Dr. Charles W. Powers
Principal Investigator
Consortium for Risk Evaluation and Stakeholder Participation
317 George Street, Suite 202
New Brunswick, NJ 08901-2008
Phone: 732 296-1960
Fax: 732 235-9607
E-mail: cwpowers@eohsi.rutgers.edu
Number of Human Subjects projects reported: 10
"An Update of The Worker Cohort Mortality Study at Nuclear Fuels Production Facility on the Savannah River site"
Principal Investigator: Dr. Daniel Wartenberg, University of Medicine and Dentistry of New Jersey
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: 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:
Project was reviewed and accepted by SRS IRB chairman James O. Hightower January 6, 2000. Notification was made by letter. No new data were collected.
Additional IRB approvals from other institutions:
Type of Review: Expedited
Approving Institution: Savannah River Site
Most recent approval: 01/06/00
IRB approval number: ESH-MED-2000-00002
Explanation of additional approval:
For one year ending 1/6/01
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 2001
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. Phase II and III currently inactive.
"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.
Identifier or number: 2971-E 06
Institutional Review Board (IRB) Review:
Type of Review: Full Board
Approving Institution: University of Washington
Most recent approval: 08/23/01
IRB approval number: 96-2971-E04
Explanation of IRB approval:
The approval period was 8/23/01 to 8/22/02.
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 40
Reporting period for number of human subjects:
Fiscal Year 2001
Type(s) of Human Subjects Involvement:
The purpose of this project is to determine the feasibility of measuring mRNA responses to heat stress in a working population under exertion. Uro-epithelial cells were harvested from routine urine collections and the mRNA activity analyzed in the Kavanagh lab at the University of Washington. Subjects were workers at the Hanford Nuclear Reservation’s tank farms, collected for a NIOSH/DOE study on heat stress.
Background: Heat stress is a significant exposure for remediation workers for hazardous waste sites. The study seeks to 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.
The research is aimed at developing biomarkers of exposure that would be applicable to remediation workers at nuclear waste sites. Information from the project may improve knowledge of health risks for remediation workers exposed to job-imposed heat stress.
"Combined Effects of Radiation and Asbestos in Producing Pulmonary Fibrosis"
Principal Investigator: Dr. Timothy Takaro, University of Washington
Project started in: 1996
Funding for Human Subjects Research:
This project does not involve the use of multiple protocols/subprojects.
Identifier or number: 3369C
Institutional Review Board (IRB) Review:
Type of Review: Full Board
Approving Institution: University of Washington
Most recent approval: 07/09/01
IRB approval number: 96-3368-C05
Additional IRB approvals from other institutions:
Type of Review: Expedited
Approving Institution: Pacific Northwest National Laboratory
Most recent approval: 08/10/01
IRB approval number: 2001-32
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 1300
Reporting period for number of human subjects:
Fiscal Year 2001
Type(s) of Human Subjects Involvement:
Objectives: The purpose of this study is to determine whether ionizing radiation contributes to the fibrogenic effects of asbestos in workers at a former nuclear weapons facility. Worker protections are based upon single exposures and do not account for the constellation of exposures frequently encountered by nuclear weapons production and site clean-up workers or by the growing number of hazardous waste workers. Protection factors are generally based on exposure standards for individual agents rather than combined hazards.
The intent in this study is to characterize the independent and combined effects of asbestos and radiation using a model to assess interaction in this asbestos exposed cohort. Similar cellular mechanisms seem to be involved in the two fibrotic processes, but the degree of commonality of these mechanisms is unknown. If the two processes are the same this study should show an additive effect. If the mechanisms are different a synergistic effect may be seen. Given the common aspects of the pathophysiology of pulmonary fibrosis from asbestos and pulmonary fibrosis, antagonism is unlikely. Determining the degree of interaction will help illuminate the mechanisms of each disease process.
Methodology: This study design is a cross-sectional evaluation of the associations between ionizing radiation doses, asbestos exposure, and radiographically and spirometrically determined pulmonary fibrosis. The data comes from an existing computerized medical surveillance database from the two Hanford Former Worker Medical Monitoring Programs. The database contains information, smoking history, chest radiography and spirometry data, but no identifying information.
Involvement of Human Subjects: No new human subjects will be enrolled in this study. The data from this study will contain no personal identifier information and no subjects will be approached. Code numbers will be assigned to these workers and the identity of individual workers will not be revealed to the radiation and asbestos project investigators.
"Screening for establishing the prevalence of Beryllium sensitization at Hanford"
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.
Identifier or number: 97-3907-C/E 05
Institutional Review Board (IRB) Review:
Type of Review: Full Board
Approving Institution: University of Washington
Most recent approval: 05/03/01
IRB approval number: 97-3907-CE
Additional IRB approvals from other institutions:
Type of Review: Full Board
Approving Institution: Pacific Northwest National Laboratory
Most recent approval: 07/07/01
IRB approval number: 97-10
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 711
Reporting period for number of human subjects:
Fiscal Year 2001
Type(s) of Human Subjects Involvement:
This study continues as a prevalence study of beryllium sensitization and disease in a potentially exposed population of former Hanford workers. We use years worked, building and task information to determine high-risk jobs and buildings. This information may benefit current and future remediation workers as they enter beryllium-contaminated areas. Initial determination of sensitization is cross-sectional and is linked to chest radiograpbs and spirometry data where available. This study also compares effectiveness measures (sensitivity and specificity) of two laboratory techniques for determining beryllium sensitivity. With the modification approved in 1998, the study has collected DNA from blood cells and cells scraped from the cheek to determine possible genetic susceptibility. With the modification approved in 1999, the study began to include de-identified data from former Hanford workers from two medical monitoring programs. With these additions the study goal of 200 samples has been exceeded. With the modification approved in 2001, the study prepared to include de-identified data from current workers at Hanford collected by the Hanford Environmental Health Foundation (data expected Autumn 2001).
Over 500 former Hanford workers who may be at risk from beryllium disease due to work at Hanford have been contacted. 241 have signed consent forms to participate and completed questionnaires, 132 of these have had blood samples taken and five are positive. Fifty-four subjects have consented to donate cells for genetic analysis. De-identified data from 711 former workers who received beryllium medical screening examinations as part of the Hanford Former Worker Programs have been added to the study’s data set. Of these 711, fifty-two have positive results for sensitization. We have requested and received support from Hanford Environmental Health Foundation to obtain de-identified data from current Hanford worker beryllium medical surveillance programs.
"Zirconium Lymphocyte Proliferation Test Development"
Principal Investigator: Dr. Timothy Takaro, University of Washington
Project started in: 2000
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: 4158E
Institutional Review Board (IRB) Review:
Type of Review: Expedited
Approving Institution: University of Washington
Most recent approval: 06/12/01
IRB approval number: 00-4158-E02
Additional IRB approvals from other institutions:
Type of Review: Expedited
Approving Institution: Pacific Northwest National Laboratory
Most recent approval: 06/14/01
IRB approval number: 2000-21
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 22
Reporting period for number of human subjects:
Year prior to last IRB approval date
Type(s) of Human Subjects Involvement:
Objectives: The purpose of this study is to determine if a blood test used to diagnose chronic beryllium disease, a lung disease caused by exposure to beryllium, may be useful to diagnose a similar lung disease caused by exposure to zirconium.
Methodology/Human Subjects Involvement: Using existing job history information from another study (DE-FC03-96SF21258), fifty people who probably had zirconium exposure will be identified. People identified will be those previously employed at the Hanford Nuclear Reservation, predominately male, and between the ages of 21 and 75. A newspaper advertisement may be placed as well. A letter describing the study, consent form, and information sheet will be mailed to people identified from job history information and those who respond to the recruiting advertisement. When the consent form is received, the participant will be called and invited to participate in a job history interview, to be conducted in person or by telephone. The interview gathers information about work history, medical history relevant to lung disease, and smoking history. Interviewers use a script and structured questionnaire. Following the interview, investigators will review the records and questionnaires to confirm zirconium exposure. Exposed people will be invited to donate 50 ml of blood for testing at the National Jewish Medical and Research Center in Denver Colorado. Blood will be drawn by standard venipuncture by a licensed phlebotomist. The blood will be analyzed using the lymphocyte proliferation test (LPT) with exposure to zirconium salts. At the time of study initiation, we do not anticipate providing individual test results to participants because the test is still under development.
"A Critical Analysis of Technology Incubation"
Principal Investigator: Dr. Michael R. Greenberg, Rutgers University
Project started in: 2000
This project ended in fiscal year 2001.
Funding for Human Subjects Research:
This project does not involve the use of multiple protocols/subprojects.
Identifier or number: Survey and Interviews About Incubator Success
Institutional Review Board (IRB) Review:
Type of Review: Expedited
Approving Institution: Rutgers University
Most recent approval: 05/31/00
IRB approval number: E00-321
Explanation of IRB approval:
Project ended in FY01
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 80
Reporting period for number of human subjects:
Fiscal Year 2001
Type(s) of Human Subjects Involvement:
The purpose of this study is to examine the success of technology incubation across the United States and in regions around DOE sites. In one part of the project, about 60 directors of technology incubators were surveyed using a mailed survey instrument. In a second phase of the research, about 20 people were interviewed in the regions around INEEL and Hanford, including business leaders, technology directors and site officials.
Interviewees participated voluntarily and were assured that individual names will not be used in reports. No sensitive information was obtained and there were no personal or economic risks to the respondents.
"Regional Social Capital Study"
Principal Investigator: Dr. Michael R. Greenberg, Rutgers University
Project started in: 2000
This project ended in fiscal year 2001.
Funding for Human Subjects Research:
This project does not involve the use of multiple protocols/subprojects.
Identifier or number: Idaho and Washington Regional Interviews
Institutional Review Board (IRB) Review:
Type of Review: Expedited
Approving Institution: Rutgers University
Most recent approval: 05/22/00
IRB approval number: E00-408
Explanation of IRB approval:
Project ended in FY01
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 2001
Type(s) of Human Subjects Involvement:
The purpose of this project is to examine the current status of social networks and the strength of the non-profit, business and government sectors in regions around the major U.S. nuclear weapons sites at INEEL and Hanford. A total of about 30 people were interviewed with open-ended questions about the strengths of their organizations and their formal and informal ties to other regional organizations. Interviewees included local government officials, regional economic development groups and local business and community leaders.
Interviewees participated voluntarily and are assured that individual names will not be used in reports. No sensitive information was obtained and there were no personal or economic risks borne by the respondents.
"Evaluation of Occupational Health Services for Subcontractors at Hanford"
Principal Investigator: Dr. Mary K. Salazar, University of Washington
Project started in: 2001
Funding for Human Subjects Research:
This project does not involve the use of multiple protocols/subprojects.
Identifier or number: 7392-C01
Institutional Review Board (IRB) Review:
Type of Review: Expedited
Approving Institution: University of Washington
Most recent approval: 04/17/01
IRB approval number: 01-7392-C-01
Additional IRB approvals from other institutions:
Type of Review: Expedited
Approving Institution: Pacific Northwest National Laboratory
Most recent approval: 05/22/01
IRB approval number: 2000-17
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 2001
Type(s) of Human Subjects Involvement:
a. Objectives: The objective of this study is to examine the adequacy and efficacy of occupational health and safety services among subcontractors who work at DOE sites. The study will consist of a pilot project that will be conducted among workers who are subcontracted at the Hanford sites. The specific aims of the study are to 1) describe subcontracted worker’s perceptions about their occupational health and safety risks; 2) determine the extent of training and medical qualification examinations that they receive; 3) describe the type and nature of occupational health and safety services available to them; and 4) determine the workers’ perceptions of the availability and appropriateness of occupational health and safety services.
b. Methodology: This is the second phase of a two-phased effort to learn about subcontracted workers occupational health and safety risks. The first phase, which was completed in July 2000, consisted of a written survey that was completed by managers of subcontracted workers. The purpose was to determine the manager’s perception of occupational hazards at the site and to determine what types of services are currently being provided to workers. In order to achieve the aims of this study, interviews will be conducted among a sampling of workers who have been subcontracted to work at the Hanford site. Subject recruitment will occur through mailings to managers of subcontracted workers. Managers will be asked to post recruitment flyers and return cards.
Data collection will consist of individual, in-person interviews with the subjects. The interviews will take place in a private room, will last approximately 1/2 hour, and will be tape recorded with the subject’s permission (if the subject does not wish to be recorded, than detailed notes will be taken). Prior to the interview, the subject will be provided with a consent form. The data collection instrument consists of an interview guide that was developed in order to achieve the study aims. Subjects will be asked to provide the type of work they perform at Hanford, their perceptions of potential risks related to that work, and the type of health and safety training that they receive. They will also be asked if they completed an Employee Job Task Analysis (EJTA) which is a method used at Hanford to determine worker risk and medical monitoring needs.
c. Ionizing radiation, radioactive substances, chemical substances: N/A
d. Involvement of Human Subjects:
1. Procedures: Individual, in-person interviews will be conducted, as described in the methodology section.
2. Risks: Workers may be concerned that their responses may become known to their managers and may affect their future ability to be hired for jobs. There is also the possibility that a discussion of risks and hazards related to their work may cause some level of stress.
Benefits: It is anticipated that the information provided by these workers will lead to more targeted and more effective occupational health and safety services that will address areas of need among these individual workers as well as among other workers who are subcontracted at this site.
3. Privacy/confidentiality/consent: Identifiable data will be coded and the code will be kept separate from the data. All data will be kept in a file in a restricted access room. Data will only be available to the investigator and to the selected members of the research team as appropriate for completing the analysis.
"Decision Mapping to Promote Transparency of Long Term Environmental Stewardship"
Principal Investigator: Ms. Christina H. Drew, University of Washington
Project started in: 2001
Funding for Human Subjects Research:
This project does not involve the use of multiple protocols/subprojects.
Identifier or number: 01-7563-E01
Institutional Review Board (IRB) Review:
Type of Review: Expedited
Approving Institution: University of Washington
Most recent approval: 03/13/01
IRB approval number: 01-7563-E01
Additional IRB approvals from other institutions:
Type of Review: Expedited
Approving Institution: Pacific Northwest National Laboratory
Most recent approval: 04/07/01
IRB approval number: 2001-19
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 15
Reporting period for number of human subjects:
Fiscal Year 2001
Type(s) of Human Subjects Involvement:
The objective of the project is to improve the transparency of long-term environmental cleanup decisions by designing a Decision Mapping System for a particular decision at the Hanford Site. The investigator will ask project participants to comment on a world-wide-web tool that represents long-term decisions in various ways and to collect data regarding their comments.
Methodology: The study will proceed in two major phases: design and evaluation. The purpose of the design phase is to work with affected and involved stakeholders to better understand the meaning of transparency and develop the Decision Mapping System. In the evaluation phase a broader range of stakeholders will help evaluate the ability of the system to promote transparency.
Involvement of Human Subjects:
1. Human subjects will be involved during the design phase through a series of in-depth individual and focus group interviews. The purpose of these interviews is to explore the meaning of transparency with active Hanford stakeholders, to prioritize the goals of transparency, and to validate the pursuit of certain information structures to achieve the transparency goals. Human subjects will also be involved in the evaluation phase in three ways. First there will be follow-up individual and focus group interviews with the stakeholders that participated in the design phase and others. Second, a web-based questionnaire will be conducted via the Internet. Measures will be taken to separate identifying information from questionnaire responses. Third, statistics about web page usage will be collected unobtrusively to determine the process by which users are appropriating the different information structures.
2. Risks and benefits: Subjects expected to take part in this research are not likely to be members of vulnerable populations. No injuries, undue stress, invasions of privacy or other side effects are anticipated as a result of this research. It is possible that certain questions could produce discomfort for subjects involved focus groups or interviews, but no more discomfort than might be expected during the normal course of a work day. At the beginning of every interaction, subjects will be reminded that participation is voluntary and if they become uncomfortable, they may choose to refrain from answering any questions. Individuals will benefit from this study by learning about Hanford decision-making processes and requirements. It is conceivable that they could do this on their own, but the Decision Mapping System is expected to make the relevant information more transparent (clearer, easier to access, more coherent, and more logical). Ideally, this knowledge will make subjects better (more informed) participants in the ongoing dialogue about nuclear waste management.
3. Privacy/Confidentiality/Consent: All subjects participating in focus groups and/or interviews will be asked to give written consent before participating in the study. An assurance of anonymity will be provided as part of the introductory material for the survey.
"Cross-Sectional Population Survey of Residents Living Near the U.S. DOE Nuclear Facilities"
Principal Investigator: Dr. Michael R. Greenberg, Rutgers University
Project started in: 2001
Funding for Human Subjects Research:
This project does not involve the use of multiple protocols/subprojects.
Identifier or number: Survey Protocol
Institutional Review Board (IRB) Review:
Type of Review: Expedited
Approving Institution: University of Arizona
Most recent approval: 09/17/01
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 150
Reporting period for number of human subjects:
Fiscal Year 2001
Type(s) of Human Subjects Involvement:
This project is a telephone survey to be conducted via random digit dialing. During this fiscal year, a pilot test was carried out in order to fine tune the questionnaire. The full survey will be carried out in fiscal year 2002. The goals of the study are to obtain data about (1) public understandings and perceptions about stewardship and (2) the correlates of those understandings and perceptions.
About 150 people were surveyed for the pilot test. Participation was entirely voluntary and the purpose of the study was explained to the respondents. There is no risk to respondents because responses will be anonymous, identifiable only by certain demographic characteristics which will be used as explanatory variables in describing the aggregate data. Questions are not sensitive in nature but deal with perceptions and preferences about nearby nuclear facilities.