and Human Services (HHS)
EXPIRED
This Program Announcement expires on October 1, 2003 unless reissued. DEMOGRAPHIC RESEARCH ON SEXUAL BEHAVIORS RELATED TO HIV Release Date: September 21, 2000 PA NUMBER: PAS-00-136 National Institute of Child Health and Human Development (http://www.nichd.nih.gov) National Institute of Mental Health (http://www.nimh.nih.gov) THIS PROGRAM ANNOUNCEMENT REPLACES PAS-97-093 THIS PA USES THE MODULAR GRANT AND JUST IN TIME CONCEPTS. IT INCLUDES DETAILED MODIFICATIONS TO STANDARD APPLICATION INSTRUCTIONS THAT MUST BE USED WHEN PREPARING APPLICATIONS IN RESPONSE TO THIS PA. PURPOSE The National Institute of Child Health and Human Development (NICHD) and the National Institute of Mental Health (NIMH) invite qualified researchers to submit applications to study the demographic, social, and behavioral aspects of the transmission of HIV through sexual intercourse. NICHD has a longstanding commitment to research focusing on sexual behavior, behavior change, and HIV prevention among men and women of reproductive age (including adolescents), and especially among vulnerable populations who live in high- risk environments. This program announcement describes NICHD and NIMH programs of behavioral research in the sexual transmission of HIV, which include five general areas: (1) demographic studies of sexual behaviors related to HIV transmission looking at individuals of all ages, (2) studies of the interrelationships between social, institutional, economic, and cultural contexts and sexual behavior, (3) studies of the interrelationships among pregnancy, pregnancy prevention, and HIV prevention, (4) theoretically grounded intervention studies within these areas, and (5) studies of the appropriate methodologies for addressing sensitive issues and complex data. This program announcement particularly encourages studies in populations most vulnerable to the sexual transmission of HIV both in the U.S. and world wide-- minority men and women, men who have sex with men, and youth, especially disadvantaged youth. 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 Program Announcement (PA) is related to one or more of the priority areas. Potential applicants may obtain 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, and 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. For all competing R01 applications requesting up to $250,000 per year in direct costs, specific application instructions have been modified to reflect MODULAR GRANT and JUST-IN-TIME streamlining efforts being examined by the NIH. Applications that request more than $250,000 in any year must use the standard PHS 398 (rev. 4/98) application instructions. Complete and detailed instructions and information on Modular Grant applications can be found at http://grants.nih.gov/grants/funding/modular/modular.htm. FUNDS AVAILABLE The NICHD intends to commit approximately $2 million in total costs [direct plus Facilities and Administrative (F&A) costs] in FY 2001 to support new and/or competing continuation applications submitted in response to this PA. The NIMH intends to commit approximately $1.2 million in FY 2001 to support new and/or competing continuation applications submitted in response to this PA. An applicant may request a project period of up to five years. Because the nature and scope of the research proposed may vary, it is anticipated that the size of awards also will vary. Although the financial plans of NICHD and NIMH provide support for this program, awards pursuant to this PA are contingent upon the availability of funds and the receipt of a sufficient number of meritorious applications. RESEARCH OBJECTIVES Background Until such time as vaccines and cures for infection with the HIV virus are a practical reality, prevention of infection must rely upon individuals practicing protective behavior. Specific sexual behaviors that reduce the risk of infection - such as avoiding sexual intercourse with infected individuals and using condoms - are influenced both by personal factors such as attitudes, knowledge, and abilities and by more distal factors characterizing the contexts in which individuals behaviors are carried out. While most behaviors that are protective have been well-defined, new information may require altered messages regarding risk and protective behaviors. For example, recent reports have suggested that oral sexual practices (e.g., oral-genital receptive sex), previously considered to be relatively risk-free, actually may pose risks for HIV transmission. Individuals on HAART [Highly Active Anti-Retroviral Therapy], whose infectivity may be lowered, but is not at zero, may or may not alter their behavior. Social and cultural environments may predispose people to act in certain ways, and may also influence how easy it is for them to change their behaviors or to maintain protective behaviors. Competing motivations for establishing and maintaining sexual relationships, and for pregnancy or pregnancy prevention, may interact with HIV prevention motives and with the social environment to influence behavioral outcomes. Such motives are, in turn, likely to be shaped in important ways by life course experience: health and development, educational and economic achievement, migration, entry into and exit from specific social and sexual networks, marriage and marital dissolution, and fertility. These personal and contextual factors can interact in powerful and complex ways to determine behavioral risks for HIV infection, responses at the individual and group level to those risks, and the most promising pathways to reducing risk. Methodological advances in data collection and data analytic techniques are beginning to make it possible to examine in detail the contexts in which individuals and couples make decisions about sexual risk behaviors, and to understand more clearly the structural factors influencing these decisions. This announcement calls for research grant applications that draw on both innovative theory and innovative methodologies to address the general areas of study, described below. The goal of this program announcement is improved knowledge applicable to behavioral strategies for the prevention of sexual transmission of HIV infection. Research is encouraged to address these problems worldwide, in population concentrations and geographic areas where the disease has been shown to have major impact or risk of HIV infection is high. Other sexually transmitted diseases and other sequelae of sexual behavior, as well as relevant aspects of sexual behavior itself, also may be used as endpoints of proposed research as long as the relationship of the specific research question to HIV prevention is adequately demonstrated. Research Scope Research sought includes but is not limited to the following topics: (a) Demographic Studies Theoretically grounded, population-based studies of sexual behaviors related to the risk of HIV infection contribute to HIV prevention in many ways. They provide essential information for identifying population groups and locations where sexual behaviors are increasing vulnerability to HIV infection, as well as where the potential for increasing infection rates may exist, they provide a means of monitoring trends in the prevalence of risky sexual behavior as well as protective behaviors within groups, and they permit the testing of models of the determinants of such behavior over the life course within population samples (that is, not samples recruited from clinics or on the basis of some particular personal behavior or characteristic). For example, they can elucidate changes in behaviors, norms, and status that permeate a larger population and contribute to the characteristics, resources, and behaviors of those most vulnerable to HIV. They can be used to examine processes that influence sexual behavior regardless of HIV risk and to examine how, whether, and when heightened risk, or the perception of heightened risk, of HIV affects those processes. Specific topics include, but are not limited to: o Trends in HIV-related sexual behaviors and the determinants of those trends. o Studies characterizing trends in the content of information provided to students in the health professions, health care professionals, the public or members of high-risk groups about sexual practices as related to risks for HIV transmission. Studies examining changes in target audience perceptions and understandings of messages related to the prevention of HIV transmission. o Population group differences in the determinants of HIV risk behaviors. o Impacts of changes and variations in family structure and organization on risk exposure. o Patterns of partner selection, concurrence, retention and change, and their effects on risk and protection. o The relationship of HIV-risk sexual behavior and infection to life course transitions such as entering cohabitation, marriage, separation and divorce, and parenthood, and to changes in school enrollment, labor force participation, and economic status. o Factors, both individual and social/structural, that predispose individuals to initiate sexual behaviors at an early age, which may increase the risk of HIV infection. o Studies evaluating changes in sexual behaviors in individuals and populations associated with new developments in treatment and new information on risk and protective behaviors (e.g., use of HAART or post-exposure prophylaxis). o Studies of norms and values related to sexual behavior, sexual partnerships, and disease prevention, their variation among population groups and over time, and their relationship to behavioral patterns. o Studies focusing on the relationships between migration and HIV risk and prevention, both in the U.S. and elsewhere. Anecdotal evidence suggests that individuals who contract HIV in cities return to homes in rural areas for care. Young gay men who move to large cities may be more at risk of exposure to HIV. Refugee and migrant populations may also experience heightened risk. (b) Contextual Determinants of Sexual Behavior A significant body of evidence suggests that sexual and prophylactic behaviors are influenced in important ways by the contexts in which they occur. Relevant dimensions of context include the social (relationships with partners, family, friends, and co-workers and changes in those relationships through migration or family disruption), institutional (legal, educational, economic, religious, health infrastructure), cultural (norms, values, and beliefs shared within and across social groups), and physical (community composition and resources, prevalence of disease risk, poverty and housing). The specification of the ways in which these aspects of context can influence behavior and how they interact is far from complete, and there is reason to believe that improved understanding of contextual influences could provide a powerful tool for prevention of HIV. Studies might address questions such as the following: o The individual in the community: How do individuals involvement in religious, social, and community organizations both organize their opportunities for social interaction and influence their sexual behaviors, in both protective and risky ways? How do individuals social networks influence their sexual behavior, how does sexual behavior influence change and stability in social networks? How do social networks moderate the impact of life course transitions e.g., new jobs, divorce, moves -- on risky sexual behavior? Do (and if so, how do) social and sexual networks overlap and what are the implications of this for HIV-risk behavior? What principles and processes govern the selection of sexual partners and participation in sexual networks that place individuals at risk of infection with HIV? There is evidence that the sexual marketplace varies by race, ethnicity, age, and location. How does the process of partnership formation vary by age or maturational status, gender, sexual orientation, socioeconomic status, and the prevalence of HIV in the individual"s community? How do the circumstances under which sexual partnerships are formed affect the perceptions of HIV risk within the partnership and the behaviors that occur within it? What factors influence the stability and exclusiveness of sexual partnerships, and how do HIV-risk behaviors vary with the duration and other characteristics of partnerships? o The community around the individual: How do the economic, social, and institutional characteristics of the communities, neighborhoods, or schools in which individuals and their social and sexual networks are embedded influence sexual behavior? How do families mediate or moderate such community influences? Do local policies, laws, and their implementation influence sexual risk behaviors? How do norms and values -- about gender, morality, marriage, monogamy or appropriate sexual behavior -- develop and change within and across social groups? How do such norms and values interact with other contextual and individual factors to influence individuals and couples sexual behavior? How do community civic, educational, economic, and religious institutions influence sexual behavior? How do the positions and teachings of institutions faith communities, social organizations, government agencies, educational and health agencies influence community norms regarding sexual behavior and influence the messages to be given to particular audiences, especially youth? Does institutional support for, opposition to, or conflict concerning appropriate messages and prevention strategies have an impact on patterns of sexual risk-taking in the community? What factors, if any, affect the influence of institutionally supported norms and teaching on HIV risk behaviors, in adults as well as youth? (c) Integrating Pregnancy and HIV Prevention Most heterosexual individuals who have sexual intercourse desire to protect themselves from unwanted pregnancy most of the time. At the same time, almost all individuals all of the time wish to avoid infection with HIV. However, many of the medical methods available for pregnancy protection do not provide protection from HIV and other diseases. Condoms, male and female, which are more effective at disease prevention, may not protect as well against pregnancy as do some of the hormonal methods. Research is sought that examines the inter-relationships among individuals and couples desires for pregnancy, pregnancy prevention, and avoidance of the risk of infection with HIV, and the effects of these interactions upon behavior. Examples of questions relevant to this topic include: o How do individuals at risk of HIV infection balance pregnancy prevention and disease prevention in making decisions about sexual behavior and the introduction and use of methods to prevent pregnancy and/or disease? o How do the duration and intimacy of the partnership influence the partners communication, negotiation, and decisions concerning issues of pregnancy, pregnancy and disease prevention, and the use of risk reduction methods and strategies? Does this vary over the life course? o How do individuals estimations and abilities to accurately estimate risks -- their own and their partners for pregnancy and HIV -- influence their use of protection? How do knowledge and beliefs concerning their own or their partner’s serostatus affect use of protection from pregnancy and HIV? o How does perception concerning the efficacy of various prevention methods for pregnancy and disease prevention affect the ultimate use of such protection? o How does actual, objective, epidemiological risk of exposure to disease and to pregnancy affect individuals use of protection from unwanted pregnancy and from disease? (d) Intervention Studies Innovative intervention studies are needed to build on the basic science findings concerning HIV-risk behavior and behavior change. Designing, implementing, and evaluating interventions which utilize mediating variables such as, for example, improving the ways in which social/sexual networks support risk-reduction strategies, improving the local institutions influences on community norms concerning safer sex, or engaging relevant agencies in intervention work, with the goal of enabling individuals to change or modify risky behavior, are appropriate topics for research proposals. Understanding of local issues is critical to the successful implementation of such interventions. Accordingly, interventions are encouraged which involve extant local organizations in design, implementation, and replication of the project. Such proposals may target any population vulnerable to HIV and may include consideration of co-morbid conditions such as other STDs. This PA particularly encourages studies of populations most vulnerable to the sexual transmission of HIV, both in the U.S. and world wide-- minority men and women, men who have sex with men, and youth, especially, disadvantaged youth. Questions of particular interest include, but are not limited to: o How can the social context in which individuals live -- their social networks, communities, schools, homes, work environment -- be taken into consideration when designing and implementing interventions? How can the influence exerted by elements of the social, institutional, and cultural contexts be harnessed in the development of more effective interventions? o How can HIV-related behavior change interventions be improved to take account of individuals potentially competing concerns about pregnancy and disease prevention? Given the need to combine condom (or other barrier) use with hormonal contraception or sterilization to achieve the highest levels of protection against both pregnancy and disease among at-risk sexually active heterosexual people (and the challenges inherent in such work), what strategies may be most effective under what conditions? (e) Methodological Studies Demographic, social, and behavioral studies of HIV risk and prevention continue to pose significant methodological challenges. Studies that examine the influence of context require the articulation of complex designs involving multiple levels of analysis and multiple layers of measurement. Community-level intervention efforts require innovative strategies for evaluation. Biases in self-reports of sensitive personal behaviors remain a serious concern in basic and intervention research on sexual behaviors. Methodological research is invited that addresses issues in design, data collection, measurement, and analysis related to the topics addressed in this announcement. Illustrative topics include: o Cross-cutting approaches to link data collected in large population samples with samples selected based on high-risk behaviors. o Extending and improving techniques for measurement accuracy and data collection in studies of HIV-related sexual behavior, including the use of computer-assisted methods and the development and integration of appropriate biological endpoints or other markers of behavioral risk. o Defining and standardizing appropriate models and analytic methods for examining sexual behavior in the context of a couple, and in relation to networks and the larger social context. o Improving methodologies to design non-biased but cost-effective network studies. o Developing and refining outcome measures and indicators appropriate for the evaluation of policy changes, prevention interventions, and the societal impact of HIV. Research Designs and Data Sources The utilization of existing data is strongly encouraged for its cost-efficiency whenever scientific goals can be met by its use. There is a wide range of such data collected in the U.S. and available for research purposes. Information concerning these data sets is available on the web at: http://www.nichd.nih.gov/about/cpr/dbs/resources.htm. Each data set has its particular strengths and weaknesses, which the investigator must understand and deal with. Such resources include, but are not limited to, the various rounds of the National Survey of Family Growth, the National Survey of Adolescent Males, the National Survey of Men, the National Longitudinal Study of Adolescent Health, the National Health and Social Life Survey, the Chicago Health and Social Life Survey, and data made available through the Sociometrics STD/HIV archive. Researchers may be aware of, and have access to, other data that are appropriate for answering the HIV/AIDS behavior questions they wish to pose. Data collected in or from other countries can provide powerful resources for addressing many of the research questions in this announcement. New data collection is justifiable if existing data are not appropriate to the aim of the study. In such cases, scientific sampling procedures are highly desirable to ensure that sample biases do not vitiate the research objectives. Prior contact with the program staff named under INQUIRIES, below, is strongly encouraged for any applicant considering such an effort. Applicants proposing new data collection are encouraged to make their data available for use by other researchers and should outline plans for accomplishing this in the application. Applicants proposing research that draws on social scientific approaches that have not been widely applied to research on HIV-related sexual behavior are particularly encouraged to apply. Mixed methods which include both qualitative and quantitative components are especially welcomed. As noted recently by an Institute of Medicine workshop, Assessing the Social and Behavioral Science Base for HIV/AIDS Prevention and Intervention, improved strategies for behavioral intervention will require broader perspectives than have been applied in the past. Collaborations involving anthropologists, historians, economics, sociologists, political scientists, epidemiologists, and psychologists may be needed to advance theoretical and methodological approaches to HIV prevention. Therefore, applicants are encouraged to consider research designs that are innovative, integrative of multiple perspectives, and utilize, as appropriate, a range of methods and analytic techniques. 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 or 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, published in the NIH Guide for Grants and Contracts, March 6, 1998, and available at: 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 also may provide additional relevant information concerning the policy. 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 Applications are to be submitted on the grant application form PHS 398 (revised 4/98) and will be accepted at the standard application deadlines for AIDS and AIDS-related applications, as indicated in the application kit. These forms are available at most institutional offices of sponsored research, on the Internet at http://grants.nih.gov/grants/funding/phs398/phs398.html, and from the Division of Extramural Outreach and Information Resources, National Institutes of Health, 6701 Rockledge Drive, MSC 7910, Bethesda, MD 20892- 7910, telephone 301-435-0714, E-mail: [email protected]. Applicants planning to submit an investigator-initiated new (Type 1), competing continuation (Type 2), competing supplement (Type 3), 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 they must contact the NIH program staff before submitting the application, i.e., as plans for the study are being developed. Furthermore, the applicant must obtain agreement from NIH 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 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. Modular Grant Application Instructions 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 NIH staff. The research grant application form PHS 398 (revised 4/98) is to be used in applying for these grants, with the modifications noted below. 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: 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. 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 F & A) 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 key 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 three 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 telephone number of the individual to contact concerning fiscal and administrative issues if additional information is necessary following the initial review. Submission Instructions 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 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) REVIEW CONSIDERATIONS Upon receipt, applications will be reviewed for completeness by the NIH Center for Scientific Review (CSR). 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 our understanding of biological systems, 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 also will 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 also will 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. AWARD CRITERIA Applications will compete for available funds with all other recommended applications. The following will be considered in making funding decisions: Merit of the proposed project as determined by peer review, availability of funds, and program priorities. INQUIRIES Inquiries are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Direct inquiries regarding NICHD-related programmatic issues to: 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: [email protected] Direct inquiries regarding NICHD-related fiscal matters to: Michael Loewe 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: [email protected] Direct inquiries regarding NIMH-related programmatic issues to: Willo Pequegnat, Ph.D. Center for Mental Health Research on AIDS Division of Mental Disorders, Behavioral Research and AIDS National Institute of Mental Health 6001 Executive Boulevard, Room 6205, MSC 9619 Bethesda, MD 20892-9619 Telephone: (301) 443-6100 FAX: (301) 443-9719 Email: [email protected] Direct inquiries regarding NIMH-related 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: [email protected] AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance Nos. 93.864 (Population Research) and 93.121 and 93.242 (NIMH). Awards are made under authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and administered under NIH grants policies and Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92. This program is not subject to the intergovernmental review requirements of Executive Order 12372, or to 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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