INFORMATICS TRAINING FOR GLOBAL HEALTH (ITGH) RELEASE DATE: June 26, 2003 RFA: TW-03-008 Update: The following update relating to this announcement has been issued: December 24, 2008 - This RFA has been reissued as (RFA-TW-09-001). Fogarty International Center (FIC) (http://www.fic.nih.gov) National Library of Medicine (NLM) (http://www.nlm.nih.gov) National Institute of Biomedical Imaging and Bioengineering (NIBIB) (http://www.nibib.nih.gov) National Human Genome Research Institute (NHGRI) (http://www.genome.gov) CATALOG OF FEDERAL DOMESTIC ASSISTANCE NUMBER: 93.989 LETTER OF INTENT RECEIPT DATE: September 26, 2003 APPLICATION RECEIPT DATE: October 23, 2003 THIS RFA CONTAINS THE FOLLOWING INFORMATION o Purpose of this RFA o Research Training Objectives o Mechanism of Support o Funds Available o Eligible Institutions o Individuals Eligible to Become Principal Investigators o Special Requirements o Where to Send Inquiries o Letter of Intent o Submitting an Application o Peer Review Process o Review Criteria o Receipt and Review Schedule o Award Criteria o Required Federal Citations PURPOSE OF THIS RFA The Fogarty International Center (FIC), in collaboration with the National Library of Medicine (NLM), the National Institute of Biomedical Imaging and Bioengineering (NIBIB), and the National Human Genome Research Institute (NHGRI), invites applications for the establishment or continuation of training programs in informatics for global health to address the needs of developing country institutions for information technologies and associated sciences to support biomedical research. U.S. institutions, in partnership with developing country institutions that have strong, independent or collaborative, funded medical research programs are eligible to apply with the goal of enhancing and further strengthening those research activities. Applicants are expected to develop innovative training programs for developing country biomedical and behavioral scientists and engineers, clinicians, librarians, and other health professionals that increase their capacity to access, manage, analyze, interpret, manipulate, model, display, and share biomedical information electronically. Programs that include training in data management, biostatistics, biological imaging, disease surveillance, epidemiology, computer modeling, and bioinformatics are particularly encouraged. It is envisioned that developing country institutions participating in the program may eventually serve as regional centers for medical, genome, and global health informatics training. Training programs should be directed toward building informatics capacity in the partner foreign country that can contribute directly to research in disease pathogenesis, prevention, diagnostics, or treatment. Inclusion of countries in the program with particularly severe endemic or epidemic malaria, HIV/AIDS, tuberculosis, or a growing burden of chronic, non- communicable diseases is encouraged. Institutions carrying out biomedical and behavioral research are usually composed of multiple individual laboratories and departments working on many separate research problems. However, many of these projects have common needs for research expertise and infrastructure. For example, within a single institution, training in information sciences, molecular genetic technologies, and bioethics would each benefit a large number of groups and strengthen the research capacity at the institution overall. Creating a core of expertise in these fields within institutions could serve to "glue" the disparate laboratories into a more efficient and interactive entity. Moreover, experts in any of these fields might choose to collaborate widely with a variety of institutional programs, further strengthening those ties. This RFA is a first step toward realizing the goal of "gluing" outstanding research institutions in developing countries into more cohesive and efficient operational units. Information technology is required in almost all research programs, both to access the vast information resources available internationally and to apply to research design and analysis. This need is even more pressing in the increasingly multidisciplinary and multilaboratory projects in global health, such as the recent human, Anopheles, and Plasmodium genome consortia, or in multi-site clinical trials or international disease surveillance and prevention programs. In these projects, large datasets must be shared between unrelated laboratories, posing significant data management and analysis challenges. In addition, advances in global health may be increasingly driven by new technologies that emerge at the interface of computational and biomedical science. The genomics and proteomics revolutions are stunning examples of such creative collaborations. Finally, there is a need to learn how to archive and retrieve new types of data, such as the enormous amount of information contained within images. For all of these reasons, information technology can be seen as a cornerstone of institutional research capacity. To achieve these goals, applicants should focus on developing a training program in partnership with a single developing country institution that serves as a "center of research excellence" in their region, in the sense that they have active research programs of high quality in a number of areas. The objectives are: (1) To train individuals who will apply state-of-the-art information and communication technologies to research, health surveillance, and other biomedical applications and who will function in their home institutions as trainers or leaders in these technologies; (2) To raise awareness of and access to informatics resources within the larger scientific community at the institution; and (3) To develop a plan to create a sustainable medical and global health informatics training program at the institution. Training plans should be directly integrated with the research activities at the institution. Technologies and skills that are emphasized during training must be directly related to research applications, and capacity-building activities should be substantially focused on skills beyond basic computer operations. Within that context, it is envisioned that trainees will represent a range of skill levels and responsibilities, as relevant to the specific research training and capacity building objectives of the program and the environment of the home institution. This RFA follows an earlier RFA (TW-99-003), International Training in Medical Informatics (ITMI), which focused broadly on building medical informatics capacity in developing countries of sub-Saharan Africa, Latin America, and the Caribbean. The present RFA represents a further evolution of this program. The geographical focus has been expanded to include any country that meets the World Bank criteria of a low- to middle-income economy (see below). The current focus on foreign institutions with substantial research programs is intended to encourage the integration of medical, genome, and disease informatics training with ongoing research activities to more directly create and more efficiently deploy biomedical and behavioral research informatics capacity for the region. As a critical mass of trainees return to their home institutions, it is envisioned that some of these individuals may in turn become mentors for future trainees, such that a sustainable training program can eventually be developed to serve the larger region. RESEARCH TRAINING OBJECTIVES Improving our ability to prevent and treat diseases depends fundamentally on discovery, compilation, analysis 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 analysis. The sheer volume of data generated in biomedical and behavioral research and in clinical trials can no longer be effectively managed without electronic help. Access to computers and the Internet is becoming more commonplace in research institutions throughout the developing world. To take full advantage of these tools, however, individuals with the advanced skills to use them are critically needed. This program is intended to increase the capacity of developing country scientists and medical professionals to design, access and use modern information technology in support of health sciences research. For the purposes of this RFA, "informatics for global health" is broadly defined as all computer-aided manipulation of medically-relevant scientific information. It encompasses data management, exploratory data analysis and biostatistics, algorithm-driven analysis of large data sets (bioinformatics, including genomics and proteomics analysis), access portals to public databases, computational biology and computer modeling, disease surveillance and epidemiology, and image analysis, among many other subdisciplines. Specifically, this program is designed to: o Improve the health informatics capacity of developing country institutions to advance biomedical research activities by training key researchers and institutional support staff in those institutions in the use and development of modern information technologies in the health sciences; o Provide targeted short-term training in informatics to address specific needs of the biomedical and research community of the collaborating institution; o Provide workshops, seminars, and conferences at the foreign institution to raise awareness of informatics approaches and resources of relevance to the research community in the foreign country; o Provide medium- to long-term training for individuals from the partner developing country who will become leaders and teachers of health-related informatics in the home institution; o Initiate or enhance research activities in the partner institution through the use of informatics expertise, particularly in the context of multidisciplinary approaches to public health priorities in the home country; o Expand and improve collaborative research possibilities between U.S. and developing country scientists in the prevention, control and treatment of diseases of public health relevance in the home country; and o Take initial steps or strengthen ongoing efforts towards building a sustainable training program in Global Health Informatics for health professionals within the developing country and surrounding geographical region. Required Elements of the Application The application must include the following sections: o A discussion of the need for increased informatics expertise at the foreign institution. This should include a description of the current informatics capacity, including skilled professionals and infrastructure at the institution, any barriers to use of this infrastructure, and any modest enhancements of this infrastructure that would be necessary to carry out the research-training program. These descriptions can establish a baseline against which progress may be measured and the impact and success of the program eventually evaluated. o A description of the ongoing NIH- and other funded biomedical and behavioral research and training projects at the foreign institution that the proposed training and capacity-building efforts will draw upon and support. o Identification of appropriate collaborators at both the developing country and U.S. training sites, including a primary foreign collaborator at the foreign institution (see below for eligibility requirements). o Design of a training plan that addresses the needs identified and that provides for integration of informatics training with ongoing biomedical and behavioral research and training programs at the foreign site. The training plan should include sufficient detail to judge the opportunities available to trainees, specific adaptations to curricula or programs already available at the U.S. or foreign site, design of new curricula to meet specific needs of the trainees, as necessary, and any other details that will create a clear picture of the training options. Training may focus on strengthening a single area of Global Health Informatics or providing a broader set of options, as consistent with the needs of the institution. Provisions for mentoring of students at both the U.S. and foreign sites should be emphasized. The training plan may include suggestions for short courses targeting end- users in the foreign institution/region, which address the needs identified. o An explicit description of how the training program will be linked to ongoing biomedical and behavioral research and training projects at the foreign site, with appropriate letters, where necessary, expressing willingness to integrate informatics trainees into these projects. o A detailed plan for recruitment of trainees to ensure that the most qualified individuals can be identified, and a description of the criteria and process for trainee selection. One criterion of selection should be the likelihood that the chosen individuals will return to or remain in their home countries and contribute their new skills to the biomedical research and training enterprise there. Thought should also be given to preparation of medium- to long-term trainees in English language and/or computer skills in the summer preceding studies in the U.S. or at the foreign site, where appropriate, to allow them to make optimal use of their formal training period. Fees for such courses are allowable costs. Degree candidates must meet all entrance requirements of the grantee degree-granting institution. o A discussion of how activities undertaken during the award period might begin to build a sustainable global health informatics training program in the partner foreign institution. For example, by the end of the award period this might include a plan to offer short-courses or workshops on a fee basis in the collaborating country, engaging former trainees as faculty for these courses [Note that other NIH/FIC training and research grants or other private-public sources of research funding may be able to pay some fees for this training.]; the introduction of informatics courses into existing curricula; development of distance learning courses; negotiations with host-country institutions to establish certificate or degree programs in some area of global health informatics; and other relevant activities. While a sustainable training program may not be achieved within the time period of the award, a plan and progress towards this end should be developed during the grant period. For those programs based on ongoing collaborations or previous International Training in Medical Informatics awards, some of these efforts may have already been initiated, in which case the applicant should describe how the current program will strengthen, secure, and/or expand those efforts. o Evidence should be provided of substantive institutional commitment in the foreign country (this may include space, positions, matching funds, infrastructure support, access to data and systems, trainee support during their re-entry period, a commitment to establish a degree or certificate program, etc). o A plan for self-evaluation of the program, including a plan to track trainees for at least five years after completion of their training. Awardees will be required to track and document the long-term impact of this training program on the success of the trainees as measured by the number and quality of publications, electronic products, presentations, courses developed, awards, subsequent employment, involvement in research or public health, career advancement, etc.; their sustained commitment to research careers involving medical informatics in their home countries; their ability to attract funding for their work; their contributions to future international collaborations, conferences, and training; their influence on the development and use of informatics in their countries; and their ability to act as consultants, teachers, collaborators and role models to other local investigators and further disseminate the lessons learned. Metrics should eventually encompass both the success of the individual trainees and the success in capacity- building at the institution, including the impact of the program on biomedical and behavioral research capacity at the institution and the establishment or strengthening of informatics training capability. An evaluation of the impact of training resulting from each program will be considered an important criterion during any re-competition of this RFA. Applicants should establish some mechanism to periodically review the progress of the trainees and the effectiveness of the program. This may consist of regular meetings among faculty participating in the program or periodic review by an outside group of consultants. Types of Training Many types of training plans could be considered responsive to this RFA. In considering types of training, program directors should develop a plan in consultation with the foreign collaborator that addresses the needs of the foreign institution. Training should include outreach to the larger biomedical community at the foreign institution, for example, through short courses, workshops, or conferences. Training may occur in either the U.S. or developing country institution. However, applicants are strongly encouraged to provide support and mentoring by U.S. and developing country faculty for trainees to conduct the research related to their training in the host developing country. The training program might include but would not be limited to combinations of the following: o Short-term targeted training of biomedical research and allied health personnel in the host country (e.g. medical librarians, technicians, database managers, researchers and students requiring specific informatics expertise to carry out their work, physicians, nurses, midwives, health administrators, and other health professionals). Short courses and workshops may present overviews of global health informatics or address specific topics of interest to the local scientific community. Excellent examples of such short courses in the U.S. are the NLM-funded Medical Informatics Course at Woods Hole and the NHGRI-funded Computational Genomics Course at Cold Spring Harbor Laboratories. Short courses are also a useful way to identify candidates for longer-term training. While short courses may be appropriate during each year of the program, it may be particularly effective to plan for short courses in the first year, during the period when longer-term candidates are being identified and recruited. It is expected that some of these short courses will also be open to NIH trainees in other programs in the region, whenever feasible, as a means of enhancing research capability and of fostering research collaborations among trainees from different programs within the country. For a list of FIC-sponsored training programs and PIs, see http://www.fic.nih.gov/programs/grants.html and linked sites therein. For programs from other NIH Institutes, see the corresponding websites. o Medium-term advanced training (three to six months), such as intensive courses carried out in the U.S. or in the foreign country in targeted subject areas. In some cases, this might accommodate researchers in the host country that require specific training to advance their research (for example genomics projects that require bioinformatics support or clinical trials that require biostatistics support). o Longer-term advanced training to develop a core of specialists who will become professional global health informatics research investigators and future leaders for global health informatics at the host institution and in the region. Training might include any area of computer-assisted data analysis and management for biomedical and behavioral research applications (e.g. biostatistics, Geographic Information Systems [GIS], epidemiological modeling, bioinformatics, database construction, and access and use of public biomedical databases such as GenBank, Ensembl, UniProt, or PubMed) and should be at a level that might lead to an M.S. or equivalent degree for individuals with degrees in biomedical or other health-related sciences. A smaller number of individuals may then continue on to Ph.D.s in Medical Informatics or other medically relevant informatics fields. Training and follow-up research projects should emphasize skills that will contribute to biomedical and behavioral research per se, as opposed to purely medical or public health uses such as telemedicine and the design of medical records systems, unless these are linked directly to a research program. Such training would normally require that trainees already have basic computer skills and a demonstrated aptitude for computer use. o Advanced informatics postdoctoral training and research experiences in the U.S. (generally, one to two years duration) for developing country health scientists. Long-term trainees and post-doctoral fellows may also benefit from learning grant-writing skills through workshops or courses offered during their training, and should be encouraged to compete for grant support from other NIH or international programs, such as the Fogarty International Research Collaboration Award (FIRCA) or the Global Health Research Initiative Program for New Foreign Investigators (GRIP). o Advanced research training support ("re-entry" funding), generally for one to two years duration, to enable trainees with advanced degrees or health care professionals to continue mentored informatics research in their home country as a continuation of their training program. Research projects should be related to ongoing research at the developing country institution. Such funds for a mentored research experience should not exceed $15,000 direct costs per year. Projects exceeding this limit require pre-approval from the FIC. In the interests of developing teaching programs within the home institution, some trainees may choose to develop short courses or more comprehensive curricula for use in the home country. Such activities should also be mentored and support can be provided through this grant as re-entry funds. Applicants should describe how requests for re-entry funds will be reviewed and evaluated, and how such projects will be mentored and monitored. Such research is subject to all the restrictions, assurances, and permissions required of any research program funded by the NIH. Research involving human subjects, including use of data from previous studies that contains identifiable, private information from living individuals, must be conducted under an already funded, approved, and current grant protocol from the NIH (see Regulation 45CFR46.102F). o Conferences that highlight the interconnections between informatics and research addressed to pressing health issues in the country. At later stages of the program, this might also provide a forum for trainees to present their research and as a reunion for former trainees and a means to assess the impact of the program on their careers. Integration of training with on-going biomedical or behavioral research, training, and/or hypothesis-driven health surveillance projects in the home institution is a fundamental and required aspect of this program and innovative approaches to this objective are encouraged. Medium- and long-term trainees are expected to develop independent or collaborative research projects to deepen, apply and disseminate their new skills in their home countries. These projects should be integrated with or topically related to ongoing research projects at the home institution, and examples of potential projects that would achieve this objective should be presented in the application. In addition, ways in which the trainees might interact with existing research programs at the foreign institution (either directly through collaborative research or indirectly through common research meetings or opportunities to present research results) should be described. Examples of trainee projects include: the development of a regional database to track the incidence of an important disease and ask explicit research questions using it; bioinformatics research based on genomics projects related to human disease agents (such as Plasmodium falciparum or M. tuberculosis) or human haplotypes that affect disease susceptibility or resistance; collaboration with a chronic disease research group (for example, hypertension, stroke, diabetes, or cancer) to design a system to manage and mine data; collaboration with an occupational and environmental health or epidemiological research project to test innovative approaches to data collection or contribute to biostatistical design and analysis; data analysis to support clinical trials or to assess the effectiveness of HIV-prevention projects; work with a team of collaborating laboratories to design a system to record and share data from dispersed sites, especially to develop a database system to share data from multiple resource-poor sites that might serve as a model for other groups with similar needs to share information; or computational modeling projects involving disease agents or basic metabolic processes. Collaborations to develop new technologies, such as might apply to disease diagnostics in resource-poor settings, are also appropriate. 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. Where appropriate, the design of projects should take into account potential sex and gender differences that may affect the questions asked and the analyses performed. These might include different responses to and impacts of health interventions, differences in physiology, and different behavioral bases for disease prevention strategies. Trainees Trainees should be individuals who are currently involved or will be involved in biomedical or behavioral research or health surveillance activities in their home country. A research institutional base for trainees to return to is an integral part of the eligibility of the trainees. Initially, trainees should be drawn from individuals who work or intend to work at the partner institution. However, as the needs of the institution are met, trainees may be recruited more widely from surrounding institutions in the region. The "region" may be defined as deemed appropriate by the applicants. Program directors are strongly encouraged to include women and individuals from underrepresented racial, ethnic, and socially disadvantaged groups in the country as trainees. The following categories of individuals are eligible for training: o Foreign researchers and other health professionals (M.D., D.D.S./D.M.D., Ph.D., or equivalent); o Foreign professionals with a bachelors or masters degree in a basic or health science; o Medical technicians, computer technicians, nurses, midwives, and other health care workers; o Allied health professionals, such as medical librarians; and o Highly qualified current or former trainees from other FIC or NIH programs involved in advanced research or research training in their home countries. Project Organization To achieve the objectives of this RFA, it is likely that creative coalitions of investigators and institutions will be required. The team should be multidisciplinary and include experts in medical informatics as well as in research areas related to the linked research projects targeted towards the health concerns of the collaborating foreign country. While the intention of this RFA is to build research capacity within a single foreign institution in the partner developing country, there may be compelling reasons to include more than one institution from that country within the training program. For example, it may be the case that active research projects are carried out in a research institute or medical center that does not have the capability to develop didactic degree or certificate programs in medical informatics. In this case, a plan to develop a sustainable training center for medical informatics might require a coalition with a more appropriate partner institution, such as a nearby university. Alternatively, the research programs of two institutions may be tightly linked. If more than a single institution in the developing country is proposed, these institutions should have an explicitly expressed desire to work together. Letters to this effect must be provided. At least one of these institutions must fulfill the full eligibility requirements of this RFA and will be considered the primary foreign partner. If more than one institution is proposed, a strong justification must be provided why both institutions are necessary to realize the objectives of the training program. MECHANISM OF SUPPORT This RFA will use the NIH D43 (International Training Grant) award mechanism. As an applicant you will be solely responsible for planning, directing, and executing the proposed project. This RFA is a one-time solicitation. The anticipated award date is May 31, 2004. FUNDS AVAILABLE The participating NIH Institutes and Centers (ICs) intend to commit approximately $1.5 million in fiscal year 2004 (FY04) to fund up to six new and/or competing continuation grants in response to this RFA. An applicant may request a project period of up to five years and a budget of up to $250,000 total costs [direct plus facilities and administrative costs] per year. Consortium costs are included in the $250,000 total cost cap. Because the nature and scope of the proposed research will vary from application to application, it is anticipated that the size and duration of each award will also vary. Although the financial plans of the ICs provide support for this program, awards pursuant to this RFA are contingent upon the availability of funds and the receipt of a sufficient number of meritorious applications. ELIGIBLE INSTITUTIONS You may submit (an) application(s) if your institution has all of the following characteristics: o Non-profit o Public or private organizations, such as universities, health professional schools, and research institutions capable of meeting the objectives of the RFA o Domestic Applicants, from U.S. institutions, must collaborate with a single institution in an eligible developing country and must name an individual at that institution as a primary foreign collaborator. If more than one institution is named (see "Project Organization", above), collaborators at each institution should be identified. Eligible countries are defined as low- to middle-income countries. See the World Bank website for a list of these countries (http://www.worldbank.org/data/databytopic/CLASS.XLS). The collaborating foreign institution on this application must be a non- profit public or private institution. At the time of anticipated award for this training program, this institution must be an NIH grant recipient or a substantial foreign partner in a minimum of three active FIC- or NIH-funded major research or training grants (R01, U01, P01, D43, U19). "Substantial" participation requires that scientists from the foreign institution must be listed as "key personnel" on the NIH grant. At least one of the three qualifying grants must be for research. R03 grants and current ITMI awards do not contribute to eligibility, although they may increase the attractiveness of the foreign site as a research partner. In addition, the developing country institution must have sufficient computer infrastructure and Internet connectivity in place (subject to only modest enhancement) to build upon for a training program, as the focus of these awards is training and not infrastructure development, per se. Multiple U.S. institutions may collaborate to jointly submit a single application to work with an eligible developing country institution. While not disallowed, in the interests of using this training program as a "glue" for the foreign research institution, it is desirable to have only a single training program at any individual foreign site. INDIVIDUALS ELIGIBLE TO BECOME PRINCIPAL INVESTIGATORS Any individual from an eligible institution with the skills, knowledge, and resources necessary to carry out the proposed research is invited to work with their institution to develop an application for support. Women, individuals from underrepresented racial and ethnic groups, as well as individuals with disabilities, are always encouraged to apply for NIH programs. At the time of application, applicant Principal Investigators (PIs) must be the PI or Project Director on at least one active research grant, training grant, or cooperative agreement from the NIH or another U.S. government agency or organization in the medical informatics or linked research area proposed for training. NIH-sponsored research project grants (R01) or center grants, program project grants or cooperative agreements ("P" and "U" series), and D43 grants qualify for this requirement. Equivalent research grants from other sources, including all non-NIH grants, may qualify if approved by the FIC program officer before submission of the application. The applicant training institution must demonstrate either an ongoing collaborative research relationship or high potential for development of collaborative research with the developing country institution named in the application. The foreign collaborator must have a position that will allow him or her adequate time and provide appropriate facilities and resources to participate in the proposed medical informatics research-training program. Finally, the proposed training program must be explicitly linked, through the PI, a co-investigator, or the foreign collaborator of the proposed project, to at least one of the qualifying funded research or training efforts at the collaborating foreign institution. The application must demonstrate that the award is relevant to and will enhance the activities of the related research grant(s), as well as the research needs and public health interests of the collaborating country. SPECIAL REQUIREMENTS The grantee institution must show evidence of approval for collaborative research and training between the U.S. and foreign institutions included in the program. This can be documented by providing a letter of endorsement from the appropriate officials at the collaborating institutions at the time of application. Re-competing ITMI applicants must include a description of the activities and achievements of their current ITMI award. This should include a list of the trainees and their accomplishments to date and, where appropriate, the percent of trainees that were trained in the U.S. and subsequently returned to their home countries. A list of publications in peer-reviewed scientific journals in which trainee research was supported by the previous ITMI award, i.e. publications in which trainees are authors or co-authors and the FIC award is cited in the acknowledgements, should be included. Since it is expected that other research products, particularly electronic resources, will be generated in these programs, non-publication type products should also be cited. Any other parameters that measure the impact of these programs on the collaborating foreign country's biomedical research, medical, or public health capacities should be described. Training in Responsible Conduct of Research: Applicants must include plans for training in responsible conduct of research for long-term trainees. For more information on this provision, see the NIH Guide for Grant and Contracts (volume 21, number 43 http://grants.nih.gov/grants/guide/notice-files/not92-236.html). NIH does not require a specific curriculum or format for instruction but the following areas should be included: conflict of interest, responsible authorship and institutional policies for handling scientific misconduct, human subjects, animal studies, data management and data sharing. The inclusion of international perspectives on these topics is strongly encouraged. An award will not be made unless a description of such training is included. The description should include the topics, format, faculty participation, instructional materials and the frequency and duration of the training provided. Communication and Network meetings: ITGH programs should endeavor, whenever possible, to ensure that research results and training innovations are accessible to other ITGH programs and to relevant programs in the home countries or internationally by means such as: making presentations at local and international conferences and publishing results in local and international journals; exchanging newsletters, CD-ROMs or other products among grantees; inviting trainees from other FIC programs within the home institution, country, or region to apply for short-term workshops conducted within the foreign country; or posting materials on websites accessible to the public. In addition, FIC will periodically convene network meetings of grantees and funds should be budgeted in the application to allow PIs and foreign collaborators to attend these meetings in each year of the award. As the programs mature, it will be desirable to have trainees also attend these meetings. WHERE TO SEND INQUIRIES We encourage inquiries concerning this RFA and welcome the opportunity to answer questions from potential applicants or discuss prospective proposals and eligibility issues. Inquiries may fall into three areas: scientific/research, peer review, and financial or grants management issues. o Direct your questions about scientific/research issues to: Dr. Flora Katz Division of International Training and Research Fogarty International Center National Institutes of Health Building 31C, Room B2C39 Bethesda, MD 20892-2220 Telephone: (301) 402-9591 Fax: (301) 402-0779 Email: firstname.lastname@example.org o Direct your questions about peer review issues to: Dr. Merlyn Rodrigues Scientific Review Administrator Division of Extramural Programs National Library of Medicine 6705 Rockledge Drive, Suite 301 Bethesda, MD 20892-7968 (for US mail) Bethesda, MD 20817 (for express/courier service) Telephone: (301) 496-4253 Fax: (301) 402-2952 Email: RodrigM@mail.nlm.nih.gov O Direct your questions about financial or grants management matters to: Mr. Bruce Butrum Grants Management Officer Fogarty International Center National Institutes of Health Building 31, Room B2C39 Bethesda, MD 20892-2220 Telephone: (301) 496-1670 Fax: (301) 402-0779 Email: email@example.com LETTER OF INTENT Prospective applicants are asked to submit a letter of intent that includes the following information: o Descriptive title of the proposed research o Name, address, and telephone number of the Principal Investigator o Names of other key personnel, including the major foreign collaborator o Participating institutions o Number and title of this RFA 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 plan the review. The letter of intent is to be sent by the date listed at the beginning of this document, either by mail or electronically. The letter of intent should be sent to: Dr. Flora Katz Division of International Training and Research Fogarty International Center National Institutes of Health Building 31, Room B2C39 31 Center Drive, MSC 2220 Bethesda, MD 20892-2220 Telephone: (301) 402-9591 Fax: (301) 402-0779 Email: firstname.lastname@example.org SUBMITTING AN APPLICATION Applications must be prepared using the PHS 398 research grant application instructions and forms (rev. 5/2001). The PHS 398 is available at http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive format. Applicants should follow the instructions for the institutional NRSA found at the end of the PHS 398 instructions to construct their application. For further assistance contact GrantsInfo, Telephone (301) 435-0714, Email: GrantsInfo@nih.gov. SUPPLEMENTAL INSTRUCTIONS: All expenses related to trainee participation in the program should be itemized on the PHS Form 398 (NRSA substitute budget pages 4 & 5) in the appropriate categories. All expenses related to faculty participation in the program should be itemized on the PHS Form 398 (budget form pages 4 & 5) in the appropriate categories. The total direct costs of the faculty participation budget should be identified on PHS Form 398 (NRSA substitute budget pages 4 & 5) in the "Other" category. The combining of the budgets will allow reviewers and FIC staff to review a composite budget of all costs. The grantee institution may request a Facilities and Administrative (F & A) cost allowance based on eight percent of the total allowable direct costs, exclusive of tuition and related fees and expenditures for equipment. Note that using PHS 398 budget calculations, F & A costs on a subcontract become a part of the direct costs of the grant. Although the U.S. institution will serve as the grantee institution for the purposes of this award, it is envisioned that the focus of training will gradually shift toward the host country over the course of the award period. By the fifth year of the award, it is expected that the majority of the funds will be expended in support of activities at the foreign institution. Budgets may include costs to support the various types of training proposed (tuition, academic fees, stipends, salary, travel, per diem, trainee self-only or family medical insurance) for trainees and faculty, and costs to support the administration of the program and grant. The salary for the PI, other training faculty and administrative staff must be commensurate with the salary structure and benefits at the corresponding institution. The percent effort for administrative support at either the U.S. and/or the foreign site must be justified in relationship to the number of trainees expected to be in residence at either institution. 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. Trainees may be paid a stipend, comparable to the scientist's professional level and compatible with established NIH guidelines, while undergoing training or conducting research in the U.S., or at a level comparable to that received by similar professionals in-country while undergoing training or conducting research in their home countries, but in neither case to exceed $50,808 per annum. Applicants may wish to refer to the NRSA stipend levels described at http://grants.nih.gov/training/nrsa.htm. Costs for computer hardware and software for establishment of workstations in the home country institution for use by trainees are allowable. In addition, costs to establish and maintain Internet connection at the foreign site, including telephone and Internet service provider fees, at a cost consistent with current rates available in the foreign country, are allowable. Together, these costs should not exceed $25,000 per year without prior permission from FIC. Additional trainee support of up to $15,000 direct costs per person per year for research in the home country is allowable. This may include funds to support training-related research projects, advanced research training, or preparation of teaching courses and materials in the home country. The program director is expected to ensure that activities to be supported receive appropriate review and guidance, as described under "Types of Training: Advanced research training support", above. USING THE RFA LABEL: The RFA label available in the PHS 398 (rev. 5/2001) application form must be affixed to the bottom of the face page of the application. Type the RFA number on the label. Failure to use this label could result in delayed processing of the application such that it may not reach the review committee in time for review. In addition, the RFA title and number must be typed on line 2 of the face page of the application form and the YES box must be marked. The RFA label is also available at: http://grants.nih.gov/grants/funding/phs398/label-bk.pdf. SENDING AN APPLICATION TO THE NIH: 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 must be sent to: Dr. Merlyn Rodrigues Scientific Review Administrator Division of Extramural Programs National Library of Medicine 6705 Rockledge Drive, Suite 301 Bethesda, MD 20892-7968 (for US mail) Bethesda, MD 20817 (for express/courier service) Telephone: (301) 496-4253 Fax: (301) 402-2952 Email: RodrigM@mail.nlm.nih.gov APPLICATION PROCESSING: Applications must be received on or before 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. Although there is no immediate acknowledgement of the receipt of an application, applicants are generally notified of the review and funding assignment within eight weeks. 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. However, when a previously unfunded application, originally submitted as an investigator-initiated application, is to be submitted in response to an RFA, it is to be prepared as a new application. That is, the application for the RFA must not include an Introduction describing the changes and improvements made, and the text must not be marked to indicate the changes. While the investigator may still benefit from the previous review, the RFA application is not to state explicitly how. PEER REVIEW PROCESS Upon receipt, applications will be reviewed for completeness by the CSR and responsiveness by the FIC. Incomplete and/or non-responsive applications will be returned to the applicant without further consideration. Applications that are complete and responsive to the RFA will be evaluated for scientific and technical merit by an appropriate peer review group convened by the ICs in accordance with the review criteria stated below. As part of the initial merit review, all applications will: o Receive a written critique o Undergo a process in which only those applications deemed to have the highest scientific merit, generally the top half of the applications under review, will be discussed and assigned a priority score o Receive a second level review by the FIC Advisory Board and possibly by the Advisory Councils of other co-funding ICs. REVIEW CRITERIA The goals of NIH-supported research and training are to advance our understanding of biological systems, improve the control of disease, and enhance health. In the written comments, reviewers will be asked to discuss the following aspects of the application in order to judge the likelihood that the proposed research training will have a substantial impact on the pursuit of these goals: o Significance o Approach o Innovation o Investigator o Environment The scientific review group will address and consider each of these criteria in assigning your application's overall score, weighting them as appropriate for each application. Your application does not need to be strong in all categories to be judged likely to have major scientific and capacity-building impact and thus deserve a meritorious priority score. For example, you may propose to carry out important work that, by its nature, is not innovative but is essential to move a field forward. SIGNIFICANCE: o The expected scientific and public health contributions of the proposed activity; o The strength of the training program and its potential contribution to creating a "center of excellence" for research and training at the foreign host institution, including raising the general level of awareness in the scientific community of the potential impact of information sciences on research and clinical practice; o The potential to increase the critical mass of informatics expertise at the foreign institution over the course of the award period and the likelihood that this will build toward a sustainable global health informatics research and training capability at the foreign institution. APPROACH: o Appropriateness of the training plan to address the needs identified by the foreign institution; o The appropriate mix of long- and short-term, initial and follow-up training to achieve the goals of this RFA; o The appropriate integration of didactic training with opportunities for trainees to become involved in biomedical and behavioral research or disease control and prevention projects conducted in their home country; o Adequacy of proposed procedures and criteria for 1) recruitment, review, and selection of trainees, and 2) peer review of trainee-related and re-entry research in informatics applications to biomedical and behavioral research, disease control and prevention projects; o Adequacy of plan 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 ITMI trainees; o Effectiveness of plans to disseminate newly acquired informatics skills within the foreign institution; o Overall cost-effectiveness of the training and research plan. INNOVATION: o Adequacy and creativity of plans to build modern information technology capacity in an institution that may currently have limited resources, limited access to the Internet, or limited integration of modern information sciences with research programs; o Overall creativity in integrating the training program with ongoing research activities so that the newly generated informatics expertise enhances the research capacity at the foreign institution; and o Creativity in putting together a team of computer scientists and biomedical or behavioral scientists that, through their synergy, can create an exciting and innovative research-training program. INVESTIGATOR(S): o Qualifications of the program director to lead and the named faculty to participate in the proposed research training program, including their collective depth of experience in the fields of biomedical and behavioral research and informatics, research support from the NIH and other sources, and sensitivity to the special requirements for developing country trainees; o Previous success in training scientists and others in biomedical research and informatics. Training accomplishments should be included in addition to Biographical Sketches and Other Support forms for each faculty participant; o Potential for or strength of the collaborative relationship between the applicant and foreign institutions' research and teaching faculty; o For re-competing applications, the success of the applicant in strengthening medical informatics capacity in the partner developing country during the previous award period, as requested under SPECIAL CONSIDERATIONS. ENVIRONMENT: o Demonstrated funding for relevant research and training activities from the NIH for the developing country institution and from the NIH or other approved sources for the U.S. investigator; o Quality of training environment in the foreign institution as evidenced by 1) the quality of local teaching and research facilities and other resources; 2) the availability of high-quality candidates for training; and 3) past history of institutional commitment to former trainees in other internationally-funded programs upon returning to their home institution; o Quality of training environment in the U.S., 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 the protection of human and animal subjects and the safety of the research environment where relevant. ADDITIONAL REVIEW CRITERIA: In addition to the above criteria, your application will also be reviewed with respect to the following: PROTECTION OF HUMAN SUBJECTS FROM RESEARCH RISK: The involvement of human subjects and protections from research risk relating to their participation in the proposed research will be assessed. (See criteria included in the section on Federal Citations, below). INCLUSION OF WOMEN, MINORITIES AND CHILDREN IN RESEARCH: The adequacy of plans to include subjects from both genders, all racial and ethnic groups (and subgroups), and children as appropriate for the scientific goals of the research. Plans for the recruitment and retention of subjects will also be evaluated. (See Inclusion Criteria included in the section on Federal Citations, below). CARE AND USE OF VERTEBRATE ANIMALS IN RESEARCH: If vertebrate animals are to be used in the project, the five items discussed under Section f of the PHS 398 research grant application instructions (rev. 5/2001) will be assessed. ADDITIONAL CONSIDERATIONS DATA SHARING: The adequacy of the proposed plan to share data. BUDGET: The reasonableness of the proposed budget and the requested period of support in relation to the proposed training program. RECEIPT AND REVIEW SCHEDULE Letter of Intent Receipt Date: September 26, 2003 Application Receipt Date: October 23, 2003 Peer Review Date: January 31, 2004 Council Review: May 18, 2004 Earliest Anticipated Start Date: May 31, 2004 AWARD CRITERIA Award criteria that will be used to make award decisions include: o Scientific merit and responsiveness to the research, training, and capacity-building objectives (as determined by peer review) o Availability of funds o Programmatic priorities, including the interests of co-funding ICs and geographic distribution considerations. We strongly encourage independent U.S. applicant institutions that wish to work with the same foreign institution to consider forming a collaborative joint program and submitting a single application together. REQUIRED FEDERAL CITATIONS It is not expected that human and animal subjects will be a routine component of these training programs except as related to associated funded research projects. It is the responsibility of the PI to ensure that all required assurances are in place for any research carried out by a trainee funded through this program. Applicable provisions are listed below. INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS: The NIH maintains a policy 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 is available at http://grants.nih.gov/grants/funding/children/children.htm. REQUIRED EDUCATION ON THE PROTECTION OF HUMAN SUBJECT PARTICIPANTS: NIH policy requires education on the protection of human subject participants for all investigators submitting NIH proposals for research involving human subjects. You will find this policy announcement in the NIH Guide for Grants and Contracts Announcement, dated June 5, 2000, at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html. HUMAN EMBRYONIC STEM CELLS (hESC): Criteria for federal funding of research on hESCs can be found at http://stemcells.nih.gov/index.asp and at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-005.html. Only research using hESC lines that are registered in the NIH Human Embryonic Stem Cell Registry will be eligible for Federal funding (see http://escr.nih.gov). It is the responsibility of the applicant to provide the official NIH identifier(s)for the hESC line(s)to be used in the proposed research. Applications that do not provide this information will be returned without review. PUBLIC ACCESS TO RESEARCH DATA THROUGH THE FREEDOM OF INFORMATION ACT: The Office of Management and Budget (OMB) Circular A-110 has been revised to provide public access to research data through the Freedom of Information Act (FOIA) under some circumstances. Data that are (1) first produced in a project that is supported in whole or in part with Federal funds and (2) cited publicly and officially by a Federal agency in support of an action that has the force and effect of law (i.e., a regulation) may be accessed through FOIA. It is important for applicants to understand the basic scope of this amendment. NIH has provided guidance at http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm. Applicants may wish to place data collected under this RFA in a public archive, which can provide protections for the data and manage the distribution for an indefinite period of time. If so, the application should include a description of the archiving plan in the study design and include information about this in the budget justification section of the application. In addition, applicants should think about how to structure informed consent statements and other human subjects procedures given the potential for wider use of data collected under this award. STANDARDS FOR PRIVACY OF INDIVIDUALLY IDENTIFIABLE HEALTH INFORMATION: The Department of Health and Human Services (DHHS) issued final modification to the "Standards for Privacy of Individually Identifiable Health Information", the "Privacy Rule," on August 14, 2002. The Privacy Rule is a federal regulation under the Health Insurance Portability and Accountability Act (HIPAA) of 1996 that governs the protection of individually identifiable health information, and is administered and enforced by the DHHS Office for Civil Rights (OCR). Those who must comply with the Privacy Rule (classified under the Rule as "covered entities") must do so by April 14, 2003 (with the exception of small health plans which have an extra year to comply). Decisions about applicability and implementation of the Privacy Rule reside with the researcher and his/her institution. The OCR website (http://www.hhs.gov/ocr/) provides information on the Privacy Rule, including a complete Regulation Text and a set of decision tools on "Am I a covered entity?" Information on the impact of the HIPAA Privacy Rule on NIH processes involving the review, funding, and progress monitoring of grants, cooperative agreements, and research contracts can be found at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-025.html. URLs IN NIH GRANT APPLICATIONS OR APPENDICES: All applications and proposals for NIH funding must be self-contained within specified page limitations. Unless otherwise specified in an NIH solicitation, Internet addresses (URLs) should not be used to provide information necessary to the review because reviewers are under no obligation to view the Internet sites. Furthermore, we caution reviewers that their anonymity may be compromised when they directly access an Internet site. 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 RFA 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. AUTHORITY AND REGULATIONS: This program is described in the Catalog of Federal Domestic Assistance at http://www.cfda.gov/ and is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. Awards are made under authorization of Sections 301 and 405 of the Public Health Service Act, as amended (42 USC 241 and 287b) and under Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement. The NIH Grants Policy Statement can be found at http://grants.nih.gov/grants/policy/policy.htm and under Federal Regulations 42 CFR 52 and 45 CRF Parts 74 and 92. The PHS strongly encourages all grant recipients to provide a smoke- free workplace and discourage the 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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