Mr. William R. Geer
Sandia National Laboratories
Media Relations and Communications
PO Box 5800, MS 0165
Albuquerque, NM 87185-0165
Phone: 505-844-6601
Fax: 505-844-0645
E-mail: wrgeer@sandia.gov
Number of Human Subjects projects reported: 11
| SNL-00-12 | "Pedomass Personnel Tracker" |
| SNL-00-17 | "Facial Verification System Evaluation" |
| SNL-01-04 | "Performance Evaluation of Biometric Verification Systems" |
| SNL-01-14 | "An Exploratory Study of Uranium and Thorium Isotopic Detection by ICP-MS and Its Applications" |
| SNL-01-16 | "Adaptive Awareness for Personal and Small Group Decision Making" |
| SNL-02-03 | "Populating Computational Models of Cognition with Knowledge Elicitation Data to Detect Man-Machine State Discrepancies: Knowing and Responding When the Human and Machine Are Not on the Same Page" |
| SNL-02-05 | "Acoustic Biosensors for Bacteria Detection " |
| SNL-02-06 | "FY02 Biometric Verification Systems Evaluation " |
| SNL-02-13 | "Evaluation of Toolkit for Recapature / Recovery Project" |
| SNL-02-15 | "The Relationship between Sleep & Breathing" |
| SNL-02-18 | "Flow in Organizations: Experience at Work" |
"Pedomass Personnel Tracker"
Principal Investigator: Mr. Kurt O. Wessendorf, Sandia National Laboratories
Project started in: 2000
This project ended in fiscal year 2002.
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: Sandia National Laboratories
Most recent approval: 07/10/01
IRB approval number: N/A
Explanation of IRB approval:
IRB approval was valid until 7/10/02.
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 2002
Type(s) of Human Subjects Involvement:
There are a variety of applications for a small, portable, self-contained system that can measure and record personnel movement. The goal is to develop a sensor suite, algorithms, computational hardware, and memory storage to implement such a system. The initial concept is to use an accelerometer to determine movement (which might be used like a pedometer to count steps as a person walks) and a compass to determine direction. Then by counting steps and knowing direction, one could tell how far and where an individual went. Memory would be included to store this information for later download (e.g., to a personal computer).
This project proposes using human subjects to walk around typical SNL work areas with small, lightweight sensor packages to provide data required for the development and implementation of this device. Data will be collected on human locomotion and algorithms will be developed to allow conversion of the sensor data into distance and direction information.
The benefits of this activity are that it develops a new capability that has a high level of interest from several customer groups. Physical risks to human subject participants are minimal and the activities are not out of the ordinary (walking).
Phase I
To obtain initial data, human subjects will walk within a lab room carrying small (<1lb.) sensor packages. Sensor data will be recorded via an umbilical cord to standard lab equipment. (The umbilical cord is a multi-strand small gauge wire bundle weighing only a couple pounds and about 20 feet long.) Sensor packages and wiring will be insulated to shield subject from the power supply, and cord will be held up off floor and will be kept from being a tripping hazard via careful handling. All system voltages used are to be 5 V or less. Sensors include an accelerometer and an electronic compass, and data will be used to establish baseline sensor patterns of typical human locomotion, in particular walking. Baseline data will be used to develop micro-controller software algorithms to interpret later sensor data. Subjects will walk for a few seconds at a time over distances of approximately 15 feet. This activity will be limited to walking around the lab space and hallways.
Phase II
Phase II development will include a fully self-contained sensor/computer package. This will be a battery-powered, small (~fanny pack size) unit worn by subject in a fanny-pack type pouch or carried in a briefcase. Subjects will walk around various areas (e.g., within buildings, outside, and around Tech Area I, weather permitting) for periods of an hour or less. System memory will then be downloaded and a map of the subject's travels made. The battery pack will be sealed and insulated from the wearer by using plastic containment boxes.
Phase III
Future enhancements might include the inclusion of additional sensors (such as auditory, chemical, etc.) to the sensor suite. Also additional miniaturization will occur to eventually reduce the system to a size of the order of a pager.
Physical risks to the human subject participants are minimal. Electrical power applied to the sensors is low (<5 volts, and the current in the insulated umbilical cord, and the portable battery device is in the low millampere range), so that there is minimal shock hazard. The device to be carried or attached to subject is light weight (<3 lbs.), so there is no danger from the stress of transporting heavy objects. The system would be contained in something like a fanny pack or smaller, and thus there is no mechanical pinch or other danger to the subjects. The proposed activities are routine for the subject population (i.e., walking through typical pedestrian traffic areas), so no additional risk is imposed on the participants. The potential enhancements via additional sensors will pose no additional risk as they will be non-hazardous in form and function.
"Facial Verification System Evaluation"
Principal Investigator: Mr. Larry J. Wright, Sandia National Laboratories
Project started in: 2000
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: Sandia National Laboratories
Most recent approval: 07/28/02
IRB approval number: N/A
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 2002
Type(s) of Human Subjects Involvement:
Facial verification systems use distinguishing characteristics of the face to verify a person's identity in automated entry control applications. An image of the face is captured using a video camera, and distinguishing features are extracted and compared with previously stored features. If the two match within a specified tolerance, a positive identity verification results and the person is allowed to enter the facility.
Although facial systems have been proposed and studied for a number of years, commercial systems have only been available for the last few years. Developers have had to overcome two difficult problems: (1) wide variations in the presentation of the face (e.g., head tilt and rotation, presence or absence of glasses, facial hair changes, facial expression changes) and (2) lighting variations (e.g., day vs. night, location A vs. location B).
The purpose of the test is to determine the performance of the Lau Technologies Portal, a commercial face verification system configured for physical access control. Performance will be characterized in terms of false reject rate, false accept rate, and enrollment and verification times. In addition, user acceptance of the device will be measured by administering a survey to the test participants. Other important characteristics to be observed during the test include ease of setup, resistance to spoofing (attempts to defeat the system), template storage requirements, and system cost. As configured for the test, the system consists of a face terminal, a processor/controller for the portal, and controlled lighting.
Test subjects will be recruited from employees and contractors of Sandia. Although there are no inclusion/exclusion criteria, recruitment of subjects will be limited to a convenience sample of personnel who work in building 821 or regularly travel through that facility. Participants will be asked to provide their height and whether or not they wear glasses. This information is required to understand how these factors might impact the performance of the system.
There will be no financial compensation for participating in the study, and there are no known health or personal safety risks associated with use of the facial verification system. The activities involved in this study are similar to using an automated teller machine.
To protect the privacy of subjects and the confidentiality of the data, only test project personnel will have access to information that ties image and performance data to particular test subjects, and computer database files will be password protected. The results of the study, may be published for scientific purposes, but such results will be limited to summary data only and will not provide name, picture, or any identifiable references to subjects. However, any records or data obtained in this study may be inspected by the sponsor, by any relevant governmental agency (e.g., DOE), by the Sandia Human Studies Board, or by the persons conducting this study, provided that such inspectors are legally obligated to protect any identifiable information from public disclosure, except as otherwise authorized or required by law.
"Performance Evaluation of Biometric Verification Systems"
Principal Investigator: Mr. Larry J. Wright, Sandia National Laboratories
Project started in: 2001
This project ended in fiscal year 2002.
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: Sandia National Laboratories
Most recent approval: 12/19/00
IRB approval number: N/A
Explanation of IRB approval:
IRB approval was in effect until 12/18/2001
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 2002
Type(s) of Human Subjects Involvement:
Objectives: The objective of this research is to determine the performance characteristics of three biometric verification systems based on iris recognition, hand geometry, and voice recognition.
Methodology: Test subjects will be enrolled on the system and then asked to make two to three verification attempts each day for approximately five weeks. After the verification-testing phase is completed, each subject will be asked to attempt to verify (as an imposter) against the other templates in the system.
No ionizing radiation, radioactive substances, or chemical substances are involved in this study.
Involvement of human subjects: Previous SNL biometric evaluations have used approximately 50 subjects. For this test, the target sample size is 50-100 people. Both true attempts and imposter attempts will be collected over a 3 to 4 weeks. The target number of trials will be 10-20 true attempts and 10-20 imposter attempts for each test participant. This will result in 500-2000 true attempts and 500-2000 imposter attempts. This sample size is justified by past testing experience. All volunteers will likely participate,and the only reason for exclusion on any one device would be an inability to enroll and/or verify on that device. Where temporary physical conditions impair a users ability to use a system(s), the user will be requested to continue to use the system(s) but report the inability to verify and the reason.
Privacy considerations: All subjects are enrolled on each system by identification number only. The list associating ID numbers with names is treated as Unclassified Controlled Information (UCI) and only project personnel have access to the list.
Risks to subjects were minimal.
"An Exploratory Study of Uranium and Thorium Isotopic Detection by ICP-MS and Its Applications"
Principal Investigator: Dr. Amir H. Mohagheghi, Sandia National Laboratories
Project started in: 2001
This project ended in fiscal year 2002.
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: Sandia National Laboratories
Most recent approval: 06/26/01
IRB approval number: N/A
Explanation of IRB approval:
IRB approval was valid until 6/25/02
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 2002
Type(s) of Human Subjects Involvement:
Uranium and thorium are naturally occurring isotopes to which people are exposed daily through the water they drink and the food they eat. Sandia National Laboratories (SNL) currently collects urine bioassay samples to monitor individuals for possible exposure to total uranium and thorium as part of ongoing medical surveillance of employees. However, there are several areas where this monitoring can be improved. In case of accidents or exposure to people who are not routinely monitored, the optimum window for collecting urine samples may be missed. In addition, background levels vary significantly from one person to the next and also change for the same individual over time. This is caused by variations in food and drink, metabolism, physical activity, illness, and age among many other factors. Establishing comprehensive background distributions that take into account all the important parameters is a massive task and is beyond the scope of this study. However, even a limited knowledge of background variations will be a valuable aid in determining actions levels for follow up studies.
A new analytical method in isotopic detection is developed by employing an Inductively Coupled Plasma Mass Spectrometer (ICP-MS), which allows for more accurate and distinct data retrieval on individual isotopes. Using the ICP method, this study proposes to:
· establish the accuracy of the U-235 to U-238 isotopic ratio measurement in real bioassay samples (determination of exposure source),
· investigate the use of hair for exposure monitoring (in lieu of urine),
· determine a preliminary background distribution of U-235, U-236, U-238, and Th-232 isotopes in hair, urine, and typical drinking water (an exploratory understanding of the nature of the statistics governing the background variation), and
· investigate the existence of any correlation for each isotope between the three sample types.
Three specimens will be collected from each participant: hair, urine, and typical drinking water. Each subject will receive a sample kit containing: two 80ml plastic bottles, one for urine collection and one for drinking water collection; a small plastic bag for hair collection ; and instructions on collecting and returning specimens. Subjects will also receive verbal instructions. Participants will be expected to return urine and water samples as soon as possible (within three days) to maintain sample integrity. Hair samples are expected to be returned within four weeks to accommodate different collection circumstances (i.e., waiting for a hair cut or gathering enough hair in hairbrush). Participants will not be given any kind of radioactive or non-radioactive material for internal or external use in or on the body.
No other information will be collected from any subject, participants will not be asked to use more than one kit.
There is no physical risk to participants, and other risks are no greater than an average person encounters when donating a specimen for a standard, non-invasive bioassay.
The primary benefits are the option of viewing summary results on the SNL internal web site, and the satisfaction of helping to establish a new method of monitoring potential exposure to uranium 235/238 and thorium 232. There is no financial compensation for participation.
"Adaptive Awareness for Personal and Small Group Decision Making"
Principal Investigator: Dr. Carmen M. Pancerella, Sandia National Laboratories
Project started in: 2001
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: Sandia National Laboratories
Most recent approval: 09/04/02
IRB approval number: N/A
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 2002
Type(s) of Human Subjects Involvement:
Objectives:
Many situations call for the use of sensors to monitor physiological and environmental data. In these situations, it is beneficial to have intelligent agents analyze the large amounts of sensor data, recognize cues from the data, and communicate the results to humans and other computers. This project will pilot an awareness and warning tool, comprised of heterogeneous sensors, small light-weight processors, embedded intelligent software, and a wireless network connecting these processors and computers. This tool has broad applicability to emergency teams, military squads, individual exercise and fitness monitoring, health monitor for sick and elderly, and environmental monitoring in public places.
Methodology:
To realize this tool, researchers propose to develop a sensor-independent architecture for integrating self-awareness information across a distributed team (e.g. military squads, approximately 10 soldiers working together in a relatively small geographical distance) and the design approaches, concepts, and software agents for a tool that supports squad-level decision making.
Involvement of Human Subjects:
Actual testing of the system with humans will be limited to ensuring that the sensor is functioning correctly. All intelligent algorithm training and testing will be done with simulated data. As such, the time that the sensor will be attached to subjects will be short, perhaps 5 minutes or less, as required for the software/hardware development and testing. The subject will attach the sensor as required to determine that the sensor interface is correctly transmitting the data. However, no personally identifiable information will be collected on any subject. Actual personal sensor data will not be archived in the system.
The risks associated with this study are no greater than those encountered in daily life (minimal).
"Populating Computational Models of Cognition with Knowledge Elicitation Data to Detect Man-Machine State Discrepancies: Knowing and Responding When the Human and Machine Are Not on the Same Page"
Principal Investigator: Dr. James C. Forsythe, Sandia National Laboratories
Project started in: 2002
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: Sandia National Laboratories
Most recent approval: 02/13/02
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 2002
Type(s) of Human Subjects Involvement:
The purpose of this research is to improve human decision support in high performance systems through the development of computational models of cognition. A relatively novel technique that will be applied to improve the fidelity of the computational models is a knowledge elicitation methodology developed at Sandia National Laboratories. Using a protocol of semi-structured interviews and mathematical techniques to derive associative networks, computational models will be populated with more accurate and cognitively plausible representations. Simulations of the constructed model will be compared with human performance data to examine ways of detecting man-machine state discrepancies. The anticipated outcome is a cognitive model that has a closer understanding of the user that can support decision-making in complex, time-pressured domains.
Two to four student interns will participate in this study and will be trained in an AWACS operator-like task environment. All data collected associated with the participants (e.g., video, computer data, consent forms etc.) will be stored in a locked cabinet and marked as UCI. The interface for this task will be a personal computer. Training will consist of 10-15 hours/week of self-paced practice with the task for four to six weeks. Using standard performance measures associated with AWACS operation, the objective is to raise expertise to a stable level of performance. At this point, they will be justifiably categorized as subject matter experts (SMEs).
Using information gathered from literature and semi-structured interviews with the SMEs, a cognitive model will be developed representative of SME AWACS performance. The technological objective for this phase is to establish a capability, within the computer, to detect when operator's mental models are inconsistent or diverge from the known state of the world. The SME will be utilized to test prototypes of this technology, as the technology is refined. Test sessions will be self-paced and the duration will be 1-2 hours. Test sessions will consist of individual trials lasting 10-15 minutes. Trials will involve unique vignettes in which the participant must manage a squad of airborne assets against differing configurations of threats.
For this phase of the study, each SME will participate in 2-4 iterations of this phase over a period of 2 weeks. It is anticipated that subjects will each participate in 4-6 studies of this nature, with studies occurring 2-4 weeks apart. Each test session will be recorded using video. Afterward, test sessions will be reviewed to identify instances in which subject behavior implied an inconsistency between their mental model and the actual state of the world. These data will then provide a basis for evaluating technical system performance and to derive experimental variables for future research.
The potential risks for participants in this study are similar to those associated with moderate computer work and face-to-face meetings.
"Acoustic Biosensors for Bacteria Detection"
Principal Investigator: Dr. Susan M. Brozik, Sandia National Laboratories
Project started in: 2002
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: Sandia National Laboratories
Most recent approval: 01/08/02
Additional IRB approvals from other institutions:
Type of Review: Full Board
Approving Institution: 3M
Most recent approval: 09/27/01
IRB approval number: 01-054
Explanation of additional approval:
The 3M IRB reviewed this project in FY02; however, the SNL IRB did not review until FY03
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 2002
Type(s) of Human Subjects Involvement:
The purpose of this cooperative research agreement between SNL and 3M is to develop a commercially viable prototype of an acoustic biosensor for detecting low levels of bacteria in near real-time. This biosensor will be based on acoustic sensing technology developed by Sandia and will include a handheld electronic device and a disposable fluidic cartridge that houses the sensor transducer.
Since a critical need exists for rapid, accurate testing for biological warfare agents, the overall benefit of this project is the development of biosensors for government/national use in detecting anthrax. Secondly, the technology developed will then be applied toward the development of a sensor for the detection of nosocomial infections, a critical need in the health care industry.
Phase 1 (Feasibility) – During this phase, Sandia and 3M will ascertain if the shear-horizontal surface acoustic wave (SH-SAW) biosensor is capable of measuring less than 2,000 spores (model of anthrax) per milliliter of fluid in representative samples. Antibodies raised against anthrax spores will be attached to the sensor platform as part of a recognition layer. To test the response of the sensor, B. thuringensis and B. subtilis spores will be used as anthrax simulants. No testing of anthrax spores will take place at Sandia or 3M, nor will any personnel from either establishment handle anthrax spores. Spore samples in water will be introduced to the sensor platform via a microfluidic chamber. For “real-world” samples, a “contaminated” sample will be introduced to the sensor. The “contaminated” sample will be a simulant spore in a solution of protein, dust, or other similar contaminant. We do not anticipate using nasal samples from humans in Phase 1.
Phase 2 (Development) – The goal of this phase is a prototype of the SH-SAW sensor system appropriate for clinical testing. During this phase, SNL will continue developing an anthrax detector using simulant spores. In addition, Sandia will begin developing the SH-SAW platform for he detection of Staphylococcus aureus (leading cause of nosocomial infection). As in the above experiments, antibodies and/or other receptors will be attached to the sensor platform as a recognition film. A non-pathogenic strain of Staph aureus will be used to test the device. Initially the bacteria will be introduced to the sensor in a water or buffer sample. SNL will then test “real-world” samples consisting of nasal swabs obtained from human subjects.
Protocol for obtaining nasal swabs:
The subjects’ anterior nares will be swabbed with a sterile rayon swab. Two swabs will be taken from each subject; one from each nostril. The sampling will be performed by inserting the rayon swab into the anterior tip of the subject’s nostril and rotating the swab for six complete revolutions along the nares mucosal surface. The swab will then be placed into a sterile test tube containing one milliliter of room temperature Buffered Peptone Water (BPW; Hardy Diagnostics) and mixed vigorously for 30 seconds using a standard lab vortexer. A known concentration of the test bacteria will be added to some of the samples. The test sample will then be introduced to the sensor device for detection of Staph aureus (non pathogenic strain).
Subject Recruitment
Because this is a feasibility and prototype study, the subject pool is limited to male and female members of the research team who are in good general health (as self-identified) and have no physical disabilities that would increase risk of harm. Subjects will be recruited verbally. 3M will conduct similar experiments at their facility, recruiting subjects from their personnel who are working on this project. Involvement of those subjects will be reviewed by the 3M Institutional Review Board [IRB], and a copy of that IRB’s approval will be provided to Sandia’s Human Studies Board).
Timeline
The duration of this project is 27 months with Phase 2 (human testing) to begin after the first 3 months of the project. Sample collection of nasal swabs from human subjects will take less than a minute, and collections will occur once or twice a week over a period of two to three months.
"FY02 Biometric Verification Systems Evaluation"
Principal Investigator: Mr. Larry J. Wright, Sandia National Laboratories
Project started in: 2002
This project ended in fiscal year 2002.
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: Sandia National Laboratories
Most recent approval: 01/10/02
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 81
Reporting period for number of human subjects:
Fiscal Year 2002
Type(s) of Human Subjects Involvement:
Objective: The objective of this project is to conduct performance evaluations of different biometric identification technologies. These evaluations are needed to provide security providers in the federal community with decision information when designing and purchasing security equipment. Systems included in FY02 testing were the Ultra-scan Series 700 fingerprint scanner and the Bioscrypt Veriflex fingerprint scanner.
Methodology: In the initial tests, human subjects were presented to each system for enrollment and then later for verification. These processes involved taking a series of fingerprint images, processing these images through the system's software and storing the resultant information within the computer. After collecting several thousand transactions, the data were analyzed to produce false accept rates, false reject rates and ROC Curves for the end user to use in the decision making process.
Ionizing Radiation...substances: None
Involvement of Human Subjects: Human subjects were requested to present themselves before each system to have their fingerprint scanned by the system. The Ultra-scan system scanned the finger using ultrasound techniques similar to medical ultrasound imaging. The Bioscrypt system is a silicon chip-based system that imaged the finger by measuring the capacitive difference between the finger and the chip.
The target sample for this study is 50-100 people. Both true attempts and imposter attempts will be collected over 3 to 4 weeks. The target number of trials will be 10-20 true attempts and 10-20 imposter attempts for each test participant. This will result in 500-2000 true attempts and 500-2000 imposter attempts. All volunteers will participate, and the only reason for exclusion from testing on any one device would be an inability to enroll and/or verify on that device. Where temporary physical conditions impair a users ability to use a system(s), the user will be requested to continue to use the system(s) but report the inability to verify and the reason.
"Evaluation of Toolkit for Recapature / Recovery Project"
Principal Investigator: Mr. James E. Pacheco, Sandia National Laboratories
Project started in: 2002
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: Sandia National Laboratories
Most recent approval: 03/28/02
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 2002
Type(s) of Human Subjects Involvement:
In the event that a nuclear resource falls under the control of hostile forces, measures must be taken to regain control of it as soon as sufficient forces are on hand to optimize the chances of recovery with minimal loss of life and property. The actions required to regain control of nuclear resources are known as recapture/recovery operations. Sandia National Laboratories (SNL) has identified technologies applicable to recapture/recovery operations, and is currently working with the Air Force Space Command (AFSPC) to assess current recapture/recovery capabilities for a typical AF base. A “toolkit” has been proposed to recapture Maintenance and Inspection Facilities that consists of thermal, mechanical, and explosive tools. Most of the breaching tools proposed in the toolkit have been tested and documented by SNL and outside vendors over the past 25 years to breach similar types of surfaces.
The purpose of this project is to develop a facility-specific toolkit to assist in recapture operations. The toolkit contains mechanical and thermal breaching tools and other equipment to assist in the operation. This project will evaluate the effectiveness of these tools by conducting timed tests using SNL employees and contractor personnel. No personally identifiable information will be collected.
Hazards associated with testing and using these tools include: spattering melted steel, hot spots, sparks, loud noise, sharp edges, and airborne dust and dirt. Personnel conducting the tests will be trained in the safe use of the tools being tested, and will be required to use appropriate safety equipment during these tests.
The first phase effort will evaluate and test existing non-explosive entry methods on mock-up personnel and vehicle access doors at SNL.
No explosive tests are planned for this phase (FY02-03), which will measure cutting rates of these tools to breach various door and wall surfaces. The performance of individual operators will not be measured. One to three subjects will actually use the tools.
These tests are expected to require minimal physical exertion by the participants. This assumption is based on the estimated effort required to make one to five cuts through each proposed barrier with the tools proposed. There will be breaks between the series of cuts to allow subjects to rest and for the PI to collect data and make notes. Subjects will be informed that even though the tests are timed, the objective is to measure the rate at which the tools cut through various surfaces under normal operating conditions. Subjects will also be encouraged to work at a comfortable rate and to stop if they feel stressed. Heat stress associated with wearing personal protective equipment during the summer will be addressed in the preliminary hazard assessment, safe operating procedures, or other ES&H documentation. To minimize the heat stress on subjects wearing personal protective equipment, we anticipate using cooling fans, installing temporary shading, or conducting the tests inside when possible. The tests will be videotaped, photographed, and documented, and these materials may be used in future training sessions.
Subjects may be female or male, in good general physical health, as self-identified, and have no physical disabilities that would increase risk of harm. The minimum age to participate in the study will be 18 years old. Subjects who have experience conducting similar tests or experience with the safe operation of thermal cutting tools, hand or power tools will be given preference. The research team will describe the project to all potential subjects and have them read and sign a standard form indicating their consent to participate. Subjects will be encouraged to ask questions throughout the study and will be reminded that participation is voluntary.
The risks associated with this study are the hazards caused by the use of the tools, which include spattering melted metal, hot sparks, hot spots, loud noise, air-born dust/dirt, and sharp edges. However, the tests are considered to be minimum risk because the participants will be trained in the use of the tools being tested and will be provided with, and required to use, appropriate safety equipment. The tools will be used in the manner they were designed - as they are used in standard industrial procedures. Any new information developed during the study that may affect the participant’s willingness to continue participation will be communicated to the participants.
There is no financial compensation or other benefit for participation in this study, other than personal satisfaction from helping to advance knowledge in this specific area. The US Air Force (as well as DOE, DOD, and other agencies interested in recapture capabilities) will benefit by having confidence in the effectiveness of the toolkit.
Data will be stored on electronic spreadsheets in Excel and Word documents. The computer storing these files is password controlled and inside a secured area, and access to the database will be restricted to project personnel. All personally identifiable information (if any) will be stored in a filing cabinet in building 821, room 3094. At the end of the study, results will be documented in a SAND report. All the data and final information will be retained by the project leader for a minimum of 3 years after completion of the study. This study will not produce sensitive data nor is any part of this study classified.
"The Relationship between Sleep & Breathing"
Principal Investigator: Dr. Barry J. Krakow, Sleep and Human Health Institute (SHHI)
Project started in: 2002
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: Sandia National Laboratories
Most recent approval: 06/17/02
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 2002
Type(s) of Human Subjects Involvement:
Objectives:
This study will investigate the use of nasal strips in human subjects with insomnia and sleep-disordered breathing symptoms or disorders in a randomized controlled design. It proposes to determine whether the nasal strips, without other treatment, can decrease or eliminate insomnia symptoms.
Potential Benefits:
Entering this protocol is likely to educate the subject on the value of treating insomnia, so it is not likely to delay other treatments that the subject might wish to pursue for sleep problems. Subjects may benefit directly by discovering that nasal strip treatment of SDB leads to improved sleep, and their motivation for further treatment of sleep disorders may be increased. There is no financial compensation for participation.
Methodology:
The current proposal will be a randomized controlled trial studying sleep maintenance insomniacs with SDB. Two groups will be studied to contrast the effects of nasal strips vs. a control group. The nasal strip (treatment) group will be educated on the relationship between SDB and insomnia and will be instructed in the use of nasal strips. The control group will monitor their sleep and breathing symptoms only. Both groups will prospectively monitor changes in breathing and sleep during a 4-week interval, with the option to continue for an additional 4 to 8 weeks. All wait-list control participants will be invited to participate in treatment at the end of their 4-week control period.
Involvement of human subjects:
This project will require the direct (in vivo) involvement of human subjects in all aspects of the protocol. These subjects will be recruited from the general population at SNL.
Potential Risks:
Potential physical risks associated with nasal strip use are minimal and include irritation of the skin, either through allergic reaction to the material (fairly rare) to rawness from improper removal of the strips. If subjects are known to have allergies to latex, this may trigger the allergic reaction because latex is included in the packaging of the strips, but not on the strips directly. Such individuals can actually use the strips if they can learn how to remove the strips from the packaging without getting latex on their fingers. Removal of strips requires emphasis on water and heat (preferably a shower or warm, wet washcloth) to break the adhesive seal on the skin, followed by gentle tugging on the strip to remove gradually.
Another potential non-trivial risk is breach of confidentiality; however, several precautions are incorporated into the study design to minimize this risk. All data will be collected by staff at the Sleep and Human Health Institute (SHHI) in Albuquerque. Hard copy data (including questionnaires and email reports) will contain personal identifiers and will be stored in locked file cabinets after the data has been entered into a coded database (stored in password-protected computers). Current SHHI computers are operated through the University of New Mexico (UNM) School of Medicine facilities, which have appropriate firewall protection to prevent unauthorized access from anyone outside UNM. Access to the database will be limited to appropriate SHHI staff. No part of this study is classified, and the data is sensitive to a degree similar to any medical record.
"Flow in Organizations: Experience at Work"
Principal Investigator: Mr. Ryan W. Quinn, University of Michigan
Project started in: 2002
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: Sandia National Laboratories
Most recent approval: 09/18/02
Additional IRB approvals from other institutions:
Type of Review: Expedited
Approving Institution: University of Michigan Behavioral Sciences IRB
Most recent approval: 05/09/02
IRB approval number: IRB file #7091
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 2002
Type(s) of Human Subjects Involvement:
One purpose of this study is to learn how SNL engineers can achieve a state of optimal experience in their work that psychologists call “flow.” This is a state in which people both perform their best and feel their best. Interviews with engineers, scientists, and technicians revealed that most technologically-oriented knowledge workers experience flow at work, and would like to experience it more often. Some of the results of this study will help individuals focus on things they can do to achieve a flow state more often in their work. A second purpose of this study is to help identify and thus reduce the amount of time that SNL personnel spend on unproductive activities, such as administrative paperwork or bureaucratic procedures.
The approach to studying engineers’ high performance experiences that this will use is called the Experience Sampling Method (ESM). Subjects participating in an ESM study receive a signaling device (e.g., a beeper) and a survey booklet at the beginning of a five-day workweek. During each day of the week, the signaling device will emit a signal at four random times. After the participants hear the signal, they either open the survey book and fill out a short survey, or (if the signal went off at a particularly inopportune time) they complete the activity they were engaged in and then open the survey book and fill out the survey. Previous ESM surveys of a similar length have taken respondents 3-4 minutes to complete. Thus, this study will collect data on engineers’ experiences in 20 randomly selected work activities.
The intent is to recruit 120 subjects from respondents to a e-mail message sent to randomly selected Sandia personnel. Participation is completely voluntary, and personally identifiable information will be retained only until the beepers are returned. At that point all data will become untraceable back to a particular subject. There is no financial or other compensation for participation.
This study has been approved by both the Institutional Review Board of the University of Michigan and the Sandia Human Studies Board.