HIV/AIDS, DRUG USE, AND HIGHLY VULNERABLE YOUTH: TARGETING RESEARCH GAPS RELEASE DATE: January 15, 2004 RFA NUMBER: RFA-DA-04-012 Department of Health and Human Services (DHHS) PARTICIPATING ORGANIZATION: National Institutes of Health (NIH) ( COMPONENTS OF PARTICIPATING ORGANIZATION: National Institute on Drug Abuse (NIDA) ( National Institute of Mental Health (NIMH) ( CATALOG OF FEDERAL DOMESTIC ASSISTANCE NUMBER: 93.279 (NIDA), 93.242 (NIMH) LETTER OF INTENT RECEIPT DATE: February 17, 2004 APPLICATION RECEIPT DATE: March 17, 2004 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 innovative applications to address critical gaps in research on HIV/AIDS prevention, treatment, and related health issues among highly vulnerable youth. For the purpose of this RFA, highly vulnerable youth are those children, adolescents, and young adults aged 10-24 years who are using or are at high-risk for using drugs (both injection and non-injection drug use) and who are (a) at high risk for HIV and other infectious diseases (e.g., hepatitis B virus (HBV), hepatitis C virus (HCV), (b) living with HIV/AIDS, and/or (c) affected by HIV/AIDS (e.g., youth with family living with HIV, especially youth from drug-using households; youth bereaved by HIV, including youth orphaned by HIV/AIDS). This initiative is focused on highly vulnerable youth in the United States who are particularly vulnerable to HIV/AIDS and its medical and psychosocial consequences: (a) youth in risky social environments who are exposed to multiple factors associated with drug abuse and HIV, but who have limited exposure to factors that are protective, (b) youth who live outside of the protective influences of traditional family, school, or work venues (e.g., on the street, homeless and runaway youth, youth in foster care, incarcerated youth, youth in gangs, migrant youth), (c) youth who represent the current or emerging face of the HIV epidemic in the U.S. (e.g., young minority females, young men who have sex with men, youth from rural or suburban areas), and (d) youth in families and/or communities already vulnerable as a result of poverty, HIV/AIDS, drug abuse, mental illness, stigma, discrimination, and violence. The overall objective of this RFA is to facilitate the development and implementation of interventions that reduce HIV infections and mitigate the medical and psychosocial consequences of the virus in order to improve the health and quality of life of youth at risk for, living with, or affected by HIV/AIDS. This RFA encourages innovative, culturally relevant, and gender sensitive research in the following areas: (a) epidemiology of current and emerging trends related to HIV/AIDS and drug use patterns, physical and mental health comorbidities, and social environments among highly vulnerable youth; (b) development, implementation, evaluation, and dissemination of innovative approaches to prevent the transmission of HIV infection; (c) access to, receipt of, and adherence to health and drug abuse treatment services, including research on barriers to treatment such as stigma, and on optimizing HIV/AIDS risk reduction through drug abuse treatment; (d) integration of services (e.g., HIV/AIDS prevention and treatment services, HIV/AIDS medical services with drug abuse prevention and/or treatment, HIV/AIDS and HBV/HCV prevention). RESEARCH OBJECTIVES Background In the third decade of the pandemic, HIV/AIDS continues to impact global health. An estimated 40 million people were living with HIV/AIDS in 2002 with 5 million new infections that year. In many areas of the world, including communities in the U.S., youth (those under 25 years) represent the component of the population at greatest risk for HIV infection, with young females often at highest risk. More than a third of people living with HIV globally and over half of persons newly infected in 2002 were under age 25. In the U.S., an estimated 900,000 people are living with HIV/AIDS, with 40,000 new HIV infections estimated each year, almost a quarter of these are among youth. While new infection rates in the U.S. are low in comparison with countries that have been devastated by the epidemic, the impact of the virus on individuals, families, and communities remains high. In the U.S., HIV disproportionately affects minority communities, and those infected are increasingly young, female, and minority. Among adolescents, young African American women and young men who have sex with men, particularly young men of color, are at high risk, as are young injection drug users (IDUs). Despite the existence of a highly effective vaccine, HBV continues to be highly prevalent in the U.S., with approximately 1.25 million chronic infections. An estimated 78,000 new infections, and 22,000 acute clinical cases occurred in the U.S. in 2001. The highest rates of acute disease are among 20-49 year olds; 20 percent of acute cases reported to the CDC from 1980-1990 occurred before age 21. Acute HBV is disproportionately reported by communities of color and by men. As with HIV, HBV is transmitted through unprotected sex and IDU. However, HBV is estimated to be about 100 times more infectious than HIV, with more rapid acquisition of HBV after initiating IDU. Reaching adolescents with HBV vaccination before initiating high-risk practices is crucial. An estimated 3.9 million persons in the civilian non-institutionalized U.S. population have been infected with HCV, of whom approximately 2.7 million are chronically infected. The highest incidence of acute HCV is found among persons aged 20-39 years. The incidence of HCV is higher for males than females and the prevalence higher for African Americans than whites. IDU is the major risk factor for HCV infection, accounting for 60 percent of newly reported cases. HCV infection is acquired more rapidly after the initiation of IDU than either HBV or HIV infection; about one-third of IDUs are infected within two years of initiation, down from a high of 80 percent reported in the 1980s. Although the number of cases of acute HCV among IDUs has declined since 1989, both the incidence and prevalence of HCV infection remain high. Youth- focused research on HCV prevention, treatment, and care is lacking. Highly Vulnerable Youth Many youth in the U.S. are at high risk for infection with HIV/AIDS, HBV, HCV, and other infectious diseases as a result of engagement in high risk sexual and/or drug use behaviors (e.g., unprotected sexual intercourse, injection drug use, exchanging sex for drugs or goods). Youth who live in social environments with high exposure to risk factors and limited exposure to protective factors as well as youth outside of the protective influences of traditional family, school, or work venues are at particular risk. High rates of HIV-risk behaviors are reported for incarcerated youth, youth in foster care, youth receiving psychiatric care, youth involved with gangs, and homeless, on the street, and runaway youth. For example, high rates of HIV, HBV, HCV, and STIs are reported among the estimated 500,000 to two million homeless youth in the U.S. HIV-risk behaviors including substance abuse, lifetime IDU, needle sharing, and participation in survival sex (i.e., exchanging sex for food, shelter, drugs, or money) are also high. Despite their risky behavioral practices, these youth report an interest in learning and engaging in methods to protect their health. Over 30,000 young people have been reported with AIDS with estimates of over 100,000 youth living with HIV/AIDS. Research with youth infected through horizontal transmission indicates engagement in HIV-risk behaviors, including unprotected sexual intercourse and substance abuse. Less is known about the risk behaviors of youth infected through vertical transmission who are aging into adolescence. In addition to the common challenges associated with pubertal development, youth living with HIV face the additional challenges associated with living with a chronic illness including complex therapeutic drug regimens and decisions regarding disclosure of their conditions to peers. In addition, youth vulnerable to the consequences of HIV infection often live in communities with high exposure to risk and limited access to services. Prevention interventions that address drug-related risk behavior are needed for youth living with HIV to reduce the possibility of reinfection and additional HIV transmissions and maintain health status. In addition, given the CDC estimates that one third of infected individuals are unaware of their HIV status, innovative research is needed on interventions that link infected youth to care. With over 900,000 persons in the U.S. estimated living with HIV, there are millions of youth affected by the virus and its medical and psychosocial consequences vis- -vis parents, caregivers, siblings, partners, friends, and neighbors. It is estimated that over 100,000 children have been orphaned by HIV/AIDS in the U.S; worldwide the estimate is a staggering 14 million children. Affected youth may experience psychosocial and economic stresses associated with caring for a person with a chronic illness, or with grieving a parent or loved one who is dying or deceased. Children of women infected through drug use risk behaviors, especially IDUs and their sexual partners, experience multiple challenges related to parental illness and to drug abuse, situations associated with risk for substance abuse, mental health, and behavioral problems. Furthermore, many affected youth live in communities already vulnerable as a result of poverty, HIV/AIDS and other infectious diseases, drug abuse, violence, discrimination, and stigma. While research indicates that interventions can reduce risk behaviors of HIV affected youth, many communities are unable to benefit from these or other health interventions due to limited access to prevention, treatment, and other health services. Social/contextual, developmental, and gender-related factors can influence HIV risk behavior and should be taken into consideration when designing prevention, treatment, and care interventions. Factors such as gender norms, stigma, discrimination, homelessness, poverty, unemployment, and neighborhood characteristics can impact individuals HIV risk behaviors and the effectiveness and access to interventions to reduce HIV and related consequences. For example, economic inequalities associated with youth status or poverty can result in increased exposure to risk factors as well as limited access to protective factors such as access to HIV/STD prevention and treatment services. Risk and protective factors and corresponding avenues of intervention can vary across developmental period. For example, adolescent females are more vulnerable to HIV/AIDS than adult women due to their immature reproductive organs. High rates of STDs among adolescents also increase vulnerability to HIV/AIDS; approximately one-quarter of the 15 million incident cases of STDs reported in the U.S. each year are among teenagers. In terms of cognitive and emotional development, adolescence is associated with perceptions of invulnerability and increased risk-taking and experimentation that occur in a context of developing biological, cognitive, emotional, and social capacities. Relatedly, substance use and abuse increases across adolescence. As youth develop, susceptibility or protection conferred vis- - vis particular risk mechanisms can also change (e.g., the changing role of family and peer influence across adolescence). Research on gender and HIV/AIDS has demonstrated gender differences across many areas of HIV research including but not limited to biological susceptibility, viral load, HIV related risk behaviors and their mediators, effectiveness of prevention interventions, access to prevention and care, and engagement in research studies. In addition to biological differences, a variety of social contextual factors including gender roles, gender norms, inequalities, substance abuse histories, experiences of sexual and physical abuse, and access to resources may be impacting outcomes. Gender specific interventions may be required for some sub-populations of highly vulnerable youth; at minimal, gender analysis of risk factors and intervention effects are necessary. It is important to note that youth at highest risk experience multiple areas of vulnerability. Thus, the need for multifaceted and multilevel interventions is greatest where there is greatest risk. For example, many street youth are exposed to multiple risk factors: incarceration, foster care, living with HIV, HBV or HCV, substance abuse, psychiatric illness, physical and/or sexual abuse, economic inequalities, stigma, discrimination, and violence. Furthermore, the problems that these youth face are compounded by poor access to health care. Interventions are needed to address the multiple levels and types of risk and protection factors that influence highly vulnerable youth including peer, family, partner, community and structural levels as well as individual level biological, cognitive, emotional, and social factors. This RFA is designed to address critical gaps in research on HIV/AIDS prevention, treatment, and related health issues among highly vulnerable youth. Proposals in response to this RFA are encouraged to utilize innovative methods to design prevention and treatment interventions and to recruit and retain highly vulnerable youth participants. Interventions should be culturally relevant and gender sensitive. Developmental issues of youth and social contextual factors that influence drug abuse and HIV/AIDS including gender, race, ethnicity, culture, and economic resources should be taken into consideration. Secondary data analysis related to HIV/AIDS and drug use for highly vulnerable youth is welcome. For the purpose of this RFA, youth are defined as persons aged 10-24 years. For research that includes persons 18-24 that is not youth focused or developmentally sensitive (e.g., interventions aimed at adult populations), please refer to NIDA PA Drug Abuse Aspects of HIV and other Infections Research Areas Epidemiology of current and emerging trends related to HIV/AIDS and drug use patterns, physical and mental health comorbidities, and social environments of highly vulnerable youth, including behaviors associated with HIV exposure. Children aging into adolescents and adolescents aging into young adults represent new cohorts of persons vulnerable to HIV and its consequences. Many of these youth initiated sexual and drug use risk behaviors after the advent of HAART. Changing social contexts, social norms, social policies and new technologies can create new vulnerabilities for youth as well as new avenues for interventions. Informed by epidemiological studies, earlier interventions may need to be adapted or new interventions developed to reflect current trends in sexual and drug use HIV related risk behaviors and social cultural influences (e.g., media, including the internet) among sub-populations of highly vulnerable youth. Illustrative epidemiological research topics include but are not limited to: o Studies to examine mechanisms underlying risk for groups reporting increased HIV infection rates (e.g., youth in the southern U.S., young men who have sex with men, particularly young men of color, including young Asian and Pacific Islanders). o Research on emerging drugs of abuse in relation to HIV risk for highly vulnerable youth, including but not limited to club drugs (e.g., ecstasy (MDMA), GHB, and ketamine), inhalants, crack cocaine, hallucinogens, amphetamines, heroin, potent marijuana and prescription drugs as well as access to drugs over the internet. o Research on current youth trends and HIV risk and protective behaviors among highly vulnerable youth at-risk for, living with, or affected by HIV (e.g., HIV risk associated with tattoos and other body modifications, HIV, drug use, and the internet). o Studies to examine longitudinal risk and protective or predictive factors for HIV and other infectious diseases in young adulthood for highly vulnerable youth. o Studies examining drug use, HIV-related risk behaviors, and medical and mental health comorbidities including HCV and HBV, especially for youth living with HIV and youth affected by HIV. Development, implementation, evaluation, and dissemination of innovative approaches to prevent the transmission of HIV infection Evaluations of HIV prevention interventions for youth indicate that theory- based, model-driven programs can reduce both HIV risk behaviors and relevant mediators. However, these interventions do not fully reduce risk behaviors, changes are difficult to sustain over time, many communities have limited access to prevention programs, and youth continue to be infected with HIV and other blood borne and sexually transmitted pathogens. Therefore, the development of new or adaptation of earlier interventions is needed to reduce the drug use related spread of HIV and other infectious diseases. As noted earlier, youth at highest risk experience multiple vulnerabilities. Effective prevention interventions should consider multiple levels of risk (dyadic, family, community, structural, in addition to individual). Since many highly vulnerable youth are difficult to reach in traditional intervention settings (e.g., school-based programs) research that develops new approaches for recruitment and retention including new intervention venues is encouraged. Studies that include both behavioral and biological outcomes (e.g., STIs, HCV, HBV, and other biomarkers for HIV infection) are also encouraged. Illustrative research topics include but are not limited to: o Studies on innovative approaches to recruitment and retention to reach drug-using youth in venues frequented outside of the school setting (e.g., parks, shopping malls, clubs, the internet). o Formative research to understand the particular prevention needs of youth affected by HIV. o Formative research to develop youth-focused and developmentally- appropriate interventions with young IDUs including youth initiating drug use and/or initiating sexual risk behaviors associated with drug use. o Feasibility and acceptability studies of new technologies for highly vulnerable youth (e.g., rapid testing). o Research to develop dyadic interventions for highly vulnerable youth (e.g., youth involved with partners who engage in high risk HIV/STD- related behaviors including injection drug use, youth living with HIV and their partners). o Research to develop appropriate community level interventions to link highly vulnerable youth to prevention, treatment, and care services, including voluntary counseling and testing for HIV and other infectious diseases (e.g., community mobilization, popular opinion leader for affected youth, and media, including the internet). o Studies on innovative prevention interventions for youth living with HIV. o Research on gender-related factors that affect access to and effectiveness of HIV prevention interventions. o Research on the long-term impact of prevention interventions delivered to highly vulnerable youth earlier in life on HIV-related behaviors in adolescence and young adulthood. Optimizing HIV/AIDS risk reduction through drug abuse treatment Drug abuse treatment represents one potentially powerful intervention to reduce HIV/AIDS risk among highly vulnerable youth. There is strong, convergent evidence that a number of behavioral treatments for adolescent drug abuse reduce drug use behavior. Given that drug use is a risk behavior associated with HIV directly and indirectly (through other risk behaviors), it is reasonable to predict that treatment for adolescent drug abuse can reduce HIV/AIDS risk. While this link has been demonstrated in populations of adult drug users, this remains a gap area for youth in drug abuse treatment. Research is also lacking regarding how to optimize treatment efficacy in reducing both drug use and HIV/AIDS risk behaviors for these populations. Please refer to the Behavioral Therapies Development Program Announcement ( for more information about NIDA’s stage model of research aimed at optimizing behavioral treatment. Illustrative topics include, but are not limited to: o Research to develop and test novel culturally relevant and gender sensitive behavioral treatments that address HIV/AIDS risk, including research that incorporates knowledge from basic behavioral, affective and cognitive science into the development of interventions. o Studies to adapt existing treatments to target HIV/AIDS sexual and drug use risk reduction. This includes adapting existing treatments for adults to the different social, physiological, cognitive and developmental stages of youth. o Studies that investigate the mechanisms of action of a behavioral treatment’s effect on HIV/AIDS risk. o Development of psychometrically sound measures and methods of studying HIV/AIDS risk reduction among youth in drug abuse treatment. Access to, receipt of, and adherence to health and drug treatment services, including research on barriers to treatment such as stigma for highly vulnerable youth Integration of services (e.g., HIV/AIDS medical services with drug abuse prevention and/or treatment, HIV/AIDS prevention and treatment services) There is need for adolescent-specific studies aimed at understanding and improving adherence to treatment to minimize the negative physical, psychological, cognitive, and social consequences of HIV infection for highly vulnerable youth. Drug abuse and sexual HIV risk behaviors reported by highly vulnerable youth can interfere with treatment adherence and utilization and negatively impact health. Youth vulnerable to the consequences of HIV infection may face many barriers to accessing treatment including stigma and limited opportunities in their communities for health care. Research is needed to develop innovative approaches that improve access to and utilization of prevention and treatment services. Integration of HIV prevention and treatment services with other health services including substance abuse treatment may improve health outcomes for highly vulnerable youth. Illustrative topics include, but are not limited to: o Research on adherence to treatment for highly vulnerable youth including the effect of illicit drug use on adherence to HIV therapy and research to develop strategies to enhance adherence to HIV medications among youth living with HIV in drug abuse treatment. o Research on barriers to accessing treatment at the individual, family, community, and policy levels including stigma as well as specific issues of HIV infected youth, HIV affected youth, and other groups of highly vulnerable youth (e.g., homeless youth, youth involved in the juvenile justice system, migrant youth, especially non-English speakers). o Development of screening instruments and counseling strategies for early diagnosis of HIV and other infectious diseases for youth in drug abuse treatment and other healthcare settings. o Development of strategies to improve utilization of services by highly vulnerable youth. o Studies on gender-related factors that affect access to and utilization of HIV-related treatment and care. o Studies on integration of services (e.g., HIV/AIDS prevention and HIV/AIDS treatment, HIV/AIDS prevention/treatment and drug abuse prevention/treatment, HIV/AIDS, HBV vaccinations, HCV prevention and drug abuse/mental health treatment). MECHANISMS OF SUPPORT This RFA will use the NIH research project (R01), the small grant (R03) and the exploratory/development (R21) award mechanisms ( 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, 2004. Applications supported by NIMH will be funded after October 1, 2004. Applications that are not funded in the competition described in this RFA may be resubmitted as NEW investigator-initiated applications using the standard receipt dates for NEW applications described in the instructions to the PHS 398 application. This RFA uses just-in-time concepts. It also uses the modular budgeting as well as the non-modular budgeting formats (see Specifically, if you are submitting an application with direct costs in each year of $250,000 or less, use the modular budget format. Otherwise follow the instructions for non-modular budget research grant applications. This program does not require cost sharing as defined in the current NIH Grants Policy Statement at FUNDS AVAILABLE NIDA intends to commit approximately $1,500,000 million in FY 2004 and NIMH intends to commit approximately $500,000 in FY 2005 to fund 3 to 7 grants in response to this RFA. An applicant may request for the R01 a project period of up to 5 years. For the R03, the project period is 2 years and direct costs up to $50,000 for each of those years. For the R21, the project period is 2 years and up to $275,000 in direct costs for the two-year period. 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 institutions/organizations o Faith-based or community-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. 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: Nicolette Borek, Ph.D. Center on AIDS and Other Medical Consequences of Drug Abuse National Institute on Drug Abuse/NIH/DHHS 6001 Executive Boulevard, Room 5198, MSC 9555 Bethesda, MD 20892-9555 Telephone: (301) 402-0866 FAX: (301) 594-6566 Email: Dianne Rausch, Ph.D. Deputy Director, Center for Mental Health Research on AIDS National Institute of Mental Health 6001 Executive Blvd., Room 6212, MSC 9619 Bethesda, MD 20892-9619 Telephone: (301) 443-7281 FAX: (301) 443-9719 Email: o Direct your questions about peer review issues to: Teresa Levitin, Ph.D. Office of Extramural Affairs National Institute on Drug Abuse/NIH/DHHS 6101 Executive Boulevard, Suite 220, MSC 8401 Bethesda, Maryland 20892-8401 Telephone: (301) 443-2755 FAX: (301) 443-0538 Email: o Direct your questions about financial or grants management matters to: Gary Fleming, J.D., M.A. Grants Management Branch National Institute on Drug Abuse/NIH/DHHS 6101 Executive Boulevard, Suite 220, MSC 8403 Bethesda, MD 20892-8403 Telephone: (301) 443-6710 FAX: (301) 594-6849 Email: Mr. Brian Albertini Grants Management Branch National Institute of Mental Health 6001 Executive Blvd., Room 6115 Bethesda, MD 20892 Telephone: (301) 443-0004 Fax: (301) 443-0219 Email: 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 6101 Executive Boulevard, Suite 234, MSC 8401 Bethesda, MD 20892-8401 Rockville, MD 20852 (for express/courier service) Telephone: (301) 443-2755 FAX: (301) 443-0538 Email: SUBMITTING AN APPLICATION Applications must be prepared using the PHS 398 research grant application instructions and forms (rev. 5/2001). Applications must have a DUN and Bradstreet (D&B) Data Universal Numbering System (DUNS) number as the Universal Identifier when applying for Federal grants or cooperative agreements. The DUNS number can be obtained by calling (866) 705-5711 or through the web site at The DUNS number should be entered on line 11 of the face page of the PHS 398 form. The PHS 398 document is available at in an interactive format. For further assistance contact GrantsInfo, Telephone (301) 710-0267, Email: 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 includes step-by-step guidance for preparing modular grants. Additional information on modular grants is available at 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: 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 and all copies of the appendix material must be sent to: Director Office of Extramural Affairs National Institute on Drug Abuse/NIH/DHHS 6101 Executive Boulevard, Suite 220, MSC 8401 Bethesda, MD 20892-8401 Rockville, MD 20852 (for express/courier service) APPLICATION PROCESSING: Applications must be received on or before 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. Although there is no immediate acknowledgement of the receipt of an application, applicants are generally notified of the review and funding assignments within 8 weeks. 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. However, when a previously unfounded application, originally submitted as an investigator-initiated application, is to be submitted in response to an RFA, it is to be prepared as a NEW application. That is, the application for the RFA must not include an Introduction describing the changes and improvements made, and the text must not be marked to indicate the changes from the previous unfunded version of the application. PEER REVIEW PROCESS Upon receipt, applications will be reviewed for completeness by the CSR and responsiveness by NIDA. Incomplete applications will not be reviewed. If the application is not responsive to the RFA, NIH 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 appropriate NIH 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 NIDA in accordance with the review criteria stated below. As part of the initial merit review, all applications will: 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 written critique 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 evaluate the application in order to judge the likelihood that the proposed research will have a substantial impact on the pursuit of these goals. The scientific review group will address and consider each of the following criteria in assigning the application's overall score, weighting them as appropriate for each application. o Significance o Approach o Innovation o Investigator o Environment 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: Please assess the extent to which the study aims are consistent with the goals of the RFA. 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? Does the study address an important problem consistent with the goals of this RFA? (2) APPROACH: Are the conceptual framework, design, methods, and analyses adequately developed, well-integrated, and appropriate to the aims of the project? Does the applicant acknowledge potential problem areas and consider alternative tactics? (3) INNOVATION: Does the project employ novel concepts, approaches or methods? Are the aims original and innovative? Does the project challenge existing paradigms or develop new methodologies or technologies? (4) INVESTIGATOR: Is the investigator appropriately trained and well-suited to carry out this work? Is the work proposed appropriate to the experience level of the principal investigator and other researchers (if any)? (5) ENVIRONMENT: Does the scientific environment in which the work will be done contribute to the probability of success? Do the proposed experiments take advantage of unique features of the scientific environment or employ useful collaborative arrangements? Is there evidence of institutional support? ADDITIONAL REVIEW CRITERIA: In addition to the above criteria, the following items will be considered in the determination of scientific merit and the priority score: PROTECTION OF HUMAN SUBJECTS FROM RESEARCH RISK: The involvement of human subjects and protections from research risk relating to their participation in the proposed research will be assessed. (See criteria included in the section on Federal Citations, below). INCLUSION OF WOMEN, MINORITIES AND CHILDREN IN RESEARCH: 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 in the sections on Federal Citations, below). ADDITIONAL REVIEW CONSIDERATIONS 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: February 17, 2004 Application Receipt Date: March 17, 2004 Peer Review Date: June/July 2004 Council Review: September 2004 Earliest Anticipated Start Date: September 30, 2004 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 HUMAN SUBJECTS PROTECTION: Federal regulations (45CFR46) require that applications and proposals involving human subjects must be evaluated with reference to the risks to the subjects, the adequacy of protection against these risks, the potential benefits of the research to the subjects and others, and the importance of the knowledge gained or to be gained. DATA SAFETY AND MONITORING PLAN: Data and safety monitoring is required for all types of clinical trials, including physiologic, toxicity, and dose-finding studies (phase I); efficacy studies (phase II); efficacy, effectiveness and comparative trials (phase III). The establishment of data and safety monitoring boards (DSMBs) is required for multi-site clinical trials involving interventions that entail potential risk to the participants. Data and safety monitoring is required for all types of clinical trials, including physiologic, toxicity, and dose-finding studies (phase I); efficacy studies (phase II); efficacy, effectiveness and comparative trials (phase III). The establishment of data and safety monitoring boards (DSMBs) is required for multi-site clinical trials involving interventions that entail potential risk to the participants. (NIH Policy for Data Safety and Monitoring, NIH Guide for Grants and Contracts, June 12, 1998: 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 (; a complete copy of the updated Guidelines are available at 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 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 HUMAN EMBRYONIC STEM CELLS (hESC): Criteria for federal funding of research on hESCs can be found at and at Only research using hESC lines that are registered in the NIH Human Embryonic Stem Cell Registry will be eligible for Federal funding (see It is the responsibility of the applicant to provide, in the project description and elsewhere in the application as appropriate, 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 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. STANDARDS FOR PRIVACY OF INDIVIDUALLY IDENTIFIABLE HEALTH INFORMATION: The Department of Health and Human Services (DHHS) issued final modification to the Standards for Privacy of Individually Identifiable Health Information , the Privacy Rule, on August 14, 2002. The Privacy Rule is a federal regulation under the Health Insurance Portability and Accountability Act (HIPAA) of 1996 that governs the protection of individually identifiable health information, and is administered and enforced by the DHHS Office for Civil Rights (OCR). Those who must comply with the Privacy Rule (classified under the Rule as covered entities ) must do so by April 14, 2003 (with the exception of small health plans which have an extra year to comply). Decisions about applicability and implementation of the Privacy Rule reside with the researcher and his/her institution. The OCR website ( provides information on the Privacy Rule, including a complete Regulation Text and a set of decision tools on Am I a covered entity? Information on the impact of the HIPAA Privacy Rule on NIH processes involving the review, funding, and progress monitoring of grants, cooperative agreements, and research contracts can be found at 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 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 under the Funding, or may be obtained by calling (301) 443-2755. 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 AUTHORITY AND REGULATIONS: This program is described in the Catalog of Federal Domestic Assistance at and is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284 and under Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement. The NIH Grants Policy Statement can be found at 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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