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: 5
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 1997.
Project used human subjects in Fiscal Year 1997.
Funding Sources:
Project does not involve use of multiple protocols/subprojects.
IRB Review:
Type of Review: Full Board
Most Recent Approval: July 21, 1997
IRB Approval Number: INEL-IRB-001
Number of Human Subjects who participated in this project/protocol during
FY 1997 (10/1/96 - 9/30/97): 20
Type of Human Subjects Involvement:
a. Objective: The purpose of this study is to (a) approximate the amount of explosive contamination transferred from a thumb print onto airline boarding passes, and (b) 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 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. Philip M. Rice
Principal Investigator's Institution: Idaho National Engineering Laboratory
Project started in: 1995
Project Funding Information:
Project received funding in Fiscal Year 1997.
Project used human subjects in Fiscal Year 1997.
Funding Sources:
Project does not involve use of multiple protocols/subprojects.
IRB Review:
Type of Review: Full Board
Most Recent Approval: July 21, 1997
IRB Approval Number: INEL-IRB-004
Number of Human Subjects who participated in this project/protocol during
FY 1997 (10/1/96 - 9/30/97): 6
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-96-INEL-96-001
Project Title:
An Industrial Hygiene Survey of a Waste Reduction Facility - Heat
Principal Investigator:
Mr. Troy Collins
Principal Investigator's Institution: Idaho National Engineering Laboratory
Project started in: 1996
This project ended in Fiscal Year 1997.
Project Funding Information:
Project received funding in Fiscal Year 1997.
Project did not use human subjects in Fiscal Year 1997.
Explanation:
Project was never completed because the approval of the project was too late in the season - the heat stress conditions were over.
Funding Sources:
Funding for project was $18,300
Project was never started - the heat stress season ended before authorization was received.
Total Funding: $18,300
Project does not involve use of multiple protocols/subprojects.
IRB Review:
Type of Review: Expedited
Most Recent Approval: July 21, 1997
Number of Human Subjects who participated in this project/protocol during
FY 1997 (10/1/96 - 9/30/97): 0
Type of Human Subjects Involvement:
a. The objective of this project is to monitor workers heart rate and body temperature in a heat stress environment by using a personal heat stress monitor.
b. The consenting subject may be asked to wear a personal heart stress monitor while working in the size reduction room, a known heat stress environment. This device will enable the PI to monitor the individual worker's reaction to heat stress caused by his/her job function. The sensors are to be worn next to the subject's skin just below the mammary glands. If the device is worn properly it should not interfere with their normal job function and will be sanitized after each use. The consenting subject may be asked to try different ensembles of personal protective gear while performing their job. The core control suit will be assessed to determine its efficiency in this type of environment. This suit pumps ice water through small tubes within the suit. The last thing the subject may be asked to do is wear a personal air sampling monitor on their lapel while working in the sizing room. This will enable air contaminant levels to be measured that are produced by the plasma arc torch when cutting various metals. This information will be used to determine or support the type of respirator that should be used during this process.
c. The human subjects will not be exposed to ionizing radiation, radioactive substances, or chemical substances.
c. See 18b. for the description of the procedure. The physical and social risks are anticipated to be minimal. The workers will not be required to do anything out of the ordinary of their job description.
18.d.3. The results of the study, including laboratory or any other data may be published for scientific purposes, but will not give the name or any identifiable reference to the subject. Confidentiality will be maintained by designating a four digit number to each participating volunteer. This number will be used exclusively as the identifier at the work site. This information will be coded to the master list kept at the PI's home. Any reports generated from this study will list the subjects as A, B, C, etc., in no specific order. Any records or data obtained as a result of the subject's participation in the study may be inspected by the sponsor, by any relevant governmental agency (e.g., U.S. Dept. of Energy), by the INEL IRB, or by the persons conducting this study, provided that such inspectors are legally obligated to protect any identifiable information from public disclosure, except as otherwise authorized or required by law.
Project Identifier: INEEL-97-INEEL-97-002
Project Title:
Evaluation of Patient Satisfaction with Occupational Health Nursing Service
Principal Investigator:
Ms. Jacque Leanna
Principal Investigator's Institution: Idaho State University/INEEL
Project started in: 1997
This project ended in Fiscal Year 1997.
Project Funding Information:
Project received funding in Fiscal Year 1997.
Project used human subjects in Fiscal Year 1997.
Funding Sources:
This project was a survey used in conjunction with a graduate student pursuing a Master of Science Degree in Nursing. It was a self-funded project.
Project does not involve use of multiple protocols/subprojects.
IRB Review:
Type of Review: Expedited
Most Recent Approval: March 10, 1997
Number of Human Subjects who participated in this project/protocol during
FY 1997 (10/1/96 - 9/30/97): 200
Type of Human Subjects Involvement:
18.a. The objective of this study was to establish what the perceptions of care expressed by patients in an occupational health program are in five areas: reliability, assurance, tangibles, empathy, and responsiveness; and what aspects of nursing care do patients value most.
18.b. The study included 200 employees, randomly selected, who were asked to complete an anonymous questionnaire to evaluate factors they think are important in nursing care in an occupational health facility. The results were reported in aggregate numbers and all surveys were destroyed by the PI after analysis to ensure confidentiality.
18.c. The participants were not exposed to any chemical or radioactive substance or ionizing radiation.
18.d.1. A survey was distributed to 200 randomly selected employees. Participation in the study was voluntary.
18.d.2. There were no risks to the participants, no exposures to chemicals, radioactive substances, or ionizing radiation.
18.d.3. Complete confidentiality and anoymity was maintained. The results of the study were analyzed and reported only in total numbers.
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 1997.
Project used human subjects in Fiscal Year 1997.
Funding Sources:
Project does not involve use of multiple protocols/subprojects.
IRB Review:
Type of Review: Full Board
Most Recent Approval: January 15, 1997
Number of Human Subjects who participated in this project/protocol during
FY 1997 (10/1/96 - 9/30/97): 11
Type of Human Subjects Involvement:
18.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 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. Wyoming will destroy any samples sent to them by November 30, 1997.
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.