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: 11
| PNNL-87-23 | "Therapy of Lymphoma/Leukemia with Monoclonal Antibodies" |
| PNNL-93-3 | "Comprehensive Epidemiologic Data Resource (CEDR) Related Tasks" |
| PNNL-99-5 | "Hanford Cultural Resources Project" |
| PNNL-02-25 | "Lighting Quality, Task Performance, and Well Being" |
| PNNL-03-04 | "General Services Administration Workplace 20-20" |
| PNNL-04-01 | "Proteomics Research Resource for Integrative Biology" |
| PNNL-05-01 | "Development of a Training Tool for Radiological Detection in U.S. Ports" |
| PNNL-06-03 | "Air Cargo Pilot Program" |
| PNNL-07-07 | "Mechanisms of Cutaneous Vasodilation in Humans" |
| PNNL-07-08 | "Design for Geovisual Synthesis" |
| PNNL-07-10 | "Center for Novel Biomarkers of Response" |
Other projects of interest associated with this site:
| NIOSH-95-004 | "Leukemia Case-Control Study" |
| UOW-96-DE-FC03-96SF21258 | "Medical Surveillance Program/Former DOE Hanford Production Workers" |
| NIOSH-97-007 | "Cohort Mortality Study of DOE Chemical Laboratory Workers" |
| CPWR-05-96SF21262 | "The Building Trades National Medical Screening Program" |
"Therapy of Lymphoma/Leukemia with Monoclonal Antibodies"
Principal Investigator: Dr. Darrell R. Fisher, Pacific Northwest National Laboratory
Project started in: 1987
Status of the Research this Fiscal Year:
Recruitment and/or enrollment of new participants or review of records/specimens continue.
Funding for Human Subjects Research:
This project does not involve the use of multiple protocols/subprojects.
Identifier or number: 87-23
Institutional Review Board (IRB) Review:
Type of Review:
Full Board
Approving Institution: Pacific Northwest National Laboratory
Most recent approval: 04/13/07
Additional IRB approvals from other institutions:
Type of Review:
Full Board
Approving Institution: Fred Hutchinson Cancer Research Center
Most recent approval: 02/08/07
IRB approval number: 1366
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 27
Reporting period for number of human subjects:
Fiscal Year 2007
Type(s) of Human Subjects Involvement:
This protocol remains the same as reported earlier. The Pacific Northwest National Laboratory (PNNL) provides medical internal radiation dosimetry support and assistance to the Fred Hutchinson Cancer Research Center (FHCRC) 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 (b) 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 two individuals. Patient identifiers are maintained by the PI in his locked office and accessible only to him. A data management plan has been developed to ensure protection of data on this project.
"Comprehensive Epidemiologic Data Resource (CEDR) Related Tasks"
Principal Investigator: Dr. Jeff A. Buchanan, Pacific Northwest National Laboratory
Project started in: 1993
Status of the Research this Fiscal Year:
Recruitment and/or enrollment of new participants or review of records/specimens continue.
Funding for Human Subjects Research:
This project does not involve the use of multiple protocols/subprojects.
Identifier or number: 93-3
Institutional Review Board (IRB) Review:
Type of Review:
Expedited
Approving Institution: Pacific Northwest National Laboratory
Most recent approval: 04/15/07
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 2007
Type(s) of Human Subjects Involvement:
This protocol remains the same as reported earlier. Hanford worker radiation exposure, work history, and vital status records/data have been and are being utilized in epidemiologic studies conducted by National Institute for Occupational Safety and Health (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 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: Ms. Ellen P. Kennedy, Pacific Northwest National Laboratory
Project started in: 1999
Status of the Research this Fiscal Year:
Study is not currently enrolling subjects or enrollment of participants is currently suspended, but may resume in the future.
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: 08/27/07
IRB approval number: 99-5
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 2007
Type(s) of Human Subjects Involvement:
This protocol remains the same as reported earlier. The Cultural Resources Project assures DOE-Richland Operations Office (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, Pacific Northwest National Laboratory (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.
"Lighting Quality, Task Performance, and Well Being"
Principal Investigator: Ms. Carol C. Jones, Pacific Northwest National Laboratory
Project started in: 2002
Status of the Research this Fiscal Year:
Study is not currently enrolling subjects or enrollment of participants is currently suspended, but may resume in the future.
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: 07/20/07
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 2007
Type(s) of Human Subjects Involvement:
This protocol remains the same as originally reported. 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.
"General Services Administration Workplace 20-20"
Principal Investigator: Dr. Mary D. Zalesny, Pacific Northwest National Laboratory
Project started in: 2003
Status of the Research this Fiscal Year:
Recruitment and/or enrollment of new participants or review of records/specimens continue.
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: 04/09/07
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 50
Reporting period for number of human subjects:
Fiscal Year 2007
Type(s) of Human Subjects Involvement:
This protocol remains the same as originally reported. This research is being conducted for the Public Buildings Service (PBS) of the General Services Administration (GSA) as part of GSA's Workplace 20-20 Research Project. PBS has secured the participation of eleven federal governement agencies in several pilots of an innovative approach to workspace design/redesign that examines the inter-relationships among the physical environment, individual behavior, and organizational effectiveness. The pilots represent workspace design/redesign projects whose goals include improved communications, collaborations, and interactions among agency staff. Pacific Northwest National Laboratory (PNNL) has been asked to assist in the identification of the existing and post-design/redesign interaction networks in the pilots by using social network analysis. It is expected that successful designs/redesigns will lead to increased quality and breadth of communication/collaboration/interaction networks in each agency.
"Proteomics Research Resource for Integrative Biology"
Principal Investigator: Dr. Richard D. Smith, Pacific Northwest National Laboratory
Project started in: 2004
Status of the Research this Fiscal Year:
Recruitment and/or enrollment of new participants or review of records/specimens continue.
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: 11/03/06
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 2007
Type(s) of Human Subjects Involvement:
This P41 Research Resource from the National Institutes of Health/National Center for Research Resources (NIH/NCRR) will focus on the development and integration of novel analytical, instrumental, and biological strategies for studying expressed proteins, their complexes and post-translational modifications. Areas of development include single-chain antibody technology, improved mass spectrometry-based approaches for mammalian proteomics, and improved bioinformatics and software tools to analyze proteomics data. A component of the Resource is collaborative research projects with other NIH-funded researchers. Some of which will use established, commercially available human cell lines. The service component of the Resource makes the provision for establishing additional NIH-funded, collaborative interactions during the course of the project. These additional projects could potentially expand the scope to include human samples requiring IRB review and possibly Health Insurance Portability and Accountability Act (HIPAA) compliance from the collaborating institutions.
"Development of a Training Tool for Radiological Detection in U.S. Ports"
Principal Investigator: Dr. Richard A. Pappas, Pacific Northwest National Laboratory
Project started in: 2005
This project ended in fiscal year 2007.
Status of the Research this Fiscal Year:
Current study is completed.
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: 06/02/06
Explanation of IRB approval:
This project closed before the continuing review date of 06/02/07.
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 2007
Type(s) of Human Subjects Involvement:
A subject recently injected with a medical isotope, such as Iodine-130, for medical testing purposes is asked to ride in a vehicle or walk through a radiation portal monitor. The subject is then "scanned" by hand-held monitors by customs and border control officers who are being trained to detect different kinds of signals produced by in-vivo and external sources. Only, otherwise healthy, adults are solicited for this study and, while the IRB considered the risks to the subjects low, there was concern regarding possible vulnerability as a result of their recent tests. Also, the training is videotaped.
"Air Cargo Pilot Program"
Principal Investigator: Dr. Robert C. Thompson, Pacific Northwest National Laboratory
Project started in: 2006
This project ended in fiscal year 2007.
Status of the Research this Fiscal Year:
Current study is completed.
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: 06/15/06
IRB approval number: 2006-03
Explanation of IRB approval:
This study ended before the IRB approval expired. This study should be closed in the system.
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 3
Reporting period for number of human subjects:
Year prior to last IRB approval date
Type(s) of Human Subjects Involvement:
The purpose of this research is to improve the overall effectiveness and efficiency of airline security by using non-invasive, non-instrusive sensors to detect human presence in shipping containers.
"Mechanisms of Cutaneous Vasodilation in Humans"
Principal Investigator: Dr. Christopher T. Minson, Pacific Northwest National Laboratory/University of Oregon
Project started in: 2007
Status of the Research this Fiscal Year:
Recruitment and/or enrollment of new participants or review of records/specimens continue.
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: 05/29/07
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 2007
Type(s) of Human Subjects Involvement:
The purpose of this research is to study vascular function as it pertains specifically to circulation in the skin. Dr. Minson is interested in the neural and non-neural mechanisms by which skin blood flow is able to increase under a variety of different stimuli and perturbations, including 1)non-painful local heating of a small area of skin, 2) whole body heat stress, 3) short term occlusion of blood flow with resultant reactive hyperemia, and 4) isometric handgrip exercise, all of which have been used previously as a means to study vascular function. All human subject activities are conducted at the University of Oregon as approved by their IRB. Risk to subjects, who are fully consented, is minimal.
"Design for Geovisual Synthesis"
Principal Investigator: Dr. Richard May, Pacific Northwest National Laboratory
Project started in: 2007
Status of the Research this Fiscal Year:
Recruitment and/or enrollment of new participants or review of records/specimens continue.
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: 07/20/07
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 2007
Type(s) of Human Subjects Involvement:
This work is intended to inform the design of new visualization tools to support the result-gathering and organization stage of visual analytics. Specific objectives are to: a) characterize the current methods that analysts use to synthesize analytical results, b) identify new strategies for visually synthesizing analytical results, and 3) create interactive prototype synthesis tools. The IRB has determined that this research presents minimal risk to the subjects who will be fully consented and whose privacy is adequately protected.
"Center for Novel Biomarkers of Response"
Principal Investigator: Dr. Joel Pounds, Pacific Northwest National Laboratory
Project started in: 2007
Status of the Research this Fiscal Year:
Project funded, but no participants have been enrolled to date.
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: 07/20/07
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 2007
Type(s) of Human Subjects Involvement:
The ultimate goal of the National Institutes of Health (NIH) Exposure Biology Program is to understand the development and progression of complex disease by precisely, accurately, and quantitatively asessing the individual's exposure to environmental stressors and the individual's responses to these stressors. The PNNL U54 Center will apply state-of-the-art proteomic and sensor technologies to provide the National Institute of Environmental Health Sciences (NIEHS) with a database of mode-of-action informing biomarkers of response and reagents for selected markers tested, validated in humans and informed by parallel studies in mice, and deployed on (a) a laboratory-based Enzyme-Linked ImmunoSorbent Assay (ELISA) Microarray platform and(b) on a robust, clinic-deployable nanoparticle-based sensor suitable for use in large-scale human biomonitoring studies to evaluate the interaction of genes and the environment. Results from the U54 Center will also improve the scientific community's ability to compare contracts and extrapolate biomarkers between humans and mice. Human plasma gathered at the University of Utah will be provided to PNNL for this study. All interaction with subjects will take place at the University of Utah, under the direction of Dr. Mark Leppert who has provided documentation of current IRB approval and consent.