NRSA INSTITUTIONAL TRAINING GRANTS IN ENVIRONMENTAL HEALTH SCIENCES Release Date: January 5, 2000 PA NUMBER: PAR-00-038 National Institute of Environmental Health Sciences PURPOSE The National Institute of Environmental Health Sciences (NIEHS) announces the availability of support for training programs in disciplines and research areas which focus on the effects of chemical, physical and biological environmental agents on human health and well-being and the linking of these effects of exogenous environmental factors to the cause, moderation or prevention of human diseases or disorders. The purpose of this Program Announcement (PA) is to ensure the long term progress of research in the environmental health sciences by developing training programs which will produce a cadre of scientists who can carry the state of knowledge from fundamental and laboratory findings on the adverse health effects of exposure to environmental agents to a higher level and who can relate these findings to the human disease state. The NIEHS is concerned with effects resulting from a broad array of chemical, physical, and biological environmental agents found in the ambient environment (indoor and outdoor) to which humans are exposed at work, home, and recreational or leisure activities. Exposure may occur by absorption (i.e. through the skin), inspiration (i.e., through the lungs), ingestion (through the gastrointestinal track), or transmission (i.e. sunlight or electromagnetic radiation). Chemical factors include health related studies of chemical transformations of environmental agents, chemical structural/biological function relationships and interactions, including gene-environment interactions, among environmental agents in the promotion of diseases and dysfunctions. Examples of chemical factors include, but are not limited to, industrial chemicals and solvents, air pollutants, pesticides, heavy metals, hazardous substances, food additives, and botanical dietary supplements. Additionally, the NIEHS supports research on naturally occurring chemical agents that are capable of adverse or beneficial health effects. The NIEHS training programs support both broad multidisciplinary training programs, which are often built around a theme or problem area, and in-depth training programs in a particular discipline. The essential elements for the establishment of a successful training program are the presence of a cadre of well-funded, productive scientists performing research in areas germane to the environmental health sciences who can serve as the training program faculty, and the development of a cohesive training program for students. Thus the goals for this NIEHS Program Announcement are: 1) to encourage institutions with academically outstanding departments and programs which could provide training in scientific disciplines or problem areas associated with the environmental health sciences to consider developing training programs, and 2) to expand the number of institutions capable of training scientists in the environmental health sciences. 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 Environmental Health", is related to the priority area of environmental health. Potential applicants may obtain a copy of "Healthy People 2000" at: http://odphp.osophs.dhhs.gov/pubs/hp2000 ELIGIBILITY REQUIREMENTS Eligibility for institutional National Research Service Award support is limited to domestic public and nonprofit research organizations. 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 This program will be supported through the institutional National Research Service Award Program (T32). These institutional training grants may support pre-doctoral, postdoctoral, and short-term trainees. Short-term training opportunities are intended to provide a limited period of research experience for medical or other health professional students who have completed at least one quarter at an accredited health-professional school leading to a clinical doctorate and who wish to participate in research projects on a full-time basis during the summer or other "off-quarter" periods. Particular emphasis has been placed on the research training of physicians. The National Research Service Award must be used to support a program of research training. The NRSA may not support studies leading to the M.D., D.O., D.V.M., or other clinical, health professional degrees, nor to support residencies, the primary purpose of which is the attainment of specialty training. Institutional NRSA awards are made for project periods of up to five years and are renewable. RESEARCH OBJECTIVES Most human diseases and disorders result from interactions among genetic factors, exposure to environmental factors, time or age, and socio-economic status (SES). The major goal of the research and research training programs of the NIEHS is to develop the knowledge base and research capacity that will support both current and future efforts in the prediction, prevention or treatment of human diseases and disorders associated with toxic effects of exposures to environmental agents or factors. Attaining this goal ensures that the knowledge gained from studies as diverse as the molecular basis of disease and population based studies of disease will permit a better management of the associated risks for relevant diseases or disorders. Thus, the focus of the programs of the NIEHS extends to a wide range of diseases, disease processes, and organ systems, with the emphasis being placed on the understanding of the manifestations and mechanisms of the disease process brought about or exacerbated by environmental exposures. The environmental health science training programs of the NIEHS are organized within three very broad areas: Toxicological Sciences (including Genetic Toxicology and Mutagenesis), Experimental Pathology, and Epidemiology and Biostatistics, which have historically described the main research objectives of the training program. It is realized, however, that there are no definitive models for successful training programs in the environmental health sciences and institutions are encouraged to develop innovative training programs and training models that are responsive to the research needs of the NIEHS. Therefore, institutions that can demonstrate academic excellence in disciplines appropriate to studies of environmental exposures on human health and have access to a pool of highly qualified graduate and postdoctoral trainees are encouraged to consider developing these research and training resources into training plans. Programs which fall under the program area of toxicological sciences will continue to be an important part of the training as well as the research program at the NIEHS in the future. It is noted that the NIEHS defines this program area very broadly to include basic science, as well as clinical studies of adverse responses resulting from environmental exposures. These may be effects at the genomic level, at the molecular and cellular level, at the organ and organ system levels, or at the level of whole organisms and human populations. Research in toxicology can be approached from many basic disciplines and programs are needed which promote strong basic training plus the ability to learn and deal with other areas of science relevant to environmental health problems. The development of programs which emphasize fundamentals so that trainees will be prepared to meet a range of professional challenges during their subsequent careers is encouraged. The face of toxicology has changed considerably in the last 20 years and will change even more rapidly in the next 20 years. Scientists will be needed who are well grounded in principles and knowledge that will permit them to conduct studies on the highly complex interactions of chemical and physical agents with genetic influences and factors (toxicogenomics, toxicoproteomics) and develop even newer paradigms to yet further extend such knowledge. Training in experimental pathology, especially from programs which combine basic pathology training with molecular medicine and technical advances in the field, are expected to play a key role in the development and application of new tools to investigate the mechanisms of human diseases related to environmental and occupational exposures. Research training for Ph.D."s, physician pathologists, and veterinary pathologists, involving training in molecular biology, molecular based models and new technologies, and the preparation of trainees to make important extrapolations between in vitro systems, animal models of disease, and human populations is encouraged. Importantly, pathology programs that develop links to patient oriented research are needed. The need for doctoral and postdoctoral level trainees in environmental epidemiology and in biostatistics has grown substantially and the demand is expected to continue to grow as increasingly complex research challenges present themselves. Epidemiologists are needed who can approach complicated research questions involving the characterization of exposure/disease relationships for low level exposures that exert subtle biologic effects that ultimately culminate in excessive risks or disease. These research strategies often include the development and validation of biomarkers that reflect specific exposures, exposure effects, or susceptibility and predict disease risk in individuals that links a given exposure to a disease or disease process. Identification of subgroups of the population who are particularly susceptible to environmental exposure, by virtue of genetic traits or other host factors, is now recognized as a critical aspect of environmental epidemiology research. Training programs that offer appropriate course work and research experience in the core disciplines of epidemiology, environmental exposure assessment, biostatistics, toxicology, genetics, and molecular biology are encouraged. In particular, training programs based on the molecular epidemiology of human environmental diseases and/or disorders are encouraged. Likewise, the need for doctoral and postdoctoral trained biostatisticians with interests in environmental applications has been increasing steadily. Current environmental health research, whether it be laboratory research, epidemiologic research or research to support the environmental genome project, cannot be optimally conducted without the use of state-of-the-art biostatistical design and analytical methods. Biostatistics training programs with a strong emphasis on statistical theory and application, attendant with some supplementary training in important subject-matter areas pertinent to environmental health (e.g., epidemiology, environmental health, toxicology, or genetics) are encouraged. Programs proposing training in biologically based risk assessment for adverse health outcomes in susceptible and/or exposed populations are also encouraged. Physician-Scientists will be needed to develop the field of environmental medicine research encompassing all clinically relevant areas related to the environmental health sciences, including patient related aspects of toxicology, experimental pathology and environmental epidemiology and biostatistics. Applications from programs that can promote research training in these topic areas are particularly encouraged. AREAS OF RESEARCH EMPHASIS The NIEHS continues to support research on the molecular and cellular mechanisms involved in the biological response to toxic agents and the development of specific therapies based on these mechanisms for a variety of environmentally associated diseases. Mechanisms of continuing interest include those that are both genotoxic and nongenotoxic, as well as multidisciplinary approaches integrating the environmental, genetic and age or developmental aspects of the impact of environmental exposures on organ systems or whole animals. The NIEHS also continues its encouragement of research in the particularly difficult areas of low dose effects and effects of complex mixtures. Within the wide spectrum of research supported by the NIEHS, the research areas listed below have been identified by the National Environmental Health Sciences Council as topics of special interest to forwarding the research programs of the institute. Training programs are encouraged to consider these special emphasis areas when designing their programs: Environmental Genome Project: Research in this area addresses the range of variability among individuals in a population with respect to disease risk associated with environmental exposures, which in some part may be attributed to the individual variability in genetic parameters and host characteristics which has been found at the molecular level. Presently, in most cases risk assessment and subsequent regulation of environmental chemicals are based on assumptions of homogeneity in the population. The ability to target effective intervention and prevention strategies will be enhanced by the identification of potentially susceptible subgroups and individuals and elaboration of the biological significance of these genetic variations. In addition, it is recognized that new statistical and informatics paradigms are needed to handle and interpret the large amount of data expected to be generated. Basic Molecular Mechanisms of Environmental Insult: The NIEHS continues to emphasize research on the molecular and cellular mechanisms involved in the biological response to toxic agents and the development of specific therapies based on these mechanisms for a variety of environmentally associated diseases. Mechanisms of interest include those that are both genotoxic and nongenotoxic, and multidisciplinary approaches integrating the environmental, genetic and age or developmental aspects of the impact of environmental exposures on organ systems or whole animals are also considered important. Research on the influence of low exposures in the following is particularly encouraged: genetic recombination and genome instability, alterations in cellular communications, environmental influences on cell cycle regulation/control, and environmental influences on epigenetic mechanisms. Reproductive Health: The NIEHS continues to emphasize studies of environmental agents, such as endocrine disrupting chemicals, affecting the reproductive status of humans, and in particular the health of the male and female reproductive systems. Priority areas for research include changes in fertility, increased risk of prostate or breast cancer, increased risk of male or female genitourinary birth defects, including hypospadias and cryptorchidism or ovarian and utero-tubal dysgenesis. Immune System Modulation: It is recognized that environmental insults can lead to activation or suppression of the immune system resulting in autoimmune diseases or infections, respectively. Likewise, the immune status of the individual may influence the individual response to the environmental exposure. Expanded programs in basic, clinical and epidemiologic research are anticipated to explore these links. Neurodegenerative/Neurobehavioral Diseases or Disorders: Research training is needed in all areas of neurodegenerative/neurobehavioral disease for which there are environmental factor inputs into the disease causation, progression or outcomes. This includes approaches that are mechanistic, behavioral or epidemiologic in nature as well as those aimed at developing biomarkers of preclinical disease or models of the clinical disease. The relative roles of genetics, environmental factors and genetic/environmental interactions in the etiology of a wide variety of neurodegenerative and neurobehavioral diseases have only recently become appreciated and more research effort, particularly focusing on gene environment interactions is needed. Diet and Nutrition: Nutritional status is likely to interact significantly with environmental exposures to either exacerbate the adverse effects of the toxicant, or to serve a protective function. The molecular mechanisms responsible for these interactions are likely to be important in the modulation of birth defects resulting from environmental exposures, the mobilization of body burdens of environmental agents during pregnancy and lactation, and modulation of environmental effects in other diseases, such as asthma, neurodegenerative diseases, cognitive disorders, and cardiovascular disease. In addition, the NIEHS has a special interest in interactions between environmental exposures and the beneficial or detrimental effects of botanical (herbal) and/or nutriceutical dietary supplements. ATTRIBUTES OF A GOOD TRAINING PROGRAM In September of 1999, the NIEHS convened a Training Evaluation workshop that brought together external scientists with extensive research and research training experience representative of academic, industry and governmental perspectives. The participants identified elements that characterize an outstanding training program. These Attributes of a Good Training Program are included below for the consideration of those formulating a response to this program announcement. These elements should be, as appropriate, addressed in a training grant application. Program Plan o The program has defined goals and objectives, and clearly defines the proposed areas of training. o The training proposed is an identifiable program within the institutional setting of the training program. o There is a demonstrated cohesive graduate and/or postdoctoral training program incorporating appropriate course work, seminars, tutorials, laboratory rotations, etc. relevant to future directions in environmental health sciences research. o The program incorporates specialized training in current "state-of-the- art" methodologies to be used in environmentally related research. o The primary element of the training is the development, execution and publication of an independent laboratory research project in environmental health and disease. o The program includes a plan for development of oral and written communication skills and a plan for ongoing professional development activities for trainees. Trainees should have the opportunity to present at relevant national meetings. o Upon completion of the program, trainees can be expected to be adequately prepared to pursue research careers in a field appropriate to the environmental health sciences. o An appropriate administrative framework is in place to monitor trainee progress and ensure a quality training experience for each trainee. o A plan is in place to systematically track the career progress of former trainees. o Plans are in place for regular internal and external review and evaluation of the training program. Training Director and Faculty o The Training Director has an extensive record of research achievements, research publications and research training experience in an area of environmental health directly related to the goals and objectives of the training program. The Training Director should have current R01 or related research funding. o The faculty who are identified as training preceptors have strong records of research, research publications, research funding, and research training. o The faculty who are identified have demonstrated leadership in scientific societies, meetings and panels relevant to environmental health and public policy. o There is evidence of interactions and collaborations among faculty in graduate training and research. o The areas of research competence represented by the faculty are appropriate to the goals and objectives of the training program, and are relevant to the proposed areas of training. o The training faculty, taken as a whole, have sufficient breadth of background and experience to offer strong and comprehensive training, in terms of course work, research, and laboratory experience to the trainees in the program. o The training faculty shows commitment and involvement with the training program. o The training faculty has sufficient time to commit to the training program, and to the graduate/postdoctoral educational experiences outlined. o There is a sufficient number of training faculty members to supervise the trainees and offer the didactic program. Past Training Record o The training program has a strong record of graduate recruiting, training and placement of scientists in leadership positions in academia, government, industry and other occupations related to environmental health and public policy. o Research of present and past trainees has been published in competitive peer reviewed journals. Trainees have been the recipients of awards from societies for travel, abstracts, and/or research. o Postdoctoral trainees have a good record of success in competing for individual fellowships and career transition awards, graduates of predoctoral programs compete well for postdoctoral fellowships. o Trainees of the program are sought for permanent positions, there is evidence that past trainees have a choice of career options in academia, government, and industry. o Past trainees are able to approach a wide variety of research problems. The Trainee Pool o There is an active recruitment program that is attracting an adequate number of competitive applicants to the program. o Strong applicants are attracted to the program. o There is selectivity demonstrated in that the trainees selected for training support represent the best applicants to the program. Training Environment o There is sufficient research grant funding available to the faculty of the training program to support trainee research. The funding should be from sources appropriate to support innovative in-depth trainee research projects and reflect the aims of the training. o Appropriate seminar series and/or journal clubs are available. o Appropriate space and equipment are available to the training program. o There is appropriate course work of sufficient rigor to support the training program. There should be evidence that the course work is offered with sufficient frequency to meet trainee needs, and that the trainees in the program are taking advantage of the course work. o There is sufficient course work available in addition to required courses so that trainees can gain meaningful experience in fields pertinent to their career goals, or compensate for deficiencies in their background. o If laboratory rotations are a part of the proposed program, ample laboratories and experiences are available to fit the training interests of the students. o There are mechanisms in place to ensure interaction between faculty and trainees will occur. o The academic standing of the sponsoring department and supporting departments are of a quality that the training program can be expected to flourish. o The history and background of the sponsoring department and supporting departments are conducive to the establishment of a training program in the environmental health sciences. o There are relevant research and training activities elsewhere in the Institution that can lend strength to the proposed program. There should be evidence that these institutional strengths are readily accessible to the trainees of the program. Institutional Commitment o The Institution actively and tangibly supports the establishment and maintenance of a training program in the environmental health sciences. o There is a commitment on the part of the program/institution to support seminar programs relevant to the proposed training program and to support students to attend national society meetings to present their research findings. o There is a commitment on the part of the institution and participating departments for recruitment to and support of the proposed training program in the environmental health sciences. Impact of the Establishment of the Training Program on the Department and Institution o There is evidence that the training program will serve to enhance the research efforts and academic standing of the participating departments and institutions. o There is evidence that the training program will contribute to a growth in research support for the department. o There is justification for expanding the training capabilities of the institution in the proposed areas. Other Areas The program includes training in the ethical conduct of research. The training provided includes a systematic program of career counseling of trainees with discussion of available career options, and guidance in attaining the desired career outcome. Included in this career counseling is discussion of the training record of the program and of the career outcomes of former graduates. The program includes training in preparation of grant applications, CV"s, resumes, etc. The program has evidence of a mechanism to ensure all trainees receive adequate mentoring. The program has an active program of minority recruitment and evidence of success. 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. Available on the web at the following URL address: http://grants.nih.gov/grants/guide/notice-files/not94-100.html 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 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 these policies. 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) 435-0714, Email: GrantsInfo@nih.gov and from the NIH web page: http://grants.nih.gov/grants/forms.htm. The title and number of the program announcement must be typed on line 2 of the face page of the application form and the YES box must be marked. 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 same time, two copies of the full application must be sent to: Ethel Jackson, Ph.D. Chief, Scientific Review Branch Office of Program Operations Division of Extramural Research And Training National Institute of Environmental Health Sciences 111 T.W. Alexander Drive P.O. Box 12233 (EC-24) Research Triangle Park, NC 27709 Telephone: (919) 541-7826 Fax: (919) 541-2503 REVIEW CONSIDERATIONS Applications received by the NIH are assigned to Institutes of the NIH 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 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 NIEHS research training mission and mission emphasis areas, 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 an environmental health 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 environmental 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: 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 National Advisory Environmental Health Sciences Council will review applications for relevance to its scientific mission. Among the information the Council 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 NIEHS 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 research and research training goals of the NIEHS, leadership capabilities of the program director and the quality of the participating faculty, commitment of the 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 Direct inquiries regarding programmatic issues to: Carol K. Shreffler, Ph.D. Scientific Program Administrator Organs and Systems Toxicology Branch Office of Program Development Division of Extramural Research and Training National Institute of Environmental Health Sciences Mail Drop Code EC-23 P. O. Box 12233 Research Triangle Park, NC 27709 Telephone: (919) 541-1445 Fax: (919) 541-5064 Email: shreffl1@niehs.nih.gov Direct inquiries regarding fiscal matters to: Ms. Jackie Russell Grants Management Specialist Grants Management Branch Office of Program Operations Division of Extramural Research and Training National Institute of Environmental Health Sciences Mail Drop Code EC-22 P. O. Box 12233 Research Triangle Park, NC 27709 Telephone: (919) 541-0751 Fax: (919) 541-2860 Email: russel1@niehs.nih.gov AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.894. 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 USC 241 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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