INTERNATIONAL TRAINING IN MEDICAL INFORMATICS Release Date: April 30, 1998 RFA: TW-98-003 P.T. Fogarty International Center National Library of Medicine Letter of Intent Receipt Date: May 25, 1998 Application Receipt Date: June 25, 1998 PURPOSE The Fogarty International Center (FIC) and the National Library of Medicine (NLM) invite applications to establish model training programs in medical informatics for African scientists and health professionals. The overall goal of the FIC-NLM International Training in Medical Informatics (ITMI) Program is to build the capacity of biomedical scientists, clinicians, librarians and other health professionals in developing countries to access, utilize and construct computer- based tools such as automated libraries, on-line communication, databases and analytical software that may best advance biomedical research and public health in those countries. This Request for Applications (RFA) constitutes an initial effort that will concentrate on Sub-Saharan Africa, and is intended to complement the efforts of other programs, such as USAID's Leland Initiative, that are facilitating the establishment of Internet connections on that continent. Training programs will produce a cadre of experts from Sub-Saharan Africa who will apply state-of-the-art communications technologies to research and health surveillance activities or who will function in their home countries as trainers or leaders in medical informatics. It is envisioned that trainees will represent a range of skill levels and responsibilities, as relevant to the specific objectives of a program and the environment of the home institution. Technologies and skills that are transferred must be directly related to research, surveillance or clinical applications, and capacity-building activities should be substantially focused on skills beyond basic computer operations. A variety of approaches will be considered responsive to this RFA, including U.S.-based training, formal courses and workshops in home countries, and combinations thereof. Association of a proposed effort with other internationally funded research or training efforts in the home country will significantly enhance the sustainability of any application. Applicants are encouraged but not required to include collaborations with research and training programs currently funded by the FIC, the NLM or other organizations. Efforts that establish sustainable programs will likely function as models for future competitive funding efforts in this area. HEALTHY PEOPLE 2000 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2000," a PHS-led national activity for setting priority areas. This RFA, International Training in Medical Informatics, is related to several priority areas, including those of surveillance and data systems. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0 or Summary Report: Stock No. 017-001-0473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202-512-1800). ELIGIBILITY REQUIREMENTS The grantee institution must be a U.S. non-profit private or public institution capable of meeting the objectives in the RFA. Applicant investigators (or co- investigators) must be a U.S. Principal Investigator of at least one active relevant grant, contract or cooperative agreement from the NIH or another U.S. or international organization. In the interests of building sustainable training programs the proposed project must be explicitly linked, through either the principal or a co-investigator of the proposed project, to a funded research or public health effort in the collaborating country. Applications associated with the Multilateral Initiative on Malaria (MIM) are encouraged. For this RFA eligible collaborating countries are those within Sub-Saharan Africa. A subsequent RFA may be broadened to include other developing countries. The application must demonstrate that the award is relevant to and will enhance the activities of the related grant, and benefit the research needs and public health interests of the collaborating country, and of participating scientists and health professionals. MECHANISM OF SUPPORT This RFA will use the international training grants (D43) mechanism. Awards will be made for a period of up to 4 years. Continuing support during this period will be contingent upon satisfactory progress as demonstrated in annual progress reports, site visits and meetings of program directors. Allowable costs: The following cost categories are eligible for reimbursement under this program. The stipends and allowances are maximums and applicants are encouraged to design the most cost-effective programs: For foreign scientists from developing nations: - Living allowance (stipend) comparable to scientist's professional level and compatible with established NIH guidelines, but not to exceed $45,000 per annum while undergoing training or conducting research in the U.S.; - Stipend, if necessary and justified, to cover the added time for scientists to conduct in-country research if not paid for by the home institution at a level comparable to that received by similar professionals in-country, but also not to exceed $45,000 per annum; - Tuition and fees at the U.S. university; - Round trip economy class air fare between the U.S. and home country (via U.S. air carrier when possible); - Allowance for the grantee institution of up to $600 monthly per scientist to cover health insurance, travel to scientific meetings, and incidental research expenses; - Computer hardware and software for establishment of workstations in the home country institution, not to exceed $10,000 per trainee; - Additional research support of up to $15,000 per person to support training- related project-development or advanced research training in the developing country (the program director is expected to ensure that projects submitted for this funding are peer reviewed by the U.S. institution). Because the ITMI is dedicated to training, the costs to establish and maintain Internet connection and access fees are not generally allowable expenses under this award, unless they are required to execute training as outlined in the proposal. A number of NIH programs that are likely candidates to satisfy this RFA's call for a linked research program already pay Internet access fees in Africa and elsewhere, as a regular cost of doing research. ITMI payment for such costs will generally be limited to training expenses and will require prior FIC approval. For U.S. scientists affiliated with grantee institution: - Economy class travel (via U.S. carrier) and per diem for the program director and U.S. faculty colleagues to provide guidance to trainees conducting related field studies or advanced research training in their home countries; - Economy class travel (via U.S. carrier) and per diem for U.S. faculty presenting short-term courses in the foreign country; - Longer-term support (travel, per diem and pro-rated salary, up to 10 percent of annual salary or $10,000, whichever is less) to enable U.S. faculty to conduct informatics training and associated research in-country; For administrative expenses: - Only limited funds are available for support of administrative expenses at the U.S. institution (e.g., salary support for administration of award, secretarial expenses, etc.). Such expenses should not exceed 10 percent of the direct costs of this award. For related activities with other industrialized nations: - Support for travel and subsistence of U.S. or foreign investigator(s), and the exchange of data, materials and supplies, not to exceed 10 percent of direct costs of this award unless prior approval is secured from the FIC. As a condition of this special expenditure, the applicant must indicate that some form of cost-sharing will be provided by the counterpart institution in an industrialized nation. Requests for an administrative supplemental budget will be considered for increases of up to 20 percent of funded levels in a given budget year. These funds may be requested to meet special needs and to take advantage of unusual opportunities. Such requests will be reviewed by FIC program staff in consultation with NLM, and support will depend upon merit and availability of funds. The grantee institution may request an indirect cost allowance based on 8 percent of the total allowable direct costs, exclusive of tuition and related fees and expenditures for equipment. FUNDS AVAILABLE An estimated $400,000 is available from the FIC to initiate the program in FY 1998, supporting an estimated three new awards. Approximately $350,000 of additional funds from FIC will be allocated to this program in FY 1999 to support two to three additional awards in that year from this competition, contingent on availability of resources and meritorious applications. Applicants can propose budgets of up to $150,000 total costs for year 1, with budget increases of 2% per year for years 2 through 4. Contingent upon availability of funds and achievement of strong results during this first round, recompetition of this RFA is anticipated in the fourth year of this program. Results and impact of the program will be determined by a program evaluation initiated by FIC, working closely with NLM. RESEARCH AND TRAINING OBJECTIVES Improving our ability to prevent and treat diseases depends fundamentally on discovery, compilation and subsequent access to scientific information by researchers, clinicians and public health professionals. Our ability to manage and communicate scientific information has increased exponentially in recent years as computer-based tools have been developed to aid the process of inquiry and health management. While computer-based communication and data management have become central and ubiquitous features of health science and decision making in the developed world, much of the developing world has gained only very limited access to these tools and the benefits they are yielding. This program is intended to address the gap between developed and developing countries in the area of modern information technologies in order to strengthen health sciences research and the collaborative relationships between U.S. scientists and those of developing countries. These efforts will assist developing country scientists and their U.S. partners to address local and global health needs through improved access to scientific and clinical information on health threats and improved research and surveillance capabilities. Specifically, the program is designed to: o Improve the informatics capacity of developing country institutions in order to advance research and health surveillance activities by training key researchers and institutional support staff in those institutions in the use and development of modern informatics technologies in the health sciences; o Provide targeted short-term training in informatics and related disciplines at U.S. institutions and in the home country to develop and disseminate locally adapted knowledge of the informatics technologies in collaborating countries; o Expand and improve ongoing collaborative research between U.S. and African scientists in prevention, control and treatment of infectious and other diseases. Types of Training Emphasis should be given to creating nuclei of experts composed of multiple highly qualified African nationals at specific African institutions through combinations of U.S.-based, medium-term (usually a minimum of one year) training and follow-up supervision and re-entry into home country institutions, as needed to accomplish the objectives of the program. Active involvement in on-going research and health surveillance projects is vital for a successful research and/or public health training experience. Innovative ways to involve trainees in research and monitoring projects conducted in their home countries is especially encouraged. A significant proportion of trainees are expected to develop independent or collaborative research, clinical, or didactic projects to develop, apply and disseminate their new skills in their home countries. Examples of such projects are the development of a regional database to track the incidence of an important disease or a workshop to provide training on accessing and using available databases on biomedical literature. Applicants and trainees should work together to plan and develop projects that complement the objectives of the linked research or surveillance programs and are appropriate to local needs and resources. Applicants are encouraged to develop multi-stage programs that support and track the progress of trainees and their specific projects for several years following their initial training. The following types of training would contribute to satisfying the objectives of this RFA: 1. Formal U.S.- based training for African trainees in computer assisted data analysis and management for biomedical research applications (e.g. biostatistics, Geographic Information Systems [GIS], epidemiological modeling, database construction, and access and use of public biomedical databases) which may lead to an M.S. or the equivalent degree for individuals with degrees in biomedical or other health related science. Such training would normally require that trainees already had basic computer skills and a demonstrated aptitude for computer use. The duration of training is expected to range from one to four academic semesters. Academic courses will normally be taken in the U.S. Associated field studies and research projects could be conducted in the United States, but to the extent possible, should take place in the trainee's home country. 2. Postdoctoral training and research experiences (generally of one to two years duration) for African health scientists (in the United States). 3. Practical and applied short-term training (up to three weeks) targeted to specific needs in support of disease control and prevention research for scientists, technicians, librarians and allied health professionals, including training necessary to support development or use of existing local, national or international medical databases. An excellent example of such a short course in the U.S. is the NLM funded Medical Informatics Course at Woods Hole. This training could take place at the home institution or at regionally important centers such as the NLM funded MEDLARS Centers. 4. Advanced informatics training (generally of one to two years duration) for current and/or former trainees, including re-entry grants to enable them to develop projects that apply newly acquired skills in association with ongoing research or public health efforts. 5. Follow-up training in the home country using distance learning techniques where useful and appropriate. 6. Support to enable U.S. faculty to be involved in advanced research training activities conducted in-country. Trainees Trainees shall be individuals who are involved in or are expected to be involved in biomedical research or health surveillance activities in their home country. Applicants are especially encouraged to recruit junior faculty at African universities or research institutes. The following categories of individuals are eligible for training: 1. Foreign researchers and other health professionals (M.D., D.D.S./D.M.D., Ph.D., or equivalent); 2. Foreign professionals with a bachelors or masters degree in a basic or health science; 3. Medical technicians, computer technicians and health care workers; 4. Allied health professionals such as behavioral scientists, medical librarians, and nurses; 5. Highly qualified current or former trainees from other FIC or NIH programs involved in advanced research training in their home countries. SPECIAL REQUIREMENTS This program should be directed toward informatics associated with research in disease prevention, treatment and research capacity-building in developing countries. Countries that are eligible to participate are limited to Sub-Saharan Africa at this time. Inclusion of countries in the program with particularly severe problems in AIDS, malaria, tuberculosis and other emerging and reemerging infectious diseases are encouraged. Before any funds can be expended from this award, the grantee institution must show evidence of approval for collaborative research between the U.S. and foreign countries and institutions included in the program through an endorsement from the Minister of Health or other appropriate government officials as well as from the collaborating institutions. The application must include a plan describing the recruitment and selection procedures for trainees, types of training they will receive, and the locations of training, including any collaborating U.S. institutions. A plan should also outline the process for peer review of training-related and advanced in-country research (re-entry grants) as well as plans for continued supervision of and collaboration with former trainees. These re-entry grants should support relevant in-country research and health monitoring projects with budgets generally not exceeding $15,000. Projects exceeding this limit require pre-approval from the FIC. The criteria and mechanisms for review and selection of trainees and research projects will be reviewed at the NIH at the time the grant applications are reviewed competitively. After funding, these criteria and mechanisms must be instituted as described and no further outside review carried out at the FIC or elsewhere at the NIH will be required during the funding period of the grant, except for the usual and customary duties of project management at the NIH. As part of their obligations under this program, awardees are required to design and 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 countries of trainees; (3) the contributions to future collaborations with U.S. scientists; (4) the establishment or strengthening of model medical informatics centers in the home countries of trainees. Some examples of such impact will include: a) how training received under the program allows participants to share and apply their new knowledge, and to assume more responsible positions upon returning home; b) how continuing collaborations with trainees affects funding for or enhancement of disease control efforts; c) the number and quality of subsequent health surveillance and research projects in which trainees have a prominent role; d) the number and quality of publications, presentations, courses, awards, etc. in which trainees are first authors or otherwise in a leading position, and which were based upon support under this program. This tracking system and the proposed indicators, to follow trainees at least five years after completion of their training, should be described in the application. Communication International Training in Medical Informatics (ITMI) programs should endeavor to ensure that research results and training innovations are accessible to each other and to other relevant programs in the home countries and internationally by: (a) establishing email list-servers among researchers, trainers and trainees and world wide web sites; (b) sponsoring in-country meetings for all trainees in a country; and (c) exchanging newsletters, CD-ROMs or other products among grantees. In addition, FIC will periodically convene network meetings of grantees. Up to 10 percent of budgets can be utilized for these purposes and additional funds can be requested to support these activities. FIC will establish an ITMI web site linking all of the individual program web sites. Protection of Human Subjects and Laboratory Animals It is not expected that human and animal subjects will be a routine component of ITMI programs except as related to associated funded research projects. It is expected that in those cases where necessary the required assurances will be in place via the associated research when funded by the NIH or other HHS components. Applicable provisions for the protection of human research subjects and laboratory animals in research and training activities must be met in both domestic and foreign settings. Title 45 CFR, Part 46, provides guidelines concerning Department of Health and Human Services regulations for the protection of human subjects. The requirements for using animals are detailed in the Public Health Service Policy on Humane Care and Use of Laboratory Animals. These are available from the Office for Protection from Research Risks (OPRR), National Institutes of Health, 6100 Executive Boulevard, MSC 7508, Rockville, Maryland 20852-7508. In this regard, applicants must be sure to meet the requirements of obtaining single project assurances from OPRR for all projects involving human subjects at foreign sites unless otherwise covered by a multiple project assurance. Applicants must also be sure to obtain the necessary assurances including review at both U.S. and foreign sites for research in which they are actively materially engaged by virtue of consultancy (for example, resulting in co-authorship) or for research conducted on biological samples obtained from scientific colleagues in collaborating countries, if the samples are individually identifiable to any of the scientists. INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS It is the policy of the NIH that women and members of minority groups and their subpopulations must be included in all NIH-supported biomedical and behavioral research projects involving human subjects, unless a clear and compelling rationale and justification is provided that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43). All investigators proposing research involving human subjects should read the "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research," which have been published in the Federal Register of March 28, 1994 (FR 59 14508-14513), and in the NIH Guide for Grants and Contracts, Volume 23, Number 11, March 18, 1994. In this regard, the frame of reference for inclusion of minorities in research is whether the participants would be considered to be minorities in the U.S. population and most of the foreign populations under study would be considered minorities in the U.S. On a related matter, programs are encouraged to include representation of women in selecting foreign trainees and to include adequate representation of women and minorities in selecting U.S. trainees under this program. LETTER OF INTENT Prospective applicants are asked to submit, by May 25, 1998, a letter of intent that includes a descriptive title of the proposed training and research programs, the name, address, and telephone number of the Principal Investigator, the identities of other key personnel and participating institutions in collaborating countries, the identity of any associated projects and their sources of funding, and the number and title of the RFA in response to which the application may be submitted. Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows NIH staff to estimate the potential review workload and avoid conflict of interest in the review. The letter of intent is to be sent to: Joshua Rosenthal, Ph.D. Division of International Training and Research Fogarty International Center 31 Center Drive, MSC 2220 Bethesda, MD 20892-2220 Telephone: (301) 496-2516 FAX: (301) 402-2056 Email: joshua_rosenthal@nih.gov The letter of intent also will be used to communicate any additional information that may be developed to prospective applicants, including the location and time of any meetings that may be convened to answer questions from prospective applicants as well as the status of discussions and possible agreements with other potential funding partners. APPLICATION PROCEDURES The NRSA portion of the research grant application form PHS 398 (rev. 5/95) is to be used in applying for these grants. These forms are available at most institutional offices of sponsored research; 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: ASKNIH@od.nih.gov; and from the program administrator listed under INQUIRIES. The RFA label available in the PHS 398 (rev. 5/95) application form must be affixed to the bottom of the face page of the application. Failure to use this label could result in delayed processing of the application such that it may not reach the review committee in time for review. In addition, the RFA title and number must be typed on line 2 of the face page of the application form and the YES box must be marked. Submit a signed, typewritten original of the application, including the checklist, and three signed photocopies, in one package to: CENTER FOR SCIENTIFIC REVIEW NATIONAL INSTITUTES OF HEALTH 6701 ROCKLEDGE DRIVE, ROOM 1040, MSC 7710 BETHESDA, MD 20892-7710 BETHESDA, MD 20817 (for express/courier service) At the time of submission, two additional copies of the application and five copies of any appendices must be sent to: Dr. Sharee Pepper Extramural Programs National Library of Medicine Bethesda, MD 20894 Telephone: (301) 496-4253 FAX: (301) 402-0421 Email: sp38o@nih.gov Applications must be received by June 25, 1998. If an application is received after that date, it will be returned to the applicant without review. The Center for Scientific Review (CSR) will not accept any application in response to this RFA that is essentially the same as one currently pending initial review, unless the applicant withdraws the pending application. The CSR will not accept any application that is essentially the same as one already reviewed. This does not preclude the submission of substantial revisions of applications already reviewed, but such applications must include an introduction addressing the previous critique. REVIEW CONSIDERATIONS Upon receipt, applications will be reviewed for completeness by the CSR and responsiveness by the FIC. Incomplete applications will be returned to the applicant without further consideration. If the application is not responsive to the RFA, the application will be returned to the applicant without review. Applications that are complete and responsive to the RFA will be evaluated for scientific and technical merit by a peer review group convened by the NLM 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 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 review, comments on the following aspects of the application will be made 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 the assignment of the overall score. Factors to be considered in the scientific evaluation of each application include: In general, the likelihood that the applicant institution can meet the goals and objectives stated in this RFA and specifically considering the following: (1) Significance o The expected public health and scientific contributions of the proposed activity; o The demonstrated capacity and/or potential to achieve sustained research and training efforts and to build the informatics skill base for research and public health capacity within a country; o Strength of the academic and training program. (2) Approach o The appropriate mix of long- and short-term, initial and follow-up training to achieve the goals of this RFA; o Opportunities for trainees to become involved in medical research and disease control and prevention projects conducted in their home countries; o Adequacy of proposed procedures and criteria for 1) recruitment, review and selection of trainees, and 2) peer review of informatics applications to medical research, disease control and prevention projects; o Demonstrated capacity and/or potential to collaborate with other institutions and to coordinate program activities with related efforts of other NIH programs, other federal agencies (e.g., CDC, USAID), international organizations and programs (e.g., WHO, MIM), and NGOs; o Systems for documenting the long-term impact of the program on research and public health capacity in the home countries of trainees, including the impact of the program on the careers of current and former ITMI trainees; o Effectiveness of plans to disseminate newly acquired medical informatics skills within institutions and countries of collaborators and trainees; o Overall cost-effectiveness of the training and research plan. (3) Innovation o Adequacy and creativity of plans to build modern information technology capacity in countries and institutions that may currently have limited resources and limited access to the internet; and o Overall creativity of the training and research plan. (4) Investigator(s) o Qualifications of the program director to lead and the named faculty to participate in the proposed training and research program; including their collective depth of experience in the fields of health research and medical informatics, and research support from the NIH and other sources; o Documentation of previous international collaboration with developing country scientists and institutions included in the proposed program; and o Previous success in training scientists and others in medical research and informatics. (5) Environment o Demonstration of continued or of future support for the program from governments and institutions and other non-governmental organizations from collaborating countries; o Demonstrated support for associated research and training from the NIH or other sources; o Training environment in-country as evidenced by 1) the quality of local teaching and research facilities and other resources; 2) the availability of high-quality candidates; and 3) past history of success as mentors and institutional commitments to former trainees in other internationally funded programs upon returning to their home countries; o Training environment in the United States including the institutional commitment, the caliber of preceptors, the quality of teaching, and research facilities and resources. The initial review group will also examine the adequacy of the process for or the protection of human and animal subjects and the safety of the research environment where relevant. AWARD CRITERIA Applications will compete for available funds. In making funding decisions, the following will be considered: responsiveness to the research and training objectives, scientific merit as determined by peer review, availability of funds, and programmatic priorities. Schedule Letter of Intent Receipt Date: May 25, 1998 Application Receipt Date: June 25, 1998 Review for Scientific Merit: August 1998 Review by the FIC Advisory Board: September 1998 Anticipated Award (Start) Date: September 30, 1998 INQUIRIES Prospective applicants are encouraged to discuss their applications, including proposed collaborating countries and institutions with FIC program staff before submitting a formal application. Potential resources and collaborators including currently funded research and training programs and their directors, as well as several other useful links can be found at the following www address: http://www.nih.gov/fic/opportunities/. Programmatic and scientific inquiries, including any requests for further instructions to prepare applications, may be directed to: Dr. Joshua Rosenthal Division of International Training and Research Fogarty International Center 31 Center Drive - MSC 2220 Bethesda, MD 20892-2220 Telephone: (301) 496-2516 FAX: (301) 402-2056 Email: joshua_rosenthal@nih.gov Inquiries related to the review of these applications may be directed to: Dr. Sharee Pepper Extramural Programs National Library of Medicine Building 38A, Room 5N519 Bethesda, MD 20894 Telephone: (301) 496-4253 FAX: (301) 402-0421 Email: sp38o@nih.gov Inquiries regarding fiscal matters may be addressed to: Ms. Silvia Mandes Division of International Training and Research Fogarty International Center 31 Center Drive - MSC 2220 Bethesda, MD 20892-2220 Telephone: (301) 496-1653 FAX: (301) 402-0779 Email: silvia_mandes@nih.gov AUTHORITY AND REGULATIONS Awards are made under authorization of the Public Health Service Act, Title III and Title IV, Part A (Public Law 78-410, as amended by Public Law 99-158, 42 USC 241, 242l and 287b) and administered under PHS grants policies and Federal regulations 42 CFR 52 and 45 CFR Part 74. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or to Health Systems Agency review. The 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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