Ms. Sherry E. Davis
902 Battelle Blvd.
Richland, WA 99352
Phone: 509-375-3610
Fax: 509-375-3621
Email: se_davis@pnl.gov
Projects are approved by an IRB located at: Pacific Northwest National Laboratory.
The approving IRB operates under a Multiple Project Assurance (MPA) recognized by DOE or by the Department of Health and Human Services (HHS).
MPA number of the IRB: PNL-MPA-2
Number of Human Subjects Projects reported: 2
Project Identifier: PNNL-86-HSC93-5
Project Title:
Mechanisms of Radon-Induced DNA Damage in Selected Cells
Principle Investigator:
Dr. Ralph F. Jostes
Project started in: 1986
Project Funding Information:
Project received funding in Fiscal Year 1995.
Project used human subjects in Fiscal Year 1995.
Funding Sources:
Project does not involve use of multiple protocols/subprojects.
IRB Review:
Type of Review: Full Board
Most Recent Approval: March 15, 1995
Number of Human Subjects in the Last Reporting Period for this Project: 6
(Reporting periods vary.)
Type of Human Subjects Involvement:
The primary thrust of this research is to develop a fundamental understanding of the mechanisms involved in radon-induced deoxyribonucleic acid (DNA) damage, specifically those lesions implicated in the generation of cancer. The effects of radon exposure on DNA and the molecular processes involved in mutations will be analyzed for a number of cell types, including human cell lines such as peripheral blood lymphocytes. This project also conducts and collaborates in studies relating to dosimetry, molecular mutagenesis, cytogenetics and DNA damage and repair with researchers at Pacific Northwest Laboratory (PNL) and elsewhere. This project serves as a core facility for the in vitro radon exposure facility. Data from the in vitro system will be compared with data from the PNL microbeam facility, and this project will act in support of the microbeam facility. An understanding of the mechanisms involved in alpha particle-induced DNA damage will strengthen the overall understanding of processes involved in radiation-induced carcinogenesis.
PNL's in vivo and in vitro radon exposure systems will be collaboratively used to expose animals and to irradiate cell cultures for the mechanistic study of chromosomal aberrations, mutations, and DNA strand-break production and repair. This project will also provide biological support to the PNL microbeam. The resulting mechanistic data will ultimately be incorporated into oncogenic models to facilitate extrapolation of high exposure rate and high exposure level data, typically observed in worker exposures, to environmental levels of radon exposure.
Only blood will be drawn from the human subjects. There are possible risks of bruising at the site of needle puncture, the development of a hematoma, and infection from the needle.
Project Identifier: PNNL-95-HSC95-5
Project Title:
Field Applicability of an Exposure-To-Risk Monitoring System
Principle Investigator:
Dr. Karla D. Thrall
Project started in: 1995
Project Funding Information:
Project received funding in Fiscal Year 1995.
Project used human subjects in Fiscal Year 1995.
Funding Sources:
Total Funding: $140,000
Project does not involve use of multiple protocols/subprojects.
IRB Review:
Type of Review: Expedited
Most Recent Approval: August 03, 1995
Number of Human Subjects in the Last Reporting Period for this Project: 5
(Reporting periods vary.)
Type of Human Subjects Involvement:
The ultimate goal of this research is to demonstrate field-applicability of a semi-portable, real-time monitoring instrument capable of characterizing human tissue levels of volatile chemicals in waste-site cleanup workers at Hanford and elsewhere in the DOE complex. The development of this instrument will greatly enhance ongoing efforts to improve the health protection of workers in the field. This research will provide the means of relating a quantitative measurement of organic chemicals in the exhaled breath of a worker and the associated health risk based on exposure/risk conversion factors determined by the Environmental Protection Agency (EPA).
The participating workers will pass through the system upon entry and exit of the chemical hazards control zone. Workers will be identified by code-number, which will also be used to access a worker's data file containing individual physiological characteristics--body weight and height. Industry standard chemical sensors will be placed on the workers to record chemical exposures. The time of stay in the control zone will be recorded, chemical exposure will be analyzed immediately upon exit of the site using the chemical sensor connected to a mass spectrometer, and the workers will breathe for 1-2 minutes into a breath-inlet system connected to a mass spectrometer. Carbon tetrachloride in exhaled breath will be identified and quantified. The concentration data in exhaled breath will feed into a physiologically-based pharmacokinetic model to determine the worker's target tissue dose (the liver, in the case of carbon tetrachloride) in terms of milligrams per kilogram of tissue per day. This information will be combined with existing methodologies in risk assessment (conversion factors from exposure to dose to risk as predetermined by EPA) to "instantly" determine the exposure/dose/risk of each worker participating in the demonstration.
Risks: This is a demonstration of an instrument to determine worker health risk. Workers will not be exposed to any chemical in any situation other than their routine cleanup activities. In theory, a slight risk of respiratory infection could accompany the use of the breath-inlet device by several different people.