Dr. David H. Pedersen
DHHS/CDC/NIOSH
4676 Columbia Parkway
MS R-44
Cincinnati, OH 45226
Phone: 513-841-4423
Fax: 513-841-4470
E-mail: dhp1@cdc.gov
Number of Human Subjects projects reported: 32
"Cohort Mortality Study of Idaho National Engineering and Environmental Laboratory (INEEL)"
Principal Investigator: Dr. Mary Schubauer-Berigan, National Institute for Occupational Safety and Health
Project started in: 1992
Funding for Human Subjects Research:
This project does not involve the use of multiple protocols/subprojects.
Identifier or number: INEL
Institutional Review Board (IRB) Review:
Type of Review: Expedited
Approving Institution: National Institute for Occupational Safety and Health
Most recent approval: 11/04/00
IRB approval number: HSRB 93-DSHEFS-10A
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 105000
Reporting period for number of human subjects:
Fiscal Year 2001
Type(s) of Human Subjects Involvement:
An all-causes cohort mortality study of workers at the Idaho National Engineering and Environmental Laboratory has identified a total of approximately 105,000 site employees since construction began in 1949. These workers were involved in nuclear reactor research, processing and storage of nuclear wastes including highly radioactive spent nuclear fuels, as well as work for other government agencies related to these processes. The purpose of this records-based study is to determine if exposures to workers during these processes may be associated with any specific cause of death. Exposures of primary concern are external and internal radiation sources as well as concurrent exposures to chemicals at the site. Data collection was begun in 1993 and these site records have been used to build a list of unique individuals employed at the site. Initial job titles are available for most workers on the list as well as dates of first employment, employer name (e.g. contractor name) dates of birth, and Social Security Numbers. This information will be used to determine the underlying causes of death as reported on death certificates. Deaths are identified by comparison with the National Death Index and files from the Social Security Administration. Analysis of the data will include comparison of overall and cause-specific mortality rates with the U.S. and State of Idaho populations. For causes of death considered to be associated with radiation exposures, exposure-response relationships will also be examined using appropriate statistical tests. A final report will be composed and articles prepared for the open literature which describe various aspects of the study. Workers, management and the public will be informed of the results of the study through direct communications with NIOSH personnel.
This research does not involve any contact with human subjects. It is carried out using records that had already been collected by the Department of Energy. Some of these records, notably the personnel and medical records, contain personally identified information that is protected under the Privacy Act. All information obtained for this study will become part of the CDC Privacy Act System (09-20-0147, "Occupational Health Epidemiolgic Studies"). Personally identifiable information will be protected at NIOSH per requirements of the Privacy Act. The data will be held at the NIOSH facility, with access monitored and restricted to the research team. NIOSH gives the more restricted assurance of confidentiality for death certificates used in this study under Section 308(d) of the Public Health Service Act (42 U.S.C. 242m (d)).
"Cohort Mortality Study of Portsmouth Naval Shipyard (PNS)"
Principal Investigator: Ms. Sharon Silver, National Institute for Occupational Safety and Health
Project started in: 1993
Funding for Human Subjects Research:
This project does not involve the use of multiple protocols/subprojects.
Identifier or number: PNSP
Institutional Review Board (IRB) Review:
Type of Review: Expedited
Approving Institution: National Institute for Occupational Safety and Health
Most recent approval: 03/17/01
IRB approval number: HSRB 93-DSHEFS-10C
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 38000
Reporting period for number of human subjects:
Fiscal Year 2001
Type(s) of Human Subjects Involvement:
The mortality study of civilian employees at Portsmouth Naval Shipyard is being updated through 1996. This previously conducted study (1980) has been expanded to include all workers employed through 1992.
The objective of this study is to examine the mortality patterns among the civilian nuclear workers who maintained and overhauled the fleet of naval nuclear submarines. A cohort study of all 38,000 workers, and a stratified cohort study of the approximately 13,000 radiation monitored workers will be conducted, followed by case control analyses of leukemia and lung cancer to further explore the exposure response relationship between external (gamma) ionizing radiation and these outcomes. Exposures to asbestos and welding fume are common at the shipyard and their effect on mortality will be investigated as well.
This research does not involve any contact with human subjects. It is carried out using records that had already been collected by the Department of Energy. Some of these records, notably the personnel and medical records, contain personally identified information that is protected under the Privacy Act. All information obtained for this study will become part of the CDC Privacy Act System (09-20-0147, "Occupational Health Epidemiolgic Studies"). Personally identifiable information will be protected at NIOSH per requirements of the Privacy Act. The data will be held at the NIOSH facility, with access monitored and restricted to the research team. NIOSH gives the more restricted assurance of confidentiality for death certificates used in this study under Section 308(d) of the Public Health Service Act (42 U.S.C. 242m (d)).
"Epidemiologic Evaluation of Cancer and Occupational Exposure at Rocky Flats"
Principal Investigator: Ms. Margaret Schonbeck, Colorado Department of Public Health and Environment
Project started in: 1993
Funding for Human Subjects Research: No Funding Sources Reported
This project involves the use of multiple protocols/subprojects.
Number of protocols/subprojects associated with this project: 1
Identifier or number: RKFL
Institutional Review Board (IRB) Review:
Type of Review: Expedited
Approving Institution: Colorado Department of Health
Most recent approval: 09/30/99
IRB approval number: 95-334
Explanation of IRB approval:
Data being collected by CDC Procurement and Grants Office (PGO). Updates will be provided when available.
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 0
Reporting period for number of human subjects:
Fiscal Year 2001
Type(s) of Human Subjects Involvement:
The Colorado Department of Public Health and Environment (CDPH&E), in conjunction with NIOSH and the University of Colorado Health Sciences Center, is conducting a mortality and incidence study of workers employed between 1951 and 1994 at the Department of Energy's Rocky Flats Environmental Technology Site, near Denver, Colorado. The study began in 1993, and ended in 2001, with the final report due in early 2002. The purpose of the study is to evaluate the relationship between workers' exposures to ionizing radiation and hazardous chemicals and the development of cancer. This encompassed three efforts: (1) the cancer status of 23,000 individual workers was determined from vital records and the Colorado state cancer registry; (2) ionizing radiation dose records and air sampling data were collected and evaluated; (3) workers were interviewed about their jobs to determine if they used certain chemicals, how frequently they used them, and if they wore any type of personal protective equipment.
Another component of the study compared the exposure histories of any workers who had died of lung cancer with those of other workers at the site who did not develop lung cancer. The purpose of this lung cancer case-control portion of the study is to determine whether there is an increased risk of occurrence of lung cancer at the site, and whether this might be related to worker occupational exposure to radiation and/or hazardous materials. Smoking histories of all the workers included in the case-control study were obtained by interviewing next-of-kin, and ionizing radiation doses were collected and recalculated for these individuals. Informed consent was obtained from interview subjects as provided by the protocol for the study.
Some of the records for this study, notably the personnel and medical records, contain personally identified information that is protected under the Privacy Act. All information obtained for this study will become part of the CDC Privacy Act System (09-20-0147, "Occupational Health Epidemiologic Studies"). Personally identifiable information will be protected at NIOSH per requirements of the Privacy Act. The data obtained from the CDPH&E will be held at a NIOSH facility, with access monitored and restricted to the research team. NIOSH gives the more restricted assurance of confidentiality for death certificates used in this study under Section 308(d) of the Public Health Service Act (42 U.S.C. 242m (d)).
"Mortality Among Female Nuclear Weapons Workers"
This project is being conducted at multiple sites.
Principal Investigator: Dr. Gregg S. Wilkinson, University of Texas
Project started in: 1994
This project ended in fiscal year 2001.
Funding for Human Subjects Research: No Funding Sources Reported
This project does not involve the use of multiple protocols/subprojects.
Identifier or number: FNNC
Institutional Review Board (IRB) Review:
Type of Review: Expedited
Approving Institution: State University of New York at Buffalo
Most recent approval: 08/31/98
IRB approval number: M1270-01, M1270
Explanation of IRB approval:
Project completed. Final Report "Study of Mortality Among Female Nuclear Weapons Workers" released 6/7/00.
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 0
Reporting period for number of human subjects:
Fiscal Year 2001
Type(s) of Human Subjects Involvement:
Although 80,000 female workers have been employed at DOE facilities over the years, the small number of female workers at any one facility has limited previous health studies. Female workers from 12 DOE facilities [Fernald, Hanford, Mound, Savannah River, Linde, Pantex, Oak Ridge (K-25, Y-12, and X-10), Zia at Los Alamos, Los Alamos Laboratory, and Rocky Flats] were combined in this cohort mortality study. Risk estimates were developed for exposure to ionizing radiation or to chemical hazards. For the entire pooled cohort, mortality from mental disorders, diseases of the genitourinary system, and from ill-defined conditions was higher than expected. External ionizing radiation exposure in these workers appeared to be associated with increased relative risk for leukemia and suggestively associated with increased relative risks for all cancers combined and for breast cancer.
The final report is: Wilkinson, GS, Trieff, N, Graham, R [2000] Study of mortality among female nuclear workers. Buffalo, NY: Department of Social and Preventive Medicine, School of Medicine and Biomedical Sciences, University of Buffalo, State University of New York; (DHHS Grant Numbers: 1R01OHO3274, 1R01/CCR214546, R01/CCR61 2934-01, Final Report.) Available from U.S. Department of Health and Human Services; Public Health Service; Centers for Disease Control and Prevention; National Institute for Occupational Safety and Health (NIOSH); Division of Surveillance, Hazard Evaluations and Field Studies; Health-related Energy Research Branch, 447 pg. NIOSH [2000]. The final report is also available at /www.cdc.gov/niosh/2001-133.html or from NIOSH at 1-800-356-64674.
This research did not involve any contact with human subjects. It was carried out using records that had already been collected by the Department of Energy. Some of these records, notably the personnel and medical records, contain personally identified information that is protected under the Privacy Act. All information obtained for this study will become part of the CDC Privacy Act System (09-20-0147, "Occupational Health Epidemiolgic Studies"). Personally identifiable information will be protected at NIOSH per requirements of the Privacy Act. The data will be held at the NIOSH facility, with access monitored and restricted to the research team. NIOSH gives the more restricted assurance of confidentiality for death certificates used in this study under Section 308(d) of the Public Health Service Act (42 U.S.C. 242m (d)).
"Glycophorin A Biodosimetry in I-131 Treated Patients"
Principal Investigator: Dr. William Bigbee, University of Pittsburgh
Project started in: 1994
Funding for Human Subjects Research: No Funding Sources Reported
This project does not involve the use of multiple protocols/subprojects.
Identifier or number: GLYC
Institutional Review Board (IRB) Review:
Type of Review: Expedited
Approving Institution: University of Pittsburgh
Most recent approval: 01/28/99
IRB approval number: None, M1259
Explanation of IRB approval:
Project completed. Final Performance Report dated 12/28/98. Report being prepared by NIOSH for communication and release in 2002.
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 0
Reporting period for number of human subjects:
Fiscal Year 2001
Type(s) of Human Subjects Involvement:
This research evaluated the in vivo glycophorin A-based somatic cell mutation assay as a retrospective biodosimeter for use in epidemiologic studies. The response of the assay as a biodosimeter of radiation exposure was validated in a longitudinal study of patients receiving I-131 therapy for thyroid disease. Assessment of the glycophorin A assay in this project demonstrated that assay results are substantially reduced for low dose/low dose rate radiation exposures.
The final report is: Bigbee, WL, Brown, ML, Burmeister, LA, Carty, SE, Swanson, D, Watson, CG [1998]. Glycophorin A (GPA) biodosimetry in I-133 treated patients. Center for Environmental and Occupational Health and Toxicology; Department of Environmental and Occupational Health; Graduate School of Public Health; University of Pittsburg, Pittsburg, PA. (DHHS Grant 5 R01 OHO32376, Final performance report.) Available from U.S. Department of Health and Human Services; Public Health Service; Centers for Disease Control and Prevention; National Institute for Occupational Safety and Health (NIOSH), Cincinnati, OH; Division of Surveillance, Hazard Evaluations and Field Studies; Health-related Energy Research Branch, 36 pg. The final report is also available at /www.cdc.gov/niosh/2001-133.html or from NIOSH at 1-800-356-64674.
All information obtained for this study will become part of the CDC Privacy Act System (09-20-0147, "Occupational Health Epidemiologic Studies"). Personally identifiable information will be protected per requirements of the Privacy Act. Data access will be monitored and restricted to the research team.
"Leukemia Case-Control Study"
This project is being conducted at multiple sites.
Principal Investigator: Dr. Thurman Wenzl, National Institute for Occupational Safety and Health
Project started in: 1995
Funding for Human Subjects Research:
This project does not involve the use of multiple protocols/subprojects.
Identifier or number: LCCS
Institutional Review Board (IRB) Review:
Type of Review: Expedited
Approving Institution: National Institute for Occupational Safety and Health
Most recent approval: 07/01/01
IRB approval number: HSRB 96-DSHEFS-10
Additional IRB approvals from other institutions:
Type of Review: Expedited
Approving Institution: Pacific Northwest National Laboratory
Most recent approval:
IRB approval number: PNNL-2000-16
Type of Review: Expedited
Approving Institution: ORAU/ORNL
Most recent approval: 04/26/00
IRB approval number: NIOSH4
Explanation of additional approval:
After initial ORAU IRB review, the NIOSH IRB must annually review project for continuation.
Type of Review: Expedited
Approving Institution: LANL
Most recent approval: 10/11/01
Type of Review: Expedited
Approving Institution: Savannah River Site (WSRC)
Most recent approval: 08/23/01
IRB approval number: ESH-WHS-2001-00013
Explanation of additional approval:
For one year ending 8/23/02
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 95000
Reporting period for number of human subjects:
Fiscal Year 2001
Type(s) of Human Subjects Involvement:
The objective of this multi-site study is to clarify whether there is an association between workplace exposure to external ionizing radiation and leukemia death among US workers. This case-control study will draw cases from some 95,000 workers at 5 previously studied sites, which have a total of about 250 leukemia deaths. Each of these cases will be age-matched with 4 controls to give a study population of approximately 1250 study subjects, whose external and internal radiation records will then be reviewed. We will then determine if there is an exposure-response relationship between external radiation and leukemia mortality. We will also investigate whether any internal radiation exposures at work might be associated with leukemia death. The five sites being studied include Hanford, Savannah River, Oak Ridge National Lab, Los Alamos/Zia and the Portsmouth Naval Shipyard.
This research does not involve any contact with human subjects. It is carried out using records that had already been collected by the Department of Energy. Some of these records, notably the personnel and medical records, contain personally identified information that is protected under the Privacy Act. All information obtained for this study will become part of the CDC Privacy Act System (09-20-0147, "Occupational Health Epidemiolgic Studies"). Personally identifiable information will be protected at NIOSH per requirements of the Privacy Act. The data will be held at the NIOSH facility, with access monitored and restricted to the research team. NIOSH gives the more restricted assurance of confidentiality for death certificates used in this study under Section 308(d) of the Public Health Service Act (42 U.S.C. 242m (d)).
"Study of Multiple Myeloma among Workers at the Oak Ridge Gaseous Diffusion Plant (K-25)"
Principal Investigator: Dr. Cynthia Robinson, National Institute for Occupational Safety and Health
Project started in: 1995
Funding for Human Subjects Research:
This project does not involve the use of multiple protocols/subprojects.
Identifier or number: K25K
Institutional Review Board (IRB) Review:
Type of Review: Expedited
Approving Institution: National Institute for Occupational Safety and Health
Most recent approval: 09/08/01
IRB approval number: HSRB 96-DSHEFS-16
Additional IRB approvals from other institutions:
Type of Review: Expedited
Approving Institution: ORAU/ORNL
Most recent approval: 12/01/00
IRB approval number: NIOSH1
Explanation of additional approval:
After initial ORAU IRB review, the NIOSH IRB must annually review project for continuation.
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 47941
Reporting period for number of human subjects:
Fiscal Year 2001
Type(s) of Human Subjects Involvement:
The purpose of this study is to determine if workers with chronic low-level exposures to internally deposited uranium are at higher risk of dying of multiple myeloma. This objective will be achieved using a case-control study design. Persons who worked at K25 will be identified from site personnel records, and a National Death Index search will be used to determine which of these people died of multiple myeloma. Five controls (former K25 workers who did not die of multiple myeloma) of the same gender, race, and similar age will be matched to each case. NIOSH personnel will then use industrial hygiene, health physics, and medical records to assess each subject's exposures to internally deposited uranium, external penetrating radiation, and chemicals (nickel, cadmium, lead, copper, chromium, benzene, carbon tetrachloride). The main study objective will be achieved by accounting for the effects of these other radiation and chemical exposures while examining the relationship between internally deposited uranium and the risk of dying from multiple myeloma. This research does not involve any contact with human subjects. It is carried out using records that had already been collected by the Department of Energy. Some of these records, notably the personnel and medical records, contain personally identified information that is protected under the Privacy Act. All information obtained for this study will become part of the CDC Privacy Act System (09-20-0147, "Occupational Health Epidemiolgic Studies"). Personally identifiable information will be protected at NIOSH per requirements of the Privacy Act. The data will be held at the NIOSH facility, with access monitored and restricted to the research team. NIOSH gives the more restricted assurance of confidentiality for death certificates used in this study under Section 308(d) of the Public Health Service Act (42 U.S.C. 242m (d)).
"International Collaborative Study of Nuclear Industry Workers"
Principal Investigator: Dr. Elisabeth Cardis, International Agency for Research on Cancer (IARC)
Project started in: 1995
Funding for Human Subjects Research: No Funding Sources Reported
This project does not involve the use of multiple protocols/subprojects.
Identifier or number: IARC
Institutional Review Board (IRB) Review:
Type of Review: Expedited
Approving Institution: National Institute for Occupational Safety and Health
Most recent approval: 07/30/01
IRB approval number: 00-DSHEFS-05XM
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 600000
Reporting period for number of human subjects:
Fiscal Year 2001
Type(s) of Human Subjects Involvement:
IARC has undertaken a cancer mortality study of nuclear workers in 14 countries. Vital status, causes of death, and exposure data from nuclear facilities in the participating countries will be combined to establish sufficient statistical power to quantify small increases in cancer risk in workers exposed to low doses of ionizing radiation.
The objective is to establish a summary risk estimate to replace those currently based on the episodic experience of the atomic bomb survivors with more relevant chronic low exposure experience of workers. The methodology is to develop a risk estimate for each independent cohort and combine them with all others into one large and stable estimate. The primary radioactive exposure is to external (gamma and x-ray) with a minimum of neutron exposure.
This research does not involve any contact with human subjects. For the NIOSH U.S. cohorts, it is carried out using records that had already been collected by the Department of Energy. Some of these records, notably the personnel and medical records, contain personally identified information that is protected under the Privacy Act. All information obtained for the NIOSH cohorts is part of the CDC Privacy Act System (09-20-0147, "Occupational Health Epidemiolgic Studies"). Personally identifiable information is protected at NIOSH per requirements of the Privacy Act. The data are held at the NIOSH facility, with access monitored and restricted to the research team. NIOSH gives the more restricted assurance of confidentiality for death certificates used in these study cohorts under Section 308(d) of the Public Health Service Act (42 U.S.C. 242m (d)).
"Prevention of Stress and Health Consequences of Downsizing and Reorganization"
Principal Investigator: Dr. Lewis D. Pepper, National Institute for Occupational Safety and Health
Project started in: 1995
This project ended in fiscal year 2001.
Funding for Human Subjects Research: No Funding Sources Reported
This project does not involve the use of multiple protocols/subprojects.
Identifier or number: STDN
Institutional Review Board (IRB) Review:
Type of Review: Expedited
Approving Institution: Boston University School of Public Health
Most recent approval: 09/26/99
IRB approval number: E3967-99, M1290
Explanation of IRB approval:
Project completed. Final report issued and communicated 10/25/00.
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 0
Reporting period for number of human subjects:
Fiscal Year 2001
Type(s) of Human Subjects Involvement:
The DOE weapons complex has undergone a substantial mission change with the cessation of active nuclear weapons production and the initiation of site remediation activity. This resulted in marked changes in the need for specific worker skills and a related reorganization of the DOE workforce, which included layoffs and transfers. These factors are known to have adverse effects on the health of the workforce. This research studied the process and effects of downsizing and reorganization at five DOE sites and recommended interventions intended to minimize adverse health effects among the workers. To accomplish this multi-site research and communication, HERB used the previously developed multi-site communications system to provide one-page study findings to over 80,000 current and former workers at all five studied DOE sites.
The negative effects of downsizing and reorganization include reduced job commitment, low morale, low job satisfaction, and various other health and safety effects even among workers who retained their jobs. This study examined the downsizing process by conducting questionnaire surveys of workers and management regarding the downsizing process and the personal involvement of each respondent in that process, measuring the adequacy of communications and perceived fairness of the process at each site. In addition, job factors such as workload, decision-making authority, conflict resolution, supervisory support, and job insecurity for the remaining workforce were analyzed. The study found that managerial emphasis on fair and open policies and communications, including ongoing assessments of changed workloads and management-worker relationships, resulted in lower rates of adverse health effects in the workforce. Site-specific intervention techniques were recommended.
Publications include:
Pepper, L. [2000]. The Health effects of downsizing in the nuclear industry: findings at the Idaho National Engineering and Environmental Laboratory. Boston, MA: Department of Environmental Health, Boston University School of Public Health; CDC Cooperative Agreement U60 CCU 112215, Final Report.) Available from the National Institute for Occupational Safety and Health/Health-Related Energy Research Branch, Cincinnati, OH, 129 pg.
Pepper, L. [2000]. The Health effects of downsizing in the nuclear industry: findings at the Los Alamos National Laboratory. Boston, MA: Department of Environmental Health, Boston University School of Public Health; CDC Cooperative Agreement U60 CCU 112215, Final Report.) Available from the National Institute for Occupational Safety and Health/Health-Related Energy Research Branch, Cincinnati, OH, 135 pg.
Pepper, L. [2000]. The Health effects of downsizing in the nuclear industry: findings at the Nevada Test Site. Boston, MA: Department of Environmental Health, Boston University School of Public Health; CDC Cooperative Agreement U60 CCU 112215, Final Report.) Available from the National Institute for Occupational Safety and Health/Health-Related Energy Research Branch, Cincinnati, OH, 125 pg.
Pepper, L. [2000]. The Health effects of downsizing in the nuclear industry: findings at Pantex. Boston, MA: Department of Environmental Health, Boston University School of Public Health; CDC Cooperative Agreement U60 CCU 112215, Final Report.) Available from the National Institute for Occupational Safety and Health/Health-Related Energy Research Branch, Cincinnati, OH, 129 pg.
Pepper, L. [2000]. The Health effects of downsizing in the nuclear industry: findings at the Y-12 Oak Ridge Reservation. Boston, MA: Department of Environmental Health, Boston University School of Public Health; CDC Cooperative Agreement U60 CCU 112215, Final Report.) Available from the National Institute for Occupational Safety and Health/Health-Related Energy Research Branch, Cincinnati, OH, 129 pg.
All these reports are also available at ww.cdc.gov/niosh/2001-133.html or from NIOSH at 1-800-356-64674.
All information obtained for this study will become part of the CDC Privacy Act System (09-20-0147, "Occupational Health Epidemiologic Studies"). Personally identifiable information will be protected at NIOSH per requirements of the Privacy Act. The data will be held at the NIOSH facility, with access monitored and restricted to the research team. NIOSH gives the more restricted assurance of confidentiality for death certificates used in this study under Section 308(d) of the Public Health Service Act (42 U.S.C. 242m (d)).
"Chronic Beryllium Disease Among Beryllium-Exposed Workers"
Principal Investigator: Dr. Kenneth Rosenman, Michigan State University
Project started in: 1995
Funding for Human Subjects Research: No Funding Sources Reported
This project does not involve the use of multiple protocols/subprojects.
Identifier or number: BER1
Institutional Review Board (IRB) Review:
Type of Review: Expedited
Approving Institution: Michigan State University
Most recent approval: 05/03/99
IRB approval number: 95426, M1239
Explanation of IRB approval:
Study completed. Awaiting final report. Data on IRB approval collected by CDC Procurement and Grants Office (PGO). Updates will be provided when available.
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 0
Reporting period for number of human subjects:
Fiscal Year 2001
Type(s) of Human Subjects Involvement:
This cross-setional study of 1,000 workers at two DOE plants will examine the natural history of chronic beryllium disease and evaluate the utility of the lymphocyte transformation test in detecting beryllium sensitization and predicting chronic beryllium disease development. The effectiveness of medical treatment of sensitized workers and of control measures in preventing overt chronic beryllium disease will also be evaluated.
Initial solicitations for participation are by letter, including appropriate consent forms. For the purposes of this study, blood samples will be taken using standard phlebotomy methods, and a chest x-ray will be administered to those who do not have a recent X-ray. Bronchoalveolar lavage will be performed in a hospital, and participants will be released only after careful observation and monitoring.
All medical records will be maintained as strictly confidential, under lock and key, with limited access by study staff only. Only participating individuals will have access to their individual medical test results.
"Beyllium Disease Natural History and Exposure Response"
Principal Investigator: Dr. Lee S. Newman, National Jewish Center for Immunology and Respiratory Medicine
Project started in: 1995
Funding for Human Subjects Research: No Funding Sources Reported
This project does not involve the use of multiple protocols/subprojects.
Identifier or number: BER2
Institutional Review Board (IRB) Review:
Type of Review: Full Board
Approving Institution: National Jewish Center for Immunology and Respiratory Medicine
Most recent approval: 08/30/99
IRB approval number: HS 327, M1009
Explanation of IRB approval:
Study completed. Awaiting final report. Data on IRB approval collected by CDC Procurement and Grants Office (PGO). Updates will be provided when available.
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 0
Reporting period for number of human subjects:
Fiscal Year 2001
Type(s) of Human Subjects Involvement:
This investigation will determine the natural history of beryllium sensitization and subclinical chronic beryllium disease and identify beryllium compounds and processes associated with chronic beryllium disease. Exposure-response relationships for both sensitization and chronic beryllium disease will also be determined. Exposure assessment for take-home toxicants includes study of 60 workers at a selected plant.
There were no exposures to radiation during the testing for this study. Risks were associated with drawing blood, chest x-rays, spirometry, broncoscopy where indicated, and questionnaire completion.
Records are protected in accordance with the human subjects protections dictated by the institution granting IRB approval.
"Lung Fibrosis in Plutonium Workers"
Principal Investigator: Dr. Lee S. Newman, National Jewish Center for Immunology & Respiratory Medicine
Project started in: 1995
Funding for Human Subjects Research: No Funding Sources Reported
This project does not involve the use of multiple protocols/subprojects.
Identifier or number: LFPW
Institutional Review Board (IRB) Review:
Type of Review: Expedited
Approving Institution: National Jewish Center for Immunology & Respiratory Medicine
Most recent approval: 08/30/99
IRB approval number: HS 327, M1009
Explanation of IRB approval:
Project completed. Final Performance Report dated 12/22/99 amended and updated 09/30/01. Data on IRB approval collected by CDC Procurement and Grants Office (PGO). Updates will be provided when available.
Additional IRB approvals from other institutions:
Type of Review: Expedited
Approving Institution: National Jewish Center for Immunology and Respiratoryu Medicine
Most recent approval: 08/30/99
IRB approval number: HS 327, M1009
Explanation of additional approval:
project completed
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 0
Reporting period for number of human subjects:
Fiscal Year 2001
Type(s) of Human Subjects Involvement:
The project "Lung Fibrosis in Plutonium Workers" has as its central hypothesis that plutonium (Pu) workers are at increased risk of developing chronic fibrotic lung disease due to the inhalation of 239-Pu or other toxic compounds. The two main objectives of the study are: 1.) To confirm whether plutonium workers are at increased risk for developing chest radiograph abnormalities consistent with pulmonary fibrosis, compared to Rocky Flats workers who have no history of plutonium exposure. 2.) To determine the relationship between 239-Pu or other radionuclide/chemical exposures and the development of fibrotic lung disease in radiation workers.
A cross-sectional comparison of the frequency of abnormal chest x-rays in plutonium workers versus non-exposed workers will be performed. Next, the frequency of abnormal chest x-rays will be compared among Rocky Flats workers who differ in their absorbed doses of 239Pu to the lung. A dose-response analysis will be performed using these radiographic data as a biological outcome measure and radionuclide exposure/dose data. Risk analysis models will be constructed to examine the contribution of radionuclides, non-radionuclides, non- radioactive metals, and other variables to the prediction of disease. The physiologic significance of the x-ray findings will be determined using quantitative measures of existing pulmonary physiology data obtained in the clinical assessment of plutonium workers who have abnormal x- rays.
Any chemical or radioactive substances or ionizing radiation used or to which human subjects were exposed: Radiological and chemical materials to which human subjects may have been exposed include: 239Pu, americium 241, beryllium, smoking status, and chemicals identified for worker exposures through work performed by the Colorado Department of Public Health and the Environment (CDPH&E) as a part of the NIOSH funded cooperative agreement addressing the cancer mortality and incidence among Rocky Flats workers.
This is a record based study. Data on workers who ever worked in a plutonium area as well as workers who never worked in plutonium areas and include the entire population of past and present Rocky Flats workers will be used to select study subjects. Data on plutonium workers defining them as employees of one of the three prime contractors of Rocky Flats for any duration of time, in any job title, in any building in which plutonium was used - as well as building and job history data for each worker will be obtained through the NIOSH funded Cooperative Agreement study of Rocky Flats with CDPH&E. Chest radiographs will be obtained from the Medical Department and Health Effects Division through retrieval of the films by the Medical Department from the Denver Federal Records Center. Demographic information and smoking histories will be sought from the various screening programs' records - in which many of the 18,000 workers from Rocky Flats have participated. Records from the program for medical monitoring of former radiation workers at Rocky Flats are also being utilized. Radionuclide exposure data and chemical exposure analyses will be obtained from the NIOSH cooperative agreement with CDPH&E and the University of Colorado Health Sciences Center.
Chest radiographs will be assigned a unique study identification number on the randomly sorted master list. This enables investigators to track rates of missing radiographs, questionnaire data, and exposure data. The study identification number, social security number, and Rocky Flats worker identification number provide three means of identification on data files and the like, while maintaining confidentiality of names in a separate locked file. Questionnaire data will be transferred following verification by the researcher's staff in coordination with the Rocky Flats Occupational Health Department staff.
"Study of Heat Stress and Performance in Carpenters at DOE Sites"
Principal Investigator: Dr. Kenneth Rosenman, Michigan State University
Project started in: 1995
Funding for Human Subjects Research: No Funding Sources Reported
This project does not involve the use of multiple protocols/subprojects.
Identifier or number: HTST
Institutional Review Board (IRB) Review:
Type of Review: Expedited
Approving Institution: Michigan State University
Most recent approval: 08/24/99
IRB approval number: S13477-01, SPA
Explanation of IRB approval:
Study completed. Awaiting revision of final report. Data on IRB approval collected by CDC Procurement and Grants Office (PGO). Updates will be provided when available.
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 0
Reporting period for number of human subjects:
Fiscal Year 2001
Type(s) of Human Subjects Involvement:
This study will determine if heat stress from the use of protective clothing affects the performance of carpenters and other construction workers in remediation and hazardous waste work at the DOE Hanford and Oak Ridge sites. Since these facilities are located in hot environments, both the efficiency of the cleanup effort and worker safety are directly impacted by the personal protective equipment (PPE) policy employed. The study interacted directly with cleanup workers at the two DOE sites to characterize heat stress and other potential exposures as well as make recommendations to solve existing problems. Physiologic measures of heat stress and neurobehavioral performance will be assessed under actual working conditions.
All records for this research are accessible only by members of the research team and protected in accordance with the Provisions of the Privacy Act.
"Comprehensive Occupational Health Surveillance"
Principal Investigator: Dr. Timothy Takaro, University of Washington
Project started in: 1995
Funding for Human Subjects Research: No Funding Sources Reported
This project does not involve the use of multiple protocols/subprojects.
Identifier or number: COHS
Institutional Review Board (IRB) Review:
Type of Review: Expedited
Approving Institution: University of Washington
Most recent approval: 06/01/00
IRB approval number: UW 28-0097-C, M1183
Explanation of IRB approval:
Study completed. Awaiting final report, including appendices. Data on IRB approval collected by CDC Procurement and Grants Office (PGO). Updates will be provided when available.
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 0
Reporting period for number of human subjects:
Fiscal Year 2001
Type(s) of Human Subjects Involvement:
This project was concerned with the development of a model occupational health surveillance system intended for the early identification of occupational exposures which could result in adverse health effects in a workforce. Utilizing an Employee Job Task Analysis (EJTA) approach which organized industrial hygiene data by defined tasks, the researchers assembled a computerized system which linked specific employee tasks at the Hanford site with exposure agents and environmental levels, according to existing site records . The accuracy of these linked data were investigated by on-site walkthroughs by industrial hygienists. The validated exposure records were then linked with medical data for similar exposures and tasks at the Hanford site in a matrix format for use in a risk assessment process. This combination of industrial hygiene and medical data is used in a preliminary identification of on-site exposures and tasks which may result in adverse health effects in the workforce. This approach leads to reduction of hazardous exposures, supports evaluation of safety and health intervention efforts, and contributes to worker participation in job hazard reduction efforts.
No human chemical or physical exposures resulted from this research project since exposure inventories resulted from examination of existing records of occupational exposure by defined task without personal identifiers. These were verified by subsequent walkthrough observation and interviews with supervisory personnel. Contact with human subjects was limited to an interview process obtaining permission to access workplace records. All records created by the research are accessible only by members of the research team and protected in accordance with the provisions of the Privacy Act.
"Work Histories - Evaluating New Participatory Methods"
This project is being conducted at multiple sites.
Principal Investigator: Dr. Eula Bingham, University of Cincinnati
Project started in: 1995
Funding for Human Subjects Research: No Funding Sources Reported
This project does not involve the use of multiple protocols/subprojects.
Identifier or number: WHEP
Institutional Review Board (IRB) Review:
Type of Review: Expedited
Approving Institution: University of Cincinnati
Most recent approval: 10/13/99
IRB approval number: UC 95-6-22-01, M1138
Explanation of IRB approval:
Study completed. Awaiting final report, including appendices. Data on IRB approval collected by CDC Procurement and Grants Office (PGO). Updates will be provided when available.
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 0
Reporting period for number of human subjects:
Fiscal Year 2001
Type(s) of Human Subjects Involvement:
This project developed and tested methods to recall the occupational exposures of former construction trades workers at the nuclear weapons sites, noting that these workers were typically exposed to many chemicals and physical agents over time in a series of short-term work assignments. Part of this activity included the construction of a detailed map and chemical use history of the Oak Ridge site's buildings and work areas from historical files. A number of approaches were tried and evaluated at the Oak Ridge site, including encounter groups, standard interviews, and group discussions assisted by detailed work site maps and building-specific process histories and chemical inventories. The most successful of these approaches was the assisted group discussion model. This model was utilized in a second project phase for construction trades at the Hanford site, to demonstrate and improve the ability of the Oak Ridge recall procedure in detailing the occupational exposure history at other nuclear sites which employed construction trades workers.
No human chemical or physical exposures resulted from this research project since potential exposure inventories resulted from assisted interviews and from data collected through examination of building-specific records. Contact with human subjects was limited to an interview process. All records created by the research are accessible only by members of the research team and protected in accordance with the provisions of the Privacy Act.
"Sentinel Exposure Event Surveillance/Evaluation at DOE Sites"
Principal Investigator: Dr. James A. Ruttenber, University of Colorado HealthSciences Center
Project started in: 1995
Funding for Human Subjects Research: No Funding Sources Reported
This project does not involve the use of multiple protocols/subprojects.
Identifier or number: SEES
Institutional Review Board (IRB) Review:
Type of Review: Full Board
Approving Institution: University of Colorado Health Sciences Center
Most recent approval: 05/16/00
IRB approval number: 97-100, M1494
Explanation of IRB approval:
Study completed. Awaiting final report. Data on IRB approval collected by CDC Procurement and Grants Office (PGO). Updates will be provided when available.
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 0
Reporting period for number of human subjects:
Fiscal Year 2001
Type(s) of Human Subjects Involvement:
This project is intended to develop a generic hazard surveillance and evaluation system for chemical and radiation exposures. Based on a job/task evaluation and analysis, the sentinel exposure event system will include exposure level measurements, worker-specific task definitions, and observation data (controls, exposure conditions, and defined health and safety policies). This input will be incorporated into a system for evaluating exposures, enhancing worker communications, and identifying necessary interventions through internally generated reports.
No human chemical or physical exposures resulted from the this research, since potential exposure inventories resulted from assisted interviews and from data collected through examination of building-specific records. Contact with human subjects was limited to an interview process obtaining permission to access workplace records. All personal records created by this research are accessible only by members of the research team, and protected in accordance with the provisions of the Privacy Act.
"Hazard Surveillance in the Defense Nuclear Industry"
Principal Investigator: Dr. John R. Froines, University of California at Los Angeles
Project started in: 1995
Funding for Human Subjects Research: No Funding Sources Reported
This project does not involve the use of multiple protocols/subprojects.
Identifier or number: HSDN
Institutional Review Board (IRB) Review:
Type of Review: Expedited
Approving Institution: University of California at Los Angeles
Most recent approval: 09/30/95
IRB approval number: Not Available
Explanation of IRB approval:
Data on IRB approval collected by CDC Procurement and Grants Office (PGO). Updates will be provided when available.
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 0
Reporting period for number of human subjects:
Fiscal Year 2001
Type(s) of Human Subjects Involvement:
This project was generally intended to develop statistical models of occupational exposure to chemicals to provide estimates of health risk for former workers at the nuclear weapons sites, especially the Los Alamos National Laboratories. Attention was given to modeling exposure to single-chemical, multiple-chemical, and chemical and physical stress exposures. Using workplace measurements of exposure concentrations associated with specific tasks, these models are used to evaluate the relationships between observed concentrations and actual worker dose under actual working conditions. The result is a statistical modeling system that can be used to estimate the amount of occupational illness in a worker population in order to guide medical surveillance and illness prevention programs.
No human chemical or physical exposures resulted from this research project, and exposure data used resulted from examination of pre-existing occupational exposure observations. This research did not involve any contact with human subjects. It was carried out by the researchers using records previously collected by private industry sources. Any existing personal identifiers were eliminated from the records, which were accessible only by the research team. All research records are protected under the provisions of the Privacy Act.
"Cohort Mortality Study of Pantex Plant, Amarillo, Texas"
Principal Investigator: Mr. Travis Kubale, National Institute for Occupational Safety and Health
Project started in: 1996
Funding for Human Subjects Research: No Funding Sources Reported
This project does not involve the use of multiple protocols/subprojects.
Identifier or number: PTXP
Institutional Review Board (IRB) Review:
Type of Review: Expedited
Approving Institution: National Institute for Occupational Safety and Health
Most recent approval: 11/23/00
IRB approval number: HSRB 98-DSHEFS-01XP
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 0
Reporting period for number of human subjects:
Fiscal Year 2001
Type(s) of Human Subjects Involvement:
Pantex is an active, operational DOE facility of approximately 16,000 acres in the Texas panhandle, approximately 17 miles northeast of downtown Amarillo. Its current mission includes assembly and disassembly of nuclear weapons for the nation's stockpile. NIOSH has updated a previous records-based study whose results were suggestive of an increased risk of leukemia for these workers. Seventeen years of additional records information was available for 4,637 workers hired prior to 1979. Because complete work history records were limited to those workers who ended their work at Pantex in 1978 or before, the analysis is limited to a comparison of worker death rates to US death rates (Standardized Mortality Ratios) and selected follow-up analyses. A report of this update analysis is in preparation.
This research does not involve any contact with human subjects. It is carried out using records that had already been collected by the Department of Energy. Some of these records, notably the personnel and medical records, contain personally identified information that is protected under the Privacy Act. All information obtained for this study will become part of the CDC Privacy Act System (09-20-0147, "Occupational Health Epidemiolgic Studies"). Personally identifiable information will be protected at NIOSH per requirements of the Privacy Act. The data will be held at the NIOSH facility, with access monitored and restricted to the research team. NIOSH gives the more restricted assurance of confidentiality for death certificates used in this study under Section 308(d) of the Public Health Service Act (42 U.S.C. 242m (d)).
"Acute Radiation Syndrome in Russian Nuclear Workers"
Principal Investigator: Dr. Neil Wald, University of Pittsburgh
Project started in: 1996
Funding for Human Subjects Research: No Funding Sources Reported
This project does not involve the use of multiple protocols/subprojects.
Identifier or number: ARSR
Institutional Review Board (IRB) Review:
Type of Review: Expedited
Approving Institution: University of Pittsburgh
Most recent approval: 01/06/99
IRB approval number: 97-0130, M1259
Explanation of IRB approval:
Data on IRB approval collected by CDC Procurement and Grants Office (PGO). Updates will be provided when available.
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 0
Reporting period for number of human subjects:
Fiscal Year 2001
Type(s) of Human Subjects Involvement:
The objective of this study is to develop a computer database consisting of the clinical and dosimetric records of 59 cases of Acute Radiation Syndrome (ARS) resulting from the occupational external gamma and neutron and internal alpha radiation exposures of workers. These records have been collected since 1948 at the Institute of Biophysics (FIB1) from the Mayak PA nuclear weapons facilities in Ozersk, Chelyabinsk Oblast, Russian Federation. The database is to be used to improve the early diagnosis and management of ARS by non-expert medical and paramedical personnel in hospital and field conditions. The first application of the data will be to test the Wald-Thomas model triage scheme for early diagnosis of ARS. The database is coded without names or other personal identifiers, and copies are maintained at FIB1 and the University of Pittsburgh.
"Ionizing Radiation and Mortality Among Hanford Workers"
Principal Investigator: Dr. Steven R. Wing, University of North Carolina
Project started in: 1996
Funding for Human Subjects Research: No Funding Sources Reported
This project does not involve the use of multiple protocols/subprojects.
Identifier or number: HANF
Institutional Review Board (IRB) Review:
Type of Review: Expedited
Approving Institution: National Institute for Occupational Safety and Health
Most recent approval: 06/09/00
IRB approval number: HSRB 96-DSHEFS-08
Explanation of IRB approval:
Study analysis completed. Data on IRB approval collected by CDC Procurement and Grants Office (PGO). Updates will be provided when available.
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 0
Reporting period for number of human subjects:
Fiscal Year 2001
Type(s) of Human Subjects Involvement:
This study is an update of a previous cohort study, and applies new methodologies for epidemiologic analyses. The update will re-analyze cancer and non-cancer mortality among Hanford workers with chronic, low-level external radiation exposure. New methods will be used to estimate doses previously assumed to be zero and to consider internal dose in analysis of health risks. And, new analytical methods will be used to consider time-related exposure effects, such as age at exposure.
This study did not involve contact with human subjects. It was carried out using records that had already been collected by the Department of Energy. Some of these records, notably the personnel and medical records, contain personally identified information that is protected under Privacy Act. All information obtained for this study will become part of the CDC Privacy Act System (09-20-0147, "Occupational Health Epidemiologic Studies"). Personally identifiable information will be protected at NIOSH per requirements of the Privacy Act. The data will be held at the NIOSH facility, with access monitored and restricted to the research team. NIOSH gives the more restricted assurance of confidentiality for death certificates used in this study under Section 308(d) of the Public Health Service Act (42 U.S.C. 242m (d)).
"Case-Control Study of the Portsmouth Gaseous Diffusion Plant"
Principal Investigator: Dr. Steven H. Ahrenholz, National Institute for Occupational Safety and Health
Project started in: 1997
This project ended in fiscal year 2001.
Funding for Human Subjects Research: No Funding Sources Reported
This project does not involve the use of multiple protocols/subprojects.
Identifier or number: PORT
Institutional Review Board (IRB) Review:
Type of Review: Expedited
Approving Institution: National Institute for Occupational Safety and Health
Most recent approval: 03/17/01
IRB approval number: HSRB 93-DSHEFS-10D
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 9000
Reporting period for number of human subjects:
Fiscal Year 2001
Type(s) of Human Subjects Involvement:
Site workers with the Oil, Chemical, and Atomic Workers Union at the Portsmouth facility continued to voice concerns that exposure to uranium hexafluoride may have caused cancers among production and maintenance workers. Leukemia risks remained a concern, along with several other statistically non-significant elevated Standardized Mortality Ratios identified from a previous NIOSH mortality study. NIOSH conducted an update of the previous study, expanding the study cohort by 54% and adding nine years of follow-up. This study included dose-response analyses using exposure assessments for external and internal ionizing radiation, uranium metal, fluoride compounds, and nickel. Nested case-control studies evaluated cancer deaths of the lung, hematopoietic system, leukemia, and stomach; included dose-response for the five previously identified agents; and evaluated temporal effects and effect modification.
Overall cohort mortality was significantly less than expected, as was mortality from all cancers. No statistically significant excess in mortality from any specific cause was observed. Analyses of relationships between causes of death and the identified exposures failed to reveal any clear dose-response trends. For leukemia, no effect of cumulative exposure to either external or internal radiation was identified. Additionally, no dose-response relationships were observed for cancers of the stomach, lung, Hodgkin's disease, lymphoreticulosarcoma, and all cancers combined. Worker deaths from cancers of the lympho-hematopoietic tissue, including leukemia, equaled U.S. rates. Stomach cancer deaths were slightly greater than expected (12.7 deaths expected, 15 deaths found) but lacked statistical significance. Concerns remain among workers about the effects of unmonitored exposures although 88% of the cohort was alive at the end of study.
This study did not involve contact with human subjects. It was carried out using records that had already been collected by the Department of Energy. Some of these records, notably the personnel and medical records, contain personally identified information that is protected under Privacy Act. All information obtained for this study will become part of the CDC Privacy Act System (09-20-0147, "Occupational Health Epidemiologic Studies"). Personally identifiable information will be protected at NIOSH per requirements of the Privacy Act. The data will be held at the NIOSH facility, with access monitored and restricted to the research team. NIOSH gives the more restricted assurance of confidentiality for death certificates used in this study under Section 308(d) of the Public Health Service Act (42 U.S.C. 242m (d)).
The final report is: Mortality patterns among uranium enrichment workers at the Portsmouth Gaseous Diffusion Plant Piketon, Ohio. Final Technical Report. Cincinnati, OH: U.S. Department of Health and Human Services; Public Health Service; Centers for Disease Control and Prevention; National Institute for Occupational Safety and Health (NIOSH); Division of Surveillance, Hazard Evaluations and Field Studies; Health-related Energy Research Branch, 179 pg. NIOSH [2001]. The final report is also available at /www.cdc.gov/niosh/2001-133.html or from NIOSH at 1-800-356-64674.
"Cohort Mortality Study of DOE Chemical Laboratory Workers"
This project is being conducted at multiple sites.
Principal Investigator: Dr. Cynthia Robinson, National Institute for Occupational Safety and Health
Project started in: 1997
Funding for Human Subjects Research:
This project does not involve the use of multiple protocols/subprojects.
Identifier or number: CLWS
Institutional Review Board (IRB) Review:
Type of Review: Expedited
Approving Institution: National Institute for Occupational Safety and Health
Most recent approval: 02/25/01
IRB approval number: HSRB 97-DSHEFS-08
Additional IRB approvals from other institutions:
Type of Review: Expedited
Approving Institution: ORAU/ORNL
Most recent approval: 12/01/99
IRB approval number: NIOSH2
Explanation of additional approval:
After initial ORAU IRB review, the NIOSH IRB must annually review project for continuation.
Type of Review: Expedited
Approving Institution: Savannah River Site (WSRC)
Most recent approval: 09/18/01
IRB approval number: ESH-WHS-2001-00015
Explanation of additional approval:
Approved for one year ending 9/18/2002
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 5000
Reporting period for number of human subjects:
Fiscal Year 2001
Type(s) of Human Subjects Involvement:
Studies have been reported that workers in chemical laboratories experience higher rates of cancer. Some chemicals used in the laboratories are suspected or known to cause cancer in humans and animals. The objective of this study is to find out if chemical laboratory workers at DOE facilities experience higher death rates than the U.S. population and to identify the exposures these workers may have had. The study will assess the previously unstudied effects of external and internal ionizing radiation exposure as well as exposure to chemicals. This cohort mortality study will look at whether these long-term low-level exposures affect the worker's risk of death from cancer and other diseases. The DOE sites included in the study are Oak Ridge National Laboratory (ORNL/X-10), K-25, Y-12, Savannah River, and possibly Hanford.
To help understand the effects of chemical exposures, the study will include workers employed in chemical laboratories at DOE sites between 1943 and 1997. These sites were chosen because the study needs a large number of chemical laboratory workers. The study will be based on work records from the sites. These records will be used to compare death rates of chemical laboratory workers to rates for the U.S. population. The records will also tell about the workers' past exposures to chemicals and ionizing radiation.
This research does not involve any contact with human subjects. It is carried out using records that had already been collected by the Department of Energy. Some of these records, notably the personnel and medical records, contain personally identified information that is protected under the Privacy Act. All information obtained for this study will become part of the CDC Privacy Act System (09-20-0147, "Occupational Health Epidemiolgic Studies"). Personally identifiable information will be protected at NIOSH per requirements of the Privacy Act. The data will be held at the NIOSH facility, with access monitored and restricted to the research team. NIOSH gives the more restricted assurance of confidentiality for death certificates used in this study under Section 308(d) of the Public Health Service Act (42 U.S.C. 242m (d)).
"Multi-State Case-Control Study of Lung Cancer and External Ionizing Radiation"
This project is being conducted at multiple sites.
Principal Investigator: Ms. Sharon Silver, National Institute for Occupational Safety and Health
Project started in: 1997
Funding for Human Subjects Research:
This project does not involve the use of multiple protocols/subprojects.
Identifier or number: LUNG
Institutional Review Board (IRB) Review:
Type of Review: Expedited
Approving Institution: National Institute for Occupational Safety and Health
Most recent approval: 10/05/00
IRB approval number: HSRB 99-DSHEFS-07XP
Additional IRB approvals from other institutions:
Type of Review: Full Board
Approving Institution: ORAU/ORNL (Oak Ridge National Laboratory)
Most recent approval: 03/31/00
IRB approval number: NIOSH-3
Type of Review: Expedited
Approving Institution: Savannah River Site (WSRC)
Most recent approval: 10/18/01
IRB approval number: ESH-WHS-2001-00017
Type of Review: Expedited
Approving Institution: INEEL
Most recent approval: 06/07/01
Type of Review: Expedited
Approving Institution: Pacific Northwest National Laboratory
Most recent approval: 03/31/00
IRB approval number: PNNL-2000-15
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 28000
Reporting period for number of human subjects:
Fiscal Year 2001
Type(s) of Human Subjects Involvement:
Several recent occupational studies of radiologic workers have suggested a dose-response relationship between external ionizing radiation exposure and lung cancer mortality. The occupational settings in these studies have had potential confounding exposures including internal ionizing radiation, asbestos, and other chemical and physical agents which may have contributed to the relationship observed. Because of these multiple exposures, the association between protracted exposure to low-level external ionizing radiation and lung cancer mortality remains unclear.
This case-control study will examine the association between lung cancer mortality and protracted occupational exposure to low-level external ionizing radiation by targeting workers primarily exposed to external radiation. The study population is limited to workers in reactor operations areas at selected Department of Energy sites (Oak Ridge National Laboratory, Savannah River, Hanford, & INEEL)to focus on an occupational setting with primarily external radiation exposure and minimal potential confounding exposures. The case-control design will allow for a more complete exposure assessment than possible in previous cohort studies.
This research does not involve any contact with human subjects. It is carried out using records that had already been collected by the Department of Energy. Some of these records, notably the personnel and medical records, contain personally identified information that is protected under the Privacy Act. All information obtained for this study will become part of the CDC Privacy Act System (09-20-0147, "Occupational Health Epidemiolgic Studies"). Personally identifiable information will be protected at NIOSH per requirements of the Privacy Act. The data will be held at the NIOSH facility, with access monitored and restricted to the research team. NIOSH gives the more restricted assurance of confidentiality for death certificates used in this study under Section 308(d) of the Public Health Service Act (42 U.S.C. 242m (d)).
"Epidemiologic Studies to Evaluate Health Effects of Uranium Milling"
Principal Investigator: Dr. William E. Lambert, University of New Mexico
Project started in: 1997
Funding for Human Subjects Research: No Funding Sources Reported
This project does not involve the use of multiple protocols/subprojects.
Identifier or number: EPUM
Institutional Review Board (IRB) Review:
Type of Review: Full Board
Approving Institution: Univerity of New Mexico
Most recent approval: 09/30/98
IRB approval number: not available, M1450
Explanation of IRB approval:
Study completed. Awaiting final report. Data on IRB approval collected by CDC Procurement and Grants Office (PGO). Updates will be provided when available.
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 0
Reporting period for number of human subjects:
Fiscal Year 2001
Type(s) of Human Subjects Involvement:
In the western United States, uranium ore is mined in quartz sandstone. From the 1950s to the 1980s, when conventional milling practices were followed, workers were exposed to silica and uranium dusts during several steps in the milling process, including crushing, ball and rod milling, precipitation, filtration, drying, and packaging. Two previous analyses of mortality in cohorts of mill workers suggest premature deaths may occur due to non-malignant lung disease and kidney disease. To investigate the potential long-term respiratory and renal effects associated with employment in uranium mills, a cross-sectional study of 500 former mill workers and 100 reference workers will be conducted. Company employment records will be used to develop a sample of persons who worked in the mills for at least a year in jobs associated with uranium processing and who never worked in underground uranium mines. The reference group will consist of workers of comparable ages and ethnic backgrounds who never worked in uranium mills or uranium mines. Clinical tests of lung and kidney function will be performed, and chest x-rays and spirometry will be conducted to quantify the presence of silicosis, pulmonary fibrosis, and abnormalities of pulmonary function. The prevalence of impaired respiratory and renal function in former uranium millers will be compared to the prevalence in the reference workers. Where possible, industrial hygiene measurements of uranium and silica dusts will be used to construct individual estimates to characterize exposure-response relationships. All research records are protected under the provisions of the Privacy Act.
"Surveillance Methods for Solvent-Related Hepatotoxicity"
Principal Investigator: Dr. Carl A. Brodkin, University of Washington
Project started in: 1998
Funding for Human Subjects Research: No Funding Sources Reported
This project does not involve the use of multiple protocols/subprojects.
Identifier or number: SMSH
Institutional Review Board (IRB) Review:
Type of Review: Expedited
Approving Institution: University of Washington
Most recent approval: 01/13/00
IRB approval number: 29-0140-C/B, M1183
Explanation of IRB approval:
Data on IRB approval collected by CDC Procurement and Grants Office (PGO). Updates will be provided when available.
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 0
Reporting period for number of human subjects:
Fiscal Year 2001
Type(s) of Human Subjects Involvement:
This research will examine the hypothesis that solvent-related hepatic injury is characterized by parenchymal changes of steatosis and fibrosis, without associated necrotic changes detectable by hepatic transaminasis. The study is a cross-sectional investigation of 100 industrial painters at the DOE Hanford Nuclear Reservation, exposed subacutely and chronically to a variety of solvent mixtures. These persons will be compared to a reference group of 100 non-exposed carpenters, matched by gender, race, and age.
All data will be collected using a mobile medical clinical laboratory. Data collection will involve a structured interview using a questionnaire to gather demographic information, and data on occupational and exposure history, alcohol consumption, medication use, and cigarette smoking. A phlebotomist will obtain a 20ml blood sample by routine antecubital venipuncture, and a certified technician will conduct limited hepatic ultrasonology. Data analysis will take place at the University of Washington Harborview Medical Center. Subjects will furnished with the results of routine biochemical and serological tests, with an indication of any abnormality or need for follow-up.
Improper release of data will be prevented by computer storage of data in password-protected computer files that do not contain personal identifiers, and all hard copy data will be stored in locked filing cabinets within secured offices.
"Correcting for Measurement Errors in Radiation Exposure"
Principal Investigator: Dr. Xiaonan Xue, New York University Medical Center
Project started in: 1999
Funding for Human Subjects Research:
This project does not involve the use of multiple protocols/subprojects.
Identifier or number: CMER
Institutional Review Board (IRB) Review:
Type of Review: Expedited
Approving Institution: New York University Medical Center
Most recent approval: 06/06/00
IRB approval number: H151-01, M1177
Explanation of IRB approval:
Data on IRB approval collected by CDC Procurement and Grants Office (PGO). Updates will be provided when available.
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 8318
Reporting period for number of human subjects:
Fiscal Year 2001
Type(s) of Human Subjects Involvement:
Recognition has been growing that radiation epidemiology studies need to assess the degree of measurement error in their radiation doses and a small number of attempts have been made to adjust radiation dose-response risk estimates for measurement error. However, the statistical assumptions and methods to correct for measurement error have had weaknesses that need to be addressed, and this proposal is a contribution to that end.
Radiation exposure measurement error from differential sources will be classified into two groups: unsystematic error and systematic error. Different models will be developed for these two types of measurement errors. A special type of systematic error caused by exposures below the minimum detection limit of dosimeters will be addressed separately from the other systematic errors. A study of a subset of workers with detailed dosimeter readings will be used to evaluate this type of error. Issues for choosing statistical distributions to characterize the true dose will be discussed and Gamma distribution will be used in this study to model both individual measurement of exposure and cumulative exposure at a longer interval. Methods for correcting for radiation exposure measurement errors will be developed. Currently, measurement error is corrected in two steps: estimation of the true dose and assessment of the risk based on the estimated doses. In this research, a joint model for measurement error and dose-response relationship will be developed, which leads to a more precise and accurate assessment of risk. Results from the proposed research will have widespread application. The methods for modeling and correcting measurement errors will have application to ongoing and planned worker radiation studies and to a wide range of environmental exposure-response data.
No human chemical or physical exposures will result from this research project, and exposure data used resulted from examination of pre-existing occupational exposure observations. This research does not involve any contact with human subjects. It will be carried out by the researchers using records previously collected by private industry sources. Any existing personal identifiers will be eliminated from the records, which will be accessible only by the research team. All research records will be protected under the provisions of the Privacy Act.
"Dose of Beryllium Causing Sensitization and Disease"
Principal Investigator: Dr. Lee S. Newman, National Jewish Center for Immunology & Respiratory Medicine
Project started in: 1999
Funding for Human Subjects Research:
This project does not involve the use of multiple protocols/subprojects.
Identifier or number: DCDS
Institutional Review Board (IRB) Review:
Type of Review: Expedited
Approving Institution: National Jewish Center for Immunology & Respiratory Medicine
Most recent approval: 12/24/99
IRB approval number: HS 327, M1009
Explanation of IRB approval:
Data on IRB approval collected by CDC Procurement and Grants Office (PGO). Updates will be provided when available.
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 235
Reporting period for number of human subjects:
Fiscal Year 2001
Type(s) of Human Subjects Involvement:
Exposure to beryllium continues to produce beryllium sensitization (BeS) and chronic beryllium disease (CBD) in 2-16% of exposed workers, however, the dose that is sufficient to cause these adverse health effects remains unknown. Epidemiologic and historical exposure data suggest that the current OSHA standard of 2µg/m3 for an 8 hour time weighted average is not sufficiently protective and that process-related risks for BeS and CBD exist. These risks may be due to the particle size generated from the processes, however, the dose and particle characteristics that produce BeS and CBD remain unknown. The central hypothesis of this study is that there is a definable level of exposure below which BeS and CBD will not occur, and that this level is below the current permissible exposure limit. The specific aims of this proposal are to: (1) determine the personal beryllium dose that produces BeS and CBD in beryllium machinists, and (2) to characterize the beryllium aerosol and lung deposition that produce BeS and CBD in these individuals. These aims will be accomplished by investigating the dose of beryllium that leads to the development of BeS and CBD in a modern beryllium metal machining plant in which BeS has been shown to occur in 6.6% of employees tested with the blood beryllium lymphocyte proliferation test within the first 3 months of hire. Personal beryllium sampling will be performed on each newly hired employee, without previous beryllium exposure, during all workshifts for three months. Development of beryllium sensitization will be tested with the blood beryllium lymphocyte proliferation test. The dose of beryllium that produces BeS and CBD will be compared to the dose in those who did not become sensitized over the same period. Data will be linked to previously acquired data on the beryllium particle size distribution generated in workers' breathing zones by machining operations in the same plant, in order to calculate the respirable particle dose and lung deposition responsible for inducing this hypersensitivity immune response to beryllium. This information will help affect prevention by providing data on which to base a new beryllium exposure standard and help direct engineering and industrial hygiene practices to reduce exposure. All research records are protected under the provisions of the Privacy Act.
"Radon and Cigarette Smoking Exposure Assessment in Fernald Workers"
Principal Investigator: Dr. Susan Pinney, University of Cincinnati
Project started in: 1999
Funding for Human Subjects Research: No Funding Sources Reported
This project does not involve the use of multiple protocols/subprojects.
Identifier or number: PFRS
Institutional Review Board (IRB) Review:
Type of Review: Expedited
Approving Institution: University of Cincinnati
Most recent approval: 06/21/00
IRB approval number: UC 98-6-5-01, M1138
Explanation of IRB approval:
Data on IRB approval collected by CDC Procurement and Grants Office (PGO). Updates will be provided when available.
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 7248
Reporting period for number of human subjects:
Fiscal Year 2001
Type(s) of Human Subjects Involvement: