NATIONAL RESEARCH SERVICE AWARDS INSTITUTIONAL TRAINING GRANTS IN GENOMIC ANALYSIS AND INTERPRETATION Release Date: December 18, 1998 PA NUMBER: PA-99-028 P.T. National Human Genome Research Institute National Institute of Environmental Health Sciences Application Receipt Date: May 10 This is a reissue of Program Announcement, PA-94-085, which appeared in the NIH Guide for Grants and Contracts, Vol. 23, No. 27, July 22, 1994. PURPOSE The National Human Genome Research Institute (NHGRI) and the National Institute of Environmental Health Sciences (NIEHS) announce the availability of support for institutional training programs in genomic sciences. The purpose of this Program Announcement is to train scientists who will have the multi-disciplinary skills that will enable them to engage in research to accomplish the long-term objectives of the Human Genome Project (HGP) and to take full advantage of the resulting genomic data and resources to solve biomedical problems, such as evaluating the complex gene-environment interactions resulting from multiple exposures and variability in susceptibility because of polymorphisms in multiple genes. The multidisciplinary training programs are intended to provide broad training for individuals who wish to conduct research at the interface of (1) biological disciplines and non-biological scientific disciplines relevant to genomic sciences (e.g., physical, chemical, mathematical, computational biology, bioinformatics, computer and/or engineering sciences) and (2).biological disciplines relevant to environmental health sciences, such as molecular biology, molecular toxicology and environmental epidemiology. The goals of this program are to: (1) encourage institutions with academically outstanding departments in molecular biology and one or more of the non- biological scientific disciplines relevant to genomic sciences to consider developing training programs and (2) expand the number of institutions capable of training scientists in genomic sciences and genomic science as it applies to the Environmental Genome Project. HEALTHY PEOPLE 2000 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2000," a PHS-led national activity for setting priority areas. This PA, National Research Service Awards Institutional Training Grants in Genomic Analysis and Interpretation, is related to several of the priority area. Potential applicants may obtain a copy of "Healthy People 2000" at: http://www.crisny.org/health/us/health7.html. ELIGIBILITY REQUIREMENTS Only domestic universities and medical colleges may apply for training grants supported under the National Research Service Award (NRSA) mechanism. Only U.S. citizens or permanent residents of the United States may be appointed as trainees on NRSA-funded training grants. Racial and ethnic minority individuals, women, and persons with disabilities are encouraged to apply as principal investigators. MECHANISM OF SUPPORT Support for this program will be through the National Research Service Award Program (T32). These research training opportunities will be supported through institutional training grants which may support pre-doctoral, post-doctoral and short-term trainees. Short-term training opportunities are intended for students in non-biological scientific disciplines who wish to learn more about genomic analysis and interpretation. Institutional training grants are made for project periods of up to five years and are renewable. RESEARCH OBJECTIVES Background The National Institutes of Health (NIH) is currently engaged, along with several other federal, private, and international organizations, in a research program to characterize the human genome and the genomes of selected model organisms. The HGP has the following interrelated goals: the development of detailed maps and the determination of the complete nucleotide sequence of the human genome and the genomes of selected organisms, the development of efficient methods for identifying genes and their function, the development of the capability to collect, store, distribute and analyze the data and materials produced, the development of new technologies to achieve these goals, the examination of the ethical, legal and social implications (ELSI) of genome research, and the development of training and career development programs to ensure that there will be enough adequately trained scientists and scholars to develop and utilize the products emanating from the HGP and to address the related ELSI issues. The products of the HGP will be information and material resources, as well as new technologies, that will be available to the entire research community to facilitate further research leading to the prevention, diagnosis, and therapy of disease, as well as to further understanding of human biology. In 1990, the NIH and the Department of Energy (DOE) jointly published a plan that sets out specific goals to be achieved in the first five-year phase of the U.S. human genome program. Anticipating the attainment of much of the initial set of goals, the NIH and the DOE extended the original goals of the Human Genome Program. These goals are described in the article, "A New five-year Plan for the U.S. Human Genome Project," (Science, Vol. 262, pp. 43-46, October 1, 1993) and cover the years 1994-1998. In the Fall of 1998, the NHGRI and DOE published a new five year plan (Science, Vol. 282, p 682, October 23, 1998 and http://www.nhgri.nih.gov/98plan/). The completion of the human DNA sequence and the development of technology for mapping and sequencing will continue to be areas of emphasis. New technological areas of interest will include the interpretation of genomic sequence, the study of sequence variation and the analysis of gene expression. The Human Genome Project is opening up new approaches to molecular medicine. Attaining the solutions to biomedical problems will require that the research methods of the biological sciences be augmented by and complemented with the approaches and methods of non-biological scientific disciplines. For the NHGRI, there is a critical shortage of scientists with the appropriate complementary skills to bring such multi-disciplinary approaches to genomic research. Individuals capable of developing new technology and tools are needed, as are molecular biologists who are capable of taking multi-disciplinary approaches and using the resources provided by the HGP to address important biomedical and biological research problems. For the Environmental Genome Project, molecular biology and molecular genetics have become essential tools in environmental toxicology as understanding the biological processes at the molecular level have enabled the study of the mechanisms of action of many toxic compounds. The issue of differential sensitivity among individuals within a population, and the identification of genes whose expression contributes to increased sensitivity or resistance to toxic environmental agents in humans has become a priority. Thus, there is a great need to train scientists who have the appropriate multidisciplinary expertise to develop the new approaches and tools to study the interplay of environmental exposures and population genetics. For example, individuals with backgrounds in genetics, molecular biology, biochemistry, structural biology, epidemiology, computational and statistical sciences, and non-biological disciplines relevant to genomic sciences who can expand their research capabilities are needed to evaluate the complex gene-environment interactions resulting from multiple exposures and from the variability in susceptibility resulting from polymorphisms in multiple genes. A description of the Environmental Genome Project can be found at the following URL:http://WWW.NIEHS.NIH.GOV/envgenom/ Successful training programs will attract individuals with backgrounds in relevant non-biological scientific disciplines or molecular biology and should have sufficient flexibility to provide the appropriate interdisciplinary training to individual candidates. It is essential that trainees who are supported under this program receive thorough training in multi-disciplinary approaches to modern molecular genetics and genomics research. While the training needs of the two participating institutes have genomic research as a central theme, the focus of each is very specific in order to meet the needs of the individual institutes. Therefore, prospective applicants are encouraged to contact staff listed under "INQUIRIES" prior to developing an application. Training Program Genomic science represents a new scientific approach to solving biomedical research problems. Thus, most institutions have not, as yet, developed graduate and post-graduate training programs in genomic science that would enroll students or postdoctoral fellows trained in molecular biology or one of the non-biological scientific disciplines appropriate for genomic science and provide training that would allow them to develop complementary expertise in another discipline. Because of the unique training requirements of the HGP, the participating institutes recognize that institutions will need to develop new training programs. Therefore, we strongly encourage applications from institutions that can demonstrate academic excellence in molecular biology and one or more of the non-biological scientific disciplines appropriate for genomic analysis and interpretation, have outstanding faculties that are committed and willing to cooperate in developing a genomic sciences training program, have access to a pool of highly qualified graduate students and postdoctoral fellows, and have sound training plans, but have not as yet established (or are just developing) training programs in genomic science. Applications from institutions that wish to apply as a consortium are welcomed, but must demonstrate that they can mount a well-coordinated and integrated program. Format The participating institutes are seeking to support training programs that allow trainees access to broad research opportunities across disciplinary and departmental lines, while not sacrificing the standards of depth and creativity characteristic of the best doctoral and postdoctoral programs of individual departments. We recognize that there is no one model for this type of training and encourage institutions to develop innovative training programs that are responsive to the needs of genomic sciences as well as to the needs of individual trainees. Types of Training Positions Allowed All training positions, whether yearly or short-term appointments, are full-time positions with a minimum of 40 hours per week of research training required. An institutional training grant may include all of the following types of training positions: l. Pre-doctoral positions for pre-doctoral students trained in chemistry, physics, mathematics, bioinformatics, computational biology, computer sciences or engineering sciences who wish to pursue additional training in molecular biology, molecular genetics, molecular toxicology, statistics, and environmental epidemiology, or for individuals with training in molecular biology, molecular genetics, molecular toxicology, statistics, and environmental epidemiology, who wish to pursue an area of technology development as it relates to genomic science. An exposure to technology development is encouraged for all pre- doctoral trainees. 2. Postdoctoral positions--for postdoctoral students trained in chemistry, physics, mathematics, bioinformatics, computational biology, computer sciences or engineering sciences who wish to pursue additional training in molecular biology, molecular genetics, molecular toxicology, statistics, and environmental epidemiology, or for individuals with training in molecular biology, molecular genetics, molecular toxicology, statistics, and environmental epidemiology, who wish to pursue an area of technology development as it relates to genomic science. Short-term training positions--only for graduate students enrolled in a Ph D. program and trained in chemistry, physics, mathematics, bioinformatics, computational biology, computer sciences or engineering sciences who wish to spend three to six months in a molecular biology laboratory in order to get acquainted with the field. The number of postdoctoral positions should be limited to approximately one-third of the total full-time training positions. No application which requests only postdoctoral positions will be accepted. Stipends and Other Allowable Costs The stipends for pre-doctoral and postdoctoral trainees are at the new level that was announced in the NIH Guide to Grants and Contracts, January 9, 1998. Tuition may be requested for full-time pre-doctoral trainees only. Institutional costs of up to $1,500 per year per pre-doctoral trainee and up to $2,500 per year per postdoctoral trainee may be requested to defray the costs of other training- related expenses, such as staff salaries, consultant costs, equipment, research supplies, and travel. The institution may receive up to $125 per month to offset the cost of tuition, fees, travel, supplies, and other expenses for each short- term research training position. Indirect cost allowance based on 8 percent of total allowable direct costs exclusive of tuition, fees, health insurance, and expenditures for equipment, or actual indirect costs, whichever is less, may be requested. Prior to developing budgets, applicants are strongly encouraged to interact with the appropriate Grants Management staff listed under INQUIRIES. INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS It is the policy of the NIH that women and members of minority groups and their subpopulations must be included in all NIH supported biomedical and behavioral research projects involving human subjects, unless a clear and compelling rationale and justification is provided that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This policy results from the NIH Revitalization Act of 1993 (Public Law 103-43). Investigators proposing research involving human subjects should read the NIH Guidelines For Inclusion of Women and Minorities as Subjects in Clinical Research which were published in the Federal Register of March 28, 1994 (FR 59 14508-14513), and in the NIH Guide for Grants and Contracts, Volume 23, Number 11, March 18, 1994. Investigators may obtain copies from these sources or from the program staff or contact person listed under INQUIRIES. Program staff may also provide additional relevant information concerning the policy. 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://www.nih.gov/grants/guide/notice-files/not98-024.html APPLICATION PROCEDURES Applications are to be submitted on grant application form PHS 398 (rev 4/98). The submission date for new and competing applications is May 10, annually. Application kits are available at most institutional offices of sponsored research, from the Division of Extramural Outreach and Information Resources, National Institutes of Health, 6701 Rockledge Drive, MSC 7910, Bethesda, MD 20892-7910, telephone (301) 710-0267, e-mail: GrantsInfo@nih.gov, and from the NIH web page: http://www.nih.gov/grants/forms.htm. The title and number of this program announcement must be typed in Item 2 on the face page of the application. The completed original application and three legible copies must be delivered 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 same time, two copies of the full application must be sent to: OFFICE OF SCIENTIFIC REVIEW NATIONAL HUMAN GENOME RESEARCH INSTITUTE BUILDING 38A, ROOM 609 BETHESDA, MD 20892-6050 BETHESDA, MD 20817 (for express/courier service) Postdoctoral trainees and fellows supported under the National Research Service Award Program are subject to payback provisions in accordance with NRSA regulations and guidelines. Details about the policies and payback provisions governing payback requirements are posted on the NIH website: http://www.nih.gov/training/nrsaguidelines/nrsa_toc.htm . Additional information about NRSA Guidelines and NIH Grants Policy Statement (10/1/98) can be obtained from the following website: http://www.nih.gov/grants/policy/policy.htm REVIEW CONSIDERATIONS Applications will be assigned on the basis of established PHS referral guidelines. Applications will be reviewed for scientific merit by an initial review group convened in accordance with standard NIH pro procedure. The following review criteria will be applied: the research and training experience and leadership capabilities of the program director, the qualifications and commitment of the training faculty as measured by research grant support, publication record, and past training record, the quality of the applicant pool, the design of the training program including its relevance to the goals of the NHGRI"s Human Genome Program and the NIEHS"s Environmental Genome Project, as appropriate, provisions for guidance and quality control of the individual trainee"s programs, and adequacy of the resources and environment. For institutions that are in the process of developing a genomic science training program, greater weight will be given to the design of the institution"s training program than to past experience in this area. For institutions that are submitting competing renewals, both the past performance of the genomics training program and the future directions of the training program will be evaluated. Following assessment of the quality of the proposed training program and assignment of priority scores indicative of the merit, the initial review group will evaluate each application on its (1) plans for attracting and retaining individuals from underrepresented minority groups and (2) plans for instructing trainees in the responsible conduct of research. If an application is deficient in one of these areas, it may not be funded, regardless of scientific merit. Site visits will not be conducted as part of the review process, except in unusual circumstances. Therefore, applicants must present a complete and well- justified written proposal and not depend on a site visit to amplify the applications. Subsequent to the initial scientific review, the appropriate national advisory council will review applications for relevance to its scientific mission. Among the information the Councils will consider in addition to the merit of the training program is the initial review group"s comments on plans for, or experience in, the recruitment and retention of individuals from underrepresented minority groups into the training program. AWARD CRITERIA The NIH Institutes will use the following criteria in making funding decisions: quality of the training program as determined by its potential to meet the short- and long-term goals of the Human Genome Project or the Environmental Genome Project, leadership capabilities of the program director and the quality of the participating faculty, commitment of the biology and non-biology faculty to the training program, and availability of funds. NIH understands that it takes time for institutions to develop cooperative efforts across departmental and scientific discipline lines and this factor will also be considered when funding decisions for first time applicants are made. In addition, no award will be made unless plans for the recruitment and retention of minorities and for the instruction of trainees in the responsible conduct of research are deemed adequate. INQUIRIES Inquiries are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Direct inquiries regarding programmatic issues to: Bettie J. Graham, Ph.D. Division of Extramural Research National Human Genome Research Institute 9000 Rockville Pike Bethesda, MD 20892-6050 Telephone: (301) 496-7531 Email: Bettie_Graham@nih.gov Carol K. Shreffler, Ph.D. Division of Extramural Research and Training National Institute of Environmental Health Sciences MD EC-23 P.O. Box 12233 Research Triangle Park, NC 27709 Telephone: (919) 541-1445 Email: Shreffl1@niehs.nih.gov Direct inquiries regarding fiscal matters to: Ms. Jean Cahill Division of Extramural Research National Human Genome Research Institute Building 38A, Room 613 Bethesda, MD 20892-6050 Telephone: (301) 402-0733 Email: Jean_Cahill@nih.gov Ms. Jackie Russell Division of Extramural Research and Training National Institute of Environmental Health Sciences MCEC-22 P.O. Box 12233 Research Triangle Park, NC 27709 Telephone: (919) 541-0751 Email: Russell@niehs.nih.gov AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.172 (NHGRI) and 93.894 (NIEHS). 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 PHS grants policies and Federal Regulations 42 CFR 66 and 45 CFR Part 74. 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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