undergo a process in which only those applications deemed to have the highest scientific merit, generally the top half of applications under review, will be discussed, assigned a priority score, and receive a second level review by the appropriate national advisory council or board. Review Criteria The goals of NIH-supported research are to advance understanding of biological, behavioral and social sciences, improve the control of disease, and enhance health. In the written comments reviewers will be asked to discuss the following aspects of the application in order to judge the likelihood that the proposed research will have a substantial impact on the pursuit of these goals. Each of these criteria will be addressed and considered in assigning the overall score, weighting them as appropriate for each application. Note that 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. (1) 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? (2) 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? (3) 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? (4) 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)? (5) 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? In addition to the above criteria, in accordance with NIH policy, all applications will also be reviewed with respect to the following: o The adequacy of plans to include both genders, minorities and their subgroups, and children as appropriate for the scientific goals of the research. Plans for the recruitment and retention of subjects will also be evaluated. o The reasonableness of the proposed budget and duration in relation to the proposed research o The adequacy of the proposed protection for humans, animals or the environment, to the extent they may be adversely affected by the project proposed in the application o The adequacy of the proposed plan to share data, if appropriate AWARD CRITERIA Applications will compete for available funds with all other recommended applications. The following will be considered in making funding decisions: Quality of the proposed project as determined by peer review, availability of funds, and program priority. INQUIRIES Inquiries are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Direct inquiries regarding programmatic issues to: Howard S. Kurtzman, Ph.D. Division of Neuroscience and Basic Behavioral Science National Institute of Mental Health 6001 Executive Boulevard, Room 7217, MSC 9651 Bethesda, MD 20892-9651 Telephone: (301) 443-9400 FAX: (301) 443-9876 Email: kurtzman@helix.nih.gov Coryl Jones, Ph.D. Division of Epidemiology, Services, and Prevention Research National Institute on Drug Abuse 6001 Executive Boulevard, Room 5153, MSC 9589 Bethesda, MD 20892-9589 Telephone: (301) 443-6637 FAX: (301) 480-2543 Email: cj39g@nih.gov Susan Newcomer, Ph.D. Demographic and Behavioral Sciences Branch National Institute of Child Health and Human Development 6100 Executive Boulevard, Room 8B7, MSC 7510 Bethesda, MD 20892-7510 Telephone: (301) 435-6981 FAX: (301) 496-0962 Email: Snewcomer@nih.gov Paula R. Skedsvold, Ph.D. Office of Behavioral and Social Sciences Research Office of the Director, NIH Building 31, Room B1C32, MSC 2248 Bethesda, MD 20892-2248 Telephone: (301)435-6780 FAX: (301) 480-7555 Email: Paula_Skedsvold@nih.gov Loretta P. Finnegan, M.D. Office of Research on Women"s Health Office of the Director, NIH 1 Center Drive, Room 201, MSC 0161 Bethesda, MD 20892-0161 Telephone: (301) 402-1770 FAX: (301) 402-1798 Email: lf61d@nih.gov Direct inquiries regarding fiscal matters to: Diana S. Trunnell Grants Management Branch National Institute of Mental Health 6001 Executive Boulevard, Room 6115, MSC 9605 Bethesda, MD 20892-9605 Telephone: (301) 443-2805 FAX: (301) 443-6885 Email: Diana_Trunnell@nih.gov Gary Fleming, J.D., M.A. Grants Management Branch National Institute on Drug Abuse 6001 Executive Boulevard, Room 3131, MSC 9541 Bethesda, MD 20892-9541 Telephone: (301) 443-6710 FAX: (301) 594-6849 Email: gf6s@nih.gov Kathy Hancock Grants Management Branch National Institute of Child Health and Human Development 6100 Executive Boulevard, Room 8A17, MSC 7510 Bethesda, MD 20892-7510 Telephone: (301) 496-5482 FAX: (301) 402-0915 Email: kathy.hancock@nih.gov AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance Nos. 93.242 (NIMH), 93.279 (NIDA), 93.864 (Population Research, NICHD), and 93.865 (Center for Research for Mothers and Children, NICHD). Awards are made under authorization of the Public Health Service Act, Title IV, Part A (Public Law 78-410, as amended by Public Law 99-158, 42 USC 241 and 285) and administered under NIH grants policies and Federal Regulations 42 CFR 52 and 45 CFR Part 74. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. The PHS strongly encourages all grant and contract recipients to provide a smoke-free workplace and promote the non-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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