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: 8
"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: 06/13/00
IRB approval number: INEL-IRB-001
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 20
Reporting period for number of human subjects:
Fiscal Year 2000 (10/1/99-9/30/2000)
Type(s) of Human Subjects Involvement:
Objective: The overall objective of the interagency agreement between the FAA and the INEEL is to provide the FAA with the necessary information to meet its mission of assuring air passenger safety. Under the proposed tasks, the INEEL will support this mission by: 1) providing additional information about the levels of particulate explosives and volatile taggants emitted from explosives in luggage; 2) supporting the FAA mission through the necessary program management, consultation, facilities, and equipment support; 3) quantifying explosive on suitcase material; 4) quantifying explosive on personnel clothing; and 5) quantifying explosive on personal identification materials (passports, boarding passes).
Methodology/human subject involvement: The contractor will quantify the amount of explosive deposited on the surfaces of clothing material worn by improved explosive device manufactures. The types of explosives to be tested are Composition C-4, Detasheet, Semtex-H, Trinitrotoluene (TNT), and nitroglycerine dynamite, and a smokeless propellant. During testing, the participant may be instructed to (1) place their thumb and fingers on a small block of explosive material and press down at prescribed pressures, (2) use the fingerprints to transfer the particles onto other materials (such as paper or cardboard), and/or (3) manipulate an explosive in a manner that roughly simulates the making of an explosive device (e.g. unwrap explosive, place into containers or other configurations, re-wrap explosive).
After testing, the participant will proceed to a sampling/monitoring area where samples will be collected from their hands, face, and clothes using either a small vacuum or filter paper. After the first set of samples are collected, the participant may be asked to wash their hands and face and another set of samples will be collected. Depending on the results of the samples, additional samples may be collected later that day and maybe several days after.
Risks to human subjects: It is possible that handling the explosive may cause slight skin irritation. Information from explosive experts indicates that does not normally happen. Safety analysis (ER-30-9-042,Rev. C) show 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.
Human subjects used in testing are trained in the use of explosives as part of their job. Appropriate safety analyses are performed, and safety precautions are adhered to during the testing.
Confidentiality: The results of this study, including laboratory or other data may be published for scientific purposes, but will not give the subjects name or any identifiable reference to the subject. Any records or data obtained as a result of the subject's participation in this study may be inspected by the sponsor (FAA), by any relevant government agency (e.g., U.S. Department of Energy), by the INEEL IRB, or by the persons conducting the study (provided that such inspectors are legally obligated to protect any identifiable information from public disclosure, except where disclosure is otherwise required by law or a court of competent jurisdiction).
"Concealed Weapons Detection System"
Principal Investigator: Mr. Robert Polk, Idaho National Engineering and Environmental Laboratory
Project started in: 1995
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: 06/13/00
IRB approval number: INEL-IRB-004
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 3
Reporting period for number of human subjects:
Fiscal Year 2000 (10/1/99-9/30/2000)
Type(s) of Human Subjects Involvement:
Objective: The object of this portion of the study is to study the response of the INEEL/NIJ Concealed Weapons Detector to pagers, cell phones, and other non-threat items to determine if sensor response can be modified to reject these items without alarms. It will be using a commercialized version of the system in operation at the Bannock County, Idaho Courthouse which is in continuous use by the general public. INEEL test and evaluation will be limited to a few persons which will primarily be the developers and technical contributors to the project.
Methodology: The test subjects will exercise the concealed weapons detector by walking through a portal similar to that in airport metal detectors with items such as pagers and cellular telephones. Data will be recorded from the CWD sensors and analyzed offline. No samples of anything other than signal data will be taken. Subjects will participate as long as needed to get data for the project.
No exposure to ionizing radiation, chemical substances, or radioactive substances will occur during the testing.
Involvement of human subjects: See (b)
There are no risks not generally accepted by the public or by an employee having a requirement for air travel by INEEL in the course of performing official duties.
The participant's identify in this testing is confidential. The results of this work, including laboratory or other data, may be published for scientific purposes but will not give the participants name or any identifiable reference to the participant. However, any records or data obtained as a result of participation in the testing may be inspected by the sponsor, by any relevant governmental agency (e.g., U.S. Department of Energy), by the INEEL Institutional Review Board, or by the person conducting the testing.
See project NIOSH-95-015.
Project Identifier: INEEL-95-INEEL-IRB-97-003_V
Project Title: "The Employee Effects Of Downsizing in the Nuclear Industry"
Go to list of projects at Idaho National Engineering and Environmental Laboratory
"Development of Immunological Sensor Test Kits for Forensic Samples"
Principal Investigator: Ms. Vicki Thompson, Idaho National Engineering and Environmental Laboratory
Project started in: 1997
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: 06/13/00
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 2000 (10/1/99-9/30/2000)
Type(s) of Human Subjects Involvement:
The objective of this study is to establish the capabilities of the antibody profiling test procedure and the conditions under which it can conceivably be used. If the study is successful, police agencies will have a new tool to identify criminal suspects. Since the test is very fast, a suspect's blood could be checked quickly to find out if he/she was involved in a crime.
A relatively new technique called Antibody Profiling has been developed that relies on the presence of autoantibodies in biological fluids. The subject will be asked to give one (1) tube of blood and three (3) saliva samples by placing a sterile cotton pad in the mouth for a few minutes. The subject may be asked to give more samples of blood or saliva if more samples are needed for testing. The subject may decline from the study at that time if so desired.
The samples WILL NOT be tested for drugs or the AIDS virus. Possible reactions to the procedure are faintness, infection, pain, and bruising. There are no risks from giving saliva samples. Anyone who does not like to give these types of samples should not participate. If anything is found during the study that may affect the subject's willingness to participate, the Willow Creek Clinic will contact the subject.
The subject's name will be kept private, as permitted by law. The results of this work, including laboratory or other data, may be published for scientific purposes but will not give the subjects name or any identifiable references to the subject. The Willow Creek Clinic at the INEEL will be the only contact point with the project. The Occupational Medical Program Office will keep all records such as the consent form and the types of samples collected. The researchers will have no contact with the subjects and will not know their identity. The subject's name will be removed from all samples before being sent to the researchers.
"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: 06/13/00
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 2000 (10/1/99-9/30/2000)
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.
See project PACE-97-DE-FC03-97SF21512.
Project Identifier: INEEL-98-INEEL-IRB-98-001_V
Project Title: "Medical Surveillance For Former INEEL Workers"
Go to list of projects at Idaho National Engineering and Environmental Laboratory
"Human System Simulation Enterprise - Multimedia in Procedures Part 2"
Principal Investigator: Ms. Susan Hill, Idaho National Engineering and Environmental Laboratory
Project started in: 2000
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: Idaho National Engineering and Environmental Laboratory
Most recent approval: 05/15/00
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 20
Reporting period for number of human subjects:
Fiscal Year 2000 (10/1/99-9/30/2000)
Type(s) of Human Subjects Involvement:
The purpose of the research is to investigate the ability of multimedia displays to improve human performance in executing step by step procedures.
The experimental task will be a manual positioning/assembly task executed via a step-by-step procedure. Physical objects required for the procedure will be located near the participant. Each step will be displayed (written text with photographs) and the participant will carry out that step. Upon completion, the participant will move to the next step and execute that step. The participant will continue to execute steps until the task is completed. There will be approximately 10-15 steps for each task, which will take approximately 5-10 minutes total for each task. Participants will have a training phase, so that they understand and practice the type of tasks they will be asked to execute. Then each participant will execute two tasks; one in each of the two experimental conditions. Total participation time is estimated to be 1 hour.
During each task, participants will be sitting at a table in front of one computer monitor. Each participant will be videotaped during the tasks. In addition, if the participant is using the computer, all computer input and output will be recorded.
After the two experimental conditions have been completed, participants will be asked for subjective opinions of the experimental conditions.
The risks associated with this research are minimal. During the research, subjects will be seated at a table in front of a computer monitor. They will be asked to look at the computer monitor and pick up small objects within easy reach and place them on a table in front of them.
The benefits of this research will be a better understanding of the effect of multimedia presentation on procedure execution. This is of interest to organizations that use procedures, such as the Department of Energy.
The subjects' identity will be treated as confidential. All data will be identified only by a subject number. The subject's name will not be associated with any data. Any results of the study may be published for scientific purposes, but will not give any names or identifiable references to the subjects. The records or data obtained as a result of participation in the study may be inspected by the sponsor, by any relevant governmental agency, by the Bechtel, Babcock & Wilcox, Idaho (BBWI) IRB, or by the persons conducting the study, provided that such inspectors are legally obligated to protect any identifiable information from public disclosure, except as otherwise authorized or required by law.
"INEEL Human-System Simulation Enterprise: Multimedia in Composition"
Principal Investigator: Dr. Harold Blackman, Idaho National Engineering and Environmental Laboratory
Project started in: 2000
Funding for Human Subjects Research:
This project does not involve the use of multiple protocols/subprojects.
Identifier or number: INEEL-2000-003
Institutional Review Board (IRB) Review:
Type of Review: Expedited
Approving Institution: Idaho National Engineering and Environmental Laboratory
Most recent approval: 05/30/00
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 45
Reporting period for number of human subjects:
Fiscal Year 2000 (10/1/99-9/30/2000)
Type(s) of Human Subjects Involvement:
The purpose of the proposed research is to investigate the ability of multimedia to improve human performance in composition.
The proposed research will compare expository essays written using pencil and paper, work processing software, and speech recognition software. The experimental task will be the writing of an expository essay using one of three tools; pencil and paper, work processing software, or speech recognition software. Subjects assigned to the speech recognition software will take a 30 minute training session to become familiar with the use of the software. The subjects will be instructed to write the essay using the tool provided within a 45 minute block of time. They will also be instructed that their essay will be judged on two dimensions; overall quality judged by style and content, and the amount of time required to produce the essay. The participant with the best essay in the least amount of time will be awarded a $25.00 gift certificate. Upon completion of the essay, the subjects will answer a series of questions regarding their preferences regarding composition and specifically about the composition they just wrote.
During each task, participants will be sitting at a table in front of one computer monitor. Each participant will be videotaped during the tasks. In addition, if the participant is using the computer, all computer input and output will be recorded. After the two experimental conditions have been completed, participants will be asked for subjective opinions of the experimental conditions.
The risks associated with this research are minimal. During the research, subjects will be seated at a table, some in front of a computer monitor. There is minimal risk associated with this experiment. Minimal risk means that the potential for harm or discomfort is not greater than that encountered in daily living or during the performance of routine physical or psychological exams or tests. The human subject's identity in the study will be treated as confidential. All data will be identified only by a subject number, their name will not be associated with any data. The results of the study, including laboratory or any other data, may be published for scientific purposes but will not give name or include any identifiable references to the HS. The participant is free to choose whether or not to participate in the study and there is no penalty or loss of benefits if they decide not to participate. The HS participation in the study may be ended by the PI at any time. The sponsor also reserves the right to terminate the study at any time.
The benefits of this research will be a better understanding of effect of multimedia presentation on composition. This is of interest to organizations that use procedures, such as the Department of Energy.