INTERNATIONAL MALARIA RESEARCH TRAINING PROGRAM AWARD Release Date: February 22, 2001 RFA: RFA-TW-01-006 Fogarty International Center (http://www.nih.gov/fic) Letter of Intent Receipt Date: May 23, 2001 Application Receipt Date: June 28, 2001 PURPOSE The Fogarty International Center (FIC) currently supports innovative, collaborative malaria research training programs that contribute to the long-term goal of harnessing scientific knowledge and skills to enhance efforts to prevent malaria-related morbidity and mortality and to control malaria transmission in endemic developing countries (http://www.nih.gov/fic/programs/malaria.html) The International Malaria Research Training Program (IMRTP) request for applications (RFA) is being issued a second time by FIC in conjunction with the National Institute of Allergy and Infectious Diseases (NIAID) RFA for research grants entitled Malaria Vaccine Development: Understanding Malarial Anemia (AI-01-007). Applicants for this NIAID RFA are invited to submit proposals to train or expand the capabilities of scientists and health professionals from developing countries, in which malaria is endemic, to engage in research relevant to the pathogenesis of severe malarial anemia. In addition, institutions with current FIC IMRTP awards are invited to apply for supplemental funds to expand their activities to include training in this area. A major barrier to successful malaria research, treatment and control, including the clinical trials of potentially efficacious malaria vaccines, has been the scarcity of a critical mass of trained scientists and health professionals with malaria expertise in endemic countries. Each year it is estimated that close to one billion clinical episodes and between 1.5-2.7 million deaths due to malaria occur. Ninety percent of these are in Africa. The program for malaria research training will, therefore, focus primarily on Plasmodium falciparum (P. falciparum) malaria-related anemia research training to advance collaborative malaria studies between grantee researchers and colleagues in sub-Saharan Africa. However, FIC will also consider meritorious applications involving training to address Plasmodium vivax malaria-associated anemia in endemic developing countries in Asia, Latin America and the Caribbean. The impetus for supporting a malaria research training program grows out of the recognition that malaria continues to pose a major health threat in the developing world and that research training in endemic countries can lead to long-term solutions. This program supports the Multilateral Initiative on Malaria (MIM) established at a meeting in Dakar, Senegal, in January 1997, by malaria experts from sub-Saharan Africa and other countries. The goal of the conference was to identify scientific priorities and the means to pursue strengthening and sustaining, through collaborative research and training, the capability of malaria-endemic countries in Africa to carry out the research required to develop or improve tools for malaria prevention and control. The MIM is an alliance of organizations and scientists involved in malaria research and is coordinated by a secretariat currently housed at the FIC (http://www.nih.gov/fic/programs.html). In an effort to extend the activities supported by the MIM, the FIC malaria research training program supports efforts by NIH-funded malaria researchers to participate in building malaria research capability in endemic developing countries through collaborative research training efforts, especially in Africa. This RFA focuses on the specific need to understand the basis of severe anemia related to malaria infection that was identified as a scientific priority at the Dakar Conference. To develop sustainable research capacity in endemic developing countries, FIC will support malaria-related anemia research training efforts as part of the new research projects supported by NIAID in response to RFA-AI-01-007 or as part of current FIC International Malaria Research Training programs involving collaboration with internationally recognized research institutions in Africa and other highly endemic regions of the world. Proposed training programs should be designed to fill specific gaps in needed expertise and establish a critical mass of trained scientists and health professionals able to work independently on malaria-associated anemia research at the collaborating developing country institution. Each malaria research training proposal may incorporate a number of long- and short-term opportunities to provide multidisciplinary research training for endemic country scientists and clinicians in areas such as clinical tropical medicine, hematology, immunology and genetics relevant to understanding the pathogenesis of severe malarial anemia to achieve this goal. To the greatest extent possible, malaria research will be supported in the context of training conducted in the trainees home countries. 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. Potential applicants may obtain a copy of "Healthy People 2010" at http://www.health.gov/healthypeople/. ELIGIBILITY REQUIREMENTS Applications may be submitted by U.S. and foreign, for profit and non- profit public and private institutions, such as universities, colleges, hospitals, laboratories, and eligible agencies of the Federal government capable of meeting the objectives of the RFA. All new applicants for FIC IMRTP awards must also respond to the NIAID RFA-AI- 01-007 Malaria Vaccine Development: Understanding Malarial Anemia. In exceptional cases, with prior approval of the FIC program staff, an applicant may be the designated Principal Investigator (PI) for an active NIAID award (with at least 18 months of support remaining at the time of application) for malaria research directly related to this topic. The proposed PI for the FIC IMRTP award must also be the proposed PI for the above NIAID research award. No new FIC malaria research training awards will be made in response to this RFA unless the applicant is successful in receiving an NIAID award made in response to RFA-AI-01-007 or has other FIC-approved NIAID research support. Only one application is allowed from any applicant institution and institutions with current IMRTP awards may not apply for an additional award. However, institutions with current FIC IMRTP awards may apply for supplemental funding under this RFA to expand their activities to include training in malaria-related anemia research provided that they can demonstrate U.S. and/or foreign collaborator faculty mentorship capability and research grant support in this field. The applicant must demonstrate an ongoing collaborative relationship with an established institution with proven malaria research capabilities in a endemic developing country in Africa, Asia (except Japan, Singapore, South Korea and Taiwan), the Pacific Island region (except Australia and New Zealand), Latin America and the Caribbean, where the proposed research training will be based. Racial/ethnic minority individuals, women, and persons with disabilities are encouraged to apply as PIs. MECHANISM OF SUPPORT Awards made in response to this RFA will use the National Institutes of Health (NIH) international training grant (D43) award mechanism that limits facilities and administrative costs to eight percent. Responsibility for the planning, direction, and execution of the proposed project will be solely that of the applicant. The total project period for a new award funded in response to this RFA cannot exceed four years. The total project period for a supplement to a current IMRTP award cannot exceed the program period for this award. Continued support during this period depends on satisfactory performance as judged by annual progress reports, site visits, meetings with program directors, career progress of trainees, the development of institutional capacity for independent malaria-related research and continued malaria research funding. At this time, FIC has not determined whether this solicitation will be continued beyond the present RFA. FIC, in conjunction with NIAID, will conduct a program evaluation by the end of the third year that will assist the NIH in determining the re-issuance of the RFA. The applicant organization must provide the necessary management for the transfer of funds and materials to the collaborating endemic country institution. Facilities and administrative (F & A) costs required to support training and training-related research at the endemic country institution such as access to facilities, library services, internet, etc. can be charged as direct expenses when well justified. Travel, salaries and fringe benefits will be subject to the applicant institution’s rules and regulations. Allowable Costs All budget items related to trainee participation in the program should be itemized on the PHS Form 398 NRSA substitute budget pages OO and PP in the categories indicated in parentheses. All budget items related to faculty participation in the program should be itemized on the PHS Form 398 budget pages DD and EE in the categories indicated in parentheses. Stipend/Salary/Consulting Fees o Trainees (endemic country graduate students and endemic country post-advance degree participants) may be paid a stipend comparable to their professional experience similar to other equivalent trainees at the grantee institution but not exceeding $45,000 per year in accordance with the grantee institutional policies while involved in long-term training at the grantee institution. Applicants may wish to refer to the NRSA stipend levels described on the web site http://grants.nih.gov/training/nrsa.htm. (NRSA substitute pages, pre- or postdoctoral stipends) o Endemic country trainees may be paid a stipend while conducting long-term training related research at the endemic country site at levels comparable with the salary scales for similar professionals in that country in accordance with the collaborating endemic country or grantee institution’s policies but not exceeding $45,000 per year. (NRSA substitute pages, pre- or postdoctoral stipends) o Faculty at the grantee institution who provide major program administration or extended long-term training or conduct collaborative research with students at the endemic country site may receive salary and fringe benefits. The total amount of salary and fringe benefits requested for all grantee faculty may not exceed ten percent of direct costs in the budget. The administrative, training or teaching responsibilities and time commitment for personnel receiving salary should be thoroughly described. (Form 398 budget pages, personnel) o Endemic country institution faculty who provide major program administration at the endemic country site or participate in long-term training of participating students at the endemic country site and grantee faculty or endemic country faculty who teach short courses may receive a consulting fee not to exceed $2000, in accordance with their institution’s policies. No more than five percent of the direct costs in the budget may be used for consultant fees. The administrative, training or teaching responsibilities and time commitment for personnel receiving consulting fees should be thoroughly described. (NRSA substitute pages- training related expenses) o Up to ten percent direct costs to provide salary and fringe benefits for clerical support staff for the program at the grantee institution. The responsibilities and time commitment for personnel in the U.S. and foreign country receiving salary support or consulting fees should be described in detail. (Form 398 pages, personnel) Tuition, Fees and Insurance o Funds for tuition, academic fees and self-only or family medical insurance for endemic country trainees at the grantee institution not exceeding 20% of direct costs may be requested. Programs are encouraged to seek cost sharing arrangements with the grantee institutions in order to provide reduced tuition for long term trainees and tuition-free short courses. (NRSA substitute pages, tuition, fees, insurance) Trainee Travel o Funds may be requested for one round trip economy class airfare per year on U.S. carriers (to the maximum extent possible) and local ground transportation for each long-term endemic country trainee to travel to the grantee institution or for endemic country trainees to participate in short courses or attend scientific conferences to present their results. Additional travel must be approved by FIC program staff. (NRSA substitute pages, trainee travel) o Funds may be requested for per diem and lodging for endemic country trainees to participate in short courses or attend scientific conferences to present their results. (NRSA substitute pages, trainee travel) Faculty Travel o Funds may be requested for one round trip economy airfare per year on U.S. carriers (to the maximum extent possible) for each grantee faculty participant providing extended training to go to the endemic country site or teach short courses at the endemic country site. Additional travel must be approved by FIC staff. (PHS 398 pages, travel) o Funds may be requested for per diem and lodging for grantee faculty to teach short courses at the endemic country site. (PHS 398 pages, travel) o For new awards, funds should be requested for airfare, per diem and lodging comparable to U.S. government rates (see http://www.gsa.gov/Portal/gsa/ep/contentView.do?contentId=17943&contentType=GSA_BASIC l) for the program Director to attend an annual network meeting. This meeting may occur in the context of the annual conference of NIAID’s International Centers for Tropical Disease Research (see http://www.niaid.nih.gov/ictdr/default.htm) or in conjunction with the annual American Society of Tropical Medicine and Hygiene conference or another meeting of NIAID-sponsored malaria research projects. Inclusion of funds for other key personnel to attend these meetings is at the discretion of the applicant. (PHS 398 pages, travel) Training related expenses o Funds to support endemic country trainee research related costs at the grantee institution (such as reagents, lab supplies, computer access, small equipment, etc.) of up to $600 per month per trainee may be requested. (NRSA substitute pages, training related expenses) o Funds to support up to $10,000 per year for research at the endemic country site associated with fulfilling requirements for an advanced degree may be requested. (NRSA substitute pages, training related expenses) o Research support for up to $15,000 per trainee per year to facilitate conducting advanced research training at the endemic country site (re-entry grants) by those finishing training or former long-term trainees in collaboration with grantee faculty participants maybe requested. Re-entry grants may support the purchase of reagents, supplies, a computer and appropriate software, computer access fees, small equipment, one round trip to the grantee institution per year, scientific meeting fees and stipends comparable to salary scales for similar professionals at the endemic country site. The applicant should describe in detail how proposals for re-entry projects will be selected by a peer review process examining scientific merit and ethical concerns involving faculty from the grantee and endemic country institutions coordinated by the program director. (NRSA substitute pages, training-related expenses) FUNDS AVAILABLE The FIC intends to commit approximately $500,000 in FY 2002 to fund three to four new grants and two to four competing supplements in response to this RFA. New malaria research training program award applicants may request a project period of up to four years and a budget for total costs of up to $100,000 per year maximum (including eight percent F & A costs). Current malaria research training award applicants may request a project period extending to the end of this award and a budget of total costs up to $50,000 per year. Because the nature and scope of the research proposed may vary, it is anticipated that the size of each award will also vary. Although the financial plans of the FIC 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. RESEARCH TRAINING OBJECTIVES The FIC will support new multidisciplinary research training for malaria endemic country scientists involved in research on the pathogenesis of severe malarial anemia supported by NIAID and the expansion of currently supported malaria research training programs to include training in this important area. Background In P. falciparum malaria, anemia may develop acutely or chronically, and may range from mild to severe. In the case of life-threatening anemia, a feature of severe and complicated malaria, the only effective treatment currently available is blood transfusion, which carries risks for transmission of other blood-borne pathogens such as HIV. Severe malarial anemia is multifactorial, involving increased erythrocyte destruction as well as decreased erythrocyte production. Factors reported to contribute to severe anemia include hemolysis of uninfected, as well as parasitized, red cells, erythrophagocytosis, bone marrow suppression, ineffective erythropoiesis and dyserythropoiesis, inadequate erythropoietin production, and concomitant infections. The mechanisms underlying severe malarial anemia are poorly understood, apparently involving humoral (e.g. antibody and/or complement) as well as cellular (e.g. cytokine) immune responses. The immunologic basis of severe malarial anemia is of particular interest because of its potential relevance to malaria vaccine development. Recent observations of severe anemia developing in non-human primates (Aotus) following vaccination with blood-stage antigens and challenge infection, or after repeated P. falciparum infection and drug cure, suggest that improved understanding of the pathogenesis of severe malarial anemia will be an important factor in the development of safe and effective vaccines. The training objectives of this RFA support those of the MIM (http://www.nih.gov/fic/programs.html) and complement those of the WHO Roll Back Malaria program (www.rbm.who.int). The Dakar Conference recommendations (http://www.niaid.nih.gov/dmid/malaria/) called for both long-term and short-term training of African scientists and health professionals to acquire the capabilities necessary to independently carry out high quality research from its conception and protocol development to its execution and reporting and publishing results. It was recommended that training provide relevant technology transfer and create institutional expertise in malaria through balanced and productive collaborations with scientifically advanced malaria research laboratories. An extensive analysis of malaria research capacity in Africa was recently published (www.wellcome.ac.uk/mim). Training Objectives It is expected that each malaria research training program supported will: o substantially increase the expertise of trainees in malarial anemia related research; o expand collaborative malaria research interactions between grantee and malaria endemic developing country scientists; o strengthen sustainable malaria research within endemic developing country institutions, building scientific excellence for training future generations of endemic developing country scientists; o provide data for research-based decision making for malaria clinical treatment and prevention programs and to inform national health care policy in malaria endemic developing countries; and o enhance research conducted under NIAID RFA-AI-01-007. Training Plan 1. Applicants should design a training plan that attempts to fill specific gaps in malarial anemia research expertise at the collaborating endemic developing country institution that will result in a critical mass of scientists and health professionals able to address issues of high priority to treat and prevent malaria-associated anemia in their country. A proposal may incorporate a wide range of long-term and short-term research training opportunities offered to a wide range of possible endemic developing country participants to achieve the creation of or expansion to a scientifically autonomous malarial anemia research group capable of equal partnership in international collaborative efforts. A proposed training plan can include grantee institution-based research training. However, applicants are strongly encouraged to provide support and mentored research training conducted in the trainees home country to the greatest extent possible in the context of ongoing collaborative research between the grantee and endemic country investigators. Proposals for innovative ways to involve trainees in collaborative malarial anemia research projects and intervention trials in their home countries are strongly encouraged. Applicants are also strongly encouraged to include women in the selection of trainees. 2. Long-term training (usually a minimum of two years) may include studies leading to an advanced degree or a mentored post-advanced degree experience. Applicants should describe how the long-term training proposed will combine the acquisition of specific expertise to successfully answer a hypothesis-based malarial anemia research question with the opportunity to acquire multidisciplinary knowledge about the biomedical and public health aspects of malaria to the greatest extent possible. Long-term training should include academic courses taken at the grantee institution, including instruction in the responsible conduct of research, laboratory safety, medical informatics, technical writing and English as a second language, if necessary. 3. Applicants are expected to develop, promote and facilitate short- term training opportunities targeted toward the specific research needs of their endemic developing country collaborators, which will directly enhance their research capabilities. Short-term training may be offered on such topics as new laboratory, clinical or behavioral research methods, medical informatics, biostatistics, data management and intervention trial protocol development or in areas which support research efforts such as institutional review board (IRB) and biosafety procedures, proposal writing and research administration skills. When a short training course or workshop is given by one malaria research training program, it is expected that this activity will be open to trainees from the other training programs supported through this RFA to whatever extent feasible. Training activities will be coordinated, facilitated and monitored by a Training Advisory Group, comprised of malaria research training program PIs, major endemic country collaborators and FIC program staff, which will meet annually. Types of Training 1. Long-term pre-doctoral training in malaria-related anemia research leading to a masters or Ph.D. or equivalent degree for individuals with or without previous research experience in this field. Research training should relate directly to the PI’s or a co-investigator’s collaborative research in malarial anemia at the endemic country site and may range from two to four years. 2. Long-term post-advanced degree research experience for malaria endemic country scientists and health professionals including malaria- related clinical training for approximately two years duration. 3. Short-term training in either the grantee or endemic country site of up to four weeks in specific research methods or other laboratory, clinical, field or administrative skills related to the malarial anemia research efforts at the collaborating endemic country institution for technicians, health care professionals and research administrative staff. 4. Short-term training of three to six months duration for individuals with advanced degrees or health care professionals conducted in the grantee institution in research methods or other skills to support specific collaborative malarial anemia research efforts at the endemic country site. 5. Advanced research training support (re-entry grants), generally for one to two years, to enable trainees with advanced degrees or health care professionals to continue mentored malarial anemia research in their home country or to initiate independent malarial anemia research projects related to ongoing collaborative research at the endemic country collaborating institution. SPECIAL REQUIREMENTS The PI and major endemic country collaborator will be responsible for the progress made by the trainees and the overall conduct of each malaria research training program. Training Advisory Group A. Training Advisory Group (TAG) will be established after awards are made to coordinate and facilitate training activities among all malaria research training programs supported by this RFA. The TAG will include the PIs and major endemic country collaborators of each malaria research training program, and FIC and NIAID program staff. The TAG will have responsibility for advising, coordinating, and facilitating common training courses and opportunities from which all programs can benefit to enhance the progress of trainees in light of the evolving needs for malaria research. FIC will also facilitate coordination and collaboration with other U.S. government institutions within and outside of NIH (e.g. NIAID, CDC, USAID, DOD, etc.) and with international research organizations and foundations, including the MIM, the WHO, and other in-country projects funded by NIH. Training in Responsible Conduct of Research Applicants must include plans for training in responsible conduct of research for long-term trainees and short-term trainees. 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. Recruitment and Selection Plan The applicant institution must include a detailed plan describing the recruitment, criteria and selection procedures for trainees. Degree candidates must meet all entrance requirements of the grantee degree- granting institution. If applicable, proposals should describe the mechanism for internal peer review of re-entry grant applications to support malarial anemia research projects at the endemic country site conducted by returning trainees by a committee composed of grantee and endemic country investigators from participating institution(s). Trainee Tracking System Applicants should describe their plan to track the short- and long-term impact of malaria research training on their trainees. Awardees will be required to implement a system to track and document the long-term impact of this training program on: (1) the careers of all trainees; (2) the research capacity at the collaborating endemic country institution of trainees; (3) positions trainees assume upon completion of training; (4) the contributions of trainees to future NIH- or other- supported international malaria research and intervention trial efforts. Examples of training impact include how training enabled participants to assume more responsible positions upon returning home, how collaborations with former trainees resulted in the funding of malaria intervention trials or collaborative research projects for which trainees were either PIs or co-investigators, and publications of research results authored by trainees supported by this program. During the first year after the awards are made, FIC staff will work with grantees to standardize tracking systems among programs for annual progress reporting based on the ideas presented in their applications and FIC program staff experience with similar programs. It is expected that the standardized tracking system developed will be implemented in all programs. The impact of training resulting from each program will be an important criteria considered during any recompetition of this RFA. Research Training Involving Human Subjects Applicants must inform the FIC program staff that approval of research protocol involving human subjects has been obtained from U.S. and developing country IRBs and required U.S. and foreign government agencies before training in research involving human subjects is initiated. Training involving human subjects in research funded by NIAID must obtain NIAID approval of clinical protocols prior to the initiation of the study according to the policy announced in the NIH Guide on February 24, 2000 (available at http://grants.nih.gov/grants/guide/notice-files/NOT-AI-00-003.html). Full details of this policy are available at the NIAID web site (http://www.niaid.nih.gov/ncn/pdf/clinterm.pdf). INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS It is the policy of the NIH that women and members of minority groups and their sub-populations must be included in all NIH-supported biomedical and behavioral research projects involving human subjects, unless a clear and compelling rationale and justification are provided indicating that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43). All investigators proposing research involving human subjects should read the UPDATED NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research, published in the NIH Guide for Grants and Contracts on August 2, 2000 (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-048.html); a complete copy of the updated Guidelines are available at http://grants.nih.gov/grants/funding/women_min/guidelines_update.htm: The revisions relate to NIH defined Phase III clinical trials and require: a) all applications or proposals and/or protocols to provide a description of plans to conduct analyses, as appropriate, to address differences by sex/gender and/or racial/ethnic groups, including subgroups if applicable; and b) all investigators to report accrual, and to conduct and report analyses, as appropriate, by sex/gender and/or racial/ethnic group differences. NIH POLICY AND GUIDELINES ON THE INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS: It is the policy of NIH that children (i.e., individuals under the age of 21) must be included in all human subjects research, conducted or supported by the NIH, unless there are scientific and ethical reasons not to include them. This policy applies to all initial (Type 1) applications submitted for receipt dates after October 1, 1998. All investigators proposing research involving human subjects should read the NIH Policy and Guidelines on the Inclusion of Children as Participants in Research Involving Human Subjects that was published in the NIH Guide for Grants and Contracts, March 6, 1998, and is available at the following URL address: http://grants.nih.gov/grants/guide/notice-files/not98-024.html Investigators also may obtain copies of these policies from the program staff listed under INQUIRIES. Program staff may also provide additional relevant information concerning the policy. URLS IN NIH GRANT APPLICATIONS OR APPENDICES All applications and proposals for NIH funding must be self-contained within specified page limitations. Unless otherwise specified in an NIH solicitation, internet addresses (URLs) should not be used to provide information necessary to the review because reviewers are under no obligation to view the Internet sites. Reviewers are cautioned that their anonymity may be compromised when they directly access an Internet site. LETTER OF INTENT Prospective applicants are asked to submit a letter of intent that includes: 1) a descriptive title of the proposed research training program, 2) the name, address, email address and telephone number of the PI and the major endemic country collaborator, and 3) the identities of other key personnel and participating institutions. Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows staff to estimate the potential review workload and to plan the review. The letter of intent is to be sent to Dr. Barbara Sina as listed under INQUIRIES by the letter of intent receipt date listed in the heading of this RFA. APPLICATION PROCEDURES The research grant application form PHS 398 (rev. 4/98) is to be used in applying for these grants. These forms are available at most institutional offices of sponsored research and from the Division of Extramural Outreach and Information Resources, National Institutes of Health, 6701 Rockledge Drive, MSC 7910, Bethesda, MD 20892-7910, telephone 301/710-0267, email: GrantsInfo@nih.gov. The RFA label available in the PHS 398 (rev. 4/98) application form must be affixed to the bottom of the face page of the application. Failure to use this label could result in delayed processing of the application such that it may not reach the review committee in time for review. In addition, the RFA title and number must be typed on line two of the face page of the application form and the YES box must be marked. The RFA number must be typed on the label as well. The sample RFA label is available at: http://grants.nih.gov/grants/funding/phs398/label-bk.pdf has been modified to allow for this change. Please note this is in pdf format. Submit a signed, single-sided, 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 exact copies of the application and all five sets of appendices should be sent to: Nancy Saunders Ph.D. NIAID-DEA 67000B Rockledge Drive, Room 2103, MSC-7616 Bethesda, MD 20892-7616 Telephone: 301-496-8536 FAX: 301-402-2638 Email: ns120v@nih.gov For express mail carriers use zip code 20817. Applications must be received by the application receipt date listed in the heading of this RFA. If an application is received after that date, it will be returned to the applicant without review. The Center for Scientific Review (CSR) will not accept any application in response to this RFA that is essentially the same as one currently pending initial review, unless the applicant withdraws the pending application. The CSR will not accept any application that is essentially the same as one already reviewed. This does not preclude the submission of substantial revisions of applications already reviewed, but such applications must include an introduction addressing the previous critique. REVIEW CONSIDERATIONS Applications will be reviewed for completeness by the CSR and responsiveness by FIC. Incomplete and/or nonresponsive applications will be returned to the applicant without further consideration. Applications that are complete will be evaluated for scientific and technical merit by a peer review group convened by NIAID in accordance with the standard NIH peer review procedures. As part of the initial merit review, all applications will receive a written critique. Applications may undergo a streamlined review process. In this process, only those applications deemed to have the highest scientific merit, generally the top half of applications under review, will be discussed, assigned a priority score, and 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 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. Each of these criteria will be addressed and considered in assigning the overall score, weighting them as appropriate for each application. Note that the application does not need to be strong in all categories to be judged likely to have major scientific impact and thus deserve a high priority score. For example, an investigator may propose to carry out important research training that by its nature is not innovative but is essential to move a field forward. Applicants for new malaria research training program awards must also have submitted an application for malarial anemia research support in response to NAIAD AI-01-007. Current malaria research training program awardees applying for supplemental funding must demonstrate relevant research support from NIH or another funding source that will serve as the foundation for the research training proposed. The scientific evaluation of each application will include an assessment of linkage between the proposed training and malaria research support for the PI and other co-Investigators and major endemic country collaborators. Evidence of support for initiating the proposed malaria research training program from the collaborating endemic country institution (s) must be submitted with the application. Significance 1. The need for the specific malarial anemia research training proposed to fill specific gaps in malarial anemia research expertise at the collaborating endemic developing country institution 2. The expected public health and scientific contributions related to the proposed malarial anemia research training 3. The demonstrated capacity or potential to achieve independent and sustainable laboratory, clinical or public health malarial anemia research capacity through the proposed training efforts Approach 1. The clarity and feasibility of the research training objectives 2. Adequacy of the research training plan to achieve the proposed training objectives including: o a trainee recruiting, application and selection process that captures the most qualified individuals who could most benefit from the training proposed (the proposed qualifications of potential candidates should be well described in terms of academic status and previous research and/or malaria control experience); o a process for matching trainees to appropriate mentors or instructors and research projects or new skills to be acquired; o balance in the proposed long-term research training to provide a breadth of knowledge in either academic based laboratory, clinical or public health studies while providing specific malarial anemia research training to fill recognized gaps in expertise at the collaborating endemic country institution; o the adequacy of the mixture of long- and short-term training opportunities within the program as a means to achieve the overall objectives stated; o provision of training in research-related topics such as laboratory safety, responsible conduct of research, technical writing, statistical methods, good clinical practice, medical informatics, English as a second language (if necessary), etc; and o process for periodic evaluation of short- and long-term trainee progress including academic and research achievement, assistance with common trainee problems and mentorship for successful trainee presentations of research results at appropriate scientific conferences and authorship in scientific publications. 3. Adequacy of the methods to monitor the long-term impact of the malarial anemia research training experience on the subsequent careers of the trainees and malaria scientific and public health capacity in the endemic country. 4. Adequacy of plans to include an adequate representation of women among the endemic country trainees. Innovation 1. Innovation in strategies for trainees to become actively involved in malarial anemia laboratory, clinical or public health research or intervention trials conducted at the endemic country site. 2. Innovation in training strategies to produce a critical mass of independent malarial anemia researchers and sustainable malarial anemia research training by trainees at the endemic country collaborating institution after the end of the program. 3. Creativity of plans to use modern information technology to facilitate trainee access to scientific information, distance learning and collaborative interaction. Investigators 1. Qualifications of the program director to lead and the grantee and endemic country faculty to participate as mentors in the proposed research training program. (The malarial anemia research experience and training records, particularly of foreign scientists, should be included in addition to Biographical Sketches and Other Support forms for each key personnel and endemic country faculty participant.) 2. Adequacy of the ongoing collaboration between the grantee and endemic country investigators and their institutions to provide a suitable framework in which the proposed training will occur. 3. The extent and effectiveness of previous efforts made by applicants in developing biomedical and prevention research training programs necessary to support infectious disease research and biomedical research efforts in the home countries of trainees including efforts made to focus resources to build long-term clinical research, operational research and public health capacity at a model infectious diseases center in the home country of trainees. Environment 1. The adequacy of the teaching and research facilities and other resources and the overall training environment at the grantee and endemic country institutions. 2. The grantee and endemic country institutional commitments to international malaria research training. In addition to the above criteria, in accordance with NIH policy, all applications will also be reviewed with respect to the following: o The reasonableness of the proposed budget and duration in relation to the proposed research. o The adequacy of plans to include both genders, minorities and their subgroups, and children as appropriate for the scientific goals of the research involving human subjects. Plans for the recruitment and retention of subjects will also be evaluated. o The adequacy of the proposed protection for participants, animals or the environment, to the extent they may be adversely affected by the project proposed in the application. Schedule Letter of Intent Receipt Date: May 23, 2001 Application Receipt Date: June 28, 2001 Peer Review Date: October, 2001 Council Review: February, 2002 Earliest Anticipated Start Date: March, 2002 AWARD CRITERIA In addition to the outcome of the initial scientific peer review, the following may also be considered in making funding decisions: o For new awards, success in obtaining award in response to NIAID RFA AI 01-007. o Cost-effectiveness of the programs. o Collaboration with other NIH, CDC, USAID and DOD programs and institutions and with other organizations involved in malaria research and prevention and control. o The extent to which proposed training programs support and complement other NIH international infectious diseases research efforts. o The availability of funds. o FIC program balance among critical research and public health training areas of emphasis. o The geographic distribution among countries included in applications under consideration, including the need for a given program to work in a specific country. Before any funds can be expended for activities at the endemic country site from this award, the grantee institution must show evidence of approval for collaborative research and training between the grantee and endemic country countries and institutions included in the program through an endorsement from an appropriate officials from the collaborating institutions. INQUIRIES Written and telephone inquiries concerning this RFA are strongly encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Direct inquiries regarding program issues to: Barbara Sina, Ph.D. Division of International Training and Research Fogarty International Center 31 Center Drive, Room B2C39, MSC 2220 Bethesda, MD 20892-2220 Telephone: (301) 402-9467 FAX: (301) 402-0779 Email: barbara_sina@nih.gov Direct inquiries regarding review issues to: Nancy Saunders, Ph.D. Scientific Review Program NIAID-DEA 6700B Rockledge Drive, Room 2217 Bethesda, Maryland 20992-7616 (Express/courier service use 20817) Telephone: 301-402-2636 FAX: 301-402-2638 Email: ns120v@nih.gov Direct inquiries regarding fiscal matters to: Mr. Bruce Butrum Office of the Director Fogarty International Center 31 Center Drive, Room B2C39, MSC 2220 Bethesda, MD 20892-2220 Telephone: (301) 496-1670 FAX: (301) 402-0779 Email: butrumb@mail.nih.gov AUTHORITY AND REGULATIONS Awards are made under authorization of the Public Health Service Act, Title IV, Part A (Public Law 78-410, as amended by Public Law 99-158, 42 USC 241 and 285) and administered under NIH 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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