Mr. Bradley
Bugger
U.S. Department of Energy
Idaho Operations Office
Idaho Falls, ID 83401-1562
Phone: 208-526-0833
Fax: 208-526-8789
E-mail: dena.tomchak@inl.gov
Number of Human Subjects projects reported: 8
| INL-95-001 | "INEEL/TSA Explosives Detection Program (Formerly Federal Aviation Administration (FAA) Explosive Detection System and Independent Validation and Verification Project)" |
| INL-04-01 | "Human Factors Evaluation of the Power Boot Tracking System" |
| INL-06-002 | "System for Analyzing Differences in Imagery" |
| INL-06-003 | "Antibody Profiling for Forensic and National Security Applications" |
| INL-06-004 | "Enhancements to the SecureScan Concealed Weapons Detector to Improve Probability of Detection and Reduction of False Alarms " |
| INL-06-005 | "Mentoring Among Scientists: The Implications of Interpersonal Relationship Support within a Formal Mentoring Program" |
| INL-07-001 | "Evaluation of Robotic Control Interfaces and Behaviors for Navigation and Mapping" |
| INL-07-002 | "Explosive Detection Research" |
Other projects of interest associated with this site:
| QC-00-C-99-08-25-01 | "Medical Surveillance of Former Workers at INL, Phase II; Medical Screening" |
"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 Laboratory
Project started in: 1995
Status of the Research this Fiscal Year:
Recruitment and/or enrollment of new participants or review of records/specimens continue.
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 Laboratory
Most recent approval: 05/04/07
IRB approval number: n/a
Additional IRB approvals from other institutions:
Type of Review:
Full Board
Approving Institution: INL
Most recent approval: 05/04/07
IRB approval number: n/a
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 20
Reporting period for number of human subjects:
Fiscal Year 2007
Type(s) of Human Subjects Involvement:
This is an ongoing project 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 (IED) 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. The data are then used to determine where to sample either a person or luggage in airports.
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 the Power Boot Tracking System"
Principal Investigator: Mr. Eric Yarger, Idaho National Laboratory
Project started in: 2004
Status of the Research this Fiscal Year:
Study is not currently enrolling subjects or enrollment of participants is currently suspended, but may resume in the future.
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 Laboratory
Most recent approval: 07/23/04
Explanation of IRB approval:
Project has not been doing human subjects research since expiration date - if it resumes, project will be reviewed before research commences.
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 2007
Type(s) of Human Subjects Involvement:
The Power Boot is a self-contained, non-intrusive, non-cumbering device for tagging and tracking of military personnel.
The Power Boot will provide for tracking, tracing, and self generating power, power management, and battery charging capabilities while incorporating Global Positioning System (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.
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 continue 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 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 INL will only be testing for 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 battery operation. 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.
"System for Analyzing Differences in Imagery"
Principal Investigator: Mr. Derek C. Wadsworth, Idaho National Laboratory
Project started in: 2006
This project ended in fiscal year 2007.
Status of the Research this Fiscal Year:
Current study is completed.
This project does not involve the use of multiple protocols/subprojects.
Institutional Review Board (IRB) Review:
Type of Review:
Expedited
Approving Institution: Idaho National Laboratory
Most recent approval: 12/05/06
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 2007
Type(s) of Human Subjects Involvement:
The research will leverage the capability provided by Idaho National Laboratory's (INL's) Change Detection System (CDS) to capitalize on low-level human perception capabilities (movement detection) to detect differences in images and incorporate neurophysiological indicators of target detection performed at the University of Utah to create a system that maximize the abilities of both the human and machine. Event Related Potential (ERP) signatures from analysts will be assessed while the analysts attempt to identify changes within paired geosatellite images from at least three midline sites and referred to linked mastoids. These signatures will be analyzed for differences, such as positivity and negativity peak latencies in the N400 component of the ERP signature for hits, misses, false alarms, and correct rejections. This research approach will provide a means to overcome the potential for the human response bias that can result in a miss or report a false detection of a change by identifying the neurophysiological characteristics or signature of change detection that signal practical differences in images. The INL/University of Utah approach is unique in that it will allow the analyst to identify changes within actual broad area, geosatellite images.
The combination of CDS with analysis of ERP signatures will provide a means to overcome the potential for response bias by identifying the neurophysiological characteristics of change detection that can be used to signal real, practical differences in geosatellite images. Although this is a large undertaking, it is made possible because the CDS software can eliminate much extraneous information that could trigger irrelevant ERP signals. In addition, these neurophysiological cues indicative of attention and motion detection will be used in conjunction with eye tracking to not only select those images that have real changes, but also to indicate the area or areas of interest within an image. This system will both present images optimally for change detection by human analysts and separate neurophysiological indicators of change detection by the human analyst from response bias influence. We refer to this combination as "brains and chips."
"Antibody Profiling for Forensic and National Security Applications"
Principal Investigator: Dr. Vicki S. Thompson, Idaho National Laboratory
Project started in: 2006
Status of the Research this Fiscal Year:
Recruitment and/or enrollment of new participants or review of records/specimens continue.
Funding for Human Subjects Research:
This project does not involve the use of multiple protocols/subprojects.
Institutional Review Board (IRB) Review:
Type of Review:
Expedited
Approving Institution: Idaho National Laboratory
Most recent approval: 02/01/07
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 15
Reporting period for number of human subjects:
Fiscal Year 2007
Type(s) of Human Subjects Involvement:
A fairly recent discovery that all human beings produce autoantibodies against cellular components in a manner that is unique to the individual has led to the development of a technique called "antibody fingerprinting" or "antibody profiling." In the antibody profiling technique, bodily fluids such as blood, semen, tears, saliva, or perspiration are incubated with a panel of human antigens on a nitro-cellulose membrane and visualized with a colorimetric enzyme reaction. The result is a series of bands similar to a product bar code. The banding pattern has been found to be unique for each individual, even in the case of identical twins. The exception is newborns whose pattern matches their mother's for the first year of life. The major application of this technique to date has been for sample identification in the health and agricultural industries and as an identification tool by the military for post-mortem remains. The assay is extremely rapid, taking approximately 50 minutes to complete and requires small sample volumes (5 mL). In addition, autoantibodies are more resistant than DNA to degradation by temperature, sunlight, bacteria, and other contaminants. Statistical analysis of this technique has shown that the likelihood of two people having the same banding profile is approximately 1 in 1,023. The assay, which has a low cost per test kit, is easy to perform, requires only a computer, scanner, and analysis software for interpretation.
Despite the positive aspects of the antibody profiling assay, it has not been used in the forensics field or in the national security arena. The overall objective of this research is to manufacture antibody profiling strips for experimental use. We will obtain blood and saliva samples from individuals at the Idaho National Laboratory (INL) and test these samples with antibody panels produced at the INL.
"Enhancements to the SecureScan Concealed Weapons Detector to Improve Probability of Detection and Reduction of False Alarms"
Principal Investigator: Dr. Dale Kotter, Idaho National Laboratory
Project started in: 2006
Status of the Research this Fiscal Year:
Recruitment and/or enrollment of new participants or review of records/specimens continue.
Funding for Human Subjects Research:
This project does not involve the use of multiple protocols/subprojects.
Institutional Review Board (IRB) Review:
Type of Review:
Expedited
Approving Institution: Idaho National Laboratory
Most recent approval: 03/19/07
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 2007
Type(s) of Human Subjects Involvement:
This research study is designed to detect and locate ferrous objects on humans. This research is unique in that it uses a non-emitting, passive technology to pinpoint the location of ferrous objects on the human body.
This project will develop the next generation Idaho National Laboratory (INL) Concealed Weapons Detection System. The proposed work will use the SecureScan magnetometer concealed weapons detection system as the infrastructure for development of enhanced threat detection capabilities. It will serve as a platform to combine various detection methodologies into a single portal system. The passive, magneto-resistive gradiometer sensors incorporated in SecureScan measure minute fluctuations in the Earth's magnetic field and are very sensitive to ferromagnetic materials found in concealed weapons. Unlike standard electromagnetic sensors, SecureScan can detect even very small amounts of ferromagnetic material that indicate the presence of razor blades and X-acto knives.
The major benefit to this style of portal technology is that there are no emissions from the sensors. Therefore, it is not harmful to any medical implants such as pacemakers and it will not harm any magnetic storage media or devices. The system meets Transportation Security Administration (formerly, Federal Aviation Administration) detection specifications.
Ionizing Radiation, chemicals: NONE
Involvement of Human Subjects:
You will be asked to do the following:
- Remove all ferrous objects from your body.
- Hold a specific ferrous object at a specific location and orientation.
- Walk at a normal, steady pace through the portal.
- Repeat 10 to 30 times.
The duration of the experiment will vary depending on the number of ferrous objects being studied.
Risks:
The main risk in the study is possible fatigue from walking.
Privacy:
Your picture will be taken when you are in the middle of the portal. The data acquired from the pass through the portal, as well as the picture, will be archived on the system computer.
"Mentoring Among Scientists: The Implications of Interpersonal Relationship Support within a Formal Mentoring Program"
Principal Investigator: Mr. Bryan Maughan, Idaho National Laboratory
Project started in: 2006
This project ended in fiscal year 2007.
Status of the Research this Fiscal Year:
Current study is completed.
This project does not involve the use of multiple protocols/subprojects.
Institutional Review Board (IRB) Review:
Type of Review:
Expedited
Approving Institution: Idaho National Laboratory
Most recent approval: 04/11/06
Explanation of IRB approval:
Project was completed before date of review was scheduled in April of 2007.
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 2007
Type(s) of Human Subjects Involvement:
Abstract:
Mentoring is an established strategy for learning with roots in antiquity. Most, if not all, successful scientists and engineers had an effective mentor at some point in their careers. Because of recent concerns regarding the future of science and engineering in the U.S., organizations have sought to establish formal mentoring programs. Research affirms that recruiting, retaining, and educating are functions of mentoring. Although heralded as a valid educational strategy, mentoring is only mentioned a priori within literature that reports the impending challenges of a declining science and engineering (S&E) workforce. Using qualitative methodology, preliminary findings indicate that formal mentoring needs to be contextually defined and operationalized to be successful. The quality of relationships significantly influences protégés' career intentions. Relationships are a key factor that undergirds behavior management which impacts succession planning, perpetuating critical information, and communicating tacit knowledge essential to the development of leadership in industrial science and technology.
"Evaluation of Robotic Control Interfaces and Behaviors for Navigation and Mapping"
Principal Investigator: Dr. David Gertman, Idaho National Laboratory
Project started in: 2007
Status of the Research this Fiscal Year:
Study is not currently enrolling subjects or enrollment of participants is currently suspended, but may resume in the future.
Funding for Human Subjects Research:
This project does not involve the use of multiple protocols/subprojects.
Institutional Review Board (IRB) Review:
Type of Review:
Expedited
Approving Institution: Idaho National Laboratory
Most recent approval: 05/15/07
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 18
Reporting period for number of human subjects:
Fiscal Year 2007
Type(s) of Human Subjects Involvement:
This research has the goal of improving the efficiency of interaction between humans and robots. The purpose of the research is to study the usability of different control interfaces and the efficiency associated with differing levels of autonomy for the control of robots. The research is needed because it is not clear what type of control interface and autonomous behaviors should be for the next generation rotots for search or navigation type tasks. Participants will be asked to navigate a robot through a maze or within an urban search and rescue test bed and identify or find objects placed in the environment. Objects may include sealed sources selected to mock explosive devices or radiation sources (fake mines or fake bombs). Participants will navigate by one of three interfaces including a map of the environment created "on-the-fly" from the sensor information by the robot interface. 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.
There is minimal risk associated with participation. 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 carpal tunnel disease (CTD). To minimize the potential for risk, we will screen for participants who have a history of 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).
All of the data collected will be controlled by the Principal Investigator 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. All data will be identified only by a subject number; the names will not be associated with any data. The results of the study may be published for scientific purposes but with no names or identifiable references to the participants.
"Explosive Detection Research"
Principal Investigator: Ms. Carla Miller, Idaho National Laboratory
Project started in: 2007
Status of the Research this Fiscal Year:
Project funded, but no participants have been enrolled to date.
Funding for Human Subjects Research:
This project does not involve the use of multiple protocols/subprojects.
Institutional Review Board (IRB) Review:
Type of Review:
Expedited
Approving Institution: Idaho National Laboratory
Most recent approval: 09/11/07
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 2007
Type(s) of Human Subjects Involvement:
Abstract:
Detectors must be able to work in environments that have many contaminants and background signals. In the military environment, there are background contaminants inherent with the work being performed such as sweat, smoke, grease, and diesel exhaust. In areas such as farming communities, the presence of agricultural pesticides and fertilizers can be of concern. In addition, hygiene products, such as lotions, hair care products, shaving products, etc., may result in nuisance alarms or masked detection.
This study will focus on common products that may result in either nuisance alarms or masked detection of the FIDO handheld explosives detection device. Hand swipes will be taken of office workers, employees who occasionally handle explosives, security guards who handle weapons, and workers who routinely handle explosives. The swipes will be analyzed and the data recorded. In addition, a series of questions will be asked of the volunteer such as what types of things their hands have been in contact within the past hour prior to sampling, including lotions, foods, hand cleansers, sanitizers, etc.
There are no known risks associated with this research. Anticipated discomforts are skin irritation resulting from the swiping of the hand with the instrument swipe or vacuuming of the skin surface on the hand with the Quantum Sniffer explosive trace detector. However, this irritation is assumed to be minimal since only the palm of the hand will be sampled. The identity of the research subjects will not be revealed. The only means of identification is through the questionnaire stating what their occupation is. There will be multiple subjects with the same occupation, so that identification cannot occur.