Mr. Robert
D.
Daniels
CDC/NIOSH/DSHEFS/Occupational Energy Research Program
Mail Stop R-14
4676 Columbia Parkway
Cincinnati, OH 45226
Phone: 513-458-7178
Fax: 513-841-4470
E-mail: rtd2@cdc.gov
Number of Human Subjects projects reported: 7
| NIOSH-93-003 | "Cohort Mortality Study of Portsmouth Naval Shipyard (PNS)" |
| 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-97-007 | "Cohort Mortality Study of DOE Chemical Laboratory Workers" |
| 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 Portsmouth Naval Shipyard (PNS)"
Principal Investigator: Ms. Sharon Silver, National Institute for Occupational Safety and Health
Project started in: 1993
Status of the Research this Fiscal Year:
Current study is completed.
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: 03/17/07
IRB approval number: HSRB 93-DSHEFS-10C
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 37853
Reporting period for number of human subjects:
Fiscal Year 2007
Type(s) of Human Subjects Involvement:
The mortality study of civilian employees at Portsmouth Naval Shipyard is being updated through 1996. The previously conducted study (1980) of this workforce 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 37,853 workers and a stratified cohort study of the 13,468 radiation monitored workers were 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. The total cohort study, the stratified cohort study of radiation monitored workers, and the case control analyses of leukemia were completed in FY2005. The case control analyses for lung cancer were completed in FY2006.
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)).
"Leukemia Case-Control Study"
Principal Investigator: Mr. Robert D. Daniels, National Institute for Occupational Safety and Health
Project started in: 1995
Status of the Research this Fiscal Year:
Current study is completed.
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: 07/01/07
IRB approval number: HSRB 96-DSHEFS-10
Additional IRB approvals from other institutions:
Type of Review:
Expedited
Approving Institution: Westinghouse Savannah River Company
Most recent approval: 08/02/05
IRB approval number: ESH-WHS-2005-00045
Explanation of additional approval:
Current NIOSH IRB status information provided to the Savannah River Site Worker Health Studies Program. Awaiting Site IRB renewal.
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 1269
Reporting period for number of human subjects:
Fiscal Year 2007
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 draws cases from some 95,000 workers at five previously studied sites, which have a total of about 250 leukemia deaths. Each of these cases was age-matched with four controls to give a study population of approximately 1,250 study subjects, whose external and internal radiation records were then 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. Potential confounding from potential solvent exposures (benzene and carbon tetrachloride) will also be addressed. The five sites being studied include Hanford, Savannah River, Oak Ridge National Laboratory, Los Alamos/Zia, and the Portsmouth Naval Shipyard. This study includes analyses for chronic lymphocytic leukemia within this cohort.
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. James H. Yiin, National Institute for Occupational Safety and Health
Project started in: 1995
Status of the Research this Fiscal Year:
Study enrollment is permanently closed, participants have completed research-related interventions, and long-term follow-up is completed. The remaining research activities are limited only to data analysis.
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: 09/08/07
IRB approval number: HSRB 96-DSHEFS-16XM
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 2007
Type(s) of Human Subjects Involvement:
(Abstract current for FY2007)
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 K-25 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 K-25 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, and 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)).
"Cohort Mortality Study of DOE Chemical Laboratory Workers"
Principal Investigator: Dr. Travis Kubale, National Institute for Occupational Safety and Health
Project started in: 1997
Status of the Research this Fiscal Year:
Current study is completed.
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: 02/25/07
IRB approval number: HSRB 97-DSHEFS-08XP
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: 04/07/06
IRB approval number: ESH-WHS-2004-00043
Explanation of additional approval:
This study is essentially complete.
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 2007
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 assesses the previously unstudied effects of external and internal ionizing radiation exposure as well as exposure to chemicals. This cohort mortality study looks 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, and the Savannah River Site.
To help understand the effects of chemical exposures, the study includes 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 is based on worker records from the sites. These records were used to compare death rates of chemical laboratory workers to rates for the U.S. population. The records also indicate 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)).
"Cohort Mortality Study of Fernald Environmental Management Plant"
Principal Investigator: Ms. Sharon Silver, National Institute for Occupational Safety and Health
Project started in: 2001
Status of the Research this Fiscal Year:
Study enrollment is permanently closed, participants have completed research-related interventions, and long-term follow-up is completed. The remaining research activities are limited only to data analysis.
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: 11/27/06
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 2007
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 2003, expanding the cohort to include females and all racial groups. Additionally, the study incorporates a retrospective exposure assessment for external and internal radiation, radon, asbestos, uranium dust, and acid mists. Study continuation is contingent upon FY2007 funding levels.
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
Status of the Research this Fiscal Year:
Study enrollment is permanently closed, participants have completed research-related interventions, and long-term follow-up is completed. The remaining research activities are limited only to data analysis.
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 Louisville
Most recent approval: 08/29/07
IRB approval number: 438.02
Additional IRB approvals from other institutions:
Type of Review:
Expedited
Approving Institution: University of Cincinnati
Most recent approval: 03/07/07
IRB approval number: 02-04-04-01-EE
Type of Review:
Expedited
Approving Institution: University of Louisville for the University of Kentucky
Most recent approval: 03/07/07
Explanation of additional approval:
University of Louisville and University of Kentucky have an IRB Authorization Agreement for continuing IRB review and oversight to be provided by the University of Louisville IRB specifically for this study.
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 6800
Reporting period for number of human subjects:
Fiscal Year 2007
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; an estimated 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 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 feasibility component will 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. [The feasibility component has been completed. Epidemiologic study is proceeding.]
The subsequent epidemiology study (drawing upon the feasibility effort) involves the development of a complete roster of current and former PGDP workers. The study will identify sources and collect data on external/internal radiation, chemicals, and physical agent exposures and select the most appropriate epidemiological approaches for a mortality study of the PGDP cohort.
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
Status of the Research this Fiscal Year:
Current study is completed.
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: Public Health-Nursing IRB
Most recent approval: 09/28/07
IRB approval number: 02-0643
Explanation of IRB approval:
The University of North Carolina at Chapel Hill (UNC-CH) IRB approval number was previously 02-1777. The IRB renewal states that the renewal request dated 08/18/2006 renewed the study to continue as prevously approved. The PI (direct conversation) reports that the State of North Carolina has implemented legislation requiring additional review and permission requirements to use data sets containing personal identifiers. This review is in addition to the IRB review and renewal. The additional review is performed by the Office of University Counsel. This additional state regulation (implemented this year) has resulted in delays in the issuance of IRB renewals. The IRB renewal states that permission from the UNC-CH Office of University Counsel has been granted for the use of Social Security Numbers.
Additional IRB approvals from other institutions:
Type of Review:
Expedited
Approving Institution: Savannah River Site (WSRC)
Most recent approval: 05/04/05
IRB approval number: ESH-WHS-2004-00044
Explanation of additional approval:
SRS IRB was provided a copy of the current UNC-Chapel Hill IRB renewal. Requested and awaiting site IRB renewal.
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 24000
Reporting period for number of human subjects:
Fiscal Year 2007
Type(s) of Human Subjects Involvement:
(Work continued as previously proposed in FY2006)
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 U.S. DOE weapons complex. In this study, we examined a cohort of nearly 24,000 badge-monitored workers at the Savannah River Site (SRS) followed over a fifty-year period. Past research on this epidemiologically important cohort has focused on analysis of standardized mortality ratios. This study, in contrast, focuses on radiation-mortality associations under varying lag assumptions and investigates potential changes with age-at-exposure in susceptibility to the carcinogenic effects of radiation.
Next, we investigated 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 used 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 examined the role of tritium and neutron exposures in these analyses of radiation-mortality associations. We investigate whether variation in radiation risk estimates between subgroups of workers reflects heterogeneity in radiological exposures. Study results for this large U.S. DOE cohort were evaluated in relation to observations from studies of other DOE facilities. Study data were 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 U.S. DOE cohorts.
Primary database and analysis files created from secondary data sources were stored on computers with personal identifiers (name and SSN) removed. Workers were identified by a unique study number assigned by University of North Carolina (UNC) staff that 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) was 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 were stored in password protected computer files. Access to these computer files was limited to authorized project personnel. All project personnel were 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.