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
Email: buggarbp@inel.gov
Projects are approved by an IRB located at: Idaho National Engineering and Environmental Laboratory.
The approving IRB does not operate under a Multiple Project Assurance (MPA) recognized by DOE or by the Department of Health and Human Services (HHS).
Number of Human Subjects Projects reported: 6
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
Principal Investigator's Institution: Idaho National Engineering Laboratory
Project started in: 1990
Project Funding Information:
Project received funding in Fiscal Year 1998.
Project used human subjects in Fiscal Year 1998.
Funding Sources:
Project does not involve use of multiple protocols/subprojects.
IRB Review:
Type of Review: Full Board
Most Recent Approval: September 22, 1998
IRB Approval Number: INEL-IRB-001
Number of Human Subjects who participated in this project/protocol during
FY 1998 (10/1/97 - 9/30/98): 23
Type 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-INEEL-IRB-97-003
Project Title:
The Employee Effects Of Downsizing in the Nuclear Industry.
Principal Investigator:
Dr. Lewis Pepper
Principal Investigator's Institution: Boston University Medical Center
Project started in: 1995
Project Funding Information:
Project received funding in Fiscal Year 1998.
Project used human subjects in Fiscal Year 1998.
Funding Sources:
Project does not involve use of multiple protocols/subprojects.
IRB Review:
Type of Review: Expedited
Most Recent Approval: September 22, 1998
IRB Approval Number: INEEL-98-003
Number of Human Subjects who participated in this project/protocol during
FY 1998 (10/1/97 - 9/30/98): 2,383
Type of Human Subjects Involvement:
The National Institute for Occupational Safety and Health initiated project "Prevention of Stress and Health Consequences of Workplace Downsizing and Reorganization" applied directly to NIOSH's mandate to identify the causes of work-related disease and injuries and the potential hazards of new work technologies and practices and to determine new and effective ways to protect workers from hazardous working conditions.
The project will identify individual and organizational factors which will form the basis of a program to prevent the adverse consequences of downsizing and describe the consequences of downsizing, particularly as related to organizational climate, health, and performance effects.
Part of the study includes a survey of hourly and salaried workers at DOE facilities which are or will be affected by organization restructuring and/or downsizing.
The research subject will not directly benefit from participation in the project. However, little is known about the health effects of downsizing on workers, even though the economic and social implications seem obvious.
There is little risk in participating in the project. The subject may be slightly inconvenienced by the time spent answering the questionnaire and participating in the interview.
All records associated with the project will be confidential and kept in a locked file in Dr. Pepper's office. Subjects will be identified by a unique study identification number. Their identify will not be revealed in publications or reports resulting from the study.
Project Identifier: INEEL-95-004
Project Title:
Concealed Weapons Detection System
Principal Investigator:
Mr. Philip M. Rice
Principal Investigator's Institution: Idaho National Engineering Laboratory
Project started in: 1995
Project Funding Information:
Project received funding in Fiscal Year 1998.
Project used human subjects in Fiscal Year 1998.
Funding Sources:
Project does not involve use of multiple protocols/subprojects.
IRB Review:
Type of Review: Full Board
Most Recent Approval: September 22, 1998
IRB Approval Number: INEL-IRB-004
Number of Human Subjects who participated in this project/protocol during
FY 1998 (10/1/97 - 9/30/98): 2,200
Type 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.
Project Identifier: INEEL-97-INEL-97-001
Project Title:
Development of Immunological Sensor Test Kits for Forensic Samples
Principal Investigator:
Ms. Vicki Thompson
Principal Investigator's Institution: Idaho National Engineering Laboratory
Project started in: 1997
Project Funding Information:
Project received funding in Fiscal Year 1998.
Project used human subjects in Fiscal Year 1998.
Funding Sources:
Project does not involve use of multiple protocols/subprojects.
IRB Review:
Type of Review: Full Board
Most Recent Approval: September 22, 1998
Number of Human Subjects who participated in this project/protocol during
FY 1998 (10/1/97 - 9/30/98): 10
Type 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. NA
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. All samples provided by the subject will be destroyed no later than November 1997. 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.
Project Identifier: INEEL-98-INEEL-IRB-98-001
Project Title:
Medical Surveillance For Former INEEL Workers
Principal Investigator:
Dr. Steve Markowitz
Principal Investigator's Institution: Center for the Biology of Natural Systems - Queens College
Project started in: 1998
Project Funding Information:
Project received funding in Fiscal Year 1998.
Project used human subjects in Fiscal Year 1998.
Funding Sources:
Project does not involve use of multiple protocols/subprojects.
IRB Review:
Type of Review: Expedited
Most Recent Approval: September 22, 1998
Number of Human Subjects who participated in this project/protocol during
FY 1998 (10/1/97 - 9/30/98): 60
Type of Human Subjects Involvement:
The study is designed to identify the need for medical screening for health conditions that may be related to occupational exposures experienced by former workers at the Idaho National Engineering and Environmental laboratory. The study plans to obtain existing information about the nature and intensity of chemical and radiation exposures that may have occurred at INEEL in the past; to identify which workers were most likely to have high exposures; and to review existing studies of patterns of health problems among former INEEL workers. The outcome of this study will be a recommendation to the Department of Energy about the need, if one exists, for a medical screening program among former INEEL workers.
All individuals who worked at INEEL for at least 30 days will be eligible for inclusion in the needs assessment process.
The activities include: Focus groups - 2-3 groups of 10-15 former and current workers will be assembled for a 2 hour session to discuss their knowledge of the laboratory and any concerns about health as a result of having worked at the INEEL. These results will be audiotaped and transcribed without attribution of specific comments to named individuals.
Risk mapping - 6 groups of 8-10 former and current workers will be assembled for a 3 hour session to discuss their knowledge of potential radiation and chemical exposures that may have occurred during the history of operations at INEEL. The information will be collected by job location and job title. The information will be summarized in written form without attribution of information to specific individuals.
Questionnaire - Mailed to approximately 1000 former works asking detailed questions about prior exposures, job history, health concerns, and current health care.
All information that will be obtained is confidential, to the extent allowed by law, and will not be identified by individual participant to anyone external to the study team. There is no risk of physical injury in this study. Any risk of violation of confidentiality will be minimized by assigning a unique number identifier that will be used in analyzing the information obtained. The code matching names and numeric identifiers will be known only to the study investigators. All individually identified data will be kept in locked file cabinets at the academic centers that are participating in the study. There is a risk of emotional duress that some participants may feel as a result of discussing prior exposures to toxic agents, radiation, and possible subsequent health risks. This risk will be addressed by providing clear communication about the exploratory nature of the study and presentation of the results of the needs assessment project at the end of the study period in a meeting open to subjects and other former workers.
Project Identifier: INEEL-98-INEEL-IRB-98-002
Project Title:
Performance Test for Detection of Explosives
Principal Investigator:
Mr. Greg English
Project started in: 1998
Project Funding Information:
Project received funding in Fiscal Year 1998.
Project used human subjects in Fiscal Year 1998.
Funding Sources:
Project does not involve use of multiple protocols/subprojects.
IRB Review:
Type of Review: Expedited
Most Recent Approval: September 22, 1998
Number of Human Subjects who participated in this project/protocol during
FY 1998 (10/1/97 - 9/30/98): 30
Type 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, clothings, 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 eye-dropper. 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 subjects 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.