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: 8
Project Identifier:
CRESP-95-E96-108
Project Title:
"Use of Ecological Resources at DOE Sites"
Principal Investigator: Dr. Joanna Burger, 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: E96-108
Institutional Review Board (IRB) Review:
Type of Review: Expedited
Most recent IRB approval: 10/09/98
IRB approval number: E96-108
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 650
Reporting period for number of human subjects:
Fiscal Year 1999 (10/1/98-9/30/99)
Type(s) of Human Subjects Involvement:
The objective of the research is to understand ecological values at Department of Energy Sites, including how they perceive environmental issues and how often they hunt, fish or engage in other recreation, as well as fish consumption patterns.
People were interviewed in fiscal year 1999 who live around Los Alamos to provide information on another large site and to test methodology previously developed. People were interviewed at a sports event by trained interviewers using the same protocols as previously used.
People were not exposed to any radiation or chemicals, and are not identified on any of the forms. There are no risks to the people interviewed.
Project Identifier:
CRESP-95-X-0887
Project Title:
"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
Most recent IRB approval: 09/27/99
IRB approval number: X-0887
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 1999 (10/1/98-9/30/99)
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).
Project Identifier:
CRESP-96-27-0009-E
Project Title:
"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
Most recent IRB approval: 08/26/99
IRB approval number: 96-2971-E04
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 1999 (10/1/98-9/30/99)
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).
Project Identifier:
CRESP-96-E97-026
Project Title:
"CRESP Social, Landuse, Demographic, Geographic, and Economic (SLUDGE) Surveys and Interviews"
Principal Investigator: Dr. Michael Greenberg, Rutgers University
Project started in: 1996
Funding for Human Subjects Research:
This project involves the use of multiple protocols/subprojects.
Number of protocols/subprojects associated with this project: 3
Institutional Review Board (IRB) Review:
Type of Review: Expedited
Most recent IRB approval: 03/20/97
IRB approval number: E97-026
Explanation of IRB approval:
Exemption granted for all survey and interview work.
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 42
Reporting period for number of human subjects:
Fiscal Year 1999 (10/1/98-9/30/99)
Type(s) of Human Subjects Involvement:
Economic Development Study:
The objective of this project was to obtain the opinions of local economic development planners in three regions that have been affected by the downsizing of a major DOE facility. The officials were asked a series of open-ended questions in person(32) or by telephone(10). The researcher took notes and findings were aggregated into general findings. Where quotes were included in the report, no individual names were connected with the quotes.
The purpose of the project was explained to all interviewees, and participation was purely voluntary. No information of a personal nature, or information that could in any way harm the individuals, was asked and therefore there were no risks to the individuals who participated.
Institutional Review Board (IRB) Review:
Type of Review: Full Board
Most recent IRB approval: 03/20/97
IRB approval number: E97-026
Explanation of IRB approval:
Exemption granted for all survey and interview instruments.
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 30
Reporting period for number of human subjects:
Fiscal Year 1999 (10/1/98-9/30/99)
Type(s) of Human Subjects Involvement:
Planners Survey
The purpose of this project was to examine the current status of land use planning at the major DOE sites and the degree to which planning is coordinated with off-site local planners. The researcher took notes and findings were aggregated into general findings. Where quotes were included in the report, no individual names were connected with the quotes.
No information of a personal nature was asked, and response was completely voluntary. Since no personal information was requested, there are no privacy concerns. We did not discuss individual responses by name in the report of the results. There were no risks to the survey respondents.
Institutional Review Board (IRB) Review:
Type of Review: Expedited
Most recent IRB approval: 03/20/97
IRB approval number: E97-026
Explanation of IRB approval:
Exemption granted for all survey and interview instruments
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 25
Reporting period for number of human subjects:
Fiscal Year 1999 (10/1/98-9/30/99)
Type(s) of Human Subjects Involvement:
Survey of Local Officials Near small sites
The objective of this project is to assess the concerns and opinions of local planners, health officers, tax assessors and municipal executives about the presence of small, formerly used sites in their communities. These sites belong to the Formerly Utilized Sites Remedial Action Program (FUSRAP)(now under the direction of the Army Corps of Engineers), Uranium Mill Tailings Remedial Action (UMTRA) program, or are weapons sites that are small in size with relatively low levels of contamination.
Where possible, these officials were asked, either in person or by telephone, to answer a series of questions about the perceived impacts of the site on their community's health and economic
well-being, and about the public participation process. Most of the questions were close-ended scale questions, and a few were open-ended.
The purpose of the project was explained to all interviewees, and participation was purely voluntary. Responding officials were promised that they would not be mentioned by name in any publication of results. No information of a personal nature was asked, therefore there are no risks to the individuals who participated.
Project Identifier:
CRESP-97-26-0807-B/C
Project Title:
"Human Reproductive Effects of Controlled Toluene Exposure"
Principal Investigator: Dr. Elaine M. Faustman, University of Washington
Project started in: 1997
This project ended in fiscal year 1999.
Funding for Human Subjects Research:
This project does not involve the use of multiple protocols/subprojects.
Identifier or number: 86-0807-B/C
Institutional Review Board (IRB) Review:
Type of Review: Full Board
Most recent IRB approval: 08/06/97
IRB approval number: 27-0983-A/C
Explanation of IRB approval:
Data gathering ended in 1998
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 11
Reporting period for number of human subjects:
Fiscal Year 1999 (10/1/98-9/30/99)
Type(s) of Human Subjects Involvement:
The goal of this project is to determine whether the inhalation of volatile solvents, at levels permitted under current regulatory guidelines for occupational exposure, affects blood levels of reproductive hormones which are involved in regulating sperm production in men and egg maturation and release in women. Such hormone measurements could then potentially be used to monitor the reproductive health of exposed workers, providing early warning of those at risk for more serious reproductive effects.
This study evaluates the effects of exposure to solvents on reproductive hormones, luteinizing hormone and follicle stimulating hormone in men and women. It requires frequent blood sampling before, during and after a 3 hour exposure to solvent by inhalation.
Methods & Human Subject Involvement
Prior to the study potential study participants are asked to fill out a medical history questionnaire and are given a brief physical examination. On the day prior to the scheduled exposure, women of child bearing potential will provide a blood sample of 5 ml. from an arm vein for a pregnancy test.
Each subject who is not pregnant will then be given two controlled exposures on separate days at least one month apart, to toluene vapor in filtered air. The exposures may last two hours and are not more than the level of toluene permitted for workers on an 8 hour day, working lifetime basis (50 parts per million). At the beginning of each exposure day a small plastic tube is inserted into a vein in the arm and will remain in place for the day. A local anesthetic, lidocaine, will be used at a dose of 0.1-0.3 ml to avoid discomfort during this procedure. During an 8 hour period, beginning before exposure and ending after the exposure, each subject will be asked to give a total of 28 blood samples (one half teaspoonful or less) from the arm vein.
The risk from chemical exposure to males and non-pregnant females is low--the exposure will be less than allowable occupational levels and will occur only twice. If a female is pregnant at the time of exposure, there is a small risk of damage to the embryo, which could lead to spontaneous abortion or a birth defect. The risks associated with the catheter are encountered in any peripheral venipuncture: possible infection, irritation and inflammation of the vein and leakage of blood into the tissue surrounding the blood vessel.
Data from subjects is anonymous but coded with the key to the coding kept in a separate locked location
Project Identifier:
CRESP-97-27-0228-C
Project Title:
"Screening for Chronic Beryllium Disease at Hanford (DUPLICATE PROJECT SEE PNNL-97-10)"
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
Most recent IRB approval: 07/14/99
IRB approval number: 97-3907-CE
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 125
Reporting period for number of human subjects:
Fiscal Year 1999 (10/1/98-9/30/99)
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.
Project Identifier:
CRESP-97-27-0295-X
Project Title:
"Analysis of Gene Expression changes in Isolated Uroepitheleal cells"
Principal Investigator: Dr. Elaine M. Faustman, University of Washington
Project started in: 1997
This project ended in fiscal year 1999.
Funding for Human Subjects Research:
This project involves the use of multiple protocols/subprojects.
Number of protocols/subprojects associated with this project: 1
Identifier or number: 27-0295-X
Institutional Review Board (IRB) Review:
Type of Review: Full Board
Most recent IRB approval: 05/12/97
IRB approval number: 27-0295-X
Explanation of IRB approval:
Project ended in 1998
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 1999 (10/1/98-9/30/99)
Type(s) of Human Subjects Involvement:
The purpose of this study is to analyze gene expression changes in isolated uroepithelial cells from individuals exposed to fly ash (at a coal-fired power plant in Slovakia). The study is being conducted through Dr. Janice Yager at the electric Power Research Institute who is directing a study to look at arsenic urinary metabolites.
The role of this project is solely to receive aliquots of coded urine samples (we do not receive any human identification information), isolate the UE cells, amplify the RNA and look for gene expression changes.
"Surveillance Methods for Solvent-Related Hepatoxicity (DUPLICATE PROJECT - REFERENCE NIOSH-98-032)"
This project is a duplicate of project NIOSH-98-032.