Ms. Sherry E. Davis Cross
902 Battelle Blvd.
K9-81
Richland, WA 99352
Phone: 509-375-3610
Fax: 509-372-6328
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: DOE.MPA.PNNL96-2000
Number of Human Subjects Projects reported: 5
Project Identifier: PNNL-95-5
Project Title:
Field Applicability of an Exposure-To-Risk Monitoring System
Principal Investigator:
Dr. Karla D. Thrall
Principal Investigator's Institution: Pacific Northwest National Laboratory
Project started in: 1995
This project ended in Fiscal Year 1996.
Project Funding Information:
Project received funding in Fiscal Year 1996.
Project used human subjects in Fiscal Year 1996.
Funding Sources:
Total Funding: $40,000
Project does not involve use of multiple protocols/subprojects.
IRB Review:
Type of Review: Expedited
Most Recent Approval: April 19, 1996
Number of Human Subjects who participated in this project/protocol during
FY 1996 (10/1/95 - 9/30/96): 4
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.
Informed Consent will be obtained during initial discussions with the worker population at the time of acceptance into the demonstration. Researchers believe the volunteers are very interested in the feedback on how the exposure to carbon tetrachloride is interpreted by the scientific community in terms of potential risk. Carbon tetrachloride is the only substance being measured in this test. Privacy and confidentiality of the data obtained is documented as part of the Informed Consent.
Project Identifier: PNNL-96-94-4
Project Title:
PBPK Breath Analysis Instrumentation Demonstration
Principal Investigator:
Dr. Karla D. Thrall
Project started in: 1996
Project Funding Information:
Project received funding in Fiscal Year 1996.
Project did not use human subjects in Fiscal Year 1996.
Explanation:
Activities involving Human Subjects will commence in Fiscal Year 1997
Funding Sources:
Project does not involve use of multiple protocols/subprojects.
IRB Review:
Type of Review: Full Board
Most Recent Approval: April 01, 1996
Number of Human Subjects who participated in this project/protocol during
FY 1996 (10/1/95 - 9/30/96): 0
Type of Human Subjects Involvement:
The goal of this research is to develop procedures and demonstrate the use of a portable or semi-portable real-time monitoring instrument for characterizing human tissue levels of volatile chemicals in waste-site cleanup workers - in this case, carbon tetrachloride.
Approximately 12 Human Subjects will be sought from staff at the carbon tetrachloride VOC-Arid integrated demonstration site near Z-9 in the 200 West Area. They will be asked to breathe into a breath-inlet system connected to a mass spectrometer for a period of 2-3 minutes upon entering and exiting the chemical hazards control zone in which they work. Carbon tetrachloride in exhaled breath will be identified and quantified. Workers will not be exposed to any chemical other than that which occurs in their routine cleanup activities.
Risk: Readings are expected to be well within allowable occupational exposures. Standard medical practices will be used to minimize any risk of respiratory infection which could result from use of the breath-inlet device and appropriate confidentiality practices and Informed Consent will be employed according to federal regulation.
Project Identifier: PNNL-96-1
Project Title:
Imaging Neurological Processes of the Human Brain
Principal Investigator:
Dr. H. Dale Collins
Project started in: 1996
This project ended in Fiscal Year 1996.
Project Funding Information:
Project received funding in Fiscal Year 1996.
Project used human subjects in Fiscal Year 1996.
Funding Sources:
In FY96 - Dr. Peter Fox, - U. of Texas Hospital - $25,000 - Dr. Jeff Erickson - Good Samaritan Hospital, Portland, OR $5,000
Project does not involve use of multiple protocols/subprojects.
IRB Review:
Type of Review: Full Board
Most Recent Approval: July 08, 1996
Number of Human Subjects who participated in this project/protocol during
FY 1996 (10/1/95 - 9/30/96): 3
Type of Human Subjects Involvement:
The objective of this project is to conduct basic imaging research of the EEG signals generated in the cortex of the human brain using holographic imaging technology. Doctors at two medical institutions will gather data from volunteers using a 64 channel system and shifting an electrode cap which will be placed on the volunteer's scalp. The cap, with 64 electrodes spaced approximately 1.4cm apart, will be implemented over a 10cm x 10 cm aperture and will be shifted approximately three times to collect the data. Volunteers will be fitted with an elastic cap containing embedded electrodes or a net of elastically connected plastic tubes that hold wet sponges against their scalp. Several location on their face or behind their ears will be cleaned with an alcohol pad and an electrode will be attached to those sites. A small amount of electrode jelly will be applied to make good contact and the skin under each electrode will be gently rubbed to permit brain waves to be recorded clearly. Volunteers will be seated in a comfortable chair in a quiet room and asked to listen to a series of sounds or spoken words presented over headphones or to view images or words on a computer monitor. They will be asked to make decisions about what they see or hear and provide a response. Total time will be typically 2-6 hours, with frequent breaks as needed. Some volunteers may be asked to return for MRI scans to help determine which areas of the brain are generating the electrical signals. Risks associated with this study, such as sensitivity to the electrode gel are considered minimal.
Data for this work is stored at the participating hospitals under anonymous computer code. Confidentiality and privacy are addressed in the Informed Consent. Informed Consent, which is obtained by the research physician, has been approved by both the hospital IRB and the PNNL IRB.
Project Identifier: PNNL-96-20
Project Title:
Study of Heat Stress and Performance in Carpenters at DOE Sites (Courtesy Review)
Principal Investigator:
Mr. Wilfred Cameron
Principal Investigator's Institution: United Brotherhood of Carpenters Health and Safety Fund
Project started in: 1996
Project Funding Information:
Project received funding in Fiscal Year 1996.
Project did not use human subjects in Fiscal Year 1996.
Explanation:
This project was funded 9/29/96 for work to be conducted in Fiscal Year 1997
Funding Sources:
Activities involving human subjects will commence in Fiscal Year 1997
Project does not involve use of multiple protocols/subprojects.
IRB Review:
Type of Review: Full Board
Most Recent Approval: September 24, 1996
Number of Human Subjects who participated in this project/protocol during
FY 1996 (10/1/95 - 9/30/96): 0
Type of Human Subjects Involvement:
The objective of this work is to identify factors which place people at risk of heat stress by studying volunteers working under hot and cool conditions. Factors under study include workplace temperature, work effort level, work duration, physical condition, and medical history. One hundred (100) volunteers doing routine work, using protective clothing and in containment will be tested during the summer months for the effects of heat stress. Their temperature and activity levels will be closely monitored during their work day to obtain objective evidence of the physiological condition and the development of heat stress. Urine samples and weight will be taken 3 times a day to determine fluid balance and fluid consumption. Cognitive, motor (strength) and balance tests will be given in the morning (baseline) and when they complete work to identify early indicators of heat stress onset, such as changes in behavioral performance and physiological measures of blood pressure, pulse, temperature and hydration.
Risk to the volunteers, who will perform no more than their routine work activities during this study, is minimal.
Informed Consent will be obtained by researchers following an information/training session. Confidentiality and privacy issues are addressed as part of Informed Consent.
Project Identifier: PNNL-96-95-3
Project Title:
Noninvasive Approach to Testing for H. Pylori Infections Using Breath Analysis
Principal Investigator:
Dr. James J. Toth
Project started in: 1996
Project Funding Information:
Project received funding in Fiscal Year 1996.
Project did not use human subjects in Fiscal Year 1996.
Explanation:
Activities involving Human Subjects will commence in Fiscal Year 1997
Funding Sources:
Project does not involve use of multiple protocols/subprojects.
IRB Review:
Type of Review: Full Board
Most Recent Approval: October 11, 1996
Number of Human Subjects who participated in this project/protocol during
FY 1996 (10/1/95 - 9/30/96): 0
Type of Human Subjects Involvement:
1. Volunteers will drink Ensure to determine the impact of the meal upon ammonia concentrations normally found in the breath. 2. Another set of volunteers, diagnosed with H Pylori will drink 100 mg of FDA-approved N-14/C-13 urea
The objective of this research is to develop a low-cost noninvasive diagnostic test to identify the Helicobacter Pylori bacteria through breath analysis. Tests will be conducted to determine the specificity, sensitivity, efficacy and safety of the ammonia-based urea breath test using the near-infrared, laser-based, spectrometer. The study will be conducted in the following stages:
Instrument Development
Animal Studies
PBPK Modeling (In animals)
Preliminary Meal Study (first set of volunteers)
Pilot Study using Urea (second set of volunteers)
Because it is a simple test to determine the effects of a common breakfast drink on naturally occurring ammonia in the human mouth, the first set of volunteers will be solicited from the general public by the physician involved in this work. The second set of volunteers will be solicited from patients of the doctor who have been diagnosed with helicobacter pylori by GI endoscopy and are currently under treatment for the infection. Informed Consent has been developed for each of the tests in two languages.
Volunteers will be asked to fast for 6 hours prior to the tests and in both cases, preliminary base line breath tests will be administered. In the first test, volunteers will be given a standard breakfast drink and breath tests will be administered to determine the impact of the drink on naturally occurring ammonia in the mouth. In the patient test, volunteers will be given a water solution, containing 100 mg of FDA-approved N-14/C13 urea and 5 breath samples will be taken over the next 40 minutes.
Risk: All tests will be administered and monitored in the doctor's office. Because Urea is a naturally occurring bodily substance and the urea being administered is of a very low level, in addition to being FDA approved for these kinds of tests, there is minimal risk associated with the study.