PREVENTION OF HEALTH RISK BEHAVIORS IN MIDDLE CHILDHOOD Release Date: September 2, 1999 RFA: HD-99-014 National Institute of Child Health and Human Development Office of AIDS Research National Institute of Mental Health Letter of Intent Receipt Date: October 15, 1999 Application Receipt Date: December 10, 1999 THIS RFA 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 RFA. PURPOSE The National Institute of Child Health and Human Development (NICHD), the National Institutes of Health (NIH) Office of AIDS Research (OAR), and the National Institute of Mental Health (NIMH) invite applications proposing studies of behavioral strategies to prevent sexual health risk behaviors in middle childhood, with the intention of preventing pregnancy and the transmission of HIV and other sexually transmitted diseases during adolescence. The purposes of this Request for Applications (RFA) are to: (1) identify the interactions of innate cognitive, developmental and psychological characteristics of children ages 6-12 years which, in conjunction with known sociocultural and economic conditions, facilitate and predispose children to participate in high- risk sexual behaviors; (2) identify the characteristics which provide resilience to developmentally inappropriate sexual risk-taking behavior; and (3) develop, implement, and evaluate interventions to reverse, ameliorate or compensate for the risk factors involved and/or enhance the resilience factors. HEALTHY PEOPLE 2000 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2000," a PHS-led national activity for setting priority areas. This RFA is related to several priority areas. Potential applicants may obtain "Healthy People 2000" at http://odphp.osophs.dhhs.gov/pubs/hp2000. ELIGIBILITY REQUIREMENTS Applications may be submitted by domestic for-profit and non-profit organizations, public or private, such as universities, colleges, hospitals, laboratories, units of State and local governments, and eligible agencies of the Federal government. Foreign institutions are not eligible to apply for these grants; however, applicants may collaborate, through consultation or contractual agreements, with investigators at foreign institutions. Racial/ethnic minority individuals, women, and persons with disabilities are encouraged to apply as Principal Investigators. MECHANISM OF SUPPORT This RFA 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. This RFA is a one-time solicitation. Future unsolicited competing continuation applications will compete with all investigator-initiated applications and be reviewed according to the customary peer review procedures. The anticipated award date is July 2000. Specific applications instructions have been modified to reflect "MODULAR GRANT" and "JUST-IN-TIME" streamlining efforts being examined by the NIH. Complete and detailed instructions and information on Modular Grant applications can be found at https://grants.nih.gov/grants/funding/modular/modular.htm. FUNDS AVAILABLE The NIH OAR, through the NICHD, intends to commit approximately $1.2 million in total costs (direct plus Facilities and Administrative) in FY 2000 to fund three or four new grants in response to this RFA. The NIMH intends to commit $750,000 (total costs) in FY 2000 to fund two or three new awards in response to this RFA. An applicant may request a project period of up to five years and a budget for direct costs of up to $250,000 per year. 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 the OAR and NIMH provide support for this program, awards pursuant to this RFA are contingent upon the availability of funds and the receipt of a sufficient number of applications of outstanding scientific and technical merit. The National Institute of Drug Abuse (NIDA) and the National Institute of Alcohol Abuse and Alcoholism (NIAAA) share an interest in this RFA and may contribute (contingent upon the availability of funds) to the support of selected grants to be determined following peer review. RESEARCH OBJECTIVES Background Little is understood about the development, expression, and prevention of health risk behaviors during the middle childhood years that contribute to unwanted pregnancy and sexually transmitted diseases, including HIV, in adolescence and adulthood. Research suggests that health risk behaviors exhibited during adolescence and adulthood have their origins earlier in childhood and that preventive interventions are only minimally successful when applied after the high-risk behaviors are established. In January of 1997, a panel of research experts met at the NIH to discuss applied behavioral analytical approaches for preventing AIDS risks in childhood. The panel overwhelmingly endorsed the concept that early prevention efforts, initiated during the first decade of life, could have a greater impact on health risk behavior than interventions introduced in adolescence. They recommended that the NICHD initiate studies to investigate the role of family, school, peer, and community factors that influence health risk behaviors, as well as studies on the development of behaviors during middle childhood that increase the risk of unprotected sexual activities. The panel identified a need for a developmental, epidemiological, contextual model as the basis for hypotheses that could guide community intervention and prevention studies. The panel identified academic success as a major protective factor against high-risk behaviors and recommended that school success be a goal in any comprehensive prevention effort targeted toward middle childhood. Middle childhood, once described as the time when a child's character is built and consolidated or is not, has not benefitted from extensive research on health risk behaviors as has the period of adolescence. Recent research indicates that later elementary school-age children may be more interested in and amenable to learning about AIDS than middle-school children. Thus, the nine- to eleven-year-old may be in a transition time critical for the development of health habits. Using the existing research on social and behavioral factors that influence adolescents' high-risk sexual activities, this RFA seeks new efforts directed at the identification of precursors of health risk factors in children between the ages of six and twelve years. In view of the early age of initiation of sexual intercourse, especially among urban, minority youth, the real and expanding risk of HIV infection for youth engaging in high-risk sexual practices, and the significantly increased efficacy of interventions initiated prior to sexual debut, effective AIDS prevention initiatives must begin during middle childhood and address social influences on sexual behaviors. Additionally, the Centers for Disease Control and Prevention, the Surgeon General, and the American Academy of Pediatrics have endorsed the need for AIDS education within the elementary grades, beginning in kindergarten and continuing throughout the school years. Risk-Taking Behavior Among Adolescents: What Is Known As previously noted, there exists little information on sexual risk-taking behaviors and their precursors in children ages six to twelve years. However, extensive research on the different stages and developmental tasks of adolescents has provided us with a wealth of biopsychosocial information. This information should prove useful in informing research efforts that will be directed to the middle childhood years, seeking precursors of health risk behaviors and preventive interventions for sexual risk-taking behaviors. The following statistics reveal the significance of the health concerns experienced by adolescents as a result of participation in high-risk sexual behaviors: Adolescents represent one of the fastest growing risk groups for HIV in the United States, with approximately 25 percent of sexually transmitted diseases (STDs) and 25 percent of new HIV infections occurring in teenagers. Inner-city, minority youths are at particular risk because of the greater concentration of HIV in inner-city areas, the higher rates of sexually transmitted diseases, the earlier age of initiation of high-risk sexual practices (including intercourse in ten-year-olds), and the disproportionate impact of AIDS on minorities. Over the past 20 years, increasing numbers of adolescents have engaged in unprotected sexual experimentation at earlier ages and with more partners. It is not clear whether these trends are observed in children during middle childhood. The 1997 national Youth Risk Behavior Surveillance System (YRBSS) reported that many high school students were already actively participating in high- risk behaviors. For example, 50.8 percent of high school students had consumed alcohol, 26.2 percent had used marijuana , and 36.4 percent had smoked cigarettes in the 30 days before the survey. The YRBSS results indicated that in 1997, 48.4 percent of high school students had engaged in sexual intercourse, 43.2 percent of sexually active students had not used a condom at last intercourse, and 2.1 percent had ever injected an illegal drug. Research reveals an alarming prevalence of risk behaviors already evident by seventh grade and the trend increases throughout high school. Sexual activity is the major risk factor for HIV transmission. Youth exhibiting the most high-risk behavior, including frequent, unprotected sexual intercourse with numerous partners, drug use, and intercourse with intravenous drug users, are at the highest risk for AIDS. In many urban centers in the U.S., significant numbers of children are already sexually active by the completion of elementary school. Predictors of high-risk sexual behavior include alcohol and substance use, antisocial behaviors, delinquency, and family and peer influences. Risk Factors For Adolescents The determinants of early initiation of sexual activity include societal factors such as region, race, and media, as well as family characteristics including socioeconomic status or social class, number of siblings, family structure, the quality of the parent-child relationship, lower maternal education, attendance at a school with a high drop-out rate, having fewer years of high school education, having a mother who was a teen parent, living with a single parent, being less religious, having poor parental communication and discipline, being less goal oriented, being influenced by peer pressure, and being the victim of sexual abuse. Whether these or additional risk factors are equally predictive for children ages six to twelve is not yet known. Alcohol and drug use, which also may begin in late middle childhood as well as adolescence, are important indirect risk factors for early and unprotected sex, as they lower inhibitions and cloud judgment. Drug use, the exchange of sex for drugs, and disregard for safe sexual practices in adolescents are factors in HIV transmission. Risk factors for drug use among males include perceived use by peers, peer approval of drug use, low family pride, and the adolescent's general willingness to engage in non-normative behavior. Early initiation of drug use is associated with family substance use problems and parental smoking. Having peers who are serious drug users, beginning drug use at an early age, and social and developmental problems (poor relationships with peers, parents, and authority figures) are associated with use of increasingly problematic drugs. Subpopulations of adolescents at increased risk of acquiring AIDS through participation in high- risk activities include street and homeless youths, adolescent prostitutes, homosexuals, sexually abused youths, and detained youths. Street youth are at elevated risk for medical disorders, drug dependency, STDs, and HIV. Homeless youths frequently report one or more of the following risk factors: multiple sex partners; high-risk partners; inconsistent condom use; history of STD; anal sex; prostitution; and/or intravenous drug use. Victims of sexual abuse have been recognized as a population at higher risk for earlier onset of sexual activity and a greater number of lifetime sexual partners. Resilience Factors For Adolescents Resilience has been defined as functional competence in the presence of multiple risk factors, such as poverty, stress, and low educational attainment. It is the result of a complex interplay between an individual's personal characteristics, skills, and abilities to cope and his/her environmental stresses or risk factors. Resilience factors are the qualities that foster successful adaptation and transformation processes, despite risk and adversity. It is personal resilience that facilitates the development of social competence, problem-solving skills, a critical consciousness, autonomy, and a sense of purpose. Recent studies indicate that resilient adolescents are less likely than nonresilient adolescents to initiate a variety of risky behaviors. Protective factors within the individual child include problem-solving abilities, trust, helpfulness, positive self-esteem, feeling of control over one's life, planning for future events, optimism, social and academic competence, cognitive skills, creativity, and easy temperament. Caring relationships exhibited by parent(s), caregivers, mentors, and teachers provide resilience and support for children. The effect of parental support is mediated through more behavioral coping and academic competence, and less tolerance for deviance and behavioral undercontrol. The resilience provided by parental support occurs even in the presence of negative life events and deviant peer affiliations, although resilience may be attenuated by negative peer influence during late adolescence. For maltreated children, positive self-esteem, ego resilience, and ego overcontrol predict resilience. High academic expectations from parents and school personnel likewise have a positive effect on students and promote lower rates of problem behaviors such as dropping out of school, drug abuse, teen pregnancy, and delinquency. Better family functioning, higher intelligence, and psychological well-being are markers of fundamental adaptation systems protecting child development in the presence of severe adversity. Other resilience factors include closer parental monitoring, more adults in the household, higher educational aspirations, and student engagement. It is not known at what ages these variables may exert their maximum effect. Information is needed now regarding resilience in children in middle childhood. Current Research Needs Health risk behaviors are linked to both the child's psychological development (incorporating cognition, perceptions, and values) and social environment (including family, peers, school, community, and media). Important factors in the formation of risk-taking behaviors include gender, social and racial norms, chronological age, and level of biological maturation. It is the combination of social and psychological factors with sexual maturation and genetic disposition that influence an individual's behavior. What is needed now is the identification of the personal, sociocultural, cognitive, psychological, and economic factors and their interactions in middle childhood that predispose some adolescents in certain situations to engage in sexual risk behaviors. In addition, complementary research is needed to identify which resilience factors are operating in middle childhood to protect children living in high-risk environments. The AIDS educational efforts which have been effective in reducing high-risk behaviors are those that provide individuals with the skills they need to negotiate in sexual situations, not those that focus solely on disseminating factual information. Efforts to identify and understand the social and behavioral factors associated with the precursors of high-risk sexual behaviors are critical for the development of relevant and effective AIDS prevention plans. Opportunities for self-reflection, critical inquiry, problem solving, the discovery of consequences of one's actions, and dialogue are important for both academic success and effective AIDS prevention programs. Beneficial AIDS prevention efforts must begin prior to the age when children and adolescents initiate high-risk behaviors that place them in jeopardy of acquiring HIV. Developmentally appropriate interventions, responsive to changing cognitive capabilities, social skills, peer pressure, and exposure to sexual experiences, need to be developed and implemented. Research Focus This RFA has three major research aims. Applicants are encouraged to address all three aims or a combination of aims (1) and (3) or aims (2) and (3): (1) To identify the various combinations of factors (societal, psychological, cognitive, and developmental) that interact with sociocultural and economic factors to predispose certain children, ages six to twelve, to participate in sexual health risk behaviors. (2) To identify the qualities that foster resilience to sexual risk-taking during middle childhood, in the presence of factors promoting health risk- taking. (3) To develop, implement, and evaluate effective interventions for children between the ages of six and twelve years, to reduce or prevent the transmission of HIV in middle childhood and adolescence by reversing, ameliorating, or compensating for risk factors and/or enhancing resilience factors. Critical Questions The following critical questions are examples of research questions to be considered by applicants. It is not necessary to respond to every question, but it is hoped that answers to these questions will become apparent through the combined efforts of the individual projects funded as a result of this RFA. Which combination of factors contributes significantly to risk-taking behaviors in middle childhood? Do certain risk factors (i.e., social, psychological, developmental, or cognitive) carry more weight than others? Do certain resilience factors (i.e., personal versus family or school) exert more influence than others, and at which developmental stages? Can resilience factors accommodate increasing risks? If so, how many, which ones, and for how long? Do high-risk subpopulations (homeless, abused, institutionalized, emotionally disturbed youths) respond to or require different approaches to increase resiliency and reduce risk? Which factors in middle childhood are the strongest predictors of subsequent early sexual initiation? Which interventions most effectively reduce the risk of early sexual initiation? Are different interventions necessary at different ages in middle childhood? Which interventions promote and enhance resilience and mental health? Which interventions increase knowledge of HIV and STDs, social and negotiation skills, perception and understanding of high-risk situations? Which children benefit from which kinds of interventions (family-based, school-based, peer-based)? At what ages and developmental stages are interventions most effective? What is the optimal timing for delivery of the intervention and by whom should it be delivered? Do interventions need to be reinforced and updated to address developmental issues; if so, when and how often? SPECIAL REQUIREMENTS Applicants should plan to participate in twice-yearly conference calls among grantees funded through this RFA to share progress. In addition, annual collaborative meetings for Principal Investigators will be held in the Washington D.C. area. The first collaborative meeting will occur within one year of the grant awards and will focus on research designs, objectives, and possible collaborative arrangements that might foster increased productivity or efficiency in addressing the objectives proposed by the applicants. Funds for the Principal Investigator's travel to these annual meetings should be included in the application budget request. This RFA deals with sensitive issues of sexuality and young children, and will require investigators to use a thoughtful and developmentally appropriate approach to research and to issues of informed consent of parents and children. 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 subpopulations 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 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 "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research" which was published in the Federal Register of March 28, 1994 (FR 59 14508-14513) and in the NIH Guide for Grants and Contracts, Vol. 23, No.11, March 18, 1994, available on the Internet at https://grants.nih.gov/grants/guide/notice-files/not94-100.html. 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/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" that was published in the NIH Guide for Grants and Contracts, March 6, 1998, and is available on the Internet at: https://grants.nih.gov/grants/guide/notice-files/not98-024.html. Investigators may also obtain copies of these policies from the program staff listed under INQUIRIES. Program staff may also provide additional relevant information concerning these policies. LETTER OF INTENT Prospective applicants are asked to submit a letter of intent that includes a descriptive title of the proposed research, the name, address, telephone number, and E-mail address of the principal investigator, the identities of other key personnel and participating institutions, and the number and title of this RFA. Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows NICHD staff to estimate the potential review workload and avoid conflict of interest in the review. The letter of intent is to be sent to Dr. Lynne Haverkos at the address listed under INQUIRIES by October 15, 1999. APPLICATION PROCEDURES The research grant application form PHS 398 (rev. 4/98) is to be used in applying for these grants. These forms are available at most institutional offices of sponsored research, on the Internet at: https://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 301/710-0267, E-mail: GrantsInfo@nih.gov. 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 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. Applications responding to this RFA, will request direct costs in $25,000 modules, up to a total direct cost request of $250,000 per year. 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 https://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 key 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 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: https://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 RFA label available in the PHS 398 (rev.4/98) application form must be stapled to the bottom of the face page of the application and must display the RFA number HD-99-014. A sample modified RFA label is available at https://grants.nih.gov/grants/funding/phs398/label-bk.pdf. Failure to use this label could result in delayed processing of the application such that it may not reach the review committee in time for review. In addition, the RFA title and number 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 three 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) At the time of submission, two additional copies of the application should be sent to: Scott Andres, Ph.D. Division of Scientific Review National Institute of Child Health and Human Development 6100 Executive Boulevard, Room 5E01, MSC 7510 Bethesda, MD 20892-7510 Rockville, MD 20852 (for express/courier service) Applications must be received by December 10, 1999. If an application is received after that date, it will be returned to the applicant without review. The Center for Scientific Review (CSR) will not accept any application in response to this RFA 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 substantial revisions of applications already reviewed, but such applications must include an introduction addressing the previous critique. REVIEW CONSIDERATIONS Upon receipt, applications will be reviewed for completeness by the CSR and for responsiveness by the NICHD, NIMH, and OAR. If the application is not responsive to the RFA, NICHD staff may contact the applicant to determine whether to return the application to the applicant or submit it for review in competition with unsolicited applications at the next review cycle. Applications that are complete and responsive to the RFA will be evaluated for scientific and technical merit by an appropriate peer review group convened by the NICHD in accordance with the review criteria stated below. As part of the initial merit review, a process may be used by the scientific review group in which applications receive a written critique and undergo a process in which only those applications deemed to have the highest scientific merit will be discussed, assigned a priority score, and receive a second level review by the National Advisory Child Health and Human Development Council. 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 method? 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. The initial review group also will examine the provisions for the protection of human subjects and the safety of the research environment. SCHEDULE Letter of Intent Receipt Date: October 15, 1999 Application Receipt Date: December 10, 1999 Peer Review Date: April 2000 Council Review: June 2000 Earliest Anticipated Start Date: July 2000 AWARD CRITERIA Criteria that will be used to make award decisions include scientific and technical merit, as determined by peer review; programmatic priorities; and, availability of funds. INQUIRIES Inquiries concerning this RFA are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Contact information for inquiries regarding both programmatic and fiscal matters may be found at: http://www.nichd.nih.gov/rfa/HD-99-014/HD-99-014.htm AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.865, Research for Mothers and Children, and 93.242 for NIMH research grants. 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 PHS 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 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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