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: brad.buggar@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-05-001 | "NGNP/VHTR Public Outreach and Analysis" |
| INL-06-001 | "Equipment Reliability and Performance" |
| 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" |
Other projects of interest associated with this site:
| NIOSH-92-002 | "" |
| 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
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: 05/11/06
IRB approval number: n/a
Additional IRB approvals from other institutions:
Type of Review:
Full Board
Approving Institution: INEEL
Most recent approval: 05/11/06
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 2006
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 testing is done mostly with 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 the Power Boot Tracking System"
Principal Investigator: Mr. Eric Yarger, Idaho National Laboratory
Project started in: 2004
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 2006
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 a 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 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 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 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.
"NGNP/VHTR Public Outreach and Analysis"
Principal Investigator: Mr. Jeffrey C. Joe, Idaho National Laboratory
Project started in: 2005
This project ended in fiscal year 2006.
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: 07/13/05
Explanation of IRB approval:
Study was completed at the end of FY2005.
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 2006
Type(s) of Human Subjects Involvement:
Introduction:
The INL public outreach and analysis team stated in their document, Approach for Next Generation Nuclear Plant Public Outreach and Analysis, how they intend to reduce Next Generation Nuclear Power (NGNP)/Very High Temperature Reactor (VHTR) programmatic risk related to stakeholders and issue management. One of the activities this team will engage in to reduce NGNP programmatic risk is the conducting of focus group sessions with various groups of stakeholders. The goal of the focus group is to probe deeply into issues, concerns, values, framing, mental models, and possible issue resolutions. Focus groups offer an opportunity for a deeper, more meaningful level of dialogue and exchange than is possible in a public meeting setting. This more in-depth discussion should lead to an exposure of not only the positions and attitudes of the attendees, but also an exploration of the reasons, feelings, and values behind the positions and attitudes. This deeper level of understanding is fundamental in the effort to identify and understand the variety and orientation of citizen perspectives that influence the potential resolution of issues.
Two Possible Paths Forward:
There are two possible paths forward at this time. We are currently moving forward with the first path described below.
1. The first is to plan the focus group protocol and then prototype the protocol using two groups of INL summer students on the afternoons of July 13 and 14, 2005.
The advantages of this plan are:
* It fits within the scope and budget of the FY2005 workpackage.
* It is easily planned and carried out.
* It could incorporate participants with a diverse geographical background.
* It will add to our growing database of perspectives, issues, and concerns from a group that is likely to be different from those we've used in the past in age and geographical background.
* It will provide meaningful feedback to refine the process prior to reaching out to the general public.
Disadvantages of this plan are:
* INL summer students do not represent a random selection of the public. They are likely a relatively homogeneous group with respect to age, educational background, level of interest in the INL, etc.
* While there will be many things that can be learned from this group, we cannot generalize these to the public at large.
* Additionally, information derived from only two focus groups limits the total number of participants preventing a systematic and representative dataset that would lead to the ability to make generalizations to actionable information for a much larger and more diverse population (e.g., the public).
2. The second possible path forward involves beginning to conduct focus groups with members of the local and regional public, probably beginning in August or September 2005.
The advantages of this path are:
* The team begins to engage local and regional stakeholders and identify their issues, concerns, and values.
* Ideally, a number of focus groups would be conducted over the next year with members of the public from the local and regional communities. For example, groups could be created in Idaho Falls, Arco, Twin Falls, Boise, Jackson, the Sun Valley area, and the local ShoBan tribe (and other communities as deemed appropriate).
Disadvantages of this path:
* Permission to engage the public would be required from INL Public Affairs and the Department of Energy.
* FY2005 funding would be sufficient to begin this work locally, but funding would be needed in FY2006 to continue to expand regionally.
Of course, pursuing the first path does not preclude the team from transitioning to the second path as soon as permission to engage the public is secured and funding is provided. In fact, there is value in pursuing the student focus groups to refine the process and ensure that we are prepared to use the process with members of the general public.
Draft Focus Group Protocol:
It is anticipated that standard focus groups with members of the public should be restricted to no more than 3 hours. The draft protocol, therefore, would be for a 3-hour meeting in the afternoon beginning with lunch. The following agenda would be typical:
12:30-1:00 Arrival and informal buffet style lunch. (The next two agenda items will occur during the lunch period.)
1:00-1:15 Welcome and administration of pre-survey
1:15-1:30 Introductions of team members and group participants; review of goals, agenda, and ground rules
1:30-2:30 Group Discussion (see questions below)
2:30-2:45 Break
2:45-3:45 Group Discussion
3:45-4:00 Wrap-up and Post-survey
Questions to be discussed:
What do you think about the energy situation in the United States? (Follow-up probe could be: Do you think the U.S. is on-track for another major energy crisis?)
What do you think about nuclear energy in the United States?
Of the list of issues and concerns you have discussed, how would you prioritize them?
(Follow-up: What questions does the claim of a new and improved nuclear energy technology raise for you?)
Here are some things that haven't come up in the discussion, what do you think about them?
How do you think the Department of Energy and the Idaho National Laboratory should involve the public and how should they use what they hear?
INL Summer Student Focus Group's Draft Plan:
Timeframe: Wednesday, July 13 and Thursday, July 14
Focus Group Size: 8 to 10
Participants: INL Summer Students
Duration: Two half day sessions:12:30 pm to 4:00 pm
Session will be recorded, preferably videotape with audio. Ground rules will be posted on the wall covering the normal issues. An attempt will be made to have a geographically diverse group. A limited subset of the NGNP Public Outreach and Analysis Team will attend. Most likely Max, J.D., Steve, and Jeff although this point bears some discussion.
Risks and Benefits:
There is minimal risk 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.
Protection of human participants primarily comes from having all participants read and sign an informed consent form. In that form, participants are told 1) what they will be doing, 2) what the risks and benefits are in doing the task, 3) that they are free to ask questions, 4) that their responses will remain anonymous and confidential, 5) that they are free to leave the experiment at any time without penalty, and 6) that there are people they can contact if there are unresolved problems. There is no deception involved in this research. At the end of the focus group, participants will go through a debriefing session that also serves as an opportunity to answer any questions the participants might have. Participants will receive a signed copy of the informed consent form to keep for their records.
The researchers will also be told that they must respect the rights of the participant and attempt to answer every question the participant may have. In addition, all Voluntary Protection Program (VPP) and Integrated Safety Management System (ISMS) guidelines will be followed to the best of our ability.
There is no direct benefit to the participants in this study, aside from the interesting nature of the tasks to be performed. However, a better understanding of issues, concerns, values, framing, and mental models of stakeholders on the issue of NGNP/VHTR may help reduce programmatic risk related to stakeholders and issue engagement.
"Equipment Reliability and Performance"
Principal Investigator: Dr. David Gertman, Idaho National Laboratory
Project started in: 2006
This project ended in fiscal year 2006.
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: 01/03/06
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 2
Reporting period for number of human subjects:
Fiscal Year 2006
Type(s) of Human Subjects Involvement:
Objectives:
Review of the human machine interface for large-scale supervisory control and data acquisition (SCADA) systems.
Methodology:
1) Inquiry was made regarding interest in participating in a research study and interested operators applied.
After receiving an overview of the project and agreeing to continue, subjects were briefed on their rights to privacy, and confidentiality. They were encouraged to ask questions. A consent form was presented and signed by the Principal Investigator prior to implmentation of the rest of the methodology.
The study consisted of two 3-hour SCADA familiarization sessions for operators followed by observation and debrief. Observations were noted for the second session.
2) The risks involved were similar to those working in an ordinary office environment. The SCADA was a simulation and the participants understood that nothing they did could cause harm to real equipment, systems or people.
3) Subjects received a briefing on privacy, confidentiality, and overview on how their rights were protected. Prior participating in the familiarization sessions, they received and signed a consent form outlining how their rights were to be protected and how they could stop the study at any time they felt uncomfortable.
Chemical, Radioactive, or Ionizing Radiation Exposures:
No radiation other than the background radiation from CRT monitors found in any office environment was present.
Invovlement of Human Subjects:
No samples or physiological measurements of any kind were taken. Observations regarding time to notice and respond to changes in parameters presented by the SCADA/CRT interface and the degree to which the SCADA information supported problem solving was analyzed.
"System for Analyzing Differences in Imagery"
Principal Investigator: Mr. Derek C. Wadsworth, Idaho National Laboratory
Project started in: 2006
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: 12/13/05
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 8
Reporting period for number of human subjects:
Fiscal Year 2006
Type(s) of Human Subjects Involvement:
The research will leverage the capability provided by 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
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: 02/10/06
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 10
Reporting period for number of human subjects:
Fiscal Year 2006
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 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
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: 03/23/06
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 2
Reporting period for number of human subjects:
Fiscal Year 2006
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 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 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: 04/11/06
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 2006
Type(s) of Human Subjects Involvement:
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 protégé's 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.