Mr. Brad P. Buggar
U.S. Department of Energy
Idaho Operations Office
Idaho Falls, ID 83401-1562
Phone: 208-526-0833
Fax: 208-526-8789
E-mail: buggarbp@inel.gov
Number of Human Subjects projects reported: 3
| INEEL-90-95-001 | "Federal Aviation Administration (FAA) Explosive Detection System and Independent Validation and Verification Project" |
| INEEL-98-4 | "Tissue-Boron Analysis" |
| INEEL-02-IRB-02-002 | "SMC Uranium Background Bioassay Survey" |
Other projects of interest associated with this site:
| NIOSH-92-002 | "Cohort Mortality Study of Idaho National Engineering and Environmental Laboratory (INEEL)" |
| PACE-97-DE-FC03-97SF21512 | "Medical Surveillance For Former INEEL Workers" |
| NIOSH-97-009 | "Multi-State Case-Control Study of Lung Cancer and External Ionizing Radiation" |
"Federal Aviation Administration (FAA) Explosive Detection System and Independent Validation and Verification Project"
Principal Investigator: Ms. Carla Miller, Idaho National Engineering and Environmental Laboratory
Project started in: 1990
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: Idaho National Engineering and Environmental Laboratory
Most recent approval: 05/28/02
IRB approval number: INEL-IRB-001
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 15
Reporting period for number of human subjects:
Fiscal Year 2002
Type(s) of Human Subjects Involvement:
This is an ongoing project. The PI has received funding in 2002 to perform trace portal detection, including human contamination studies. The FAA placed the thumbprint test that was to be conducted in 1995 on hold. The electronic threat devices testing conducted in 1995 was completed and a final report was submitted to the FAA. There were no human subjects involved in testing in 1996. In 1997 and 1998, Explosives Longevity Testing, Fingerprint Testing, and Improvised Explosive Device Studies were conducted. These tests utilized both routine explosive handlers and non-routine handlers in activities that involved touching and handling various types of explosive materials. Explosives used were Composition C-4, Detasheet, Semtex A&H, TNT, Unigel Dynamite, and Red Dot Smokeless Powder. In these tests, personnel would perform various tasks with limited quantities of explosives. Tasks involved placing thumb and fingers on a small block of explosives from hand to materials such as paper or cardboard, and manipulating the explosives in a manner that simulates the construction of an improved explosive device (IED). At the conclusion of the handling of explosives, personnel would be sampled and evaluated using sensitive explosive detectors. Personnel that fabricated IEDs were asked to walk through portal monitor explosive detectors. The Longevity Tests required personnel to be evaluated after routine hand washing. The longevity study, fingerprint analysis, and IED contamination studies are completed. The FAA has requested and funded additional studies for luggage, boarding passes, and personnel contamination as well as continued portal explosive detector testing.
RISK: The risks from these activities are minimal. The potential concern of skin sensitization by contact with explosives did not materialize. Safety analysis (EF-30-9-042, Rev. C) shows the risk of death from explosion or fire from these tests to be extremely small, about one in 4 million/year. Material Data Safety Sheets will be present onsite for each type of explosive tested. The benefits are an improvement in the detection of explosives at airports resulting from an understanding of explosive particle transport on people, an evaluation of state of the art explosive detectors, and the determination of levels and lifetimes of explosives contamination on explosive handlers.
PRIVACY: The use of fingerprints are only required because of the unique property of fingerprints to transfer to particles to other materials. In no way will the identity of the participants be linked to any fingerprinting or sampling.
INFORMED CONSENT: The IC is reviewed and signed by the PI on 4/27/02.
"Tissue-Boron Analysis"
Principal Investigator: Dr. David Nigg, Idaho National Engineering and Environmental Laboratory
Project started in: 1998
Funding for Human Subjects Research:
This project does not involve the use of multiple protocols/subprojects.
Identifier or number: 4
Institutional Review Board (IRB) Review:
Type of Review: Expedited
Approving Institution: Idaho National Engineering and Environmental Laboratory
Most recent approval: 05/28/02
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 2002
Type(s) of Human Subjects Involvement:
Objective: Analyze boron content in tissue, blood, and in some cases cerebral-spinal fluid samples.
Methodology: The INEEL BNCT Program is party to a CRADA and several technology license agreements with a company named Neutron Therapies, LLC (NTL), an Idaho corporation currently based in La Jolla, California. The INEEL will be providing chemical analysis to determine boron content of tissue and blood samples sent to them. The analytical information we provide is then used by the experimenters who send us samples to determine boronated pharmaceutical uptake and kinetics of specific compounds they are using. Until 1999, all tissue and blood samples sent to us have been from in-vitro experiments or from in-vivo experiments performed using non-human subjects, primarily mice, rats and dogs. However, NTL is now ready to begin human testing of one particular boronated agent. NTL has submitted an Investigational New Drug Application (IND) to the FDA for these tests.
The actual administration of the boron pharmaceutical and the subsequent collection of the necessary tissue and blood samples will be done at the University of Washington School of Medicine. The INEEL IRB has deferred to the University of Washington's IRB for the collection of the tissue/blood samples.
RISK: There is no risk associated with the activities at the INEEL – there are only computations made on the blood samples sent to the INEEL by the University of Washington. The blood boron levels that are measured on the specimens sent to the INEEL are in the range where no toxicity is anticipated, based on prior animal studies. The only discomfort to the patient’s at the University of Washington is the venipuncture. If the PI at the University of Washington learns any new information as the study progresses that might affect the patient’s willingness to participate, they will be provided with that information.
However, the biodistribution study that the INEEL worked with UW on was completed last winter, 2001, with only one calculation made at the INEEL in 2002 on a specimen from the 2001 review. There was no UW IRB review in 2002.
PRIVACY: The identity of the blood and tissue samples are recorded by number only. The master list of names and record numbers will be maintained in a separate, locked filing cabinet at the University of Washington. Reports or scientific papers that may be written as a result of this study will not identify any individuals by name. All information gathered will be kept strictly confidential and will be seen only by people involved in this project. The U.S. Food and Drug Administration reserve the right to review study data which may contain identifying information. The patients participating in the study may withdraw from the study at any time without penalty or loss of benefits to which they are otherwise entitled.
CONSENT: There was not an IC for 2002, all biological specimens provided to the INEEL were processed in 2001.
"SMC Uranium Background Bioassay Survey"
Principal Investigator: Mr. Ted S. Bohn, Idaho National Engineering and Environmental Laboratory
Project started in: 2002
This project ended in fiscal year 2002.
Funding for Human Subjects Research:
This project does not involve the use of multiple protocols/subprojects.
Identifier or number: -002
Institutional Review Board (IRB) Review:
Type of Review: Expedited
Approving Institution: Idaho National Engineering and Environmental Laboratory
Most recent approval: 05/13/02
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 2002
Type(s) of Human Subjects Involvement:
Activities at the Specific Manufacturing Capability (SMC) deal with handling and machining of depleted uranium, requiring routine testing for inhalation of particulate uranium. This testing is performed by analysis of submitted worker urine samples. It is necessary that a background level of non-occupational ingested, naturally occurring uranium, representative of southeast Idaho, be subtracted from the results of each SMC workers' analysis to give an accurate indication of uptake that may have been inhaled or ingested during the execution of their jobs. The geological area of the Idaho National Engineering and Environmental Laboratory (INEEL) is felt to be a little above average for being a high uranium part of the world.
The participants in the study will be non-uranium workers. Also, no previous uranium workers will be chosen to participate in this study. The participants in the study will be provided with a 24 hour urine collection kit. The urine samples will then be chemically analyzed for uranium. Only one single sample submission will be required for participation in the study. After sample analysis, the laboratory will dispose of the residue.
There are no risks or discomfort expected of the participants in this study.
The participants identities will be protected. There will be no identifiers attached to the samples. All of the participants will be notified about the general findings of the survey at the completion of the study.