GLOBAL NETWORK FOR WOMEN"S AND CHILDREN"S HEALTH RESEARCH Release Date: October 10, 2001 RFA: RFA-HD-01-024 (This RFA has been renewed, see RFA-HD-05-025) National Institute of Child Health and Human Development ( Fogarty International Center ( Letter of Intent Receipt Date: February 11, 2002 Application Receipt Date: March 18, 2002 Expiration Date: March 19, 2002 PURPOSE The National Institute of Child Health and Human Development (NICHD) and the Fogarty International Center (FIC), in partnership with the Bill and Melinda Gates Foundation, invite applications from United States (U.S.) scientists partnered with foreign scientists in Eastern Europe and Africa for participation in the Global Network for Women"s and Children"s Health Research (Global Network). The purpose of this solicitation is to complement the existing Global Network with the addition of Research Units from Eastern Europe, the Newly Independent States, and Africa. The Global Network, also supported by the National Center for Complementary and Alternative Medicine (NCCAM) and the National Institute of Dental and Craniofacial Research (NIDCR), consists of 10 Research Units and one Data and Coordinating Center that together form an innovative and flexible research network involved in the most critical public health problems of women and children. Through competitive cooperative agreements, international, multidisciplinary teams of investigators will work collaboratively to answer scientific and/or public health questions to help improve health, and to prevent premature disease and death among women and children, primarily in developing countries. The efforts of the Global Network awardees will continue to focus on safe pregnancy and birth outcomes, within the broader context of women"s and young children"s health. The Global Network will work to increase and enhance opportunities for scientific linkages, interaction, knowledge development and transfer, and collaborative partnerships between U.S. and foreign investigators and institutions. It also is intended to strengthen and expand the global infrastructure for women"s and children"s health research. Applications for Global Network Research Unit grants will require full collaboration between scientists in the U.S. and foreign investigators in developing countries. The overall goal of the Global Network is to expand scientific knowledge relevant to improving health outcomes for women and children in developing countries. Other critical goals in establishing this network are: (1) to develop sustainable research infrastructure and public health intervention capabilities in developing countries, and (2) to strengthen international collaborative research arrangements that focus on the leading causes of morbidity and mortality in pregnancy and early childhood. A key objective for the network, and a requirement for the Research Units, is to design, implement, and evaluate evidence-based health interventions. These interventions must have a strong scientific and epidemiologic basis for their use in the foreign country. The primary endpoints in these research studies must relate to demonstrable improvement in important public health measures in the population under study. This RFA is not intended to support operations or health services research. It is intended to support biomedical and behavioral research, clinical and translational research, and associated evaluation research. It will not fund predominantly epidemiologic research, such as observational or surveillance studies. It will not fund studies of food or micronutrient supplementation in children over two years of age or studies with the evaluation of either new or existing health care delivery programs or health care utilization as a primary aim, applications proposing such activities will be returned without review. Applications that do not contain an evidence-based intervention will be returned without review. The transfer of technology to developing countries should be carefully justified, both ethically and scientifically, the proposed use of interventions that have been previously abandoned in developed countries will not be reviewed or funded. NICHD will facilitate coordination of the Global Network"s activities with relevant governmental agencies (e.g., the Centers for Disease Control and Prevention and the U.S. Agency for International Development), international organizations including the World Health Organization (WHO), United Nations Children"s Fund (UNICEF), the World Bank, and the Global Forum for Health Research, and other public and private sector institutions. NICHD will assure that the activities of the network are coordinated with the activities of other relevant and complementary NIH-supported international research programs. Among these programs are the International Collaborations in Infectious Disease Research (ICIDR) program, the HIV Prevention Trials Network (HPTN), the Tuberculosis Research Unit (TBRU) program, the Comprehensive International Program of Research on AIDS (CIPRA), managed by NIAID, and the cooperative research and training programs managed by the FIC. 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 Request for Applications (RFA) is related to several priority areas. Potential applicants may obtain "Healthy People 2010" at ELIGIBILITY REQUIREMENTS Applications may be submitted by domestic, for-profit and non-profit organizations, public and private, such as universities, colleges, and hospitals, laboratories, units of State and local governments, and eligible agencies of the Federal government. Foreign institutions are not eligible to apply for these grants, except in partnership with a U.S. applicant. Racial/ethnic minority individuals, women, and persons with disabilities are encouraged to apply as Principal Investigators. Applications for a Global Network Research Unit grant must be submitted jointly by collaborating teams of investigators that include the applicant U.S. Principal Investigator and a developing country scientist resident at an established institution in a developing country. These collaborating teams are identified as "Research Units" in the context of this RFA. For the purposes of this RFA, developing countries are defined as the resource-poor nation states of North and sub-Saharan Africa, Central/Eastern Europe, and the Newly Independent States (NIS) of the former Soviet Union. U.S. and developing country scientists and institutions applying for a network grant must provide strong evidence (e.g., established research collaborations) of their likelihood to succeed and their ability to work in effective international partnership with each other. The roles and responsibilities of collaborating scientists and institutions must be clearly defined. Research Unit applications that do not propose U.S.-foreign scientist collaborations will be considered non-responsive to the RFA and returned to applicants without review. Although the lead U.S. and foreign country investigators will collaborate closely, the application must be submitted by the U.S. institution. The U.S. awardee institution is responsible for developing and maintaining affiliation(s) with an established foreign collaborating institution(s), for example, a college or university, research institute, health department, or hospital. This affiliation(s) and the appropriate and necessary institutional and governmental endorsements should be clearly specified and well documented in the application. Specifically, it is necessary for applicants to provide evidence that a working agreement has been established with the foreign government to expedite deputation of personnel, equipment, and supplies at the local site, to monitor and verify expenditures, and to manage other legal and procedural matters. Applications may be submitted by institutions that already have a Global Network grant, however, there should be no overlap of personnel between the currently funded and proposed Research Units. Applicants with a strong base of support from the NICHD or other parts of the NIH for research related to (or with implications for) improving the health of women and children are also encouraged to apply. MECHANISM OF SUPPORT This RFA will use the National Institutes of Health (NIH) cooperative research project grant (U01) award mechanism. The U01 is a cooperative agreement mechanism, an "assistance" mechanism (rather than an "acquisition" mechanism) that is used when substantial NIH 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 the activity and otherwise working jointly with the award recipient in a partner role, but the NIH 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 NIH. Details of the cooperative agreement are discussed in this document under "Terms and Conditions of Award," below. FUNDS AVAILABLE The NICHD intends to commit approximately $1.5 million in total costs [direct plus Facilities and Administrative (F&A) costs] in FY 2002 to fund two to four Research Unit grants in response to this RFA. As part of this funding, the Bill and Melinda Gates Foundation is contributing $15 million over a three- year period to help establish the Global Network. FIC is contributing $100,000 to this effort for FY 2002. An applicant for a Research Unit grant may request a project period of up to five years and a budget for direct costs of up to $500,000 in the first year, with incremental increases not exceeding three percent in each subsequent year. It is expected that a significant proportion of these direct costs will be expended at the foreign site. Applications with budget requests for direct costs exceeding $500,000 will be returned without review. Because the nature and scope of the research proposed may vary, it is anticipated that the size of awards also will vary. Awards pursuant to this RFA are contingent upon the availability of funds and the receipt of a sufficient number of meritorious applications. At this time, it is not known if competing renewal applications will be accepted and/or if, or in what form, this RFA will be reissued. RESEARCH OBJECTIVES Background According to a recent report of the Global Forum for Health Research, of the approximately six billion people living in the world today, more than 1.3 billion live in extreme poverty, and 70 percent of these poor are women. These women are not only poor, often in poor health, and powerless, but also have the primary responsibility for caring for their children and families. Although there have been successes during the past 30 years in improving the health of women and children worldwide, there remains an unfinished agenda of unnecessary, preventable deaths, illness, and disability that disproportionately affects poor women and children, especially in the developing regions of the world. An estimated 12 million children under the age of five and 500,000 women, primarily in developing countries, die each year from infectious diseases, nutrition-related illnesses, and reproductive and perinatal health problems. Seventy percent of these deaths among children in developing countries are attributable to vaccine-preventable childhood infections, pneumonia, diarrheal diseases, malaria, and malnutrition. These conditions, and others associated with early childhood, are expected to remain the major killers of children under age five through 2020. They are associated with more than one third of the disease burden globally and approximately one half of the disease burden in the poorest regions of the world, including India and sub-Saharan Africa, where the rate of improvement in child mortality is slowing. A large proportion of these illnesses and deaths is preventable. According to World Bank reports, maternal mortality remains the human development indicator that shows the greatest gap between developing and developed countries. The perinatal health problems that contribute most to maternal deaths in the developing world include intrapartum bleeding, sepsis, eclampsia, obstructed labor, and postpartum hemorrhage. In many parts of the developing world, women are totally responsible for the well being of their children. They may themselves suffer from a number of health-related problems, including those produced by births too early, too late or too closely spaced, by unsafe family planning practices, by being last in the family to have access to food and health services, and by partners who transmit diseases. The death of a reproductive age woman significantly lowers the chances of survival of her infants and children, especially those who are ill, leaves orphans, and causes intense family distress, often with multigenerational impact. The WHO estimates that more than five million children die within the first few weeks of life each year, and there are an additional four million annual fetal deaths. Most (98 percent) of these deaths occur in developing countries. These deaths are caused most often by infectious diseases, pregnancy-related complications, and delivery-related complications, including intrapartum asphyxia, birth trauma, and premature birth. Infectious diseases are associated with 30 to 40 percent of all neonatal deaths, or 1.5 to two million deaths per year. The infections responsible for most of the early mortality are acute respiratory infections (ARI), neonatal tetanus, and sepsis, diarrhea, and meningitis. These infectious diseases also contribute to the enormous burden of disease among infants. Recent studies show that oral infections, such as periodontal diseases, are associated with premature and low birth weight (less than 2500 grams, LBW) deliveries. LBW is one of the principal contributors to neonatal morbidity and mortality worldwide and accounts for up to 70 percent of neonatal deaths in some countries. The problem of LBW is intergenerational and related to many factors throughout the lifecycle. LBW infants tend to become poorly nourished children with developmental problems and then adults who produce small infants. A number of other health problems also are associated with LBW. A 1999 report by the Child Health Research Project indicates that other factors that may increase child illness and death include poor maternal health, untreated maternal infections, including HIV/AIDS and its many sequelae, other sexually transmitted diseases (STDs), and urinary tract infections, lack of immunizations among adolescent girls and adult women, unsafe and unsanitary delivery practices, fetal and maternal malnutrition, and failure to breast feed exclusively. Problems at the family and community level that may contribute to early infant and child morbidity and mortality also may be related to women"s status, domestic violence, social and cultural norms, lack of adequate health information, poor decision-making skills and health-care seeking behaviors or limited choices, lack of trained and poorly equipped health care workers, and inadequate access to good quality medical care. Underlying these causes are widespread poverty, illiteracy, lack of access to education, and gender discrimination, often faced disproportionately by women and girls in many countries. Research is urgently needed to help improve the health of women and children, particularly in developing countries. Many questions remain unanswered even though the extremely high levels of maternal, fetal, and infant morbidity and mortality often occur despite the existence of efficacious interventions for prevention or treatment. In some instances, the results of efficacy studies have not been translated into feasible interventions for resource-poor settings where the burden of these conditions is the heaviest. In other cases, feasible interventions have been developed, yet are relatively ineffective, or basic knowledge or understanding still is inadequate. It is increasingly clear that economic investment in early intervention or prevention is sound and that, in some situations, relatively inexpensive health interventions can have enormous impact. Expanding the Global Network of linked U.S. and developing country scientists and institutions will help facilitate high quality, sustainable collaborative research that will address many of these problems and issues. Recognizing that the focus of the program is on the needs of developing countries, it is anticipated that its research findings may help inform efforts to improve the health of U.S. women and children at higher risk for morbidity and mortality. Objectives and Scope The primary scientific objectives of this RFA encompass a range of studies related to women and young children, with an emphasis on the perinatal and neonatal periods, but up to and including breast feeding and weaning. The Global Network"s initial research commitment emphasizes the development, testing, and adaptation of cost-effective, integrated biomedical, behavioral, social, and public health interventions to reduce premature morbidity and mortality among reproductive age women and young children in developing countries. Thus, applications based predominantly or solely in clinical research centers or laboratories in the U.S. will not be considered responsive to the RFA. The Global Network will function as an affiliated group that fosters communication, innovation, and research excellence. Applications will be reviewed and funded under the network for the single, meritorious research study proposed by each applicant in response to this RFA. If funds become available, other studies may be added over time and conducted in one, several or all network sites, depending upon whether or not the proposed research topic is relevant to health needs in more than one locality. Current common activities in which new grantees should expect to participate are the evaluation of overlapping outcome variables between sites and tobacco use across sites. Priority will be given to scientific activities that have the greatest likelihood of improving pregnancy and birth outcomes in developing countries. This may include research activities designed to prevent maternal and early childhood deaths and/or to improve the health of reproductive age women and of children up to the age of weaning. All research conducted under the auspices of the network must be designed such that meaningful and sustainable health improvements in the study population are likely to have a measurable health outcome. Surrogate or intermediate outcomes must be well defined and well justified scientifically. Current topics in the Global Network Research Units are: prevention of postpartum hemorrhage, reduction of cleft lip and cleft palate, including behavioral change in health care providers, reduction of perinatal and neonatal sepsis, reduction of preeclampsia, neonatal care, and reduction of low birth weight. Suitable topics for proposed research projects include, but are not limited to, the following: o Prevention or reduction of leading causes of maternal morbidity and mortality. o Interventions that improve the outcome of high-risk pregnancies. o Studies, with measurable health impact endpoints, focused on assessing and improving birth practices, routine postpartum care of the neonate, and other reproductive health behaviors. o Studies that investigate health enhancing aspects or the adverse health consequences of traditional medicine and its practice, particularly related to women and children. o Prevention and reduction of fetal loss and infant mortality, including studies of dental and cranio-facial diseases and defects that contribute to neonatal and infant morbidity and mortality. o Prevention or amelioration of infections, including, but not limited to, syphilis, HIV, gonorrhea, and chlamydia, which may be passed from mother to infant. o Prevention and treatment of infectious diseases in pregnant women and young children up to weaning, including, but not limited to, malaria, diarrheal diseases, acute respiratory tract infections, sepsis, and vaccine-preventable infections. Each Global Network Research Unit applicant should propose one fully developed research study to address a current critical or emerging health problem related to the needs of women and/or young children in the foreign collaborator"s country. The application should provide a research plan that includes an evidence-based statement of the health problem and research hypothesis, the proposed study population, the study design, methodology, and recruitment protocols, data collection, analysis, and reporting plans, suggested timelines and staffing plans, plans for enhancing research capacity at the foreign site, plans for sustaining the intervention after the funding period is over, and a proposed budget for the life of the project. The Global Network Data and Coordinating Center will be the primary contact for data collection and management. Evidence of collaboration and multidisciplinary expertise related to the proposed project should be provided. The quality of the research plan will be an important focus of the peer review of the application. Organizational Components The Global Network currently consists of 10 Research Units composed of multidisciplinary teams of collaborating U.S. scientists linked with developing country investigators (each Research Unit is led by a U.S. Principal Investigator and a Senior Foreign Investigator at the developing country site), a single Data Center, which provides research support services for the Global Network, and the NIH (represented by the NICHD Staff Science Coordinator and Staff Science Collaborators from NICHD and the other NIH co- sponsors). Guidance and Management Structure The overall guidance and management of the Global Network is provided by a Steering Committee, a Network Advisory Group, and a Data and Safety Monitoring Board. o The Steering Committee serves as the Global Network"s central point for communication, exchange of ideas, development and management of joint protocols and research activities, and problem resolution. The Steering Committee is composed of the U.S. Principal Investigator and the Senior Foreign Investigator of each Global Network Research Unit, the Principal Investigator of the Data Center, and the NICHD collaborating Staff Science Coordinator. Each Principal Investigator, Senior Foreign Investigator, and the NICHD Staff Science Coordinator has one vote. A chairperson is appointed to a minimum of a one-year term, by NICHD. Representatives of other NIH co- sponsors, a representative of the Network Advisory Group, and selected Data Center staff may participate in Steering Committee meetings as non-voting members. The Steering Committee will meet at least once annually and will participate in telephone or electronic conferences, as needed. Guidelines for publications and collaborative activities will be developed during the first year. In the event that opportunities arise and funds become available for additional research, the Steering Committee will approve the protocols for the use of such funds. If Steering Committee subcommittees need to be formed to address particular issues, they shall be established, as needed, subject to the approval of the Steering Committee chairperson and the NICHD Staff Science Coordinator. Annual meetings will include discussions of research progress. New Research Units should be expected to participate in these and future common activities. o A multidisciplinary Network Advisory Group, appointed by the Director, NICHD, shall provide scientific oversight of the research and administrative activities of the Global Network. The Network Advisory Group will meet at least once yearly and will consist of individuals familiar with the kinds of international collaboration and research undertaken by Global Network grantees. The purpose of the Network Advisory Group is to provide periodically an independent, expert review and assessment of new proposed research activity and of the progress of research projects supported by the Global Network, and to offer guidance to the Steering Committee regarding current and future network research objectives, priorities, collaborations, and potential shared projects. o A Data and Safety Monitoring Board (DSMB), established by NICHD, will advise the Global Network Steering Committee and Research Units, including the Data Center, on research design issues, data quality and analysis, and ethical and human subject issues. It also will monitor the safety of any ongoing clinical trials. DSMB membership will include, but not be limited to, individuals with expertise in clinical trial design and conduct, relevant basic, medical, and behavioral sciences research, and ethics and cultural competency issues, particularly in relation to the conduct of research with developing country populations. The Data Center will prepare reports and provide coordination, support, and funding for travel and logistics arrangements related to DSMB meetings and actions. SPECIAL REQUIREMENTS Minimum requirements for Research Unit applicants are as follows: o Scientific Productivity Applicants must demonstrate a capacity to develop and implement studies focused on the health of women and children, and provide evidence of recent research productivity in one or more areas related to the scientific scope and objectives set forth in this RFA. Relevant research studies should be described and related publications listed. o Organizational Capability Applicants should describe their research organization, and that of the developing country institutional partner, and include plans, information, and documentation that indicate their institutional or organizational capability to accomplish the proposed research successfully. Applicants also should describe how they will utilize membership in the Global Network to enhance the productivity of the network and advance the objectives of the program. o History of Collaboration Applicants must describe any relevant international collaborative research activity undertaken between the U.S. applicant Principal Investigator/institution and its developing country partner Senior Foreign Investigator/institution. Evidence of successful domestic and/or international research network or multi-center research activity also should be provided. Contributions and collaborations in areas such as protocol design, study recruitment, data analysis and interpretation, and publication should be highlighted. Documentation of recruitment and retention rates in clinical trials should be provided. The U.S. PI should clearly document previous time spent, activities, and outcomes at the foreign site. o Evidence of Foreign Institutional Support Applicants must demonstrate the foreign research partner institution’s commitment to and support for the proposed collaborative research study. Documentation from key administrative personnel at the foreign institution should indicate support for research staff participation in the Global Network and authorize some potential use of institutional resources. Examples of such resources may include administrative staff assistance, equipment, supplies, access to office, clinic or laboratory space, etc. Applicants also should provide evidence of support for their research collaboration from the appropriate foreign government authorities, as well as any international organization(s), with a regional or country mission or component that is proposed to be involved in the study. o Appropriate Staff Expertise and Capability The application must be submitted by a U.S. applicant institution on behalf of the U.S. and foreign country collaborative partners. Applicants must present evidence of the professional expertise, experience, and capacity of both the U.S. Principal Investigator and the developing country Senior Foreign Investigator, as well as their respective project staff, to develop and implement the research proposed to be undertaken within the Global Network o Multidisciplinary Approach and Staffing Applicants must demonstrate a multidisciplinary approach to the design and implementation of their proposed collaborative study. A staffing plan should be included that indicates formation of a multidisciplinary team of biomedical and behavioral scientists, physicians, and public health personnel. This team must be capable of conducting the described research and, when appropriate, providing clinical services to women and children on site or in the community. Steps to ensure effective communication and cooperation across disciplines should be identified. Prior successful experience with multidisciplinary research activities should be indicated. o Awareness of Ethical and Cultural Issues in Global Research Applicants must demonstrate an awareness of and must describe their experience with any ethical and cultural issues that need to be considered in the design, implementation, analysis, and publication of research studies undertaken with women and children in developing countries. This includes issues related to framing of appropriate research questions, recruitment and retention of study populations, informed consent and other human and animal subject considerations, design and use of research methods and instruments, data analyses and interpretation, and dissemination and application of findings to benefit the study populations, sustainability planning, as well as the international and domestic research and healthcare-providing communities. Any relationship of the study topic to national or local health policy should be clearly explained. o Capacity for Communications Applicants should include a description of existing and anticipated technological and staff resources for the establishment and maintenance of computer-based and other communications linkages to facilitate information and research data sharing between the U.S. and developing country sites. Applicants must provide, at a minimum, assurance of or planning for e-mail capability at all sites. Technological and resource needs and limitations related to communications also should be indicated. This information will help the NIH co-sponsors to assess available and potential technology, and to determine what resources might be needed to support communication among the Global Network Research Units, the Data Center, and the NIH. Travel It is expected that scientists from the U.S. institutions will travel to their foreign country counterparts for periodic consultations and collaborative work with the resident scientists in research directly related to the objectives of the grant award. It is anticipated that foreign country scientists also might travel to the U.S. for purposes of training or collaborative work related to the grant award. Applicants should indicate the purpose of any proposed staff travel and proposed duration of stay at the U.S. or foreign research unit site. Budget Research Unit applicants should provide separate budgets for the domestic site and the foreign site. The use of budget summary tables and other descriptive tools is strongly encouraged to clarify institutional and research-related expenses. Plans and procedures for monitoring budgetary expenditures at the domestic and foreign sites must be clearly specified. At time of award, a consortium agreement must be in place between the U.S. grantee and the foreign site(s). Budget requests should include, at a minimum, the following: o Estimated travel costs and related expenses for any proposed staff travel, as described above. In addition, budget requests should include funds to support travel of the Principal Investigator and the Senior Foreign Investigator of each Research Unit to periodic meetings, in the Washington, D.C. area, of the Steering Committee, usually a three-day annual meeting. o Salary support for the U.S. Principal Investigator, the Senior Foreign Investigator, study coordinator(s), outreach/recruitment workers, and any other proposed professional and support staff, with appropriate justification. o Laboratory and screening costs for study participation. o Expenses related to communications, supplies, equipment, and subject reimbursement/compensation anticipated in the research. o Resources for a physician independent of the study (Safety Monitor) to evaluate adverse events. o Expenses related to activities to strengthen research capacity at the foreign site. o Expenses related to sustainability planning. Percent Effort U.S. Principal Investigators of the Global Network Research Units must expend at least 25 percent effort annually on the award over the entire period of support, with a significant effort expended at the foreign site. The Senior Foreign Investigators of the Research Units must be substantially involved, spending at least 25 percent effort annually on the award over the entire period of support. Terms and Conditions of Award Cooperative agreements are assistance mechanisms and are subject to the same administrative requirements as grants. The following terms and conditions will be incorporated into the award statement and provided to each Principal Investigator as well as the institutional officials at the time of the award. These terms are in addition to, and not in lieu of, otherwise applicable OMB 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 Branch in accordance with HHS, PHS, and NIH Grant Administration policies. It is envisioned at this time that all awarded funds will be administered by the NICHD Grants Management Branch or by the Grants Management Offices of the other co-sponsoring NIH ICs when those Institutes or Centers provide primary funding. The cooperative agreement funding mechanism will require collaboration among the NICHD Staff Science Coordinator, the Staff Science Collaborators of the involved NIH Institutes and Centers (ICs), the Data Center Principal Investigator, and the U.S. Principal Investigators and Senior Foreign Investigators of the Global Network Research Units. The NICHD Staff Science Coordinator, in cooperation with the NIH co-sponsoring ICs, will coordinate the activities of the Global Network, and will facilitate communication and the exchange of information. 1. The Primary Rights and Responsibilities of the Awardees All awardees will agree to accept the participatory and cooperative nature of the group process. All awardees are required to submit annual progress reports to NICHD and the other co-sponsoring NIH IC(s), as appropriate, and to provide study and site performance information as stipulated by NICHD. A. The Global Network Research Unit Each Global Network Research Unit will be led by an U.S. Principal Investigator and a Senior Foreign Investigator at the developing country site. The Research Units specifically will: o Develop and implement research protocols, interventions, and evaluation strategies, with all protocol documents including, at a minimum, an introduction section with background and rationale, a statement of the study objectives, criteria for selection of subjects and enrollment procedures, clinical and laboratory evaluations to be performed, plans for data collection, management, and monitoring, and for reporting of adverse events, a complete description of the study treatment, and statistical considerations, including general design issues, endpoints, sample size, accrual and power, monitoring and analysis, and stopping rules. Some of these activities are shared with the Data Center. o Specify plans for compliance with all Food and Drug Administration regulations and for the provision of an adequate supply, if the proposed research includes an investigational new drug. o As a shared activity with the Data Center, when appropriate, collect, analyze, and interpret data, and disseminate research results from Global Network studies, while assuring quality control. o Present research concepts, plans, progress, and results to the Steering Committee. o Publish and disseminate results of both independent and shared research. When joint protocols are completed, publish in collaboration with other involved Global Network Research Units. o Collaborate with other awardees and the NIH. o Retain custody of and rights to data developed under these awards subject only to the Government rights of access consistent with current HHS, PHS, and NIH policies. o Implement any network-approved shared study protocols, where feasible, including the recruitment and monitoring of study participants, associated data collection, and study-associated quality control measures at the study sites, in collaboration with the Data Center. o Obtain institutional assurance from OHRP and local institutional review board (IRB) approval of all study protocols implemented at U.S. or foreign sites and comply with both IRB and Global Network policies and procedures. o Generate, if feasible, additional research proposals, including shared protocols, for consideration for inclusion in the Global Network. o Participate in conference calls, and attend network meetings held at least once annually. B. The Data and Coordinating Center The Data Center will provide research support services to the Global Network. These will include establishment and maintenance of a centralized information management system to help the Global Network Research Units collect, edit, store, analyze, publish, and disseminate results from their individual projects as well as from shared research. It will assist the program staff of the NICHD and other NIH co-sponsors in monitoring research progress, and will work to ensure data integrity, accuracy, and accessibility among all Research Unit sites. It will offer technical assistance and analytical support for all sites, as needed. The Data Center will provide particular attention to the needs of developing country sites, for the purpose of helping develop and enhance their capacity for data collection and analysis. Initially, the Data Center will support primarily the individual research projects undertaken by Global Network Research Units. However, as the Network becomes more established and the capacity of the Research Units to undertake common protocols is strengthened, the Data Center must be prepared to respond to the needs of shared research projects. All activities of the Data Center must be closely coordinated with the NICHD Staff Science Coordinator. In support of all research projects undertaken by the Global Network, the Data Center staff will: o Support the activities of the Network Advisory Group, Steering Committee, and the DSMB through provision of materials/documentation support, meeting planning and logistics, and conference call coordination. o Provide advice on study design, data collection, data analysis, and publication development to all Global Network research projects. o Prepare, design, and disseminate operations manuals, data collection forms, databases, and results reporting summaries for Global Network research projects. o Compile for the Network Advisory Group and Steering Committee, the DSMB, the NICHD and the other participating NIH sponsors, site visit reports, monthly and quarterly subject enrollment reports, meeting summaries, quarterly Research Unit performance and progress reports, and other reports as needed. o Maintain or assure maintenance of high quality databases resulting from any collaborative research, supervise all data collection procedures, and arrange for the most efficient transfer of study data where indicated. o Ensure that all Global Network sites and investigators fully comply with DHHS and NIH regulatory requirements, including informed consent, reporting of adverse events, human and animal subject safety and welfare provisions, and the requirements of international collaboration. o Provide training to all Research Unit site personnel as needed on data management and analysis, and quality control and quality assurance. o In coordination with the NIH co-sponsors, provide periodic on-site monitoring to the Research Units for those studies being performed at that site. o Participate in regular conference calls and attend network meetings. 2. NIH Staff Involvement It is anticipated that a number of program staff from the NICHD and from the co-sponsoring NIH Institutes and Centers also will be involved in the Global Network program, primarily as staff science collaborators. Each research study will have a staff science collaborator involved, and every protocol will be reviewed by NIH according to NIH regulations and standard practices. A. NICHD Staff Involvement: Staff Science Coordinator, Staff Science Collaborators, and Program Official Staff Science Coordinator: The NICHD Staff Science Coordinator will serve as the principal representative of the Institute and NIH and, in consultation with relevant NICHD program staff and representatives of the other NIH co-sponsors, will provide overall programmatic oversight, coordination, and assistance to the Global Network. Specifically, the NICHD Staff Science Coordinator will: o Facilitate communication, cooperation, and the exchange of information among network members and between the network components and other existing programs to support collaborative efforts. o Participate as a voting member of the Steering Committee. o Consult with NICHD program staff and NIH co-sponsors, who may be designated as staff science collaborators assigned to specific studies, when needed for optimal implementation of study designs. o Assist the Steering Committee in the selection and approval of research topics and the development and review of protocols for any specific studies. o Together with the Steering Committee chairperson, approve formation and membership of any Steering Committee subcommittees. o Oversee site participation and performance with the support of the Data Center. o Participate in study design, data analysis, interpretation, and publication of study results. NICHD Staff Science Collaborators: Other NICHD staff may be assigned as staff science collaborators for Network grants assigned to them in their areas of scientific expertise. They may participate in Steering Committee meetings as non-voting members. Specifically, the NICHD Staff Science Collaborators will, in consultation and collaboration with the NICHD Staff Science Coordinator: o Provide programmatic oversight and assistance to awardees assigned to the NICHD. o Provide advice, when needed, for optimal implementation of intervention designs. o Assist in overseeing site participation and performance, as needed, with the support of the Data Center. o Participate, as needed, in study design, data analysis, interpretation, and publication of study results relevant to the research conducted by their respective grantees. NICHD Program Official: NICHD will designate a Program Official, who will assume the administrative stewardship responsibilities and obligations for the Global Network B. NIH Co-sponsor Staff Science Collaborators Program representatives of the other NIH co-sponsors may serve as staff science collaborators for grants assigned to their respective NIH Institutes and Centers. They may participate in Steering Committee meetings as non- voting members. Specifically, the NIH Staff Science Collaborators will, in consultation and collaboration with the NICHD Staff Science Coordinator: o Provide programmatic oversight and assistance to awardees assigned to their respective NIH Institutes. o Provide advice, when needed, for optimal implementation of intervention designs. o Assist in overseeing site participation and performance, as needed, with the support of the Data Center. o Participate, as needed, in study design, data analysis, interpretation, and publication of study results relevant to the research conducted by their respective grantees. 3. Collaborative Responsibilities In addition to the above specified rights, responsibilities, and involvement, the Global Network components have collaborative responsibilities, which include interaction with the Network Advisory Group and the DSMB, and membership on the Steering Committee. Steering Committee members will: o Assist in the identification of priority research issues related to women"s and children"s health in developing countries. o Approve the direction of joint research efforts and facilitate the conduct and monitoring of these studies. o Approve all Global Network policies and procedures. o Approve the research plans based on feasibility and clinical relevance, and provide advice on implementation strategies. o Identify a need and propose members for Steering Committee subcommittees to undertake specific activities or to review issues, policies, or procedures of particular interest to the Global Network, subject to the approval of the NICHD Staff Science Coordinator and the Steering Committee chairperson. 4. Arbitration Process When agreement between an awardee and NICHD staff cannot be reached on scientific/ programmatic issues that may arise after the award, an arbitration panel will be formed. The panel will consist of one person selected by the Principal Investigator, one person selected by NICHD staff, and a third person selected by these two members. The decision of the arbitration panel, by majority vote, will be binding. This special arbitration procedure in no way affects the right of an awardee to appeal an adverse action in accordance with PHS regulations at 42 CFR Part 50, Subpart D, and HHS regulations 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 sub-populations 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 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 research involving human subjects should read the UPDATED "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research," published in the NIH Guide for Grants and Contracts on August 2, 2000 (, a complete copy of the updated Guidelines is available at The revisions relate to NIH-defined Phase III clinical trials and require: a) all applications or proposals and/or protocols to 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) all investigators to report accrual, and to conduct and report analyses, as appropriate, by sex/gender and/or racial/ethnic group differences. With regard to the population of a partner foreign country, the definition of minority groups may be different than in the U.S. If there is scientific rationale for examining subpopulation group differences within the foreign population, investigators should consider designing their studies to accommodate these differences. INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS It is the policy of NIH that children (i.e., individuals under the age of 21) must be included in all human subjects research, conducted or supported by NIH, unless there are scientific and/or ethical reasons not to include them. This policy applies to all initial (Type 1) applications submitted for receipt dates after October 1, 1998. All investigators proposing research involving human subjects should read the "NIH Policy and Guidelines" on the Inclusion of Children as Participants in Research Involving Human Subjects," published in the NIH Guide for Grants and Contracts, March 6,1998, and available at: Investigators also may obtain copies of these policies from the program staff listed under INQUIRIES. REQUIRED EDUCATION IN THE PROTECTION OF HUMAN RESEARCH PARTICIPANTS All investigators proposing research involving human subjects should read the policy that was published in the NIH Guide for Grants an Contracts, June 5, 2000 (Revised August 25, 2000), available at: URLS IN NIH GRANT APPLICATIONS OR APPENDICES All applications and proposals for NIH funding must be self-contained within the 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. Reviewers are cautioned that their anonymity may be compromised when they directly access an Internet site. 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 RFA in a public archive, which can provide protections for the data and manage the distribution for an indefinite period of time. If so, the application should include a description of the archiving plan in the study design and include information about this in the budget justification section of the application. In addition, applicants should think about how to structure informed consent statements and other human subjects procedures given the potential for wider use of data collected under this award. LETTER OF INTENT Prospective applicants are asked to submit a letter of intent that includes a descriptive title of the proposed research, the name, address, and telephone number of the U.S. Principal Investigator and the Senior Foreign Investigator, the identities of other key personnel and participating U.S. and foreign institutions, and the number and title of this RFA. Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows NICHD staff to estimate the potential review workload and plan the review. The letter of intent is to be sent to Dr. Susan Meikle, at the address listed under INQUIRIES, below, by February 11, 2002. APPLICATION PROCEDURES The PHS 398 research grant application instructions and forms (rev.5/2001) at are to be used in applying for these grants. This version of the PHS 398 is available in an interactive, searchable PDF format. Beginning January 10, 2002, the NIH will return applications that are not submitted on the 5/2001 version. For further assistance contact GrantsInfo, telephone (301) 710-0267, E-mail: Application Instructions Instructions accompanying the research grant application form PHS 398 (rev. 5/2001), including page limitations, are to be used in applying for these grants, with the modifications described below: o For the purpose of this RFA, key personnel is defined as follows: All personnel involved in each application, regardless of whether salary support is requested. Names of all personnel should be included in the application with their specific responsibilities in support of the research effort outlined and with their percent time and effort specified. Alphabetized biographical sketches for all personnel should follow the budget justification. o All information pertinent to the special requirements should be included in the research plan of the application and not in an appendix. Submission Instructions The RFA label available in the PHS 398 (rev. 5/01) application package must be stapled to the bottom of the face page of the application and must display the RFA number HD-01-024. A sample RFA label is available at Please note this is in the pdf format. Failure to use this label could result in delayed processing of the application such that it may not reach the review committee in time for review. In addition, the RFA title and number must be typed on line 2 of the face page of the application form and the YES box must be marked. Submit a signed, typewritten original of the application, including the Checklist, and three signed photocopies, in one package to: CENTER FOR SCIENTIFIC REVIEW NATIONAL INSTITUTES OF HEALTH 6701 ROCKLEDGE DRIVE, ROOM 1040, MSC 7710 BETHESDA, MD 20892-7710 BETHESDA, MD 20817 (for express/courier service) At the time of submission, two additional copies of the application should be sent to: Robert Stretch, Ph.D. Acting Director, Division of Scientific Review National Institute of Child Health and Human Development 6100 Executive Blvd., Room 5E03, MSC 7510 Bethesda, MD 20892-7510 Rockville, MD 20852 (for express/courier service) Applications must be received by March 18, 2002. If an application is received after that date, it will be returned to the applicant without review. The Center for Scientific Review (CSR) will not accept any application in response to this RFA that is essentially the same as one currently pending initial review, unless the applicant withdraws the pending application. The CSR will not accept any application that is essentially the same as one already reviewed. This does not preclude the submission of substantial revisions of applications already reviewed, but such applications must include an introduction addressing the previous critique. REVIEW CONSIDERATIONS Upon receipt, applications will be reviewed for completeness by the CSR, and for responsiveness by NICHD and the other participating Institutes and Centers. Incomplete and/or non-responsive applications will be returned to the applicant without further consideration. Applications that are complete and responsive to the RFA will be evaluated for scientific and technical merit by an appropriate peer review group convened by the NICHD, in accordance with the review criteria stated below. As part of the initial merit review, all applications will receive a written critique and may undergo a process in which only those applications deemed to have the highest scientific merit will be discussed, assigned a priority score, and receive a second level review by the appropriate National Advisory Council or Board. Review Criteria The goals of NIH-supported research are to advance our understanding of biological systems, improve the control of disease, and enhance health. In the written comments, reviewers will be asked to discuss the following aspects of the application in order to judge the likelihood that the proposed research will have a substantial impact on the pursuit of these goals. Each of these criteria will be addressed and considered in assigning the overall score, weighting them as appropriate for each application. Note that the application does not need to be strong in all categories to be judged likely to have major scientific or public health 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 the field forward. (1) Significance: Does this study address an important problem? If the aims of the application are achieved, how will scientific knowledge be advanced? What will be the effect of these studies on the concepts or methods that drive this field? (2) Approach: Are the conceptual framework, design, methods, and analyses adequately developed, well integrated, and appropriate to the aims of the project? Does the applicant acknowledge potential problem areas and consider alternative tactics? Is the scientific hypothesis clear and focused? (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 and percent effort proposed appropriate to the experience level of the Principal Investigator and other researchers (if any) and the requirements of the RFA? (5) Environment: Does the scientific environment in which the work will be done contribute to the probability of success? Do the proposed experiments take advantage of unique features of the scientific environment or employ useful collaborative arrangements? Is there evidence of institutional support? In addition to the above criteria, applications for the Global Network Research Units will be reviewed with respect to the following: o Quality of the scientific basis for the evidence-based intervention. o Adequacy and breadth of understanding of existing global research related to women’s and children’s health in developing countries. o Availability of and access to relevant and sufficient populations for studies related to women’s and children’s health in developing countries. o Strength and adequacy of plans for study site management, collaboration, and communication. o Adequacy of plans for implementing the proposed study and capacity to undertake shared research over time. o Evidence of prior successful scientific collaboration involving the U.S. investigators and foreign researchers in a developing country. o Demonstrated awareness of ethical and cultural issues and concerns related to the conduct of research within developing countries, especially focused on the foreign site(s) proposed in the application. o Evidence of foreign institutional commitment to the research effort and to the Global Network, e.g., letters of support and other documentation of commitment. o Demonstrated willingness and ability to adhere to the terms and conditions of the Cooperative Agreement award. o Quality of sustainability plan. In addition to the above criteria, in accordance with NIH policy, all applications will be reviewed with respect to the following: o The adequacy of plans to include both genders, minorities and their subgroups, and children as appropriate for the scientific goals of the research. Plans for the recruitment and retention of subjects also will be evaluated. o The reasonableness of the proposed budget and its duration in relation to the proposed research, adequacy of plans and procedures for monitoring expenditures at both the domestic and foreign sites. o Adequacy of the proposed protection for humans, animals, or the environment, to the extent they may be adversely affected by the project proposed in the application. SCHEDULE Letter of Intent Receipt Date: February 11, 2002 Application Receipt Date: March 18, 2002 Peer Review Date: June/July 2002 Council Review: September 2002 Earliest Anticipated Award Date: September 2002 AWARD CRITERIA Applications will be considered for award based on the following criteria: o scientific and technical merit, as determined by peer review, o responsiveness to the goals and objectives of the RFA, o program balance, relevance, and priorities, o geographic distribution, o complementarity with other NIH-supported international research networks, and o availability of funds. INQUIRIES Inquiries concerning this RFA are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Direct inquiries regarding programmatic issues to: Susan Meikle, M.D., M.S.P.H. Pediatric, Adolescent, and Maternal AIDS Branch National Institute of Child Health and Human Development 6100 Executive Blvd., Room 4B5OJ, MSC 7510 Bethesda, MD 20892-7510 Telephone: (301) 496-0431 FAX: (301) 496-8678 E-mail: Direct inquiries regarding fiscal matters to: Ms. Shelley Carow Grants Management Branch National Institute of Child Health and Human Development 6100 Executive Blvd., Room 8A01, MSC 7510 Bethesda, MD 20892-7510 Telephone: (301) 402-4165 FAX: (301) 402-0915 E-mail: AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance Numbers 93.865 and 93.864 (NICHD). Awards are made under authorization of Sections 301 and 405 of the Public Health Service Act, as amended (42 USC 241 and 284) and administered under NIH grants policies and Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. The PHS strongly encourages all grant recipients to provide a smoke-free workplace and promote the non-use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routine education, library, day care, health care or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people.

Weekly TOC for this Announcement
NIH Funding Opportunities and Notices

NIH Office of Extramural Research Logo
  Department of Health and Human Services (HHS) - Home Page Department of Health
and Human Services (HHS) - Government Made Easy
NIH... Turning Discovery Into Health®

Note: For help accessing PDF, RTF, MS Word, Excel, PowerPoint, Audio or Video files, see Help Downloading Files.