Full Text CA-95-002 OCCUPATIONAL EXPOSURE AND CANCER PREVENTION/CONTROL RESEARCH NIH GUIDE, Volume 23, Number 35, October 7, 1994 RFA: CA-95-002 P.T. 34 Keywords: Occupational Health and Safety Cancer/Carcinogenesis Disease Prevention+ National Cancer Institute National Institute for Occupational Safety and Health Letter of Intent Receipt Date: January 10, 1995 Application Receipt Date: February 17, 1995 PURPOSE The Divisions of Cancer Etiology and Cancer Prevention and Control, National Cancer Institute (NCI) and the National Institute for Occupational Safety and Health (NIOSH) invite grant applications for innovative epidemiologic studies among populations occupationally exposed to potential carcinogenic substances. The purpose of this Request for Applications (RFA) is to promote cancer control research activities. Special emphasis is placed on investigating minority populations and women, who have not been studied adequately in the past, as well as small businesses, because of constraints in addressing their occupational health problems. 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, Occupational Exposure and Cancer Prevention/Control Research, is related to the priority area of cancer. Potential applicants may obtain 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) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202/783-3238). ELIGIBILITY REQUIREMENTS Applications may be submitted by domestic non-profit and for-profit institutions, public and private, such as colleges, universities, hospitals, research laboratories, units of State and local governments, and eligible agencies of the Federal government. Applications from or involving minority institutions, individuals, and women are encouraged. MECHANISM OF SUPPORT This RFA will be supported through NIH research project grants (R01). Responsibility for the planning, direction, and execution of the proposed project will be solely that of the applicant. The total project period for applications submitted in response to the present RFA may not exceed four years. This RFA is a one-time solicitation. Competing continuation applications will compete with all other unsolicited applications and be reviewed by a Division of Research Grants study section. If NCI and NIOSH determine that there is a sufficient continuing program need, the NCI and NIOSH may announce a request for new and renewal applications. NIOSH has a long-standing interest in the identification, evaluation, and control of cancers caused by occupational exposures, and NIOSH will continue to accept cancer-related grant proposals under its regular grants program announcement. FUNDS AVAILABLE The funds for this RFA come from the NCI Cancer Control budget. Approximately $2.0 million per year in total costs for four years will be committed by the NCI to specifically fund applications submitted in response to this RFA. In addition, $300,000 per year in total costs will be committed by the NIOSH to fund at least one application. This funding level is dependent on the receipt of a sufficient number of applications of high scientific merit. 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 also vary. The expected number of awards is six to eight. Although this program is provided for in the financial plans of the NCI and NIOSH, the award of grants pursuant to this RFA is contingent upon the availability of funds for this purpose. RESEARCH OBJECTIVES Background The identification of occupational exposures that carry a long-term risk of disease or death is a major public health and scientific concern for the general population and especially minorities. Many well-known human carcinogens were first identified in the occupational environment on the basis of case reports by alert clinicians or pathologists. These discoveries were often serendipitous, requiring the recognition of a cluster of unusual or rare tumors in a medical practice that could be tied to an occupational exposure. Exposures and technologies in the workplace, however, are changing. Improvements in industrial hygiene and worker protection have reduced the risks of cancer in some groups. Nevertheless, exposures and risks at lower levels may remain. Many industries and occupations have reported cancer excess for which the causative agent or agents have yet to be identified. Research is needed on how occupational exposures interact with non-occupational exposures and with susceptibility factors. Occupational cancer among minority workers, inner city and rural populations is an understudied aspect of occupationally related cancer. Moreover, it has been estimated that about 5000 new chemicals are being introduced annually in the form of new commercial products, chemicals, foods, and drugs, and any potential risks are likely to be greatest and most easily detected in exposed workers. It is therefore necessary to continue evaluating the carcinogenic risks for various occupational groups. Epidemiologic studies of occupational groups are important not only to detect carcinogenic risks, but also to verify the effectiveness of reducing exposures, to define the agents responsible for the excess risk in occupations exposed to complex mixtures, and to assess how occupational agents interact with other cancer risk factors and demographic variables such as age at first exposure. It is important that information from occupational cancer studies be communicated to workers and regulatory agencies. The workers under study must be informed and educated about the potential risks associated with their employment and particular exposures. Information must also be disseminated to labor unions, industrial groups and other concerned organizations to inform workers and take necessary precautions. Improved procedures are needed to identify, trace and counsel workers who are members of specific occupational cohorts in which risks have been discovered or quantified. Modern molecular epidemiologic techniques my permit not only the direct or indirect identification of exposures to chemicals, but also the study of variations in host susceptibility that may be of genetic or environmental origin. Internal dose markers may provide an estimate of the biologically effective exposure received by an individual, or provide markers of preclinical disease response to exposure. The major goal of identifying occupational determinants of cancer is to introduce preventive measures. Occupational exposure can be controlled by the application of a number of well-known principles, including engineering techniques (substitution, isolation, and ventilation), work practices, and personal protective equipment. These principles may be applied at or near the hazard source, to the general workplace environment, or at the point of occupational exposure to individuals. Controls applied at the source of the hazard, including material substitution, process or equipment modification, isolation or automation, local ventilation, and work practices, are generally preferred and most effective in terms of both occupational and environmental concerns. Controls that may be applied to hazards that have escaped into the workplace environment include dilution ventilation, dust suppression, and housekeeping. Control measures may also be applied near individual workers, including the use of ventilated control rooms, isolation booths, supplied-air cabs, work practices, and personal protective equipment. The additional strategies for cancer control include: (l) regulation of carcinogens and appropriate substitution of agents in the work environment, (2) screening and early detection of occupationally-related cancer, (3) when appropriate, evaluation of chemopreventive agents that may inhibit the carcinogenic process, and (4) development of programs to reduce exposures (e.g., smoking) that may interact with occupational carcinogens to potentiate the risk of cancer. One area where an emphasis is needed is small businesses. The reason is that (1) the Occupational Safety and Health Administration (OSHA) is legislatively refrained from regularly inspecting businesses with 10 or fewer employees, with certain exceptions, and (2) data from NIOSH's National Occupational Exposure Survey showed that full-time health and safety services are rarely found in facilities having fewer than 50 employees. Thus, based on the OSHA constraints and NIOSH data, estimates have been made that up to 90 percent of all work sites, covering 40 percent of the total work force are not regularly inspected and do not have ready access to health and safety expertise. New research programs are needed to address the needs for health protection of workers in delivery of such materials and services in the field. Clearly a program is needed to identify potential hazards in small businesses, characterize the health and safety potential problems, develop cost-effective control recommendations and effectively transfer these recommendations to the small business sector. Research Scope and Goals The purpose of this RFA is to stimulate epidemiologic studies of cancer in the workplace and to enhance related cancer prevention and control efforts. Innovative approaches that include new diagnostic or exposure measurements are particularly encouraged. Applications that may have substantial impact on public health are encouraged. Projects should be proposed as traditional R01s. Applications that build upon ongoing research projects, utilizing already collected epidemiologic data or biospecimens, are encouraged. One important goal of this initiative is to assess the extent that occupational exposures contribute to cancer incidence and mortality among minority populations, underserved groups, and women, and to develop effective means of cancer control in these special populations. The initiative permits a wide range of epidemiologic investigations including studies directed towards modifying lifestyle behavior. Examples of areas of research that are considered to be responsive to this RFA include, but are not limited to: (1) Analytic epidemiologic studies to clarify the relation of specific occupational exposures to specific tumors, and if possible to evaluate the impact of changing exposures on time trends in cancer incidence. Once discovered, the information must be disseminated to workers in the study, and to regulatory agencies, management, unions, and other labor and industry associations. (2) Epidemiologic studies of occupational cancer that include molecular and biochemical components to more precisely identify previous exposures, intermediate outcomes or susceptibility states among particular groups of workers who are then targeted for cancer control interventions in the proposed research. Molecular epidemiologic studies could explore differences in predisposition to occupational cancer due to variations in metabolic patterns, DNA repair, formation of adducts, chromosome sensitivity to mutagens, or others, especially in minority populations and women, with appropriate cancer control interventions. The significance of biochemical or molecular analysis would be conveyed to the subjects along with suggested methods of reducing cancer risks. (3) Intervention studies with lifestyle changes, chemopreventive agents or cancer screening modalities involving population groups previously exposed to occupational carcinogens. (4) Intervention studies of engineering control, work practice modification, and use of protective equipment, with evaluation of success of interventions and assessment of applicability in other settings. (5) Cancer control intervention studies to address the impact of occupational exposures to carcinogens on the minority populations of the United States. (6) Cancer surveillance activities to utilize existing occupational data resources to identify occupational cancer risks among minority populations and women. (7) Educational interventions to inform populations-at-risk about the potential consequences of exposures to occupational carcinogens, especially as they relate to minorities and women. (8) Special research areas for small business might include the identification and characterization of potential hazards in small businesses, development of recommendations for cost effective engineering, administrative, and personal protective controls, communication of recommendations to small businesses; or education of small businesses and the public and industrial health community regarding hazards in small businesses and their control. (9) Engineering control research might include observational studies conducted in the workplace to document health hazard controls, to evaluate their performance, and to disseminate this information; investigative research to identify sources of worker exposure and subsequent development and demonstration of corrective measures. These later studies provide a much better understanding of the "etiology of occupational exposure" than previously has been possible using traditional workplace sampling. For example, it has been shown that in many cases, there are a few hazardous parts of the job that contribute most of the actual exposure. The seriousness of these exposure points was not at all apparent by observation. Intervention to control exposures at these specific hazardous points can then be much more focused, effective, supportable, and cheaper than attempts to reduce exposures without specific knowledge of the exposure profile. SPECIAL REQUIREMENTS Applicants should include, in the budget, funds for the principal investigator (and advisory board representative if a board exists) to attend an annual program meeting to be held in alternating locations of Bethesda, MD and Cincinnati, OH (or Morgantown, WV). Proposed studies must have components that provide cancer control activities, such as recommendations for substitute chemicals and for specific changes in work practices and engineering controls, informational and educational programs for workers, unions, and management, and dissemination of results to regulatory agencies, and other interested parties from labor and industry. 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-sponsored 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 new provisions that are substantially different from the 1990 policies. All investigators proposing research involving human subjects should read the "NIH Guidelines on the Inclusion of Women and Minorities as Subjects in Clinical Research," which was reprinted in the Federal Register of March 28, 1994 (59 FR 14508-14513) to correct typesetting errors in the earlier publication, and reprinted in the NIH GUIDE FOR GRANTS AND CONTRACTS of March 18, 1994, Volume 23, Number 11. 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. LETTER OF INTENT Prospective applicants are requested to submit, by January 10, 1995, a letter of intent that includes a descriptive title of the proposed research, the name, address, and telephone number of the Principal Investigator, the names 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 subsequent applications, the information that it contains is helpful in planning for the review of applications. It allows NCI and NIOSH staff to estimate the potential review workload and to avoid conflict of interest in the review. The letter of intent is to be sent to Dr. Richard L. Bragg at the address listed under INQUIRIES. APPLICATION PROCEDURES Applications are to be submitted on form PHS 398 (rev. 9/91) available at most institutional offices of sponsored research and 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. The format and instructions applicable to regular research grant applications must be followed. Applicants from institutions that have a General Clinical Research Center (GCRC) funded by the NIH National Center for Research Resources may wish to identify the GCRC as a resource for conducting the proposed research. If so, a letter of agreement from either the GCRC program director or Principal Investigator could be included with the application. The RFA label available in application form PHS 398 (rev. 9/91) must be affixed to the bottom of the face page. 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 number and title of the RFA must be typed on line 2a of the face page of the application and YES must be checked. Submit a signed, typewritten original of the application, including the Checklist, and three signed, exact, clear and single-sided photocopies, in one package to: Division of Research Grants National Institutes of Health Westwood Building, Room 240 Bethesda, MD 20892** At the time of submission, applicants must send two additional copies of the application to: Ms. Toby Friedberg Division of Extramural Activities National Cancer Institute 6130 Executive Boulevard MSC 7405 Executive Plaza North, Room 636 Bethesda, MD 20892-7405 Failure to submit these copies may delay the review and subsequent possible consideration of an application for award in FY 1995. Applications must be received by February 17, 1995. If an application is received after that date, it will be returned without review. If the application submitted in response to this RFA is substantially similar to a research grant application already submitted to the NIH for review, but has not yet been reviewed, the applicant will be asked to withdraw either the pending application or the new one. Simultaneous submission of identical applications will not be allowed, nor will essentially identical applications be reviewed by different review committees. Therefore, an application cannot be submitted in response to this RFA that is essentially identical to one that has already been 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, applications will be reviewed for completeness by DRG and responsiveness by the NCI and NIOSH. Incomplete applications will be returned to the applicant without further consideration. If NCI and NIOSH staff find that the application is not responsive to the RFA, it will be returned 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 NCI in accordance with the review criteria stated below. As part of the initial merit review, a process (triage) may be used by the initial review group in which applications will be determined to be competitive or non-competitive based on their scientific merit relative to other applications received in response to the RFA. Applications judged to be competitive will be discussed and be assigned a priority score. Applications determined to be non-competitive will be withdrawn from further consideration and the principal investigator/program director and the official signing for the applicant organization will be promptly notified. The second level of review by the National Cancer Advisory Board considers the special needs of the NCI and the priorities of the National Cancer Program. The second level of review by NIOSH will consider the number of workers affected by the hazard under study and the potential contribution to applied technical knowledge in the prevention of occupational cancers. Review criteria for RFAs are the same as those for unsolicited research grant applications: o scientific, technical, or medical significance and originality of proposed research; o appropriateness and adequacy of the experimental approach and methodology proposed to carry out the research; o qualifications and research experience of the Principal Investigator and staff, particularly but exclusively in the area of the proposed research; o availability of resources necessary to perform the research. o Adequacy of plans to include both genders and minorities and thier subgroups as appropriate for the scientific goals of the research. Plans for the recruitment and retention of subjects will also be evaluated. The review group will critically examine the submitted budget and will recommend an appropriate budget and period of support for each scored application. AWARD CRITERIA The earliest anticipated date of award is September 29, 1995. Applications 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 reasonableness of the budget in comparison with other applications; o program balance among research areas. INQUIRIES Inquiries concerning this RFA are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Richard L. Bragg, Ph.D. Division of Cancer Prevention and Control National Cancer Institute 6130 Executive Boulevard MSC 7395 Executive Plaza North, Suite 240 Bethesda, MD 20892-7395 Telephone: (301) 496-8589 FAX: (301) 496-8675 A.R. Patel, Ph.D. Divisionof Cancer Etiology National Cancer Institute 6130 Executive Boulevard MSC 7395 Executive Plaza NOrth, Suite 535 Bethesda, MD 20892-7395 Telephone: (301) 496-9600 FAX: (301) 402-4279 Roy M. Fleming, Sc.D. National Institute of Occupational Safety and Health 1600 Clinton Road, NE Building l, Room 3053, Mail Stop D-30 Atlanta, GA 30333 Telephone: (404) 639-3343 FAX: (404) 639-2196 Email: rmf2@niood1.em.cdc.gov Direct inquiries regarding fiscal matters to: Ms. Cynthia Mead Grants Research Branch National Cancer Institute 6120 Executive Boulevard MSC 7395 Executive Plaza South, Suite 243 Bethesda, MD 20892-7395 Telephone: (301) 496-7800, Ext. 254 AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance Nos. 93.393 and 93.894. Awards are made under authorization of the Public Health Service Act, Title IV, Part A (Public Law 78-140, as amended by Public Law 99.158, 42 USC 241 and 285) and administered under HHS policies and grant regulations. This program is not subject to the intergovernment review requirements of Executive Order 12372 or Health System Agency review. The Public Health Service strongly encourages all grant recipients to provide a smoke-free workplace and promote the non-use of all tobacco products. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people. .
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