DRUG ABUSE AND HIV PREVENTION IN YOUTH RELEASE DATE: January 14, 2003 RFA NUMBER: DA-03-012 National Institute on Drug Abuse (NIDA) (http://www.nida.nih.gov) National Institute of Mental Health (NIMH) (http://www.nimh.nih.gov) LETTER OF INTENT RECEIPT DATE: March 14, 2003 APPLICATION RECEIPT DATE: April 14, 2003 THIS REQUEST FOR APPLICATIONS (RFA) CONTAINS THE FOLLOWING INFORMATION o Purpose of this RFA o Research Objectives o Mechanisms of Support o Funds Available o Eligible Institutions o Individuals Eligible to Become Principal Investigators o Where to Send Inquiries o Letter of Intent o Submitting an Application o Peer Review Process o Review Criteria o Receipt and Review Schedule o Award Criteria o Required Federal Citations PURPOSE OF THIS RFA The National Institute on Drug Abuse (NIDA) and the National Institute of Mental Health (NIMH) invite grant applications for the conduct of research on drug abuse and HIV prevention in youth. The major purpose of this RFA is to fill the need for theory-driven and research-based drug abuse-related HIV prevention interventions that will be effective in decreasing the incidence of HIV infection and AIDS in youth. There is a great need for drug abuse HIV prevention interventions in youth that are efficacious and effective in the short-term and that maintain efficacy and effectiveness in the long-term. Thus, this RFA will support studies on the prevention of HIV and maintenance of effects of prior prevention interventions on youth. Youth is defined as persons under the age of 21 years. The specific purposes of this RFA are: 1) to document the prevalence, nature, and effectiveness of existing HIV prevention programs; 2) to test new drug abuse-related HIV prevention interventions in randomized control group or equivalent study designs; 3) to determine context-specific features that influence maintenance of behavior change following intervention; 4) to examine enhancers and barriers to implementing HIV prevention programs in different populations and settings; and 5) to examine long-term impact of childhood and/or adolescent drug abuse prevention interventions on subsequent HIV-related risk behaviors. Potential implementation contexts include, but are not limited to: schools and universities, health care organizations, workplaces, families, community and faith-based organizations, and media. Proposed research can test single interventions alone or combinations of interventions (e.g., school- plus peer-based interventions). Also, proposed research may capitalize on existing studies, designs and infrastructure to investigate maintenance of drug abuse and HIV-associated behavior change following prevention intervention. RESEARCH OBJECTIVES Background In the United States, data indicate that women, youth, and minorities account for a growing proportion of new AIDS cases, that increasing numbers of cases are emerging in rural and smaller urban areas, and that an increasing proportion of AIDS cases are linked to heterosexual exposure (CDC, 2000b). Further, given the extended latency period for demonstrable infection, it is likely that most young adults diagnosed with HIV contracted the infection in the adolescent years. AIDS was the ninth leading cause of death in 1998 among youth ages 15 to 24 years, and the fifth leading cause of death for individuals ages 25 to 44 years, many of whom were infected as teenagers (Murphy, 2000). Young women and racial and ethnic minorities have been disproportionately affected (IOM, 2000). Females accounted for 58 percent of reported AIDS cases in 1999 among 13- to 19-year olds and 38 percent of cases among 20- to 24-year olds. Forty-three percent of new AIDS cases in the 13- to 24-year age group were among African-Americans, and 21 percent were among Hispanics (CDC, 2000b). Although African-Americans and Hispanics combined accounted for 66 percent of all new AIDS cases in 1999, they comprised only 23 percent of the total U.S. population. Sexual exposure is the primary route of infection for youth among the known sources of risk. Most young males are infected through sex with other men, while most young females are infected through heterosexual exposure. It is well known that the period of adolescence and early adulthood is a time for experimentation and exploration, particularly for sexual and drug use behaviors. The use of alcohol and illicit drugs place individuals at risk for engaging in risky sexual behaviors because inhibitions are lowered and cognitive functioning is impaired. Moreover, adolescence is a period of cognitive development typically characterized by perceptions of invulnerability from harm. This can reinforce the use and effects of substances that result in risky behaviors, including risky sexual behaviors. In addition, adolescents who are involved in other risky behaviors (e.g., dating older persons, inconsistent use of condoms) are at increased risk of engaging in risky sexual behavior. A number of demographic and lifestyle characteristics have been identified that affect adolescents' reproductive health; they include gender, age, and race/ethnicity, as well as attitudes, involvement in activities, and academic performance. Other examples include early initiation of sexual behavior, sexual trauma, violence, SES and community norms. Also, early puberty and early menstruation and teens appearing older or more physically developed than their actual age increase the likelihood of being sexually experienced. Adolescents who are informed about reproductive health are more likely to use contraception than those without information. Interpersonal relationship quality, both perceived and real, play a role in adolescents' reproductive health. Family dynamics including parental monitoring of youth behavior, attachment of parent and child, and stated family values and expectations about sexual behavior all positively influence the choice to abstain. Adolescents with peers who drink and use drugs, and teens who think their peers engage in these activities, are more likely to have sex than same aged youth who do not engage in these risky behaviors or have these perceptions. Teens engaging in risky behaviors (e.g., drugs and alcohol use, delinquency) are more likely to have multiple sexual partners, putting themselves at increased risk for pregnancy and STDs. Adolescents who have experienced rape or sexual abuse and youth with much older sex partners also are at greater risk for engaging in risky sexual behavior. These are just some of the factors that play a role in youth being at risk or protected from HIV risk- associated sexual behaviors. To date, the majority of science-based HIV prevention interventions have been developed for high-risk youth (e.g., runaways, abused, homosexual, low- income, minority). Thus, whereas the general youth population is both at- risk for HIV infection and an important target for HIV prevention interventions, little is known about the prevalence of adolescent-focused HIV prevention programs currently offered through general population settings (e.g., primary care and other health care organizations, school health, university programs) or the nature of these programs (e.g., abstinence, safe sex, coping skills). Therefore, it is important to determine what is currently being used and to develop and test developmentally and contextually appropriate drug abuse-related HIV prevention interventions or intervention components to reach the broad youth population. As with all general population interventions, a subpopulation of individuals or groups of individuals will be at heightened risk. Including these individuals and subgroups in a general population intervention may provide the intervention necessary without the exposure to the stigma attached to programming or services for those at higher risk. A review of prevention interventions found some common approaches to reducing adolescent unprotected sex: sex and HIV education, clinic protocols, service learning programs, and multi-component programs. Sex and HIV education programs and clinic protocols focus on sexual antecedents of risk-taking (e.g., sexual beliefs, attitudes, norms, and self-efficacy related to sexual behaviors). Service learning programs address nonsexual antecedents (such as volunteer work that facilitates connection to adults or positive future beliefs). Multi-component programs address both sexual and nonsexual antecedents. The latter approach appears to have the greater impact, however a few studies have demonstrated the effectiveness of brief, modest interventions on the topics of HIV, STD risk behaviors or sexual behavior. It has also been shown that prevention programs for young children and their families have a positive impact many years later on their reproductive health. Thus, findings to date are inconclusive, suggesting that no one approach is more effective than another. Rather, some youth may have the knowledge and skills needed regarding contraception but lack the motivation to avoid unprotected sex, whereas others may lack the knowledge, attitudes, or skills, but have the attachment to adults and the motivation to avoid unprotected sex. Thus, determining the underlying reasons for sexual risk- taking is an important factor in developing program strategies to be tested. Research Goals and Scope The goal of this RFA is to generate drug abuse-related HIV risk-associated prevention interventions that are efficacious and effective and will maintain long-term behavior change in youth and ultimately reduce the rate of HIV infection and AIDS in youth. It is important that all adolescents be screened for drug abuse and HIV risk behavior and, if indicated, assessed and provided tailored interventions because adolescence is a critical phase during which youth make conscious or de facto decisions about engaging in sexual and substance abuse behaviors. Thus, applications are encouraged that target general population youth and/or high-risk youth. Research goals may include drug abuse-related HIV prevention interventions that help adolescents abstain from intercourse, delay intercourse, develop safer sexual practices, and reduce sexual risk-taking connected with substance abuse. Populations of particular interest include females, communities of color, and gay/lesbian/bisexual/transgender and questioning youth. Research proposals for international settings are also welcome. Examples of groups of youth who are at very high-risk for HIV include those engaging in a variety of risky behaviors, e.g., out-of-school youth, street youth, and youth in the juvenile justice system. Other very high-risk groups include youth in foster care and youth who have been physically or sexually abused. Youth who have already dropped out of school and other high-risk groups (e.g., youth on in-school suspension, youth in gangs, young men having sex with men, street youth, those using drugs or have parents or siblings abusing drugs, prostitution rings, etc.) may be particularly hard to reach. Moreover, because of the transient nature of many of these subgroups, developing and testing strategies that address their prevention needs and retaining these youth in programming is an important research focus. Other factors may make certain populations less likely to receive prevention services. For example, there is much controversy regarding sex education, including HIV prevention, in schools. Further, both general population and at-risk adolescents residing in rural and frontier areas are faced with the lack of availability of health care services and the stigma of seeking services when available. Females are at a particular disadvantage with regard to HIV prevention when they lack power and in some cases suffer abuse in interpersonal relationships. Many subpopulation groups may be less responsive to prevention efforts that are not sensitive to group attitudes, norms, beliefs, and context. Issues around HIV, sexuality, and substance abuse must be recognized as potentially sensitive issues in minority communities. Research that takes a novel approach to advancing the science of prevention in high-risk and special populations is of special interest. Applications must justify the need of the population being targeted for drug- related HIV prevention interventions (i.e., students in high school health classes, all adolescent patients in primary care, youth who have been raped), level of risk of the population (i.e., universal, selective, indicated or tiered), and the type of intervention to be used (i.e., brief versus more intensive, single- or multi-component interventions, sexual versus nonsexual antecedents). Interventions can: (1) be focused on risk and protective factors or mediators for HIV exposure/infection that are nonsexual in nature and examine sexual behaviors as outcomes, (2) be focused on sexual behaviors (e.g., delaying initiation of sex, increasing condom use, decreasing number of partners), or (3) constitute a combination of nonsexual and sexual behaviors. HIV prevention components can also be integrated into existing drug abuse prevention programs or drug abuse prevention can be integrated into existing HIV prevention programs. RESEARCH AREAS This initiative will support research that examines existing strategies, and designs and tests new strategies for drug abuse-related HIV prevention for youth. Please note that applications which address HIV prevention interventions for HIV-positive youth and youth in drug abuse treatment will not be accepted under this RFA. These areas of intervention are outside the scope of this RFA. Examples of types of applications that would be of interest include: New Interventions Development and testing interventions to prevent or reduce drug abuse and sexual risk behavior among uninfected youth. Determination of whether and which strategies utilized in drug abuse prevention interventions influence HIV outcomes. Examination of the potential additive effects of programming through combining an HIV prevention component with an existing drug abuse prevention program or adding a drug abuse prevention component to an existing HIV prevention program. Development of brief HIV and drug abuse prevention interventions in adolescent clinical and primary care settings that focus on HIV and drug abuse prevention. Application of effective HIV prevention programs or program components in a variety of drug abuse-related prevention contexts, such as health clinics, primary care, school health programs, faith-based programs, social organizations and community settings, to determine equivalent or differential effectiveness by setting, delivery characteristics and financial and human resources. Incorporation of technology (e.g., internet-based, personal digital assistant (PDA), two-way pager, CD-ROM, etc.) in order to enhance access, feasibility, efficacy, and dissemination of innovative, theory-driven, empirically based interventions for adolescents. Development and testing of community-based interventions, including mass media approaches that focus on HIV prevention in the context of drug abuse prevention. Development and testing of prevention programming dealing with both drug abuse and HIV tailored to the needs of special, at-risk subpopulations of youth, including ethnic minority MSM, marginalized youth, street youth, youth in foster care, etc. Risk and Protective Factors Development and testing of drug abuse interventions focused on sexual antecedents, nonsexual antecedents, and/or the combination of both on adolescent HIV risk behaviors. Examination of the impact of targeting mediators of drug abuse, HIV, and STDs, and examining subsequent sexual activity and HIV and other STD infection. Follow-Up Studies Addressing the maintenance of HIV prevention effects through examination of follow-up data from randomized control group design prevention interventions related to drug abuse. Follow-up studies of existing drug abuse and drug abuse-related HIV prevention programs to examine long-term impact on delaying initiation of intercourse and reducing adolescent unprotected sex and HIV infection. Address contextual factors influencing maintenance of behavior change following randomized control trials of preventive interventions. MECHANISMS OF SUPPORT This RFA will use the NIH research project grant (R01), the NIDA small grant (R03), and the developmental/exploratory grant (R21) award mechanisms, as well as competitive supplements. As an applicant you will be solely responsible for planning, directing, and executing the proposed project. This RFA is a one-time solicitation. Future unsolicited, competing- continuation applications based on this project will compete with all investigator-initiated applications and will be reviewed according to the customary peer review procedures. The anticipated award date is September 30, 2003. This RFA uses just-in-time concepts. It also uses the modular budgeting format. (see http://grants.nih.gov/grants/funding/modular/modular.htm). Specifically, if you are submitting an application with direct costs in each year of $250,000 or less, use the modular format. FUNDS AVAILABLE NIDA intends to commit approximately $2,000,000 and NIMH intends to commit $400,000 in FY 2003 to fund six to eight new and/or competitive continuation grants as well as competitive supplements in response to this RFA. An applicant may request a project period for the R01 of up to five years and a budget for direct costs of up to $350,000 per year. For the R21, three years and a budget for direct costs of up to $100,000. For the R03, two years and a budget for direct costs of up to $50,000. Because the nature and scope of the proposed research will vary from application to application, it is anticipated that the size and duration of each award will also vary. Although the financial plans of NIDA 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 meritorious applications. ELIGIBLE INSTITUTIONS You may submit (an) application(s) if your institution has any of the following characteristics: o For-profit or non-profit organizations o Public or private institutions, such as universities, colleges, hospitals, and laboratories o Units of State and local governments o Eligible agencies of the Federal government o Domestic or foreign o Faith-based or community-based organizations Foreign applicants are not eligible for the small grant award (R03). INDIVIDUALS ELIGIBLE TO BECOME PRINCIPAL INVESTIGATORS Any individual with the skills, knowledge, and resources necessary to carry out the proposed research is invited to work with their institution to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH programs. WHERE TO SEND INQUIRIES We encourage inquiries concerning this RFA and welcome the opportunity to answer questions from potential applicants. Inquiries may fall into three areas: scientific/research, peer review, and financial or grants management issues: o Direct your questions about scientific/research issues to: NIDA: Eve E. Reider, Ph.D. Division of Epidemiology, Services and Prevention Research National Institute on Drug Abuse/NIH/DHHS 6001 Executive Boulevard, Room 5153, MSC 9589 Bethesda, Maryland 20892-9589 Telephone: (301) 402-1719 FAX: (301) 480-2542 Email: ereider@mail.nih.gov NIMH: Andrew Forsyth, Ph.D. Center for Mental Health Research on AIDS National Institute of Mental Health 6001 Executive Boulevard, Room 6201, MSC 9619 Bethesda, Maryland 20892-9619 Telephone: (301) 443-6100 FAX: (301) 443-9719 Email: aforsyth@mail.nih.gov o Direct your questions about peer review issues to: Teresa Levitin, Ph.D. Office of Extramural Affairs National Institute on Drug Abuse/NIH/DHHS 6001 Executive Boulevard, Room 3158, MSC 9547 Bethesda, Maryland 20892-9547 Telephone: (301) 443-2755 Email: tlevitin@mail.nih.gov o Direct your questions about financial or grants management matters to: NIDA: Gary Fleming, J.D., M.A. Grants Management Branch National Institute on Drug Abuse/NIH/DHHS 6001 Executive Boulevard, Room 3131 MSC 9541 Bethesda, Maryland 20892-9541 Telephone: (301) 443-6710 E-mail: gfleming@mail.nih.gov NIMH: Brian Albertini Grants Management Branch National Institute of Mental Health National Institutes of Health 6001 Executive Boulevard, Room 6115, MSC 9605 Bethesda, MD 20892-9605 Telephone: 301-443-0004 Fax: 301-443-0219 Email: albertinib2@mail.nih.gov LETTER OF INTENT Prospective applicants are asked to submit a letter of intent that includes the following information: o Descriptive title of the proposed research o Name, address, and telephone number of the Principal Investigator o Names of other key personnel o Participating institutions o 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 NIDA staff to estimate the potential review workload and plan the review. The letter of intent is to be sent by the date listed at the beginning of this document. The letter of intent should be sent to: Director Office of Extramural Affairs National Institute on Drug Abuse/NIH/DHHS 6001 Executive Boulevard, Room 3158, MSC 9547 Bethesda, Maryland 20892-9547 Rockville, Maryland 20852 (for express/courier service) Telephone: (301) 443-2755 Fax: (301) 443-0538 Email: tlevitin@mail.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 http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive format. For further assistance contact GrantsInfo, Telephone (301) 435-0714, Email: GrantsInfo@nih.gov. 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 http://grants.nih.gov/grants/funding/phs398/phs398.html includes step-by-step guidance for preparing modular grants. Additional information on modular grants is available at http://grants.nih.gov/grants/funding/modular/modular.htm. USING THE RFA LABEL: The RFA label available in the PHS 398 (rev. 5/2001) application form must be affixed to the bottom of the face page of the application. Type the RFA number on the label. 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. The RFA label is also available at: http://grants.nih.gov/grants/funding/phs398/label-bk.pdf. SENDING AN APPLICATION TO THE NIH: 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, DHHS 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 must be sent to: Director Office of Extramural Affairs National Institute on Drug Abuse/NIH/DHHS 6001 Executive Boulevard, Room 3158, MSC 9547 Bethesda, Maryland 20892-9547 Rockville, Maryland 20852 (for express/courier service) Telephone: (301) 443-2755 APPLICATION PROCESSING: Applications must be received by the application receipt date listed in the heading of this RFA. 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. PEER REVIEW PROCESS Upon receipt, applications will be reviewed for completeness by the CSR and responsiveness by NIDA. Incomplete and/or non-responsive applications will be returned to the applicant without further consideration. 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 NIDA accordance with the review criteria stated below. As part of the initial merit review, all applications will: o Receive a written critique o Undergo a process in which only those applications deemed to have the highest scientific merit, generally the top half of the applications under review, will be discussed and assigned a priority score o Receive a second level review by the National Advisory Council on Drug Abuse or the National Advisory Mental Health 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 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 consistent with the goals of this RFA? 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: o 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. o 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) o BUDGET: The reasonableness of the proposed budget and the requested period of support in relation to the proposed research. RECEIPT AND REVIEW SCHEDULE Letter of Intent Receipt Date: March 14, 2003 Application Receipt Date: April 14, 2003 Peer Review Date: June/July 2003 Council Review: September 2003 Earliest Anticipated Start Date: September 30, 2003 AWARD CRITERIA Award criteria that will be used to make award decisions include: o Scientific merit (as determined by peer review) o Availability of funds o Programmatic 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: http://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 (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html); a complete copy of the updated Guidelines are available at http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm. The amended policy incorporates: the use of an NIH definition of clinical research; updated racial and ethnic categories in compliance with the new OMB standards; clarification of language governing NIH-defined Phase III clinical trials consistent with the new PHS Form 398; and updated roles and responsibilities of NIH staff and the extramural community. The policy continues to require for all NIH-defined Phase III clinical trials that: a) all applications or proposals and/or protocols must provide a description of plans to conduct analyses, as appropriate, to address differences by sex/gender and/or racial/ethnic groups, including subgroups if applicable; and b) investigators must report annual accrual and progress in conducting analyses, as appropriate, by sex/gender and/or racial/ethnic group differences. INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS:The NIH maintains a policy that children (i.e., individuals under the age of 21) must be included in all human subjects research, conducted or supported by the NIH, unless there are scientific and ethical reasons not to include them. 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 http://grants.nih.gov/grants/funding/children/children.htm. REQUIRED EDUCATION ON THE PROTECTION OF HUMAN SUBJECT PARTICIPANTS: NIH policy requires education on the protection of human subject participants for all investigators submitting NIH proposals for research involving human subjects. You will find this policy announcement in the NIH Guide for Grants and Contracts Announcement, dated June 5, 2000, at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html. HIV/AIDS COUNSELING AND TESTING POLICY FOR THE NATIONAL INSTITUTE ON DRUG ABUSE: Researchers funded by NIDA who are conducting research in community outreach settings, clinical, hospital settings, or clinical laboratories and have ongoing contact with clients at risk for HIV infection, are strongly encouraged to provide HIV risk reduction education and counseling. HIV counseling should include offering HIV testing available on-site or by referral to other HIV testing service for persons at risk for HIV infection including injecting drug users, crack cocaine users, and sexually active drug users and their sexual partners. For more information see http://grants.nih.gov/grants/guide/notice-files/NOT-DA-01-001.html. NATIONAL ADVISORY COUNCIL ON DRUG ABUSE RECOMMENDED GUIDELINES FOR THE ADMINISTRATION OF DRUGS TO HUMAN SUBJECTS: The National Advisory Council on Drug Abuse recognizes the importance of research involving the administration of drugs to human subjects and has developed guidelines relevant to such research. Potential applicants are encouraged to obtain and review these recommendations of Council before submitting an application that will administer compounds to human subjects. The guidelines are available on NIDA's Home Page at www.nida.nih.gov under the Funding, or may be obtained by calling (301) 443-2755. HUMAN EMBRYONIC STEM CELLS (hESC): Criteria for federal funding of research on hESCs can be found at http://grants.nih.gov/grants/stem_cells.htm and at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-005.html. Only research using hESC lines that are registered in the NIH Human Embryonic Stem Cell Registry will be eligible for Federal funding (see http://escr.nih.gov). It is the responsibility of the applicant to provide the official NIH identifier(s)for the hESC line(s)to be used in the proposed research. Applications that do not provide this information will be returned without review. PUBLIC ACCESS TO RESEARCH DATA THROUGH THE FREEDOM OF INFORMATION ACT: The Office of Management and Budget (OMB) Circular A-110 has been revised to provide public access to research data through the Freedom of Information Act (FOIA) under some circumstances. Data that are (1) first produced in a project that is supported in whole or in part with Federal funds and (2) cited publicly and officially by a Federal agency in support of an action that has the force and effect of law (i.e., a regulation) may be accessed through FOIA. It is important for applicants to understand the basic scope of this amendment. NIH has provided guidance at http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm. Applicants may wish to place data collected under this RFA 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 RFA 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 No. 93.279 (NIDA) and 93.242 (NIMH), 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 http://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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