Full Text HD-96-009 ADOLESCENT MEDICINE HIV/AIDS RESEARCH NETWORK NIH GUIDE, Volume 25, Number 31, September 20, 1996 RFA: HD-96-009 P.T. Keywords: National Institute of Child Health and Human Development National Institute of Allergy and Infectious Diseases National Institute on Drug Abuse Letter of Intent Receipt Date: October 15, 1996 Application Receipt Date: November 19, 1996 PURPOSE The National Institute of Child Health and Human Development (NICHD), the National Institute of Allergy and Infectious Diseases (NIAID), and the National Institute on Drug Abuse (NIDA) invite applications for cooperative agreements to expand the clinical science component of an existing adolescent health research network, the Adolescent Medicine HIV/AIDS Research Network. This Network is conducting basic and clinical research on the medical, biobehavioral, and psychosocial aspects of HIV/AIDS in adolescents infected with HIV through sexual or drug-taking behaviors. The network, established in 1994, is recruiting adolescents ages 12 through 18 years. Additional funding from Health Resources and Services Administration (HRSA) has been provided to the Network to fund the infrastructure to support research in clinical sites including outreach efforts and to develop and disseminate treatment and policy guidelines specific to HIV-infected adolescents. HEALTHY PEOPLE 2000 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2000," a PHS-led national activity for setting priority areas. This Request for Applications (RFA), Adolescent Medicine HIV/AIDS Research Network, centers on a high priority research area: the health and well-being of several special population groups, viz. people in minority groups (particularly Hispanic and African Americans) and people with low income, as well as specific research HIV infection Needs. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0 or Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (Telephone 202-512-1800). ELIGIBILITY REQUIREMENTS Applications may be submitted by domestic for-profit and non-profit organizations, public and private, such as universities, colleges, hospitals, laboratories, units of state and local governments, and eligible agencies of the Federal Government. Racial/ethnic minority investigators, women, and persons with disabilities are encouraged to apply. It is required that applicants for the Clinical Science Group have clinical experience pertinent to the objectives of the network delineated in this RFA. Applications from individuals without this experience will be returned without review. Applicants to join the existing Clinical Science Group of this Network must be providing comprehensive health care and support services to HIV-infected adolescents. Furthermore, they must demonstrate the proven capacity to reach sufficient numbers of adolescents with HIV infection to satisfy subject accrual expectations. In addition, applicants must be willing and able to participate in a cooperative program of research and evaluation with other successful applicants and current Clinical Science Group members. MECHANISM OF SUPPORT The administrative and funding instrument to be used for this program will be a cooperative agreement (U01), an "assistance" mechanism (rather than an "acquisition" mechanism) in which substantial NIH scientific and/or programmatic involvement with the awardee is anticipated during the performance of the activity. [GRANTS POLICY STATEMENT, DHHS PUBLICATION (OASH) 90-50,000 (REV) APRIL 1, 1994]. Under the cooperative agreement mechanism, the NIH purpose is to support and/or stimulate the recipient's activity by involvement in and otherwise working jointly with the award recipient in a partner role, but it is not to assume direction, prime responsibility, or a dominant role in the activity. Specifically, members of the NICHD, NIAID, NIDA, and HRSA scientific and program staff will cooperate with principal investigators as partners in the projects and serve as science collaborators or program managers. All parties will agree to accept the participatory and cooperative nature of the group process. Details of the responsibilities, relationship, and governance of the study to be funded under cooperative agreements are discussed later in this document under the section "Terms and Conditions of Award." The total project period for applications submitted in response to the present RFA may not exceed three years. The anticipated award date is February, 1997. At this time, NICHD, NIAID, NIDA, and HRSA have not determined whether or how this solicitation will be continued beyond the present RFA. Awards and level of support depend on receipt of a sufficient number of applications of high merit. Although this program is provided for in the financial plans of NICHD, NIAID, NIDA, and HRSA, awards pursuant to this RFA are contingent upon the availability of funds for this purpose. FUNDS AVAILABLE It is estimated that $ 1,044,000 (total costs in fiscal year 1997) will be available to fund approximately three to six awards to support the scientific and subject accrual activity of the members of the Clinical Science Group who are recruited through this RFA. Future year funding will be determined based on initial funding level. The National Institute of Child Health and Human Development will provide the total of these funds. RESEARCH OBJECTIVES Background of the Problem Through December 1995, 2,354 AIDS cases in adolescents (aged 13-19 years) were reported to the National Centers for Disease Control and Prevention. Although adolescents comprise less than one percent of all reported AIDS cases, the impact of HIV infection acquired during adolescence is far more profound for several reasons. First, the long incubation period between initial HIV infection and the development of AIDS-defining conditions suggests that the majority of AIDS cases in persons between 20 and 29 years of age, which constitute nearly 20 percent of all reported AIDS cases, can be attributed to infection as teenagers. Secondly, HIV infection, and to some extent AIDS cases under the new case definition, are not accurately estimated through reporting mechanisms because adolescents lack easy access to medical care for diagnosis. Many may actually succumb to competing causes of mortality (e.g., violence). Recent blinded HIV serosurveys indicate a range of estimates: from prevalence rates of 0.34 per 1000 in 17-19 year-old applicants to the military, 1.7 per 1000 in the users of student health services on selected college campuses, 3.9 per 1000 in Job Corps applicants, to 88 per 1000 in an urban homeless youth center. Of the groups affected by HIV, the U.S. adolescent population is the one in which basic biologic issues are the most poorly understood and the one in which therapeutic and clinical management trials have not been effectively initiated. At the present time, it is not known how HIV infection affects continuing development in those adolescents who have been infected through sexual or injecting drug use practices. It is not clear how age at infection influences the course of maturation nor is it clear how maturation might proceed in HIV+ adolescents with repeated HIV sexual exposure, drug abuse, sexually transmitted disease co-morbidity, and/or pregnancy. The heterosexual transmission of HIV is attaining increasing importance as a mode of HIV spread to uninfected individuals. This mode of HIV transmission is particularly important in the adolescent population due to the high prevalence of high-risk behaviors. The factors which modulate the heterosexual transmission of HIV have not been determined. However, it is likely that the replication of HIV at genital mucosal surfaces plays a major role in the likelihood of the occurrence of viral transmission following heterosexual exposure. Background of the Adolescent Medicine HIV/AIDS Research Network and the Scope of Its Research Agenda This Adolescent Medicine HIV/AIDS Research Network initiative calls for a descriptive examination of the full spectrum of HIV disease and its behavioral manifestations in adolescents who have become infected with HIV through sex and drug-taking behaviors in order to identify and pursue an HIV/AIDS-specific research agenda in the adolescent population between the ages of 12 and 19 years of age. The ultimate goal of this project is to achieve a better understanding of HIV disease progression and co-morbidity in adolescents and thus improve health care management. This goal is being addressed through the enrollment of HIV-infected adolescents into a standardized base protocol to characterize a population-based spectrum of disease, disease progression, and the effect of comorbidity with drug abuse, other sexually-transmitted diseases and pregnancy in the adolescent population. A secondary goal involves the resolution of remaining questions related to HIV infection in adolescents through the development of special studies to be undertaken in the assembled cohort enrolled in the base protocol. These unresolved questions include but are not limited to the susceptibility, infectivity, and transmissibility of HIV in adolescents, particularly related to developing genital mucosa; the characterization of the variation in adolescent immune function; the identification of useful adolescent-specific clinical markers of HIV disease progression; the effect of HIV on adolescent neuropsychologic function and development; and the influence and effect of specific adolescent behavioral patterns on risk-taking and health-seeking activities. Organizational Components The NIH entered into cooperative agreements establishing the network in 1994. The Adolescent Medicine HIV/AIDS Research Network consists of two interactive groups, Basic Science and Clinical Science, managed by Steering and Executive Committees, supported by a Data and Operations Center, advised by a Community Advisory Board, and reviewed by a Scientific Advisory Panel. The current Network includes an eight member Basic Science Group, a twelve member Clinical Science Group, and a Data and Operations Center. The Basic Science Group, in collaboration with the Clinical Science Group and a Data and Operations Center, has produced a base protocol which addresses the primary objective of the initiative. The study began accruing research subjects in February 1996. This solicitation seeks cooperative agreements with investigators to augment the subject accrual capacity of the Clinical Science Group in order to establish a subject cohort of sufficient size to address more completely the research objectives outlined above and thus permit the conduct of a wide- ranging, multi-stage series of investigations which examine specific facets of HIV infection in adolescents. This RFA is intended to recruit additional members of the Clinical Science Group with responsibility for the (1) implementation of the base protocol and secondary protocols where feasible and the recruitment and monitoring of study participants, associated data collection, and quality control; (2) participation in the production of the supplemental research agenda through review and evaluation at regularly scheduled interactive Network meetings; (3) clinical management guidelines for the standardization of health care delivery across network sites which address the unique biological, biobehavioral, and psychosocial issues of adolescence including pharmacologic prophylaxis, the scope and frequency of medical monitoring, and service organization, overcoming barriers to care, among others; and (4) the convening of consensus panels on the dissemination of clinical management guidelines and the definition of adolescent- specific HIV policy among other tasks consistent with functioning as a national resource body. SPECIAL REQUIREMENTS Applications to become members of the Clinical Science Group must submit evidence of clinical experience, comprehensiveness of health care and support services, and availability of subjects. All members of the Clinical Science Group are expected to participate in conference calls and attend two Network meetings per year contributing to the research and policy life of the Network. Applicants must implement an existing base protocol which measures health status, service utilization, sexual and drug-taking behaviors, and psychological state at three month intervals over the duration of the project. Sensitive information is collected through an interactive computer interview and the data collected in this manner are not available to the site personnel. Health status measures include routine physical examinations and twice-yearly genital examinations including PAP smears, cervicophotography, cervico-vaginal lavage, and swabs. Anal swabs, radiologic examination of the wrist to assess bone age, and drug assays are performed on all subjects. HIV-positive youth will be assessed for disease progression through virologic and immunologic measures, entailing blood draws, urine collection, and delayed-type hypersensitivity assessment. No measure will entail risk greater than that encountered within routine history and physical examination for sexually active youth. There will be no therapeutic intervention in this protocol, although medical management (primary therapy, prophylaxis, and immunization schedule) will be measured and its influence on outcome evaluated within statistical constraints secondary to sample size. Applicants should have access to AIDS Clinical Trials Group certified immunology and/or virology laboratories. Applicants should appropriately complete the human subjects sections of the PHS 398; however, human subjects review by institutional review boards (IRB) should be deferred until applications have been evaluated by the NIH scientific review group. All applicants meeting review criteria and recommended for funding will be provided a copy of the base protocol and supporting documents for submission for human subjects review while award criteria are evaluated. Successful applicants will be required to have approved assurance and IRB certification on file with the Office for Protection from Research Risks, National Institutes of Health, and acquire a Certificate of Confidentiality prior to the award of funds. Terms and Conditions of Award The following terms of award are in addition to, and not in lieu of, otherwise applicable OMB administrative guidelines, HHS Grant Administration Regulations at 45 CFR Part 74 and 92 and other HHS, PHS, and NIH grant administration policies. Business management aspects of these awards will be administered by the NICHD Grants Management Office in accordance with HHS, PHS, and NIH Grant Administration policies. All awarded funds will be administered by the NICHD Grants Management Office. The administrative and funding instrument to be used for this program will be a cooperative agreement (U01), an "assistance" mechanism (rather than an "acquisition" mechanism) in which substantial NIH and HRSA scientific and/or programmatic involvement with the awardee is anticipated during the performance of the activity. Under the cooperative agreement, the NIH purpose is to support and/or stimulate the recipient's activity by involvement in and otherwise working jointly with the award recipient in a partner role, but it is not to assume direction, prime responsibility, or a dominant role in the activity. Consistent with this concept, the dominant role and prime responsibility for the activity resides with the awardees for the project as a whole, although specific tasks and activities in carrying out the studies will be shared among awardees and the NICHD, NIAID, NIDA, and HRSA staff collaborators. The research effort will be a cooperative venture with participation by all awardees as outlined below, the NICHD, the NIAID, NIDA, and HRSA. The Primary Rights and Responsibilities of the Awardees Basic Science Group: The Basic Science Group consists of those awardees whose submissions were chosen on the basis of scientific merit, representative(s) of the Data and Operations Center (DOC), and the NICHD, NIAID, NIDA staff collaborators. The Basic Science Group has a chair and vice chair elected by its members for a two year term; NIH and HRSA staff collaborators may not serve as officers. The Basic Science Group does Retain the primary responsibility for defining and prioritizing the research agenda and submitting the agenda to the Steering Committee for approval; Specify research objectives for the base study to characterize a population-based spectrum of disease and disease progression and secondary special studies, develop corresponding protocols, provide for monitoring the progress of various studies, and analyze and interpret study protocol results. It is expected that this responsibility will be undertaken with significant interaction with the members of the Clinical Science Group; Consult and review Clinical Science Group plans for the evaluation of clinical management guidelines which address the unique biological, biobehavioral and psychosocial issues of adolescence including pharmacologic prophylaxis, the scope and frequency of medical monitoring, and organization of services, among others; The full database for the base protocol will come from all funded clinical sites; the full database for nested substudies may come from all or a subset of the clinical sites. These databases will be physically located at the Data and Operations Center and the use and publication of these data will be governed by policies established by the Executive Committee. NICHD, NIAID, NIDA, and HRSA staff collaborators, in collaboration with the Executive Committee, may have access to data generated under this cooperative agreement and may use these data to generate internal reports of the Network activities. Basic Science Group awardees, as a group, will retain custody of and have primary rights to the protocol data developed under these awards, subject to government rights of access consistent with current HHS, PHS, and NIH policies. Protocol development for special studies shall be undertaken when two-thirds of the Basic Science Group members approve the research concept; Performance Reports: Basic Science Group members must submit a progress report as part of the annual application for noncompetitive renewal. Clinical Science Group: The Clinical Science Group will consist of awardees, and the NICHD and HRSA staff collaborators. The Clinical Science Group has a chair and vice chair elected by its members for a two year term; NIH and HRSA staff collaborators may not serve as officers. The Clinical Science Group does Participate in the production of the research agenda through review and evaluation at regularly scheduled interactive Network meetings; and by submitting concepts for study (both primary or secondary analyses). Clinical Science Group members will be strongly encouraged to submit research concepts to the Basic Science Group and may participate in their subsequent protocol development. Decisions related to protocol development and protocol team formation are the responsibility of the Basic Science Group; Retain primary responsibility for the implementation of the base protocol and secondary protocols where feasible and the recruitment and monitoring of study participants, associated data collection, and quality control; Awardees will be required to accept and implement the common protocol developed by the Basic Science Group and all procedures approved by the Steering Committee; Derive clinical management guidelines for the standardization of health care delivery across network sites which address the unique biological, biobehavioral, and psychosocial issues of adolescence including pharmacologic prophylaxis, the scope and frequency of medical monitoring, and service organization, overcoming barriers to care, among others; and submit a corresponding evaluation plan to the Basic Science Group for consultation and review; The full database for the base protocol will be developed from research data collected in all funded clinical sites; the full database for nested substudies may come from all or a subset of the clinical sites. These databases will be physically located at the Data and Operations Center and the use and publication of these data will be governed by policies established by the Executive Committee. Data from individual sites may have limited value or may have substantial independent scientific value for specific research questions. The Executive Committee may establish policies encouraging or limiting publication of such site- specific institutional data as appropriate for a given circumstance. NICHD, NIAID, NIDA, and HRSA staff collaborators, in collaboration with the Executive Committee, may have access to data generated under this cooperative agreement; and may use these data to generate internal reports of the Network activities. Clinical Science awardees, as a group, will retain custody of and have primary rights to the data specific to guidelines evaluation developed under these awards, subject to government rights of access consistent with current HHS, PHS, and NIH policies. Study development for the secondary analyses of data generated through the clinical management guideline evaluation shall be undertaken when two-thirds of the Clinical Science Group members approve the research concept; Clinical Science awardees, as a group, will convene consensus panels on the dissemination of clinical management guidelines and the definition of adolescent- specific HIV policy among other tasks consistent with functioning as a national resource body; Clinical Science Group members will recruit two adolescent/family member community representatives from each clinical site (one as primary representative, and the other as an alternate), at least one of whom from each site must be an adolescent between 15 and 19 years, to serve on the Community Advisory Board; Satisfy the expectations of participation in the Network committee and group activities, research subject recruitment and retention, timely data reporting and quality control measures. Individual awards may be curtailed or terminated by the government if these expectations are not met, or a major breach of protocol, or substantive protocol changes are undertaken without prior approval from the staff collaborators and Basic Science Group members; Performance Reports: Clinical Science Group members must submit as part of the progress report for the non-competing continuation application information detailing progress towards achieving patient accrual and retention goals and other measures of performance (including followup activities, data quality, timeliness of data submission, proportion of required repository specimen volumes collected and sent to Central Repository, and specific contributions to the Network's agenda which involves active participation in the scientific and clinical research activities of the Network). The purpose of this report is to inform funding requirements for the remaining budget period. Future year funding is contingent upon persistent satisfactory performance in meeting goals and measures noted above; Existing Track B awardees will be required to comply with the reporting requirements imposed on HRSA funded Title IV Pediatric-Adolescent Demonstration Projects. The Data and Operations Center (DOC): The Data and Operations Center does Manage all meetings of the Network, Basic and Clinical Science Groups as well as the Community and Scientific Advisory Boards including necessary conference calls among members; Support protocol development and distribution; and assume responsibility for protocol site registration and training, site-monitoring for subject safety, data collection practices, and regulatory compliance; Support development of clinical management guidelines assuming responsibility for required consensus conferences and guidelines dissemination; Remain responsible for the integrity of the scientific databases and provide statistical consultation during protocol development as well as timely analyses; Program Staff Involvement: The research effort is a cooperative venture with participation by all awardees as outlined above, the NICHD, the NIAID, the NIDA, and HRSA. One NICHD, one NIAID, one NIDA, and one HRSA staff collaborator do: Participate in the Steering Committee which oversees the establishment and maintenance of the Network and Network progress in achieving program goals; Assist the Basic Science Group in the selection of research topics and the development of protocols for specific studies and interventions; Assist the Clinical Science Group in the development and evaluation of the clinical management guidelines; Arrange, when necessary, for the external peer review of the protocols for the base study, special studies, and clinical management guideline evaluation clearing these studies for implementation; Explore mechanisms to offer study subjects the opportunity to participate in clinical drug trials funded through mechanisms outside the network and provide this information and organizational support to clinical sites; Assist the Executive Committee in monitoring the progress of ongoing studies, including field data collection, standardization of methods across study sites, and adherence to protocol and quality control measures; Assist in data analyses, interpretation and publication of study results. Collaborative Responsibilities: The Research Network The Research Network is composed of all principal investigators of the Basic Science Group, all principal investigators of the Clinical Science Group, all members of the Study Coordinators Group, all representatives of the Community Advisory Board, the principal investigator and project coordinator from the Data and Operations Center, the NICHD, the NIAID, NIDA, and HRSA. The entire Network will attend interactive annual meetings to inform and review the research agenda. The Steering Committee The Steering Committee is the main governing body of the Network. The Committee is composed of the Chair, Vice Chair, and two elected representatives from the Basic Science Group; the Chair, Vice Chair, and two elected representatives from the Clinical Science Group; the Chair and Vice Chair of the Study Coordinators Group; the Chair and Vice Chair of the Community Advisory Board; the principal investigator and project coordinator from the Data and Operations Center; and the NICHD, the NIAID, the NIDA, and the HRSA staff collaborators. All members will have one vote each; NICHD, NIAID, NIDA, and HRSA will have one vote each, and motions will carry with simple majority. The Chair and Vice Chair of the Steering Committee will be elected by the entire committee from among the principal investigators of the Basic Science Group and the Clinical Science Group; none of the NICHD, NIAID, NIDA, or HRSA staff collaborators are eligible to serve as Chair or Vice Chair of the Steering Committee. The Steering Committee will Maintain primary responsibility for the identification of adolescent HIV/AIDS research issues; Approve the direction of the research effort, and facilitate the conduct and monitoring of the studies; Approve the research agenda specific to its feasibility and clinical relevance and advise on the development of implementation strategies; Approve the clinical management guidelines addressing the unique biological, biobehavioral, and psychosocial issues of adolescence including pharmacologic prophylaxis, the scope and frequency of medical monitoring, and service organization, among others; and the plans for their evaluation. The Executive Committee The Steering Committee chairperson will chair the Executive Committee as well. The Executive Committee, composed of the Steering Committee chair and vice chair, the chair and vice-chair of the Basic Science Group, the chair and vice chair of the Clinical Science Group, the principal investigator and project coordinator of the Data and Operations Center, the NICHD, NIAID, NIDA, and HRSA staff collaborators, will supervise the functioning of the network and will Establish timelines for the completion of tasks and monitor progress; Coordinate the integration of data collection for base protocol and guidelines evaluation procedures; Oversee site participation and performance informing the appropriate program managers; Define rules regarding access to data and publication and direct the publication process. Study Coordinators Group The Study Coordinators Group is composed of all the primary research nurses or associates at the clinical sites supported by the grant award. The Study Coordinators Group, with a chair and a vice chair elected for a two year term, does Recommend issues of concern to be studied within the research agenda and collaborate on their development; Advise on the Network's subject recruitment and retention strategies; Review and evaluate the study and evaluation research protocols for acceptability and feasibility; Review and evaluate subject protection procedures and confidentiality of records in support of the Clinical Science Group principal investigators; Review and evaluate the integrity of data collection procedures in support of the Clinical Science Group principal investigators; Provide consultation to the Clinical Science Group at consensus conferences for policy or management affecting HIV+ youth. Community Advisory Board The Community Advisory Board will consist of two adolescent or family member community representatives from each clinical site, one of whom must be an adolescent between 15 and 19 years of age and who are to be chosen by the principal investigator at the corresponding clinical site. The Community Advisory Board will Recommend issues of concern to be studied within the research agenda; Choose a chair and vice-chair to coordinate and organize its Community Advisory Board meetings and conference calls and represent community interests on the Steering Committee; Advise the Network on subject recruitment and retention strategies; Review and evaluate the study and evaluation research protocols for acceptability and feasibility; Provide consultation to the Clinical Science Group at consensus conferences for policy or management affecting HIV+ youth. Scientific Advisory Panel A Scientific Advisory Panel, consisting of federal and non-federal experts in the disciplines related to the Network's research agenda, will be appointed by the NICHD in consultation with NIAID, NIDA, and HRSA and will report directly to the Director, NICHD. The Scientific Advisory Panel will undertake the following functions: Review and evaluate the overall direction, objectives, content and progress of the Basic Scientific Research Agenda in an annual meeting or more frequently if necessary; Review and evaluate the overall direction, objectives, content and progress of the Clinical Management Evaluation Research Agenda in an annual meeting or more frequently if necessary. Data and Safety Monitoring Board The intention of the Network is to establish a cohort of adolescents for whom an observational study will be conducted. No primary intervention studies were envisioned in the original RFA. However, the potential for the implementation of intervention studies exists, particularly in the area of secondary prevention strategies and the evaluation of clinical management guidelines. If this potential is realized, the NICHD, NIAID, NIDA, and HRSA science collaborators will establish a Data and Safety Monitoring Board and establish procedures for its conduct. Any Data and Safety Monitoring Board will report to the NIH and HRSA science collaborators and the Network Steering Committee. Approval Process for Research Undertaken in the Network The Basic Scientific Agenda will be approved in the following manner: Potential research areas will be proposed through multiple mechanisms, including professional (internal and external to Network) and community presentations/ sessions at the Research Network meetings, as well as individual concept proposals submitted by principal investigators (alone or in collaboration); The Basic Science Group, supported by the Data and Operations Center, will define and prioritize the agenda, assess the merit of concept sheets, proposing protocol development around those with specific study hypotheses consistent with the research agenda, returning others to proposing investigators with constructive comments attached; The Clinical Science Group will review and evaluate the agenda and proposed protocol(s); The Community Advisory Board will review and evaluate the agenda and proposed protocol(s); The Steering Committee will vote to approve the Network Scientific Agenda; if approved the protocol will be forwarded to the Scientific Advisory Panel; if unapproved, the protocol will be returned to the Basic Science Group; Before implementation of the base protocol in the first year, the Scientific Advisory Panel will review its direction, its objectives, and its content; the Scientific Advisory Panel will meet annually (or more frequently if necessary) thereafter to review the direction and progress of the Network Scientific Research Agenda. The Clinical Management Evaluation Research Agenda will be approved in the following manner: The development of the Clinical Management Guidelines is the responsibility of the Clinical Science Group, alone or in consultation with clinical expertise and community experience external to the Network, and supported by the Data and Operations Center; The Clinical Science Group will define the scope of the guidelines and propose hypothesis-driven evaluation for their effectiveness; The Basic Science Group will review the research protocol for the clinical management guidelines evaluation; The Community Advisory Board will review the evaluation research protocol; The Steering Committee will vote to approve the evaluation research protocol; if approved the protocol will be forwarded to the Scientific Advisory Panel; if unapproved, the protocol will be returned to the Clinical Science Group; Before implementation of the evaluation protocol in the first year, the Scientific Advisory Panel will review its direction, its objectives, and its content; the Scientific Advisory Panel will meet annually (or more frequently if necessary) thereafter to review the direction and progress of the Clinical Management Evaluation Research Agenda. Arbitration Process These procedures will be in addition to the customary programmatic and financial negotiations that occur in the administration of grants. Arbitration procedures will be invoked only when agreement cannot be reached on programmatic issues that may arise between awardee(s) and the science collaborator(s) after the award has been made. In that event, an arbitration panel will be composed of three members-- one selected by the executive committee (with the NICHD, NIAID, NIDA, and HRSA science collaborators not voting) or by the individual awardee in the event of an individual disagreement, a second member selected by the science collaborators, and a third member selected by the two prior selected members. The decision of the arbitration panel by majority vote will be binding. This special arbitration procedure in no way affects the awardee's right to appeal an adverse action that is otherwise appealable in accordance with the PHS Regulations at 42 CFR Part 50, Subpart D and HHS Regulation at 45 CFR Part 16. INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS It is the policy of the NIH that women and members of minority groups and their subpopulations must be included in all NIH supported biomedical and behavioral research projects involving human subjects, unless a clear and compelling rationale and justification are provided that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This new policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43) and supersedes and strengthens the previous policies (Concerning the Inclusion of Women in Study Populations, and Concerning the Inclusion of Minorities in Study Populations), which have been in effect since 1990. The new policy contains some provisions that are substantially different from the 1990 policies. All investigators proposing research involving human subjects should read the "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research," which have been published in the Federal Register of March 28, 1994 (FR 59 14508-14513) and reprinted in the NIH Guide for Grants and Contracts, Volume 23, Number 11, March 18, 1994. Investigators also may obtain copies of the policy from the program staff listed under INQUIRIES. Program staff may also provide additional relevant information concerning the policy. LETTER OF INTENT Prospective applicants are asked to submit, by October 15, 1996, a letter of intent that includes a descriptive title of the proposed research, the name, address and telephone number of the Principal Investigator and the number and title of the RFA in response to which the application may be submitted. Although a letter of intent is not required, is not binding, and does not enter into the review of subsequent applications, the information that it contains is helpful in planning for the review of applications. It allows NICHD staff to estimate potential review workload and to avoid conflict of interest in the review. The letter of intent is to be sent to: Audrey Smith Rogers, Ph.D., M.P.H. Center for Research for Mothers and Children National Institute of Child Health and Human Development 6100 Executive Boulevard, Room 4B11, MSC 7510 Bethesda, MD 20892-7510 Telephone: (301) 496-7339 APPLICATION PROCEDURES Applications are to be submitted on PHS Form 398 (rev. 5/95). Applications kits are available at most institutional offices of sponsored research and may be obtained from the Grants Information Office, Office of Extramural Outreach and Information Resources, National Institutes of Health, 6701 Rockledge Drive, MSC 7910, Bethesda, MD 20892-7910, telephone 301/710-0267, email: ASKNIH@odrockm1.od.nih.gov; and from the NIH program administrator named below. Materials to Include in the Application To permit evaluation of the merits of an application (peer review), information is needed on the following topics. Applications to become members of the Clinical Science Group must include 1. Documentation of three or more years of clinical experience in adolescent health care for the physician candidate for the Clinical Science Group; 2. A description of the physical structure and administrative arrangement for the site at which health care and support services are provided (including hours of operation, provision for off-hour coverage, and established patterns of referral); 3. Evidence of an interdisciplinary approach to the delivery of adolescent health care and support services ( the breadth of services and qualifications of the corresponding providers should be listed and described); 4. Demonstration of availability of on-site gynecologic services and case management, on-site or established and functioning referral networks for mental health services, substance abuse treatment, and enabling services such as childcare and transportation; 5. Numbers of the adolescent population categorized by ages 10-11, 12-14, 15- 17 years currently served by the clinic; 6. Description of the population in #5 must include gender, race/ethnicity, and should include (if available) socioeconomic strata, educational achievement, blinded serosurveys of HIV infection, AIDS cases numbers (cumulative and annual), STD and pregnancy rates, substance abuse statistics, and other evidence of high risk behaviors. If women or minorities are excluded or inadequately represented in clinical research, particularly in proposed population-based studies, a clear and compelling rationale must be provided; 7. Evidence of ability to enroll 20 HIV-infected adolescents and 10 HIV- negative but high risk adolescents between the ages of 12 and 19 years within the first year of funding; 8. The interaction between the clinic and the community it serves should be described. Of specific interest are community advisory or consultative groups which have substantial adolescent participation, efforts at parental or community education, clinic policies for adolescent involvement in their own care and details of existing or planned community outreach and prevention programs to identify adolescents and bring them into care; 9. Budgets for the Clinical Science Group applications should include physician principal investigator salary support at 0.10 FTE, clinical associate/research nurse at 1.0 FTE, and three research visits for study subjects (estimated by comprehensive routine physical/laboratory examination costs, HIV RNA PCR and culture, and immunologic panel for subjects for three research encounters). Travel for the principal investigator and the research nurse should be requested to two (three day meetings) in the Washington DC area. A budget worksheet is available on request and its use is strongly recommended. This application will be used to judge the clinical expertise and technical proficiency of the applicant and should not exceed the 25 page limit (including graphics) for the entire submission. For all applications, the RFA label available in the application form PHS 398 must be affixed to the bottom of the face page. 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 evaluation. In addition, the RFA title ("Adolescent Medicine HIV/AIDS Research Network") and number must be typed on line 2 of the face page of the application form and the "YES" box must be marked. The signed, typewritten original of the application, including the Checklist, and three signed photocopies must be sent or delivered in one package to: DIVISION OF RESEARCH GRANTS NATIONAL INSTITUTES OF HEALTH 6701 ROCKLEDGE DRIVE ROOM 1040 MSC 7710 BETHESDA, MD 20892-7710 BETHESDA, MD 20817 (for express/courier service) At the time of submission, in addition to the applications and copies mailed to the Division of Research Grants, two copies of the application must be sent under separate cover to: Susan Streufert, Ph.D., Director Division of Scientific Review National Institute of Child Health and Human Development 6100 Executive Boulevard, Room 5E01 - MSC 7510 Bethesda, MD 20892 Bethesda, MD 20852 (for express/courier service) Applications must be received by close of business on November 19, 1996. If an application is received after that date, it will be returned to the applicant without review. The Division of Research Grants (DRG) 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 DRG 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 an application must follow the guidance in the PHS 398 application instructions for the preparation of revised applications, including an introduction addressing the previous critique. REVIEW CONSIDERATIONS Upon receipt, applications will be reviewed for completeness by DRG and responsiveness by the NICHD. Incomplete applications will be returned to the applicant without further consideration. If the application is not responsive to the RFA, the application will be returned to the applicant. Applications that are complete and responsive to the RFA will be evaluated for scientific and technical merit by an appropriate peer review group convened by the NICHD in accordance with the review criteria stated below. As part of the initial merit review, a process may be used by the initial review group in which applications will be determined to be competitive or non-competitive based on their scientific merit relative to other applications received in response to the RFA. Applications judged to be competitive will be evaluated for scientific and technical merit and assigned a priority score. Applications determined to be non-competitive will be withdrawn from further consideration and the Principal Investigator and the official signing for the applicant organization will be notified and receive a summary statement containing reviewers' comments. Review Criteria: Clinical training and experience of project staff specific to adolescent care; Evidence of an interdisciplinary approach; Adequacy of site characteristics as described in this RFA; Appropriateness of the plans for inclusion of women and minorities; Appropriateness of recruitment and retention methods and willingness to work as part of the cooperative study with existing awardees and NICHD, NIAID, NIDA, and HRSA scientists. The review group will also examine the provisions for the protection of human and animal subjects, the safety of the research environment, and the appropriateness of accompanying budget. AWARD CRITERIA Applications recommended by the National Advisory Council to the National Institute of Child Health and Human Development will be considered for award based upon (a) merit as reflected in the priority score; (b) program balance including sufficient compatibility of features to make a successful collaborative program likely; (c) availability of funds; (d) identified needs in the established network. Schedule Letter of Intent Receipt Date: October 15, 1996 Application Receipt Date: November 19, 1996 Review by NICHD Advisory Council: January 1997 Anticipated Award Date: February 1, 1997 INQUIRIES Inquiries are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Direct inquiries regarding programmatic issues to: Audrey Smith Rogers, Ph.D., M.P.H. Center for Research for Mothers and Children National Institute of Child Health and Human Development 6100 Executive Boulevard, Room 4B11 - MSC 7510 Bethesda, MD 20892-7510 Telephone: (301) 496-7339 FAX: (301) 496-8678 Email: rogersa@hd01.nichd.nih.gov Judy Lew, M.D. Division of AIDS National Institute of Allergy and Infectious Diseases 6003 Executive Boulevard, MSC 7620 Bethesda, MD 20892-7620 Telephone: (301) 496-6178 Email: jlew@exec.niaid.pc.niaid.nih.gov Katherine Davenny, M.P.H. or Vincent Smeriglio, Ph.D. Division of Clinical and Services Research National Institute of Drug Abuse 5600 Fishers Lane, Room 11A33 Rockville, MD 20857 Telephone: (301) 443-1801 Email: kdavenny@aoada.ssw.dhhs.gov Email: vsmerigl@aoada.ssw.dhhs.gov Direct inquiries regarding administrative/fiscal matters to: Ms. Mary Daley Tozzolo Grants Management Branch National Institute of Child Health and Human Development 6100 Executive Boulevard, Room 8A17F - MSC 7510 Bethesda, MD 20852-7510 Telephone: (301) 496-1303 Email: tozzolom@hd01.nichd.nih.gov AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.865. Awards are made under the authorization of the Public Health Service Act, Title IV, Part A (Public Law 78-410, as amended by Public Law 99-158, 42 USC 241 and 285) and administered under PHS grants policies and Federal Regulations 42 CFR 52 and 45 CFR Part 74. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. The PHS strongly encourages all grant and contract recipients to provide a smoke-free workplace and promote the non-use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routine education, library, day care, health care or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people. .
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