and Human Services (HHS)
EXPIRED
INTERNATIONAL MATERNAL AND CHILD HEALTH RESEARCH AND TRAINING Release Date: March 9, 2000 RFA: TW-00-007 Fogarty International Center National Institute of Child Health and Human Development Letter of Intent Receipt Date: April 14, 2000 Application Receipt Date: July 13, 2000 PURPOSE The Fogarty International Center (FIC) invites applications for the International Maternal and Child Health Research and Training Program (IMCHRT) for award in FY 2001. This RFA is issued simultaneously with and is closely related to the Global Network for Women’s and Children’s Health Research program (RFA HD-00-007), herein referred to as the Global Network. The Global Network award will be funded by the National Institute of Child Health and Human Development (NICHD), the National Institute of Allergy and Infectious Diseases (NIAID), the National Cancer Institute (NCI), the National Institute of Dental and Craniofacial Research (NIDCR), the National Center for Complementary and Alternative Medicine (NCCAM), and the National Institute of Mental Health (NIMH) in partnership with the Bill and Melinda Gates Foundation and with complementary support from the FIC IMCHRT. The training and research capacity building efforts of the FIC IMCHRT are meant to facilitate maternal and child health research such as will be undertaken under the Global Network program. NOTE: Investigators may apply for: (1) a Global Network Research Unit award in response to RFA HD-00-007 or (2) BOTH a Global Network Research Unit award in response to RFA HD-00-007 and an IMCHRT award in response to this RFA (TW- 00-007) or (3) an IMCHRT award separately, subject to the eligibility requirements described below. The purpose of this FIC training program is to stimulate high quality training and to build research capacity in support of current and future collaborative research on maternal and child health issues in developing countries. The intent of the IMCHRT program is to provide training opportunities for foreign investigators to build research capacity and to strengthen foreign and U.S. cooperation related to maternal and early childhood health. Integration of the FIC IMCHRT program and the Global Network program enhances and reinforces the purposes of both programs. Therefore, in awarding IMCHRT grants, first priority will be given to those meritorious applications that are linked to applications that have received or will receive Global Network Research Unit awards. The FIC IMCHRT will support training experiences for foreign scientists in the context of the Global Network priority research areas to improve pregnancy and birth outcomes in developing countries. For the purposes of this RFA, developing countries are defined as the resource-poor nations of Latin America, the Caribbean, North and sub-Saharan Africa, the Middle East, South and South East Asia, including the People’s Republic of China, Oceania, Central /Eastern Europe, and the newly Independent States (NIS) of the former Soviet Union. There are three overall objectives for the FIC IMCHRT: 1) to increase expertise of scientists in developing countries in maternal and early childhood biomedical, behavioral, and prevention research, 2) to support and expand collaborative training in maternal and early childhood biomedical and behavioral research between U.S.-based and foreign scientists, and 3) to establish or strengthen maternal and early childhood biomedical and behavioral research and prevention centers of excellence in the home countries of trainees. Adverse pregnancy outcomes are associated with a variety of cultural, medical, environmental, and health system factors, and affect millions of mother-baby dyads each year. The battle to improve maternal and early childhood health is particularly critical in developing countries and is becoming increasingly important in Russia and the newly independent states of the former Soviet Union. This RFA generally is intended to address maternal and newborn health training and research capacity building for factors other than HIV infection, except for those applications linked to a Global Network Research Unit application that includes HIV. However, for situations in which there is a high prevalence of HIV infection, one must consider the totality of factors, including HIV, which contribute to poor pregnancy outcomes and the poor health status of mothers and children. Recent advances in interventions to improve the health outcomes in HIV- infected mothers and newborns (e.g., nutritional supplements to pregnant women to decrease adverse pregnancy outcome, vitamin A supplements to improve health outcome in HIV-infected children, chlorhexidine vaginal cleansing at birth to decrease maternal and neonatal sepsis, and the use of antibiotics to prevent and treat chorioamnionitis) may also have more general health benefits for all mothers and children in developing countries. Consequently, investments made in HIV/AIDS research are now seen to provide general benefits to the health of HIV-negative persons in developing countries. The goal of this initiative is to strengthen and sustain, through collaborative research and training, the capability of developing countries to carry out research required to develop new strategies and to apply existing knowledge through operational research to improve health outcomes for mothers and newborns. Although this RFA is considered to be a non-AIDS program, applicants planning to work in areas with a high HIV/AIDS prevalence would be expected to consider HIV status in designing their research and training programs. They are encouraged to form collaborations with FIC AIDS International Training and Research Programs working in common countries of interest. The training program is intended to be multidisciplinary and to include biomedical and behavioral research so that the social and cultural determinants of health-related behaviors in various societies, (e.g., breastfeeding, sexual practices, smoking, and alcohol use), can be examined. HEALTHY PEOPLE 2010 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of Healthy People 2010, a PHS- led national activity for setting priority areas. This Request for Applications (RFA) International Maternal and Child Health Research and Training, is related to one or more priority areas. Potential applicants may obtain information about Healthy People 2010 at http://www.health.gov/healthypeople/. ELIGIBILITY REQUIREMENTS Applications may be submitted by U.S. for-profit and non-profit organizations, public and private institutions, such as universities, colleges, hospitals, and laboratories, units of State and local governments, and eligible agencies of the Federal government. While for-profit and non- academic organizations are eligible, they should establish linkages with academic institutions to be able to offer the full range of training opportunities included in the FIC IMCHRT. It is recommended that all applicants for the FIC FY 2001 IMCHRT awards also apply for a Global Network Research Unit award. As noted in the Global Network RFA, FY 1999 IMCHRT program grantees also are strongly encouraged to submit applications for Global Network Research Unit awards and to describe how their training efforts and experiences relate to and support proposed research activities under the network. Although applicants may apply for either a Global Network Research Unit grant or an IMCHRT grant, in awarding IMCHRT grants, priority will be given to institutions that submit meritorious applications in response to both the Global Network RFA and the FY 2001 IMCHRT RFA and to whom a Global Network award is expected to be made. However, Global Network awards may be made to institutions without IMCHRT awards and FIC may make IMCHRT awards without a Global Network award. There is no limit to the number of IMCHRT applications, linked to a Global Network application, that may be submitted by any given institution. However, preference will be given to meritorious IMCHRT applications linked to meritorious Global Network applications. Institutions previously awarded an IMCHRT award may not apply for an additional freestanding IMCHRT award, regardless of how many applications that institution submits for a Global Network award. Institutions that are applying only for a freestanding IMCHRT award may submit only one application. Racial/ethnic minority individuals, women and persons with disabilities are encouraged to apply as Principal Investigators. The U.S. grantee institution is responsible for developing an affiliations(s) with an established institution (e.g. university, research institute, federal or state health department, or hospital) in the host country. MECHANISM OF SUPPORT Awards will be made by the FIC under the international training grants (D43 mechanism), which limits facilities and administrative (F & A) costs to eight percent. The total project period for an IMCHRT application, submitted in response to this RFA, may not exceed five years. At this time, the FIC has not determined whether and how this solicitation will be continued beyond the present RFA. The FIC, with NICHD, will conduct a program evaluation during the fourth year of the IMCHRT. The results will assist the NIH in determining whether the RFA would be re-issued. If, by the end of the fourth year of the award, the FIC has not announced its intent to reissue the RFA, incumbents should contact program staff before preparing a re-competing application to seek advice on the most appropriate method of application submission. The applicant organization"s administrative support (including that available through a companion Global Network award) must provide the necessary management for the transfer of funds and material to the off-site component. Facilities and administrative (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 user fees, 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 of the FIC IMCHRT (as well as any companion Global Network award that may be made) as judged by annual progress reports, site visits, 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 maternal and child health related research and prevention, including the establishment or strengthening of model maternal and child health research and prevention centers of excellence in the home countries of trainees. Assessment of performance will be made jointly by FIC and NICHD. Special program reviews will be conducted by the FIC and NICHD. FUNDS AVAILABLE Approximately $600,000 is anticipated for support of three to four awards in this program in FY 2001, depending upon quality and availability of funds. The maximum allowable support for the first year is $200,000 (total costs including eight percent F & A costs). A budget increase of three percent may be requested for years two to five. Also, administrative supplemental budget requests up to 20% may be requested in any one year to cover unusual, unique scientific opportunities or emergency situations. Requests for budget supplements should not be submitted without prior discussion with and approval for submission by FIC staff. These requests will be reviewed jointly by FIC and NICHD and awarded based upon merit and availability of funds. RESEARCH OBJECTIVES Scope of Training A. Training Objectives The integration of the FIC IMCHRT program and a companion Global Network program will facilitate training of foreign scientists in the context of Global Network research priority areas and facilitate sustainable collaborative research between the U.S. and foreign countries. The establishment and strengthening of scientific linkages between U.S. and foreign investigators stimulate self-sufficiency of the collaborating foreign institution and enhance the scientific infrastructure for additional international collaborative arrangements. The linkage of the Global Network research program and the IMCHRT training and research capacity building program is a logical extension of collaborative efforts between FIC and NICHD to build research capacity and to support interventions to improve the health of mothers and children in the developing world, as well as in Russia and the newly independent states of the former Soviet Union. B. Training Plan The training plan should include U.S.-based, long-term (usually a minimum of two years) training that would lead to an advanced degree or would provide mentored postdoctoral research training. The IMCHRT also will promote and facilitate training courses targeted toward specific needs, such as learning laboratory, social science, or behavioral research techniques and transferring medical informatics, biotechnology and other methods required to support maternal and young child health research efforts in the home countries of the trainees. When a specific scientific course is given by one IMCHRT program, it is expected that this course will be open to trainees of other IMCHRT award institutions, with the expenses to be included within the regular budgets of each program that would send its trainees to such courses. C. Types of Training: 1. Pre-doctoral training in maternal and young child biomedical and behavioral research disciplines, and data management and analysis in support of that research, which may lead to an M.S. or Ph.D. or equivalent degree for individuals with or without previous field research experience. Individual training programs should relate directly to Global Network priority research areas to improve pregnancy and birth outcomes in developing countries, and may range up to four years. In general, academic courses will be taken at the U.S. institution. Field studies and research should occur in the trainees" home country in the context of Global Network projects. Active involvement in ongoing research and prevention projects is vital for a successful research and/or public health training experience. Innovative ways to involve trainees in Global Network research projects conducted in their home countries is encouraged. 2. Postdoctoral research experiences including related clinical training as needed, generally of two years duration for foreign health scientists, 3. Short-term training (either in the U.S. or in-country) of up to four weeks in focused research methodologies, related to improvement of maternal and newborn/child health outcomes, 4. Medium-term training of about three to six months duration, conducted in the U.S. in laboratory procedures and research techniques, such as the development of pilot biomedical studies or development of behavioral research instruments. These efforts could be relevant for individuals with M.S. and M.D. or Ph.D. degrees, as well as for persons with special relevant qualifications and experiences, such as nurses and midwives. 5. One-time awards for advanced research training (one to two years duration) upon return to the home country (supported through this award or a companion Global Network award if available) at levels of funding specified under allowable costs in this RFA, 6. Research training experiences for exceptionally promising pre- and postdoctoral U.S. health science students (including medical students and residents), with prior FIC approval. D. Trainees: Trainees shall be individuals who are, or are expected to be, involved in maternal and early childhood biomedical and behavioral research and prevention activities in their home country. The following categories of foreign individuals are eligible for training: 1. Health professionals with doctoral degrees (M.D., D.D.S./D.M.D., Ph.D., or equivalent), 2. Health professionals with a bachelors or masters degree in a basic or health science, or persons with special relevant qualifications and experiences such as nurses and midwives, 3. Medical technicians and health care workers (short courses), 4. Allied health professionals such as behavioral scientists, and social workers (short courses), 5. Current or former FIC trainees involved in advanced research training in their home countries, and, in addition, 6. Pre- and postdoctoral U.S. health science students, with prior FIC approval. Programs are strongly encouraged to give special emphasis to include women in selecting foreign trainees under this program and to ensure adequate representation of women and minorities in selecting U.S. trainees under this program. SPECIAL REQUIREMENTS Each grantee will have a U.S. Principal Investigator (PI) and a Major Foreign Collaborator (MFC). The PI and MFC will be responsible for the overall conduct of the IMCHRT. Training activities will be coordinated with the Global Network program. Training in Responsible Conduct of Research. Applicants are required to include training in responsible conduct of research as a part of the program. An award will not be made unless a description of such training is included. 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 (re-entry grants), and plans for continued collaboration with former trainees. Degree candidates must meet all entrance requirements of the U.S. degree-granting institution. The grant applications 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 in-country research projects. 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 a system to fully track and document the long-term impact of this training program on: (1) the careers of current and former trainees, (2) research capacity in the home institution of trainees, (3) types of positions the proposed trainees may assume upon completion of training, (4) the contributions to future NIH international maternal and early childhood research and prevention efforts, (5) the establishment or strengthening of maternal and early childhood health research and prevention centers of excellence in the home countries of trainees, and (6) the impact of program graduates in contributing to improving the health status of women and children 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 maternal and early childhood prevention or collaborative research projects for which trainees were either Principal 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 tracking system 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 re-competition of this program. Coordination and Collaboration. Coordination and collaboration of the IMCHRT Program with other FIC and NIH award programs and affiliated institutions, especially when operating within the same country, will be of benefit to all partners. The coordination of activities among training sites will be facilitated by the FIC, in conjunction with NICHD, and will include organization of joint meetings to be held during international and regional scientific or public health meetings. Program applicants are strongly encouraged to include plans, if possible, for coordination and collaboration with other FIC training programs. These include the FIC AIDS International Training and Research Program, the International Training and Research Program in Emerging Infectious Diseases (and the related TB and malaria initiatives), the International Training and Research Program in Environmental and Occupational Health, the International Training and Research Program in Population and Health, the Minority International Research Training Program (maternal and child health-related activities), the International Training Program in Medical Informatics as well as with other NIH-sponsored programs when working in common countries and/or regions. Given the increased emphasis on maternal and early childhood research and research training globally, FIC will also facilitate coordination and collaboration with other government agencies (e.g., the Centers for Disease Control and Prevention (CDC), the U.S. Agency for International Development (USAID), the Department of Defense), with bilateral and multilateral international organizations, including the World Health Organization (WHO), Pan American Health Organization (PAHO), the World Bank, United Nations Children’s Fund (UNICEF), with in-country projects funded by NIH including those by NICHD and other Institutes, and with foundations (e.g., Bill and Melinda Gates Foundation, U.N. Foundation). 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. The following cost categories are allowable but serve only as a guide under the research-training program. Programs are encouraged to be as cost- effective as possible in implementing their activities. (Stipend/Salary/Consultant Fees) 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 (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 ten percent 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 a consultant fee not to exceed $2,000, in accordance with their institution’s policies. No more than five percent of direct costs in the budget may be used for consultant fees. (NRSA substitute pages, training related expenses). o The applicant institution may request up to ten percent 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 family health 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 the results of research supported under this award. (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 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 (http://policyworks.gov/org/main/mt/homepage/mtt/perdiem/perd04d.html) for the program director to attend network meetings (estimated at one per year) 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 $10,000 one time expense 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 $10,000 per trainee per year (up to two years) 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) 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 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 "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research," which was published in the Federal Register of March 28, 1994 (FR 59 14508-14513) and in the NIH Guide for Grants and Contracts, Vol. 23, No. 11, March 18, 1994, and is available on the web at: http://grants.nih.gov/grants/guide/notice-files/not94-100.html. 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. 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. LETTER OF INTENT Prospective applicants are asked to submit, by April 14, 2000, a letter of intent that includes a descriptive title of the overall proposed research, the name, address and telephone number of the Principal Investigator, the identities of other key personnel, the country(ies) and possible institutions to which the U.S. institution will be linked, and the number and title of this RFA. The letter of intent should also indicate whether prospective applicants intend to apply for a Global Network Research Unit grant. Although the letter of intent is not required, is not binding, does not commit the sender to submit an application, and does not enter into the review of subsequent applications, the information that it contains allows NIH staff to plan for the review in a timely fashion for the benefit of the investigators and to avoid conflict of interest in the review. The letter of intent is to be sent to Dr. Jeanne McDermott APPLICATION PROCEDURES Applications are to be submitted on the standard research grant application form PHS 398 (rev. 4/98), using the instructions and forms for Institutional National Research Service Awards and PHS Form 398 as noted in the previous section, Allowable Costs. Application kits are available at most institutional offices of sponsored research and may be obtained from the Division of Extramural Outreach and Information Resources, National Institutes of Health, 6701 Rockledge Drive, MSC 7910, Bethesda, MD 20892- 7910, telephone (301) 710-0267, email: [email protected]. For purposes of identification and processing, item 2 on the face page of the application must be marked "YES" and the RFA number "TW-00-007 " and the words "International Maternal and Child Health must be entered on the face page. Applications must be received by July 13, 2000. The RFA label available in the application form PHS 398 must be affixed to the bottom of the face page. Failure to use this label could result in delayed processing of the application such that it may not reach the review committee in time for review. The sample RFA label 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, typewritten original of the application, including the checklist, and three signed, exact, single-sided 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 exact copies of the grant application and all five sets of any appendix material should be sent to: Laurence Stanford, Ph.D. Director Division of Scientific Review National Institute of Child Health and Human Development 6100 Executive Blvd., Room 5E03, MSC 7510 Bethesda, MD 20892-7510 Rockville, MD 20852 (for express/courier service) Telephone: (301) 496-1485 Applications must be received by the application receipt date listed in the heading of this RFA. 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 Center for Scientific Review (CSR) and for responsiveness by FIC and NICHD staff. Incomplete and/or non-responsive applications will be returned to the applicant without further consideration. NICHD will conduct the initial scientific review on behalf of the FIC, as part of the overall review of the IMCHRT and Global Network applications. Applications that are complete and responsive to the RFA will be evaluated for scientific and technical merit by a 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 be discussed, assigned a priority score and receive a written critique as well as receive a second level review by the FIC Advisory Board. Review Criteria Applicants for the IMCHRT award are strongly encouraged to apply for a Global Network research award. The scientific evaluation of each application will include assessment of the linkage between proposed training and maternal and early childhood health research defined in the Global Network application. Evidence of support for the IMCHRT from collaborating institutions and host governments must be submitted with the application. The goals of NIH-supported research are to advance our understanding of biological systems, improve the control of disease, and enhance health. In the written comments reviewers will be asked to discuss the following aspects of the application in order to judge the likelihood that the proposed research will have a substantial impact on the pursuit of these goals. Each of these criteria will be addressed and considered in assigning the overall score, weighting them as appropriate for each application. Note that the application does not need to be strong in all categories to be judged likely to have major scientific 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 a field forward. Additional review criteria are: A. Significance 1. The expected public health and scientific contributions of the proposed activity, and 2. The demonstrated capacity and/or potential to achieve sustained maternal and young child health research priorities and training efforts, and to build associated clinical and operational research and public health capacity within a country. B. Approach 1. Balance in the proposed training program to provide breadth of training opportunities in the field of academic-based, maternal and young child training in biomedical, behavioral science, clinical sciences and prevention research, 2. 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 operational research and public health capacity at a model maternal and young child research and prevention center of excellence within a collaborating country, 3. Adequacy of proposed procedures and criteria for 1) recruitment, review and selection of trainees, and 2) peer review of research and related maternal and early childhood prevention projects, and 4. Adequacy of plans to include an adequate representation of women among foreign trainees, including nurses and midwives, and women and minorities among U.S. trainees. C. Innovation 1. Plans for trainees to become involved in maternal and young child biomedical and behavioral research, and prevention projects conducted in their home countries, and 2. Adequacy and creativity of plans including use of the modern information technology to facilitate access to scientific information, distance learning, coordination, and research collaboration. D. Investigator(s) 1. Qualifications of the program director to lead and the named faculty to participate in the proposed training and research program, and 2. Active research support of the program director and participating faculty. E. Environment 1. 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 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 2. Training environment in the U.S., including the institutional commitment, the caliber of preceptors, and the quality of teaching and research facilities and resources. F. 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. The IRBs in the home countries of trainees will be responsible for determining the adequacy of inclusion of women and minorities as well as 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: 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 humans, animals or the environment, to the extent they may be adversely affected by the project proposed in the application. o The adequacy of the proposed budget and duration in relation to the proposed research. Schedule Letter of Intent Receipt Date: April 14, 2000 Application Receipt Date: July 13, 2000 Scientific Review Date: October, 2000 FIC Advisory Board: February, 2001 Earliest Award Date: March 1, 2001 AWARD CRITERIA Award criteria that will be used to make award decisions include: o scientific merit (as determined by peer review) o availability of funds o programmatic priorities In addition to the above, the following will be considered in making funding decisions: Whether a companion Global Network award has or is expected to be awarded and: 1. The extent and effectiveness of efforts made by applicants in developing biomedical behavioral, and prevention research training programs necessary to support maternal and young child health research and related prevention efforts in the home countries of trainees, including efforts made to focus resources to build sustainable long-term clinical research, operational research and public health capacity at a model maternal and early childhood health research and prevention center of excellence in the home country of trainees, 2. Efforts made to collaborate with other NIH Institutes and Centers, with CDC, with USAID and WHO programs, and with other institutions and organizations, 3. The extent to which proposed training programs support and complement other NIH international maternal and young child health research efforts, 4. Program balance among critical research and public health training areas of emphasis, and 5. Geographic distribution among countries included in applications under consideration, including the need for a given program to work in a specific country. Before any funds can be expended from this award, 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 Minister of Health or Education or other appropriate government official as well as from the collaborating institutions. INQUIRIES Inquiries concerning this RFA are strongly encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Direct inquiries regarding IMCHRT programmatic (training scope and eligibility) issues to: Jeanne McDermott, C.N.M., M.P.H., Ph.D. Program Officer Division of International Training and Research Fogarty International Center Bldg. 31, Room B2C39, 31 Center Drive, MSC 2220 Bethesda, MD 20892-2220 Telephone: (301) 496-1492 FAX: (301) 402-2056 Email: [email protected] Direct inquiries regarding review issues to: Laurence Stanford, Ph.D. Director Division of Scientific Review National Institute of Child Health and Human Development 6100 Executive Blvd., Room 5E03, MSC 7510 Bethesda, MD 20892-7510 Rockville, MD 20852 (for express/courier service) Telephone: (301) 496-1485 Direct inquiries regarding IMCHRT fiscal matters to: Ms. Silvia Mandes Grants Management Officer Fogarty International Center Bldg. 31, Room B2C39 31 Center Drive, MSC 2220 Bethesda, MD 20892-2220 Telephone: (301) 496-1653 FAX: (301) 402-0779 Email: [email protected] AUTHORITY AND REGULATIONS Awards are made under authorization of Section 301 and Title IV, Part A, as amended (42 USC 241 and 287) of the Public Health Services Act, and administered under NIH grants policies and Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92s. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or to Health Systems Agency review. The PHS strongly encourages all grant and contract recipients to provide a smoke-free workplace and promote the non-use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routine education, library, day care, health care or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people.
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