Ms. Sherry E. Davis
902 Battelle Blvd.
K1-67
Richland, WA 99352-
Phone: 509-375-3610
Fax: 509-375-2592
E-mail: Sherry.Davis@pnl.gov
Number of Human Subjects projects reported: 8
| PNNL-87-23 | "Therapy of Lymphoma/Leukemia with Monoclonal Antibodies" |
| PNNL-87-30 | "Retrospective Internal Dosimetry for Clinical and Experimental Radioimmunotherapy" |
| PNNL-93-3 | "Comprehensive Epidemiologic Data Resource (CEDR) Related Tasks" |
| PNNL-99-5 | "Hanford Cultural Resources Project" |
| PNNL-99-6 | "Communicating Effectively with NABIR Stakeholders" |
| PNNL-00-1 | "Energy Efficient Lighting Applications and Productivity at the Internal Revenue Service Andover Data Center Facility" |
| PNNL-01-28 | "Columbia River Recreational Survey" |
| PNNL-02-25 | "Lighting Quality, Task Performance, and Well Being" |
Other projects of interest associated with this site:
| NIOSH-95-004 | "Leukemia Case-Control Study" |
| NIOSH-95-022 | "Study of Heat Stress and Performance in Carpenters at DOE Sites" |
| NIOSH-95-033 | "Comprehensive Occupational Health Surveillance" |
| NIOSH-95-034 | "Work Histories - Evaluating New Participatory Methods" |
| NIOSH-96-023 | "Ionizing Radiation and Mortality Among Hanford Workers" |
| CRESP-97-27-0228-C | "Screening for establishing the prevalence of Beryllium sensitization at Hanford " |
| UOW-96-DE-FC03-96SF21258 | "Medical Surveillance Program/Former DOE Hanford Production Workers" |
| CPWR-96-DE-FC03-96SF21262 | "The Hanford Building Trades Medical Screening Program " |
| NIOSH-97-007 | "Cohort Mortality Study of DOE Chemical Laboratory Workers" |
| NIOSH-97-009 | "Multi-State Case-Control Study of Lung Cancer and External Ionizing Radiation" |
| NIOSH-98-032 | "Surveillance Methods for Solvent-Related Hepatotoxicity" |
| CRESP-01-7392-C01 | "Evaluation of Occupational Health Services for Subcontractors at Hanford" |
"Therapy of Lymphoma/Leukemia with Monoclonal Antibodies"
Principal Investigator: Dr. Darrell R. Fisher, Pacific Northwest National Laboratory
Project started in: 1987
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: 87-23
Institutional Review Board (IRB) Review:
Type of Review: Full Board
Approving Institution: Pacific Northwest National Laboratory
Most recent approval: 06/11/02
Additional IRB approvals from other institutions:
Type of Review: Full Board
Approving Institution: Fred Hutchinson Cancer Research Center
Most recent approval: 06/26/02
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 20
Reporting period for number of human subjects:
Fiscal Year 2002
Type(s) of Human Subjects Involvement:
The Pacific Northwest National Laboratory provides medical internal radiation dosimetry support and assistance to the Fred Hutchinson Cancer Research Center in their study to determine the efficacy of iodine-131-labeled monoclonal antibodies as a therapeutic agent against (a) non-Hodgkin's B-cell lymphoma, and (2) acute myelogenous leukemia in human cancer patients. The FHCRC study involves a Phase I/II dose-escalation study to determine limiting normal organ toxicity (Phase I) and optimum treatment regimes (Phase II). Work conducted at PNNL involves radiation dosimetry calculations for the tracer studies that are performed before any decisions are made concerning treatment. Work conducted at PNNL involves the risk of miscalculation and potential for loss of patient privacy. Calculations are checked and double checked by no less than 2 individuals. Patient identifiers are maintained by the PI in his locked office and assessable only to him. A data management plan has been developed to ensure protection of data on this project.
"Retrospective Internal Dosimetry for Clinical and Experimental Radioimmunotherapy"
Principal Investigator: Dr. Darrell R. Fisher, Pacific Northwest National Laboratory
Project started in: 1987
Funding for Human Subjects Research:
This project does not involve the use of multiple protocols/subprojects.
Institutional Review Board (IRB) Review:
Type of Review: Expedited
Approving Institution: Pacific Northwest National Laboratory
Most recent approval: 10/16/01
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 2002
Type(s) of Human Subjects Involvement:
PNNL performs retrospective internal dosimetry calculations for NeoRx/NIH in a study being conducted to determine the efficacy of Yttrium-90-labeled monoclonal as a therapeutic agent against non-Hodgkin's lymphoma. Risks to subjects from the work being performed at PNNL involve only the possible release of private data. A data management plan has been developed to ensure the protection of that data. Only the PI has access to the patient data, which is maintained in his locked office.
"Comprehensive Epidemiologic Data Resource (CEDR) Related Tasks"
Principal Investigator: Dr. Jeff A. Buchanan, Pacific Northwest National Laboratory
Project started in: 1993
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: 93-3
Institutional Review Board (IRB) Review:
Type of Review: Expedited
Approving Institution: Pacific Northwest National Laboratory
Most recent approval: 04/16/02
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 2002
Type(s) of Human Subjects Involvement:
Hanford worker radiation exposure, work history and vital status records/data have been, and are being utilized in epidemiologic studies conducted by NIOSH and NIOSH-subcontractors under their memorandum of understanding with DOE. These studies often involve combining Hanford worker data with data from other DOE sites. The primary objective of such studies is to investigate the relationship of radiation exposures and worker health effects, including mortality.
Human subjects are not involved in the overall, long-term Comprehensive Epidemiologic Data Resource (CEDR) study (93-3). However, identifiable records are used in this particular task (93-3-1). Federal Regulations regarding the proper access, use and protection of the records which are promulgated in Federal Regulation 10 CFR Part 1008 (Volume 60, No. 124, pp. 33520-33522) and clarified in the DOE/EH-556 "Access Handbook for Conducting Health Studies at DOE Sites apply to the management of these records.
"Hanford Cultural Resources Project"
Principal Investigator: Dr. Darby C. Stapp, Pacific Northwest National Laboratory
Project started in: 1999
Funding for Human Subjects Research:
This project does not involve the use of multiple protocols/subprojects.
Institutional Review Board (IRB) Review:
Type of Review: Expedited
Approving Institution: Pacific Northwest National Laboratory
Most recent approval: 08/09/02
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 35
Reporting period for number of human subjects:
Fiscal Year 2002
Type(s) of Human Subjects Involvement:
The Cultural Resources Project assures DOE-RL that potential impacts of site operations on cultural resources at Hanford are identified and evaluated, and that historic properties are protected in a systematic, documented manner as required by National preservation, protection, religious freedom, and repatriation acts. In addition, PNNL provides DOE/RL with information it needs to interact with federal, state, tribal agencies, and other parties on technical cultural resource issues, thereby assisting DOE-RL in maintaining positive working relationships with organizations concerned with the cultural heritage of the Hanford Site.
PNNL conducts cultural resource reviews whenever a Hanford Site project or activity has the potential to disturb the ground surface, or affect historic structures.
Human Subjects may be involved during various steps in the process in the identification and evaluation of properties; they may be included in interviews, consultations, and ethnographic field work, including the gathering of oral histories.
Although risk to the human subjects is minimal, informed consents, photograph release forms and methods for conducting, recording and storing records have been developed to ensure that their privacy, rights and welfare are fully protected.
"Communicating Effectively with NABIR Stakeholders"
Principal Investigator: Dr. Gordon R. Bilyard, Pacific Northwest National Laboratory
Project started in: 1999
Funding for Human Subjects Research:
This project does not involve the use of multiple protocols/subprojects.
Institutional Review Board (IRB) Review:
Type of Review: Expedited
Approving Institution: Pacific Northwest National Laboratory
Most recent approval: 05/14/02
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 2002
Type(s) of Human Subjects Involvement:
The objectives of this project are to develop a representative picture of stakeholder issues for the Natural and Accelerated Bioremediation Research (NABIR) program, and to develop and help NABIR scientists use new tools to communicate effectively with stakeholders across the NABIR complex. This project supports the NABIR program in developing the necessary effective partnerships with internal and external stakeholders across the nation who have an interest in NABIR activities-either in the laboratory or the field. The project: 1) educates and engages stakeholders about NABIR activities, 2) develops and helps implement communication tools that scientists can use to invite and enhance stakeholders' understanding of the NABIR program and its values, 3) assists scientists in actively addressing stakeholder concerns during the conduct of their research, and 4) assists in transferring knowledge between the disciplines of communication and science. Involved stakeholders receive an information sheet and sign-up for participation.
"Energy Efficient Lighting Applications and Productivity at the Internal Revenue Service Andover Data Center Facility"
Principal Investigator: Mr. Eric E. Richman, Pacific Northwest National Laboratory
Project started in: 2000
Funding for Human Subjects Research:
This project does not involve the use of multiple protocols/subprojects.
Institutional Review Board (IRB) Review:
Type of Review: Expedited
Approving Institution: Pacific Northwest National Laboratory
Most recent approval: 09/25/02
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 2002
Type(s) of Human Subjects Involvement:
Objectives: 1)Measure the impact of lighting on human performance, comfort, and satisfaction, 2) provide results that can be applied to the IRS facility-wide renovation in Andover; the significant lighting energy savings can be applied in a whole building analysis, allowing for a deeper level of energy savings through integrated design, and 3)provide results as a reference for other federal government office environments. This study will use a repeated measure, "mixed factor" design to evaluate lighting design at the Andover facility. Lighting design will be a "within subjects" factor, indicating that all workers will be exposed to a variety of lighting conditions. Other factors, such as "job type" will be considered. Worker satisfaction, environmental satisfaction and work performance will be measured, through questionnaires. As the work world gradually evolves into a mostly paperless office, it will be very important to know if office lighting has differential effects on workers who combine paper and computer work versus those who work solely with the computer. Subjects will be consented and assured that their participation is voluntary. To ensure anonymity, workers will be identified by number only, with all data analyzed and presented as group outcomes. Individual data will not be analyzed, nor will it be made available to any source.
"Columbia River Recreational Survey"
Principal Investigator: Dr. Amoret Bunn, Pacific Northwest National Laboratory
Project started in: 2001
This project ended in fiscal year 2002.
Funding for Human Subjects Research:
This project does not involve the use of multiple protocols/subprojects.
Institutional Review Board (IRB) Review:
Type of Review: Expedited
Approving Institution: Pacific Northwest National Laboratory
Most recent approval: 06/20/01
Explanation of IRB approval:
Project Closed 8/30/01
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 2002
Type(s) of Human Subjects Involvement:
Understanding recreation use is important to plans for the Columbia River corridor of the Hanford Site and the Hanford Reach National Monument. The purpose of this study is to establish a current baseline of recreation use and value on the Columbia River in the Tri-Cities vicinity to be used in estimating health and economic impact. Study teams will conduct interviews/surveys and observe activities of participants engaged in shore-based and boat-based activities at pre-determined sites on the Columbia River. They will identify themselves to potential interviewees and will carry a letter of introduction that clearly explains the research and ultimate use of data gained from the interviews. The subjects are free to decline participation at any time. No identifying information will be solicited from subjects who choose to participate in this study.
"Lighting Quality, Task Performance, and Well Being"
Principal Investigator: Ms. Judith Heerwagen, Pacific Northwest National Laboratory
Project started in: 2002
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: Pacific Northwest National Laboratory
Most recent approval: 07/22/02
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 2002
Type(s) of Human Subjects Involvement:
The objective of this study is to determine the effects of "best practice" office lighting on task performance and feelings of well-being over a complete working day. After the subjects, who will be solicited from a "temp" employment agency, are consented, they will conduct a variety of simulated work tasks under different lighting conditions and will be interviewed periodically to assess their current physical and emotional state. The subjects will not be personally identified in any of the materials gathered or maintained by the research project. Data gathered during the study will be used for the purposes of this research only. The employment agency will receive no information relating to the subject's participation in the research, even if they choose to leave the experiment early in the process.