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
Project Identifier:
INEEL-90-95-001
Project Title:
"Federal Aviation Administration (FAA) Explosive Detection System and Independent Validation and Verification Project"
Principal Investigator: Mr. Steve Hartenstein, 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
Most recent IRB approval: 08/10/99
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 1999 (10/1/98-9/30/99)
Type(s) of Human Subjects Involvement:
a. Objective: The purpose of this study is to (1) approximate the amount of explosive contamination transferred from a thumb print onto airline boarding passes, and (2) assist in the development of a check standard for verifying the operational status of instruments used for detecting explosives being installed at airports. Information obtained from this study supports the FAA mission for the detection of explosive devices at airports.
b. Methodology/human subject involvement: The types of explosives to be tested are Composition C-4, Detasheet, Semtex-H, Trinitrotoluene (TNT), and nitroglycerine dynamite. Under controlled conditions, human participants will first press down on a block of explosives using their thumb. The participants will then press down with the same thumb to a secondary substrate (e.g., airline boarding pass), thereby transferring explosive particles from the explosive to the secondary substrate. The amount of pressure used to press on the explosive and on the secondary substrate will be measured with balances. The number of thumb print transfers per individual is estimated to be 30-40 per explosive. The tests will have variations in the thumb pressures used, hand washing frequencies, and types of secondary substrates. After testing for an explosive, a series of thumbprint and fingerprint samples will be collected from the participant and analyzed to determine the presence or absence of explosive residues.
c. Risks to human subjects: Human subjects are exposed to trace amounts of three secondary explosives (proprietary). Toxicity of explosives is through ingestion. There is a minimal risk of minor skin irritation from touching the explosives. The explosives used are secondary explosives and no detonators are used in the experiments. 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. The risk to human subjects is minimal.
d. 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).
Project Identifier:
INEEL-95-004
Project Title:
"Concealed Weapons Detection System"
Principal Investigator: Mr. E. G. Shell, 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
Most recent IRB approval: 08/10/99
IRB approval number: INEL-IRB-004
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 100
Reporting period for number of human subjects:
Fiscal Year 1999 (10/1/98-9/30/99)
Type(s) of Human Subjects Involvement:
a. Objective: To design, build, and demonstrate a system based on magnetic field sensing technology that can quickly and inexpensively be deployed to accommodate the weapons detection needs of a courthouse environment.
b. Methodology: The proposed technology uses magnetic gradiometers that detect aberrations in the earth's magnetic field to detect the presence of ferromagnetic objects such as guns and knives. A stand-alone unit much like an airport scanner system is being developed. The scanner consists of an electronic threshold unit, several magnetic gradiometer devices, and a computer system that will generate magnetic profiles of the individuals who pass through the systems. Computer analysis will provide information about the presence, location, and type of weapon concealed by a person passing through the scanner.
c. No exposure to ionizing radiation, chemical substances, or radioactive substances will occur during the testing.
d.1. Involvement of human subjects: Magnetic profiles will be generated of persons carrying a variety of weapons and non-weapon personal artifacts through the system to establish a catalog of magnetic signatures. The flux gate magnetometers used to detect the presence of a weapon are passive instruments that do not generate an electromagnetic field, or a radio frequency field, or produce ionizing radiation as an active instrument might. The magnetometers will not affect the use of any electrical equipment brought in close proximity to them, including pacemakers or other medical devices. There are no known risks associated with the human subject testing. Prior to the start of the test, the participant will be provided with a briefing of the concealed weapons detection system. The briefing shall explain how the system functions and the expected results of the test. The participant will become familiarized with the concealed weapons detection system. The participant is free to stop the test at any time.
d.2. There are no known health risks or safety issues related to the use of the prototype concealed weapons detection system. The magnetometers used to detect the presence of a weapon do not generate an electromagnetic field or produce x-rays, and they will not effect the use of any electrical equipment brought in close proximity to them, including heart pacemakers or other medical devices.
d.3. 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.
"The Employee Effects Of Downsizing in the Nuclear Industry.(DUPLICATE PROJECT SEE NIOSH-95-015)"
This project is a duplicate of project NIOSH-95-015.
Project Identifier:
INEEL-97-INEEL-97-001
Project Title:
"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
Most recent IRB approval: 08/10/99
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 1999 (10/1/98-9/30/99)
Type(s) of Human Subjects Involvement:
a: 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.
b. A relatively new technique called Antibody Profiling has been developed that relies on the presence of autoantibodies in biological fluids. The study will consist of two parts. The experimental procedures and analysis of blood, urine, and saliva using the antibody technique will be established during the first segment of the study. The second part of the study will be conducted in collaboration with the Wyoming State Crime Laboratory. The PI will collect blood samples from INEEL volunteers and will send one tube of blood from each to the Wyoming State Crime Laboratory. An experimental matrix of typical conditions found at crime scenes will be constructed. The Wyoming Crime Laboratory will expose blood to various conditions and run polymerase chain reaction (PCR) tests on the samples. INEEL will receive aliquots of these samples and perform the antibody profiling assays. Blood samples for this portion of the work will be provided by volunteers solicited by the PI.
c. In Fiscal year 99/2000 the protocol will be tested with saliva samples from approximately 20 volunteers. They will also have their blood samples compared with the antibody profiles obtained from the saliva.
d.1. The volunteer will be asked to provide two tubes of blood. The volunteer will be asked to provide a urine sample in a sterile cup. The volunteer will be asked to give a saliva sample by placing a sterile cotton pad in their mouth for a few minutes. The volunteer may be asked to give additional samples of blood, urine, or saliva if more samples are required for testing. They may say no at that time if they wish.
d.2. A nurse will take blood from the subject's arm with a needle. Possible reactions to this procedure are faintness, infection, pain, and bruising. There are no risks from the collection of urine and saliva samples. If any new information is discovered during the study that may affect the subject's willingness to participate, the Willow Creek Clinic at the INEEL will contact the subject.
d.3. 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.
"Medical Surveillance For Former INEEL Workers (DUPLICATE, SEE PACE-97-DE-FC03-97SF21512)"
This project is a duplicate of project PACE-97-DE-FC03-97SF21512.
Project Identifier:
INEEL-98-INEEL-IRB-98-002
Project Title:
"Performance Test for Detection of Explosives"
Principal Investigator: Mr. Greg English, Idaho National Engineering and Environmental Laboratory
Project started in: 1998
This project ended in fiscal year 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
Most recent IRB approval: 08/10/99
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 8
Reporting period for number of human subjects:
Fiscal Year 1999 (10/1/98-9/30/99)
Type(s) of Human Subjects Involvement:
The research study is designed to support the efforts of Lockheed Martin Idaho Technologies Company Security Operations at the Idaho National Engineering and Environmental Laboratory to detect explosive materials. As a person handles or manufactures an explosive device, small particles are deposited on their hands, clothing, or secondary objects. The objective of this study is to test the ability of security personnel and their instrumentation to detect minute quantities of explosives on hands, clothes, and/or secondary objects such as briefcases, books, etc.
The procedure involves using pre-made standards of explosives in either an aqueous solution/suspension form or in the form of a glass slide containing a 'fingerprint' of explosive. These pre-made standards will contain a trace (dilute) amount of an explosive, e.g. C-4, detasheet, TNT, or dynamite, smokeless propellant. If the standard is in the 'fingerprint' form, a swipe will transfer the fingerprint of explosive from a glass slide onto the subjects cloths or hands. For an aqueous standard, the explosive will be deposited with an eyedropper. The subject will perform regular work tasks and later, samples will be collected from the hands or clothes and analyzed.
There will be instructions in the test procedure and type of explosive being tested. After testing the subject will wash their hands and face and be released. It is possible that contact with an explosive may cause a slight skin irritation. This is unlikely because of the small amounts being used. There is no risk of explosion from the explosives because the quantities used are non-detonable. Material safety data sheets (MSDS) will be present on site for each type of explosive tested.
The results of the study may be published for scientific purposes but will not give the subject's name or give any identifiable reference to the subject. The subject is free to choose whether or not to participate in the study and there is no penalty or loss of benefit should the subject choose not to participate.
Project Identifier:
INEEL-99-1
Project Title:
"INEEL Human System Simulation Enterprise"
Principal Investigator: Mr. Bruce Hallbert, Idaho National Engineering and Environmental Laboratory
Project started in: 1999
This project ended in fiscal year 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
Most recent IRB approval: 08/10/99
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 1999 (10/1/98-9/30/99)
Type(s) of Human Subjects Involvement:
The purpose of the proposed research is to investigate cognitive aspects of individual and team behavior under a variety of communications conditions. It is hypothesized that the most successful behaviors take place when team members can communicate face-to-face. However, teams cannot always be physically co-located. Thus, the effect of remote communications conditions on individual and team behavior is of interest.
The proposed research will compare face-to-face decision making against dispersed decision making under a variety of communications conditions. Four levels of sound communications will be crossed with four levels of sight communications to yield a total of sixteen dispersed communication conditions. However, the No sound, No sight combination will not be investigated while a single face-to-face communication condition will be investigated. Thus, there will be sixteen communication conditions (15 dispersed, 1 face-to-face) to be investigated.
The subjects will be from INEEL non-active-duty naval personnel. Selection will be limited to males who have attained the rank of lieutenant or above. Subjects will be questioned about their command experience, their management experience, and their computer game playing experience in order to form teams with equivalent experience. Forty-five subjects will be grouped into fifteen teams of 3 subjects each.
The mechanism for actually exploring behavior under the various communications conditions will be to place subjects in roles within a decision-making scenario. The scenarios are being developed through the use of 2 video games (Jane's Fleet Command and Tom Clancy's Rainbow Six). The scenarios will place each subject in the position of a military commander. Each scenario develops a military situation in which the subjects, in their roles of military commanders, are responsible for decision making. Scenario information will be presented to the subjects through a variety of media (text, graphics, video, sound). At four points within each scenario, subjects will be asked to make a decision. In order to make the decisions, subjects within a team will have to communicate to one another. The scenarios will end after the fourth decision point. Scenarios will be approximately 15-30 minutes in length. Overall, nine scenarios will be developed, three each of three difficulty ratings; easy, intermediate, and hard.
The sixteen communications conditions will each be investigated at each of the three levels of scenario difficulty. Each of the fifteen teams of three subjects will participate in either three or four scenarios. In addition, five of the teams will perform an additional three scenarios in the face-to-face condition.
During a scenario, subjects will either be sitting at a table or sitting in front of one or two computer monitors. Each subject will be videotaped during each scenario. In addition, if the subject is using the computer (e.g., watching a monitor or typing input), all computer input and output will be recorded. Also, all communications between the subjects on a team during a scenario will be recorded. The decisions that each team makes during each scenario will be recorded.
After each scenario, subjects will be asked for subjective ratings of their workload and situational awareness during the scenario. In addition, subjects may be asked objective questions about details of the scenario which might reflect upon situational awareness (e.g., relative geometry of assets during the scenario).
The risks associated with this research are minimal. During the research, subjects will be seated at a table or in front of a computer monitor. The scenarios may produce a moderate level of mental workload for the subjects.
The benefits of this research will be a better understanding of the role of varying communications conditions upon group behavior. This is of considerable interest to military and civilian teams that must operate in separated conditions.
Project Identifier:
INEEL-99-4
Project Title:
"Tissue-Boron Analysis"
Principal Investigator: Dr. David Nigg, Idaho National Engineering and Environmental Laboratory
Project started in: 1999
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
Most recent IRB approval: 08/10/99
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 32
Reporting period for number of human subjects:
Fiscal Year 1999 (10/1/98-9/30/99)
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.