Dr. Charles
W. Powers
Executive Director
Consortium for Risk Evaluation and Stakeholder Participation
317 George Street, Suite 202
New Brunswick, NJ 08901-2008
Phone: 732 235-9600
Fax: 732 235-9607
E-mail: cwpowers@eohsi.rutgers.edu
Number of Human Subjects projects reported: 4
"An Update of The Worker Cohort Mortality Study at Nuclear Fuels Production Facility on the Savannah River site"
Principal Investigator: Dr. Daniel Wartenberg, Rutgers University
Project started in: 1995
Funding for Human Subjects Research:
This project does not involve the use of multiple protocols/subprojects.
Identifier or number: X-0887
Institutional Review Board (IRB) Review:
Type of Review: Full Board
Approving Institution: University of Medicine and Dentistry of New Jersey
Most recent approval: 09/27/99
IRB approval number: X-0887
Explanation of IRB approval:
An application is in process for IRB approval through the University of Medicine and Dentistry of New Jersey. Project was reviewed and accepted by SRS IRB chairman James O. Hightower January 6, 2000. Notification was made by letter.
Additional IRB approvals from other institutions:
Type of Review: Expedited
Approving Institution: Savannah River Site
Most recent approval: 01/06/00
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 16489
Reporting period for number of human subjects:
Fiscal Year 2000 (10/1/99-9/30/2000)
Type(s) of Human Subjects Involvement:
This Study investigates whether workers at the Savannah Power Site (SRS) are more likely, on average, to die of specific causes of death, particularly certain cancers, than the total US population. In Phase I, we will compare causes of death of SRS workers to the causes of death of the total US population, for each gender male or female and race (white or African American ) group. In Phase II of our study, we will use data based on the records of radiation badges that record the dose of external radiation that each worker was exposed to over the period of time that they worked at SRS to determine whether greater radiation exposure is associated with particular causes of death. In Phase III of our study we will examine the possible risk from radiation due to radionuclide exposure (including tritium).
"Laboratory Evaluation of Field Collected Cells"
Principal Investigator: Dr. Timothy K. Takaro, University of Washington
Project started in: 1996
Funding for Human Subjects Research: No Funding Sources Reported
This project does not involve the use of multiple protocols/subprojects.
Institutional Review Board (IRB) Review:
Type of Review: Full Board
Approving Institution: University of Washington
Most recent approval: 08/26/99
IRB approval number: 96-2971-E04
Explanation of IRB approval:
The project was not active between 10/1/99 and 9/30/00.
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 0
Reporting period for number of human subjects:
Fiscal Year 2000 (10/1/99-9/30/2000)
Type(s) of Human Subjects Involvement:
Heat Stress is a significant exposure for remediation workers at hazardous waste sites. This study will determine if mRNA heat shock proteins up-regulate in heat stressed Hanford remediation workers, and if this biomarker can be used to assess risk from such exposure.
Uroepitheleal cells are harvested from routine urine collections at the Hanford site, and the mRNA activity is analyzed in the laboratory at the University of Washington. The subjects are workers at the Hanford nuclear Reservations tank farms that were recruited for this study on heat stress. The tank farms at Hanford are located along the Columbia River and often experience summer temperatures above 90 degrees Fahrenheit. Because of the extremely hazardous contents of the tanks and the poor characterization of their contents, fully self-contained occlusive suits are often worn by workers in this area.
Methods
Voided urine samples are collected before and after the work shift. Following the measurement of specific gravity and the pH, the sample is centrifuged, and the cell pellet is collected and resuspended in a solution containing RNAse inhibitors. The resuspended cells are then frozen on dry ice, and are transported to the laboratory. Commercially available cDNA stress response gene probes are used to characterize the induction of the stress response in uroepithelial cells. The probes include genes coding for the heat stress proteins of the Hsc70 family, and more general stress response genes, such as thiol glutathione, Gadd43, Gadd153 and p21(Waf1). Because there is a wide variation in the species and quantity of mRNA induction depending upon the cell type, this study aims to identify the stress genes that are most responsive in the transitional uroepthelieal cells harvested in a routinely voided urine sample.
The only samples obtained from the subjects are routine voided spot urine samples collected in privacy. University of Washington investigators will not know the identity of the subjects at any time. Data are identified by a number with the consent form, which is the only document having both a name and number. A member of a cooperating research group from Michigan State University will maintain the identification information.
Adverse effects are not anticipated as subjects will only provide investigators with a urine specimen.
Due to difficulties in recruiting subjects, no additional progress has been made since last years report(9/98).
"Screening for Chronic Beryllium Disease at Hanford"
See also: PNNL-97-10_V
Principal Investigator: Dr. Timothy K. Takaro, University of Washington
Project started in: 1997
Funding for Human Subjects Research:
This project does not involve the use of multiple protocols/subprojects.
Institutional Review Board (IRB) Review:
Type of Review: Full Board
Approving Institution: University of Washington
Most recent approval: 07/07/00
IRB approval number: 97-3907-CE
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 8
Reporting period for number of human subjects:
Fiscal Year 2000 (10/1/99-9/30/2000)
Type(s) of Human Subjects Involvement:
Investigators obtain names of potential participants for this study from the DOE. Subjects that respond are requested to provide information about work experience, exposures, smoking, and health status; and provide permission to review employment and medical records to determine the extent of beryllium exposure that they may have encountered.
Workers with prior exposure to beryllium are consented to provide 40ml of peripheral blood. The standard venous blood draw is slightly painful at the moment of venipuncture. Rarely, local transient swelling occurs and there is an extremely rare risk of infection from the procedure. Blood cells are isolated, cultured, and tested for beryllium sensitization using the lymphocyte proliferation test.
Personal identification is kept in a separate location from other information. Subjects sign an informed consent form that has been approved by the human subjects review committee.
In this period, the primary emphasis has been on identifying subjects, characterizing their exposure, and testing for beryllium sensitization among exposed workers. Until now, blood samples from 125 Hanford workers were collected and tested for beryllium sensitization under this protocol. Unidentified blood test results, clinical and exposure data are now also collected. This modification was approved July 14, 1999 by the UW IRB and July 17, 1999 by the Pacific Northwest National Labs (PNNL) IRB. During the report period we also received de-identified data from two separate US-DOE grant projects. Another major point of emphasis has been the development of a quantitative decision analytic framework for the use of biomarkers in medical surveillance.
See project NIOSH-98-032.
Project Identifier: CRESP-98-29-0140 C/B_V
Project Title: "Surveillance Methods for Solvent-Related Hepatotoxicity"
Go to list of projects at Consortium for Risk Evaluation w/ Stakeholder Participation