and Human Services (HHS)
EXPIRED
INTERNATIONAL TRAINING AND RESEARCH IN ENVIRONMENTAL AND OCCUPATIONAL HEALTH Release Date: December 8, 2000 RFA: TW-01-002 (This RFA has been reissued, see RFA-TW-06-004) Fogarty International Center (http://www.nih.gov/fic/) National Institute of Environmental Health Sciences (http://www.niehs.nih.gov) National Institute for Occupational Safety and Health of the Centers for Disease Control and Prevention (http://www.cdc.gov/niosh) Letter of Intent Receipt Date: January 16, 2001 Application Receipt Date: March 16, 2001 PURPOSE The Fogarty International Center (FIC), in collaboration with the National Institute of Environmental Health Sciences (NIEHS) of the National Institutes of Health (NIH), and the National Institute for Occupational Safety and Health (NIOSH) of the Centers for Disease Control and Prevention (CDC), invites applications from non-profit public or private institutions in the U.S. to continue or initiate international training and research support in environmental and occupational health-related sciences. The program vision is to build global capacity and collaboration to better understand, investigate, control and prevent environmental and occupational health problems in developing countries and the United States. During the first five years, the major emphasis of the program was on epidemiology, risk assessment and surveillance. During the next five years the major emphasis will be on prevention and intervention research to reduce risks in participating collaborating countries. Knowledge and experience from the first five years of training in the environmental and occupational health problems will be utilized. The broad objectives are to: 1. Train scientists from developing countries in a variety of disciplines necessary to identify and prevent environmental and occupational risks including but not limited to: o laboratory and toxicology research o epidemiologic research and surveillance o environmental monitoring o workplace risk assessment o engineering control o hazardous waste assessment o disease prevention and control 2. Develop and strengthen centers of research excellence in environmental and occupational health-related sciences in developing countries through long-term partnerships with U.S. institutions, with particular emphasis on research activities that will have the potential to benefit a whole region. 3. Complement and reinforce environmental and occupational health research and training activities of the NIH and partner agencies. 4. Facilitate the transition of trainees to positions of responsibility, authority, and influence in their home countries, regionally, and internationally 5. Translate the results of research into public health practice. This Request for Applications (RFA) was developed considering the recommendations of a program review committee chaired by Dr. John F. Finklea of the Centers of Disease Control and Prevention (CDC), and former Director of the National Institute for Occupational Safety and Health (NIOSH). This committee report is available on the FIC webpage (http://www.nih.gov/fic/). The program honors the memory of the late Dr. Irving Selikoff of the Mount Sinai School of Medicine, and Dr. Norton Nelson of New York University, in recognition of their lifelong commitment to the training of health professionals in the occupational and environmental health sciences. 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, International Training and Research in Environmental and Occupational Health (ITREOH), is related to one or more of the priority areas. Potential applicants may obtain a copy of "Healthy People 2010" at http://www.health.gov/healthypeople. ELIGIBILITY REQUIREMENTS The grantee institution must be a U.S. non-profit private or public institution capable of meeting the objectives in this RFA. An increasing proportion of resources under this award (at least 25% by the end of the funding cycle) must be spent in-country, specifically to build research and public health capacity within the collaborating country(ies): e.g. by strengthening medical informatics, Institutional Review Boards (IRBs) formation and ethical review, grants management, supporting advanced in- country research, facilitating preparation of research grants or research coupled to intervention projects. Only one application from any U.S. institution will be allowed under this program. Racial/ethnic minority individuals, women, and persons with disabilities are encouraged to apply as Principal Investigator (PI). Participation in the program by investigators at minority institutions is strongly encouraged. MECHANISM OF SUPPORT This RFA will use the NIH international training grant (D43) mechanism, which limits facilities and administrative (F & A) costs to eight percent of allowable direct costs. Applicants may request a project period of up to five years and a budget for total costs up to $300,000 per year for the first year for recompeting programs, and $200,000 for new starts. Responsibility for planning, direction and execution of the proposed activities will be solely that of the applicant in collaboration with their foreign partners. The application should describe research and research training objectives to be pursued both in the U.S. and at collaborating institutions in the cooperating country or region. Applications may incorporate cooperative activities with scientists from one or several developing countries or regions, based on the research and training objectives of the program. However, applicants are encouraged to focus their efforts on activities which provide maximum national and regional impact. The applicant organization’s administration must provide the necessary management for the transfer of funds and material to the off-site component. Facilities and administrative (F & A) costs will not be paid on any expense incurred by the foreign institution(s), although expenses required to support in-country training and training-related research (such as access to facilities), establishing ethical review committees, supporting grant writing seminars, strengthening grants management, library services and the Internet, can be charged as direct expenses if well-justified and approved by the FIC program officer. Travel, salaries, and fringe benefits will be subject to the applicant institution’s rules and regulations. Continued support during this period depends on satisfactory performance as judged by: annual progress reports, site visits, participation in annual meetings of program directors, career progress of trainees (e.g., positions occupied in home country), research undertaken and research awards received, first author publications and presentations by current and former trainees, and, development of institutional, national or regional capacity for environmental and occupational research and public health actions including the establishment or strengthening of model environmental and occupational health research centers of excellence in the home countries of trainees and in influencing policies that reduce environmental and occupational health risks. Assessment of performance will be made jointly by FIC, NIEHS, and NIOSH. Special program reviews may be conducted periodically by the FIC, NIEHS, and NIOSH. FUNDS AVAILABLE It is anticipated that about $3,000,000 (total costs) will be available for the first year of the recompeted program. An estimated 12 awards will be made, with no single award exceeding $300,000 (in total costs). Awards will be contingent upon availability of funds and receipt of a sufficient number of meritorious applications. Requests for an administrative supplemental budget may be invited periodically by Program Staff and will be considered for increases of up to 20 percent of funded levels in a given budget year. These funds may be requested to meet special local or regional research or training needs and take advantage of unusual opportunities such as geographic expansion, field research, or emergency situations. Such requests, which should be discussed with FIC program staff prior to submission, will be reviewed by FIC in consultation with NIEHS and NIOSH, and support will depend upon need, merit and availability of funds. The grantee institution may request an F & A cost allowance based on eight percent of the total allowable direct costs, exclusive of tuition, insurance, related fees and expenditures for equipment. Applicants should assume a budget increase of three percent per year for each succeeding year, contingent upon availability of funds. The anticipated date of award is on or before September 30, 2001. TYPES OF TRAINING The FIC ITREOH program provides resources for U.S. institutions and collaborating foreign institutions to train scientists from developing countries, including those in Africa, Asia, Latin America, the Middle East, emerging democracies in Eastern Europe and Russia’s newly independent states. Research-related training programs in environmental and occupational health sciences for foreign scientists and health professionals may include the following types of training: o Long-term (more than nine months) training in pre- or post-doctoral programs. o Short-term (less than three months) training, to include focused workshops and technology transfer. o Intermediate-term training, including specialized activities in support of population-based studies, pilot trials or interventions. While a range of short and long-term training is allowable, emphasis will be on intermediate to longer-term training, including mid-career training. This approach will accelerate building an enduring research and public health capability at collaborating institutions in participating countries. Long-term training would generally take place in the U.S. Short-term training could take place in the U.S. or in-country. Training-related research and advanced in-country research would generally take place in the trainee’s home country. The research activities are performed preferentially and predominantly in the trainees home country or region. As part of the application, the applicant institution must describe in detail the recruitment and selection procedures for the foreign pre- and post- doctoral scientists and other beneficiaries of the training program (short and intermediate term trainees, workshop participants, etc). To a limited extent, U.S. trainees will be eligible for foreign research experiences under this program, with prior FIC approval, particularly if they are involved in training or research collaboration with developing country scientists. The ITREOH encourages directors to include foreign women as trainees and, if U.S. trainees are involved, to include women and minorities. RESEARCH OBJECTIVES Air, water, and soil pollution and hazardous wastes have been accelerating globally during the twentieth century. This is due to expanding industrialization, use of newer technologies, including pesticides, and the resulting increased consumption of combustible fossil fuels, forests, and other natural resources. Industrialization has also exposed workers to dangerous machinery, chemicals, and other conditions that are hazardous to health, livelihood, and life. With the sequencing of the human genome new opportunities are presented to study gene-environment and occupational exposure interactions relevant to the expression or modification of genes that determine health and disease susceptibility. Such studies are especially timely. Scientific advances and economic progress have brought great benefits, but with these have come more complex environmental and occupational hazards, particularly in developing countries. At the same time, there is growing recognition of the true global nature of the environment and the need for a global response to protect the world’s environment and people. Through international research and training efforts, NIH, CDC, and other U.S. government and non-governmental agencies and organizations can play an important role in improving global response and increasing national capacity to identify and address health risks related to environmental change and degradation. To this end, the ITREOH program supports capacity development, including training and research in laboratory research, epidemiologic methodologies, environmental and occupational hazard assessment, engineering control, intervention and control research and related policy development designed to facilitate and support prevention of environmental and occupational health risks. Collaborations established through this program will help to facilitate standardized assessment and monitoring of environmental and occupational health hazards and prepare for the coordinated conduct of scientifically valid and ethically sound studies and interventions worldwide. Most importantly, a new and larger cadre of scientists and public health specialists will understand, evaluate, and help control and prevent the many environmental and occupational dangers that we face globally in the twenty-first century. Emphasis will be placed on collaborative activities in countries and regions where environmental and occupational health conditions adversely impact public health and economic progress. Examples of research and training priorities include, but are not limited to, the following: o Reduction in childhood environmental and adult occupational lead poisoning, o Reduction in traffic-related injury and deaths, o Hazardous waste management, o Safe drinking water programs, o Food sanitation and safety, o Environmental and occupational exposure surveillance, o Ambient air and drinking water monitoring, o Industrial hygiene, including measurement and engineering control, o Environmental hazard exposure and infectious disease interactions including vector-borne diseases, o Environmental hazard exposure and nutrition interactions. o Environmental hazard exposure and neurologic, pulmonary, and allergic (including asthma) interactions. o Reduction of personal environmental risk factors, including smoking and diet. o Environmental and occupational health implications of climate change, deforestation, soil salinization, and/or reduction in arable land, and drinking and irrigation water resources. o Understanding gene-environmental interactions, including identification of biomarkers. While applicants may choose from a wide range of activities, they are encouraged to focus on a limited number of scientific and geographic areas so as to make a real impact at collaborating institutions and in collaborating countries. This pertains, in particular, to new starts. SPECIAL REQUIREMENTS o Commitments: Each awardee will have a U.S. PI and a Major Foreign Collaborator (MFC), if collaboration occurs in two or more countries, there will be a MFC in each country. The PI and MFC will be responsible for the overall conduct of the ITREOH. The institution of the PI and MFC must have entered into a long-term commitment in writing to build the capacity of the foreign institution through governmental-supported or other resources. o Recruitment and Selection Plan: The applicant must include a detailed plan describing the recruitment and selection procedures for trainees and a detailed description of peer review for training-related and advanced in- country research. Degree candidates must meet all entrance requirements of the U.S. degree-granting institution or of the foreign degree-granting institution, if applicable. The application should clarify and completely specify: (a) criteria and procedures for the selection of trainees as, for example, by a committee composed of U.S. and foreign investigators at participating institution(s) and (b) a mechanism for internal peer review of applications to support U.S. and in-country research projects. o Establishing research priorities: Applicants should assure that research priorities reflect those of the participating countries and should describe the procedures to assure this takes place. o Strategy for regional impact: The application should emphasize capacity building at, and in collaboration with, institutions(s) in participating country(ies). The application should also describe strategies to achieve a wider regional impact by strengthening of other institutions with the goal to become a national and regional center of excellence. o National support for the program: Evidence should be provided in writing for national support of the program through cost-sharing by the host country and willingness of the host country to utilize trainees experience and knowledge gained from the program to reduce environmental and occupational risks. o Plans for continued collaboration with former trainees once they return home must be presented. For PIs applying for a continuation of their ITREOH grant, detailed evidence of such continuing collaboration must be provided. o Tracking system for long-term impact. As part of their obligations under this program, awardees are required to design initially as part of their application, implement and maintain, a system to track fully and document the long-term impact of this training program on: (1) the career choices and progress of current and former trainees, if this is a reapplication, a table should be included with this information, (2) building research and public health capacity in the home institution and country of trainees, (3) types of positions the proposed trainees may assume upon completion of training and documentation of career progress, (4) the possible contributions to future NIH- and CDC- and other U.S. and non-U.S. government agency supported international environmental and occupational health research and public health efforts, (5) the establishment or strengthening of environmental and occupational research centers of excellence for training and referral in the home countries of trainees, and (6) the contributions of the program toward interventions or policies that reduce environmental and occupational health risks in the home country(ies) of trainees. Impact will be an important criterion for assessing success in the recompetition of this program. Detailed examples of past (or expected) impact should be included and address how training received under the program has allowed participants to assume more responsible positions upon returning home, how continuing collaborations with former trainees resulted in obtaining grants or other support by environmental and occupational health science investigators or co-investigators, publications in which trainees were first authors and which were based upon support under this program, and development and implementation of health policies that were based on work by returning trainees in their home countries. After awards have been made, but before tracking of impact is implemented, FIC will work with awardees to design a standardized web-based tracking system for individual trainees and reporting program impact and accomplishments. This system will build upon an FIC experience in other research training programs and be compatible with them. Once this standardized tracking system has been finalized, it will be implemented across all programs. o Before any funds may be expended on in-country research, the grantee institution must show written evidence of formal approval from responsible authorities at the U.S.-based and foreign collaborating institutions, including an institutional (or ethical) review board or committee and the relevant government authority. These approvals should be included in the application and must be available for review before any award can be made. o There will be annual program network meetings in Bethesda or other sites to exchange research and training experience and coordinate program activities. PIs, MFCs, and selected trainees are expected to attend. Funds for this activity (travel and per diem) should be included in the budgetary requests. o As part of the proposed training program, the applicant must describe in detail how they propose to train students and investigators in the responsible conduct of research, consistent with NIH policies, updated July 2000 and listed on the Office of Research Integrity, NIH website http://ori.dhhs.gov. NIH requires that all staff at extramural institutions engaged in research or research training with NIH funds, or who work on NIH-supported research projects shall successfully complete a program of instruction in the responsible conduct of research. An award will not be made unless such a plan is included. ALLOWABLE COSTS All budget items related to trainee participation in the program should be itemized on the PHS Form 398 (4/98), 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/Honoraria) o Trainees (foreign graduate students and advanced degree participants) may be paid a stipend comparable to their professional experience, not exceeding $45,000 per year, in accordance with the U.S. institutional policies while involved in long-term training in the U.S. Applicants should refer to the NRSA stipend levels described on the web site http://www.nih.gov/fic/opportunities/index.html (NRSA substitute pages, pre- or postdoctoral stipends). o Foreign trainees may be paid a stipend while conducting long-term training-related research in their home countries at levels comparable with the salary scales for similar professionals in that country, in accordance with the collaborating foreign institution’s policies, but not exceeding $45,000 per year (NRSA substitute pages, pre- or postdoctoral stipends). o U.S. faculty, including the program director, who provide major program administration or who provide extended training and mentoring of students at the foreign site may receive salary and fringe benefits. The total amount of salary and fringe benefits requested for all U.S. faculty cannot exceed 10% of direct costs. The administrative, training, teaching and mentoring and collaborative research responsibilities and time commitment for personnel receiving salary must be completely described and justified for each faculty member (Form 398, budget pages, personnel) o The applicant may request up to 10% of direct costs to provide salary and fringe benefits for clerical and administrative support staff for the program. The responsibilities and time commitment for personnel receiving salary support must be completely described and justified (Form 398 pages, personnel). o Foreign institution faculty who provide major program administration at the foreign site or participate in training and mentoring and research, and U.S. faculty or foreign faculty who teach short courses, may receive an honorarium, not to exceed $2,000 per year, in accordance with their institution’s policies. No more than 5% of direct costs may be used for honoraria. The administrative, training or teaching responsibilities for each foreign faculty member must be completely described and justified (NRSA substitute pages-training related expenses). o Tuition, Fees and Insurance: Funds for tuition and academic fees at the U.S. institution can be requested. In addition, family health insurance will be an allowable cost for trainees and fellows who have families and are eligible for family health insurance coverage at the sponsoring institution. Tuition, fees and insurance cannot exceed 20% of direct costs. Programs are strongly encouraged to seek cost-sharing arrangements with the U.S. institutions (and foreign institutions where possible) to provide reduced tuition for long-term trainees and tuition-free short courses and indicate institutional commitment to the ITREOH program (NRSA substitute pages, tuition, fees, insurance). o Trainee Travel: Funds may be requested for round-trip economy class airfares and/or ground transport on U.S. carriers, to the maximum extent possible, for long- or short-term trainees in the U.S., and, for foreign trainees to participate in short courses or attend scientific conferences to present their results. One round-trip ticket to the host country per year for research purposes is allowed (NRSA substitute pages, trainee travel). o Funds may be requested for per diem and lodging for foreign trainees to participate in short courses or attend scientific conferences yearly to present their results (NRSA substitute pages, trainee travel). o Faculty Travel: Funds may be requested for a round-trip economy airfare on U.S. carriers, to the maximum extent possible, for U.S. faculty providing extended training to go to the foreign site or teach short courses at the foreign site: (PHS 398 pages, travel). o Funds may be requested for per diem and lodging for U.S. faculty to teach short courses at the foreign site: (PHS 398 pages, travel). o Funds should be requested for airfare, per diem and lodging comparable to U.S. government rates (http://policyworks.gov/org/main/mt/homepage/mtt/perdiem/perd04d.html) for the program director to attend an annual network meeting in the Washington, DC area (PHS 398 pages, travel). o Training-related expenses: Funds to support trainee research-related costs (such as reagents, lab supplies, computer access, small equipment, etc.) up to $600 per month per trainee may be requested (NRSA substitute pages, training- related expenses). o Funds (up to $10,000 per year) to support research at the foreign site associated with fulfilling requirements for an advanced degree may be requested (NRSA substitute pages, training-related expenses). o Research support up to $15,000 per trainee per year to facilitate conducting advanced research training (one time re-entry grants) in the home country by former long-term trainees usually at the post-doctoral level. The applicant should describe in detail how proposals for re-entry projects will be selected by a competitive peer review process examining scientific merit and ethical concerns involving faculty from the U.S. and foreign institutions coordinated by the program director (NRSA substitute pages, training-related expenses). o Special research capacity building support at institutions in the participating country(ies): Details can be submitted on medical informatics, operation of ethical review committees, grants writing seminars, etc., in support of the ITREOH and the center of excellence. This includes appointment of trainees to receive long-term training in their home country with mentors who were former trainees in the program. o Equipment: list separately each item of equipment, including computers for trainees to take back to the host country, and justify each item (NRSA substitute page, training related expenses). PROTECTION OF HUMAN SUBJECTS AND LABORATORY ANIMALS The new Office for Human Research Protections (OHRP) was created in on June 6, 2000 at the Department of Health and Human Services to lead efforts for protecting human subjects in biomedical and behavior research. In accordance with OHRP guidelines (ohrp@od.nih.gov) all investigators submitting NIH applications for grants, or receiving new or non-competing awards for research involving human subjects, will require education on the protection of human research participants. Applicants should refer to NIH Guide Notice OD-00-039, dated June 5, 2000 and revised August 25, 2000 (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html. The new Office of Laboratory Animal Welfare will oversee the responsible treatment for animal subjects (olaw@od.nih.gov). 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 " 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 is 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. INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS It is the policy of NIH that children (i.e., individuals under the age of 21) must be included in all human subjects research, conducted or supported by the NIH, unless there are scientific and ethical reasons not to include them. This policy applies to all initial (Type 1) applications submitted for receipt dates after October 1, 1998. All investigators proposing research involving human subjects should read the "NIH Policy and Guidelines" on the Inclusion of Children as Participants in Research Involving Human Subjects that was published in the NIH Guide for Grants and Contracts, March 6, 1998, and is available at the following URL address: http://grants.nih.gov/grants/guide/notice-files/not98-024.html. Investigators also may obtain copies of these policies from the program staff listed under INQUIRIES. Program staff may also provide additional relevant information concerning the policy. URLS IN NIH GRANT APPLICATIONS OR APPENDICES All applications and proposals for NIH funding must be self-contained within specified page limitations. Unless otherwise specified in an NIH solicitation, internet addresses (URLs) should not be used to provide information necessary to the review because reviewers are under no obligation to view the Internet sites. Reviewers are cautioned that their anonymity may be compromised when they directly access an Internet site. LETTER OF INTENT Prospective applicants are asked to submit, by January 16, 2001, a letter of intent that includes a brief descriptive title, the name, address, and telephone number of the PI, the identities of other key personnel and participating institutions and foreign collaborators, and the number and title of the RFA in response to which the application may be submitted. Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows staff to estimate the potential review workload and to plan the review. The letter of intent is to be sent to: Joel G. Breman, M.D., D.T.P.H. Deputy Director Division of International Training and Research Fogarty International Center National Institutes of Health Building 31, Room B2C39 31 Center Drive, MSC 2220 Bethesda, MD 20892-2220 Email: joel_breman@nih.gov APPLICATION PROCEDURES The research grant application form PHS 398 (rev. 4/98) is to be used in applying for these grants. These forms are available at most institutional offices of sponsored research and from the Center for Scientific Research, National Institutes of Health, 6701 Rockledge Drive, MSC 7910, Bethesda, MD 20892-7910, telephone 301/710-0267, e-mail: grants@nih.gov. Application forms are also available on the Internet at http://grants.nih.gov/grants/funding/phs398/phs398.html. 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. A sample RFA label is available at http://grants.nih.gov/grants/funding/phs398/label-bk.pdf and has been modified to allow for this change. Please note this is in pdf format. Submit a signed, typewritten original of the application, including the checklist, and three signed, photocopies, in one package to: CENTER FOR SCIENTIFIC REVIEW NATIONAL INSTITUTES OF HEALTH 6701 ROCKLEDGE DRIVE, ROOM 1040, MSC 7710 BETHESDA, MD 20892-7710 BETHESDA, MD 20817 (for express/courier service) At the time of submission, two additional copies of the application and appendices must be sent to: DR. LINDA BASS NATIONAL INSTITUTE OF ENVIRONMENTAL HEALTH SCIENCES 79 T. W. ALEXANDER DRIVE BUILDING 4401, ROOM 118 RESEARCH TRIANGLE PARK, NC 27709 It is important to send these copies at the same time as the original and three copies are sent to the Center for Scientific Review. These copies are used to identify conflicts of interest and to help ensure the appropriate and timely review of the application. Applications must be received by March 16, 2001. 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 CSR. Incomplete and/or non-responsive applications will be returned to the applicant without further consideration. Applications that are complete will be evaluated for scientific and technical merit by an appropriate peer review group convened by the NIEHS in consultation with FIC and NIOSH 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 and other appropriate Advisory Councils. REVIEW CRITERIA Review criteria include those generally applicable to research training programs and research. The scientific evaluation of each application will include assessment of the linkage between proposed training and environmental and occupational science-related research supported by FIC, NIEHS, NIOSH. Evidence of support for this program by collaborating institutions and foreign governments must be submitted in writing with the application. 1. Significance: o Does this training program address an important problem and do the program priorities reflect those of the collaborating country(ies)? If the aims of the application are achieved, how will scientific knowledge be advanced? What will be the effect of the training and studies on the concepts or methods that drive this field? o The expected public health and scientific contributions of the proposed activity at a country and regional level, and o The demonstrated capacity and/or potential to achieve sustained environmental and occupational health-related research and training efforts, and to build associated clinical and operational research and public health capacity within a country. 2. Approach: o Are the conceptual framework, design, methods, and analyses adequately developed, well-integrated, and appropriate to the aims of the research training? Details of the training plan should be included. Does the applicant recognize potential problem areas and consider alternative tactics? o Is there a balance in the proposed training program, to provide breadth of training opportunities in academic- and public health-based environmental and occupational research in biomedical and behavioral sciences? o Does the mix of long- and short-term training achieve the goals of this RFA, including focused efforts to build long-term biomedical, behavioral, clinical and operations research, and public health capacity at a model center of research excellence within a collaborating country? o Are the proposed procedures and criteria adequate for 1) recruitment, review and selection of trainees, and 2) peer review of research? o Is there evidence of a long-term commitment by the U.S. institution to collaborate with its foreign partner(s) and a cost sharing by the U.S. and foreign institutions involved in the program? o Have the foreign institute(s) and government(s) expressed a willingness to take advantage of returning former trainees and information gained from the program to improve environmental and occupational health? 3. Innovation: o Does the research training program employ novel concepts, approaches or methods? Are the aims original and innovative? Does the program challenge existing paradigms or develop new methodologies or technologies? o Does the proposal include concrete plans for trainees to become involved in environmental and occupational health sciences, biomedical and behavioral research, and prevention projects conducted in their home countries? o Is there adequate and creative planning for the use of modern information technology to facilitate access to scientific information, distance learning, coordination and research collaboration? o Are there creative strategies to achieve a regional impact? 4. Investigator: o Are the Principal Investigator, co-Principal Investigators, and mentors in the U.S. and abroad, appropriately trained and well-suited to carry out this work? Is the work proposed appropriate to the experience level of the PI and other researchers, if any? o Are the qualifications of the PI, MFC, and the named faculty adequate to lead and to productively participate in the proposed training and research program? o Do the PI, MFC, and participating faculty provide active and adequate research support? 5. Environment: o Does the scientific environment in which the training and research work will be done in the U.S. and abroad contribute to the probability of success? Do the proposed activities take advantage of unique features of the scientific environment or employ useful collaborative arrangements? Is there firm evidence of institutional support by the U.S. and foreign institutions? o Are there adequate mentoring and strength of resources and training environment in-country as evidenced by 1) the quality of teaching and the in- country research facilities and other resources, 2) the availability and history of high-quality candidates chosen on merit, and 3) past history of success of former trainees returning to their home countries and their continued involvement in the program, for example, the participation of past trainees in advanced in-country research and as faculty and mentors for new trainees? o The initial review group will also examine the adequacy of the process for providing for the protection of human and animal subjects, the safety of the research environment, and, plans to include training in responsible conduct of research and training in the operation of Institutional Review Boards (IRBs), data and safety monitoring boards and community advisory boards as a part of the program. IRBs in the home countries of trainees will be responsible for determining the adequacy of inclusion of women, minorities and children in research involving human subjects in their countries. In addition to the above criteria, in accordance with NIH policy, all applications will also be reviewed with respect to the following: 1. Past research training record for both the PI and MFCs in the U.S. and abroad, and designated preceptors, in terms of tracking careers of their past U.S. and foreign trainees and the rate at which former trainees establish independent and productive research and public health careers, and, for foreign trainees, percent who return to their home country, please include tables with this information, including current status of foreign and other selected trainees for at least the past five years. 2. Past research training record in terms of the success of former trainees in obtaining individual awards such as fellowships, career awards, and research grants for further development, major scientific breakthroughs by trainees should be highlighted. 3. Recruitment and selection plans in detail for appointees and the availability of high quality candidates. 4. The record of the research training program in retaining health professional postdoctoral trainees for at least two years in research training or other research activities. 5. When appropriate, the concomitant training of health professional post- doctorates (e.g., individuals with the M.D., D.O., D.D.S.) with basic science post-doctorates (e.g., individuals with a Ph.D., Sc.D.). 6. The adequacy of plans to include both genders, minorities and their subgroups, and children as appropriate for the scientific goals of the research. Plans for the recruitment and retention of subjects will also be evaluated. 7. The reasonableness of the proposed budget and duration in relation to the proposed research and training. 8. The adequacy of the proposed protection for humans, animals or the environment, to the extent they may be adversely affected by the project proposed in the application. Where specific research protocols are proposed, additional review criteria, applicable to research grants, will be as follows: 1. Scientific, technical, medical and public health significance, and originality of proposed research. 2. Appropriateness and adequacy of the experimental approach and methodology proposed to carry out the research. 3. Qualifications and research experience of the Principal U.S. and Foreign Investigator(s) and staff, particularly, but not exclusively, in the area of the proposed research. 4. Availability of the resources necessary to perform the research. 5. Appropriateness of the proposed budget and duration in relation to the proposed research. SCHEDULE Letter of Intent Receipt Date: January 16, 2001 Application Receipt Date: March 16, 2001 Date of Initial Review: June/July, 2001 Review by Advisory Council: September, 2001 Anticipated Award Date: on or before September 30, 2001 AWARD CRITERIA The most important factor to be considered in making funding decisions will be the quality of the proposed project as determined by initial scientific peer review. The proposed instruction in the responsible conduct of research must be rated adequate for an award to be made. Geographic and programmatic balance (e.g. the opportunities to have meritorious programs in Africa, Asia, Latin America, the Middle East and Russia/Eastern Europe) as well as input from the collaborating partners and the FIC Advisory Board will also be considered in making funding decisions. Before any funds can be expended for in-country research, the grantee institution must show evidence of approval for collaborative research and training between the U.S. and foreign countries and institutions included in the program through written endorsements from the appropriate government official(s) as well as from the collaborating institutions. INQUIRIES Inquiries concerning this RFA are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome and prospective applicants are strongly encouraged to discuss their proposals with program staff prior to submission. Direct inquiries regarding programmatic issues to: Joel G. Breman, M.D., D.T.P.H. Deputy Director 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) 496-1653 FAX: (301) 402-0779 Email: joel_breman@nih.gov Direct inquiries regarding fiscal matters to: Ms. Nancy Coulter Program Specialist Division of International Training and Research Fogarty International Center Building 31, Room B2C39 31 Center Drive, MSC 2220 Bethesda, MD 20892-2220 Telephone: (301) 496-1653 FAX: (301) 402-0779 Email: ncoulter@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 Parts 74 and 92. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or to Health Systems Agency review. The Public Health Service (PHS) strongly encourages all grant recipients to provide a smoke-free workplace and promote the non-use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routine education, library, day care, health care or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people.
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