Full Text TW-95-002 INTERNATIONAL RESEARCH AND TRAINING IN POPULATION AND HEALTH NIH GUIDE, Volume 23, Number 40, November 18, 1994 RFA: TW-95-002 P.T. 34 Keywords: Biomedical Research Training Population Studies Human Reproduction/Fertility Fogarty International Center National Institute of Child Health and Human Development Letter of Intent Receipt Date: January 16, 1995 Application Receipt Date: April 20, 1995 PURPOSE The Fogarty International Center (FIC), in collaboration with the National Institute of Child Health and Human Development (NICHD) of the National Institutes of Health, invites applications from non- profit public or private institutions in the United States to support international research and training in population-related sciences. The intent of this program is to enable NIH grant recipients to extend the geographic base of research and training efforts to developing nations, in support of international population priorities. Broad objectives are to: o Enhance domestic population research programs through training and international collaborative studies related to population, including the study of reproductive processes, contraceptive development, contraceptive and reproductive evaluation, reproductive epidemiology, and social and behavioral factors that influence population dynamics. o Assist 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. HEALTHY PEOPLE 2000 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2000," a PHS-led national activity for setting priority areas. This Request for Applications (RFA), International Research and Training in Population and Health, is related to the priority area of family planning and maternal and infant health. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0) or "Healthy People 2000" (Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202-783-3238). 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 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 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. Under certain circumstances, an NIH research contract will be considered as meeting the eligibility requirements. 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. Within allowable limits, research collaborations can include other industrialized nations in addition to the U.S. MECHANISM OF SUPPORT International Research and Training in Population and Health (D43) will be available to U.S. investigators at a funding level not to exceed $150,000 per year in direct costs for the first year, for a maximum of five years. The application should describe both research and training objectives to be pursued in the United States and in the cooperating developing nation(s) of Africa, Asia and the Pacific region, the Middle East and Latin America (including the Caribbean). 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. 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 (which may lead to a degree) will be undertaken in the U.S. in disciplines that may include: demographic and behavioral science, endocrinology, pharmacology and toxicology, pharmaceutical development, cell and molecular biology, genetics, embryology, physiology, epidemiology and other population-related fields; research projects may be undertaken either at the U.S. host institution or in the trainee's home country; o Postdoctoral training in laboratory procedures and research projects and techniques related to population research, to be conducted at the host U.S. institutions or in the trainee's home country; o Participation in advanced research training conducted by U.S. faculty in the host country and also short-term in-country training for foreign scientists and health professionals in the host country. As part of the application, the applicant institution must describe recruitment and selection procedures for the foreign pre- and postdoctoral scientists. Allowable Costs Eligible costs include: travel and subsistence related to research and training conducted at a foreign site; support for short and long- term training of pre- and postdoctoral scientists and health professionals from developing nations; provision of research supplies and materials to the foreign site in support of joint activities; and limited support for relevant activities with institutions in industrialized nations which would provide scientific contributions. The following cost categories are eligible for reimbursement under this program. The stipends and allowances are maximums and applicants are encouraged to design the most cost-effective programs: For foreign scientists from developing nations: o Living allowance (stipend) comparable to scientist's professional level and compatible with established NIH guidelines, but not to exceed $45,000 per annum while undergoing training or conducting research in the U.S.; o Living allowance (stipend) for scientists to conduct in-country research at a level comparable to that received by similar professionals in-country, but also not to exceed $45,000 per annum; o Tuition and fees at the U.S. university; o Round trip economy class air fare between the U.S. and home country; o Allowance for the grantee institution of up to $600 monthly per scientist to cover health insurance, travel to scientific meetings, and incidental research expenses; o Additional research support of up to $15,000 per person to support training-related research or advanced research training in the developing country (the program director is expected to ensure that projects submitted for this funding are peer reviewed by the U.S. institution); For U.S. scientists affiliated with grantee institution: o Economy class travel and per diem for the program director and U.S. faculty colleagues to provide guidance to trainees conducting related field studies or advanced research training in their home countries; o Economy class travel and per diem for U.S. faculty presenting short-term courses in the foreign country; o Longer-term support (travel, per diem and pro-rated salary, up to 10 percent of annual salary or $10,000, whichever is less) to enable U.S. faculty to conduct advanced research training activities in- country; For administrative expenses: o Administrative expenses at the U.S. institution (secretarial expenses, etc.) not to exceed 10 percent of the direct costs of this award. It is expected that the portion of salary for the program director for the purpose of administering this award will be provided for under the parent grant(s) associated with this proposal. For related activities with other industrialized nations: o Support for travel and subsistence of U.S. or foreign investigator(s), and the exchange of data, materials and supplies, not to exceed 10 percent of direct costs of this award unless prior approval is secured from the FIC. As a condition of this special expenditure, the applicant must indicate that some form of cost- sharing will be provided by the counterpart institution in an industrialized nation. Requests for an administrative supplemental budget will be considered for increases of up to 10 percent of funded levels in a given budget year. These funds may be requested to meet special needs and take advantage of unusual opportunities. Such requests will be reviewed by FIC program staff in consultation with NICHD and support will depend upon availability of funds. The grantee institution may request an indirect 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 four percent per year for each succeeding year. The anticipated date of award is on or before September 30, 1995. FUNDS AVAILABLE It is anticipated that six to seven awards will be made, with an estimated total of $1,000,000 available for the entire program in the first year, with no single award exceeding $150,000 (in direct costs). RESEARCH OBJECTIVES Although world population growth peaked at 2.3 percent and began to decline in the late 1970's, the age structure of the present population will result in significant population increases well into the next century. According to projections of the United Nations (U.N.) Population Division, world population will increase to 8.5 billion over the next 35 years. Of the projected increase of some 3.2 billion, it is estimated that less than 200 million will occur in industrialized countries; at least 3 billion, or 95 percent, will be in the less developed countries. By the year 2025, 16 of the world's most populous cities will be situated in the developing world. This trend has significant ramifications for global health. In developing nations, high birth rates may impede sustainable economic development. Consequences 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. Where declines in growth rates have occurred, they are attributed to increased economic productivity and cultural change, 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. Through international research and training efforts, NIH-supported institutions are positioned to advance technological and social adaptations needed to meet the challenge of unsustainable population growth. This program is designed to create and expand research partnerships between U.S. scientists and counterparts in developing regions of the world on population issues of mutual priority. It will assist to train a cadre of research and health professionals in developing nations who may contribute to the development of population policies that are based on scientific information and also are responsive to societal mores and values in their home countries. Emphasis will be placed on collaborative activities with 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, including development of the reproductive system, male and female fertility, processes and mechanisms 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; o Evaluative studies of contraceptive and fertility-related drugs and products for safety and efficacy; evaluation of safety of male and female sterilization; o Studies on social and behavioral factors that influence population growth and change, including contraceptive use and choice, operational research related to family planning, migration and spatial distribution of populations, family composition and parental roles, and population policies. SPECIAL REQUIREMENTS Before any funds may be expended on in-country research, the grantee institution must show evidence of formal approval from responsible authorities at the collaborating institution and the host government. These approvals should be included in the application. As part of proposed training programs, the applicants must describe their training in the responsible conduct of research, consistent with NIH policy (NIH Guide for Grants and Contracts, Volume 21, Number 43, November 27, 1992) to be part of the program. An award will not be made unless such a description is included. 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. 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 subpopulations 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) and supersedes and strengthens the previous policies (Concerning the Inclusion of Women in Study Populations, and Concerning the Inclusion of Minorities in Study Populations), which have been in effect since 1990. The new policy contains some provisions that are substantially different from the 1990 policies. All investigators proposing research involving human subjects should read the "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research," which have been published in the Federal Register of March 28, 1994 (59 FR 14508-14513) and printed in the NIH Guide for Grants and Contracts, Volume 23, Number 11, March 18, 1994. Investigators also may obtain copies of the policy from the program staff listed under INQUIRIES. Program staff may also provide additional relevant information concerning the policy. LETTER OF INTENT Prospective applicants are asked to submit, by January 16, 1995, 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 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 as well as to provide important information to prospective applicants. The letter of intent is to be sent to: Dr. Kenneth Bridbord International Studies Branch Fogarty International Center 31 Center Drive MSC 2220 Bethesda, MD 20892-2220 APPLICATION PROCEDURES The research grant application form PHS 398 (rev. 9/91) is to be used in applying for these grants. These forms are available at most institutional offices of sponsored research; from the Office of Grants Information, Division of Research Grants, National Institutes of Health, 5333 Westbard Avenue, Room 449, Bethesda, MD 20892, telephone 301/710-0267; and from the program administrator listed under INQUIRIES. The RFA label available in the PHS 398 (rev. 9/91) 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 2a of the face page of the application form and the YES box must be marked. Submit a signed, typewritten original of the application, including the Checklist, and three signed, photocopies, in one package to: Division of Research Grants National Institutes of Health Westwood Building, Room 240 Bethesda, MD 20892** At the time of submission, two additional copies of the application must be sent to: Susan Streufert, Ph.D. Division of Scientific Review National Institute of Child Health and Human Development 6100 Executive Boulevard, Room 5E03 Bethesda, MD 20892-7510 Applications must be received by April 20, 1995. If an application is received after that date, it will be returned to the applicant without review. The Division of Research Grants (DRG) will not accept any application in response to this RFA that is essentially the same as one currently pending initial review, unless the applicant withdraws the pending application. The DRG will not accept any application that is essentially the same as one already reviewed. This does not preclude the submission of 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 DRG and responsiveness by the FIC and the NICHD. Incomplete applications will be returned to the applicant without further consideration. If the application is not responsive to the RFA, the application will be returned to the applicant 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 accordance with the review criteria stated below. As part of the initial merit review, a process (triage) may be used by the initial review group in which applications will be determined to be competitive or non-competitive based on their scientific merit relative to other applications received in response to the RFA. Applications judged to be competitive will be discussed and be assigned a priority score. Applications determined to be non- competitive will be withdrawn from further consideration and the Principal Investigator and the official signing for the applicant organization will be notified. The second level of review will be provided by the FIC Advisory Board in September 1995. Review criteria include those generally applicable to research training programs and research: o past research training record for both the program and designated preceptors in terms of the rate at which former trainees establish independent and productive research careers; o 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; o objectives, design, and direction of the research training program; o caliber of preceptors as researchers including the institutional commitment, the quality of the facilities, and the availability of research support; o training environment including the institutional commitment, the quality of the facilities, and the availability of research support; o recruitment and selection plans for appointees and the availability of high quality candidates; o 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; o 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.) will receive special consideration. Where specific research protocols are proposed, additional review criteria, applicable to research grants, will be as follows: o scientific, technical, or medical significance and originality of proposed research; o appropriateness and adequacy of the experimental approach and methodology proposed to carry out the research; o qualifications and research experience of the Principal Investigator and staff, particularly, but not exclusively, in the area of the proposed research; o availability of the resources necessary to perform the research; o appropriateness of the proposed budget and duration in relation to the proposed research; The initial review group will also examine the provisions for the protection of human and animal subjects, the safety of the research environment, and the adequacy of plans for instruction in the responsible conduct of research. Additional factors to be considered in the scientific evaluation of each application include the likelihood that the applicant institution can meet the objectives stated in this RFA and specifically: o the expected scientific contribution of the proposed activity; o the strength of the research program in health sciences related to the proposed research and training; o quality of teaching and research facilities and resources of the U.S. institution, as well as the cooperating institution(s) in other countries including documentation of previous international collaboration with developing country scientists and institutions; o previous training experience at the pre- and postdoctoral levels and success in maintaining collaboration with former trainees; o demonstrated capacity or potential to provide in- country advanced research or technical training; o demonstrated capacity or potential to conduct future population- related research projects with collaborating scientists and institutions from developing nations. 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. The proposed instruction in the responsible conduct of research must rated adequate for an award to be made. In addition, FIC, in consultation with NICHD, 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 and Latin America (including the Caribbean). 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. 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: Dr. Kenneth Bridbord International Studies Branch Fogarty International Center 31 Center Drive MSC 2220 Bethesda, MD 20892-2220 Telephone: (301) 496-2516 FAX: (301) 402-2056 Email: sn5@cu.nih.gov Direct inquiries regarding fiscal matters to: Ms. Silvia Mandes International Research and Awards Branch Fogarty International Center 31 Center Drive MSC 2220 Bethesda, MD 20892-2220 Telephone: (301) 496-1653 FAX: (301) 402-0779 Email: som@cu.nih.gov AUTHORITY AND REGULATIONS This general type of program is described in the Catalog of Federal Domestic Assistance No. 93.154. 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 PHS grants policies and Federal regulations 42 CFR 52 and 45 CFR Part 74. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or 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. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people. .
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