INTERNATIONAL TRAINING AND RESEARCH IN POPULATION AND HEALTH Release Date: December 20, 1999 RFA: TW-00-004 (This RFA has been modified, see RFA-TW-05-002) Fogarty International Center (http://www.nih.gov/fic/) National Institute of Child Health and Human Development (http://www.nichd.nih.gov) National Institute on Aging (http://www.nih.gov/nia) Letter of Intent Receipt Date: February 14, 2000 Application Receipt Date: March 29, 2000 Expiration Date: March 30, 2000 PURPOSE The Fogarty International Center (FIC), in collaboration with the National Institute of Child Health and Human Development (NICHD) and the National Institute on Aging (NIA) of the National Institutes of Health, invites applications from non-profit public or private institutions in the U.S. to support international training and research in population-related sciences. The intent of this program is to enable NIH grant recipients to extend their geographic base of research and training efforts to developing countries and emerging democracies, in support of population issues of mutual priority. Broad objectives are to: o Enhance international and U.S. population research programs through training of foreign nationals and international collaborative studies related to populations, including the study of: a) reproductive processes (including biology, immunology, genetics), contraceptive development, contraceptive and reproductive health evaluation, reproductive epidemiology, and b) demographic processes, including: aging, longevity, biodemography, mortality, morbidity, fertility, migration, linkages between health and economic development, and other social, behavioral and economic factors that influence population dynamics. o Strengthen ability of scientists from developing nations to contribute to global population research efforts and advance knowledge in support of population policies appropriate for their home countries and established international guidelines. o Develop and strengthen centers of research excellence in population- related sciences in developing countries through training and training related research. HEALTHY PEOPLE 2000 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2000," a PHS-led national activity for setting priorities to improve health status. This Request for Application (RFA), International Training and Research in Population and Health (ITRPH) is related to one or more of the priority areas. Potential applicants may obtain a copy of "Healthy People 2000" at http://odphp.osophs.dhhs.gov/pubs/hp2000. ELIGIBILITY REQUIREMENTS The grantee institution must be a U.S. non-profit private or public institution capable of meeting the objectives in this RFA. Applicant investigators (or co-investigators) must be either a U.S. Principal Investigator (PI) of at least one NIH-sponsored research project grant (R series) or a Project Director of an NIH-sponsored center grant, program project grant or cooperative agreement (P and U series) related to population studies that will be funded during at least one year of the proposed grant award period. On submission of an application, at least eighteen months of active research support must remain on the listed parent grant(s). Investigators may request five years of support in anticipation that a renewal application for the parent grant(s) will be submitted and awarded or that other research support will be available to complement this training award. Under certain circumstances, an NIH research contract will be considered as meeting the eligibility requirements. Institutions currently awarded an NIA Demography of Aging Center (P30) grant are especially encouraged to apply. Institutions currently holding a FIC ITRPH award are encouraged to collaborate with NIA Demography of Aging Centers at their own or other institutions. The application must demonstrate that the award is relevant to and will enhance the activities of the NIH-supported parent grant(s) and benefit the research needs of the host country or countries of participating scientists and health professionals. With approval from the FIC program officer, research collaborations can also include other industrialized nations linked to U.S. institutions if these collaborations enhance the research training capacity of developing countries. Racial/ethnic minority individuals, women, and persons with disabilities are encouraged to apply as PI. Participation in the program by investigators at minority institutions is strongly encouraged. MECHANISM OF SUPPORT This RFA will use the D43 mechanism, which limits facilities and administrative (F & A) costs to eight percent of allowable direct costs. The ITRPH will be available to U.S. investigators at a funding level not to exceed $200,000 per year in direct costs for the first year, for a maximum of five years. Responsibility for planning, direction and execution of the proposed activities will be solely that of the applicant. The application should describe research and research training objectives to be pursued both in the U.S. and in the cooperating developing nation(s) of Africa, Asia and the Pacific region, the Middle East, and Latin America (including the Caribbean) and the newly emerging democracies of Eastern Europe, and the former Soviet Union. Applications may incorporate cooperative activities with scientists from one or several developing countries or regions, based on the research and training objectives of the program. However, applicants are encouraged to focus their efforts on a limited number of countries. The applicant organization’s administration must provide the necessary management for the transfer of funds and material to the off-site component. F & A costs will not be paid on any expense incurred by the foreign institution(s) although expenses required to support in-country training and training-related research such as access to facilities, library services and the Internet, can be charged as direct expenses when well justified. Travel, salaries, and fringe benefits will be subject to the applicant institution’s rules and regulations. Grants will be made as D43 training grant awards for a project period of up to five years. Continued support during this period depends on satisfactory performance as judged by: annual progress reports, site visits and meetings of program directors, career progress of trainees (e.g., positions occupied in home country, first author publications, presentations, research undertaken and research awards received), and, development of national capacity for population and health-related research, including the establishment or strengthening of model population and health research centers of excellence in the home countries of trainees. Assessment of performance will be made jointly by FIC, NICHD, NIA and other partners, should they join. Special program reviews will be conducted by the FIC, NICHD, and NIA. FUNDS AVAILABLE It is anticipated that about $1,600,000 (total costs) will be available for the first year of the recompeted program. Seven to eight awards will be made, with no single award exceeding $200,000 (in direct costs). Awards will be contingent upon availability of funds and receipt of a sufficient number of meritorious applications. When invited, requests for an administrative supplemental budget will be considered for increases of up to 20 percent of funded levels in a given budget year. These funds may be requested to meet special research or training needs and take advantage of unusual opportunities such as geographic expansion, field research, or emergency situations. Such requests, which should be discussed with FIC program staff prior to submission, will be reviewed by FIC in consultation with NICHD and NIA, and support will depend upon need, merit and availability of funds. The grantee institution may request an F & A cost allowance based on eight percent of the total allowable direct costs, exclusive of tuition and related fees and expenditures for equipment. Applicants should assume a budget increase of three percent per year for each succeeding year, contingent upon availability of funds. The anticipated date of award is on or before September 29, 2000. Types of Training Research-related training programs for foreign scientists and health professionals may include the following elements: o Predoctoral training in research related to population. Academic courses that may lead to a degree will be undertaken in the U.S. in disciplines that may include: demographic, social, behavioral and economic sciences, endocrinology, pharmacology and toxicology, pharmaceutical development, cell and molecular biology, genetics, immunology, embryology, physiology, epidemiology and other population- related fields. Research projects may be undertaken either at the U.S. institution or, preferentially, in the trainee’s home country, o Postdoctoral training in laboratory procedures, clinical trials research methodology and research projects and techniques related to population research, to be conducted at the U.S. institution or, preferentially, in the trainee’s home country, o Short-term training (either in the U.S. or in-country) of up to four weeks in focused research methodologies, o Medium-term training of about three to six months duration conducted in the U.S. in laboratory procedures or clinical trails research methods and research techniques, such as, development of pilot biomedical studies or development of behavioral research instruments for individuals with M.S. and M.D. or Ph.D. degrees, o One-time awards for advanced in-country research training (one to two years duration) upon return to the trainee’s home country at levels of funding specified under allowable costs in this RFA, o Participation in advanced research training conducted by U.S. faculty in the foreign country, short-term in-country training for local scientists and health professionals in the foreign country, and technology transfer. This collaboration must have as its goal the training of scientists in the developing country, enhancement of local programs, and strengthening of centers of research excellence. o When a specific scientific course is given by one program it is expected that this course may be widely publicized and open to trainees of the other grantee institutions under this program. The expenses for this training would be included in the regular budgets for each program that intends to send its trainees to such courses. As part of the application, the applicant institution must describe in detail the recruitment and selection procedures for the foreign pre- and post-doctoral scientists and other beneficiaries of the training program (short and intermediate term trainees, workshop participants, etc). To a limited extent, U.S. trainees will be eligible for foreign research experiences under this program, with prior FIC approval, particularly if they are involved in training-research collaboration. The ITRPH encourages directors to include foreign women as trainees and, if U.S. trainees are involved, to include women and minorities. RESEARCH OBJECTIVES According to projections by the U.S. Bureau of the Census, world population will increase from 6.0 billion in 1999 to over 7.9 billion by 2025, to 9.3 billion by 2050. The future of human population growth is largely being decided by the world’s less developed countries (LDCs). Ninety-six percent of world population increase occurs in the LDCs of Africa, Asia, and Latin America, and this percentage will rise over the course of the next quarter century. Indeed, 99 percent of global natural population increase the difference between numbers of births and deaths occurs in the developing world. This trend has important ramifications for global health. In some developing nations, high birth rates and poor health may impede sustainable economic development which, in turn, affects a population’s health. Consequences of unchecked population growth may include increasing pollution and worsening sanitation, the spread and emergence of infectious diseases, over-exploitation of land, destruction of natural ecosystems, unemployment, and inadequate access to health care and education. With declines in population growth rates, there has been increased economic productivity, improved health and cultural changes, including acceptance of and access to a wide choice of birth control methods, sustained improvements in child survival, and improvements in the education and societal status of women. In the vast majority of countries that contribute the most to the world population growth, fertility remains the driving force behind natural population increase. A key determinant of current and future fertility is the extent to which couples use or fail to use contraception to control the number and spacing of their children. In spite of the rapid growth in the number of women using modern contraception worldwide over the past 20 years, an estimated 120 million married women in the world’s developing regions have an unmet need for contraceptive services and products. Over the course of the next 25 years, the age structure of world population will continue to shift. Although children will still account for three-fourths of all dependents in the less developed regions of Africa, Asia and Latin America, older age groups will comprise an increasingly larger share of the total. In the 21st century, continued lower fertility and improved health and longevity suggest that population aging is destined to emerge as an important worldwide phenomenon. While developing countries still have a relatively low proportion of older people, the absolute numbers of elderly in developing nations are often large and everywhere increasing. Over half of the world’s elderly (aged 65 and over) now live in developing nations (59 percent or 241 million people, as of 1999). By 2030, this proportion is projected to increase to 71 percent (680 million). Through international research and training efforts, NIH-supported institutions are positioned to advance technological and social adaptations needed to meet the challenges of population growth. This program is designed to create and expand research partnerships between U.S. scientists and those in developing regions of the world on population issues of mutual priority. It will assist in training a cadre of research and health professionals in developing nations who will contribute to the development of evidence-based population policies or who will implement such policies with regard to societal mores and values in their home countries. Emphasis will be placed on collaborative activities in countries and regions where population growth adversely impacts public health, the environment and economic progress. Examples of research and training topics include, but are not limited to, the following: o Studies on reproductive processes and mechanisms, including development of the reproductive system, male and female fertility, male and female reproductive diseases and disorders, to include preimplantation embryo development and implantation, o Studies on contraceptive development, including natural or synthetic agents, products to reduce transmission of sexually-transmitted diseases, new contraceptive devices and reversible sterilization techniques, clinical trials of new contraceptives, o Evaluative studies of contraceptive and fertility-related drugs and products for safety and efficacy, evaluation of the safety and efficacy of male and female sterilization, o Studies on social and behavioral factors that influence population growth and change, including contraceptive access and utilization, migration and spatial distribution of populations, family composition and dynamics, aging, health, disability and mortality, and population policies. o Biodemography, including the demographic aspects of heritability and familial aggregation of disease and longevity, incorporation of genetic and disease variables into demographic models and age-specific mortality rates, the social roles of the elderly in nature, biological mediators of the relationship between socioeconomic status and health throughout the life course, and fetal origins of adult disease. o Estimation of the impact of health (including links with geography and demography) on economic development, including productivity and wealth accumulation, especially in developing countries. SPECIAL REQUIREMENTS o Each awardee will have a U.S. PI and a Major Foreign Collaborator (MFC), if collaboration occurs in two or more countries, there will be a MFC in each country. The PI and MFC will be responsible for the overall conduct of the ITRPH. o Recruitment and Selection Plan. The applicant institution must include a plan describing the recruitment and selection procedures for trainees, a detailed description of peer review for training-related and advanced in-country research, and plans for continued collaboration with former trainees. For PIs applying for a continuation of their ITRPH grant, detailed evidence of such collaboration must be provided. Degree candidates must meet all entrance requirements of the U.S. degree granting institution. The application should clarify and completely specify: (a) criteria and procedures for the selection of trainees as, for example, by a committee composed of U.S. and foreign investigators at participating institution(s) and (b) a mechanism for internal peer review of applications to support U.S. and in-country research projects. o Tracking System For Long Term Impact. As part of their obligations under this program, awardees are required to initially design as part of their application and ultimately to implement and maintain a system to fully track and document the long-term impact of this training program on: (1) the career choices of current and former trainees, (2) changing research capacity in the home institution of trainees, (3) types of positions the proposed trainees may assume upon completion of training and documentation of career program, (4) the possible contributions to future NIH-supported international population sciences research efforts, (5) the establishment or strengthening of reproductive and population sciences-related research centers of excellence for research training and referral in the home countries of trainees, and (6) program graduates contributions to improving the health status of women, children, and families in their home countries. Examples of such impact include how training received under the program has allowed participants to assume more responsible positions upon returning home, how continuing collaborations with former trainees resulted in the funding of reproductive and population sciences investigators or co-investigators, publications in which trainees were first authors and which were based upon support under this program, and health policies that were influenced or implemented by returning trainees in their home countries. After awards have been made, but before tracking of impact is implemented, FIC will work with awardees to design a standardized web-based tracking system for individual trainees and reporting program impact and accomplishments building upon the ideas in the original proposals combined with FIC experience in other similar programs. Once this standardized tracking system has been agreed to, it is expected to be implemented across all programs. Impact will be an important criterion for recompetition of this program. o Before any funds may be expended on in-country research, the grantee institution must show written evidence of formal approval from responsible authorities at the collaborating institution and the relevant government authority. These approvals should be included in the application. o There will be an annual program network meeting to coordinate program activities. Principal Investigators (U.S. and international), and selected trainees will attend. This activity should be included in the budgetary requests. o As part of proposed training programs, the applicants must describe in detail how they propose to train students and investigators in the responsible conduct of research, consistent with NIH policy (NIH Guide for Grants and Contracts, Volume 21, Number 43, November 27, 1992). An award will not be made unless such a plan is included. Allowable Costs All budget items related to trainee participation in the program should be itemized on the PHS Form 398 NRSA substitute budget pages OO and PP in the categories indicated in parentheses. All budget items related to faculty participation in the program should be itemized on the PHS Form 398 budget pages DD and EE in the categories indicated in parentheses. (Stipend/Salary/Honoraria) o Trainees (foreign graduate students and post-advance degree participants) may be paid a stipend comparable to their professional experience not exceeding $45,000 per year in accordance with the U.S. institutional policies while involved in long term training in the U.S. Applicants may wish to refer to the NRSA stipend levels described on the web site http://www.nih.gov/fic/opportunities/index.html (NRSA substitute pages, pre- or postdoctoral stipends) o Foreign trainees may be paid a stipend while conducting long term training related research in their home countries at levels comparable with the salary scales for similar professionals in that country in accordance with the collaborating foreign institution’s policies but not exceeding $45,000 per year. (NRSA substitute pages, pre- or postdoctoral stipends). o U.S. faculty who participate in administrating the program or providing extended training of students at the foreign site may receive salary and fringe benefits. The total amount of salary and fringe benefits requested for all U.S. faculty may not exceed 10% of direct costs in the budget. The administrative or training or teaching responsibilities and time commitment for personnel receiving salary should be thoroughly described. (Form 398 budget pages, personnel) o Foreign institution faculty who administer the training program at the foreign site or participate in training and U.S. faculty or foreign faculty who teach short courses may receive an honorarium not to exceed $2000, in accordance with their Institution’s policies. No more than 5% of direct costs in the budget may be used for honoraria. (NRSA substitute pages- training related expenses) o The applicant institution may request up to 10% direct costs to provide salary and fringe benefits for clerical and administrative support staff for the program. The responsibilities and time commitment for personnel receiving salary support should be thoroughly described. (Form 398 pages, personnel) (Tuition, Fees and Insurance) o Funds for tuition, academic fees and self-only medical insurance for foreign trainees at the U.S. institution not exceeding 20% of direct costs may be requested. Programs are encouraged to seek cost sharing arrangements with the U.S. institutions in order to provide reduced tuition for long term trainees and tuition-free short courses. (NRSA substitute pages, tuition, fees, insurance) (Trainee Travel) o Funds may be requested for round trip economy class airfare on U.S. carriers (to the maximum extent possible) and local ground transportation for long term foreign trainees to travel to the U.S., U.S. trainees to travel to the foreign site for extended training and foreign trainees to participate in short courses or attend scientific conferences to present their results. (NRSA substitute pages, trainee travel) o Funds may be requested for per diem and lodging for foreign trainees to participate in short courses or attend scientific conferences to present their results. (NRSA substitute pages, trainee travel) (Faculty Travel) o Funds may be requested for round trip economy airfare on U.S. carriers (to the maximum extent possible) for U.S. faculty providing extended training to go to the foreign site or teach short courses at the foreign site. (PHS 398 pages, travel) o Funds may be requested for per diem and lodging for U.S. faculty to teach short courses at the foreign site. (PHS 398 pages, travel) o Funds should be requested for airfare, per diem and lodging comparable to U.S. government rates (httphttp://policyworks.gov/org/main/mt/homepage/mtt/perdiem/perd04d.html) for the program director to attend the annual network meeting in the Washington D.C. area. (PHS 398 pages, travel) (Training related expenses) o Funds to support trainee research related costs (such as reagents, lab supplies, computer access, small equipment, etc.) of up to $600 per month per trainee may be requested. (NRSA substitute pages, training related expenses) o Funds to support up to ($5,000-$7,500) per year for research at the foreign site associated with fulfilling requirements for an advanced degree may be requested. (NRSA substitute pages, training related expenses) o Research support for up to ($5,000-$7,500) per trainee per year to facilitate conducting advanced research training (re-entry grants) in the home country by former long term trainees. The applicant should describe how proposals for re-entry projects will be selected by a peer review process examining scientific merit and ethical concerns involving faculty from the U.S. and foreign institutions coordinated by the program director. (NRSA substitute pages, training related expenses) Protection of Human Subjects and Laboratory Animals Applicable provisions for the protection of human research subjects and laboratory animals in research and training activities must be met in both domestic and foreign settings (http://www.hhs.gov/ohrp/). Title 45 CFR, Part 46, provides guidelines concerning Department of Health and Human Services regulations for the protection of human subjects and the Public Health Service Policy on Humane Care and Use of Laboratory Animals. These are available from the Office for Protection from Research Risks, National Institutes of Health, 6100 Executive Boulevard, Suite 3B01 Rockville, MD 20852. 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 is provided that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This new policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43). All investigators proposing research involving human subjects should read the "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research," which have been published in the Federal Register of March 28, 1994 (59 FR 14508-14513) and printed in the NIH Guide for Grants and Contracts, Volume 23, Number 11, March 18, 1994 (http://grants.nih.gov/grants/guide/notice-files/not94-100.html). While it is desirable that women and minority groups in foreign countries be included as research subjects, it is the responsibility of collaborating institutions to make such decisions. Women and minorities should be encouraged as candidates for training. 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 that was published in the NIH Guide for Grants and Contracts, March 6, 1998, and is available at the following URL address: 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. LETTER OF INTENT Prospective applicants are asked to submit, by February 14, 2000, a letter of intent that includes a brief 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 the RFA in response to which the application may be submitted. Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows NIH staff to estimate the potential review workload, and avoid conflict of interest in the review. The letter of intent is to be sent to: Joel G. Breman, M.D., D.T.P.H. Deputy Director Division of International Training and Research Fogarty International Center National Institutes of Health Building 31, Room B2C39 31 Center Drive, MSC 2220 Bethesda, MD 20892-2220 Email: joel_breman@nih.gov APPLICATION PROCEDURES The research grant application form PHS 398 (rev. 4/98) is to be used in applying for these grants. These forms are available at most institutional offices of sponsored research and from the Office of Grants Information, Division of Research Grants, Extramural Outreach and Information Resources, National Institutes of Health, 6701 Rockledge Drive, MSC 7910, Bethesda, MD 20892-7910, telephone 301/710-0267, e-mail: grants@nih.gov. Applications are also available on the Internet at http://grants.nih.gov/grants/funding/phs398/phs398.html. The RFA label available in the PHS 398 (rev. 4/98) application form must be affixed to the bottom of the face page of the application. 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 number must be typed on the label as well. The sample RFA label is available at: http://grants.nih.gov/grants/funding/phs398/label-bk.pdf has been modified to allow for this change. Please note this is in pdf format. Submit a signed 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 and appendices must be sent to: Scott Andres, Ph.D. Division of Scientific Review National Institute of Child Health and Human Development 6100 Executive Boulevard, Room 5E03, MSC 7510 Bethesda, MD 20892-7510 It is important to send these copies at the same time as the original and three copies are sent to the Center for Scientific Review. These copies are used to identify conflicts and to help ensure the appropriate and timely review of the application. Applications must be received by March 29, 2000. 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 CSR and responsiveness by the FIC, NICHD and NIA. Incomplete and/or non- responsive applications will be returned to the applicant without further consideration. If the application is not responsive to the RFA, the application will be returned to the applicant without review. 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 consultation with FIC and NIA in accordance with the review criteria stated below. As part of the initial merit review, a process will be used by the initial review group in which applications receive a written critique and 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 FIC Advisory Board in September 2000. Review Criteria Review criteria include those generally applicable to research training programs and research. The scientific evaluation of each application will include assessment of the linkage between proposed training and reproductive and population-related research supported by FIC, NICHD, NIA and other components of the NIH. Evidence of support for this program by collaborating institutions and foreign governments must be submitted with the application. 1. Significance: o Does this training program address an important problem? If the aims of the application are achieved, how will scientific knowledge be advanced? What will be the effect of the training and studies on the concepts or methods that drive this field? o The expected public health and scientific contributions of the proposed activity, and o The demonstrated capacity and/or potential to achieve sustained population related research and training efforts, and to build associated clinical and operational research and public health capacity within a country. 2. Approach: o Are the conceptual framework, design, methods, and analyses adequately developed, well-integrated, and appropriate to the aims of the research training? Does the applicant recognize potential problem areas and consider alternative tactics? o Balance in the proposed training program, to provide breadth of training opportunities in the field of academic-based, maternal and population sciences related training in biomedical and behavioral sciences. o The mix of long- and short-term training to achieve the goals of this RFA, including focused efforts to build long-term biomedical, behavioral, clinical and operations research and public health capacity at a model center of research excellence within a collaborating country, o Adequacy of proposed procedures and criteria for 1) recruitment, review and selection of trainees, and 2) peer review of research. 3. Innovation: o Does the research training program employ novel concepts, approaches or methods? Are the aims original and innovative? Does the program challenge existing paradigms or develop new methodologies or technologies? o Plans for trainees to become involved in population sciences, biomedical and behavioral research, and projects conducted in their home countries, and o Adequacy and creativity of plans including use of the modern information technology to facilitate access to scientific information, distance learning, coordination and research collaboration. 4. Investigator: o Are the Principal Investigator, co-Principal Investigators, and mentors in the U.S. and abroad, 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? o Qualifications of the PI and MFC program directors to lead and the named faculty to participate in the proposed training and research program, and o Active research support of the PI, MFC, and participating faculty. 5. Environment: o Does the scientific environment in which the training and research work will be done in the U.S. and abroad contribute to the probability of success? Do the proposed activities take advantage of unique features of the scientific environment or employ useful collaborative arrangements? Is there evidence of institutional support? o The strength of resources and training environment in-country as evidenced by 1) the quality of teaching and the in-country research facilities and other resources, 2) the availability and history of high-quality candidates chosen on the basis of merit, and 3) past history of success of former trainees returning to their home countries and their continued involvement in the program, for example, the participation of past trainees in advanced in-country research and as faculty and mentors for new trainees, and o The initial review group will also examine the adequacy of the process for providing for the protection of human and animal subjects and the safety of the research environment, and plans to include training in responsible conduct of research and training in the operation of Institutional Review Boards (IRBs), data and safety monitoring boards and community advisory boards as a part of the program. IRBs in the home countries of trainees will be responsible for determining the adequacy of inclusion of women, minorities and children in research involving human subjects in their countries. In addition to the above criteria, in accordance with NIH policy, all applications will also be reviewed with respect to the following: 1. Past research training record for both the PI and MFC in the U.S. and abroad, and designated preceptors, in terms of tracking careers of trainees and the rate at which former trainees establish independent and productive research careers, and for foreign trainees return to their home country, 2. Past research training record in terms of the success of former trainees in obtaining individual awards such as fellowships, career awards, and research grants for further development, 3. Recruitment and selection plans for appointees and the availability of high quality candidates, 4. The record of the research training program in retaining health professional postdoctoral trainees for at least two years in research training or other research activities, 5. When appropriate, the concomitant training of health- professional postdoctorates (e.g., individuals with the M.D., D.O., D.D.S.) with basic science postdoctorates (e.g., individuals with a Ph.D., Sc.D.). 6. 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. 7. The reasonableness of the proposed budget and duration in relation to the proposed research. 8. The adequacy of the proposed protection for humans, animals or the environment, to the extent they may be adversely affected by the project proposed in the application. Where specific research protocols are proposed, additional review criteria, applicable to research grants, will be as follows: 1. Scientific, technical, or medical significance and originality of proposed research, 2. Appropriateness and adequacy of the experimental approach and methodology proposed to carry out the research, 3. Qualifications and research experience of the Principal Investigator and staff, particularly, but not exclusively, in the area of the proposed research, 4. Availability of the resources necessary to perform the research, 5. Appropriateness of the proposed budget and duration in relation to the proposed research, Schedule Letter of Intent Receipt Date: February 14, 2000 Application Receipt Date: March 29, 2000 Date of Initial Review: June 2000 Review by Advisory Council: September 19, 2000 Anticipated Award Date: on or before September 29, 2000 AWARD CRITERIA The most important factor to be considered in making funding decisions will be the quality of the proposed project as determined by peer review and responsiveness to the review considerations. The proposed instruction in the responsible conduct of research must be rated adequate for an award to be made. In addition, FIC, in consultation with NICHD and NIA, will attempt to ensure a reasonable balance of basic, clinical, behavioral and demographic research training, as well as a geographic distribution among developing nations of Asia and the Pacific region, Africa, the Middle East, Latin America (including the Caribbean), and the newly emerging democracies of Eastern Europe, and countries of the former Soviet Union. The number and amount of the awards made under this program will depend upon the availability of funds and cost- effectiveness will be one of the factors considered in making funding decisions. Before any funds can be expended from this award for in-country research, the grantee institution must show evidence of approval for collaborative research and training between the U.S. and foreign countries and institutions included in the program through an endorsement from the appropriate government official(s) as well as from the collaborating institutions. INQUIRIES Inquiries concerning this RFA are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome and prospective applicants are strongly encouraged to discuss their proposals with program staff prior to submission. Direct inquiries regarding programmatic issues to: Joel G. Breman, M.D., D.T.P.H. Deputy Director Division of International Training and Research Fogarty International Center National Institutes of Health Building 31, Room B2C39 31 Center Drive, MSC 2220 Bethesda, MD 20892-2220 Telephone: (301) 496-1653 FAX: (301) 402-0779 Email: joel_breman@nih.gov Direct inquiries regarding fiscal matters to: Ms. Silvia Mandes Grants Management Officer Division of International Training and Research Fogarty International Center Building 31, Room B2C39 31 Center Drive, MSC 2220 Bethesda, MD 20892-2220 Telephone: (301) 496-1653 FAX: (301) 402-0779 Email: silvia_mandes@nih.gov AUTHORITY AND REGULATIONS Awards are made under authorization of the Public Health Service Act, Title IV, Part A (Public Law 78-410, as amended by Public Law 99-158, 42 USC 241 and 285) and administered under 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 to Health Systems Agency review. The Public Health Service (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.


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