Full Text OH-94-001 OCCUPATIONAL RADIATION AND ENERGY-RELATED HEALTH RESEARCH NIH GUIDE, Volume 23, Number 7, February 18, 1994 RFA: OH-94-001 P.T. 34 Keywords: Health, Radiation Effects National Institute for Occupational Safety and Health Letter of Intent Receipt Date: April 1, 1994 Application Receipt Date: May 18, 1994 PURPOSE The Centers for Disease Control and Prevention (CDC), National Institute for Occupational Safety and Health (NIOSH) is soliciting grant applications for research projects relating to occupational safety and health concerns associated with occupational exposures to radiation and other hazardous agents at Department of Energy (DOE) facilities and in other energy-related industries. Studies in the nuclear power industry and deliberate exposure of human subjects in radiation experiments are outside the scope of this Request for Applications (RFA). The purpose of the grant program is to develop knowledge that can be used in preventing occupational diseases and injuries. NIOSH will support the following types of applied research projects: causal research to identify and investigate the relationships between health outcomes and occupational exposure to radiation and other hazardous agents; methods research to identify early markers of adverse health effects that are associated with such occupational exposures; and research related to assessing past occupational exposures. When this research is to be conducted at a DOE facility, any DOE data required will be supplied to the applicant by NIOSH. 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 to reduce morbidity and mortality and improve the quality of life. This RFA, Occupational Radiation and Energy-Related Health Research, is related to the priority area of occupational safety and health. A copy of "Healthy People 2000" (Full Report: Stock No 017-001-00474-0) or "Healthy People 2000" (Summary Report: Stock No. 017-001-00473-1) may be obtained through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone (202) 783-3238). ELIGIBLE APPLICANTS Eligible applicants include domestic and foreign non-profit and for-profit organizations, universities, colleges, research institutions, and other public and private organizations, including State and local governments and small, minority and/or woman-owned businesses. MECHANISMS OF SUPPORT Research support may be obtained through applications for a regular research grant (R01). Applicants for R01s may request support for up to three years. Because the nature and scope of the research proposed in response to this RFA may vary, it is anticipated that the size of an award will vary also. FUNDS AVAILABLE For fiscal year (FY) 1994, approximately $500,000 is available to fund projects ranging in amount from $25,000 to $200,000 in total costs. RESEARCH OBJECTIVES Background The Secretary, Department of Health and Human Services (HHS) and the Secretary, Department of Energy (DOE) signed a memorandum of understanding (MOU) transferring the authority and resources to manage and conduct energy-related analytic epidemiologic research from DOE to HHS. This includes the authority, resources, and responsibility for the design, implementation, analysis, and scientific interpretation of analytic epidemiologic studies of the following populations: workers at DOE facilities; other workers potentially exposed to radiation; and workers exposed to potential hazards resulting from non-nuclear energy production and use. The Secretary, HHS, delegated responsibility for implementation of the MOU to the Centers for Disease Control and Prevention (CDC). The National Institute for Occupational Safety and Health has responsibility for the conduct of occupational studies. Scope The focus of grants should reflect: (1) retrospective occupational exposure assessment, (2) radiation measurement issues, (3) non-cancer morbidity and mortality outcomes, (4) meta-analysis and combined analysis methodologies, (5) uncertainty analysis, and (6) effects of measurement error on risk estimates. o Retrospective Exposure Assessment Epidemiologic studies of occupational cohorts frequently involve, and can generally benefit from, retrospective exposure assessment to provide estimates of exposure or categorize groups of workers by common exposure. Exposure assessment in energy-related occupational epidemiology requires evaluating exposures to various hazards including ionizing and non-ionizing radiation, metals, acids, and solvents. Grant opportunities encompass the fields of industrial hygiene and retrospective exposure assessment of health physics dosimetry. Research areas of general interest include: methods to use limited data to best advantage; how to treat censored data in retrospective exposure assessment; uncertainty analysis techniques for industrial hygiene exposure data and health physics dosimetry; insight to sampling strategy design yielding a representative understanding of exposed groups; decision logic to select/use the most appropriate exposure metric for epidemiologic and risk assessment use; and, development approaches of "Homogeneous Exposed Groupings" and the advantages/limitations for epidemiologic use. Research opportunities of specific interest include: reconstruction and dose adjustment of historic film badges; exposure assessment for acid mists, carcinogenic solvents, exotic metals, and leukemogens; and evaluation of biomarkers of exposure. o Radiation Measurement Issues This topic will focus on the applicability and utility of radiation dose data in epidemiological research. Examples of such issues include how to use nondetectable values and missing dose data in historical radiation exposure measurements, the accuracy of historical external dosimetry techniques (film and pocket dosimeters), combining external and internal doses into a useful index, historical bioassay, and radiochemistry techniques. o Non-cancer Morbidity and Mortality Outcomes The majority of analytical epidemiologic research of health effects of energy-related occupational exposures has focused historically on the assessment of the association between cancer mortality and exposure to ionizing radiation. Although the importance of this research should not be underestimated, it is essential that other potential adverse health effects, as well as possibly other energy-related exposures, be thoroughly evaluated as well. Among these would be the possible effects of radiation on the reproductive, neurologic, and immune systems. Chemical exposures highly prevalent in Department of Energy facilities, such as beryllium and mercury, have also been associated with a variety of disease outcomes, particularly respiratory and neurologic in nature. An important avenue of research is the identification, validation, and use of biomarkers of both diseases and exposures in energy-related epidemiologic research. o Meta-Analysis and Combined Analysis Methodologies Many of the cohorts at DOE facilities are not individually large enough to detect statistically significant increases in mortality or incidence for rare cancer types. Methods and/or analyses for combining data across studies whether in summary form or individual data are valuable to the NIOSH research effort involving energy-related health research. o Uncertainty Analysis Measures of occupational exposure are inherently uncertain. Even though measures of external radiation exposure are generally available for all workers at DOE facilities, the models used to estimate organ dose, shallow versus deep dose, neutron dose, etc., are subject to error. Measures of dose derived from biological monitoring of urine, feces, blood, etc. are even less precise. Methods for assessing the degree of error in various estimates of exposure to both ionizing radiation as well as other toxic agents (i.e., chemicals) are desirable. o Effects of Measurement Error on Risk Estimates Estimation of both bias and imprecision introduced into risk analyses through exposure measurement error have recently received considerable attention. Many of the suggested approaches are very computer intensive. Practical solutions to this problem with regard to the spectrum of epidemiologic designs (cohort, case-control, cross-sectional, etc.) are needed, with particular attention to the nature of exposure measurement in radiation epidemiology. STUDY POPULATIONS SPECIAL INSTRUCTIONS TO APPLICANTS REGARDING IMPLEMENTATION OF NIH POLICIES CONCERNING INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH STUDY POPULATIONS NIH policy is that applicants for NIH clinical research grants and cooperative agreements will be required to include minorities and women in study populations so that research findings can be of benefit to all persons at risk of the disease, disorder or condition under study; special emphasis should be placed on the need for inclusion of minorities and women in studies of diseases, disorders and conditions which disproportionately affect them. This policy is intended to apply to males and females of all ages. If women or minorities are excluded or inadequately represented in clinical research, particularly in proposed population-based studies, a clear compelling rationale should be provided. The composition of the proposed study population must be described in terms of gender and racial/ethnic group. In addition, gender and racial/ethnic issues should be addressed in developing a research design and sample size appropriate for the scientific objectives of the study. This information should be included in the form PHS 398 in Sections 1-4 of the Research Plan AND summarized in Section 5, Human Subjects. Applicants are urged to assess carefully the feasibility of including the broadest possible representation of minority groups. However, NIH recognizes that it may not be feasible or appropriate in all research projects to include representation of the full array of United States racial/ethnic minority populations (i.e., Native Americans (including American Indians or Alaskan Natives), Asian/Pacific Islanders, Blacks, Hispanics). The rationale for studies on single minority population groups should be provided. For the purpose of this policy, clinical research includes human biomedical and behavioral studies of etiology, epidemiology, prevention (and preventive strategies), diagnosis, or treatment of diseases, disorders or conditions, including but not limited to clinical trials. The usual NIH policies concerning research on human subjects also apply. Basic research or clinical studies in which human tissues cannot be identified or linked to individuals are excluded. However, every effort should be made to include human tissues from women and racial/ethnic minorities when it is important to apply the results of the study broadly, and this should be addressed by applicants. For foreign awards, the policy on inclusion of women applies fully; since the definition of minority differs in other countries, the applicant must discuss the relevance of research involving foreign population groups to the United States' populations, including minorities. If the required information is not contained within the application, the application will be returned. Peer reviewers will address specifically whether the research plan in the application conforms to these policies. If the representation of women or minorities in a study design is inadequate to answer the scientific question(s) addressed AND the justification for the selected study population is inadequate, it will be considered a scientific weakness or deficiency in the study design and will be reflected in assigning the priority score to the application. All applications for clinical research submitted to NIH are required to address these policies. NIH funding components will not award grants or cooperative agreements that do not comply with these policies. LETTER OF INTENT Prospective applicants are asked to submit, by April 1, 1994, a letter of intent that includes a descriptive title of the proposed effort, the name and address of the principal investigator, the names of other key personnel, and the participating institutions, and the number and title of this RFA. The letter of intent is requested in order to provide an indication of the number and scope of applications to be reviewed. This letter of intent does not commit the sender to submit an application, nor is it a requirement for submission of an application. The letter of intent is to be sent to Dr. Fleming at the address listed under INQUIRIES. APPLICATIONS PROCEDURES The research grant application form PHS 398 (rev. 9/91) is to be used in applying for these grants. These forms are available at most institutional offices of sponsored research; from the Office of Grants Information, Division of Research Grants, National Institutes of Health, Westwood Building, Room 449, Bethesda, MD 20892, telephone 301/710-0267; and from NIOSH program administrator listed under INQUIRIES. The RFA label available in the PHS 398 (rev. 9/91) 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, Radiation Studies, OH-94-001, must be typed on line 2a of the face page of the application form and the YES box must be marked." Applications submitted in response to this RFA must be received on May 18, 1994. Submit a signed, typewritten original of the application, including the Checklist, and five photocopies of the PHS 398, in one package to: Division of Research Grants National Institutes of Health Westwood Building, Room 240 Bethesda, MD 20892** The timetable for receiving applications and awarding grants in fiscal year 1994 is: Letter of Intent Receipt Date: April 1, 1994 Application Receipt Date: May 18, 1994 Initial Review: August 1994 Secondary Review: September 1994 Earliest Possible Start Date: September 30, 1994 Applications must be received on the above receipt date. To guard against problems caused by carrier delays, retain a legible proof-of-mailing receipt from the carrier, dated no later than one week prior to the receipt date. If the receipt date falls on a holiday, it will be extended to the following work day. REVIEW CONSIDERATIONS The applications will be reviewed by an initial review group convened by NIOSH. The initial (peer) review is based on scientific merit and significance of the project, competence of the proposed staff in relation to the type of research involved, feasibility of the project, likelihood of its producing meaningful results, appropriateness of the proposed project period, adequacy of the applicant's resources available for the project, and appropriateness of the budget request. In the secondary (programmatic importance) review, the following factors will be considered: o The results of the initial review; o Magnitude of the problem in terms of numbers of workers affected; o Severity of the disease or injury in the worker population; and o Usefulness to applied technical knowledge in the identification, evaluation, and/or control of occupational safety and health hazards. Applicants will compete for available funds with all other approved applications. The following will be considered in making funding decisions: o Quality of the proposed project as determined by peer review o Availability of funds 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 and address the letter of intent to: Roy M. Fleming, Sc.D. National Institute for Occupational Safety and Health Centers for Disease Control and Prevention 1600 Clifton Road, NE Building 1, Room 3053, Mail Stop D-30 Atlanta, GA 30333 Telephone: (404) 639-3343 Direct inquiries regarding fiscal matters to: Ms. Lisa Tamaroff Grants Management Branch, PGO Centers for Disease Control and Prevention 255 E. Paces Ferry Road, NE Room 300, Mail Stop E-13 Atlanta, GA 30305 Telephone: (404) 842-6796 AUTHORITY AND REGULATIONS This program is authorized under the Public Health Service Act, as amended, Section 301 (42 U.S.C. 241); the Occupational Safety and Health Act of 1970, Section 20 (a) (29 U.S.C. 669[a]); and the Federal Mine Safety and Health Amendments Act of 1977, as amended, Section 501 (30 U.S.C. 951). The applicable program regulations are in 42 CFR Part 52. The Catalog of Federal Domestic Assistance number is 93.262. This program is not subject to the Public Health System Reporting Requirements. Applications are not subject to review as governed by Executive Order 12372, Intergovernmental Review of Federal Programs. .
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