THE IDENTIFICATION AND PREVENTION OF MIDDLE CHILDHOOD PRECURSORS OF RISKY SEXUAL BEHAVIOR RELEASE DATE: April 30, 2002 PA NUMBER: PA-02-101 EXPIRATION DATE: February 1, 2005, unless reissued. National Institute of Child Health and Human Development (NICHD) (http://www.nichd.nih.gov) National Institute of Mental Health (NIMH) (http://www.nimh.nih.gov) National Institute of Nursing Research (NINR) (http://www.ninr.nih.gov) THIS PA CONTAINS THE FOLLOWING INFORMATION o Purpose of the PA o Research Objectives o Mechanism of Support o Eligible Institutions o Individuals Eligible to Become Principal Investigators o Special Requirements o Where to Send Inquiries o Submitting an Application o Peer Review Process o Review Criteria o Award Criteria o Required Federal Citations PURPOSE OF THIS PA The National Institute of Child Health and Human Development (NICHD), the National Institute of Mental Health (NIMH), the National Institute of Nursing Research (NINR), and the National Institutes of Health (NIH) Office of AIDS Research (OAR) invite applications proposing biobehavioral and neuroimaging studies of children ages six to 12 years to identify the precursors of risky sexual behavior. Risky sexual behavior is defined for this Program Announcement (PA) as any sexual intercourse before the child or adolescent is cognitively, emotionally, and physically prepared for the potential consequences. The goal is to prevent early, unwanted pregnancy and the transmission of sexually transmitted diseases (STDs), including HIV, during childhood and adolescence by identifying antecedents of risk, resilience factors, and effective interventions. The specific aims of this PA are to: (1) identify the interactions of individual characteristics (biologic, behavioral, cognitive, developmental, gender, genetic, and temperament) with environmental factors (family, peers, community, culture, school, religion, media, and socioeconomic status) during the middle childhood years that increase the likelihood that certain children will engage in risky sexual behavior; (2) identify the characteristics (biologic, behavioral, cognitive, developmental, emotional, genetic, social, cultural, and environmental) that protect children from participation in risky sexual behavior; and (3) develop, implement, and evaluate interventions designed for children between the ages of six and 12 years to promote healthy sexual development and prevent risky sexual behavior. Principal Investigators may elect to study any one or a combination of the aims stated above. This PA particularly encourages interdisciplinary approaches to research, and the design and evaluation of theory-driven, effective interventions. RESEARCH OBJECTIVES Risky sexual behavior is occurring at earlier ages, at higher rates in minority youths, and with serious potential consequences such as pregnancy and STDs. This PA encourages research to study the antecedents of risky sexual behavior, the influences promoting resilience, and the processes by which intrinsic and extrinsic factors influence sexual development and behavior. Investigations of the development of sexuality and sexual health behavior in middle childhood are also of interest. This knowledge of antecedents, processes, and influences will guide the development of effective prevention programs to delay the onset of risky sexual behavior. Applications proposing epidemiologic studies are invited to study the processes by which biological and environmental characteristics, and interactions among them, influence sexual health behavior in children. Also highly encouraged are intervention studies that promote academic success, support effective, nurturing parenting and mentoring, and identify effective motivational strategies to deter the early onset of risky sexual behavior. Gene, neuroendocrine, and neuroimaging studies to delineate the links between risky sexual behavior and biological underpinnings are also welcomed. This PA is designed to further stimulate research involving children ages six to 12 years designed to 1) identify antecedents of risky sexual behavior, 2) understand and encourage healthy sexual development and behavior, and 3) prevent sexual behavior before the child or adolescent is cognitively, emotionally, and physically prepared for the potential consequences. Research proposals may address the entire middle childhood age spectrum (six to 12 years of age) or selected years within this age range. Background Health behaviors, including sexual health behaviors, are normal aspects of human development that begin in childhood and adolescence, and influence physical and mental health throughout life. The rate of sexual development, although fairly standard for humans, shows remarkable variability among individuals and influences sexual health behavior. When sexual development precedes cognitive and emotional development, sexual experimentation may lead to unintended pregnancy and/or exposure to a variety of STDs. The teen pregnancy rate in the United States is among the highest of the industrialized nations. An early, unintended birth can disrupt the adolescent's life and that of her siblings, parents, and the infant's father. Teenage mothers face potential limitations on educational achievement and employment opportunities, and an increased likelihood of need for public assistance. For young fathers, premature marriage and/or parenthood can profoundly disrupt their earning patterns. Four potential concerns for the children born to teenage mothers include low birth weight, prematurity, infant mortality, and developmental problems. Adolescents represent one of the fastest-growing risk groups for HIV in the United States, with approximately a quarter of all new STD infections occurring in teenagers. According to the Youth Risk Behavior Surveillance of 1997, nearly half of all high school students surveyed had initiated sexual intercourse. Sexual experience and age at first intercourse are critical indicators of the risk of pregnancy and sexually transmitted diseases. Inner city, minority youths are at particular risk because of the documented greater concentration of HIV and STDs, the earlier age of initiation of unplanned, unprotected sexual practices with multiple partners, and the disproportionate impact of AIDS on minorities. Little is understood about the identification, development, expression, and prevention of precursors of risky sexual behavior occurring during middle childhood. Between ages six and 12 years, children spend more time with peers, in formal learning environments, and away from parents. This period of expanding cognitive competence may be the ideal time for the development of sound health habits. Recent research indicates that later elementary school-age children may be more receptive to learning about AIDS than children in junior high school. What is known is that risky sexual behavior occurs at younger ages and contributes to unwanted pregnancy and sexually transmitted diseases, including HIV, in adolescents. With only palliative treatment for HIV available, it is imperative that researchers identify preventive measures to halt the AIDS epidemic, especially among minority adolescents and marginalized populations. One effective method to prevent STDs and pregnancy is to deter the initiation of early sexual intercourse. Because interventions are more effective when initiated prior to sexual debut than after sexual activity has begun, new interventions should be introduced during middle childhood prior to sexual experimentation in adolescence. The Surgeon General, the American Academy of Pediatrics, and the Centers for Disease Control and Prevention (CDC) all concur with the need for AIDS education beginning within the elementary grades and continuing throughout the school years. In June of 2001, the Surgeon General issued his Call to Action to Promote Sexual Health and Responsible Sexual Behavior. In this document, he encourages the promotion of basic research across the lifespan in areas of human sexual development, sexual health, and reproductive health, as well as social and behavioral research on risk and protective factors for sexual health. Promising Elements of Sexual Education Programs: The majority of sexual education and abstinence education programs have been developed for adolescents; there are currently few programs being developed and tested for middle school populations. Early findings reveal that in order for educational programs to be likely to change behavior, they must incorporate factual information, provide a theoretical basis, pay attention to the social context of the participants, and assure conceptual understanding by the children. Promising sexuality education curricula targeting younger adolescents incorporate a broad-based skills-building approach that addresses the biological, sociocultural, psychological, and spiritual dimensions of sexuality in the cognitive, affective, and behavioral domains. According to the CDC, elements of promising HIV/AIDS prevention programs include the following: a clearly defined target population; cultural relevance; a theoretical framework; equal emphasis on abstinence and on lowering risk behavior rather than on abstinence alone; specific skills training; active rather than passive learning; and the cooperation of the community and community leaders. This information may help inform the development of new, innovative sexual education and HIV/STD/pregnancy prevention programs for children of middle childhood. Psychosocial and Contextual Influences on Adolescent Sexual Behavior: There are several psychosocial and contextual factors that influence adolescent sexual behavior and may also exert an influence on younger children. Psychosocial factors associated with early sexual intercourse among adolescents include the following: self-esteem, self-efficacy, temperament, values, involvement in prosocial activities, religiosity, early and steady dating, and stress. School factors influencing sexual behavior include the following: poor school performance, lack of motivation, lack of future educational plans, low educational level of parents, lack of school safety, and diminished sense of attachment to school. Living in impoverished areas or with high levels of violence is also related to the onset of sexual activity. Factors associated with early sexual debut in males include: racial and ethnic characteristics, with rates higher for blacks than for Hispanics or whites, being retained a grade in school, low church attendance, and maternal work outside the home during the formative years. Much research has been done on the influence of parents, families, and peers on the sexual behavior of adolescents. Lowered parental monitoring and presence, single parenting, parental divorce or separation during early adolescence, homes without mothers, being the child of a teen mother, and maternal employment outside the home during the formative years are associated with early sexual behavior. Poor parent-child relationships, parent-child communication, and parental attitudes about premarital sex also influence adolescents' sexual behavior. Sexually active peers and siblings increase the risk of early sexual behavior for adolescents, as does the perception of friends' involvement in sexual activity. It is not known whether these same psychosocial and contextual influences serve as precursors of risky sexual behavior for six- to 12-year-olds. Risk and Resilience in Adolescents: Resilience factors are the qualities that foster successful adaptation and transformation processes, despite risk and adversity. Recent studies indicate that nonresilient adolescents are more likely to initiate a variety of risky behaviors than resilient adolescents. These factors may also operate during middle childhood. 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. 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. Many of the risk factors and their antecedents identified in adolescents have not been studied in younger children. Not all children exposed to risk factors go on to participate in risky sexual activity, perhaps because of resilience factors, personality types in combination with parenting styles, or developmental and environmental assets. Research Scope Research to address the three key research issues (antecedents of risk, resilience factors, and effective interventions) includes, but is not limited to, the following topics and examples: (a) Developmental, Biobehavioral, Genetic, and Imaging Studies The role of individual cognitive abilities; personality characteristics; motivational factors; the influence of the family, peers, community, religion, school, sports and extracurricular activities; genetic and neuroendocrine factors are all potential influences on risky sexual behavior. Understanding children's cognitive, social, emotional, and physical development in a contextual manner should be considered. Genetic, neuroendocrine, and neuroimaging studies may provide insight into the development of the risk-taking personality and behavior, and are encouraged. Examples of relevant research topics include: o Theoretical models that influence behavior change in the context of development (cognitive, social, emotional, and physical). o Behavioral and developmental studies of risk-taking personality types, self-regulation, emotion-regulation, behavior change, and motivation. o Timing of pubertal development in relation to peers and implications for risky sexual behavior. o Genetic, neuroimaging, and/or neuroendocrine studies of children in middle childhood, including those with risk-taking personality types. o Gender identity and its relationship to early sexual risk behavior. (b) Psychosocial and Contextual Influences The role of psychosocial and contextual influences on the sexual risk behavior of adolescents is well studied. It is not known if these same influences, when present in middle childhood, function as precursors to subsequent risky behavior. Examples of relevant research issues include: o Psychosocial factors of middle childhood that influence risk-taking behavior in preadolescents and adolescents. o The significance of academic success and religiosity in the avoidance of risky sexual behavior. o The influence of parents, family, and peers during middle childhood in the context of sexual development and behavior. o Contextual studies of neighborhood, socioeconomic status, school, and extracurricular opportunities in relation to precursors of risky sexual behavior. (c) Substance Use Alcohol and drug use, currently being initiated by some middle school children, 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. Studies and questions of interest include the following: o Do risk-taking individuals (for drugs, sex, accidents, etc.) share common characteristics or identifiers (genetic, neuroendocrine, neuro-anatomical, behavioral)? o What role do inhaled, injected or ingested drugs play in the sexual behavior of pre-teens? o Examine the influence of substance use or abuse by parents, siblings, and peers on subsequent sensation-seeking activity by pre-teens. (d) Subpopulations 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. Subpopulations of adolescents at increased risk of acquiring AIDS through participation in high-risk activities include street and homeless youths, adolescent prostitutes, detained youths, gay, lesbian, bisexual, and transgendered youth. Examples of relevant research include: o Investigate the effects of early sexual abuse or exposure to sexually explicit material on subsequent sexual behavior of young children and teens. o Can intervention programs prevent early sexual activity in high-risk youths? (e) Risk and Resilience Factors It is not known at what ages risk and resilience factors exert their maximum effect. Caregiving in the child's first year of life has been seen by some as the most powerful predictor of childhood resilience. Social relationships among family members have been cited as the best predictors of behavioral outcomes in children. Additional information is needed regarding middle childhood resilience and risk factors, and may include the following studies and questions: o The identification of precursors of risky sexual behavior, of protective factors, and the influences and interactions of these forces. o Which risk factor or combination of factors (social, psychological, developmental or cognitive) in middle childhood are the strongest predictors of and/or contributors to early sexual initiation? o Do certain resilience factors (i.e., personal versus family or school) exert more influence than others, and at which developmental stages? o Do high-risk subpopulations (homeless, abused, institutionalized, emotionally disturbed or marginalized youths) respond to or require different approaches to increase resiliency and reduce risk? (f) Intervention Studies Few evaluation studies have been done on interventions for preadolescents to promote healthy sexual development and to delay sexual initiation, although there is compelling evidence that educational efforts should begin early. Developmentally and culturally appropriate, effective interventions are needed to reduce risky sexual behavior and subsequent problems of pregnancy and STDs. Relevant questions include: o Which interventions most effectively reduce the risk of early sexual initiation, and for which children? o Which interventions promote and enhance resilience and mental health? o Which interventions increase knowledge of HIV and STDs, social and negotiation skills, perception and understanding of high-risk situations? o Which children benefit from which kinds of interventions (church-based, family-based, school-based, peer-based, multisystemic, individual or group)? o At what ages and developmental stages are interventions most effective? o What is the optimal timing for delivery of the intervention and by whom should it be delivered? o Do interventions need to be reinforced and updated to address developmental issues; if so, when and how often? MECHANISM OF SUPPORT This PA will use the NIH research project grant (R01) award mechanism. As an applicant, you will be solely responsible for planning, directing, and executing the proposed project. This PA uses just-in-time concepts. It also uses the modular as well as the non-modular budgeting formats (see https://grants.nih.gov/grants/funding/modular/modular.htm). Specifically, if you are submitting an application with direct costs in each year of $250,000 or less, use the modular format. Otherwise follow the instructions for non- modular research grant applications. ELIGIBLE INSTITUTIONS You may submit an application if your institution has any of the following characteristics: o For-profit or non-profit organizations o Public or private institutions, such as universities, colleges, hospitals, and laboratories o Units of State and local governments o Eligible agencies of the Federal government o Domestic or foreign o Faith-based organizations INDIVIDUALS ELIGIBLE TO BECOME PRINCIPAL INVESTIGATORS Any individual with the skills, knowledge, and resources necessary to carry out the proposed research is invited to work with their institution to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH programs. SPECIAL REQUIREMENTS Applicants should plan to participate in twice-yearly conference calls among investigators funded through this PA to share progress. In addition, annual collaborative meetings for Principal Investigators funded through this PA and through RFA HD-99-014 will be held in the Washington D.C. area. The meetings 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 PA 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. Issues of confidentiality and Data Safety and Monitoring should be considered. WHERE TO SEND INQUIRIES We encourage your inquiries concerning this PA and welcome the opportunity answer questions from potential applicants. Inquiries may fall into two areas: scientific/research and financial or grants management issues: o Direct your questions about NICHD scientific/research issues to: Lynne Haverkos, M.D., MPH Child Development and Behavior Branch National Institute of Child Health and Human Development 6100 Executive Boulevard, Room 4B05, MSC 7510 Bethesda, MD 20892-7510 Telephone: (301) 435-6881 FAX: (301) 480-0230 Email: haverkol@mail.nih.gov o Direct your questions about NIMH scientific/research issues to: Nicolette Borek Ph.D. Program Director National Institute of Mental Health 6001 Executive Boulevard, Room 6206, MSC 9605 Bethesda, MD 20892-9605 Telephone: (301) 443-4526 FAX: (301) 443-9719 Email: nborek@mail.nih.gov o Direct your questions about NINR scientific/research issues to: Hilary D. Sigmon Ph.D., R.N. Program Director National Institute of Nursing Research 45 Center Drive, MSC 6300 Bethesda, MD 20892-6300 Telephone: (301) 594-5970 FAX: (301) 480-8260 Email: hilary_sigmon@nih.gov o Direct your questions about NICHD fiscal matters to: Mary E. Daley Lead Grants Management Specialist National Institute of Child Health and Human Development 6100 Executive Boulevard, Room 8A17, MSC 7510 Bethesda, MD 20892-7510 Telephone: (301) 496-1305 FAX: (301) 402-0915 Email: md74u@nih.gov o Direct your questions about NIMH 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 o Direct your questions about NINR fiscal matters to: Cindy McDermott Grants Management Officer National Institute of Nursing Research 45 Center Drive, MSC 6300 Bethesda, MD 20892-6300 Telephone: (301) 594-6869 FAX: (301) 480-8260 Email: cindy_mcdermott@nih.gov SUBMITTING AN APPLICATION Applications must be prepared using the PHS 398 research grant application instructions and forms (rev. 5/2001). The PHS 398 is available at https://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive format. For further assistance contact GrantsInfo, Telephone (301) 710-0267, Email: GrantsInfo@nih.gov. APPLICATION RECEIPT DATES: Applications submitted in response to this program announcement will be accepted at the standard application deadlines, which are available at https://grants.nih.gov/grants/dates.htm. Application deadlines are also indicated in the PHS 398 application kit. SPECIFIC INSTRUCTIONS FOR MODULAR GRANT APPLICATIONS: Applications requesting up to $250,000 per year in direct costs must be submitted in a modular grant format. The modular grant format simplifies the preparation of the budget in these applications by limiting the level of budgetary detail. Applicants request direct costs in $25,000 modules. Section C of the research grant application instructions for the PHS 398 (rev. 5/2001) at https://grants.nih.gov/grants/funding/phs398/phs398.html includes step-by-step guidance for preparing modular grants. Additional information on modular grants is available at https://grants.nih.gov/grants/funding/modular/modular.htm. SPECIFIC INSTRUCTIONS FOR APPLICATIONS REQUESTING $500,000 OR MORE PER YEAR: Applications requesting $500,000 or more in direct costs for any year must include a cover letter identifying the NIH staff member within one of NIH institutes or centers who has agreed to accept assignment of the application. Applicants requesting more than $500,000 must carry out the following steps: 1) Contact the IC program staff at least six weeks before submitting the application, i.e., as you are developing plans for the study; 2) Obtain agreement from the IC staff that the IC will accept your application for consideration for award; and, 3) Identify, in a cover letter sent with the application, the staff member and IC who agreed to accept assignment of the application. This policy applies to all investigator-initiated new (type 1), competing continuation (type 2), competing supplement, or any amended or revised version of these grant application types. Additional information on this policy is available in the NIH Guide for Grants and Contracts, October 19, 2001, at https://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-004.html. SENDING AN APPLICATION TO THE NIH: Submit a signed, typewritten original of the application, including the checklist, and five signed photocopies in one package to: Center for Scientific Review National Institutes of Health 6701 Rockledge Drive, Room 1040, MSC 7710 Bethesda, MD 20892-7710 Bethesda, MD 20817 (for express/courier service) APPLICATION PROCESSING: Applications must be received by or mailed on or before the receipt dates described at https://grants.nih.gov/grants/funding/submissionschedule.htm. The CSR will not accept any application in response to this PA that is essentially the same as one currently pending initial review unless the applicant withdraws the pending application. The CSR will not accept any application that is essentially the same as one already reviewed. This does not preclude the submission of a substantial revision of an application already reviewed, but such application must include an Introduction addressing the previous critique. PEER REVIEW PROCESS Applications submitted for this PA will be assigned on the basis of established PHS referral guidelines. An appropriate scientific review group convened in accordance with the standard NIH peer review procedures (http://www.csr.nih.gov/refrev.htm) will evaluate applications for scientific and technical merit. As part of the initial merit review, all applications will: o Receive a written critique o Undergo a selection process in which only those applications deemed to have the highest scientific merit, generally the top half of applications under review, will be discussed and assigned a priority score o Receive a 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 your application in order to judge the likelihood that the proposed research will have a substantial impact on the pursuit of these goals: o Significance o Approach o Innovation o Investigator o Environment The scientific review group will address and consider each of these criteria in assigning your application's overall score, weighting them as appropriate for each application. Your 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, you 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 your study address an important problem? If the aims of your application are achieved, how do they advance scientific knowledge? 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? Do you acknowledge potential problem areas and consider alternative tactics? (3) INNOVATION: Does your project employ novel concepts, approaches or methods? Are the aims original and innovative? Does your project challenge existing paradigms or develop new methodologies or technologies? (4) INVESTIGATOR: Are you appropriately trained and well suited to carry out this work? Is the work proposed appropriate to your experience level as the principal investigator and to that of other researchers (if any)? (5) ENVIRONMENT: Does the scientific environment in which your work will be done contribute to the probability of success? Do the proposed experiments take advantage of unique features of the scientific environment or employ useful collaborative arrangements? Is there evidence of institutional support? ADDITIONAL REVIEW CRITERIA: In addition to the above criteria, your application will also be reviewed with respect to the following: PROTECTIONS: 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. INCLUSION: The adequacy of plans to include subjects from both genders, all racial and ethnic groups (and subgroups), and children as appropriate for the scientific goals of the research. Plans for the recruitment and retention of subjects will also be evaluated. (See Inclusion Criteria included in the section on Federal Citations, below.) BUDGET: The reasonableness of the proposed budget and the requested period of support in relation to the proposed research. AWARD CRITERIA Applications submitted in response to a PA will compete for available funds with all other recommended applications. The following will be considered in making funding decisions: o Scientific merit of the proposed project as determined by peer review o Availability of funds o Relevance to program priorities REQUIRED FEDERAL CITATIONS MONITORING PLAN AND DATA SAFETY AND MONITORING BOARD: Research components involving Phase I and II clinical trials must include provisions for assessment of patient eligibility and status, rigorous data management, quality assurance, and auditing procedures. In addition, it is NIH policy that all clinical trials require data and safety monitoring, with the method and degree of monitoring being commensurate with the risks (NIH Policy for Data Safety and Monitoring, NIH Guide for Grants and Contracts, June 12, 1998: https://grants.nih.gov/grants/guide/notice-files/not98-084.html). INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH: It is the policy of the NIH that women and members of minority groups and their sub-populations must be included in all NIH-supported clinical research projects unless a clear and compelling justification is provided indicating that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43). All investigators proposing clinical research should read the AMENDMENT "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research - Amended, October, 2001," published in the NIH Guide for Grants and Contracts on October 9, 2001 (https://grants.nih.gov/grants/guide/notice- files/NOT-OD-02-001.html); a complete copy of the updated Guidelines is available at https://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm . The amended policy incorporates: the use of an NIH definition of clinical research; updated racial and ethnic categories in compliance with the new OMB standards; clarification of language governing NIH-defined Phase III clinical trials consistent with the new PHS Form 398; and updated roles and responsibilities of NIH staff and the extramural community. The policy continues to require for all NIH-defined Phase III clinical trials that: a) all applications or proposals and/or protocols must provide a description of plans to conduct analyses, as appropriate, to address differences by sex/gender and/or racial/ethnic groups, including subgroups if applicable; and b) investigators must report annual accrual and progress in conducting analyses, as appropriate, by sex/gender and/or racial/ethnic group differences. INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS: The NIH maintains a policy that children (i.e., individuals under the age of 21) must be included in all human subjects research, conducted or supported by the NIH, unless there are scientific and ethical reasons not to include them. 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 is available at https://grants.nih.gov/grants/funding/children/children.htm. REQUIRED EDUCATION ON THE PROTECTION OF HUMAN SUBJECT PARTICIPANTS: NIH policy requires education on the protection of human subject participants for all investigators submitting NIH proposals for research involving human subjects. You will find this policy announcement in the NIH Guide for Grants and Contracts, dated June 5, 2000, at https://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html. PUBLIC ACCESS TO RESEARCH DATA THROUGH THE FREEDOM OF INFORMATION ACT: The Office of Management and Budget (OMB) Circular A-110 has been revised to provide public access to research data through the Freedom of Information Act (FOIA) under some circumstances. Data that are (1) first produced in a project that is supported in whole or in part with Federal funds and (2) cited publicly and officially by a Federal agency in support of an action that has the force and effect of law (i.e., a regulation) may be accessed through FOIA. It is important for applicants to understand the basic scope of this amendment. NIH has provided guidance at https://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm. Applicants may wish to place data collected under this PA in a public archive, which can provide protections for the data and manage the distribution for an indefinite period of time. If so, the application should include a description of the archiving plan in the study design and include information about this in the budget justification section of the application. In addition, applicants should think about how to structure informed consent statements and other human subjects procedures given the potential for wider use of data collected under this award. URLs IN NIH GRANT APPLICATIONS OR APPENDICES: All applications and proposals for NIH funding must be self-contained within specified page limitations. Unless otherwise specified in an NIH solicitation, Internet addresses (URLs) should not be used to provide information necessary to the review because reviewers are under no obligation to view the Internet sites. Furthermore, we caution reviewers that their anonymity may be compromised when they directly access an Internet site. HEALTHY PEOPLE 2010: The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2010," a PHS-led national activity for setting priority areas. This PA is related to one or more of the priority areas. Potential applicants may obtain a copy of "Healthy People 2010" at http://www.health.gov/healthypeople. AUTHORITY AND REGULATIONS: This program is described in the Catalog of Federal Domestic Assistance Nos. 93.865 (NICHD), 93.242 (NIMH) and 93.361 (NINR) and is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. 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 described at https://grants.nih.gov/grants/policy/policy.htm and under Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92. The PHS strongly encourages all grant recipients to provide a smoke-free workplace and discourage the use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routine education, library, day care, health care, or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people.
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