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: 31
"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: 11/05/99
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 2000 (10/1/99-9/30/2000)
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: Mr. Tim Taulbee, 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: 03/01/00
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 2000 (10/1/99-9/30/2000)
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: Dr. Norma C. Morin, Colorado Department of Health
Project started in: 1993
This project ended in fiscal year 2000.
Funding for Human Subjects Research:
This project does not involve the use of multiple protocols/subprojects.
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, M1498
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: 23000
Reporting period for number of human subjects:
Fiscal Year 2000 (10/1/99-9/30/2000)
Type(s) of Human Subjects Involvement:
The Colorado Department of Public Health and Environment, in conjunction with NIOSH and the University of Colorado Health Sciences Center, is conducting a mortality and incidence study of workers who worked between 1951 and 1994 at the Department of Energy's Rocky Flats Environmental Technology Site, near Denver, Colorado. The study began in 1993, and will end in 2000. The purpose of the study is to evaluate the relationship between workers' exposures to ionizing radiation and hazardous chemicals and the development of cancer. To do this, 1) 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 asking if they used certain chemicals and how frequently they were used, and if they wore any type of personal protective equipment. No chemical or radiation procedures were used to determine any results for the study, and there were no risks to any human subject as a result of this research. Personally identifiable records were obtained and are being maintained confidential under provisions of the Federal Privacy Act and Colorado State Law.
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. This type of study is called a case-control study, because exposures are compared between cases (those workers who died of lung cancer) and controls (other workers who did not develop lung cancer). The purpose of the lung cancer case-control study is to determine whether there is an increased risk of occurrence of lung cancer among workers at the site, and whether this might be caused by their exposure to radiation exposure and /or hazardous materials used in their work. Individual workers' cancer status was determined from vital records and the Colorado state cancer registry; smoking histories of all workers included in the case-control study (about one thousand from the Rocky Flats workforce) were obtained by interviewing next-of-kin; ionizing radiation doses were collected and recalculated for these individuals; and workers were interviewed about their jobs asking if they used certain chemicals and how frequently, and if they wore any type of personal protective equipment. No chemical or radiation procedures were used to determine any results for the study. Informed consent was obtained from interview subjects as provided by the protocol for the study, and by the site IRB approvals.
The results of both studies will be published and workers at the site will be informed of these results as soon as all the data are analyzed and reported and carefully evaluated by other scientists. The results are expected early in the year 2001.
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)).
"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
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 "Mortality Among Female Nuclear Workers" released 6/7/00.
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 68338
Reporting period for number of human subjects:
Fiscal Year 2000 (10/1/99-9/30/2000)
Type(s) of Human Subjects Involvement:
Although 80,000 female workers have been employed at DOE facilities over the years, small numbers 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] will be combined in this cohort mortality study. Risk estimates will be developed for exposure to ionizing radiation or to chemical hazards. As of July 1, 1997, the Principal Investigator was relocated to the State University of New York at Buffalo.
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)).
"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.
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 12
Reporting period for number of human subjects:
Fiscal Year 2000 (10/1/99-9/30/2000)
Type(s) of Human Subjects Involvement:
This study involves the direct interaction with human subjects in the form of medical testing, use of human tissue, biomonitoring or interviews. The glycophorin A (GPA)-based human in vivo somatic cell mutation assay, because of it's demonstrated long-term biological memory of past genotoxic exposures together with it's relatively low cost and high sample thruput, is unique among presently available human biomarker assays for practical use as a retrospective biodosimeter in epidemiological investigations of large human populations. Here we propose to further validate the response of the assay as a biodosimeter of radiation exposure in a longitudinal study of patients receiving 131I therapy for thyroid disease. These patients will receive clinically well-characterized doses ranging from 2 to 200 cGy of whole body bone marrow exposure to ionizing radiation resulting from the radioactive decay of administered 131I. Peripheral blood samples from approximately 100 patients will be drawn prior to, during, and following therapy to follow the induction, accumulation, and persistence of radiation-induced somatic mutation at the GPA locus in bone marrow stem cells. These mutations in nucleated bone marrow progenitor cells give rise to erythrocytes in the peripheral circulation expressing a GPA allele-loss variant phenotype. These variants are directly enumerated in the assay using immunolabeling with GPA allele-specific monoclonal antibodies and flow cytometry. Based on GPA assay results obtained in high radiation dose populations, this study is designed to investigate the radiation-dose response of the assay over a range of doses that surround the extrapolated doubling dose over background response of the assay of approximately 30 cGy. The longitudinal design of the study, applied to patients receiving relatively low doses of 131I, will permit a test of the practical ultimate sensitivity of the assay by comparing GPA variant cell frequencies in post-therapy samples to those observed in pre-therapy samples within individual patients. This design, where a repeated measures analysis can be applied to individual responses, avoids the limitations inherent in studies using exposed versus matched control populations where inter-individual variability in response and in background frequencies limit the power of the assay to detect small increases in variant cell frequencies induced by low-dose exposures. These data will provide critical information to assess the power of the assay to demonstrate, or to estimate the upper limits of, radiation exposures in population surveys of occupationally-exposed workers. In addition, since a number of patients receiving very similar 131I doses will be enrolled in the study, the design will also permit an investigation of the range of individual responses in the assay to similar exposures. These data will also contribute significantly to population risk assessment models that attempt to includes this heterogeneity as well as narrowing the range of uncertainty surrounding individual estimates of received radiation dose inferred from individual responses in the assay.
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. See also: LANL-99-05_V
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: 07/01/00
IRB approval number: HSRB 96-DSHEFS-10
Additional IRB approvals from other institutions:
Type of Review: Expedited
Approving Institution: ORAU/ORNL (Oak Ridge National Laboratory)
Most recent approval: 04/26/00
IRB approval number: NIOSH-4
Type of Review: Full Board
Approving Institution: LANL
Most recent approval: 10/12/00
IRB approval number: LANL-99-05
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 2000 (10/1/99-9/30/2000)
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: 09/08/00
IRB approval number: HSRB 96-DSHEFS-16
Additional IRB approvals from other institutions:
Type of Review: Full Board
Approving Institution: ORAU/ORNL (Oak Ridge National Laboratory)
Most recent approval: 12/01/99
IRB approval number: NIOSH-1
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 2000 (10/1/99-9/30/2000)
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:
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: 09/30/95
IRB approval number: Not Applicable
Explanation of IRB approval:
Exempt from CDC IRB review under 45 CFR 46.101(b)(4) until 7/04/01.
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 2000 (10/1/99-9/30/2000)
Type(s) of Human Subjects Involvement:
IARC has undertaken a cancer mortality study of nuclear workers in 14 countries. De-identified data from two U.S. cohorts (Portsmouth Naval Shipyard and Idaho National Engineering and Environmental Laboratory) are being supplied to the study by NIOSH. 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"
This project is being conducted at multiple sites. See also: INEEL-95-INEEL-IRB-97-003_V, LANL-97-02_V, ORAU-97-BU-1_V
Principal Investigator: Dr. Lewis D. Pepper, Boston University School of Public Health
Project started in: 1995
This project ended in fiscal year 2000.
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 being prepared by NIOSH for communication and release on 10/25/00.
Additional IRB approvals from other institutions:
Type of Review: Full Board
Approving Institution: ORAU/ORNL (Oak Ridge National Laboratory)
Most recent approval: 12/01/99
IRB approval number: BU-1
Type of Review: Full Board
Approving Institution: LANL
Most recent approval: 02/14/00
IRB approval number: LANL-97-02
Type of Review: Expedited
Approving Institution: INEEL
Most recent approval: 06/01/00
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 5894
Reporting period for number of human subjects:
Fiscal Year 2000 (10/1/99-9/30/2000)
Type(s) of Human Subjects Involvement:
The specific aims of this project are to: (a) Identify and measure the effects of downsizing on organizational climate, health and performance using qualitative and quantitative research methods including focus groups, open-ended interviews, structured surveys, and archival data. (b) Identify and measure the characteristics of downsizing which adversely affect organizational climate, health, and performance using similar techniques. (c) Determine and describe the relationship between downsizing and employee health and consider areas for intervention. (d) Develop a health promotion program based on the most significant problems associated with downsizing.
Data collection in this phase of the project will include an employee survey and review of summary archival data. The Boston University Workplace Survey has been administered to approximately 10,000 DOE contractor employees at five DOE sites(Idaho National Engineering and Environmental Laboratory, Nevada Test Site, Oak Ridge Y-12, Los Alamos National Laboratory, Pantex) including LANL. Employees were randomly selected based on their work organization, size, and location. The survey, which was developed over a one and one-half year period, is designed to examine organizational and individual consequences of downsizing and restructuring as well as human health.
A database system has been developed with the assistance of the Data Coordinating Center (DCC) at Boston University School of Public Health. This database will provide a method of recording each survey. Each survey has a unique study identification number. The participant's name neither appears on the survey nor is entered into the study database. Organizational outcome data will be stored in either electronic or paper format. No individual identifiers will be included in this database. All information requests to the sites will indicate that individual identifiers not be included with the requested data. Therefore, it will not be possible to link organizational outcome data, such as employee assist program (EAP), with any individual study participant. The DCC will maintain strict confidentiality of the project database.
All records associated with this project will be kept confidential to the extent allowable by law. Project staff reviewing records will not reveal a participant's identity in publication of reports resulting from the study or in any other way. Project researchers will review and analyze all the responses to the survey and report on the findings. Results will be made available without personal identifiers to all study participants through presentations, written reports and postings in site publications and web sites. In addition, the results of the project will be released in aggregate both in the final project report and in any articles in scientific journals.
Some of the records collected, 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 per requirements of the Privacy Act. Data access will be monitored and restricted to the research team.
"Chronic Beryllium Disease Among Beryllium-Exposed Workers"
Principal Investigator: Dr. Kenneth Rosenman, Michigan State University
Project started in: 1995
This project ended in fiscal year 2000.
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:
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: 5111
Reporting period for number of human subjects:
Fiscal Year 2000 (10/1/99-9/30/2000)
Type(s) of Human Subjects Involvement:
This cross-sectional study of current and former workers at 4 beryllium facilities will examine the natural history of chronic beryllium disease (CBD) and evaluate the utility of the lymphocyte transformation test (LTT) in detecting beryllium sensitization and predicting CBD development. Two of the four facilities included were beryllium production facilities, one is a beryllium ceramic facility and one is a beryllium alloy facility. The effectiveness of medical treatment of sensitized workers and of control measures in preventing overt CBD will also be evaluated.
In the initial cross-sectional approach, a panel of three readers will independently review all chest x-rays. An established laboratory will perform blood lymphocytc proliferative testing. Workers who screen positive in the initial cross-sectional study will receive a comprehensive diagnostic evaluation which will include bronchoalveolar lavage with lymphocyte proliferative testing. Two referents matched by date of hire and facility will be selected for each worker who screens positive. The positive cases and matched referents will be followed in 3-5 years of the agreement to observe the natural history of individuals who are sensitized to beryllium in comparison to exposed workers who are not sensitized.
Initial solicitation to participate will be by letter. A consent form and postage paid envelope to review medical records will be included. The majority of participants will have existing medical tests to review. The blood test and for those individuals who have not had a recent chest x-ray, a chest x-ray will be obtained for the purpose of this study. There is minimal risk in the initial screening. Most individuals will have existing tests reviewed. Blood for lymphocyte proliferative tests will be taken using standard phlebotomy methods and so there is minimal risk for the procedure. Bronchoalveolar lavage will be performed in the hospital and participants will only be released from the hospital after careful observation and monitoring.
All medical records will be maintained strictly confidential under lock and key with limited access only to study staff. All staff on this project have a long history of biomedical research and the risk of breach of confidentiality is minimal. Only the individuals will have access to their individual medical results.
"Beryllium Disease Natural History and Exposure Response"
Principal Investigator: Dr. Lee S. Newman, National Jewish Center for Immunology & Respiratory Medicine
Project started in: 1995
This project ended in fiscal year 2000.
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: 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:
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: 109
Reporting period for number of human subjects:
Fiscal Year 2000 (10/1/99-9/30/2000)
Type(s) of Human Subjects Involvement:
Although the hazards of beryllium have been known for more than 50 years, chronic beryllium disease (CBD) continues to afflict American workers. This granulomatous lung disorder results when exposed individuals mount a beryllium-specific cell-mediated immune response. A blood test of this immune response (beryllium lymphocyte proliferation test) has proven to be a sensitive biological marker for the detection of workers who have: (a) beryllium sensitization but no disease, (b) subclinical granulomatous lung disease, having no symptoms or pulmonary physiologic abnormalities at the time of diagnosis, and (c) clinically significant CBD. While it has been observed that some individuals with beryllium sensitization develop CBD and that some workers with subclinical CBD worsen and require treatment, it is not known how often such progression occurs. The natural history of beryllium sensitization and subclinical disease remains obscure. CBD continues to appear in new segments of industry, such as beryllium copper alloy machining, raising concern that more broad- based screening efforts are warranted to determine the scope of the beryllium problem. Several workplace surveillance studies using the blood test have identified process-related risks of beryllium sensitization and disease. However more rigorous characterization of exposures that confer risk is needed. To help effect primary and secondary prevention of beryllium sensitization and CBD, this study will use a multidisciplinary approach to: (1) determine the natural history of beryllium sensitization and disease, (2) identify host- and exposure-related risk factors for progression of sensitization and of subclinical CBD, (3) identify specific beryllium compounds and processes associated with CBD, and (4) assess exposure-response relationships for beryllium sensitization and disease. A collaborative study is proposed that would build prospectively on an existing case series of beryllium-sensitized and subclinical CBD workers, utilize historical industrial hygiene data from plants in which epidemiologic investigations have been conducted, and conduct prospective, state-of-the-art exposure assessment, relating exposure data to disease risks in ceramic and metal machining industries. Observations made in this investigation may be extended to investigations of exposure- response relationships in beryllium mining, beryllium copper machining, and beryllium remediation industries.
There were no exposures to radiation during testing. Risks were associated with drawing blood, chest x-rays, completion of questionnaire, and spirometry, and bronchoscopy when indicated.
Records are protected in accordance with the human subjects protections dictated by the institution granting IRB approval. This study involves the direct interaction with human subjects in the form of medical testing, use of human tissue, biomonitoring or interviews.
"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: 10/13/98
IRB approval number: HS 327, M1009
Explanation of IRB approval:
Project completed. Final Performance Report dated 12/22/99. Report being prepared by NIOSH for communication and release.
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 170
Reporting period for number of human subjects:
Fiscal Year 2000 (10/1/99-9/30/2000)
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 239Pu 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 239Pu 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"
This project is being conducted at multiple sites.
Principal Investigator: Dr. Kenneth Rosenman, Michigan State University
Project started in: 1995
This project ended in fiscal year 2000.
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:
Data being 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: PNNL
Most recent approval: 01/20/00
IRB approval number: 96-20
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 100
Reporting period for number of human subjects:
Fiscal Year 2000 (10/1/99-9/30/2000)
Type(s) of Human Subjects Involvement:
This study will determine if heat stress from the use of protective clothing affects performance of carpenters and other construction workers in remediation and hazardous waste work at Hanford and Oak Ridge. Since these DOE facilities are located in hot environments both the efficiency of the clean up effort and worker safety are directly impacted by the personal protection equipment (PPE) policy employed. The project interacts directly with cleanup workers at these DOE sites to characterize heat stress and other potentials 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 personal records created by the research are accessible only by the members of the research team and protected in accordance with the provisions of the Privacy Act.
"Comprehensive Occupational Health Surveillance"
Principal Investigator: Dr. Scott Barnhart, 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
Additional IRB approvals from other institutions:
Type of Review: Expedited
Approving Institution: PNNL
Most recent approval: 03/08/00
IRB approval number: 97-1
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 47601
Reporting period for number of human subjects:
Fiscal Year 2000 (10/1/99-9/30/2000)
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
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 450
Reporting period for number of human subjects:
Fiscal Year 2000 (10/1/99-9/30/2000)
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"
This project is being conducted at multiple sites.
Principal Investigator: Dr. James A. Ruttenber, University of Colorado Health Sciences Center
Project started in: 1995
This project ended in fiscal year 2000.
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: Expedited
Approving Institution: Colorado Multiple Institutional Review Board
Most recent approval: 05/16/00
IRB approval number: 97-100, 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 2000 (10/1/99-9/30/2000)
Type(s) of Human Subjects Involvement:
This project was intended to produce a computerized hazard surveillance and evaluation system for workplace exposures to chemicals. This system linked a job/task-based inventory of identified chemical exposures with observation data such as environmental level, controls, and conditions of exposure to create a system for immediate and continuing occupational health use. This Sentinel Exposure Event (SEE) system is based on commonly available generic software, and designed for application by non-programmer personnel. It provides the detailed information needed for evaluating exposures, identifying necessary interventions, and communicating with affected workers through generation of agent-, task-, or work area-specific reports of occupational exposure. After development and implementation at the Rocky Flats site, the potential for general application of the SEE system was tested in a multi-site (Oak Ridge, Savannah River, and Los Alamos National Laboratory) survey of site-specific occupational health surveillance systems.
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 obtaining permission to access workplace records. All personal records created by the research are accessible only by the 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 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 2000 (10/1/99-9/30/2000)
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: Dr. Barbara Grajewski, 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: 11/23/99
IRB approval number: HSRB 98-DSHEFS-01XP
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 4668
Reporting period for number of human subjects:
Fiscal Year 2000 (10/1/99-9/30/2000)
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
This project ended in fiscal year 2000.
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 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: 59
Reporting period for number of human subjects:
Fiscal Year 2000 (10/1/99-9/30/2000)
Type(s) of Human Subjects Involvement:
The objectives of this project are to develop a computer database consisting of the clinical and dosimetric records of 59 cases of the Acute Radiation Syndrome (ARS) from occupational external gamma and neutron and internal alpha radiation exposure of workers collected at the Institute of Biophysics (FIB1) since 1948 at the Mayak PA nuclear weapons facilities in Ozersk, Chelyabinsk Oblast, Russian Federation, and to use it 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-Thoma model triage scheme for early diagnosis of ARS. The database is coded without names or other personal identifiers, and copies are maintained at FIB 1 and the University of Pittsburgh.
"Ionizing Radiation and Mortality Among Hanford Workers"
Principal Investigator: Dr. Steven B. Wing, University of North Carolina
Project started in: 1996
This project ended in fiscal year 2000.
Funding for Human Subjects Research:
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-088
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 33472
Reporting period for number of human subjects:
Fiscal Year 2000 (10/1/99-9/30/2000)
Type(s) of Human Subjects Involvement:
Populations living in communities surrounding the Hanford DOE facility in southeastern Washington were exposed to radionuclides, particularly iodine-131, during the mid to late 1940's. The purpose of this project is to investigate whether rates of infant mortality and fetal death differ according to the iodine-131 exposure classification of mother's residence at the time of birth in an 8 county region surrounding Hanford for the years 1940 through 1952. In order to do this analysis, birth, infant death and fetal death certificates were abstracted for the 13 year study period. The mother's place of residence at time of birth was geocoded and the location was assigned a dose level from the Hanford Environmental Dose Reconstruction project for each record. The analysis will look at gradations of maternal dose by rates of adverse outcomes and causes of death. The study only involves the use of existing data records retained by the State of Washington. Only aggregate information will be reported and no individuals will be identified or contacted for this study. Permission for access to birth and death vital records was reviewed and approved by the state health agency.
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 per requirements of the Privacy Act. Data access will be monitored and restricted to the research team.
"Case-Control Study of the Portsmouth Gaseous Diffusion Plant"
Principal Investigator: Mr. Larry Elliott, National Institute for Occupational Safety and Health
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: PORT
Institutional Review Board (IRB) Review:
Type of Review: Expedited
Approving Institution: National Institute for Occupational Safety and Health
Most recent approval: 03/17/00
IRB approval number: HSRB 93-DSHEFS-10E
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 2000 (10/1/99-9/30/2000)
Type(s) of Human Subjects Involvement:
The objective of the study is to describe the mortality patterns experienced by uranium enrichment workers. These are workers with exposure to internal emitters of radiation, external radiation, and some chemicals encountered by workers in industrial settings outside the Department of Energy (nickel, fluorides, uranium). The gaseous diffusion workers were studied as a cohort of workers. Cases and controls "nested" within the cohort were identified to explore exposure/response relationships. Case-control analyses are being conducted for lung, stomach, leukemia, and total hematopoietic cancers to investigate possible dose- response relationships.
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 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: 02/25/00
IRB approval number: HSRB 97-DSHEFS-08
Additional IRB approvals from other institutions:
Type of Review: Full Board
Approving Institution: ORAU/ORNL (Oak Ridge National Laboratory)
Most recent approval: 12/01/99
IRB approval number: NIOSH-2
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 2000 (10/1/99-9/30/2000)
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: 10/05/99
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: Full Board
Approving Institution: Savannah River Site
Most recent approval: 11/17/99
IRB approval number: ESH-MED-990073
Type of Review: Expedited
Approving Institution: INEEL
Most recent approval: 06/01/00
Type of Review: Expedited
Approving Institution: PNNL
Most recent approval: 03/31/00
IRB approval number: 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 2000 (10/1/99-9/30/2000)
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
This project ended in fiscal year 2000.
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: Expedited
Approving Institution: University of New Mexico
Most recent approval: 09/30/98
IRB approval number: Not Available, M1450
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: 500
Reporting period for number of human subjects:
Fiscal Year 2000 (10/1/99-9/30/2000)
Type(s) of Human Subjects Involvement:
In the western United States, uranium ore is contained in quartz sandstone. From the 1950s to 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 health effects associated with employment in uranium mills, we will conduct a cross-sectional study of 500 former mill workers and 100 reference subjects. Company employment records will be used to develop a sample of persons who worked in mills for at least one year in job titles associated with uranium processing, and who never worked in underground uranium mines. A group of reference subjects of comparable ages and ethnic backgrounds who never worked in uranium mills or mines will be assembled. Using a mobile facility, clinical tests of lung and kidney function will be performed in communities in the Four Corners States where the millers now live. Chest x-rays and spirometry will be conducted to quantify the presence of silicosis, pulmonary fibrosis, and abnormalities of pulmonary function. To assess kidney function, specifically proximal tubular function, urinalysis for levels of beta-2-microglobulin, amino acids, and hexosaminidase excretion will be conducted. The prevalence of impaired respiratory and renal function in the former uranium mill workers will be compared to the prevalence among the reference group. If it is possible to use industrial hygiene measurements of uranium and silica dusts to construct individual exposure estimates, it may be possible to characterize exposure-response relationships. All research records are protected under the provisions of the Privacy Act.
"Surveillance Methods for Solvent-Related Hepatotoxicity"
See also: CRESP-98-29-0140 C/B_V, PNNL-98-7_V
Principal Investigator: Dr. Carl A. Brodkin, University of Washington
Project started in: 1998
This project ended in fiscal year 2000.
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
Additional IRB approvals from other institutions:
Type of Review: Expedited
Approving Institution: PNNL
Most recent approval: 01/15/00
IRB approval number: 98-7
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 200
Reporting period for number of human subjects:
Fiscal Year 2000 (10/1/99-9/30/2000)
Type(s) of Human Subjects Involvement:
OBJECTIVES:
A. To establish a scientific basis for surveillance of hepatic effects in solvent exposed workers, we propose conducting a cross-sectional study investigating 100 industrial painters at the Hanford Nuclear Reservation, exposed subacutely and chronically to a variety of solvent mixtures over their working careers, compared to a referent group of 100 non-exposed carpenters, matched by age, gender, and race. The proposed study will examine the hypothesis that solvent- related hepatic injury is characterized by parenchymal changes of steaosis and fibrosis, without associated necrotic changes detectable by hepatic transaminases, and will address a priority research area posed by the National Occupational Research Agenda for the development of effective surveillance methods.
METHODS
B. All data will be collected in the Occupational and Environmental Medicine Program's (OEMP) mobile medical clinical laboratory, at a location and time convenient for subjects, under the supervision of Dr. Brodkin. Data collection will involve a structured interview using a questionnaire eliciting data on demographics, occupational and environmental exposure history, alcohol consumption, medication use and cigarette smoking. The study phlebotomist will then obtain a blood sample of 20 ml by routine antecubital venipuncture. Limited hepatic ultrasonology will then be performed by a certified sonographic technician, in a private sonography suite within the mobile research van, and will not require undressing. In all, the questionnaire should take approximately 20 minutes, blood collection 10 minutes and hepatic ultrasonography 15 minutes
The blood samples will be labeled with confidential 6-digit study ID numbers, centrifuged, with serum storage at 20 degrees celsius. Samples will be stored in a secured freezer with access limited to study investigators. Serum samples will be sent via Federal Express to the University of Washington Department of Laboratory Medicine, and assayed for 1) biochemical tests including ALT, AST, GGT, alkaline phosphate, and total and direct bilirubin: 2) collagen metabolic biomarkers, including pro-collagen III, pro-collagenIV and TGF-BI; 3)hepatitis serologies to rule out hepatitis B (HBsAG), and anti-HCV (ELISAII); and 4) blood glucose to rule out diabetes mellitus.
Data will be analyzed at Harborview Medical Center. Subjects will be sent results of routine biochemical and serological tests, with an indication of whether any abnormality or need for follow-up is required.
RISKS AND CONFIDENTIALITY PROTECTION
The main potential risk to subjects is some localized but temporary discomfort associated with venipuncture. This procedure will be performed by a trained health professional; therefore physical and psychological risks will be minimized. The amount of blood removed (20 ml) will not be clinically significant. A small bruise may result at the site of venipuncture, which usually resolves within several days. Ultrasound does not produce ionizing radiation : there are no known harmful effects of this procedure in humans, and it is used routinely for clinical diagnosis. Other potential risks relate to the security of the biochemical, serologic and questionnaire data. Improper release of data will be prevented by computer storage of data on password-only access computer files that will not contain personal identifiers (name, address). All hard copy of data will be stored in locked file cabinets within secured offices for the study coordinator (Hanford, Comprehensive Occupational Health Surveillance Program) or similarly secured in Dr. Brodkin's Haborview office. Subjects will be appraised of these safeguards on the consent form.
Clinically significant abnormalities -i.e., suspicious masses found on ultrasound and elevated serum biochemical levels- will be reported to subjects for further evaluation and /or follow-up. Referral to appropriate follow-up sources will be offered, but subjects(or their medical insurance) will be responsible for the cost of such evaluations. Ultrasound photographic copies will be provided to any physician conducting a follow-up evaluation (after receipt of signed consent for release of information).
"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
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 2000 (10/1/99-9/30/2000)
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
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 2000 (10/1/99-9/30/2000)
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:
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
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 2000 (10/1/99-9/30/2000)
Type(s) of Human Subjects Involvement:
Workers at the Feed Materials Production Center (FMPC) at Fernald, Ohio, a former Department of Energy (DOE) weapons production facility, were exposed to ionizing radiation in the process of uranium metal production. Large amounts of radium bearing radioactive waste were shi