PARTNERSHIPS FOR HIV/AIDS RESEARCH IN AFRICAN POPULATIONS Release Date: November 6, 2001 RFA: RFA-HD-02-003 National Institute of Child Health and Human Development (http://www.nichd.nih.gov) National Institute of Mental Health (http://www.nimh.nih.gov) National Center for Complementary and Alternative Medicine (http://nccam.nih.gov/) Fogarty International Center (http://www.nih.gov/fic/) Letter of Intent Receipt Date: March 19, 2002 Application Receipt Date: April 16, 2002 PURPOSE The National Institute of Child Health and Human Development (NICHD), the National Institute of Mental Health (NIMH), the National Center for Complementary and Alternative Medicine (NCCAM), and the Fogarty International Center (FIC) invite applications for resource-related grants in support of behavioral and social science research relevant to the critical and expanding prevention and care needs of women, children, and families affected by HIV/AIDS in Africa. The unprecedented and accelerating HIV/AIDS epidemic in Africa, particularly among women and young people, requires focused, intensified, innovative, multi-disciplinary, and culturally relevant research activity that is responsive to local African needs, challenges, priorities, and realities. A primary goal of this Request for Applications (RFA) is to encourage partnerships between skilled African investigators and U.S. and/or other developed country investigators that will result in the increased capacity and capability of the African scientific community to conduct rigorous HIV/AIDS-related behavioral and social science research. These partnerships are intended to support the strengthening of the research capability and capacity of African investigator(s), research team(s), and/or institution(s). African scientists and clinical researchers are encouraged strongly to apply as the Principal Investigators and/or to assume other leadership roles in the proposed studies. Grants may be awarded to Principal Investigators from the United States, other developed countries, or from countries in Africa, particularly those that have been most affected by the HIV epidemic. This RFA encourages projects designed to: (1) develop research infrastructure and strengthen the capacity of African institutions and investigators to conduct relevant HIV/AIDS research; (2) establish and/or enhance linkages among local in-country investigators, public health officials, community institutions, and health care providers, including traditional health practitioners; and (3) support relevant developmental and/or exploratory studies. It is anticipated that such research projects will contribute to the field as well as enhance the ability of African investigators to compete successfully for HIV/AIDS-related funding under other research grant mechanisms. For the purposes of this RFA, infrastructure development and capacity- strengthening refer to the enhancement of resources (including laboratory, field support, training, administration, ethical review and oversight, sample storage and management, instrument design and data collection, data management and analysis, information exchange and dissemination, and other resources) that are needed by investigators to pursue research independently and to compete successfully for research funding. HEALTHY PEOPLE 2010 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of Healthy People 2010, a PHS- led national activity for setting priority areas. This RFA is related to one or more of the priority areas. Potential applicants may obtain Healthy People 2010 at http://www.health.gov/healthypeople/. ELIGIBILITY REQUIREMENTS Applications may be submitted by domestic or foreign, 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. Faith-based organizations are eligible to apply for these grants. Racial/ethnic minority individuals, women, and persons with disabilities are encouraged to apply as Principal Investigators. Applications from U.S. or other developed country scientists and institutions must demonstrate a strong commitment to and record of partnership involving African scientists in Africa and African institutions. Principal Investigators from the U.S. or other developed nations are required to partner with investigators from Africa. Principal Investigators from Africa are eligible to apply on their own but are strongly encouraged to submit an application in partnership with investigators from the U.S. or other developed countries. Eligible applications must demonstrate a linkage between the applicant research institution and in-country African clinical, community-based or other public health organizations, and institutions that provide preventive services, care and/or support to the populations that are the focus of the research effort. The goal of this linkage should be to facilitate the use of research findings directly to improve or expand HIV/AIDS prevention, care or management programs in Africa. This program is designed to complement other NIH programs focused on global HIV/AIDS research and research training, such as the Fogarty International Center’s AIDS International Training and Research Program (AITRP). Investigators from applicant institutions that are applying for a Comprehensive International Program of Research on AIDS (CIPRA) grant (http://www.niaid.nih.gov/daids/cipra; http://grants.nih.gov/grants/guide/notice-files/NOT-AI-01-018.html) from the National Institute of Allergy and Infectious Diseases (NIAID) must demonstrate that their applications in response to this RFA do not overlap with (though they may be complementary to) their institution’s CIPRA application. Applicants should make clear all levels of involvement and provide scientific justification if investigators or other staff proposed for this RFA are also proposed for involvement on a CIPRA application. Potential applicants are strongly encouraged to contact staff listed under INQUIRIES, below, to discuss eligibility prior to submission of an application. MECHANISM OF SUPPORT This RFA will use the National Institutes of Health (NIH) resource-related research project grant (R24) award mechanism. Responsibility for the planning, direction, and execution of the proposed project will be solely that of the applicant. This RFA is a one-time solicitation. The anticipated award date is September 30, 2002. FUNDS AVAILABLE The NICHD intends to commit approximately $2 million in total costs [Direct plus Facilities and Administrative (F&A) cost] in FY 2002. The NIMH intends to commit approximately $300,000 and the NCCAM intends to commit approximately $500,000 in total costs in FY 2002 to fund or partially fund grants relevant to their missions in response to this RFA. The FIC intends to commit approximately $200,000 in total costs in FY 2002, with the highest priority accorded to proposals that link to existing FIC training and capacity building programs (e.g., AITRP, the International Maternal and Child Health Research Training program, etc.). It is anticipated that available funds will support up to 10 grants in response to this RFA. An applicant may request a project period of up to five years and a budget for total costs of up to $300,000 in the first year. Incremental increases for direct costs may not exceed three percent in each subsequent year. It is expected that a majority of the direct costs requested will be used in Africa. Applicants should request support appropriate to the size and impact of their scientific portfolio and to the goals and justified needs of their infrastructure development and capacity-building program. Because the nature and scope of the research proposed may vary, it is anticipated that the size of each award also will vary. Although the financial plans of the NICHD and the other co-sponsors provide support for this program, awards pursuant to this RFA are contingent upon the availability of funds and the receipt of a sufficient number of meritorious applications. RESEARCH OBJECTIVES Background In Africa, HIV/AIDS affects entire populations, societies, and countries with enormous and tragic consequences at the national, community, family, and individual level. More than 25 million adults and children are living with HIV/AIDS in sub-Saharan Africa, where the access to care is severely limited. In 16 African countries, more than 10 percent of the population in the 15-49 year old age group is HIV-infected. Overall, in sub-Saharan Africa, where the mode of transmission is overwhelmingly heterosexual, 55 percent of HIV- positive adults are women, with many at risk of transmitting the virus to their infants. Twelve to 13 African women are currently infected for every 10 African men. AIDS is now the leading cause of mortality in this region where 2.4 million people died from the disease in 2000 and over 17 million people have died since the beginning of the epidemic. By the end of 2000, an estimated 3.8 million adults and children were newly infected with HIV, and millions of Africans infected in earlier years are experiencing ill health. More than 90 percent of the 11 million children worldwide who have lost one or both parents to AIDS are African children. It is estimated that by 2010, AIDS will account for 68.4 percent of parental deaths leading to orphaning-- an increase from 16.4 percent in 1990. Because the large majority of AIDS- orphans are HIV-negative, it is estimated that the total number of children orphaned by AIDS will continue to grow through at least 2020. The cumulative impact of HIV/AIDS-related death and illness has radically diminished the expected life spans of the African population, and has created unprecedented challenges in coping with the effects of the epidemic for African orphans, other survivors, families, care providers, communities, and countries. There is increasing recognition worldwide that AIDS-related activities and support must be expanded dramatically to address the epidemic in Africa. There is also growing recognition that the appropriate implementation of effective prevention, care, and treatment strategies must be informed by a clear understanding of African contexts. This understanding can evolve from research into the social, cultural, and behavioral milieu within which the HIV epidemic is occurring in Africa. To expand understanding of these contextual issues, research is needed that is designed to address conditions specific to African experiences. Moreover, research infrastructure development and capacity-strengthening activities are urgently needed to support research efforts that can inform and foster the development of realistic and sustainable African solutions to the HIV challenges in African populations. Prevention efforts face significant challenges in all countries. In many African countries, adoption of effective prevention strategies by individuals and by institutions remains low and unprotected sex between men and women continues, contributing to increasing rates of heterosexual transmission of HIV and other sexually transmitted infections. Family systems and lack of autonomy often reduce a woman’s ability to introduce protective measures or to refuse sex with a possibly infected partner. As is the case in many countries, women and girls are sometimes forced into sex work for economic reasons. School and community-based sex education efforts are too few and are often started too late in parts of Africa. Yet improved understanding by the general population of the route of transmission of HIV and how to stop it is critical to interrupt the cycle of disease transmission from one generation to the next. Around the world, women are most often responsible for the health and health care of all family members. In addition, women in Africa often are expected to undertake other productive household and communal labor and activities, the loss of which, during serious illness, may have long-term and disastrous consequences for the social, economic, physical, and psychological well-being of the household. The care-giving role of women includes not only husbands, children, or other immediate family members, but also may extend to the care of children of other relatives or neighbors, who become orphans when one or both parents have died from AIDS. Investigators undertaking research in response to this RFA should be mindful of the efforts by more than 20 African countries to develop and implement strategic plans on the national and community levels to address the HIV/AIDS- related challenges and problems in their respective countries. Research efforts should support the achievement of objectives included in these plans, to the greatest degree possible. It is understood that research priorities and goals will differ depending on the African country, region, and population groups that are the focus of the resource projects or studies proposed. Objectives and Scope Research Infrastructure Development and Capacity-Strengthening: Applications may request funds to strengthen the research infrastructure of African institutions to enhance the capability of African investigators to undertake rigorous behavioral and social science research in relation to HIV/AIDS prevention, care, and management problems and issues in African populations. These grants should provide capacity-strengthening support that will enhance the competitiveness of African institutions, organizations, and scientists in future efforts to obtain research support. As a result of this program, it is anticipated that the African investigators involved in these grants will emerge as recognized African leaders in the fields of behavioral, social, biomedical, and traditional medicine research related to HIV/AIDS. All infrastructure development and capacity-strengthening requests must relate to the general goals of the research program. Research Projects: Proposed studies under this program must address problems and issues considered of urgent scientific and public health importance by the African scientific and health care communities. Recommendations that emerged at the March 2001 Botswana Consultation to Explore a Research Agenda to Improve the Care and Management of Mothers and Children Affected by HIV in Africa may suggest relevant areas of need and concern (see Consultation report under clinical conferences at http://www.NICHDnetwork-PACTG.org). These recommendations include behavioral, cultural, social, psychosocial, and institutional factors that are thought to have an impact on prevention, care and management, child development, nutrition, and reproductive health in relation to HIV/AIDS in Africa. Although the focus of the Botswana Consultation was primarily on the improvement of HIV/AIDS care and management, the participants concluded that care and prevention of HIV are interconnected. They noted that the provision of treatment, care, and illness management options often is one key to effective prevention activities. Research questions of interest may focus on social, cultural, psychosocial, and biological factors that have an impact on nutrition status of HIV- affected women and children; stigma associated with all aspects of HIV/AIDS; gender inequities and their impact on prevention, health-seeking behavior, care, treatment, and diagnosis of HIV-infected individuals and their families. Research may also address the impact of HIV/AIDS on families, including child development and family structure; types of traditional health practices applied to HIV/AIDS prevention and treatment; role and/or impact of traditional healers/practices in the prevention and/or treatment of HIV/AIDS; models of HIV/AIDS care integration between traditional healers and Western trained physicians; and biomedical and behavioral studies of the role of reproductive health on the risk of HIV and related diseases. Each of these grants will also support a portfolio of relevant and innovative research, optimally to be conducted with the leadership and involvement of African scientists in Africa, in partnership with scientists in the U.S. and/or other developed countries. Applicants may concentrate on any combination of relevant topics that are broadly described below. Each application should propose one to three developmental or exploratory projects that will contribute to the knowledge base required to address the HIV/AIDS epidemic in Africa. It is envisioned that the developmental projects funded under this RFA may have the potential to be developed into larger-scale research proposals that might lead to funding under other grant programs through the NIH or other funding sources. The research projects described in the application should be designed to take advantage of the infrastructure development and capacity-building activities also proposed for funding. Potential areas for research, often interrelated and overlapping, are described below. Illustrative, but not exhaustive, examples of possible research questions can be found at http://www.nichd.nih.gov/RFA/HD-02-003/HD-02-003.htm. 1. Behavioral, Cultural, Social, and Psychosocial Factors that Influence HIV/AIDS Prevention, Care and Management. Preventing HIV transmission, encouraging acceptance of care, and providing care and treatment in Africa involve the development of locally sustainable, effective interventions, designed for or adapted to the unique needs and conditions of specific populations and communities, and the understanding of behavioral, cultural, social, economic, and institutional factors that influence individual and community actions. In Africa, such behavior must be seen in the context of individual, family, and community resources, including the limited availability of health care and services. Research is needed to increase understanding of gender inequities and their relation to prevention, health care-seeking behavior, and care of HIV-infected individuals and their families. Gender-based customs, beliefs, and behaviors in different African settings influence all aspects of prevention and health care, including a woman’s risk of HIV acquisition and the subsequent provision of support and care for her and her children who are affected and/or infected by HIV/AIDS. Women often are expected to follow traditional health practices and to use only health care resources available through such practices. The role of African men in relation to HIV/AIDS prevention, care, and treatment in families requires more attention. Efforts to reach and educate men about their own sexual health and that of their partners need to be increased. Raising awareness of their risk can change certain of these behaviors. There is a need for behavioral interventions that reach men, as well as women, if women and other family members are to be protected and to obtain the care they need. 2. The Role and Impact of Traditional Health Practitioners and Practices Traditional health practitioners in Africa provide preventive, curative, psychological, palliative, and spiritual help and support in many communities. The care and support provided may be based on different concepts of health and illness than those of the biomedical model. Traditional health practitioners also play a prominent role in shaping and promulgating public opinion and practice in their communities. Because they often function outside the context of conventional scientific endeavor or rely on different evidence for decision-making, imposition of standards and practices derived from outside cultures might be problematic. A better understanding of decision-making paradigms of traditional health practitioners might contribute to their more effective involvement in HIV prevention and care. Research is needed to understand a) the efficacy and safety of traditional practices in the prevention and treatment of HIV/AIDS, their effect on HIV viral load and on opportunistic infections, and their impact on patients quality of life; b) how effective traditional practices could be integrated in current public health efforts, and c) the influence of traditional practices and practitioners on issues related to stigma, prevention, and HIV/AIDS care. 3. The Impact of HIV/AIDS on Child Health and Development in Africa The HIV/AIDS epidemic is creating an unprecedented threat to children’s health, well-being, and development in Africa, yet there is little research available to guide response and intervention. Of concern are the well-being and development of children who are HIV-infected as well as those who are uninfected, but may be living in AIDS-affected families. Little is known about the consequences of HIV/AIDS and its treatment for child development. The effects of AIDS-related morbidity and mortality on children’s vulnerability and development begin well before a parent dies, and are not limited to effects on children who themselves are HIV-infected. Deepening poverty leads to withdrawal from schooling, food insecurity, reduced access to health services, and worsening material resources. Children are pressed into caring for ill and dying parents and earning income for the family, becoming the de facto head of household at unknown cost to their development. Girls, in particular, are pressured into sex to earn favors or income for the family, thereby increasing their risk of HIV-exposure. The psychosocial and economic problems related to the loss of parental and family support at a young age may be further compounded by the stigma of HIV/AIDS and the impact of the pandemic on the community and extended family. Once orphaned, children may find themselves living with caregivers too old or too young (including child heads of household) and without the means to provide for them. They may also be abused, exploited or abandoned by relatives charged with caring for them. They may be unable to obtain health care for themselves. This RFA encourages research to increase knowledge and understanding of the long-term effects of the HIV/AIDS epidemic on African children’s health, development, and access to education and training, among both uninfected and infected children. 4. Understanding Stigma and its Influence on HIV/AIDS Prevention, Care, and Management Countries like Senegal and Uganda have demonstrated that the growth of the AIDS epidemic can be reduced through effective prevention efforts and multi- sector initiatives, including schools, faith-based organizations, and health facilities, to address the problems. In these countries, the topic of HIV/AIDS has been brought more into the open, reducing the stigma associated with the disease, and enabling progress related to prevention, treatment, and care. This RFA encourages research that would contribute to an understanding of the role and causes of HIV/AIDS- related stigma in Africa, and its influence on all aspects of HIV/AIDS prevention, care, and management. Studies are encouraged that would evaluate strategies and interventions to reduce stigma associated with the use of prevention, such as increasing and expanding the use of voluntary counseling and testing, undertaking child-feeding approaches that do not conform to the social norm, and the use of antiretroviral therapy and other effective treatment strategies. 5. Factors Affecting the Availability and Acquisition of a Healthy Diet for HIV-Affected People The interaction of HIV infection and AIDS with nutritional status and dietary behavior has been a distinguishing characteristic of the disease course since the earliest days of the epidemic. In many areas of the developing world, particularly sub-Saharan Africa, the HIV epidemic has been superimposed on a preexisting and longstanding background of extensive malnutrition, both in terms of macronutrient malnutrition, i.e., marasmus and kwashiorkor, and the hidden hunger of micronutrient deficiencies. Most of the research attention related to nutrition and HIV has been focused on the impact of the disease on metabolism and, in particular, the AIDS wasting syndrome. Less attention has been paid to the identification of factors that limit the access to and acquisition of a healthful diet as part of the prevention, care, and management of HIV/AIDS-infected and -affected individuals, particularly in Africa. Furthermore, much of the evidence that does exist with regard to either the metabolic consequences of HIV infection or the potential role of diet or specific nutrients in the course of HIV infection is limited to data collected from adult patients. Although some data exist about the deleterious metabolic effects of HIV infection on the growth of infected children, little data exist about the impact of HIV on the access to and availability of food, the development of healthful food/eating behaviors, or related social factors relevant to growth and development in HIV-infected and -affected children. Behavioral and social factors related to breastfeeding and the impact of breastfeeding on infants and mothers also are critical areas for additional research. A better understanding of the social and cultural factors that underlie the acquisition of a nutritionally well- balanced and safe diet is essential to support the role of diet in the care and treatment of HIV-infected and -affected women, infants, and children in Africa. 6. The Role of Reproductive Health in the Acquisition, Prevention, Progression, and Treatment of HIV There are many issues associated with the reproductive health of women in Africa that may have an impact on HIV disease acquisition, transmission, and progression. For example, women are at increased risk of sexually transmitted infections (STIs) for biological as well as social and cultural reasons. There appears to be a linkage between certain STIs and increased risk of HIV. Likewise, use of hormonal contraceptives may place women at increased risk of disease acquisition. Certain culturally-condoned sexual practices may also increase the risk of infection. Women who are HIV positive are less fecund, which may cause family problems. In addition, although pregnancy appears to have no adverse effect on disease progression in HIV- infected women in the U.S., little is known about the effect in developing countries. The highest rate of transmission to African women reportedly occurs within the first few months following delivery. Short inter-birth intervals and the sequelae of abortion may facilitate disease transmission as well. In the U.S., epidemiological cohorts have been established to understand the impact of reproductive health status of HIV-infected and uninfected women, but few cohorts have been established in Africa. Research is needed to better understand the effect of HIV on reproductive health behavior of at-risk adolescent girls and women in Africa and, conversely, how the status of women’s reproductive health influences HIV acquisition and transmission. The initial focus of such research in response to this RFA should be on social and behavioral factors. SPECIAL REQUIREMENTS Minimum Application Requirements o Each application should include three components: (1) a description, including justification, of the infrastructure development and capacity- strengthening support requested and the activities proposed; (2) a description of the local linkages and international partnerships to be established or enhanced; and (3) a description of one to three developmental research projects that will be conducted. o The application must clearly demonstrate how the infrastructure development and capacity-strengthening support requested will be used to enhance the research project(s) proposed. o The application must also include a statement of long-term research objectives and a description of how the research and infrastructure components of the application will contribute to the achievement of these long-term objectives. o The proposed Principal Investigator must commit to spending at least 25 percent effort annually on the award over the entire period of support, with a significant effort expended in Africa engaged in project implementation and oversight of the appropriate use of resources on the project. o The research component of the grant should not exceed 50 percent of the total costs. Allowable Costs The participating NIH co-sponsors recognize that the applicant institutions in Africa may require different types and levels of research infrastructure development and capacity-building support depending on the particular research needs, activities, and initiatives proposed in the application. The NIH also allows (beginning October 1, 2001) foreign and international organizations to request facilities and administrative (F&A) costs up to eight percent of total direct costs, less equipment. Also, domestic organizations that submit applications with a foreign or international consortium, may request eight percent of total direct costs, less equipment, for the consortium. Information about the allowability of F&A costs for foreign and international organizations is available in the NIH Guide for Grants and Contracts at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-01-028.html. Areas considered as infrastructure development and capacity-strengthening support include those listed above under PURPOSE: recruitment, training and retention of staff, statistical and other relevant consultations, data management, and collaborations with other institutions. In this regard, funds may be requested for the following: o Salary support for trainers/educators and trainees, based on level of effort and institutional salary commitments, for individuals involved in the project, including research technicians and assistants and staff from local non-governmental organizations, who may also be trainees. o Laboratory or research facility enhancement directly required for the implementation of the proposed research. Enhancement may include improvement of existing facilities, but support for de novo construction is not allowed. o Project-specific equipment and supplies, including computing and electronic communications hardware and software. o Acquisition of reference and other library materials, or electronic access to such materials, related to the research effort. o Information dissemination and diffusion of research results through modern technology to ensure wide distribution of findings among relevant end-users. o Support for planning, implementing, and evaluating mechanisms, including specialized training, to ensure effective ongoing, sustainable research programs and retention of skilled investigators and other technical staff. Areas for which research-related support may be requested include, but are not limited to, the following: o Salary support for African and other scientists, clinicians, and technical staff to enhance their capability to conduct research linked to the goals of this project and future research, including training in the use of locally appropriate and transferable research tools, techniques, and methods. o Research subject costs and support for informing subjects participating in the research about the results. o Field site support and field site visit costs. o Data acquisition, data management, and statistical analysis costs, including scientific and statistical consultation, as well as the costs of making data available to others. o Well-justified travel to scientific meetings for the Principal Investigator and other research staff to present findings from the studies. 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 (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-048.html); a complete copy of the updated Guidelines is available at http://grants.nih.gov/grants/funding/women_min/guidelines_update.htm. 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. 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 the NIH, unless there are scientific and ethical reasons not to include them. This policy applies to all initial (Type 1) applications submitted for receipt dates after October 1, 1998. All investigators proposing research involving human subjects should read the NIH Policy and Guidelines on the Inclusion of Children as Participants in Research Involving Human Subjects, published in the NIH Guide for Grants and Contracts, March 6, 1998, and available on the Internet at: http://grants.nih.gov/grants/guide/notice-files/not98-024.html. Investigators also may obtain copies of these policies from the program staff listed under INQUIRIES. Program staff may also provide additional relevant information concerning the policy. URLS IN NIH GRANT APPLICATIONS OR APPENDICES All applications and proposals for NIH funding must be self-contained within specified page limitations. Unless otherwise specified in an NIH solicitation, Internet addresses (URLs) should not be used to provide information necessary to the review because reviewers are under no obligation to view the Internet sites. 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: http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm. Applicants may wish to place data collected under this RFA in a public archive, which can provide protections for the data and manage the distribution for an indefinite period of time. If so, the application should include a description of the archiving plan in the study design and include information about this in the budget justification section of the application. In addition, applicants should think about how to structure informed consent statements and other human subjects procedures given the potential for wider use of data collected under this award. 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: http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html. 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 Principal Investigator, the identities of other key personnel and participating 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 Mr. F. Gray Handley at the address listed under INQUIRIES, below, by March 19, 2002. APPLICATION PROCEDURES The PHS 398 research grant application instructions and forms (rev. 5/2001) available at http://grants.nih.gov/grants/funding/phs398/phs398.html must be used in applying for these grants. This version of the PHS 398 is available in an interactive, searchable format. For further assistance contact GrantsInfo, Telephone 301/710-0267, Email: GrantsInfo@nih.gov. 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: The application in response to this RFA should also contain the following: 1) Infrastructure Development, Capacity-Strengthening, and Linkages Plan (25 page limit) o Identification of gaps and needs that can be met through this grant award o Specific goals o Proposed activities to be undertaken to develop and strengthen the research infrastructure of the African institution and the capacity and capability of the African investigators to conduct the research o Description of institutional commitment to provide additional or matching support for the proposed infrastructure development and staff capacity building, including contributions from FIC training and capacity building programs o Description of the partnership between the African investigator and the U.S. and/or other developed country partner(s) to strengthen infrastructure and capacity building o Description of any relevant linkages that are to be developed or strengthened among the researchers, public health officials, health care providers, non-governmental agencies and community organizations o Description of equipment, space, and other resources available to support the infrastructure development and capacity-strengthening plan and extent to which enhancement of these resources is needed o Detailed budget (application not to be submitted in modular format) 2) Research Project Plan (10 page limit for Sections a d for each proposed research project) For each proposed research project, in addition to the requirements outlined in PHS 398, address: o Linkages to overall infrastructure development and capacity-strengthening plan o Identification of unmet needs in African populations or community(ies) that can be addressed through the proposed research project o Relevant recent past or ongoing research activity o Plan for dissemination of research results and their application in an appropriate program or intervention o Detailed budget for each proposed project 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 infrastructure development, capacity-strengthening, and research effort outlined and with their percent time and effort specified. Alphabetized biographical sketches for all personnel should follow the budget justifications. Submission Instructions The RFA label available in the PHS 398 (rev. 5/2001) application form must be affixed to the bottom of the face page of the application. Type the RFA number on the label. Failure to use this label could result in delayed processing of the application such that it may not reach the review committee in time for review. In addition, the RFA title and number must be typed on line 2 of the face page of the application form and the YES box must be marked. The RFA label is also available at: http://grants.nih.gov/grants/funding/phs398/label-bk.pdf. 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: Director, Division of Scientific Review National Institute of Child Health and Human Development 6100 Executive Boulevard, Room 5E03, MSC 7510 Bethesda, MD 20892-7510 Rockville, MD 20852 (for express/courier service) Applications must be received by April 16, 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 the 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, generally the top half of the applications under review, will be discussed, assigned a priority score, and receive a second level review by the appropriate National Advisory Council. Review Criteria The following criteria will be used to evaluate the overall merit of each application: o Quality of the scientific program and its impact on the field, including the significance, innovation, and quality of the current and recent contributions of program scientists in the areas of HIV/AIDS research relevant to the scope of this RFA. o Quality and potential impact of proposed infrastructure development and capacity-strengthening program, including overall quality, scientific merit, and innovation of the activities to be supported. Consideration will be given to the likelihood that, based on the existing capabilities, resources and activities, the proposed program will enhance behavioral and social science HIV/AIDS-related research in Africa, promote new research directions, foster on-going research partnerships, facilitate interactions across disciplines, and advance knowledge that will contribute to the improvement of prevention, care, and management services. o Research competence of key personnel, including the capability and scientific credentials of the Principal Investigator to direct the program and to maintain high standards of research collaboration, as well as the scientific and technical accomplishments of all participating investigators and individuals engaged in capacity-building. o Adequacy of plans and procedures for monitoring expenditures at both the African and non-African sites engaged in research. o Institutional commitment and research environment of the applicant institution and any cooperating institutions, including contributions from FIC training and capacity building programs. Institutional commitment will be evaluated relative to the institutional context. Reviewers will consider the existing academic and physical environment as it relates to research opportunities, space, equipment, and the potential to conduct the proposed collaborations and research through the appropriate use and application of proposed resources to develop research infrastructure and enhance staff research skills and capabilities. o Institutional partnerships, linkages, and collaborations, including overall plans to establish and/or enhance linkages between the research investigators/institutions and the local public health community, nongovernmental organizations, and other sectors. Consideration will be given to the quality of the plans for collaboration and the likelihood that the research findings will be used to improve prevention, care and management services. Consideration will also be given to the applicant’s demonstrated commitment to and record of partnership involving African investigators and institutions and U.S. and/or other developed country scientists and institutions. Please note that applications submitted by African investigators and institutions without developed country partners are eligible for consideration. o Sustainability of the proposed infrastructure development and capacity- strengthening elements, including the extent to which they will enable the African scientists and institutions to conduct the proposed research as well as to improve and enhance their ability to conduct, over time, quality behavioral, social science, and biomedical research in the area of HIV/AIDS. o Demonstrated awareness of the ethical and cultural issues and concerns related to the conduct of HIV/AIDS research within developing countries, especially focused on the African site(s) proposed in the application. The following criteria will be used to evaluate the merit of individual research projects: The goals of NIH-supported research are to advance our understanding of biological systems and behavioral and social factors that improve the control of disease and enhance health. In the written comments, reviewers will consider 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 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? To what extent will the research findings contribute to improvement of HIV prevention, care, and management services in Africa? To what extent will the findings likely be transferable into program interventions appropriate to and sustainable in Africa? (2) Approach: Are the conceptual framework, design, methods, and analyses adequately developed, well-integrated, multi-disciplinary and collaborative, and appropriate to the aims of the project? Does the applicant acknowledge potential problem areas and consider alternative tactics? Are the plans to guarantee the quality and integrity of collected data adequate? (3) Innovation: Does the project employ novel concepts, approaches or methods? Are the aims original and innovative? Does the project challenge existing paradigms or develop new methodologies or technologies? (4) Investigator: Is the investigator appropriately trained and well suited to carry out this work? Is the work proposed appropriate to the experience level of the Principal Investigator and other researchers (if any)? (5) Environment: Does the scientific environment in which the work will be done contribute to the probability of success? Do the proposed studies take advantage of unique features of the scientific environment or employ useful collaborative arrangements? Is there evidence of prior successful scientific collaboration involving the U.S. (or other developed country) investigators and the involved African researchers? Is there evidence of foreign and U.S. (or other developed country) institutional support, e.g., letters of support and other documentation of commitment? In addition to the above criteria, in accordance with NIH policy, all applications will also 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 will also be evaluated. o The reasonableness of the proposed budget and duration in relation to the proposed research. o The adequacy of the proposed protection for human, animals or the environment, to the extent they may be adversely affected by the project(s) proposed in the application. SCHEDULE Letter of Intent Receipt Date: March 19, 2002 Application Receipt Date: April 16, 2002 Peer Review Date: June/July 2002 Council Review: September 2002 Earliest Anticipated Start Date: September 30, 2002 AWARD CRITERIA Criteria that will be used to make award decisions include: o scientific and technical merit (as determined by peer review) o responsiveness to the goals and objectives of the RFA including the intent to foster African research leadership o program balance, relevance, and priorities o geographic distribution o availability of funds. INQUIRIES Inquiries concerning this RFA are encouraged. The opportunity to clarify any issues or answer questions from potential applicants is welcome. A complete listing of contacts for programmatic, review, and fiscal/administrative inquiries may be found at: http://www.nichd.nih.gov/RFA/HD-02-003/contact.htm. AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance Nos. 93.865 and 93.864 (NICHD), 93.242 (NIMH), 93.213 (NCCAM), and 93.154 (FIC). 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 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)
  USA.gov - 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.