Dr. Steven H. Ahrenholz
DHHS/CDC/NIOSH/HERB
Mail Stop R-44
4676 Columbia Parkway
Cincinnati, OH 45226
Phone: 513-841-4471
Fax: 513-841-4470
E-mail: sha1@cdc.gov
Number of Human Subjects projects reported: 19
| NIOSH-92-002 | "Cohort Mortality Study of Idaho National Engineering and Environmental Laboratory (INEEL)" |
| NIOSH-93-003 | "Cohort Mortality Study of Portsmouth Naval Shipyard (PNS)" |
| NIOSH-93-013 | "Epidemiologic Evaluation of Cancer and Occupational Exposure at Rocky Flats" |
| NIOSH-95-004 | "Leukemia Case-Control Study" |
| NIOSH-95-005 | "Study of Multiple Myeloma among Workers at the Oak Ridge Gaseous Diffusion Plant (K-25)" |
| NIOSH-95-014 | "International Collaborative Study of Nuclear Industry Workers" |
| NIOSH-95-017 | "Beyllium Disease Natural History and Exposure Response" |
| NIOSH-95-021 | "Lung Fibrosis in Plutonium Workers" |
| NIOSH-96-023 | "Ionizing Radiation and Mortality Among Hanford Workers" |
| NIOSH-97-007 | "Cohort Mortality Study of DOE Chemical Laboratory Workers" |
| NIOSH-97-009 | "Multi-Site Case-Control Study of Lung Cancer and External Ionizing Radiation" |
| NIOSH-97-026 | "Epidemiologic Studies to Evaluate Health Effects of Uranium Milling" |
| NIOSH-99-006 | "Correcting for Measurement Errors in Radiation Exposure" |
| NIOSH-99-011 | "Dose of Beryllium Causing Sensitization and Disease" |
| NIOSH-99-024 | "Reconstruction of Doses for Chernobyl Liquidators" |
| NIOSH-99-025 | "Uncertainty Analysis for Characterizing Plutonium Exposure/Lung Cancer Estimates" |
| NIOSH-01-038 | "Cohort Mortality Study of Fernald Environmental Management Plant " |
| NIOSH-02-039 | "Health Effects of Occupational Exposures in PGDP Workers" |
| NIOSH-02-041 | "Susceptibility and Occupational Radiation Risks" |
"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: 11/05/02
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 2003
Type(s) of Human Subjects Involvement:
An all-causes cohort mortality study of workers at the Idaho National Engineering and Environmental Laboratory (INEEL) 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 individuals employed at the site. Initial job titles are available for most workers on the list as well as date of first employment, employer name (e.g., contractor name), date of birth, and Social Security Number. 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 and articles for publication will be prepared for the open literature describing 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 Centers for Disease Control and Prevention (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: Mr. Dennis Zaebst, 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: 03/17/03
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 2003
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 Centers for Disease Control and Prevention (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
This project ended in fiscal year 2003.
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: 09/12/02
IRB approval number: 95-334
Explanation of IRB approval:
Project completed. Final report released and communicated by NIOSH 04/17/2003.
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 23000
Reporting period for number of human subjects:
Fiscal Year 2003
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; and (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 Centers for Disease Control and Prevention (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)).
"Leukemia Case-Control Study"
Principal Investigator: Dr. Mary Schubauer-Berigan, 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: 07/01/03
IRB approval number: HSRB 96-DSHEFS-10
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 2003
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 U.S. workers. This case-control study will draw cases from some 95,000 workers at five previously studied sites, which have a total of about 250 leukemia deaths. Each of these cases will be age-matched with four controls to give a study population of approximately 1,250 study subjects, whose external and internal radiation records will then be reviewed. We will 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 Laboratory, 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 Centers for Disease Control and Prevention (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. Gregory V. Macievic, 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: 09/08/03
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 2003
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 the K25 Gaseous Diffusion Plant in Oak Ridge, Tennessee 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 Centers for Disease Control and Prevention (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: 07/03/03
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 2003
Type(s) of Human Subjects Involvement:
The International Agency for Research on Cancer (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 Centers for Disease Control and Prevention (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)).
"Beyllium Disease Natural History and Exposure Response"
Principal Investigator: Dr. Lee S. Newman, National Jewish Medical and Research 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: BER2
Institutional Review Board (IRB) Review:
Type of Review: Full Board
Approving Institution: National Jewish Medical and Research Center
Most recent approval: 06/12/03
IRB approval number: HS 1360
Explanation of IRB approval:
Study completed. Final report scheduled for release and communication by NIOSH in 2004.
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 2003
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 Medical and Research Center
Project started in: 1995
This project ended in fiscal year 2003.
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:
Study completed. Final report scheduled for release and communication by NIOSH 11/07/2002.
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 2003
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 239-Pu 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: 239-Pu, americium 241, beryllium, effects of smoking, 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 records-based study. Data on workers who ever worked in a plutonium area, as well as workers who never worked in plutonium areas including 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 program 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.
"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: UNC School of Public Health Institutional Review Board
Most recent approval: 06/09/03
IRB approval number: 96-088
Explanation of IRB approval:
Final report received by NIOSH Grants Office. NIOSH communication and release of final report scheduled for 2004.
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 2003
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. In addition, 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 Centers for Disease Control and Prevention (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)).
"Cohort Mortality Study of DOE Chemical Laboratory Workers"
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: 02/25/03
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 2003
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 workers' 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 Site, Y-12 National Security Complex, Savannah River Site, 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 Centers for Disease Control and Prevention (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-Site Case-Control Study of Lung Cancer and External Ionizing Radiation"
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: 10/05/02
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
Explanation of additional approval:
Site IRB approval follows documentation of annual review and approval by NIOSH IRB.
Type of Review: Expedited
Approving Institution: Savannah River Site (WSRC)
Most recent approval: 10/18/01
IRB approval number: ESH-WHS-2001-00017
Explanation of additional approval:
Site IRB approval follows documentation of annual review and approval by NIOSH IRB
Type of Review: Expedited
Approving Institution: INEEL
Most recent approval: 06/07/01
Explanation of additional approval:
Site IRB approval follows documentation of annual review and approval by NIOSH IRB
Type of Review: Expedited
Approving Institution: Pacific Northwest National Laboratory
Most recent approval: 03/31/00
IRB approval number: PNNL-2000-15
Explanation of additional approval:
Site IRB approval follows documentation of annual review and approval by NIOSH IRB
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 2003
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 Site, Hanford, and the Idaho National Engineering and Environmental Laboratory) 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 Centers for Disease Control and Prevention (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:
Final report submitted to NIOSH Grants Office. Communication and release of study results scheduled for 2004.
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 2003
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.
"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: No Funding Sources Reported
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:
HHS Exemption #4 identified. The study does not use humans and the databases used are stripped of personal identifiers.
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 2003
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 Medical and Research Center
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: DCDS
Institutional Review Board (IRB) Review:
Type of Review: Expedited
Approving Institution: National Jewish Medical and Research Center
Most recent approval: 06/12/03
IRB approval number: 1362
Explanation of IRB approval:
Study completed. Final report scheduled for release and communication by NIOSH in 2004.
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 2003
Type(s) of Human Subjects Involvement:
Exposure to beryllium continues to produce beryllium sensitization (BeS) and chronic beryllium disease (CBD) in 2 to 16 percent 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 Occupational Safety and Health Administration (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 percent of employees tested with the blood beryllium lymphocyte proliferation test within the first three 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.
"Reconstruction of Doses for Chernobyl Liquidators"
Principal Investigator: Dr. Elisabeth Cardis, International Agency for Research on Cancer (IARC)
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: RDCL
Institutional Review Board (IRB) Review:
Type of Review: Expedited
Approving Institution: International Agency for Research on Cancer (IARC)
Most recent approval: 12/21/99
IRB approval number: S-017261-02, SPA
Explanation of IRB approval:
HHS HSRB Exemption #4 identified. This is a foreign study authorized by various European participants. No U.S. human subjects involved.
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 140
Reporting period for number of human subjects:
Fiscal Year 2003
Type(s) of Human Subjects Involvement:
The objective of the proposed effort is two-fold. To develop and validate methods for dose reconstruction for Chernobyl accident recovery workers - the so-called "liquidators" - and to apply them to the reconstruction of individual doses and associated uncertainty for the subjects included on-going collaborative case-control studies of leukemia, non-Hodgkin's lymphoma, and thyroid cancer in Belarus and Russia.
Much research on the levels of dose and health effects due to the Chernobyl accident has been carried out in the decade since the accident occurred. Because of their numbers and because of their levels of radiation dose, the population of Chernobyl accident recovery workers or "liquidators" is one of the most likely to be informative for the study of risks following low-dose protracted radiation exposure. To be informative for the evaluation of radiation related risks, however, these studies must rely on individual estimates of radiation dose.
Up to now, very little effort has been put into reconstructing doses specifically for Chernobyl liquidators. The exception is for a limited number of professional radiation workers and staff of the Chernobyl Nuclear Power Plant (ChNPP) who worked on the industrial site of the plant. For these, dose reconstruction methods have been developed which make use of extensive databases of radiation measurements inside and outside buildings at the industrial site and in the vicinity of the plant, together with a detailed questionnaire about the routes, schedules, and activities performed on the industrial site. A large proportion of the liquidators included in the epidemiologic studies in Belarus and Russia are not professional radiation workers. Dose reconstruction methods developed for professional radiation workers, therefore, need to be modified to take into account the less precise and accurate knowledge of the place and conditions of work, different exposure conditions, and different dosimetric control practices.
"Uncertainty Analysis for Characterizing Plutonium Exposure/Lung Cancer Estimates"
Principal Investigator: Dr. James A. Ruttenber, University of Colorado
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: ACPE
Institutional Review Board (IRB) Review:
Type of Review: Expedited
Approving Institution: Colorado Multiple Institutional Review Board
Most recent approval: 03/13/03
IRB approval number: 00-468, M1494
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 867
Reporting period for number of human subjects:
Fiscal Year 2003
Type(s) of Human Subjects Involvement:
We propose to expand upon our current epidemiologic studies of workers at the Rocky Flats Environmental Technology Site (RFETS) to explore important issues of measurement errors in quantifying exposures and their effects on estimates of risk in epidemiologic studies. Our extensive experience with characterizing exposure to chemicals and ionizing radiation allows us to integrate three areas of NIOSH programmatic interest into a single project. Our goals are to: (1) Develop and explore methods to assess the measurement error of radiation doses-particularly those from internal exposures to isotopes of plutonium so that they can be used in epidemiologic studies. (2) Develop methods for analyzing exposure data from different sources for use in epidemiologic studies of combined populations of radiation workers. (3) Evaluate current methods and develop new ones for incorporating estimates of measurement error for radiation doses into estimates of risk in epidemiologic studies. All research records are protected under the provisions of the Privacy Act.
"Cohort Mortality Study of Fernald Environmental Management Plant"
Principal Investigator: Dr. James Yiin, National Institute for Occupational Safety and Health
Project started in: 2001
Funding for Human Subjects Research:
This project does not involve the use of multiple protocols/subprojects.
Identifier or number: FNUP
Institutional Review Board (IRB) Review:
Type of Review: Expedited
Approving Institution: National Institute for Occupational Safety and Health
Most recent approval: 11/27/02
IRB approval number: 00-DSHEFS-08XP
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 7300
Reporting period for number of human subjects:
Fiscal Year 2003
Type(s) of Human Subjects Involvement:
This study is an update of a previous mortality study of Fernald workers. The research updates the mortality status of Fernald workers through 1996, expanding the cohort to include females and all races. Additionally, the study will incorporate a retrospective exposure assessment for external and internal radiation, radon, asbestos, uranium dust, and acid mists.
The previous cohort mortality study found a statistically significant excess of lung cancer mortality among hourly workers (Standardized Mortality Ratio, SMR=1.26), and a statistically significant excess of stomach cancer among salaried workers (SMR=2.61). Dose-response associations were seen between lung cancer and external radiation exposure, and between non-malignant respiratory disease and internal exposure.
This study does not involve contact with human subjects. It is being 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 Centers for Disease Control and Prevention (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)).
"Health Effects of Occupational Exposures in PGDP Workers"
Principal Investigator: Dr. David J. Tollerud, University of Louisville
Project started in: 2002
Funding for Human Subjects Research:
This project does not involve the use of multiple protocols/subprojects.
Identifier or number: PAD1
Institutional Review Board (IRB) Review:
Type of Review: Expedited
Approving Institution: University of Kentucky
Most recent approval: 09/08/03
IRB approval number: 438.02
Additional IRB approvals from other institutions:
Type of Review: Expedited
Approving Institution: University of Cincinnati
Most recent approval: 05/07/03
IRB approval number: 02-04-04-01-EE
Type of Review: Expedited
Approving Institution: University of Kentucky
Most recent approval: 07/10/03
IRB approval number: 02-0001-P3B
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 8000
Reporting period for number of human subjects:
Fiscal Year 2003
Type(s) of Human Subjects Involvement:
The Paducah Gaseous Diffusion Plant (PGDP) is located in Western Kentucky, about 10 miles west of the city of Paducah. It currently employs approximately 1,700 workers; some 8,000 individuals have worked at the plant since it opened in 1952. The plant is in a rural area and some areas adjacent to the site are protected conservation, wildlife, and recreation areas. The primary function of the PDGP has been to produce enriched uranium for use by commercial reactors or as feed material for other plants that further enrich the uranium. Workers, government officials, and the surrounding community have raised concerns about potential health effects from current and past exposures at the plant. The proposed studies will develop new information to help address these concerns. These investigations will take a two-pronged approach, evaluating the impact of historical exposures on worker mortality, and characterizing the effects of more recent exposures on current and future risk of disease. The specific aims of this feasibility study are:
AIM 1: Carry out site visits to the PGDP facility in Paducah and to the one in Oak Ridge, in order to initiate direct communications with these two important sources of records and other information.
AIM 2: Develop and refine a panel of biomarkers to assess exposure and tissue response to radiation at PGDP, including: Chromosome Aberrations, Somatic Mutations, and Protein Adducts.
AIM 3: Develop and validate systems and procedures to procure, transport, and test biological samples from PGDP workers.
AIM 4: Identify current PGDP workers with higher and lower levels of exposure. The overall purpose of this study is to assess the feasibility of undertaking a comprehensive investigation of both historical exposures that may have affected the health of PGDP workers and more recent exposures that may affect current and future disease risk.
There are no physical risks to subjects in the record review portion of the study. Other potential risks to subjects are deemed minimal since the study will analyze existing records. In the interest of subject confidentiality, although data from subjects may be linked to vital statistics (mortality), identifiers will not be attached to data analysis files. For the epidemiological studies of existing records, there will be no subject recruitment. The project qualifies for expedited review under CFR Title 45 Part 46.10(b)(4) and informed consent is not required.
"Susceptibility and Occupational Radiation Risks"
Principal Investigator: Dr. David Richardson, University of North Carolina at Chapel Hill
Project started in: 2002
Funding for Human Subjects Research:
This project does not involve the use of multiple protocols/subprojects.
Identifier or number: SORR
Institutional Review Board (IRB) Review:
Type of Review: Expedited
Approving Institution: University of North Carolina
Most recent approval: 09/10/03
IRB approval number: 02-1777
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 22000
Reporting period for number of human subjects:
Fiscal Year 2003
Type(s) of Human Subjects Involvement:
Epidemiological studies of U.S. nuclear weapons workers allow evaluation of the effects of low dose, low dose rate radiation exposures accrued in an environment of mixed radiological and non-radiological exposures associated with the USDOE weapons complex. In the proposed study, we will examine a cohort of nearly 22,000 badge-monitored workers at the Savannah River Site (SRS) who will be followed over a fifty-year period. Past research on this epidemiologically important cohort has focused on analysis of standardize mortality ratios. The proposed study, in contrast, will focus on radiation-mortality associations under varying lag assumptions, and investigate potential changes with age-at-exposure in susceptibility to the carcinogenic effects of radiation. Next, we will investigate differences between workers in the carcinogenic effects of radiation exposure due to non-radiological exposures accrued at SRS. Mechanistic models of carcinogenesis suggest that initiating exposure to some non-radiologic carcinogens may modify the effects of subsequent ionizing radiation exposures. We will use a job-exposure matrix to identify workers with routine potential for exposure to several non-radiological agents, and apply innovative methods to examine the joint effects of radiological and non-radiological exposures. Finally, we will examine the role of tritium and neutron exposures in these analyses of radiation-mortality associations. We will investigate whether variation in radiation risk estimates between subgroups of workers reflects heterogeneity in radiological exposures. Study results for this large USDOE cohort will be evaluated in relation to observations from studies of other DOE facilities. Study data will be compiled in a manner that will facilitate future pooled analyses. In this way, the proposed work will substantially strengthen the available epidemiological information about low-level radiation effects in USDOE cohorts.
Primary database and analysis files created from secondary data sources will be stored on computers with personal identifiers (name and SSN) removed. Workers will be identified by a unique study number assigned by University of North Carolina (UNC) staff that will link all basic data required for this study. One master key file which links the UNC-Chapel Hill study number with personal identifiers (name and SSN) will be maintained. All files containing personally identifiable information, including secondary data files received from NIOSH or the Comprehensive Epidemiological Data Resource (CEDR) at the University of California Berkeley, the master key file and files created for vital status follow-up will be stored in password protected computer files. Access to this computer file is limited to authorized project personnel. All project personnel will be trained in the importance of confidentiality of individual records and required to sign a confidentiality agreement. Reported study results will pertain to analyses of aggregate data (mortality rates). No individual's name will ever be associated with any published or unpublished report of this study.