INTERNATIONAL CLINICAL, OPERATIONAL AND HEALTH SERVICES RESEARCH AND TRAINING AWARD (ICOHRTA) Release Date: February 13, 2001 RFA: RFA-TW-01-003 (This RFA has been reissued, see RFA-TW-06-002) Fogarty International Center (FIC) (http://www.nih.gov/fic) National Institute of Mental Health (NIMH) (http://www.nimh.nih.gov/) National Institute on Drug Abuse (NIDA) (http://www.nida.nih.gov/) National Institute on Aging (NIA) (http://www.nih.gov/nia/) National Center for Complementary and Alternative Medicine (NCCAM) (http://nccam.nih.gov/) National Institute of Dental and Craniofacial Research (NIDCR) (http://www.nidr.nih.gov/) Letter of Intent Receipt Date: March 15, 2001 Application Receipt Date: April 27, 2001 PURPOSE The International Clinical, Operational and Health Services Research and Training Award (ICOHRTA) supports training to facilitate collaborative, multidisciplinary, international clinical, operational, health services and prevention science research between U.S. institutions and those in developing countries, as well as emerging democracies of Eastern Europe, Russia, and the Newly Independent States (NIS). The ICOHRTA will address global health problems by extending and enhancing the research of the collaborating U.S. and foreign scientists while increasing the clinical, operational, health services and prevention research capacity of the collaborating foreign scientists and their institutions. Awards will be made to the U.S. applicant institution to support a clinical, operational and health services research training program that will include training at the U.S. and foreign collaborating sites and mentored clinical, operational, health services and prevention science research carried out mainly at the foreign site. Applicant institutions can request up to five years support for a standard program or up to three years support to plan and develop a program. The Fogarty International Center (FIC) together with the National Institute of Mental Health (NIMH), the National Institute on Drug Abuse (NIDA), the National Center for Complementary and Alternative Medicine (NCCAM), National Institute on Aging (NIA) and the National Institute of Dental and Craniofacial Research (NIDCR), invite applications for international clinical, operational, health services and prevention science research and training programs which encourage the development of evidence-based interventions, for major global health problems, which are appropriate to local circumstances in the foreign collaborating country. Eligible topics are all clinical, operational, health services and prevention science research areas supported by or relevant to the participating NIH institutes (including mental health/neuropsychiatric disorders, drug abuse/addiction, aging-related and dental/craniofacial-related diseases and disorders and complementary and alternative medicine). NIMH will also consider applications in the area of HIV/STD prevention. Research topics must also be relevant to a major current or anticipated future medical or public health problem(s) in the foreign collaborating country of trainees participating in the program. Future competitions of this RFA will focus on clinical, operational, health services and prevention science research and training, in additional areas of biomedical research, to reduce the global burden of disease and disability. Consult the World Health Organization "Global Burden of Disease" website at http://www.who.int/msa/mnh/ems/dalys/intro.htm#intro. For the purposes of this RFA, clinical research is patient-oriented research in which an investigator directly interacts with human subjects. This area of research includes: therapeutic interventions, clinical trials, epidemiologic, behavioral and demographic studies and the development of new technologies. For example, a program under this RFA might focus on preventive interventions to reduce the risk of suicide in high-risk populations or develop or adapt treatments (including pharmacological, other somatic, psychosocial or a combination) to enhance functional outcomes for individuals and families. In particular, programs are encouraged that train clinical investigators in the basic development, conduct and interpretation of intervention trials research in order that they may function effectively as independent researchers or collaboratively with their US colleagues as part of multi-site networks. A program proposed to NIMH under this RFA might include collaborative interventions to prevent the spread of HIV in high risk populations. Health services and outcomes research include studies which examine the organization, financing, management and delivery of health services and their impact on access to, and utilization, quality, cost and outcomes of care. Operational research encompasses translation of knowledge and technologies to field and clinic use, how to best implement existing and new prevention strategies, therapeutic tools and other interventions for broad-based field use, and the study of barriers to such translation and implementation. When interventions have been shown to be successful on a small scale or in limited situations, operations research will help determine how to best generalize such interventions for widespread and sustainable use. Operational research includes research that studies factors (such as economics, demographics and the characteristics of service delivery systems) that influence the effectiveness of interventions in real world settings . Excluded from consideration are: o Projects that do not involve some component of research or evaluation (e.g., demonstration projects or health services delivery projects that do not involve evaluation) o Studies of animals. The research subjects for all types of eligible research may be individuals, families, organizations, institutions, communities, populations or nations. 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 Clinical, Operational and Health services Research and Training Award (ICOHRTA), is related to one or more of the priority areas. Potential applicants may obtain a copy of Healthy People 2010 at http://www.health.gov/healthypeople/. ELIGIBILITY REQUIREMENTS Applications may be submitted by U.S. non-profit public and private institutions, such as universities, colleges, and eligible agencies of the Federal government capable of meeting the objectives of the RFA. The U.S. scientist will apply as Principal Investigator (PI) with a major foreign collaborator (MFC) from a single foreign institution in an eligible country. This is intended to concentrate resources to maximize the impact of the investments in building clinical, operational, health services and prevention science research capacity at the foreign institution. For the purpose of this program, eligible foreign countries, where the proposed research training will be based, include those in the following regions: Africa, Russia and the Newly Independent States (NIS), Asia (except Japan, Singapore, South Korea and Taiwan), the Pacific Island region (except Australia and New Zealand), the Middle East (except Israel), Latin America (Mexico, Central and South America) and the Caribbean. This international capacity building effort is intended to build upon a strong U.S.-based research training or curriculum development program. Consequently, to be eligible for an ICOHRTA, the following requirements must be met: o U.S. applicants must be program directors or project directors on an eligible parent grant, defined as an institutional research curriculum development or institutional research training award, or center grant which includes training in clinical, population or operational/health services research from participating NIH institutes. Other FIC D43 training and capacity building awards do not meet the requirement for an eligible parent grant for an ICOHRTA application. With prior approval from the FIC program staff, institutional awards for clinical, operational or health services research and training from other sources (other government agencies, foundation grants) may be considered. In such cases, the ICOHRTA would support a unique clinical , operational or health services research opportunity of importance to the foreign country and relevant to the mission of the collaborating NIH Institutes. The parent grant must be active and funded at the start of the proposed ICOHRTA budget period. The parent grant must have a minimum of 15 months (12 months if applying for a Developmental Award application) of funding remaining, at the time of application deadline, to be eligible for ICOHRTA funding. The ICOHRTA funding period may extend beyond the parent grant funding period. o The ICOHRTA clinical, operational, health services and prevention science research training proposal should, in general, be an extension of the area or areas of clinical, operational or health services research training covered by the parent grant. o Diseases or conditions, such as physical disabilities and injuries, which are addressed in the application, must be of interest to the collaborating NIH institute and relevant to a major current or anticipated future medical or public health problem(s) in the foreign collaborating country of anticipated trainees. In general, the problem addressed will be associated with a current or anticipated high level of morbidity, disability or mortality in the foreign collaborating country. (Please refer to the WHO "Global Burden of Disease" website at http://www.who.int/msa/mnh/ems/dalys/intro.htm#intro.) The applicants are strongly encouraged to contact the institute program staff listed under INQUIRIES before preparing an application. Applications that are not within the mission of, or relevant to, the collaborating NIH institutes will be returned. o The MFC must hold a faculty research position at a public or private non-profit research institution that will allow him or her adequate time and provide appropriate facilities and resources, including access to patients or patient data, to provide mentored clinical, operational or health services research experience for trainees upon return to the home country. o With prior approval from FIC staff, an individual U.S. institution may submit more than one application (up to a maximum of three) if each application involves a different area of health science/parent grants (e.g. mental health, aging, drug abuse/addicion etc). Each application must be associated with a separate, active, identified NIH-funded or other eligible parent grant, but all of these applications from a given U.S. institution must be for collaboration with the same foreign institution. Any exceptions require prior approval of the FIC program staff. o An intramural NIH investigator may not serve as PI on an ICOHRTA. However, participation of NIH intramural programs as training sites is encouraged, consistent with NIH policies on visiting scientists. Participation by NIH intramural programs requires concurrence by both the Scientific Directors of the participating institutes as well as the Deputy Director for Intramural Research of the NIH. A participating NIH intramural program must pay for the participation of its own staff, including travel expenses and for any research cost at NIH. Stipends for the foreign trainees would be paid under the ICOHRTA award. o Racial/ethnic minority individuals, women, and persons with disabilities are encouraged to apply as PIs. MECHANISM OF SUPPORT Awards made in response to this RFA will use the National Institutes of Health (NIH) international training grant (D43) award mechanism that limits facilities and administrative (F & A) costs to eight percent. The standard ICOHRTA will provide up to $250,000 per year in direct costs for up to five years. The Developmental ICOHRTA grant will provide up to $100,000 per year in direct costs for up to three years. Five-year standard awards are intended for applicants who already are involved in collaborative research and training at the foreign institution. Three-year developmental awards are for applicants who have already initiated research and training collaboration at the foreign site and wish to build upon that. Developmental awards may include support for time and travel to plan the program, for curriculum development and for the initiation of short-term training. Responsibility for the planning, direction, and execution of the proposed project will be solely that of the applicant. The applicant organization must provide the necessary management for the transfer of funds and materials to the collaborating MFC country institution. Costs required to support research and training at the MFC country institution, such as institutional review boards and access to facilities, library services, Internet, etc., with justification, can be charged as direct costs. Travel, salaries and fringe benefits will be subject to the applicant institution’s rules and regulations. The initial training is generally expected to take place in the U.S, however, it may take place at the foreign site if appropriate facilities and resources are available. The training-related mentored clinical, operational, health services and prevention science research under the ICOHRTA award is expected to occur mainly at the foreign site. Greater than 50 percent of the funds, over the period of the award, must be spent at the foreign site to support the research training and other components of clinical, operational, health services and prevention science research capacity building at the foreign site. As the research capacity increases over time at the foreign sites a greater emphasis will be placed on training at the foreign sites by the foreign collaborators. Continued support during this period depends on satisfactory performance as judged by: annual progress reports, site visits, participation in periodic meetings of program directors, career progress of trainees (e.g., positions occupied in MFC country), research undertaken and research awards received, first-author publications and presentations by current and former trainees, development of institutional, national or regional capacity for clinical, operational, health services and prevention science centers of research excellence in the home countries of trainees and in influencing policies that reduce health risks. 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/Consulting Fees Trainees may be paid a stipend while conducting long-term training- related research at the MFC country site at levels comparable with the salary scales for similar professionals in that country in accordance with the collaborating MFC country or grantee institution’s policies but not exceeding $45,000 per year. Applicants may consider the NRSA stipend levels at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-01-011.html as basis for setting stipends when no appropriate institutional level exists. Faculty at the grantee institution who provide major program administration or extended long-term training or conduct collaborative research with students at the MFC country site may receive salary and fringe benefits. The total amount of salary and fringe benefits requested for all grantee faculty may not exceed ten percent of direct costs in the budget. The administrative training , mentoring, and teaching responsibilities and time commitment for personnel receiving salary should be thoroughly described. (Form 398 budget pages, personnel) MFC country institution faculty who provide consultation at the MFC country site, or participate in long-term training of participating students at the MFC country site, and grantee faculty or MFC country faculty who teach short courses may receive a consulting fee not to exceed $3000, in accordance with their institution’s policies. Standard ICOHRTAs may not use more that $25,000 directs costs for consultant fees during a single budget period. Developmental ICOHRTAs may not use more that $10,000 direct costs for consultant fees during a single budget period. The administrative, training or teaching responsibilities and time commitment for personnel receiving consulting fees should be thoroughly described. (NRSA substitute pages- training related expenses) Up to $25,000 direct costs may be used to provide salary and fringe benefits for clerical support staff for the program at the grantee institution or foreign site for a Standard ICOHRTA. Up to $10,000 direct costs may be used to provide salary and fringe benefits for clerical support staff for the program at the grantee institution or foreign site for a Developmental ICOHRTA. The responsibilities and time commitment for personnel in the U.S. and foreign country receiving salary support or consulting fees should be described in detail. (Form 398 pages, personnel) Tuition, Fees and Insurance Funds for academic fees and self-only or family medical insurance for MFC country trainees at the grantee or MFC institution may not exceed $62,500 and $25,000 direct costs for Standard and Developmental ICOHRTA grants, respectively. Programs are encouraged to seek cost-sharing arrangements with the grantee institutions in order to provide reduced tuition for long-term trainees and tuition-free short courses. (NRSA substitute pages, tuition, fees, insurance) Trainee Travel Funds may be requested for one round trip economy class airfare per year on U.S. carriers (to the maximum extent possible) and local ground transportation for each long-term MFC country trainee to travel to the grantee institution or other approved training sites or for MFC country trainees to participate in short courses or attend scientific conferences to present their results. Additional travel must be approved by FIC program staff. (NRSA substitute pages, trainee travel.) Funds may be requested for per diem and lodging for MFC country trainees to participate in short courses or attend scientific conferences to present their results. (NRSA substitute pages, trainee travel) Faculty Travel Funds may be requested for one round trip economy airfare per year on U.S. carriers (to the maximum extent possible) for each grantee faculty participant providing extended training to go to the MFC country site or teach short courses at the MFC country site. Additional travel must be approved by FIC staff. (PHS 398 pages, travel) Funds may be requested for per diem and lodging for grantee faculty to teach short courses at the MFC country site. (PHS 398 pages, travel) Funds should be requested for airfare, per diem and lodging comparable to U.S. government rates (see http://www.gsa.gov/Portal/gsa/ep/contentView.do?contentId=17943&contentType=GSA_BASIC) for the program Director and other participants to attend network meetings. Inclusion of funds for other key personnel to attend these meetings is at the discretion of the applicant. (PHS 398 pages, travel) Training-related expenses Funds to support MFC country trainee-related research costs at the grantee institution (such as textbooks, course material, research supplies, computer access, etc.) of up to $600 per month per trainee may be requested. (NRSA substitute pages, training related expenses) Funds (up to $10,000 per year) to support research at the MFC country site associated with fulfilling requirements for an advanced degree may be requested. (NRSA substitute pages, training related expenses.) Research support, of up to $20,000 per trainee per year, to facilitate conducting advanced research training at the MFC country site (re-entry grants) by those finishing training or former long-term trainees in collaboration with grantee faculty participants may be requested. Re- entry grants may support the purchase of research supplies, a computer and appropriate software, computer access fees, small equipment, one round trip to the grantee institution per award, scientific meeting fees and stipends comparable to salary scales for similar professional at the MFC country site. The applicant should describe in detail how proposals for re-entry projects will be selected by a peer review process examining scientific merit and ethical concerns involving faculty from the grantee and MFC country institutions coordinated by the program director. (NRSA substitute pages, training related expenses) FUNDS AVAILABLE It is anticipated that about $3,000,000 will be available for the first year of the initial awards under this program from the FIC and collaborating partners. This would support an estimated eight new awards and seven developmental awards. Awards will be contingent upon availability of funds and the number of meritorious applications. Subject to availability of funds, it is the intent to reissue the RFA on an annual basis for the next four years, thus allowing developmental programs the opportunity to apply for full awards in the future and for new areas of health science to be included as additional collaborating NIH institutes and centers participate in the program. The grantee institution may request an F & A cost allowance based on eight percent of the total allowable direct costs, exclusive of tuition, trainee- 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. FIC welcomes cost-sharing or other means of support from U.S. and foreign institutions. Such support, while not a prerequisite for an award, could include U.S. institution’s coverage of U.S. faculty participation, waiver or reduction of tuition for foreign trainees, donation of equipment to the foreign site, or, on the foreign side, waiver of custom duties for equipment. TYPES OF TRAINING The main objective of the ICOHRTA program is to support research training to build clinical, operational, health services and prevention science research capacity at the collaborating foreign institutions from which trainees are selected and to which trainees are expected to return. These collaborations should extend or enhance the clinical, operational, health services and prevention science research interests of both the U.S. PI and the foreign co-investigator equally. At the same time, the research capacity of the foreign investigator and institution should increase such that sustained and productive clinical, operational, health services and prevention science research, to address health problems relevant to the participating foreign country, can be conducted. Clinical, operational, health services and prevention science research- related training for health scientists and health professionals may include the following types of training: o long-term (greater than 12 months and up to two years or more depending on resources) training in pre- or post-doctoral programs, with the understanding that all thesis-related work would be done in the trainee"s home-county. o short-term (less than three months) training that could include focused workshops on program and grants administration, technology transfer, data management or Internet connection. o intermediate-term (three to 12 months) training, including specialized activities in support of clinical, operational, health services and prevention science research, pilot trials or interventions. Such training could include topics above as well as ethical review issues and practicalities. While a range of short- and long-term training is allowable, emphasis will be on intermediate to longer-term training, including mid-career training. This approach will accelerate building an enduring clinical, operational, health services and prevention science research and public health capability at the collaborating institution in participating countries. To a limited extent, U.S. trainees will be eligible for foreign research experiences under this program, with prior FIC approval, if they have uniquely relevant expertise or skills which will contribute to the training and research at the foreign institution. The ICOHRTA encourages program directors to include women as trainees and faculty and, if U.S. trainees and faculty are involved, to include women and minorities. RESEARCH OBJECTIVES Background By the year 2020, projections from the World Health Organization indicate that non-communicable diseases will contribute up to 60 percent of the world’s burden of disease (http://www.who.int/msa/mnh/ems/dalys/intro.htm#intro). Changing economic and demographic trends in developing nations, including increasingly aging populations, will play a major role in this epidemiologic shift. Increases in chronic, non-communicable conditions such as mental health disorders, drug abuse/addiction, dementia, obesity, tobacco-related diseases including cancer, pulmonary and cardiovascular diseases, hypertension, diabetes and asthma will add to the already unacceptable burden of illness caused by infectious diseases such as HIV/AIDS, TB and malaria. Lack of access to appropriate care for most of a country’s population, along with out-dated care when available, has been cited as contributing to mortality and morbidity, regardless of cause, in many resource-poor countries. Knowledge gained through new methods of research and current methods extended into new areas as appropriate, will profoundly influence the scope of clinical investigation and implementation of health services and prevention strategies in international health. Unique opportunities exist for international partnerships to confront the changing burdens of disease and health disparities among developing nations. Along with implementation of proven interventions, many promising scientific advances, such as the development of new diagnostics, therapies and vaccines, could contribute to reductions in global health disparities. However, the health care systems in many countries, for a variety of reasons, have failed to implement even proven interventions or the most promising advances. To be successful, a well-trained cadre of scientists in developing nations will be needed to plan, design and conduct clinical, operational, health services and prevention science investigations, including epidemiological, behavioral, demographic and economic studies, prevention research and investigations of complementary and alternative therapies. The training of international scientists alongside U.S. researchers will help to produce this cadre of experts and will facilitate collaborative clinical trials and operational, health services and prevention science research for the benefit of developed and developing country populations. These awards are intended to strengthen the global capacity to conduct clinical, operational, health services and prevention science research necessary to measure incidence and prevalence of diseases and chronic conditions, characterize disease burdens, to devise and evaluate practical and affordable therapeutic or preventive interventions, and to help developing nations contribute to, and benefit from, international efforts to apply current knowledge and new discoveries to clinical public health practice. Proposed institutional and capacity- strengthening training programs should be designed to fill specific gaps in needed expertise and to establish a critical mass of trained biomedical and behavioral scientists and health professionals able to work cooperatively on clinical, operational, health services and prevention science research issues in collaborating institutions in developing countries. Curriculum topics may include topics such as: clinical trials design, community-level studies, observational study design, survey and sampling methodology, disease mechanisms and pathogenesis, research bioethics, biostatistics, specialized courses in epidemiology, outcomes research, cost-effectiveness studies, pharmacokinetics, internet technology, telemedicine, computer-based training for basic behavioral science, policy analysis, data management and analysis, grantsmanship and other related topics. Each training proposal should incorporate a number of long-term (greater than one year), intermediate(three to 12 months) and short-term (less than three months) training opportunities (including in-country research) in a wide range of relevant disciplines and skills necessary to advance research objectives while building sustainable clinical, operational, health services and prevention science research capacity at a center of research excellence at a foreign site. The overarching research objective is to develop a cadre of experts in clinical, operational, health services and prevention science research in the developing world that can assist in advancing joint research efforts. Future competitions of this RFA will continue to seek applications to build clinical, operational, health services and prevention science research capacity at foreign sites in response to global health threats. The areas of emphasis under this RFA reflect the research missions of the participating NIH institutes in mental health, aging, drug abuse/addiction and complementary and alternative medicine. For global health concerns of NIMH also please refer to http://www.nimh.nih.gov/publicat/burden.cfm. The NIDCR would be particularly interested in international applications addressing disorders such as oral cancer, soft tissue diseases of the oral cavity, craniofacial anomalies, temporomandibular disorders, oral and facial pain and salivary gland diseases. SPECIAL REQUIREMENTS o Commitments: The PI and MFC will be responsible for the overall conduct of the ICOHRTA. The institution of the PI and MFC must have entered into a long-term commitment in writing to build the clinical, operational, health services and prevention science research capacity of the foreign institution through governmental-supported or other resources. A copy of this agreement must be included with the application. Should NIH intramural labs or programs be involved in the ICOHRTA application, they should also be party to these agreements. Participation by NIH intramural programs requires concurrence by both the Scientific Directors of the participating institutes as well as the Deputy Director for Intramural Research of the NIH. o Integration of the ICOHRTA with the parent grant program is required. List the specific aims of the parent grant. Also list the specific aims of the ICOHRTA proposal and discuss how the specific aims of the ICOHRTA relate to the aim(s) of the parent grant. While not required, integration of the ICOHRTA with other relevant programs funded by FIC, NIH or other sources will strengthen the application. Applicants should also describe any plans to integrate ICOHRTA with other relevant programs in the foreign institution and within the country. o Recruitment and Selection Plan: The domestic applicant institution must include a plan describing the recruitment and selection procedures for trainees and a detailed description of peer review for training- related and advanced in-country clinical, operational, health services and prevention science research. Degree candidates must meet all entrance requirements of the U.S. degree-granting institution or of the foreign degree-granting institution, if applicable. 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 the participating institution(s) and (b) a mechanism for internal peer review of applications to support U.S. and in-country clinical, operational, health services and prevention science research projects. o Establishing research priorities: Applicants should assure that clinical, operational, health services and prevention science research priorities reflect those of the participating foreign country and should describe the procedures to assure this takes place within the context of the collaborative relationship. o Strategy for regional impact: The application should emphasize clinical, operational, health services and prevention science research capacity building at the collaborating foreign institution. It is also desirable for the application to describe strategies to achieve a wider regional impact. This could be done by strengthening other institutions in the MFC country or in neighboring countries. The goal is to become not only a national but also a regional center of clinical, operational, health services and prevention science research excellence, capable of offering training in these areas, and introducing sophisticated technology as appropriate, to scientists from other countries. o Evidence of host country support for the program will strengthen the application. Such evidence of support should be provided in writing and could be in the form of one or a combination of the following: a statement of support from a senior administrator at the MFC country institution, evidence of cost-sharing by the host country and willingness of the host country to utilize trainees experience, and knowledge gained from the program, to build clinical, operational, health services and prevention science research capacity at a center of research excellence in the collaborating country. o Plans for continued collaboration with former trainees once they return home must be described. o Tracking system for long-term impact: As part of their obligations under this program, awardees are required to design, as part of their application, a system to track fully and document the long-term impact of this training program on: (1) the career choices and progress of current and former trainees, (2) the participation of former fellows in ICOHRTA as faculty and trainees, (3) building clinical, operational, health services and prevention science research capacity in the home institution and country of trainees, (4) types of positions the proposed trainees may assume upon completion of training and documentation of career progress, (5) the possible contributions to future NIH and other U.S. and non-U.S. government agency-supported international research and public health efforts, (6) the strengthening of the foreign institution for clinical, operational, health services and prevention science research training, and (7) the contributions of the program toward interventions or policies that address health problems in the home country of trainees. Impact will be an important criterion for assessing success in any future recompetition of this program. Detailed examples of past and future expected successes should be included. Examples of successes 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 obtaining grants or other support, how training contributed to publications in which trainees were first authors and which were based upon support under this program, how training and related research findings contributed to development and implementation of health policies, how any existing FIC/NIH programs were enhanced by ICOHRTA and vice versa. 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. This system will build upon FIC experience in other research training programs and be compatible with them. Once this standardized tracking system has been finalized, it will be implemented across all programs. o Before any funds may be expended on in-country research, the grantee institution must show written evidence of formal approval (assurances) from responsible authorities at the collaborating institution, from an institutional (or ethical) review board or committee at both the U.S. and foreign institutions and from the relevant government authority. Please see: Procedures for Registering Institutional Review Boards and Filing Federalwide assurances of Protection for Human Subjects (FWAs) http://www.hhs.gov/ohrp/assurances/assurances_index.html. o There will be periodic network meetings in Bethesda or other sites during the course of a five-year grant. Those receiving Developmental awards would be expected to participate in these meetings, the purpose of which will be to exchange research and training experience and coordinate program activities. PIs, MFCs, program administrators and selected trainees are expected to attend. Funds for this activity (travel and per diem) 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 existing NIH policies for Institutional NRSA awards located at http://grants.nih.gov/grants/guide/pa-files/PA-00-103.html. An award will not be made unless such a plan is included. o Applicants must inform the FIC program staff that approval of research protocols involving human subjects has been obtained from U.S. and developing country institutional review boards and required U.S. and foreign government agencies before training-related research involving human subjects is initiated. INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS It is the policy of the NIH that women and members of minority groups and their sub-populations must be included in all NIH-supported biomedical and behavioral research projects involving human subjects, unless a clear and compelling rationale and justification are provided indicating that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43). All investigators proposing research involving human subjects should read the updated NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research, published in the NIH Guide for Grants and Contracts on August 2, 2000 (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-048.html), a complete copy of the updated guidelines are available at http://grants.nih.gov/grants/funding/women_min/guidelines_update.htm: The revisions relate to NIH-defined Phase III clinical trials and require: a) all applications or proposals and/or protocols to provide a description of plans to conduct analyses, as appropriate, to address differences by sex/gender and/or racial/ethnic groups, including subgroups if applicable, and b) all investigators to report accrual, and to conduct and report analyses, as appropriate, by sex/gender and/or racial/ethnic group differences. NIH POLICY AND GUIDELINES ON THE 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 formatting and 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 a letter of intent, by March 2, 2001, that includes: 1) a descriptive title of the proposed research training program, 2) the name, address, email address and telephone number of the PI and the MFC, and 3) the identities of other key personnel and participating institutions. 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 staff to estimate the potential review workload and to plan the review. The letter of intent is to be sent to: Kathleen M. Michels, Ph.D 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: ICOHRTA@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 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: GrantsInfo@nih.gov. Applications are also available on the Internet at http://grants.nih.gov/grants/funding/phs398/phs398.html. Budget on pages as defined under allowable costs. 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 two 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. Applications should clearly specify whether the proposal is for a full five-year ICOHRTA or for a developmental award. 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: Jean G. Noronha, Ph.D. NIMH Referral Liaison Division of Extramural Activities National Institute of Mental Health 6001 Executive Boulevard, Room 6154, MSC 9609 Bethesda, MD 20892-9609 Rockville, MD 20852 (for express/courier service) 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. 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 of interest and to help ensure the appropriate and timely review of the application. If an application is received after the receipt 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 and collaborating NIH institutes. Incomplete and/or non-responsive applications will be returned to the applicant without further consideration. Applications will be assigned to the FIC. The clinical, operational, health services and prevention science research training and capacity building proposals will be reviewed for scientific and technical merit and quality of the collaboration by a special emphasis panel comprised of a broadly multidisciplinary review group convened by the NIMH. As part of the initial merit review, all applications will receive a written critique and assigned a priority score. Following the scientific-technical review, the applications will receive a second level review by the FIC Advisory Board. REVIEW CRITERIA The ICOHRTA program addresses the need to build clinical, operational, health services and prevention science research capacity at specific institutions in a collaborating country to combat problems relevant to that country’s health. In the written comments, reviewers will be asked to discuss these aspects of the application in order to judge the likelihood that the proposed clinical, operational, health services and prevention science research training will have a substantial impact on the pursuit of these goals, including building sustainable capacity to support future clinical, operational, health services and prevention science research at the foreign site. 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 clinical, operational, health services and prevention science research and current training programs supported by FIC, as well as other research and prevention programs supported by collaborating NIH institutes, and USG agencies, foundations, etc. Evidence of support for this program by collaborating institutions and foreign governments must be submitted in writing with the application. The following review criteria will be used for both full and developmental applications with the understanding that a full application will be judged on the likelihood of success in building upon an existing collaboration and a developmental application by the likelihood of success in establishing a new collaboration. 1. Significance: o Does this training program address an important clinical, operational or health services research problem and do the program priorities reflect those of the collaborating country? 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 at an institutional, country and regional level including potential to serve as a training site for other countries, and o The demonstrated capacity and/or potential to achieve sustained clinical, operational, health services and prevention science research and training efforts at the MFC site, and to build associated clinical, operational, health services and prevention science research and public health capacity within a country and within the region. 2. Approach: o Are the conceptual framework, and training plan adequately developed, well integrated, and appropriate to the aims of the research training and to the capabilities established by the designated parent grant? Details of the training plan should be included. Does the applicant recognize potential problem areas and consider alternative tactics? o Is there a balance in the proposed training program, to provide breadth of training opportunities in academic- and public health-based clinical, operational, health services and prevention science research? o Does the mix of long- and short-term training achieve the goals of this RFA, including focused efforts to build long-term biomedical, behavioral, clinical, operational research, and public health capacity at the institution within a collaborating country? o Is the proposed training plan well integrated into the host institution’s research infrastructure and the training plan reflect integration of previous FIC and current FIC and NIH support involving the foreign collaborating institution? o Are the proposed procedures and criteria adequate for 1) recruitment, review and selection of trainees, and 2) peer review of research? o Considering the challenge grant requirement, is there evidence of a long-term commitment by the U.S. institution to collaborate with its foreign partner(s) and a significant cost sharing by the U.S. and foreign institutions involved in the program? o Have the foreign institute(s) and government(s) expressed a willingness to take advantage of returning former trainees and information gained from the program to improve clinical, operational, health services and prevention science research? 3. Innovation: o Does the clinical, operational, health services and prevention science 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 Does the proposal include concrete plans for trainees to become involved in clinical, operational, health services and prevention science research sciences, biomedical and behavioral research, and prevention projects conducted in their home countries? o Is there adequate and creative planning for the use of modern information technology to facilitate access to scientific information, distance learning, coordination and research collaboration? o Are there creative strategies to take advantage of training opportunities in other countries and to achieve a regional impact? o Is there evidence of integration among and with other FIC programs, NIH research and activities of other relevant organizations at the foreign site? 4. Investigator: o Are the PI, MFC, co-PI, 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 PI and other MFC researchers, if any? o Are the qualifications of the PI, MFC, and the named faculty adequate to lead and to productively participate in the proposed training and research program o Do the PI, MFC, and participating faculty provide active and adequate research support? o Have the parent grant requirements been met and does the area of health science in the parent grant relate to and support the proposed training program? o Have the PI, MFC and key faculty previously collaborated on either research or training? 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 written evidence of institutional support by the U.S. and foreign institutions to build clinical, operational, health services and prevention science research capacity at the foreign institution? o Are there adequate mentoring and 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 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? o The initial review group will also examine the adequacy of the process for providing for the protection of human and animal subjects, 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) or equivalent ethical review boards, 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. Is required training on protection of human subjects documented in application? 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 MFCs in the U.S. and abroad, and designated preceptors, in terms of tracking careers of their past U.S. and foreign trainees and the rate at which former trainees establish independent and productive research and public health careers, and, for foreign trainees, percent who return to their home country, please include tables with this information, including current status of foreign and other selected trainees for at least the past five years. 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, major scientific breakthroughs by trainees should be highlighted. 3. Recruitment and selection plans in detail 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 multidisciplinary training of health professionals. 6. The adequacy of plans to include both genders, minorities (U.S. trainees only) 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 and training. 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, medical and public health 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 U.S. and Foreign Investigator(s) 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: March 15, 2001 Application Receipt Date: April 27, 2001 Date of Initial Review: July, 2001 Review by Advisory Council: September, 2001 Anticipated Award Date: September, 2001 AWARD CRITERIA The most important factor to be considered in making funding decisions will be the quality of the proposed project as determined by initial scientific peer review. The proposed instruction in the responsible conduct of research must be rated adequate for an award to be made. Geographic and programmatic balance, as well as input from the collaborating partners and the FIC Advisory Board and the adequacy of the cost-sharing challenge grant components of the program will also be considered in making funding decisions. A consideration for funding will be whether the proposed training and capacity building is integrated with or duplicates efforts in other FIC and NIH programs and whether it supports a unique intervention opportunity not able to be accommodated by another FIC program. 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 country and institution included in the program through an endorsement from the appropriate government official(s) as well as from the collaborating institutions. INQUIRIES Inquiries are encouraged. Also please refer to our web site for frequently asked questions (FAQs) http://www.nih.gov/fic/. The opportunity to clarify any issues or questions from potential applicants is welcome. Direct inquiries regarding programmatic issues to: Kathleen Michels, Ph.D 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: ICOHRTA@nih.gov Steven Gust, Ph.D. Acting Director, International Program National Institute on Drug Abuse Room 5-274 6001 Executive Blvd Bethesda, MD 20892 301-443-6480 Email: sgust@nih.gov Willo Pequegnat, Ph.D Center for Mental Health Research on AIDS Division of Mental Disorders, Behavioral Research and AIDS National Institute of Mental Health Room 6205 NSC, 6001 Executive Blvd., Bethesda, MD Phone: 301 443 6100. Email: wpequegn@mail.nih.gov Enid Light, Ph.D Program Official Career Development and Research Training and Fellowships Programs National Institute of Mental Health 6001 Executive Boulevard, Rm. 7117, Bethesda, MD 20892-9629 Phone: 301-443-1185, E-mail: elight@nih.gov Rose Maria Li, MBA, PhD Behavioral and Social Research Program National Institute on Aging 201 Wisconsin Avenue, Suite 5C533, MSC 9205 Bethesda, MD 20892-9205 Telephone: (301) 496-3138 FAX: (301) 402-0051 Email: BSRquery@nia.nih.gov (e-mail correspondence is preferred) Nancy A. Hazleton, MPH National Center for Complementary and Alternative Medicine National Institutes of Health 6707 Democracy Boulevard, Suite 106 Bethesda, Maryland 20892-5475 email: hazleton@mail.nih.gov James A. Lipton, DDS, Ph.D. Assistant Director, Office of Training and Career Development Division of Extramural Research, NIDCR Building 45, Room 4AS-37J Bethesda, MD 20892-6402 Telephone: (301) 594-2618 FAX: (301) 480-8318 Email: james_lipton@nih.gov For grants management and fiscal matters, contact: Mr. Bruce Butrum Grants Management Officer Fogarty International Center Building 31, Room B2C39 31 Center Drive, MSC 2220 Bethesda, MD 20892-2220 Telephone: (301) 496-1670 FAX: (301) 594-1211 Email: butrumb@mail.nih.gov AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.934. 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 Public Health Service (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 Health Systems Agency review. The PHS strongly encourages all grant recipients to provide a smoke- free workplace and promote the non-use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routine education, library, day care, health care or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people.


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