Ms. Sherry
E. Davis-Cross
902 Battelle Blvd.
K1-67
Richland, WA 99352-
Phone: 509-375-3610
Fax: 509-375-2592
E-mail: Sherry.Davis-Cross@pnl.gov
Number of Human Subjects projects reported: 13
"Holographic Milllimeter Wave Real-Time Surveillance Imaging System"
Principal Investigator: Mr. Douglas L. McMakin, Pacific Northwest National Laboratory
Project started in: 1991
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: 03/20/00
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 2000 (10/1/99-9/30/2000)
Type(s) of Human Subjects Involvement:
The objective of this work is to collect microwave holographic images of professional models who have weapons, such as guns, knives, and simulated explosives, concealed under their clothing. These images will be used to develop privacy algorithms, based on neural network techniques, that will remove human features in an advanced concealed weapons surveillance commercial system. The models will stand in front of the microwave holographic camera for one to two seconds while front and back scans are taken. Images from the scans will be collected in a computer and assigned a code, such as "Model A". The models identities will never be associated with their personal images. Precautions have been taken to ensure there are two female models in attendance at all times and the models apply the "weapons" to themselves or to each other in private quarters. They receive an information packet that includes an explanation of the imaging system, millimeter wave imaging, and a sample of the type of images that will result from their participation, which they are free to see, as well.
"Comprehensive Epidemiologic Data Resource (CEDR) Related Tasks"
Principal Investigator: Dr. John J. Fix, 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: 93-3-1
Institutional Review Board (IRB) Review:
Type of Review: Expedited
Approving Institution: Pacific Northwest National Laboratory
Most recent approval: 04/06/00
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 44500
Reporting period for number of human subjects:
Fiscal Year 2000 (10/1/99-9/30/2000)
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.
"Field Evaluation of Polarized and Full Spectrum Polarized Lighting"
Principal Investigator: Mr. Eric E. Richman, Pacific Northwest National Laboratory
Project started in: 1996
This project ended in fiscal year 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: 01/08/00
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 18
Reporting period for number of human subjects:
Fiscal Year 2000 (10/1/99-9/30/2000)
Type(s) of Human Subjects Involvement:
The purpose of this research is to determine any potential energy savings associated with the use of full spectrum and polarized lighting in federal office spaces in place of current standard lighting. Over an 18-20 week period, the lighting in the subject's offices will be changed several times, and they will be asked to give their candid evaluation, once a week in a one-page survey, for how effective, comfortable, and useful the lighting is in each case. An initial survey will be conducted to gather basic information about the subjects and their current situation.
There is no risk to privacy as the identity of the human subjects will be coded and their responses to the survey will never be associated with their names. The subject will be notified of the study and their rights in a project announcement letter.
See project CRESP-97-27-0228-C.
Project Identifier: PNNL-97-10_V
Project Title: "Screening for Chronic Beryllium Disease at Hanford"
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"Handwriting Science, Moving From Art to Science"
Principal Investigator: Dr. Richard C. Hanlen, Pacific Northwest National Laboratory
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: Expedited
Approving Institution: Pacific Northwest National Laboratory
Most recent approval: 04/20/00
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 3500
Reporting period for number of human subjects:
Fiscal Year 2000 (10/1/99-9/30/2000)
Type(s) of Human Subjects Involvement:
Objective and Methodology: The defining purpose for this project is to enhance the accuracy and credibility of the US forensic document examination community by demonstrating an underlying scientific foundation that validates the premise of forensic document examination. Three objectives, when achieved, would satisfy this purpose: (1) validate the individuality of handwriting as a premise for document comparison as practiced by the US community of forensic document examiners (FDEs); (2) explore standardization of methods and procedures that demonstrate a valid scientific basis for handwriting examination, and (3) develop a tool or automated aid that would provide FDEs with practical, scientifically based, statistically valid, automated assistance in document comparison.
Involvement of Human Subjects: Objectives 1 and 2, which were accomplished in the first 3 years of this project, were reviewed as exempt. Objective 3 involves the exchange and use of pre-existing data sets (examplars) supplied by the client, some of which are identified, and some of which are of prisoners or known felons. To ensure protection of the identifiers, all project staff are required to read, sign, and adhere to a detailed set of procedures included in a Data Management Plan (DMP) developed specifically for this study. Access to the data is limited to project staff as authorized by the principal investigator. Upon receipt, all identifying data is immediately stripped from the documents and stored on a separate hard drive that is then stored in a locked vault and accessible only by the project manager and one other person. All media containing identifying information is kept in locked storage when not under the control of authorized project staff. No identifying information is transferred to locations other than those secured and operated by authorized staff who have read and signed the DMP. Only data and images completely "scrubbed" of all personal identifiers are used in the development of characterization algorithms and testing.
See project UOW-96-DE-FC03-96SF21258.
Project Identifier: PNNL-97-2_V
Project Title: "Medical Surveillance Program/Former DOE Hanford Production Workers"
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See project CPWR-96-DE-FC03-96SF21262.
Project Identifier: PNNL-97-5_V
Project Title: "Hanford Building Trades Medical Screening Project"
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"Fundamental Research on Solvent-laden Soils"
Principal Investigator: Dr. Karla D. Thrall, Pacific Northwest National Laboratory
Project started in: 1997
This project ended in fiscal year 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: Full Board
Approving Institution: Pacific Northwest National Laboratory
Most recent approval: 09/29/99
Explanation of IRB approval:
The project was completed before the 9/29/00 review was due.
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 5
Reporting period for number of human subjects:
Fiscal Year 2000 (10/1/99-9/30/2000)
Type(s) of Human Subjects Involvement:
The objective of this research is to determine real-time response for human percutaneous bioavailability of organic solvents in soil and water. This data will be used in biologically based dose-response models to estimate human health risk assessments.
Subjects will be exposed to various organic solvents (trichloroethylene) over varied amounts of time, either by a patch that holds the solvent against the skin, or by moving their hand through soil or water. At predetermined intervals, their breath will be analyzed to detect any biological uptake of the solvents.
Exposure to the solvents could make subjects dizzy. However, at the doses planned for the study, side effects and long term effects are not expected. Risk is considered minimal.
Pregnant volunteers, those with skin disease, or known allergic reaction to the solvents will be excluded from this project. All other subjects will be consented.
See project NIOSH-98-032.
Project Identifier: PNNL-98-7_V
Project Title: "Surveillance Methods for Solvent-Related Hepatotoxicity"
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"Hanford Cultural Resources Project"
Principal Investigator: Mr. 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: 08/29/00
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 2
Reporting period for number of human subjects:
Fiscal Year 2000 (10/1/99-9/30/2000)
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
This project ended in fiscal year 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: 05/15/00
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:
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 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 value, 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: 09/28/00
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 2000 (10/1/99-9/30/2000)
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.
"Groundwater/Vadose Zone Integration - System Assessment Capability"
Principal Investigator: Ms. Amoret L. Bunn, 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: 08/16/00
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:
The Groundwater/Vadose Zone Integration Project, System Assessment Capability (SAC) is currently developing tools and supporting data to assess the cumulative impacts to human and ecological health and the region's economy and cultures from waste that will remain at the Hanford Site after the site closes. SAC is looking at a greater breadth of risks and impacts than has been done on the Hanford Site in the past in response to requests by stakeholders and the public. Socio-cultural risk assessment is not a well-defined process, and SAC will be the first assessment at Hanford to consider such impacts. The portion of the socio-cultural risk assessment that will involve human subjects will evaluate how much of the Hanford Site and Columbia River will have concentrations of contaminants that exceed a level of concern. The concentration at which a contaminant becomes a concern is called a cultural threshold. Interviews with cultural groups will be conducted to determine the cultural thresholds, which will be used in the SAC assessment to calculate the acreage of the Hanford Site and portion of the Columbia River that is contaminated above those cultural thresholds. The results of the assessment will be included in the final report for the first iteration of SAC. Subjects will be contacted by phone and a meeting will be arranged between them and project staff at which time a presentation on the project will be given, focusing on the socio-cultural risk assessment and how the information collected will be used in the assessment. All subjects will be consented. No identifiers will be linked with the study results nor will they be reported in any manner.