Ms. Ann
M. Shirley
PO Box 2008
MS 6103
Oak Ridge, TN 37831-6103
Phone: 865-576-8262
Fax: 865-574-4084
E-mail: shirleyam@ornl.gov
Number of Human Subjects projects reported: 8
"Measurement of Environmental Tobacco Smoke Constituents in Occupied Spaces"
Principal Investigator: Dr. Roger A. Jenkins, Oak Ridge National Laboratory
Project started in: 1993
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: Oak Ridge National Laboratory
Most recent approval: 12/01/99
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 2007
Reporting period for number of human subjects:
Fiscal Year 2000 (10/1/99-9/30/2000)
Type(s) of Human Subjects Involvement:
Objectives
The purpose of this study has been to determine the personal exposure to environmental tobacco smoke (ETS) of non-smoking subjects in occupational and away-from-work settings. Exposures have been related to occupational categories, living and working environments, and demographic factors.
Methodology
Individual participants wore one of two personal sampling pumps, one each at work and away-from-work. (For Phase 2, restaurant and tavern servers wore only one sampling system: in their workplace.) Samples of breathing zone air were collected, and analyzed for both particle- and vapor-phase markers of environmental tobacco smoke (ETS), including respirable suspended particulate matter, UV-absorbing and fluorescing particulate matter, scopoletin, solanesol, nicotine, 3-ethenyl pyridine, and myosmine. In addition, prior- and post-exposure saliva samples were collected by having the subjects chew on a piece of cotton dental dam in order that the smoking status can be assessed through cotinine levels. In the first phase of this study, 1566 subjects participated in the study. The subjects were distributed geographically around the United States, with about 100 subjects in each of 16 urban areas. In the second phase of the study, 165 subjects participated. All were recruited form the Knoxville, TN Standard Metropolitan Statistical Area.
In the course of analyzing the data from the first phase of the study, it was determined that for one of the targeted occupational groups, waiters/waitresses/bartenders, there was an insufficient number of subjects in the study pool to confidently distinguish exposure differences. For that reason, we increased the subject pool by about 165 subjects. This increased the overall study population by about 11%, to approximately 1729 subjects. All of the added subjects were recruited from the aforementioned occupational category in one of the urban areas studied in the first phase: Knoxville, TN. Essentially, the same experimental protocol as that previously employed will be used to judge occupational exposure. Area samplers were also placed in the subjects' place of employment. An extension of Phase I, which began near the beginning of FY98, involved about 270 subjects and have a sampling and subject protocol identical to that of Phase 1. However, subjects were recruited to fill specific demographic categories so that the overall study population was representative of the non-smoking population from which the subjects were recruited.
Exposure of Human Subjects
Human subjects are not exposed to any experimental atmospheres, or anything else that they would not encounter in their daily occupational or non-occupational routines. The purpose of the investigation is to determine the extent of natural exposure to ETS.
Involvement of Human Subjects
Procedures
Two aspects of the study qualify it for human studies consideration. First, a sample of saliva is acquired from each subject upon the entrance into and departure from the study. Depending on timing, sample acquisition could be as little as 24 hours or as much as 72 hours apart. The purpose of the saliva collection is to determine the concentration of a nicotine metabolite (cotinine) present. Salivary cotinine levels are used to confirm the absence of smoking among self reported non-smokers, and to determine the potential efficacy of use of salivary cotinine as a quantitative indicator of ETS-nicotine exposure. Saliva samples will be used for no other purposes.
Secondly, a great deal of demographic and exposure information is gathered on the subjects, which could not be collected via normal observation of the subjects. The confidentiality of the subjects is protected by several measures. First, subjects are assigned an identification number when they enter the study. The only place where the subject's name and address is tied to the identification number is on the written questionnaires which they complete. These questionnaires are stored in files maintained at ORNL in a restricted access area. A contractual requirement of any firm sub-contracted to recruit subjects or assist with field operations is that they make no permanent copies of the written questionnaires. In no place on the electronic data bases developed for the study are the subjects identified by anything other than a participant identification number.
Risks
Risks to the subjects are minimal. Subjects are asked to partake in normal activities, and are cautioned against wearing the sampling pumps around heavy machinery or during other activities in which wearing the sampling pump may compromise their safety.
Privacy
Subject names and addresses are only stored in hard copy (no electronic copy) in a restricted access area (combination lock access). Subject confidentiality is protected through the use of pseudo-identifiers. Acquisition of saliva samples is minimally invasive, and amounts to having to chew on a sterile piece of cotton dental dam for 60 seconds, and expelling it into a sterile vial. A videotape training film of 20-25 minutes in length is produced for each experimental protocol, and augments the formal human studies consent form.
"Characterization of Components of Fingerprints"
Principal Investigator: Dr. Michelle V. Buchanan, Oak Ridge National Laboratory
Project started in: 1994
Funding for Human Subjects Research:
This project involves the use of multiple protocols/subprojects.
Number of protocols/subprojects associated with this project: 2
Institutional Review Board (IRB) Review:
Type of Review: Full Board
Approving Institution: Oak Ridge National Laboratory
Most recent approval: 12/01/99
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 20
Reporting period for number of human subjects:
Other: 05/01/00 to 09/30/00
Explanation:
Approval received in December 1999 but funding was reinstated ~April 2000.
Type(s) of Human Subjects Involvement:
This project will chemically characterize the components present on the fingertip skin to determine if information about age, sex, and personal habits can be ascertained. The long-term goal of the project is to obtain methodologies that can be used in forensic applications, but could also lead to non-invasive clinical assays. Samples will be obtained by asking the subject to deposit material from fingertips on glass slides or beads in order to collect the material from the skin. After the sample is returned to the lab, then the materials will be removed from the surface by solvent wash. This protocol will NOT expose the subject to any chemicals (or other hazards). No risks to the subject are involved. During FY 2000, we will gather samples from up to 300 subjects to determine general trends in chemical components present and identify specific compounds that might be useful for distinguishing individuals based on skin components.
Institutional Review Board (IRB) Review:
Type of Review: Full Board
Approving Institution: Oak Ridge National Laboratory
Most recent approval: 06/01/00
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 14
Reporting period for number of human subjects:
Other: 06/01/00 to 09/30/00
Explanation:
Did not begin until approval was received, which was not at the beginning of FY'00.
Type(s) of Human Subjects Involvement:
This part of the project looks for drugs of abuse that may be found on fingertip surfaces. The sample collection is similar to subtask 1 Amendment (a), where volunteers provide samples by rubbing a glass bead between their fingertips. The volunteers are never exposed to chemicals or other hazardous material and are not subject to any risk by agreeing to participate in this research. The subjects used in this study will be different than those used in amendment (a). The volunteers for this study are from Davidson County Community Corrections (Nashville) and will have to read and sign an informed consent form in order to participate. The samples are coded with an identifier that is determined by Davidson County Community Corrections. The samples are then re-coded at ORNL to further protect the privacy of the volunteer. The individual results obtained at ORNL are never shared with Davidson County to protect the volunteers' confidentiality.
"Advanced Robotics for Remanufacturing and Aircraft Support Functions"
Principal Investigator: Dr. John V. Draper, Oak Ridge National Laboratory
Project started in: 1994
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: Oak Ridge National Laboratory
Most recent approval: 12/01/99
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 0
Reporting period for number of human subjects:
Fiscal Year 2000 (10/1/99-9/30/2000)
Type(s) of Human Subjects Involvement:
Abstract:
Objectives: This report describes preliminary testing to garner feedback about the heavy lift dexterous manipulator (HDM) arm from experienced fighter load crewmen. The purpose of the testing was to provide preliminary information about control system parameters and to gather feedback from users about manipulator arm functionality. To that end, subjects interacted with the next generation munitions handler (NGMH) in informal testing sessions and provided feedback about the performance of the system. Certain control system parameters were changed during the course of the testing and feedback from the participants was used to make a rough estimate of "good" initial operating parameters. Later, formal testing will concentrate within this range to identify optimal operating parameters.
Ionizing radiation, radioactive substances, chemical substances: Human subjects were not exposed to any ionizing radiation, radioactive substances, or chemical substances during testing.
Methodology: Operational safety was an important concern during this testing program because of the nature of the HDM and its payloads, and because of the relative inexperience of the load crews with the NGMH program. For that reason, the first half-day of the testing program was devoted to a formal briefing on the NGMH project and testing program safety. Subject safety was further safeguarded by: (1) presence of a safety observer, who held a switch enabling him to shut down the manipulator arm in the event of an unplanned incident; (2) presence of a test observer, who monitored control system parameters and manipulator function via computer, and who could shut down the system should a problem appear; and (3) the deadman switch built into the manipulator controller, which shuts down the manipulator if the handle is released.
The testing itself was conducted using an informal format that encouraged the participants to interact with the HDM in a manner that allowed them to become familiar with its capabilities. At the end of each exercise with the NGMH, the participant was briefly questioned about his experience with the machine. Any evaluative comment made by the user was recorded, as were suggestions for improving it. The observer also noted important events or noteworthy differences in operating style during the task, and then briefly questioned the participant about problems with the system and reactions to the control system set-up for that task. Comments were recorded in a logbook for later review and analysis.
Involvement of Human Subjects: Human subjects were involved as described in the preceding paragraphs. In addition, the research subjects received a pre-test briefing outlining the conditions for their participation and testing conditions. The former included receipt of and explanation of the informed consent form. Research subjects also participated in a post-testing debriefing.
"Measurement of Environmental Tobacco Smoke Constituents in Occupied Spaces. Phase III"
Principal Investigator: Dr. Roger A. Jenkins, Oak Ridge National Laboratory
Project started in: 1998
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: Oak Ridge National Laboratory
Most recent approval: 12/01/99
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 24
Reporting period for number of human subjects:
Fiscal Year 2000 (10/1/99-9/30/2000)
Type(s) of Human Subjects Involvement:
Objectives
The purpose of the study was to document the levels of environmental tobacco smoke ETS in a recently constructed corporate facility where smoking is unregulated, but which employs an advanced HVAC system, and to determine non-smoker personal exposure to ETS within the facility.
Methodology
Experimental protocol was similar to that used in ORNL-93-17, in which subjects wear a small sampling system which collects indoor air samples from their personal breathing zone air. Samples of breathing zone air were analyzed for both particle- and vapor-phase markers of environmental tobacco smoke (ETS) and other combustion derived particles and vapors, including respirable suspended particulate matter, UV-absorbing and fluorescing particulate matter, solanesol, nicotine, and 3-ethenyl pyridine. Personal breathing zone samples were collected for three consecutive days, usually Tuesday, Wednesday, and Thursday. Fixed location area samples were acquired in the vicinity of the subjects’ work stations. In contrast to the ORNL-93-17 protocol, no saliva samples were collected, since the smoking status (based on observational data acquired in the workplace) was known to the investigatory team.
Exposure of Human Subjects
Human subjects are not exposed to any experimental atmospheres, or anything else that they would not encounter in their daily occupational routine. The purpose of the investigation is to determine the extent of natural exposure to ETS.
Involvement of Human Subjects
Procedures
One aspect of the study qualifies it for human studies consideration. Demographic and exposure information is gathered on the subjects, which could not be collected via normal observation of the subjects. The confidentiality of the subjects is protected by several measures. First, subjects are assigned an identification number when they enter the study. The only place where the subject's name and address is tied to the identification number is on the written questionnaires which they complete. These questionnaires are stored in files maintained at ORNL in a restricted access area. In no place on the electronic data bases developed for the study are the subjects identified by anything other than a participant identification number.
Risks
Risks to the subjects are minimal. Subjects are asked to partake in normal activities, and are cautioned against wearing the sampling pumps around heavy machinery or during other activities in which wearing the sampling pump may compromise their safety. (Note that since all of the subjects in this protocol were office workers, this was deemed to be a minimal risk.)
Privacy
Subject names and addresses are only stored in hard copy (no electronic copy) in a restricted access area (combination lock access). Subject confidentiality is protected through the use of pseudo-identifiers. Because of the relatively small number of subjects in this protocol, no videotaped instructions were given. Instead, ORNL staff explained the purpose of the study, trained each subject on the wearing and use of the personal sampling pumps, answered subjects’ questions about the protocol, and obtained witnessed Human Studies consent.
"Study of Neurotransmitters in Children with ADD or ADHD"
Principal Investigator: Dr. Gary A. Sega, Oak Ridge National Laboratory
Project started in: 1998
Funding for Human Subjects Research: No Funding Sources Reported
This project does not involve the use of multiple protocols/subprojects.
Institutional Review Board (IRB) Review:
Type of Review: Expedited
Approving Institution: Oak Ridge National Laboratory
Most recent approval: 12/01/99
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 20
Reporting period for number of human subjects:
Year prior to last IRB approval date
Type(s) of Human Subjects Involvement:
The purpose of this research is to investigate the blood levels of the following neurotransmitters: dopamine, serotonin, serotonin to tryptophan ratio and melatonin in children with attention deficit hyperactive disorder (ADHD) diagnosed according to the DSM-III-R criteria and in children diagnosed as being autistic. The blood will be drawn for clinical diagnostic tests and 1 or 2 cc of extra blood will be used for the study of the neurotransmitters. This blood will be centrifuged and the plasma will be stored frozen at -80C until the samples are ready to be analyzed by high performance liquid chromatography.
The specific objective of this project is to gain knowledge on the neurobiological factors leading to the behavioral abnormalities. The long-term goal is to define the metabolic changes and genetic mechanisms involved in the hope that this knowledge may lead to the development of more effective therapeutic interventions.
There is no foreseeable risk for these studies because the blood will be drawn for clinical purposes (diagnostic studies needed prior to treatment and monitoring of the level of medication during treatment) and an extra 1 or 2 cc of blood from the same stick will be used for this research.
The results of this research will be kept strictly confidential and will not be incorporated in the clinical file. Therefore, the results of the research will not be released to schools or other agencies which receive clinical records.
"Driver Research by the Human Systems Research Group"
Principal Investigator: Dr. Dan R. Tufano, Oak Ridge National Laboratory
Project started in: 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: Full Board
Approving Institution: Oak Ridge National Laboratory
Most recent approval: 11/12/99
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 0
Reporting period for number of human subjects:
Fiscal Year 2000 (10/1/99-9/30/2000)
Type(s) of Human Subjects Involvement:
a. Objectives
Individuals are invited to participate in evaluating new displays that give messages to drivers of automobiles. In the near future, these messages will come to the driver from a variety of new devices in cars; for example, navigation directions, collision warnings, pager messages. The study will take place in a driving simulator. Two types of displays will be compared in this study. One is a Head-Up Display (HUD) which projects messages onto the windshield of the car. In this study, the HUD will be simulated by projecting the messages onto the same screen as the road scene. The other type of display is a head-down display, similar to a small television, mounted inside the car, to the right of the driver’s seat. We will be measuring how well the participants can drive the simulated car when messages are presented on one or the other display.
b. Methodology
The functioning of the driving simulator, the two displays, the driving scenario, and the task to be performed with the displays will be explained to all participants. We will also describe and explain the series of tests we will ask each participant to do. These tests are to measure the drivers’ general abilities in (for example) short-term memory and reaction time. These tests will be conducted before the driving simulator tests.
c. There will be no exposure of human subjects to ionizing radiation, radioactive substances, or chemical substances.
d. Involvement of Human Subjects
Capability Pre-Tests: Participants will sit in front of a desk-top computer for a series of eight tests, which have been selected to measure abilities related to driving: static visual acuity, dynamic visual acuity, contrast sensitivity, selective attention, manual tracking, simple reaction time, useful field of view, and monocular depth perception. These tests will be administered one after the other. Participants will receive instructions before starting.
Driving Simulator Tests: Before participants begin the simulator tests, we will walk them through the set-up and functioning of the simulator, and they will have a five minute practice run to get the feel of the controls. There will be two test runs: one for the head-up display task and one for the head-down display task. Each of these runs will involve driving the simulated car while keeping track of one of the displays for a target word. Participants will be instructed on what to do in the display tasks before each run, and will be given the opportunity to ask any questions they may have.
Because the tests will be conducted with a desk-top computer and a driving simulator (not an actual vehicle), there is no risk of physical injury to participants. The only possible discomfort might be a sense of nausea, similar to car sickness, caused by driving the simulator, because the computer generated road scene moves, but the cab where they are sitting does not. This disconnect between visual movement and the absence of physical movement may cause a feeling called simulator sickness, in some individuals. If any individuals experience such discomfort, they are free to end the testing without loss of their participation fee.
Participant's identity in this testing will be treated as confidential. The results of this work, including laboratory or other data, may be published for scientific purposes but will not give out names or any identifiable references.
Privacy and the confidentiality of any records or data obtained as a result of participation in this testing will be protected to the extent allowable by law. However, they may be inspected by the sponsor, by any relevant agency with the necessary justification (e.g., Department of Energy), by the ORAU/ORNL Institutional Review Board or by the person conducting the testing.
"In-Vehicle Information Integration Study"
Principal Investigator: Dr. Philip F. Spelt, Oak Ridge National Laboratory
Project started in: 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: Full Board
Approving Institution: Oak Ridge National Laboratory
Most recent approval: 12/01/99
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 0
Reporting period for number of human subjects:
Fiscal Year 2000 (10/1/99-9/30/2000)
Type(s) of Human Subjects Involvement:
A. The purpose of this research is to evaluate different ways of presenting information messages to drivers of automobiles.
B. Methodology: The study will take place in a driving simulator, and will involve simulated messages coming from several different systems, for example: cell phone, pager, and warning system. This study will compare the impact of these separate messages on driving performance, when they are either presented in a prioritized fashion or presented as they are generated by the separate systems.
C. No exposure to harmful substances is involved.
D. Subjects will drive a stationary driving simulator. Because no motion in the simulator is involved, there is no physical danger to subjects. A very few people may become slightly nauseated due to "simulator sickness, and they will be allowed to withdraw with no penalty. Data are strictly confidential, and will not be released or used with any identifying characteristics included. Summary statistics will be reported.
"LDRD Driver Research: Phase II"
Principal Investigator: Dr. Dan R. Tufano, Oak Ridge National Laboratory
Project started in: 2000
This project ended in fiscal year 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: Full Board
Approving Institution: Oak Ridge National Laboratory
Most recent approval: 12/14/99
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 0
Reporting period for number of human subjects:
Fiscal Year 2000 (10/1/99-9/30/2000)
Type(s) of Human Subjects Involvement:
Abstract:
a. Objectives:
Subjects will participate in evaluating new systems that give messages to drivers of automobiles. In the near future, these messages will come to the driver from a variety of new devices in cars; for example, navigation directions, collision warnings, pager messages. The study will take place in an instrumented vehicle. Two types of safety warning systems will be tested in this study. A collision warning system detects obstacles, which the vehicle might hit, and gives you warnings of how likely a crash is. A lane tracking system looks at where the vehicle is on the road and gives a warning when it senses that the vehicle is about to leave the road. We will be measuring whether or not these warning systems actually help the driver avoid obstacles and stay on the road. We will also be measuring any possible negative effects the warnings might have on the driver; for example, a startle effect.
b. Methodology:
The functioning of the vehicle, the two safety warning systems, the roadway, and the task to be performed with the types of obstacles they will encounter will be explained to them. A maximum of forty individuals will be invited to participate in this study. Their involvement will require no more then two hours of your time and is entirely voluntary.
Before the start of the procedure described below, they will be given an explanation of the purpose of the study and the sequence of activities: practice run to get the feel of the car, experimental runs in the vehicle, and a post-test interview to get their opinions on the tests and the warning systems. They will be familiarized with the set ups for the test runs on the roadway. If they feel uncomfortable participating in the test, they will be under no obligation to continue.
They may ask any questions about the study and the procedures or other concerns they have about participating, at any time.
TEST APPARATUS:
The main piece of test equipment is a car, which has been outfitted with special equipment. It has two safety warning systems: one for collision warning, the other for tracking the car’s location in the lane and giving warnings if the car is about to run off the road. There are two displays in the car: a Head-Up Display, which projects images onto a transparent piece of plastic (called a combiner) attached to the windshield; and a flat-panel computer screen mounted in the center of the dashboard. There are also several devices for collecting data on what the vehicle is doing (its position, speed, and heading) and on what the driver is doing. The types of data we will be collecting on what they are doing concern: 1) reactions to obstacles when they appear in the road; 2) reactions to the warnings from the safety systems; and 3) normal driving, when there are no obstacles or warnings. There are several types of data we will be collecting to measure these things. Control of the car will be measured by how fast they are driving, how well they stay in the lane, and their responses to avoid hitting obstacles. This last set of measures includes: steering wheel reactions, brake and accelerator pedal actions, and whether or not they hit the obstacles. We will also be using a set of monitors, which they will wear on their hands and arms, to measure heart rate and galvanic skin response (a measure related to how startled you might be by an event). There are six miniature video cameras. Four of the cameras record what is on the road. Two of the cameras record the driver’s face and hands.
The test road is a regular stretch of road, with lane markings, which has been closed off to other traffic while you are driving the test runs.
There are several artificial obstacles which have been set up to appear in front of the car at random times. These obstacles are made of foam with a metal foil backing.
c. No exposure to ionizing radiation, radioactive substances, chemical substances.
d. Involvement of Human Subjects:
1. TEST PROCEDURE:
Tests will only be run during daytime, and when the road is dry. Seat belts must be worn.
In order to help ensure their safe participation in this test, they will be asked to demonstrate their basic driving ability. First, they will drive themselves to Building 6025 at ORNL (they will be given directions). Here they will meet the Principal Investigator and take a standard test of vision: reading an eye chart. They will then drive to the test site, a distance of about two miles, with the Principal Investigator in the car. During this short trip, they will demonstrate their basic driving abilities: observe and obey the speed limit, control the vehicle during turns and staying in lane, recognize and obey traffic control devices, such as stop signs.
Before any of the test runs are done, they will be given detailed instructions on the test procedure and will be familiarized with the vehicle, the safety warning systems, and the data collection systems on the car (the video cameras, the physiological monitors, and the computers in the trunk). They will also be shown the artificial obstacles and how they are set up along the test road. They will have the opportunity to drive the car on the test road to become used to the car and the road. During the test runs, they will be asked to drive the car on the test road at normal speeds, keep the car in the lane, and avoid any obstacles. On some of the test runs, the safety warning systems will be turned on, on other test runs these systems will be turned off. The artificial obstacles will appear in the road at random times. At the end of the series of test runs, we will ask them to give us their opinions of the safety warning systems and on the conduct of the test itself.
2. POSSIBLE RISKS/DISCOMFORTS:
Because the tests will be conducted with them driving an automobile, there is the risk of injury from an accident. We have minimized the risks by ensuring there is no other traffic on the test road, while they are driving the test runs. Nonetheless, we cannot eliminate all risks completely. In addition, the safety warning systems, which we are testing, may create a feeling of discomfort or even distract them, because they are unfamiliar to them. If they are uncomfortable with such risks, for any reason, they are free to end the testing without loss of their participation fee.
3. CONFIDENTIALITY:
Their identity in this testing will not be treated as confidential. Although their names will not be associated with any of the data collected, there will be video recordings of their faces, while they are driving the test runs, which could be used to identify them. The results of this work, including laboratory or other data, may be published for scientific purposes but will not give their names or any identifiable references to them other than segments of the video recordings.
Their privacy and the confidentiality of any records or data obtained as a result of their participation in this testing will be protected to the extent allowable by law. However, they may be inspected by the sponsor, by any relevant agency with the necessary justification (e.g., Department of Energy), by the ORAU/ORNL Institutional Review Board or by the person conducting the testing.