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: 6
"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: 06/07/01
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 2001
Type(s) of Human Subjects Involvement:
Objective: The overall objective of the interagency agreement between the FAA and the INEEL is to detect explosive materials in airports. As a person handles or manufactures an explosive device, small particles are deposited on their hands and clothing. The ability to detect small amounts (trace quantities) of explosives on hands and clothes will give the FAA a tool in preventing aircraft related terrorist activities. The objective of this study is to investigate how the particles are distributed on hands and clothes and how long the particles can be detected.
Methodology/human subject involvement: The procedure for this study involves touching or handling various types of explosive materials. The participant will perform a few simple tasks that are designed to (1) simulate the construction and carrying of an improvised explosive device (IED), and/or (2) transfer particles from a fingerprint to other materials (such as cardboard, plastics, etc.). After the tasks, samples will be collected from hands, face, and clothes using filter paper or a small vacuum that collects particles onto a filter paper.
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) 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.
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).
"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: 06/07/01
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 2001
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. We will be developing an Antibody Profiling kit that will be ultimately used by law enforcement for analysis of blood samples found at crime scenes. We will utilize approximately 5 test subjects to examine the various components of the kit and to test kit stability under various conditions. We will also work to develop tests for illegal drugs including marijuana, cocaine, and methamphetamine. Saliva samples from volunteers will be used to determine if there are any matrix effects present. All saliva samples will be spiked with drugs purchased under our laboratory's DEA license. 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 INEEL 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: 06/07/01
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 1
Reporting period for number of human subjects:
Fiscal Year 2001
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_IRB
Project Title: "Medical Surveillance For Former INEEL Workers"
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"Perceptions of Risk"
Principal Investigator: Mr. Jeffrey C. Joe, Idaho National Engineering and Environmental Laboratory
Project started in: 2001
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: 06/07/01
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 55
Reporting period for number of human subjects:
Fiscal Year 2001
Type(s) of Human Subjects Involvement:
The purpose of this research is to examine how different configurations of storage facilities for hazardous materials and how those configurations are presented affect peoples' perceptions of how safe those storage facilities are.
Human subjects are involved in this research because it is their perceptions that we want to examine in the hopes that some insights can be made in how to conduct long-term stewardship and hazardous waste management more effectively.
The human subjects will be non-technical employees of the Idaho National Engineering and Environmental Laboratory, consisting of both male and female, most likely varying from 22-65 in age. The PI would like to sample only non-technical employees because of the interest in how their perceptions of risk of various storage facility configurations for hazardous materials compares to the actual risk of those configurations. An advertisement for recruitment of participants will be distributed to various buildings at the INEEL.
The participants will be asked to evaluate information on numerous storage facilities for hazardous materials. This information will be presented on a computer monitor. They will be asked a series of questions after each presentation and then they will be asked to advance to the next presentation until they have completed the task. The participants will be asked to answer a number of questions on two different questionnaires, one of which may be administered to them before they make their evaluations of the storage facilities. The total participation may take as long as 1.5 hours.
There is minimal risk associated with participation in this experiment. 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 participants will be reminded that they are free to stop and leave the experiment if they feel like they are at risk. There will be no deception manipulation in the experiment aside from not revealing the hypotheses the PI is trying to test, until after the participant is finished with the experiment. A full debriefing session will occur at the end of the experiment to explain what the PI is trying to test and to answer any questions the participants might have.
There is no direct benefit to the participant in this study. A better understanding of how perceptions of risk vary as a function of how various configurations of storage facilities for hazardous materials are presented may help improve efficiency and decision making in both government and civilian arenas. The PI feels the risks are minimal and the benefit of the INEEL gaining new insights into how perceptions of risk vary as a function of how different configurations of storage facilities are presented could be valuable to both the government and civilian arenas.
All of the data collected during the study will be controlled by the principal investigator so as to ensure privacy. The data will be kept in a locked cabinet, accessible only by the investigator. The data will be kept for three years. The participants' identity in this 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 the PI will not give the participants' names or include any identifiable references to the participants.
Informed consent will be obtained by having the participant read the informed consent form, initial every page, and sign the last page indicating they consent to the experiment. Informed consent will be obtained by the PI and a copy of the signed IC will be made and given to the participant.
"Multimedia and Environmental Decision Making"
Principal Investigator: Ms. Susan Hill, Idaho National Engineering and Environmental Laboratory
Project started in: 2001
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: 06/07/01
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 2001
Type(s) of Human Subjects Involvement:
The purpose of the research is to investigate the effects of the use of multimedia in decision making. The principal investigator is interested in examining the process of decision making when presented with information via an advanced multimedia presentation. The PI will be using an experimental task that contains scientific information about eutrophication.
The participants for the research were advertised for from the INEEL employee population. Selection was limited to persons with self-reported normal hearing and normal vision.
The experimental task is to role-play the part of an aide to a senior decision maker and to view and evaluate information and come to a decision to recommend to the decision maker. Prior to the multimedia presentation, the participants will complete an environmental attitude questionnaire and an affect scale. During the information viewing, the participants will periodically be prompted to report their decision making state. After completing the presentation, the participants will retake the environmental attitude questionnaire and the affect scale. Participants will be asked to make a recommendation to the senior decision maker and be questioned about why they made that recommendation. Finally, general questions about the experiment and the participant's attitude toward it will be administered. Demographic information about the subject will be collected.
During the task, participants will be sitting in front of a computer monitor. All computer input and output will be recorded. All reports of decision making state and the decision that each participant makes will be recorded. Questionnaire, scale, and final question answers will also be recorded.
There is minimal risk associated with participation in this experiment. 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. During the research, subjects will be seated in front of a computer monitor.
The benefits of this research will be a better understanding of the role of multimedia upon decision making and affect. From the use of a task with specific scientific information, the PI will be able to draw more general insights in the area of decision making, presentation format, and communicating other kinds of scientific information. This is of considerable interest to the Department of Energy and all who must deal with conveying scientific information, especially in public communications.
The subject's identity will be treated as confidential. All data will be identified only by a subject number. The participants name will not be associated with any data.
"Environmental Communication and Presentation Format"
Principal Investigator: Ms. Susan Hill, Idaho National Engineering and Environmental Laboratory
Project started in: 2001
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: 06/07/01
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 34
Reporting period for number of human subjects:
Fiscal Year 2001
Type(s) of Human Subjects Involvement:
The purpose of the research is to investigate the effects of the use of multimedia in scientific information communications. It is hypothesized that different presentation methods will result in differences in learning, decision making, and affect. The principal investigator will use an experimental task that contains scientific information about eutrophication.
The proposed research will compare three conditions of information presentation: paper-based text presentation, web-based presentation, advanced multimedia presentation.
The participants for the research will be advertised for from the INEEL employee population. Selection will be limited to persons with self-reported normal hearing and normal vision. The experimental task will be to role-play the part of an aide to a senior decision maker and to read/view and evaluate information and come to a decision to recommend to the decision maker. Prior to the presentation, each participant will be asked to complete an environmental attitude questionnaire, an affect scale, and a subject matter pretest. The participants will then read/view one of the three presentation formats. After completing the presentation, the participants will take a test to assess their learning and will retake the environmental attitude questionnaire and the affect scale. Participants will be asked to make a recommendation to the senior decision maker and be questioned about why they made that recommendation. Finally, general questions about the experiment and the participant's attitude toward it will be administered. Demographic information about the subject will be collected. During the task, participants will be sitting in front of a computer monitor. All computer input and output will be recorded. All answers to questionnaires, scales, tests, and final questions will also be recorded.
There is minimal risk associated with participation in this experiment, the potential for harm or discomfort being not greater than that encountered in daily living or performance of routine physical or psychological exams or tests. During the research, the subjects will be seated in front of a computer monitor or at a table. There is no direct benefit to the participant in the study. However, a better understanding of the effects of different presentation methods may help improve efficiency in both government and civilian arenas. All data will be identified only by a subject number, the participants name will not be associated with any data.
See project NIOSH-97-009.
Project Identifier: INEEL-01-NIOSH_IRB
Project Title: "Multi-State Case-Control Study of Lung Cancer and External Ionizing Radiation"
Go to list of projects at Idaho National Engineering and Environmental Laboratory