INTERNATIONAL COLLABORATIVE GENETICS RESEARCH TRAINING PROGRAM Release Date: November 19, 2001 RFA: RFA-TW-02-001 Fogarty International Center (http://www.nih.gov/fic) National Institute of Mental Health (http://www.nimh.nih.gov/) National Institute on Aging (http://www.nih.gov/nia) National Institute of Environmental Health Sciences (http://www.niehs.nih.gov/) National Institute on Alcohol Abuse and Alcoholism (http://www.niaaa.nih.gov/) National Institute of Neurological Disorders and Stroke (http://www.ninds.nih.gov/) National Human Genome Research Institute (http://www.nhgri.nih.gov/) National Institute on Drug Abuse (http://www.nida.nih.gov/) Letter of Intent Receipt Date: January 25, 2002 Application Receipt Date: March 25, 2002 PURPOSE The Fogarty International Center, in partnership with the National Institute of Mental Health, National Institute on Aging, National Institute of Environmental Health Sciences, National Institute on Alcohol Abuse and Alcoholism, National Institute of Neurological Disorders and Stroke, National Human Genome Research Institute and National Institute on Drug Abuse, invites applications from nonprofit, private or public, domestic or international educational and research institutions in developed countries to establish research-training programs that contribute to the capacity of developing country investigators and institutions to conduct human genetics research relevant to the health needs of the country. Applications are solicited to create innovative research training programs within existing scientific collaborations between developed and developing country researchers to begin to build a critical mass of scientists, health professionals and academics with human genetics expertise and a sustainable research environment at the collaborating developing country institution. The International Collaborative Genetics Research Training programs will enhance and promote equitable international collaborations between investigators in the developed world and those in developing countries where a base level of institutional infrastructure for the advancement of sustainable genetic science is already established. Each proposed program should provide opportunities to generate the combined expertise at the developing country institution that could contribute to the long-term goal of harnessing new genetic knowledge and skills to diagnose, prevent or ameliorate morbidity and mortality related to a disease with a significant genetic component that occurs with substantial public health cost in that country and is relevant to the sponsoring NIH institutes. Programs should include training in one or more of the following areas: genetic epidemiology, population genetics, molecular genetics, clinical genetics, statistical genetics, and bioinformatics. Expertise should be developed simultaneously on the ethical, social and legal implications of human genetics research in each program. The training programs supported will begin to address and reduce the growing disparity in genetic sciences between those nations that have been at the forefront of the human genome research revolution and those with a limited but growing capacity in genetic science in developing regions of the world. HEALTHY PEOPLE 2010 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2010," a PHS- led national activity for setting priority areas. This Request for Applications (RFA), International Public Health Genetics Research Training Program, is related to one or more of the priority areas. Potential applicants may obtain a copy of "Healthy People 2010" at http://www.health.gov/healthypeople/. ELIGIBILITY REQUIREMENTS Applications may be submitted by domestic and foreign developed country, for- profit and non-profit public and private organizations, such as universities, health professional schools, research institutions capable of meeting the objectives of the RFA. Faith-based organizations are eligible to apply for these awards. Applicants must be the principal investigator or project director on an NIH "parent" research grant from one of the sponsoring NIH institutes in the human genetics area proposed for training, as outlined in the Research Training Objectives Section, with at least 18 months of active research support remaining at the time of application. NIH sponsored research project grants (R series) or center grants, program project grants or cooperative agreements (P and U series) from one of the co-sponsoring NIH institutes or centers qualify as "parent" research grants. Equivalent research grants from other sources may qualify as "parent" research grants if approved by the FIC program officer before submission of the application. Racial/ethnic minority individuals, women, and persons with disabilities are encouraged to apply as Principal Investigators. The applicant training institution must demonstrate either an ongoing collaborative research relationship or high potential for development of collaborative research with the human genetics researcher named as the primary foreign collaborator from a single institution. The foreign collaborators should be from Africa, Russia and Eastern Europe, Asia (except Japan, Singapore, South Korea and Taiwan), the Pacific Island region (except Australia and New Zealand), the Middle East (except Israel), Latin America and the Caribbean. The primary foreign collaborator must either hold a full time faculty research position or should have a full-time faculty position with a strong research commitment. The individual may be based at a public or private university, health professional school or research institution that will allow him or her adequate time and provide appropriate facilities and resources to participate in the proposed human genetics research training program. RESEARCH TRAINING OBJECTIVES Background The exploration of molecular mechanisms and widespread use of genetic methodology is rapidly becoming a fundamental component of biomedical research globally. Due to the rapid pace and expense of human genome research, however, the disparity in genetic science capabilities continues to widen between the developed and developing world. If the power and promise of human genome research to improve health is to come to fruition for most of the world"s population, it is essential for biomedical researchers and health professionals in developing countries to: 1) better understand how these scientific advances might be utilized to diagnose, prevent or ameliorate infectious and chronic diseases prevalent in their countries, 2) participate fully in human genetics research to meet the health needs of their country, and 3) guide the conditions under which human genetics research is conducted in their country. Low- and middle-income nations suffer over ninety percent of the world"s burden of premature mortality as measured in lost years of life. These countries, constituting three-quarters of the world"s population, now share a double burden: the persistent cluster of infectious diseases and malnutrition with a growing incidence of chronic disease and disabilities due to increased life spans and new risk exposures that accompany this demographic transition. It is essential to integrate advances in the field of genetics into the conduct of research, medical education and health services in developing countries, in order to maximize the impact of this progress on the health of people globally. While pockets of excellence in research genetics are present in some countries in the developing world, the numbers of individuals who have the expertise to perform this work are few. Increasing capacity in terms of both proficiency and numbers of trainees is essential in order to promote sustainable efforts to address global and local disease challenges. A number of middle-income and some low -income developing countries support ongoing human genetics research efforts and some include basic medical genetics services. Studies suggest that developing countries that attain an infant mortality rate of 50/1000 live births are those able to initiate genetics services within their health care systems. With limited resources, and scientific infrastructure, however, developing country geneticists have few opportunities to work in collaboration with colleagues abroad or with primary health care professionals in their own countries. In addition, in many settings, insufficient attention is given to the legal, social and ethical protections for the conduct of international genetic research. As U.S. scientists and their counterparts around the world work to incorporate genetics technologies into sustainable and collaborative research partnerships, a range of activities should be supported in developing country institutions. Training Objectives It is expected that each human genetics research-training program supported will: o substantially increase the expertise of trainees from developing countries in human genetics-related research and thereby strengthen sustainable human genetics research within the developing country institutions by providing a crucial level of human genetics expertise and building an integrated biomedical genetics and research training environment for future generations of developing country scientists and health professionals, o simultaneously increase trainee expertise in the legal, ethical and social implications of genetics research. This expertise might include but should not be limited to issues surrounding informed consent for individuals participating in genetics research, the role of ethics review committees in dealing with international genetics research, the cultural implications of policies related to effectively maintaining privacy and confidentiality of genetic information, questions raised by the commercialization of the products from human genetics research (e.g. ownership of tissue and tissue- derived products, patents, copyrights, and accessibility of data and material), o expand collaborative human genetics research interactions between developed and developing country scientists and health professionals at the collaborating developing country institution, o generate data for research-based decision making in genetic disease clinical treatment and prevention programs, for creating guidelines and procedures for conducting human genetics research and for informing national health care policy in the collaborating developing country, and, o stress an interdisciplinary approach that integrates behavioral and basic human genetics research with clinical training and public health priorities. Examples of research and training priorities include, but are not limited to: o Application of genetic epidemiologic methods in family-based association and linkage designs, population-based studies that correlate genetic variation with disease risk and studies of gene-environment interactions, o Design and implementation of genetic epidemiologic studies of complex diseases, including cancer, cardiovascular disease, diabetes, mental disorders, alcoholism and drug abuse, neurological diseases and asthma, as well as individual variation in drug response (pharmaco-genomics), o Assessments of the population impact of gene variation, disease, death and disability including surveillance systems, o Development of tools, models and algorithms which could facilitate assessment, utility and priority for genetic services in developing countries, o Assessing the genetic susceptibility to environmental exposures, including nutritional factors, pollutants, chemical toxins and substance abuse, on the initiation and progression of disease, or, o Research on the ethical, legal and social implications of performing human genetic research (as an adjunct to the other research training). Priority will be given to programs that include research objectives for the proposed training related to the creation of low-cost diagnostic methods that might facilitate the recognition of specific diseases (where applicable) endemic to a particular country or region, and the development of preventive or ameliorative treatment options. The design of human genetics research training programs must demonstrate that the critical mass of genetics expertise at the collaborating developing country institution will increase over time. This must include activities, including research and a support structure to encourage trainees to return to their home countries on completion of training. In addition, since genetics is a multidisciplinary field, in order to build a critical mass of genetics expertise at the developing country institution it is expected that trainees supported in each program will represent diverse academic backgrounds. Trainees may include pre- and post-doctoral behavioral or biomedical scientists, physicians, or individuals from a variety of other academic disciplines. Training Plan 1. Applicants should design a training plan that attempts to fill specific gaps in human genetics research expertise and expertise in the ethical, legal and social implications of this research at the collaborating developing country institution. The end result should be a critical mass of scientists and health professionals who will be able to conduct genetic research, understand the patho-physiology and prevent or treat a high priority disease with a genetic component in their country while simultaneously addressing the ethical, legal and social issues of associated with these activities. Proposals may incorporate a wide range of long- or short-term research training opportunities or a mixture of training possibilities that can be offered to a wide range of possible developing country participants. The purpose will be to achieve the creation of or expansion to a scientifically autonomous and sustainable human genetics research group capable of equal partnership in international collaborative efforts. A proposed training plan should include developed country grantee institution-based research training. However, applicants are also strongly encouraged to provide some support and mentored research training that will be conducted at the trainees" home institution in the developing country. This should take place to the greatest extent possible in order to promote sustainable and ongoing collaborative research once the training is complete. Applicants are also strongly encouraged to include women and developing country ethnic minorities as 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 would combine the acquisition of specific expertise to successfully answer a hypothesis- based human genetic research question with the opportunity to acquire multidisciplinary knowledge about the biomedical and public health impact and the related ethical, legal and social implications of performing human genetics research to the greatest extent possible. Long-term training should include academic genetics courses taken at the grantee institution, as well as instruction in the responsible conduct of research, laboratory safety, computational biology, bioinformatics, 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 genetic research needs of their 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, genetic counseling, 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 human genetics research training program, it is expected that this activity will be open to trainees from the other training programs supported by this RFA to the extent that this is feasible. Training activities should be coordinated, facilitated and monitored by a Training Advisory Committee, comprised of grantee institution human genetics research training program faculty and collaborating developing country faculty that should meet at least annually. Types of Training 1. Long-term pre-doctoral training in human genetics research associated with a human genetics research study 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 human genetics at the developing country institution and may range from two to four years. 2. Long-term post-advanced degree human genetics research associated with a human genetics research study for developing country scientists and health professionals including human genetics-related clinical training for approximately two years duration. 3. Short-term training in either the grantee or developing country institution of up to four weeks in specific research methods or other laboratory, clinical, field or administrative skills related to human genetics research associated with human genetics research study efforts at the collaborating developing 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, in order to support specific collaborative human genetics research efforts at the developing country institution. 5. Advanced research training support ("re-entry" funding), generally for one to two years, to enable trainees with advanced degrees or health care professionals to continue mentored human genetics research in their home country or to initiate independent human genetics research projects related to ongoing collaborative research at the developing country collaborating institution. SPECIAL REQUIREMENTS Training in the Ethical, Legal and Social Implications of Genetic Research Applicants must include plans for training in the ethical, legal and social implications of genetics or genomics research. 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. 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 and what criteria will be used to demonstrate that trainees will be reintegrated into their institution of origin upon return. 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 funding applications by a committee composed of grantee and developing country investigators from participating institution(s) to support human genetics research projects at the developing country institution relevant to a genetics-related health problem in that country to be conducted by returning trainees. Trainee Tracking System Applicants should describe their plan to track their trainees with respect to the short- and long-term impact of both human genetics training and training in the ethical, legal and social implications related to genetics research studies on their trainees. Awardees will be required 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 developing country institution from which the trainees originated in the developing world, (3) positions trainees assume upon completion of training, (4) the contributions of trainees to future international human genetics research and intervention trial efforts supported either by NIH or by other granting institutions. Examples of training impact might include data on (1) how training may have enabled participants to assume more responsible positions upon returning home, (2) how collaborations with former trainees resulted in the funding of human genetics intervention trials or (3) collaborative research projects on which trainees were either PIs or co-investigators, and (4) research publications authored by trainees supported by this program. The evaluation and impact of training resulting from each program will be considered an important criterion during any recompetition of this RFA. This RFA is co-sponsored by the World Health Organization. The WHO Genetics Collaborating Centres http://www.who.int/ncd/hgn/collcentres.htm are eligible and encouraged to apply for funding under the terms of reference of this RFA. The WHO will participate in the annual network meeting of awardees, co- funding agencies and selected international genetics trainees outlined in this RFA. MECHANISM OF SUPPORT This RFA will use the National Institutes of Health (NIH) international research training grant (D43) award mechanism that limits facilities and administrative (F&A) costs to eight percent of allowable direct costs. F&A costs up to eight percent can be requested in applications submitted by foreign institutions or for a subcontract to a foreign institution (see http://grants.nih.gov/grants/guide/notice-files/NOT-OD-01-028.html. The applicant organization must provide the necessary management for the transfer of funds and material to the collaborating developing country institution. Responsibility for the planning, direction, and execution of the proposed project will be solely that of the applicant. The total project period for an application submitted in response to this RFA may not exceed five years. Continued support during this period depends on satisfactory performance as judged by: annual progress reports, institution visits, participation in periodic meetings of program directors, career progress of trainees, continued "parent" research grant funding and the long term development of sustainable human genetics research capacity at the collaborating developing country institution. The International Collaborative Genetics Research Training awards will provide up to $400,000 per year in direct costs for up to five years of support. The anticipated award date is September 30, 2002. Although the intent of this RFA is to facilitate long-term scientific research capacity development at participating developing country institutions, the FIC and its partners have not determined at this time whether this solicitation will be continued beyond this RFA. 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. The totals for Form 398 budget pages DD and EE should be placed in the "Other" category on Form 398 NRSA substitute budget pages OO and PP listed as "Totals from budget pages DD and EE." Form 398 NRSA substitute budget pages OO and PP will be the composite budget showing all the funds requested. Trainees Stipends Trainees (developing country graduate students and post-advanced degree participants) studying at the developed country grantee institution may be paid a stipend comparable to their professional experience similar to other equivalent trainees 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) Salary for Developing Country Faculty Professional and clerical support staff at the grantee developed country institution who provide major program administration or extended long-term training or conduct collaborative research with trainees at the developing country institution may receive salary and fringe benefits. The total amount of salary and fringe benefits requested for all grantee faculty may not exceed $100,000 of direct costs per year in the budget request. The administrative, training or teaching responsibilities and time commitment for personnel receiving salary should be thoroughly described in the budget justification. (Form 398 budget pages, personnel) Consulting Fees for Developing Country Faculty Developing country institution faculty who provide major program administration at the developing country institution or participate in long- term training of participants at the developing country institution and grantee faculty or developing country faculty who teach short courses may receive a consulting fee not to exceed $3,000, in accordance with their institution"s policies. No more than $40,000 of the direct costs per year may be requested 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) Tuition, Fees and Insurance for Trainees Funds for tuition, academic fees and self-only or family medical insurance for developing country trainees at the grantee institution 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) Travel for Trainees 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 developing country trainee to travel to the grantee institution or for developing country trainees to participate in short courses or to attend scientific conferences. Funds may also be requested for developing country trainees and developed country grantees to present their results at an annual NIH network meeting for all grantees. FIC program staff must approve additional travel. (NRSA substitute pages, trainee travel) o Funds may be requested for per diem and lodging for developing country trainees to participate in short courses or attend scientific conferences to present their results. (NRSA substitute pages, trainee travel) Training related expenses o Funds to support developing country participant training or research related costs at the grantee developed country may be requested. (NRSA substitute pages, training related expenses) Faculty Travel for Developed Country Staff 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 or participating in collaborative research to go to the developing country institution or teach short courses at the developing country institution. FIC staff must approve additional travel. (PHS 398 pages, travel) o Funds may be requested for per diem and lodging for grantee faculty to teach short courses at the developing country institution. (PHS 398 pages, travel) o Funds should be requested for airfare, per diem and lodging comparable to U.S. government rates (see http://policyworks.gov/org/main/mt/homepage/mtt/perdiem/perd04d.html) for the Program Director and the primary foreign collaborator to attend an annual network meeting in Bethesda, Maryland. Inclusion of funds for trainees and other key personnel to attend these meetings is at the request of the applicant and at the discretion of FIC. (PHS 398 pages, travel) FUNDS AVAILABLE It is anticipated that approximately $3,000,000 will be available for the first year of the initial awards under this program from the FIC and collaborating partners. The National Institute on Nursing Research will consider supporting meritorious applications that are relevant to its mission. This will support an estimated seven to eight new awards. Because the nature and scope of the research proposed may vary, it is anticipated that the size of each award may also vary. Although the financial plans of the FIC and its partners 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 Involving Human Subjects Applicants must inform the FIC program staff that approval of research protocols involving human subjects has been obtained from U.S. and developing country ethics review committees registered under Institutional assurances with the Office of Human Research Protection and required U.S. and foreign government agencies before research involving human subjects is initiated. INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS It is the policy of the NIH that women and members of minority groups and their sub-populations must be included in all NIH-supported biomedical and behavioral research projects involving human subjects, unless a clear and compelling rationale and justification are provided indicating that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43). All investigators proposing clinical research should read the AMENDMENT "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research - Amended, October, 2001," published in the NIH Guide for Grants and Contracts on October 9, 2001 (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html), a complete copy of the updated Guidelines are available at http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm. The amended policy incorporates: the use of an NIH definition of clinical research, updated racial and ethnic categories in compliance with the new OMB standards, clarification of language governing NIH-defined Phase III clinical trials consistent with the new PHS Form 398, and updated roles and responsibilities of NIH staff and the extramural community. The policy continues to require for all NIH-defined Phase III clinical trials that: a) all applications or proposals and/or protocols must 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) investigators must report annual accrual and progress in conducting 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. This 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. REQUIRED EDUCATION ON THE PROTECTION OF HUMAN SUBJECT PARTICIPANTS NIH policy requires education on the protection of human subject participants for all investigators submitting NIH proposals for research involving human subjects. This policy announcement is found in the NIH Guide for Grants and Contracts Announcement dated June 5, 2000, at the following website: http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html. PUBLIC ACCESS TO RESEARCH DATA THROUGH THE FREEDOM OF INFORMATION ACT The Office of Management and Budget (OMB) Circular A-110 has been revised to provide public access to research data through the Freedom of Information Act (FOIA) under some circumstances. Data that are (1) produced in a project that is supported in whole or in part with Federal funds and (2) cited publicly and officially by a Federal agency in support of an action that has the force and effect of law (i.e., a regulation) may be accessed through FOIA. It is important for applicants to understand the basic scope of this amendment. NIH has provided guidance at http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm. Applicants may wish to place data collected under this RFA in a public archive, which can provide protections for the data and manage the distribution for an indefinite period of time. If so, the application should include a description of the archiving plan in the study design and include information about this in the budget justification section of the application. In addition, applicants should think about how to structure informed consent statements and other human subjects procedures given the potential for wider use of data collected under this award. LETTER OF INTENT Prospective applicants are asked to submit a letter of intent that includes a descriptive title of the proposed research, the name, address, and telephone number of the Principal Investigator, the identities of other key personnel and participating institutions, 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 IC staff to estimate the potential review workload and 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 PHS 398 research grant application forms (rev. 5/2001) at http://grants.nih.gov/grants/funding/phs398/phs398.html must be used in applying for these grants. Applicants should follow the instructions for the Institutional NRSA found at the end of the PHS 498 instructions to construct their application. This version of the PHS 398 is available in an interactive, searchable format. For further assistance contact GrantsInfo, Telephone 301/710-0267, Email: GrantsInfo@nih.gov. The RFA label available in the PHS 398 (rev. 5/2001) application form must be affixed to the bottom of the face page of the application. Type the RFA number on the label. Failure to use this label could result in delayed processing of the application such that it may not reach the review committee in time for review. In addition, the RFA title and number must be typed on line 2 of the face page of the application form and the YES box must be marked. The RFA label is also available at: http://grants.nih.gov/grants/funding/phs398/label-bk.pdf. Submit a signed typewritten original of the application, including the Checklist, and five 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) 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 Upon receipt, CSR will review applications for completeness and the Fogarty International Center will review applications for responsiveness. Incomplete and/or non-responsive applications will be returned to the applicant without further consideration. Applications that are complete and responsive to the RFA will be evaluated for scientific and technical merit by an appropriate peer review group convened by the Center for Scientific Review in accordance with the review criteria stated below. As part of the initial merit review, all applications will receive a written critique with an assigned priority score, and receive a second level review by the Fogarty International Center Advisory Board and other participating ICs. 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 training and research capacity building 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 must demonstrate specific relevant research support from NIH (eligible parent grant) 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 human genetics research support for the PI and other co- Investigators and developing country collaborators. Evidence of support for initiating the proposed human genetics research-training program from the collaborating developing country institution must be submitted with the application. Significance 1. The need for the specific human genetics research training proposed to fill the identified gaps in human genetics research expertise at the collaborating developing country institution. 2. The expected public health and scientific contributions related to the proposed human genetics research training to address major health issues in the collaborating developing country. 3. The potential to achieve independent and sustainable molecular or clinical human genetics research capacity at the developing country institution 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 research training objectives including: o A trainee recruiting, application and selection process that captures the most qualified individuals with the appropriate variety of professional backgrounds from the developing country 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 accomplishments and experience), o The process for determining appropriate trainee skill development plans, research project participation and mentorship, o For proposed long-term research training, the adequacy of the training opportunities to provide a breadth of knowledge in either academic-based molecular or clinical studies including the legal, ethical and social implications of human genetics research, while providing disease-specific human genetics research training to fill recognized gaps in expertise at the collaborating developing country institution, o If short courses or non-degree training are proposed, 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 Appropriate assessment and enhancement of background skills through training in research-related areas such as laboratory safety, 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 and mentoring activities o Methods to monitor the long-term impact of the human genetics research training experience on the subsequent careers of the trainees and on the capacity for human genetics research in the collaborating developing country. o Plans to include an adequate representation of women and ethnic minorities in the collaborating developing country among the developing country trainees. Innovation 1. Innovation in strategies for trainees to become actively involved in human genetics laboratory, clinical or public health research, development of ethical, legal and social guidelines and procedures for conducting human genetics research or intervention trials conducted at the developing country institution. 2. Innovation in training strategies to produce a critical mass of independent human genetics researchers and build a sustainable human genetics research training environment at the developing country collaborating institution during the course of the program. 3. Creativity of plans to use modern information technology training to facilitate trainee access to electronic information resources, distance learning and collaborative interaction. Investigators 1. Qualifications of the program director to lead and other faculty from the grantee and the collaborating developing country to participate as mentors in the proposed research training program. (The human genetics research experience and training accomplishments should be included in addition to Biographical Sketches and Other Support forms for each faculty participant.) 2. Qualifications of the program director or other faculty to provide research training and, if proposed, mentorship in research on the ethical, legal and social implications of performing human genetics research in developing countries. 3. Adequacy of the ongoing collaboration between the grantee and developing country investigators and their institutions to provide a suitable framework in which the proposed training will occur. 4. Commitment to building a long-term partnership with the developing country institutions to build a sustainable genetics research capacity. Environment 1. The adequacy of the teaching and research facilities and other resources and the overall training environment at the grantee and developing country institutions. 2. The grantee and developing country institutional commitments to international human genetics research and training in the ethical, legal and social implications related to the genetics research. (Letters of commitment from the appropriate institutional officials should be included in the application.) 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 training program. 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: January 25, 2002 Application Receipt Date: March 25, 2002 Peer Review Date: July 2002 Council Review: September 2002 Earliest Anticipated Start Date: September 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 The extent to which proposed training programs support and complement FIC and other NIH international human genetics research efforts. o The availability of funds. o Program balance among critical research and public health training areas of emphasis, including the scientific interests of the co-funding NIH partners in this program. o The geographic distribution among countries included in applications under consideration, including the strength of the rationale for a given program to be carried out in a specific country. 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 research/training 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: Dr. Camilla Day Genetics Sciences Integrated Review Group Center for Scientific Review 6701 Rockledge Drive MSC 7890 Bethesda, MD 20892 Telephone: (301)-435-1037 FAX: 301-480-2067 Email: dayc@csr.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 Direct inquiries regarding the specific scientific interests of the participating NIH Institutes to: Steven Moldin, Ph.D. Division of Neuroscience and Basic Behavioral Science National Institute of Mental Health 6001 Executive Blvd., Room 7189, MSC 9643 Bethesda, MD 20892-9643 Telephone: (301) 443-2037 Fax: (301) 443-9890 Email: smoldin@mail.nih.gov Jennifer Harris, Ph.D. Behavioral and Social Research Program National Institute on Aging 7201 Wisconsin Ave., Suite 533 Bethesda, MD 20892-9205 Telephone: (301) 496-3138 Fax: (301) 402-0051 Email: harrisje@mail.nih.gov Jose Velazquez, Ph.D. Division of Extramural Research and Training National Institute of Environmental Health Sciences 111 Alexander Drive, P.O. Box 12233 Research Triangle Park, NC 27709 Telephone: (919) 541-4998 Fax: (919) 316-4606 Email: velazqu1@niehs.nih.gov Samir Zakhari, Ph.D. Division of Basic Research National Institute on Alcohol Abuse and Alcoholism 6000 Executive Blvd., Suite 402 Bethesda, MD 20892-7003 Telephone: (301) 443-0799 Fax: (301) 594-0673 Email: szakhari@niaaa.nih.gov Robert Finkelstein, Ph.D. Division of Extramural Research National Institute of Neurological Disorders and Stroke 6001 Executive Blvd., Room 2142 Bethesda, MD 20892-9527 Telephone: (301) 496-5745 Fax: (301) 402-1501 Email: finkelsr@ninds.nih.gov Jean E. McEwen, J.D., Ph.D. Ehtical, Legal and Social Implications Program National Human Genome Research Institute 31 Center Drive, Room B2B07 Bethesda, MD 20892-2033 Telephone: (301) 402-4997 Fax: (301) 402-1950 Email: jm522n@nih.gov Jonathan Pollack, Ph.D. Genetics and Molecular Neurobiology Research Branch National Institute on Drug Abuse 6001 Executive Blvd., Room 4274 Bethesda, MD 20892 Telephone: (301) 435-1309 Fax: (301) 594-6043 Email: jp183r@nih.gov AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.989, (use appropriate program number). Awards are made under authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) 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 Health Systems Agency review. The PHS strongly encourages all grant recipients to provide a smoke-free workplace and promote the non-use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routine education, library, day care, health care, or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people.

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