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: 4
| INL-90-95-001 | "INEEL/TSA Explosives Detection Program (Formerly Federal Aviation Administration (FAA) Explosive Detection System and Independent Validation and Verification Project)" |
| INL-02-02-001 | "Human Factors Evaluation of Interfaces for Control of Robots" |
| INL-04-04-002 | "The Effects of Physician Advice on Changes in Lifestyle and Clinical Risk Factors" |
| INL-04-04-01 | "Human Factors Evaluation of the Power Boot Tracking System" |
Other projects of interest associated with this site:
| NIOSH-92-002 | "Cohort Mortality Study of Idaho National Engineering and Environmental Laboratory (INEEL)" |
| PACE-97-DE-FC03-97SF21512 | "Medical Surveillance for Former INEEL Workers" |
| NIOSH-97-009 | "Multi-Site Case-Control Study of Lung Cancer and External Ionizing Radiation" |
"INEEL/TSA Explosives Detection Program (Formerly 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: 05/10/04
IRB approval number: n/a
Additional IRB approvals from other institutions:
Type of Review: Full Board
Approving Institution: INEEL
Most recent approval: 05/10/04
IRB approval number: n/a
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 5
Reporting period for number of human subjects:
Fiscal Year 2004
Type(s) of Human Subjects Involvement:
This is an ongoing project is designed to aid the Transportation Security Administration in determining how, when, and where to do searches at airports for explosives. Since the Federal Aviation Administration has become the Transportation Security Administration, the scope has grown to include all modes of transportation, including buses, subways, railroads, ships, etc.
The basic steps to this research are to build an improvised explosive device and by tracking the contamination on either the builder, the carrier of the device, or the luggage that the device is placed in, determine where the explosive contamination is easiest to locate and how it spreads. This data is then used to determine where to sample either a person or luggage in airports.
The human subjects for most of the testing are males. There are no special characteristics, traits, or ages that are used. The testing is normally done by males just to decrease the scope of the testing. If both males and females were used, then all of the tests would have to be run in duplicate by each of the sexes, doubling the cost of the activities. We are under the assumption that the majority of terrorist activities involving explosives are performed by men.
The subjects will be handling explosives and then they will be sampled in at least one of several possible ways. The person will be sampled by swiping a cloth over the area of interest, vacuuming the area of interest, or cutting patches of clothing from the area of interest.
The risks associated with this activity are those associated with handling the explosives. Many of the explosives can be absorbed through the skin and act as vasodilators. It is important that people who know they have heart problems declare that prior to handling the explosives. The amount of time a person handles the explosive will be limited. Training will be provided to ensure everyone understands the risks. Gloves will always be worn with nitroglycerin based explosives.
There are no preconceived benefits to the human subject other than knowing that they helped to perform tests to benefit National Security. The data from these tests will be used to determine when, how, and where to sample people in airports and eventually in other modes of transportation prior to boarding to decrease the threat of explosives on the transportation mode. The benefits to society are that there will be increased safety amongst transportation modes and the results should decrease the amount of time that people are required to wait in line prior to boarding any type of transportation.
Data are recorded in both a logbook and stored on computers which are located with the instrumentation. The data are considered to be Official Use Only. The subject is known as a number and not a name. These numbers are randomly generated. Parts of the data are stored in various places and cannot be put together by anyone except in the report where no subject numbers are used.
Informed consent is normally discussed in a prework meeting and the paperwork is signed after the discussions. The Principal Investigator (PI) is responsible for describing the informed consent program and getting the paperwork in order. The informed consent incorporates an explanation of the project and requirements, a description of risks, and a description of alternative procedures. The PI offers to answer questions and termination rules.
"Human Factors Evaluation of Interfaces for Control of Robots"
Principal Investigator: Ms. Julie Marble, Idaho National Engineering and Environmental Laboratory
Project started in: 2002
Funding for Human Subjects Research:
This project does not involve the use of multiple protocols/subprojects.
Identifier or number: 02-001
Institutional Review Board (IRB) Review:
Type of Review: Expedited
Approving Institution: Idaho National Engineering and Environmental Laboratory
Most recent approval: 05/10/04
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 12
Reporting period for number of human subjects:
Fiscal Year 2004
Type(s) of Human Subjects Involvement:
This is on-going research on the usability and interaction of humans and robots. The purpose of this research is to assess the usability of different control modes or architectures and the efficiency of adapting the degree of autonomony for the control of robots. Adjustable autonomy or adaptive control is a novel approach in human-robot interaction. This research is needed because it is not clear what type of control architecture or method for sensor information fusion and presentation will lead to the greatest usefulness of robots in search or navigation type tasks.
Human subjects are involved in this research because it is their perceptions that we want to examine in order to increase the acceptance and usefulness of this technology. The purpose of the research is to design robotic systems to best support human needs, capabilities, and limitations. It is not possible to simulate the interaction of humans with robots in the mode of adaptive control because this type of control architecture has not previously been implemented, there is little information on the human operators needed for sensor information, nor do we know how increased levels of autonomy will change how humans can perform the task. In addition, the purpose of this research is to study the interaction of humans and robots with this type of control architecture.
The participants will be employees of INEEL. Participants can be male or female and will vary in age from 18 to 65. We are interested in employees' varying levels of experience in the control of robots either in real life or through video games because we wish the participants to be accurate reflections of users who may only infrequently need to use robots as well as those who may receive intensive training with the system.
Risks related to control of the robot are very similar to those of office work or playing video games; therefore, risk to pregnant participants or the fetus is considered to be very low. Female participation will be encouraged because in real world applications, such as urban search and rescue, both men and women will interact with the robots. Pregnant woman will not be barred from participating if they so choose. Participants will be volunteers solicited by email from the INEEL.
Participants will be asked to navigate an ATVR Jr. robot through a softwall maze or within an urban search and rescue (USAR) test bed and asked to identify or find objects placed in the environment. Objects may include mannequins and stuffed animals (to simulate victims) mock explosive devices (fake mines or fake bombs). Participants will navigate by video feed to the computer that controls the robot and/or via a map of the environment created on-the-fly from the sensor information by the robot interface. Control of the robot and feedback from the robot (e.g., camera information, mapping information, or other sensor information) may be split between two or more operators to allow us to assess how information is used, and each time when information is more critical for the user. Operators may be asked a series of questions after each navigation regarding their subjective assessment of the ease of use of the interface and the task. Non-intrusive physiological measures of operator workload (such as pulse rate measured with a finger monitor or monitor imbedded in the joystick, pupil diameter measured via video, or voice stress) may also be assessed. Total participation may take as long as 2 hours or as little as 5 minutes.
There are minimal risks associated with participation in this experiment. Minimal risk means that 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. Participants may need to make multiple rapid keystrokes during the robot navigation task, which could aggravate an injury, such as carpal tunnel syndrome or other cumulative trauma disorder. To minimize the potential for risk, we will screen for participants who have history of cumulative trauma disorders (CTDs), or injury to their wrists or shoulders. In addition, participants will be encouraged to stand or walk and stretch between trials (approximately every 15 minutes). Because the participants will be separated from the robots, there is little potential for injury from contact with the robots.
All Voluntary Protection Program (VPP) and Integrated Safety Management System (ISMS) guidelines will be followed to the best of our ability. The Principal Investigator (PI) will remind the participant that they are free to stop and leave the experiment if they feel like they are at risk without penalty. There will be no deception manipulation in the experiment. A full debriefing session will occur at the end of the experiment to explain what we are trying to test and to answer any questions the participants might have. To minimize the potential for risk of CTDs, the PI will screen for participants who have history of CTDs, or injury to wrists or shoulders. In addition, participants will be encouraged to stand or walk and stretch between trials. Participants will be allowed to stand while controlling the robot, if they so choose.
To avoid the potential for injury from the robots, contact with the robots will be minimized. During the navigation task, the participants will be seated in at a table or desk in a separate part of the building from where the robot will navigate the course. Although the participants may be given a tour of the area that the robots navigate, the robots will not be functioning at that time. During navigation, robots will be under surveillance at all times, and a technician or the experimenter will be able to power off or stop robot movement at any time, should that be required.
There is no direct benefit to the participant in this study, aside from the interesting nature of the tasks to be performed, and the opportunity to learn about potential uses of semi-autonomous robots. Participants will be given a charge number (i.e., they will be paid their normal salary for participation in this research project). Increased ease of use and usability of robots will allow implementation of robots in tasks that are dangerous or inaccessible to humans. In order to incorporate robots into critical tasks, it is necessary to know what information operators need to gain from the interfaces, how sensor information should be presented, and the behaviors that the robot needs to have in order for a search to succeed. Additionally, by determining factors that indicate when a human operator is in an error prone situation (e.g., a high workload situation) the robot can be programmed to take more responsibility for its own safety or to provide greater assistance to the human operator, thus reducing the probability of human error. Experimentation on how to present sensor information is especially critical for organizations that require humans to enter high-risk or dangerous situations, such as some Department of Energy or Department of Defense facilities or sites. Increased navigation ability and more effective and efficient human-robot interfaces will allow robots to be used in situations such as waste clean up, or urban search and rescue of areas where it is infeasible to allow humans.
The PI feels the benefits outweigh the risks primarily because the risks are minimal (roughly equivalent to those involved in typical office work or playing video games) while the benefit of the INEEL implementing adjustable autonomy in robots will reduce the need to expose human workers to risk in tasks such as waste clean up. One outcome of this research is to allow robots to reduce workload on human operators, thus reducing the probability of error in critical or high consequence environments. (In critical environments like search and rescue an error can lead to a missed victim or a rescue worker becoming a victim.) In addition, the task itself should be enjoyable for those who have the opportunity to participate.
All of the data collected during the study will be controlled by the PI to ensure privacy. The data will be kept in a locked cabinet, accessible only by the experimenters. The data will be kept for three years.
Participant identities in this study will be confidential. All data will be identified only by a subject number; participant names 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 we will not give names or include any identifiable references to the participants.
Informed consent will be obtained by having the participant read our informed consent form. Participants will be required to initial each page, and sign the last page indicating they consent to the experiment. Informed consent will be obtained by the experimenters or other designated assistant. A copy of the signed informed consent will be made and given to the participant to keep in their records.
"The Effects of Physician Advice on Changes in Lifestyle and Clinical Risk Factors"
Principal Investigator: Dr. Evan L. Thomas, Idaho National Engineering and Environmental Laboratory
Project started in: 2004
Funding for Human Subjects Research:
This project does not involve the use of multiple protocols/subprojects.
Identifier or number: 04-002
Institutional Review Board (IRB) Review:
Type of Review: Expedited
Approving Institution: Idaho National Engineering and Environmental Laboratory
Most recent approval: 03/18/04
IRB approval number: n/a
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 10000
Reporting period for number of human subjects:
Other: 03/18/04 to 09/30/04
Explanation:
This study is a retrospective analysis of existing records for the past 9 years.
Type(s) of Human Subjects Involvement:
The purpose of this study is to examine how effective physician counseling in facilitating or motivating patients to change at risk health behaviors. National disease prevention objectives and practice guidelines call for a physician to advise patients more routinely to modify health-related behaviors like tobacco use, physical activity, and eating unhealthy diets.
Underlying these recommendations are four basic assumptions: 1) certain behaviors can lead to increased risk for chronic disease, 2) effective strategies exist to help patients make behavioral changes, 3) making such changes can reduce a persons disease risk, and 4) patients who receive physician advice are often more likely to successfully enact behavioral changes.
A large body of epidemiologic evidence and intervention evaluations supports the first three assumptions. However, the nature of the physician advice-patient behavior relationship is less well understood. Although some studies have shown physician-counseling intervention to help patients quit smoking, evidence for efficacy of counseling patients to modify eating habits, physical activity, or coronary risk factors is minimal. Our group has just finished a study looking at the efficacy of the health risk assessment process given to the INEEL employees not subject to a mandatory full physical exam. What was discovered was that greater improvements in employee health were observed the more often employees were exposed to the health risk assessment intervention. The question now is: Do the same dose effects exist for physician advice?
Since 1995 all medical records have been recorded electronically into the Occupational Medical Surveillance System (OMSS) database. This system now allows researchers to extract data from thousands of records in minutes instead of months as was typical with hard copy files. We propose the following experiment to test our hypothesis that the more frequently an employee is exposed to physician advice to change their behavior the more likely that is to occur.
Through the use of logit regression and cross-tab analysis as well as Multiple Analysis of Variance (MANOVA) analysis of means for each year that the employee received a full physical we plan to address the following questions: Is physician counseling during periodic health examination in an occupational setting effective in improving health behaviors? If so, can a dose effect be demonstrated where the magnitude of change is associated with the number of times the individual had a physical exam? How do changes in prostate specific antigen relate to lifestyle and demographic variables? How do changes in smoking status affect changes in risk measures adjusted for lifestyle behaviors? According to a time-series design, what is the most cost-effective time interval to deliver physical exams and health screenings?
Since the analysis will be identical to that used by the previous study, we will also be able to establish which intervention model is more effective. The electronic database that is being analyzed is unique in that it contains serial data over a span of almost a decade and lends itself to some unique analyses that cannot be fully anticipated until a preliminary statistical analysis has been completed.
There are minimal risks associated with this study since the data have already been collected and the study is a retrospective analysis. The term, Minimal Risk, means that potential for harm or discomfort is not greater than that encountered in daily living or the performance of routine physical exam or tests.
Since the data have already been collected over the last nine years, the potential for harm or discomfort from the procedure has already been incurred. The only risk that exists is that since medical data are being analyzed that the employee could somehow be identified in the study. That risk has been minimized in that all data used during the study will be controlled by the Medical Director to ensure privacy. The data are kept on servers isolated from the INEEL network and can only be accessed by the Medical Director who has specific access rights. Participant identities in this study will be confidential. Data cases will be identified by only a randomly generated subject number. Employee name, employee number, company, or work location or any other potential identifier associated with the data will be removed. The results of the study may be published for scientific purposes and any publication will contain only summarized group averages and will not and cannot include names or any possible identifier.
Any direct benefits to participating in this study for each employee have already been realized in that they have received a comprehensive physical exam at no cost to them and on company time. They have been counseled on ways to improve their health status, received routine health screens, and been referred to their personal medical doctor for follow-up care if needed.
"Human Factors Evaluation of the Power Boot Tracking System"
Principal Investigator: Mr. Eric Yarger, Idaho National Engineering and Environmental Laboratory
Project started in: 2004
Funding for Human Subjects Research:
This project does not involve the use of multiple protocols/subprojects.
Identifier or number: 04-01
Institutional Review Board (IRB) Review:
Type of Review: Expedited
Approving Institution: Idaho National Engineering and Environmental Laboratory
Most recent approval: 07/23/04
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 2004
Type(s) of Human Subjects Involvement:
The Power Boot is a self-contained non-intrusive, non-cumbering device for tagging and tracking of personnel.
The Power Boot will provide for tracking, tracing, and self generating power, power management, and battery charging capabilities while incorporating a Global Positioning Satellite (GPS) tracking capability. The boot is specifically designed to provide the location of each individual using a micro oscillator circuit. The Power Boot will also have an active and passive radio frequency (RF) tagging system. The transmit and receive capabilities of the GPS system installed within the boot will be activated by the active RF sensor when the location of the individual is polled by a customer.
The Power Boot is comprised of a power management circuit, a sensor, a storage capacitor, a passive RF transmitter / receiver tag, an active RF tag, a GPS transmitter/receiver, and a super magnet micro-motion generator, all of which have been molded into the heel of the boot. The Power Boot also includes a rechargeable Lithium Polymer battery that has been molded into the sole of the boot. The boot will have a specially designed antenna that has been molded into the entire circumference of the sole of the boot.
The battery is connected to a power management circuit that will monitor the battery and control the charging algorithm of the battery. The power management circuit, in conjunction with a storage capacitor, is also designed to bleed power at a controlled rate into the battery pack from the generator that is located in the heel of the boot. The generator is designed to provide power output with micro motions.
The power from the battery pack will operate the passive RF tag, the active RF tag, and the GPS transmitter/receiver tag. The system of tags will provide for the tracking of an individual at almost any location worldwide. The power output of the Power Boot will have the capability to not only supply power for the tracking module within the boot but also generate power for other personnel devices.
The software associated with the power source will be limited to simple activation commands, which will be used to activate the GPS transmitter. The software will also provide the interface between the sensors and the power management systems. The hardware interface for the sensors and tagging system will be incorporated into the power management system software and hardware interface.
The participants will be asked to walk with the modified boot on for not more than 1/2 mile at a time on a treadmill and then after resting or at a later date outside in the parking lot. This is the total extent of the participants input.
The ability to track an individual soldier in real time mode will enhance the military's capabilities to manage the wise use of personnel resources and prevent loss of life and soldier capture in hostile combat situations. Constant real-time tracking will also help prevent friendly fire deaths due to inaccurate fire mission data.
On the commercial side the use of tracking devices placed in children's shoes will help prevent lost or stolen children. Police force and fire fighters will be tracked and health status of each individual can be monitored in real time. There are several uses for this technology that have not been explored. The INEEL will only be testing for the military applications.
There are minimal risks associated with this study. The RF signal strength is less than 2 watts, and the power generation will be isolated from the individual by the boot. The magnetic source will be shielded, and the power management circuit will manage the battery capabilities. The lithium polymer battery was chosen to substantially reduce the risk to personnel. There is no free lithium in the battery, and damage to the battery will not cause a shorting effect that could cause harm or injury to the personnel using the devices. The tasks will require walking which has been associated with fatigue, or possible trauma to the foot in the form of blisters, trips, slips, or possible falls. The amount of RF radiation emitted by the Power Boot is well below harmful limitations for personnel.
All of the data collected during the study will be coded alpha numerically and controlled by the Principal Investigator to ensure privacy. The data will be kept in a locked cabinet, accessible only by the investigators. The data will be kept for three years.
There is no direct benefit to the participant in this study, aside from the interesting nature of the task to be performed.