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: 9
| 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-99-6 | "Communicating Effectively with NABIR Stakeholders" |
| 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-04-04 | "Engineering Device Surfaces that Instruct Cell Behavior" |
| PNNL-04-08 | "Sigma Xi Postdoc Survey" |
Other projects of interest associated with this site:
| NIOSH-95-004 | "Leukemia Case-Control Study" |
| NIOSH-96-023 | "Ionizing Radiation and Mortality Among Hanford Workers" |
| 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-Site Case-Control Study of Lung Cancer and External Ionizing Radiation" |
| ADEC-00-DE-FC03-02-EH02039 | "" |
"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: 04/20/04
Additional IRB approvals from other institutions:
Type of Review: Full Board
Approving Institution: Fred Hutchinson Cancer Research Center
Most recent approval: 02/11/04
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 60
Reporting period for number of human subjects:
Fiscal Year 2004
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 (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 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
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: 04/08/04
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 2004
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: 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: 08/24/04
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 10
Reporting period for number of human subjects:
Fiscal Year 2004
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.
"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 2004.
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: 05/01/04
Explanation of IRB approval:
Final Report submitted 5/1/04.
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 2004
Type(s) of Human Subjects Involvement:
The protocol remains the same as orginally reported. 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.
"Lighting Quality, Task Performance, and Well Being"
Principal Investigator: Ms. Carol C. Jones, 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: Expedited
Approving Institution: Pacific Northwest National Laboratory
Most recent approval: 07/22/04
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 2004
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
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: 04/10/04
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 17
Reporting period for number of human subjects:
Fiscal Year 2004
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
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: 09/02/04
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 2004
Type(s) of Human Subjects Involvement:
This P41 Research Resource from 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 of the project to include human samples requiring IRB review and possibly HIPAA compliance from the collaborating institutions.
"Engineering Device Surfaces that Instruct Cell Behavior"
Principal Investigator: Ms. Heather Mottaz, Pacific Northwest National Laboratory
Project started in: 2004
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: 02/09/04
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 10
Reporting period for number of human subjects:
Fiscal Year 2004
Type(s) of Human Subjects Involvement:
The purpose of this research is to learn more about how human blood cells respond to synthetic materials and to compare these processes with the normal wound healing response. The results of the study will be used to design new synthetic materials to be used as medical implants.
"Sigma Xi Postdoc Survey"
Principal Investigator: Ms. Christine Espy, Pacific Northwest National Laboratory
Project started in: 2004
This project ended in fiscal year 2004.
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: 06/17/04
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 110
Reporting period for number of human subjects:
Fiscal Year 2004
Type(s) of Human Subjects Involvement:
Sigma Xi (the Scientific Research Society) has asked PNNL postdoctoral staff members to participate in a national survey designed to gain a better understanding of postdoctoral research experience and enable research institutions to benchmark their policies and practices against peer institutions and enhance their postdoctoral programs.