Full Text ES-96-004 LINKING OF ENVIRONMENTAL AGENTS AND DISEASE NIH GUIDE, Volume 25, Number 3, February 9, 1996 RFA: ES-96-004 P.T. 34 Keywords: Environmental Biology 0705048 National Institute of Environmental Health Sciences Letter of Intent Receipt Date: April 5, 1996 Application Receipt Date: May 8, 1996 PURPOSE The National Institute of Environmental Health Sciences (NIEHS) supports research to identify the role of environmental agents in perturbations of normal physiologic processes leading to human disease. Although direct links between environmental agents and health outcomes have been established for some diseases, there are numerous chronic dysfunctions and diseases where there are minimal scientific data to substantiate a role for the environment in their etiology or progression, despite the plausibility of these hypotheses. Therefore, the goal of this Small Grants Program (R03), Request for Applications (RFA) is to encourage research that will establish whether there is sufficient evidence either mechanistically or from epidemiologic studies to justify further investigations into the role of environmental agents in the initiation or exacerbation of human diseases. Research is specifically encouraged to determine the sound scientific connection between environmental agent and the initiation or progression of disease. 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 RFA, Linking of Environmental Agents and Disease, is related to the priority area of environmental health. Potential applicants may obtain a copy of "Healthy People 2000: (Full Report: Stock no. 017-001-00474-0 or Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone: (202) 512-1800). ELIGIBILITY REQUIREMENTS Applications may be submitted by domestic, for-profit and non-profit organizations, public and private, such as universities, colleges, hospitals, laboratories, units of State or local governments and eligible agencies of the Federal government. Foreign institutions and organizations are not eligible. Applications from minority individuals and women are encouraged. Submission of an application precludes concurrent submission of a regular research projfect grant application (R01 or R29) containing the same research proposal. In addition, small grant research support may not be used to supplement research projects currently supported by Federal or non-Federal funds or to provide interim support for projects under review by the Public Health Service. MECHANISM OF SUPPORT This RFA will use the NIH Small Grants Program (R03) awards. Responsibility for the planning, direction, and execution of the proposed project will be solely that of the applicant. The requested costs and project period will be $50,000 (direct cost) for a maximum of one year. Small grants are not renewable but may be extended at the discretion of the applicant organization. FUNDS AVAILABLE The total estimated funds available for this small grants program is $750,000 which will support approximately 10 to 12 awards. This level of support is dependent on the receipt of sufficient number of applications of high scientific merit. Although this program is provided for within the financial plans of the NIEHS, awards pursuant to this RFA are contingent upon the availability of funds for this purpose. RESEARCH OBJECTIVES Objectives and Scope A major goal of the NIEHS is to improve our understanding of the contribution of environmental factors to the development of disease. In order for NIEHS to successfully carry out this mission, it is imperative to have information on the role of the environment in a wide variety of disease states. Preliminary data are needed to foster the development of mechanistically-based research on the relationship between environmental agents and diseases. This RFA is designed specifically to develop preliminary data on the possible role of the environment in diseases in which links to exposure are suggested but remain unproven. It is anticipated that these preliminary data will support development of hypothesis-based research to establish the cause and effect relationship between environmental exposures and disease etiology. Research Goals The goals and scope of the RFA are two-fold. The first is to encourage and support mechanistically-based research designed to establish the linkage between exposure to an environmental agent, tested at environmentally relevant concentrations, and the initiation or exacerbation of diseases. The second area of emphasis is to utilize human populations studies to develop hypotheses relating environmental exposure to the initiation or exacerbation of diseases. In either situation, emphasis should be placed on developing the preliminary data that would lead to the development of an R01 or R29 application. The role of environmental agents in disease may be approached using animal models, human tissue/cell-lines or human epidemiologic studies. In any case, environmentally relevant concentrations using dose-response data is encouraged. The effect of age and the timing of exposure relative to the toxicity or effect should also be included as part of the experimental design. The purpose of this RFA is to expand data on non-cancer diseases. Therefore, research on the role of environmental agents in the initiation or exacerbation of cancers of any type will be considered nonresponsive. SPECIAL REQUIREMENTS Animal Welfare Considerations Investigators are encouraged to consider alternative methods and approaches in their research applications that do not require the use of whole animals, that use alternative species such as nonmammals or invertebrates, that reduce the number of animals required, and that incorporate refinements to procedures that will result in the elimination or further minimization of pain and distress to animals. 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 new policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103 43) and supersedes and strengthens the previous policies (Concerning the Inclusion of Women in Study Populations, and Concerning the Inclusion of Minorities in Study Populations), which have been in effect since 1990. The new policy contains some provisions that are substantially different from the 1990 policies. All investigators proposing research involving human subjects should read the NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research, which have been published in the Federal Register of March 28, 1994 (FR 58 14508-14513) and reprinted in the NIH Guide for Grants and Contracts, Volume 23, Number 11, March 18, 1994. Investigators also may obtain copies of the policy from the program staff listed under INQUIRIES. Program staff may also provide additional relevant information concerning the policy. LETTER OF INTENT Prospective applicants are asked to submit, by April 5, 1996, 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 consultants, the 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 subsequent application, the information that it contains is helpful in planning for the review of applications. It allows NIEHS staff to estimate the potential review work load and to avoid conflict of interest in the review. The letter of intent is to be sent to: Ethel B. Jackson, D.D.S. Extramural Division National Institute of Environmental Health Sciences P.O. Box 12233, MD 17-09 104 T.W. Alexander Drive, Building 17, Room 1717 Research Triangle Park, NC 27709 Telephone: (919) 541-7826 FAX: (919) 541-2503 EMAIL: jackson4@niehs.nih.gov APPLICATION PROCEDURES The research grant application form PHS 398 (rev. 5/95) is to be used in applying for these grants. These forms are available at most institutional offices of sponsored research and may be obtained from the Grants Information Office, Office of Extramural Outreach and Information Resources, National Institutes of Health, 6701 Rockledge Drive, MSC 7910, Bethesda, MD 20892-7910, telephone 301/435-0715, email: girg@drgpo.drg.nih.gov. The following supplemental instructions are given: Only one small grant application may be submitted by a principal investigator. Due to the limited size of awards, no specific budget categories and percent efforts will be required. This will be a $50,000 award - direct cost. Equipment will be limited to $5,000. The applicant must be explicit in describing the proposed interface between an environmentally relevant agent and the induction or exacerbation of a specific disease. Background information must suggest, or at least not preclude, a possible interaction between these parameters. Since this award is to support pilot studies, preliminary data are not required except to indicate the expertise of the PI to carry out the proposed studies. The Research Plan (Specific Aims, Background and Significance, Preliminary Studies, Research Design and Methods sections) is not to exceed 10 pages. Tables and figures are included in the 10 page limitation. Applications that exceed page limitations or PHS 398 requirements for font size (height or letters), type density (characters per inch), and margins (see PHS 398 directions) will be returned to the investigator. Do not submit an appendix. The RFA Label available in the PHS 398 (rev. 5/95) application form must be affixed to the bottom of the face page of the application. Failure to use this label could result in delayed processing of the application such that it may not reach the review committee in time for review. In addition, the RFA title and number must be typed on Line 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, clear, and single sided photocopies in one package to: DIVISION OF RESEARCH GRANTS NATIONAL INSTITUTES OF HEALTH 6701 ROCKLEDGE DRIVE, ROOM 1040 - MSC 7710 BETHESDA, MD 20892-7710 BETHESDA, MD 20817 (for express/courier service) At the time of submission, two additional copies of the application must be sent to Dr. Ethel Jackson, at the address listed under LETTER OF INTENT. It is important to send these two copies at the same time as the original and three copies are sent to the Division of Research Grants. Otherwise the NIEHS cannot guarantee that the application will be reviewed in competition for this RFA. Applications must be received by May 21, 1996. If an application is received after that date, it will be returned to the applicant without review. Responsiveness of Applications to RFA Upon receipt, all applications will undergo an administrative review by senior scientific staff of the NIEHS for their responsiveness to the RFA. Only those applications considered to be responsive to the RFA will be forwarded for peer review. Applications considered non-responsive to the RFA will be returned to the applicant without further consideration. The following criteria will be considered: o Is the application focused on an environmental agent and its linkage to a disease state that is within the mission of the National Institute of Environmental Health Sciences? o Is the application focused on the linkage of exposure to an environmental agent and a non-cancer disease endpoint? o Is there reasonable evidence or suggestion that there may exist a linkage between an environmental exposure and a disease state? o Is there a plausible biological mechanism suggested linking the environmental exposure and the disease state? o Areas of science in which there are sufficient preliminary data that would support the submission of a regular research project grant application do not qualify under this RFA. REVIEW CONSIDERATIONS 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 NIEHS in accordance with NIH peer review procedures. As part of the initial merit review, all applications will receive a written critique and undergo a process in which only those applications deemed to have the highest scientific merit, generally the top half of applications under review, will be discussed and assigned a priority score. Review Criteria o scientific, technical, or medical significance of the proposed research as it relates to the connection between an environmental agent and the initiation or exacerbation of human disease; o potential of the proposed research to result in the development of hypothesis-based research establishing cause and effect relationships; o appropriateness and adequacy of the experimental design and methods proposed to carry out the research; innovativeness or promise of the research idea; o qualifications and research experience of the Principal Investigator and staff, particularly, but not exclusively, in the area of the proposed research; o reasonableness/appropriateness of the requested budget in relation to the proposed research; o availability of resources necessary to perform the research; and o adequacy of plans to include both genders and minorities and their subgroups as appropriate for the scientific goals of the research. Plans for the recruitment and retention of subjects will also be evaluated. AWARD CRITERIA The anticipated date of award is September, 1996 pending availability of funds. The following will be considered in making funding decisions: o quality of the proposed project as determined by peer review; o availability of funds; and o program balance among research areas of the announcement. INQUIRIES Written and telephone inquiries concerning this RFA are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Direct inquiries regarding programmatic issues to: Jerrold J. Heindel, Ph.D. Organs and Systems Toxicology Branch National Institute of Environmental Health Sciences P.O. Box 12233, MD 3-02 104 T.W. Alexander Drive, Building 3, Room 316 Research Triangle Park, NC 27709 Telephone: (919) 541-0781 FAX: (919) 541-2843 EMAIL: heindel_j@niehs.nih.gov Gwen W. Collman, Ph.D. Chemical Exposures and Molecular Biology Branch National Institute of Environmental Health Sciences P.O. Box 12233, MD 3-04 104 T.W. Alexander Drive, Building 3, Room 306 Research Triangle Park, NC 27709 Telephone: (919) 541-4500 FAX: (919) 541-2843 EMAIL: collman@niehs.nih.gov Direct inquiries regarding fiscal matters to: Mr. David L. Mineo Grants Management Branch National Institute of Environmental Health Sciences P.O. Box 12233, MD 2-01 104 T.W. Alexander Drive, Building 2, Room 203B Research Triangle Park, NC 27709 Telephone: (919) 541-7628 FAX: (919) 541-2860 EMAIL: mineo@niehs.nih.gov AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.113 and 93.115. 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, 43 USC 241 and 285) and administered under PHS grants policies and Federal Regulations 42 CFR 52 and 45 CFR Part 74. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. The PHS strongly encourages all grant and contract recipients to provide a smoke-free workplace and promote the non-use of all tobacco products. In addition, Public Law 103-227, the Pro Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routine education, library, day care, health care or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people. .
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