Mr. William
R.
Geer
Sandia National Laboratories
Public Relations and Communications Center
P.O. 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: 17
| SNL-03-0221 | "Integrated Microfluidic System for Oral Diagnostics" |
| SNL-04-11 | "Augmented Musculature Device" |
| SNL-04-18 | "Voice Stress Analysis Systems Test and Evaluation" |
| SNL-05-0536 | "Ethnographic Observation of Intelligence Analysts for Collaborative Environment and Tool Design" |
| SNL-05-14 | "Computational Economics Human Decision Experiments" |
| SNL-05-15 | "Pinpointing the Benefits of Collaboration Capability for a Federation of Application-Centered Simulation Analysis Teams: A Case Study" |
| SNL-05-37 | "Patterns of Communication and Information Seeking within Software Development" |
| SNL-05-39 | "A Study of Operator Reaction Time with Respect to the Calibration of Stopwatches and Timers" |
| SNL-06-04 | "A Survey of Worker Views about Genetic Disorders and Testing " |
| SNL-06-10 | "Enhancing Cognitive Performance for the Crew of US Marine Light Vehicles" |
| SNL-06-14 | "Collaborative Situational Awareness in High Consequence Environments" |
| SNL-06-15 | "Secure Portal" |
| SNL-06-19 | "Augmented Reality Training System Evaluation" |
| SNL-06-20 | "Cross-Functional Teams & Informal Social Networks" |
| SNL-06-24 | "Distributed Sensor Network Security System" |
| SNL-06-34 | "Evaluation of Stand-Off Concealed Threat Detection Systems " |
| SNL-06-44 | "Development of a Medical Screening Program for Former Workers from Sandia National Laboratories" |
"Integrated Microfluidic System for Oral Diagnostics"
Principal Investigator: Dr. Anup K. Singh, Sandia National Laboratories
Project started in: 2003
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: 12/07/05
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 50
Reporting period for number of human subjects:
Fiscal Year 2006
Type(s) of Human Subjects Involvement:
Analysis of saliva and other oral fluids has great potential in diagnosis of oral and systemic diseases, in monitoring levels of environmental toxins and drugs-of-abuse, and in preliminary screening for exposure to biological and chemical warfare reagents. The use of saliva and other oral fluids as diagnostic samples may be preferred in many applications over other bodily fluids because of the ability for fast and inexpensive sampling in clinical as well as non-clinical settings. Although, clinical studies have demonstrated usefulness of saliva and other oral fluids in some applications for detection of markers of oral and systemic diseases, the development of diagnostic technology and devices has not met expectations. Moreover, current assay techniques are time-consuming, require relatively large quantities of samples, and are not amenable to automation and portability.
The objectives of this study are to: (1) develop an integrated microfluidic system for simultaneous multi-analyte detection in saliva and other oral fluids; (2) analyze mediators of oral and periodontal diseases found in oral fluids (i.e., P. gingivalis endotoxin, interleukins, and bone breakdown fragments) using the proposed benchscale prototype; and 3) validate the technology in a longitudinal human trial of patients at low and high risk for the development of periodontal diseases.
The human subjects involved in this trial will be entered through the University of Michigan Clinical Periodontology Research Center. The proposed study is approved through the University of Michigan Health Science IRB (IRB File No. 1353, Assurance M-1184). Human subjects will provide oral fluid samples for the pilot studies on the handling of saliva and "gingival crevicular fluid" (GCF). A study cohort of 100 individuals will include 50 subjects in the low-risk periodontal disease group and 50 subjects in the high-risk periodontal disease group.
Subject participation will involve the collection of three different sample fluids: GCF sampling, GCF rinsing, and saliva. For GCF sampling, a small piece of filter paper will be placed along the gum line, adjacent to the tooth. The paper will be left in place for 30 seconds to collect the fluid, and then removed. GCF rinsing involves rinsing with tap water for 10 seconds, waiting for two minutes, and then rinsing with six teaspoons of dilute saline solution (salt water) for 10 additional seconds. Saliva will also be collected using a small plastic tube via passive drooling (harvesting a total of about four teaspoons of saliva for about five minutes). Subjects will also have measurements made around their gums for a standard examination and have four different dental x-rays taken at six-month intervals around back (molar) teeth.
There are no known risks associated with the collection of gingival fluid or saliva, except for minor trauma from using the collection devices that would likely be less than one would expect with a standard oral examination. Involvement in the study would pose a risk to patients with untreated periodontal disease. However, all research subjects will be carefully monitored in this study and will receive 'rescue therapy' should disease activity occur. This treatment would include localized tooth scaling and the local delivery of an antibiotic.
The potential benefits to the patient would be that with this newly developed assay method, clinicians may be able to diagnose and intercept bone disease in its early stages. In addition, patients will receive comprehensive periodontal therapy, dental radiographs, and monitoring at no cost to them.
Any information obtained about the participants in this study, including their identity, will be held confidential. Subjects identities will be coded, and all data will be kept in a secured, limited access location. Any photographs taken during the study will not identify the research subjects, and any research data released or published will not identify volunteers by name.
We plan to enter an equal number of males and females in this study as well as a distribution of a diverse ethnic/racial profile. We plan to enroll numbers of patients reflective of the patient population in the area to include: Asian/pacific islanders, Hispanics, African Americans, and American Indian subjects. Patients will be in the age range of 18 to 90. Children are not specifically targeted in this patient population since they do not represent the chronic periodontitis target population.
"Augmented Musculature Device"
Principal Investigator: Mr. Brandon R. Rohrer, Sandia National Laboratories
Project started in: 2004
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: Sandia National Laboratories
Most recent approval: 02/22/05
Explanation of IRB approval:
IRB approval was in effect until 2/21/06.
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 2006
Type(s) of Human Subjects Involvement:
This project proposes to develop an Augmented Musculature Device (AMD) that assists the movements of its wearer. It could be directly applied to aiding military and law enforcement personnel, the neurologically impaired, or those requiring any type of cybernetic assistance. As proposed, the AMD consists of a collection of artificial muscles, each individually actuated, strategically placed along the surface of the human body. Well-fitted, heavy-duty nylon clothing would provide a framework for attaching the artificial muscles to the body.
The actuators are known as "air muscles" and operate pneumatically. They are commercially available from several vendors, are relatively inexpensive, and have a remarkably high force-to-weight ratio [as high as 400:1 (as compared to 16:1 typical of DC motors)]. They are flexible and elastic, even when powered, making them ideal for interaction with humans.
A number of human performance enhancing devices has been proposed, but to date, few have been realized in any practical application. This is due in part to the weight of the exoskeleton and actuators. In contrast, the AMD relies on the human skeletal system to kinematically constrain motion, eliminating the need of an exoskeleton. Also, the low weight of air muscles allows much greater assist from much less hardware. For instance, an air muscle 30 mm in diameter and 290 mm long weighs 80 g and can lift as much as 70 kg -- nearly 1,000 times its own weight. With these light, powerful actuators augmenting users' motions, the AMD could become the first practical human assist device.
This project proposes to develop a benchtop prototype upper-extremity AMD. This effort will include:
1. Characterization of air muscle dynamic properties, including impulse response and bandwidth;
2. Design of electrical and compressed air subsystems for powering muscles, switching valves, supplying sensors, and running control hardware;
3. Fabrication of a wearable air muscle network, consisting of a number of air muscles securely sewn into a heavy-duty nylon shirt, each with its own three-way valve for alternately supplying compressed air and venting to the atmosphere; and
4. Integration with data acquisition and controller hardware, comprised of a personal computer and appropriate analog-to-digital and analog-output boards.
In this study, subjects will don the AMD and interact with it both passively (providing no intentional movement) and actively (intentionally moving with and against the device). A computer program will command the AMD to assist subjects in performing a large number and variety of pre-programmed movements. Information about the extent to which the AMD is able to assist subjects will be gathered. The verbal information they provide will be recorded by hand and will be identified only by gender and age. This information will be used to improve the construction and operation of the AMD. This testing is experimental in its entirety; it is the first instance in which a user will wear the AMD.
There will be no set regimen for how often the testing will take place, nor how long each session will last. It is anticipated that using the AMD for 15 minutes will be more than sufficient for obtaining the ease of use and ergonomics information that are the goal of this pilot study. However, subjects may withdraw from participation at any point during the study. Also, they may wear the AMD for a longer period, if they wish to, at the discretion of the Principal Investigator (PI). During the testing, the PI will be present at all times, actively monitoring both the subject and the device.
The AMD has been designed so as to be inherently safe. It has no rigid members. The air muscles are soft and compliant. There are no pinch points and no sharp corners. It is lightweight. The air muscles' limited range of motion keeps the AMD in a natural configuration. Remaining potential risks and discomforts are judged to be minor.
There are no known benefits to participating in this research, aside from the potential benefits to the PI and members of the research team stemming from successful completion of the development project. It is anticipated that the device resulting from this testing, however, will be beneficial in rehabilitating children with varying types and degrees of neurological damage. It will be capable of perceiving and assisting motion with greater flexibility, precision, and stamina than an unassisted human therapist would be able to. In addition, it is anticipated that subsequent generations of the AMD may be able to assist soldiers and security personnel in performing their duties.
"Voice Stress Analysis Systems Test and Evaluation"
Principal Investigator: Mr. Frank L. Lucero, Sandia National Laboratories
Project started in: 2004
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:
Expedited
Approving Institution: Sandia National Laboratories
Most recent approval: 05/19/05
Explanation of IRB approval:
Study was completed before IRB approval expired on 5/18/06.
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 6
Reporting period for number of human subjects:
Fiscal Year 2006
Type(s) of Human Subjects Involvement:
Voice Stress Analysis systems (VSAs) claim to measure stress in a person's voice as an indicator of deception. The National Institute of Justice (NIJ), in conjunction with the Air Force Research Laboratory/Information and Intelligence Exploitation Division (AFRL/IFE), published a report on the evaluation of some of the VSAs commercially available. This report indicated that VSAs do recognize stress through voice analysis; however, system deception detection was not proven for all situations. The authors therefore suggested future work.
Approximately 10 participants will be used to evaluate the validity of the deception detection claims of the various products. Participants will be asked to read typed scripts and voice predetermined answers which will either be true or false. All questions will be designed so no personal information will be required or collected. For example, colored cards will be shown to participants, and they will be asked to correctly or incorrectly identify the color of the card. Stress will also be evaluated by rapid reading of typed scripts. Some tape recordings will be made to upload into the computer.
Use of the system will be by two-person password control of the computer that contains the operating software. The systems will be kept in a vault type room (VTR) dedicated to the project; access to the VTR will be limited to the research team, a security consultant, and the appropriate manager. Participants will be identified in the data logs as Participant 1, Participant 2, etc. Voice recordings will be kept for the duration of the project and then degaussed and destroyed. Evaluation of the systems will be tracked as data points of positive or negative detection in a spreadsheet on the computer(s) containing the VSAs.
Participants will be asked to test the systems on a periodic basis, no more than approximately twice a week over a total time span of six months. This frequency may vary and is dependent on the system responses over the course of the project.
Evaluation of the systems in terms of performance and vulnerabilities of the hardware/software will be limited to personnel within Center 05900 who have the required clearance levels. It is necessary for the sponsor that this project be conducted at the Official Use Only (OUO) level and participants must be willing to treat this project at that level. Participation will be strictly voluntary.
Although it will be beneficial to have participants of varying ages and gender, since this is an objective evaluation of whether a commercial product performs as advertised, we will accept volunteers on a first-come, first-served basis. The only inclusion/exclusion criteria will be the clearance level noted above. Participants will be recruited by word-of-mouth via departmental/center meetings.
The risks of participation in this study are minimal and no greater than those encountered in everyday life. There is no financial compensation or other tangible benefit to subjects for participation in this research. Sandia and the sponsor will benefit from this evaluation by determining the reliability of the technology in identifying deception and assessing the state of development of the technology.
Any pair of the listed investigators can collect data. No data will be collected unless there are at least two investigators present. No personal information will be collected or used in the evaluation of the VSAs. Files collected and data points generated will not reflect the actual identification of any of the participants.
The data will be accessible to the investigators and the sponsor both during the study and the subsequent three years that the data are required to be saved. The data will be retained on the electronic media inside an approved General Services Administration safe for the required retention period. The customer will only know participant numbers and will never know the actual identities of the participants. The data will only be at the OUO level. All performance related information of the VSAs from the SNL gathered data would be at the OUO level. Any data provided by the sponsor and the corresponding analysis, as well as conclusions on ways to circumvent the systems, will be classified.
"Ethnographic Observation of Intelligence Analysts for Collaborative Environment and Tool Design"
Principal Investigator: Dr. Laura A. McNamara, Sandia National Laboratories
Project started in: 2005
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: 08/23/06
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 35
Reporting period for number of human subjects:
Fiscal Year 2006
Type(s) of Human Subjects Involvement:
This study investigates factors influencing collaboration among intelligence analysts, with a focus on factors related to collaborative technologies in intelligence. This is applied research for a specific purpose: implementation of technological and workspace design initiatives to improve collaboration and is not controversial.
Participation in the study consists of being observed in one's worksite for two weeks, followed by an interview. All individuals who undergo observation in their workplace will be interviewed. Participant observation is a standard anthropological technique in which the researcher spends time embedded in the community of study, following members through their daily activities and taking extensive notes to document observations. The benefit of participant observation is the ability to observe community members' behaviors in as natural a context as possible.
Interviews comprise the second phase of this research. Schedules of questions will be developed after all observation periods are completed, to ensure the questions are appropriate for decoding observations made during the field studies. Interviews will be semi-structured, using open-ended questions around specific topical areas identified as important during the observation period. However, a list of general interview topics would likely include the following:
- Educational background, career path through workplace, key skills, areas of research/expertise
- General areas of analysis
- Types of software used in day-to-day tasks
- Frequency of partnering with other co-workers
- How work products are generated and where they go
Researchers will interview the same personnel they observed. Interviews will take place off the worksite, under the assumption that subjects who are away from their work environment will be more comfortable speaking freely about their worksite. Subjects can refuse to answer any questions that they do not want to answer.
Although physical risks are minimal, agreeing to be part of any workplace study involves potential social and career risks. Many subjects will be uncomfortable with the idea of a researcher taking notes on their behavior. For example, they may worry that the data collected could be used in evaluations of job performance.
The researchers will take appropriate measures to ensure subject privacy and confidentiality of data. Subjects will be provided a list of aliases and asked to select one. Researchers will then use these aliases in their notes. The researchers will be the only ones with the key that links subjects' true names to their aliases and, in turn, to the observation and interview data.
Field notes and interview transcripts are solely the possession of the researchers. Once the study is complete, the field notes will be kept in the researchers' possession, in a locking receptacle in their workplaces, until federal records requirements allow the field notes to be destroyed. At no time will the raw field notes be released to the sponsors, to the research subjects, to their managers, or another external party. Workplace managers will not have access to any raw data, while sponsors will only be provided data after identifying characteristics are removed.
Subjects may withdraw from the study at any time without penalty. Data will be destroyed for any subject who withdraws.
The goal of the study is to identify ways to facilitate collaboration within the intelligence community, to improve the community's forecasting ability. Subjects will accrue no professional or financial benefits from participation in this study, though they will have an opportunity to review the research results and may gain greater insight into the dynamics of their workplace.
"Computational Economics Human Decision Experiments"
Principal Investigator: Dr. Andrew J. Scholand, Sandia National Laboratories
Project started in: 2005
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: 02/27/06
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 2006
Type(s) of Human Subjects Involvement:
Sandia National Laboratories (SNL) spent many years developing the computer science behind sophisticated microeconomic simulations, yet surprisingly little research has been directed at understanding the extent to which the algorithms truly mimic human decision-making behavior, both under 'normal' competitive economic market conditions, and under disrupted conditions where various components of the nation's critical infrastructure may be non-operational. The economic literature makes clear that the way in which the market performs is a function both of the market structure (rules determining how the market clears) and the behavior of the participants in the market (consumers and suppliers). This study proposes to address this gap through a series of on-going experiments, collaboratively performed by both Sandia and the University of New Mexico, in which people actively participate in a running economic simulation as decision makers.
The goal of these experiments is to provide the data necessary to compare and improve existing artificial intelligence (AI) approximations of human decisions in the economic and business arenas, and to understand how those decisions may vary with the demographics of the persons making them. The need for demographics is to assess whether certain sectors of the economy make decisions differently, and so need differently tuned AI. For example, do business buyers react differently to varying prices than household buyers? These data will allow SNL to refine individualized decision making models in economic simulations, increasing both the range of questions we can adequately address and the value of the recommendations from those tools.
Subjects will be asked to use computer software to interact with a running economic simulation. The software will allow them to make decisions, such as at what price to sell a commodity, given only limited information, such as the volume of sales on preceding days at various prices. The research team also plans to gather information from participants after making decisions by administering surveys during the experiment. Survey questions would seek to elicit information on both participant demographics and the strategies used in making their decisions. The surveys will be anonymous but will be associated with specific simulation runs by a randomly selected agent identifier.
To encourage participation, and to make sure that subjects are actively trying to act in a rational economic sense (a fundamental assumption in economic theory), subjects will receive a financial reward based on their performance. The typical financial reward is $30 to $40, and particularly astute subjects could earn as much as $50. We seek to capture a diverse range of decision makers, since the goal is to match the diversity and breadth of individuals making decisions in the U.S. national economy (effectively, all of us). We therefore obtained approval to conduct this study on any general member of the U.S. population over 18 (excluding prisoners and other captive populations).
Experiments will be administered at various times over the next year. Four runs have been conducted to date. Each data gathering session is planned to last approximately 90 minutes, consisting of up to 12 individual experiment runs.
Risks are minimal, since the entire experiment is conducted via software and survey. The outcomes of decisions made by the subjects (i.e., prices, sourcing decisions, and production levels) are captured electronically and anonymously. The most sensitive information gathered, survey responses providing anonymous demographic data that can be associated to economic decisions, will be collected on paper and converted to electronic format by the PIs. The simulation record and the transcribed data will contain no personally identifiable information.
"Pinpointing the Benefits of Collaboration Capability for a Federation of Application-Centered Simulation Analysis Teams: A Case Study"
Principal Investigator: Dr. John M. Linebarger, Sandia National Laboratories
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: Sandia National Laboratories
Most recent approval: 02/27/06
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 2006
Type(s) of Human Subjects Involvement:
The National Infrastructure Simulation and Analysis Center (NISAC), a Department of Homeland Security program, provides advanced modeling and simulation capabilities for the analysis of critical infrastructures, their interdependencies, vulnerabilities, and complexities. These capabilities help improve the robustness of U.S. critical infrastructures by aiding decision makers in the areas of policy analysis, investment and mitigation planning, education and training, and near real-time assistance to crisis response organizations.
NISAC and related programs are frequently called upon for rapid turn-around analysis. The primary metrics for this high-pressure, time-constrained collaboration are time to solution and quality of solution. A primary time consumer is the data interchange required to establish a common mental model (also called a common analysis picture) of the problem(s) and solutions(s) among all members of the rapid analysis team.
Numerous observations of rapid analysis teams have distilled four stages in forming a common analysis picture. The first stage is awareness and consists of two levels: identifying other members of the analysis team and the knowledge of the specific tasks that they are currently working on. The second stage is specialization, in which subgroups form to carry out the overall rapid analysis task. These subgroups are formed recursively and reflect the hierarchical structure of the particular rapid analysis problem. The third stage is synchronization, which also consists of two levels: Ensuring that each member of the subgroup is looking at the same thing (common content) in the same way (common view of the common content). In practice, achieving this synchronization between members of a geographically distributed collaboration community can require an enormous amount of time. The final stage, collaborative interaction proper, is only possible once synchronization has been established.
To support such rapid turn-around analysis teams, a software framework for synchronous collaboration has been developed to address each of these stages. This framework, the NISAC Agent-Based Laboratory for Economics (N-ABLE) tool, is an agent-based economic modeling and simulation package.
Our primary operating hypothesis is that the synchronous collaboration framework does indeed improve the ability of an application-centered collaboration community to form a common mental model of both the problem(s) and potential solutions(s). The primary benefit is hypothesized to be time, not necessarily the quality of the understanding of the problem(s) or of the solution(s) discovered. A secondary hypothesis is that the benefit of synchronous collaboration will diminish as the time duration of the analysis increases. The goal of this secondary hypothesis is to explore and identify the boundary between synchronous and asynchronous collaboration capabilities.
The subject pool will consist of four to five N-ABLE analysts who already have experience with the N-ABLE application and its collaboration capabilities. The research project will be presented in an N-ABLE project team meeting, and members of the existing N-ABLE analysis team will be invited to volunteer for the experiment by sending an email message to the principal investigator.
A four-hour pilot experiment will be conducted to exercise the data-gathering capabilities and equalize the training effect. Then the six independent rapid analysis problems will be analyzed, one at a time, in a randomly chosen order. Ideally, the same analysis team will participate in all of the experiments. However, if a team member is unable to participate in all six, other N-ABLE analysts will be invited to volunteer to take their place. All experiments are expected to be completed within a month. Following each experiment a questionnaire form will be administered to each participant, and the collaboration log data files stored on participants machines will be collected. Transcripts of the group chat messages will also be saved and analyzed.
Privacy of the participants will be preserved in several ways. No full names will be used in published versions of the transcripts or screen images. Names are not required on the questionnaires, and once individual data from the transaction logs are loaded into an Excel spreadsheet and sanitized for analysis, the original data files will be destroyed. Data from the experiment will be treated as unclassified controlled information and protected accordingly.
The only known risk is potential fatigue and strain due to computer use, so the participants will be requested to take frequent breaks, just as they would do during a normal work day.
"Patterns of Communication and Information Seeking within Software Development"
Principal Investigator: Ms. Alisa Bandlow, Sandia National Laboratories
Project started in: 2005
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: 07/27/06
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 2006
Type(s) of Human Subjects Involvement:
Effective collaboration and communication are important aspects of any successful group. This study will examine the question of how two rapidly growing departments at Sandia National Laboratories (SNL) communicate and work together. The purpose of the research is to help the departments better understand their intra- and inter-group communication behaviors, which may in turn improve the quality of software development processes.
Team members in these departments use many communication methods ranging from face-to-face (e.g., business meetings and informal social gatherings) to computer-mediated communication tools (e.g., e-mail, SameTime, and wiki). Driving the research will be an inquiry into the social practices supporting the use of technology within the workplace, as well as an examination of how those social processes are affected by demographic factors, physical collocation, group size, and project specifications.
Ethnographic research methods including surveys, interviews, and participant observation will be used to better understand the communication processes and information seeking patterns of these two departments. The Principal Investigator will oversee research conducted by two other investigators to ensure policy compliance and to review study focus, whereas the enlisted investigators will conduct the majority of the research to retain research objectivity and scientific diligence.
To protect participants from any adverse effects of investigation, confidentiality will be strictly guarded, and collected data will be reported without personal identifiers. However, because of the relatively small size of the groups under study, reports may contain enough information for fellow employees to identify participants. Therefore, participants will be cautioned to provide only information they are comfortable sharing with colleagues. Reports published from this research may include suggestions that would require changes to the work practices of the group. These changes may make participants uncomfortable. It is also possible that time devoted to participating in this study will reduce time available to participants for work on their projects. Investigators will endeavor to minimize any inconvenience resulting from the investigation.
There will be no financial compensation for participation in this research project. Results of the study, however, are anticipated to improve the quality of communication and collaboration within the departments. All employees are expected to benefit from the review of communication practices through greater understanding of the work environment that will be gained.
"A Study of Operator Reaction Time with Respect to the Calibration of Stopwatches and Timers"
Principal Investigator: Mr. Robert M. Graham, Sandia National Laboratories
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: Sandia National Laboratories
Most recent approval: 08/16/05
Explanation of IRB approval:
IRB approval was in effect until 8/15/06.
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 2006
Type(s) of Human Subjects Involvement:
In the field of Metrology, whenever a precise measurement is made and recorded, an estimate of the combined total uncertainty (CTU) of that measurement is normally included. This CTU estimate is composed of each of the individual uncertainties that affect the measurement; the way those uncertainties are combined is determined by the type, how it was measured or estimated, and the amount of the influence. In Stopwatch and Timer Calibrations, one major component of the CTU is the operator's reaction time. This component has never been quantified in a systematic way. The purpose of this study is to accumulate data from potential stopwatch and timer calibration technicians, both inside and outside SNL, and to see if certain demographic factors (age, sex, or occupation) have an influence on the data.
The Principal Investigator (PI) will be conducting several classes and tutorials on stopwatch and timer calibrations at various national conferences and symposiums. During these classes, he will collect data from class attendees as they perform one or more stopwatch or timer calibrations. Participation is strictly voluntary and consent will be informed and documented. No personal information will be kept, only demographics such as gender, age, and occupation. No attempt will be made to record which class attendees participated. All efforts will be taken to ensure the anonymity of the study subjects.
The calibration methods to be used (Direct Comparison method and Totalize method) will be taught during the courses, and the data collected during the practice sessions (or during breaks or after class). Each subject will be asked to calibrate a stopwatch or timer with a known offset (measured using the Timebase method). The difference between the operator's reported value and the true value will be due to the operator's reaction time. Subjects will record their times on 10-second intervals. If time allows, the measurements will be repeated several times to show the amount of variability for each operator, or a different technique will be used. The total time commitment is expected to be approximately 15 to 30 minutes.
Subject involvement will occur during the classes taught by the PI at the Measurement Science Conference (MSC) to be held in Anaheim, CA, and the National Conference of Standards Laboratories - International (NCSLI) in Nashville, TN. Subject recruitment may also include attendees at other seminars as well, such as the Measurement Quality Division of the American Society of Quality. There are no inclusion criteria other than attendance at a class taught by the PI, and there is no prerequisite for the classes. The projected target number of subjects is 100. There is no financial compensation to subjects for participation in this research project.
This project is expected to last approximately three years, which should provide ample time to gather enough data to be statistically significant and to perform the necessary analysis.
"A Survey of Worker Views about Genetic Disorders and Testing"
Principal Investigator: Dr. Teddy D. Warner, University of New Mexico
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: Sandia National Laboratories
Most recent approval: 11/17/05
IRB approval number: N/A
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 256
Reporting period for number of human subjects:
Fiscal Year 2006
Type(s) of Human Subjects Involvement:
Over 139 million people are employed in the United States, and careful efforts to protect and promote the health of these workers are crucial to our society's well being and our country's economic stability. Advances in biomedical science will soon lead to the development of genetic tests that may be very useful in identifying, monitoring, and preventing genetically-based health conditions of workers. However, these tests will not only clarify the presence of disease but will also help determine whether individuals have increased susceptibility to health conditions that are linked directly to occupational exposures (e.g., asbestosis, chronic beryllium disease, radiation-related cancers), as well as to other illnesses that often influence worker productivity or performance (e.g., diabetes, heart disease, depression, and substance dependence). Although the importance of such testing is clear, the ethical, legal, and social issues (ELSI) encountered in obtaining, handling, and using confidential genetic information are profound. These ethical concerns have yet to be examined using evidence-based methods.
In a preliminary study to assess employee attitudes, preferences, concerns, and decision-making regarding genetic testing in the workplace, workers expressed serious concerns about the possible consequences of genetic testing in the workplace in four areas: (1) informed consent for genetic testing; (2) handling and retention of genetic samples by employers; (3) safeguards for confidentiality of genetic information gathered in the workplace; and (4) uses of genetic information by employers in decision-making.
Volunteers will be recruited through newsletter advertisements and online postings from individuals currently employed at Sandia National Laboratories and the University of New Mexico (UNM) Health Sciences Center. Potential respondents will be asked to sign onto the secure UNM website to complete the 188-question survey. The survey website will be fully protected by UNM firewalls and extensive security procedures. Recruitment ads will include a password specific to each work site.
Surveys will be stratified by five broad work categories to ensure sufficient sample sizes are obtained to allow comparisons across different types of workers who may experience different types or degrees of exposure risks and who may have different perceptions of health, genetics, and related risks. Once sufficient workers of each job type at each work site have completed the survey, others in that job type will be prevented from completing the survey. Similar messages will also be provided to individuals who sign on the survey website but who answer screening questions (age, employment duration, and site) indicating they are not qualified for the study, and they will be signed off the website.
Data from the secure survey web site will be downloaded to a secure database. Identifying information will not be linked to survey responses in the database. Respondent identifying information will be downloaded to a distinct database to be used solely to process compensation checks of $40 mailed to each survey completer. Thus, data will be analyzed anonymously.
In addition, a volunteer subsample of workers (20 per site) from all work groups will be invited to participate in telephone follow-up structured interviews within several weeks after completing the web-based survey. Phone interviews will be tape-recorded as the main method of data collection, and the trained interviewer will also take notes of subject responses as backup data collection. Subject responses will then be numerically coded separately from their names and other identifiers on the written interview notes and the digital recordings, and no identifiers will be included in the notes, recordings, or subsequent database. If subjects inadvertently identify themselves on the recordings, that will be noted by the interviewer who, at the end of the interview, will remind the subject of this fact, inform them that the identifying information will be expunged from the digital recording, and ask the subject if that is acceptable to them or if they wish to have their entire interview erased. Interview data will thus be anonymous as soon as the interview is over or when inadvertent identifiers are expunged shortly thereafter. Interview questions will explore subject attitudes toward genetic testing in the workplace, as well as seek narrative responses to questions pertaining to personal values, ethical considerations, and direct experience with genetic testing. Those completing interviews will be compensated an additional $40 for their time. The interview will contain 15 to 20 questions and last 20 to 30 minutes.
"Enhancing Cognitive Performance for the Crew of US Marine Light Vehicles"
Principal Investigator: Dr. Chris Forsythe, Sandia National Laboratories
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: Sandia National Laboratories
Most recent approval: 01/18/06
Explanation of IRB approval:
Study was reviewed 1/18/06, but approval has not yet been granted pending resolution of a few remaining issues.
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 proposed experiment serves as an operational test of prototype technology jointly developed by Sandia National Laboratories and DaimlerChrysler Corporation. This technology allows a vehicle to recognize when a driver is experiencing high cognitive demands and adapt in a manner that facilitates the driver coping with these demands. Two sources are used to assess cognitive demands. First, continuous electroencephalogram (EEG) is measured and signal processing algorithms identify patterns of activity indicative of high cognitive demand. Second, data from the automobile (e.g., wheel speed, lateral acceleration, pressure applied to accelerator and brake pedals, etc.) is used to infer the ongoing driving context (e.g., entering high-speed roadway, approaching slow moving vehicle, etc.) When the vehicle detects a high cognitive demand, it may adapt in ways that include delaying communication of non-urgent information, presenting urgent visual information through an auditory modality, eliminating all but the most essential information from map displays, etc.
Through experiments conducted the past couple of years by DaimlerChrysler in Stuttgart Germany in collaboration with Sandia, the viability and potential performance gains obtainable with this technology have been established. Currently, the U.S. Marine Corps, through the Office of Naval Research has expressed an interest in assessing the potential for this technology applied to military light vehicles. The prototype technology has been adapted to a Mercedes G-Wagon and implemented to allow assessment relative to military-relevant tasks. Through Phase 4 of the Defense Advanced Research Projects Agency (DARPA) Augmented Cognition program, DARPA has provided funding to conduct these experiments.
The proposed experiment will be conducted at Camp Pendleton, California using U.S. Marine Corps personnel. For the test platform, there will be a two-person crew concept of operations in which one crewmember acts as driver and navigator, while performing a secondary task that introduces cognitive demands comparable to monitoring military radio traffic. The second crewmember acts as the Commander/Gunner and has responsibility for identifying and engaging targets, while performing a secondary task that introduces cognitive demands comparable to military communications.
In the experiment, the driver will be given a test route to follow. Participants will be instructed that they must drive only on established paths (i.e., dirt roadways) and must not exceed 30 kph. While performing this task, through headphones, the driver will receive a series of communications. The driver will have two secondary tasks. For one, they must categorize communications by pushing one of five labeled buttons mounted on the dash. For the second, they will push a separate dash-mounted button when they hear communications containing their call sign. Performance measures for the driver will include: (1) number communications categorized, (2) accuracy in categorizing communications, (3) reaction time in categorizing communications, (4) number of call signs correctly detected, (5) number of false positives in detecting call signs, and (6) reaction time to call signs.
Certain segments of the route will be designated as threat zones. The Commander/Gunner will be alerted to having entered a threat zone by a verbal warning in their headphones. Within a threat zone, their task will be to detect targets mounted on the roadside and engage those targets using an M-45 M240G 7.62 machine gun mount on the roof of the vehicle. For this experiment, there will be no gun affixed to the machine gun mount. To determine targeting success, a photo is taken with each activation of the trigger and these photos are assessed with respect to the position of the reticle relative to the target. In a secondary task, the Commander/Gunner will be presented a series of communications through their headphones and must indicate communications that contain their call sign by pressing a button on their control handle mounted on the armrest. Performance measures will include: (1) number of targets successfully engaged, (2) accuracy of shots on targets, (3) number of call signs correctly detected, (4) number of false positives in detecting call signs, and (5) reaction time to call signs.
Experimental data will be collected and jointly analyzed by Sandia and DaimlerChrysler. Sandia will retain ownership of experimental data providing a summary report to the Office of Naval Research, the U.S. Marine Corps, and DARPA.
These experiments serve two purposes. First, they provide an initial assessment of the viability of this technology for military platforms. Second, the study provides experimental data, but more importantly, input from operating forces personnel, to assist developers in refining the technology to enhance its potential effectiveness and relevance to military applications. This development is important in that military forces are being increasingly challenged by the need to manage large volumes of information imposing high levels of cognitive load, while successfully fulfilling their assigned missions. However, it should be noted that beyond the military application targeted in these experiments, vital insights are provided for adapting the same technology for incorporation into general automotive applications providing an opportunity to enhance overall automotive safety.
"Collaborative Situational Awareness in High Consequence Environments"
Principal Investigator: Mr. John H. Ganter, Sandia National Laboratories
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: Sandia National Laboratories
Most recent approval: 01/18/06
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 34
Reporting period for number of human subjects:
Fiscal Year 2006
Type(s) of Human Subjects Involvement:
This research seeks to study and model expert collaboration in time-sensitive environments. It employs methods from cognitive psychology (information-driven thinking) and ethnography (cultural patterns, beliefs, and values) to model individual and group work, specifically collaborative situational understanding and decision making in high consequence environments. The primary goal is increased understanding of human and organizational factors for advanced systems engineering. The secondary goal is to offer an analytical and theoretical perspective for operational managers and personnel.
The methods that involve human subjects are workplace observation and interviews. During workplace observation, the researcher typically sits with individuals and teams, observing and taking notes in a role similar to a trainee. Depending on work conditions, the researcher asks questions to seek elaboration or clarification. Under no conditions are observations allowed to significantly impact operations.
Interviews are one hour or less and are scheduled at the subject's discretion and convenience. The purpose of the interviews is to obtain individual perspectives and backgrounds. Basic demographic information is requested including professional history and specialized training.
Study subjects can "go off the record" at any time and can direct the researcher to leave their work area for a specified period or until summoned. Potential subjects who work as members of a team have the right to anonymously "Opt-Out" of this study by email or telephone. Any anonymous "No" vote among team members excludes the team from study. When personally-identifiable data are collected, the subject is asked to choose an alias that will be their identity throughout the study and all resulting publications. No data that contains identifying characteristics or contextual information that could reasonably be used to identify a subject is released to the sponsor, peers, or managers. Subjects are provided a copy of any publishable material resulting from study of their work and have an opportunity to review the material at least six weeks before it is published or distributed. The subjects may request the removal or disguise of any information that they feel compromises their confidentiality.
Although no physical risks are attached to this study, agreeing to be part of any workplace study involves potential social and career risks. The study does involve a small time burden, similar to hosting a trainee. Privacy and confidentiality are protected, but there is some risk that a subject could say or do something that could affect their performance evaluation or professional standing. General findings of the study could lead to changes in workplace policies or procedures.
Subjects have expressed curiosity about the social and psychological processes underlying their work and have reported that discussions and initial documents have given them professional and personal insights. Management and engineering organizations will benefit from increased understanding of work conditions, processes, and requirements that are crucial to performance but difficult to document with standard reductionist approaches. The DOE and the larger applied social science community will benefit from an experiment in practical engineering application of social and psychological theory.
"Secure Portal"
Principal Investigator: Dr. Trina D. Russ, Sandia National Laboratories
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: Sandia National Laboratories
Most recent approval: 01/24/06
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 600
Reporting period for number of human subjects:
Fiscal Year 2006
Type(s) of Human Subjects Involvement:
A compelling need in security systems is the ability to rapidly and accurately grant authorized users access to a facility or secure area while denying access to unauthorized personnel. Computer programs (algorithms) can be used to recognize individuals using different types of images and different types of information extracted from images. The goal of this study is to develop recognition algorithms using gait (how people walk and move) and facial features.
The recognition process is performed as follows: the sensor captures an image or recording of the subject. Then, distinguishing characteristics are extracted from the imagery and stored for comparison or matching against a set of characteristics acquired at a later time (these characteristics could be obtained of the same subject or a different subject). During matching, if two sets of characteristics are matched and their score is within a certain tolerance threshold, then the characteristics belong to the same subject, identity has been verified, and access may be granted to a secure area. In an alternative scenario, a subject is compared to a database of many subjects and if the correct match has the closest score to the subject, then the subject of interest has been identified. In essence, verification involves a single match (1-1) and identification involves many matches (1-N). These processes may be used for access control or to identify individuals on a watch list. Both scenarios (verification and identification) are important to recognition for a variety of applications.
As part of the evaluation, biometric data (physical characteristics in the form of a 3D and/or 2D image of the face and/or gait video) will be collected from each participant and stored in a database. In addition, we seek to utilize existing databases of face and gait data that have been collected in the academic community. This will enable broader testing to better access system performance. Performance will be characterized in terms of probability of verification, probability of incorrect verification, verification times, probability of identification, and identification times.
All volunteers will be included in this test. The only reason for exclusion from testing will be scheduling conflicts or an overwhelming response, in which case volunteers will be taken on first-come basis. A typical data acquisition session should take no longer than 30 minutes.
To protect the confidentiality of the data acquired at Sandia National Laboratories, participants will be identified by a number assigned at the initial acquisition, and only project personnel with a need to know will have access to information that ties image data to a particular test subject's name. Computer database files will reside on a password protected computer to which only authorized project personnel will have access.
"Augmented Reality Training System Evaluation"
Principal Investigator: Mr. Daniel E. Small, Sandia National Laboratories
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: Sandia National Laboratories
Most recent approval: 02/01/06
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 27
Reporting period for number of human subjects:
Fiscal Year 2006
Type(s) of Human Subjects Involvement:
Sandia National Laboratories (SNL) is developing a state-of-the-art Augmented Reality Training System (ARTS) for close-quarters combat. This system uses wearable augmented reality systems to place multiple users in a real environment while engaging multiple virtual enemy combatants. The enabling technology that makes this possible is the new generation of large-scale, high-accuracy six-degree-of-freedom motion trackers. The system exploits current technologies in wireless networking and portable computing to achieve immersive, 3D realism in a domain that was previously limited to shooting ranges using 2D projection screens or paper cutouts of targets in static poses.
Researchers have reached the beta-testing phase of this project and now need unbiased opinions of the utility of the system developed to date. Specifically, they need people who participate in this kind of training as a regular part of their professional lives to help evaluate the system as a whole. The participant pool is therefore limited to SNL Protective Force and civilian personnel who regularly participate in this sort of training. The research team anticipates 50 subjects will participate.
Two to four subjects at a time will be asked to don the following equipment: a combat helmet outfitted with a camera, a head-mounted display (HMD), and a tracking system; a lightweight backpack carrying a tablet-PC; and a mock M4 replica weapon.
The helmet is a standard-issue assault helmet with all appropriate straps and adjustments to account for variability in head shape and size. The HMD is similar to the night vision goggle systems that subjects already train with. The tracking system is non-intrusive and consists of eye-safe red light-emitting diodes (LEDs) and a sync controller unit that wirelessly connects it to the overall tracking system.
Once the subjects have the equipment on and functioning properly, they will run through a series of standard shoot-house scenarios of room entry and clearing. This will involve going through a door as a team and subduing any perceived threat (shooting the virtual bad guys) while avoiding unnecessary collateral damage (not shooting the avatars that do not pose a threat). A brief usability/utility survey will be administered after the subjects complete the training exercise.
Two pieces of information will be stored and neither will contain the subjects' identity. The first piece will be the real-time data collected from the tracking sensors and the trigger mechanism of the weapon. The tracking data consists of the position (x,y,z) and pointing angles (roll, pitch, and yaw) of the helmet and weapon. The trigger information just records a timestamp when the trigger was pulled. This is all time series information that starts recording when the system is started and ceases when it is shut down. This allows for automated playback of a training session to analyze whether the appropriate tactics, techniques, and procedures were followed accordingly. The only identifying information associated with this recording ability is that the filename has a timestamp of when the data was created. The second piece of data that will be gathered and kept is the user evaluation/survey.
The risks subjects may encounter in this study are no greater than risks they encounter when performing this type of decision support training in a shoot-house environment as a part of their regular jobs; in fact it is quite substantially reduced.
There are no implied benefits to participating other than the knowledge that the subjects are helping to evaluate the next generation in firearm decision support training systems.
No personal information will be gathered other than each subjects' professional affiliation and the responses to the survey.
Access to the raw data will be limited to those who have a need to know. Access to the analyzed data (e.g., average and median scores of each survey question plus aggregate comments) will potentially be unlimited release data if we choose to publish/present the results. All unlimited release data will not in any way allow for identification of individual subjects or for the determination of individual performance levels. No part of this study is classified.
"Cross-Functional Teams & Informal Social Networks"
Principal Investigator: Mr. Maximo M. Valdez, Sandia National Laboratories
Project started in: 2006
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: Sandia National Laboratories
Most recent approval: 02/10/06
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 30
Reporting period for number of human subjects:
Fiscal Year 2006
Type(s) of Human Subjects Involvement:
The purpose of this research was to identify individual and team level antecedents that affected the development and performance of cross functional teams with the focus on one project team in particular. The outcome of this study will assist Sandia National Laboratories (SNL) managers and employees in identifying methods or ways in which to improve the development and performance of cross-functional teams. Potential benefits of this study could include improved efficiency and innovation in research and development process.
Thirty individuals from a particular project were non-randomly selected to participate in a semi-structured interview. These interviews were 30 minutes and were conducted off-site, via telephone or email. A content analysis was conducted of the data collected during the interview process. This analysis was used to identify which organizational and individual factors such as organizational climate, managerial support, leadership, etc impacted the performance and development of a team. The data were aggregated and summarized in tables.
The use of human participation was necessary to gain a broad perspective of those involved with project development as to what constitutes an effective multidisciplinary team. Only semi-structured interviews were conducted. To mitigate potential concerns regarding privacy and confidentiality, the following steps were implemented:
- Neither supervisors nor coworkers were able to see individual responses from any subject. Only the PI had access to this raw data.
- Interviews were scheduled away from work location or via phone or e-mail so supervisors were not able to tell who participated in study or who withdrew.
Although physical risks were minimal, agreeing to be part of any workplace study involves potential social and career risks. Some subjects may be uncomfortable providing feedback on their management or fellow workers. Others may feel coerced to participate or fear retribution if they answer questions honestly.
This study may benefit managers and team members involved with project development by providing insight for improving the project development and team formation process. However, due to the selection of a single case and a small sample size, making generalizations to the larger population is difficult. The results from this pilot study should only be used as a starting point for further investigation.
"Distributed Sensor Network Security System"
Principal Investigator: Dr. Kenneth N. Groom, Sandia National Laboratories
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.
Identifier or number: 24
Institutional Review Board (IRB) Review:
Type of Review:
Expedited
Approving Institution: Sandia National Laboratories
Most recent approval: 04/07/06
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 2006
Type(s) of Human Subjects Involvement:
Using a network of wireless sensors to provide security monitoring for sensitive installations is an active topic of research and development in which Sandia National Laboratories (SNL) is playing a significant role. In two previous efforts, sensors were employed in an observe, classify, and report mode. Neither project employed human subject studies as a development tool, and there are no known incidences of accidents or injuries that occurred during the execution of these projects. In the current work, a network of 100 sensors has been designed, constructed, and fielded to allow better understanding of distributed sensing and security systems. The current project is supported by SNL Laboratory Directed Research and Development funding.
The goal of this course of research is to better understand how to deploy, monitor, and interpret distributed sensors in natural terrain so as to reliably detect and identify human intruders. In order to test the performance of the sensor network during development, human subjects will be required to simulate intruders by walking through the terrain. Without this component, it would be difficult and costly to get reliably human-like excitation of the sensor system.
The data collected during the execution of this study will be limited to that gathered by the distributed sensor network. Currently this sensor network consists only of passive infrared motion detectors and geophones (seismic activity detectors). No personally identifiable information such as name, age, weight, etc will be collected in connection with this study.
"Evaluation of Stand-Off Concealed Threat Detection Systems"
Principal Investigator: Mr. Eric S. Varley, Sandia National Laboratories
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:
Expedited
Approving Institution: Sandia National Laboratories
Most recent approval: 05/05/06
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 purpose of this study is to evaluate the performance of several concealed threat detection systems that are intended to detect threats concealed on a person's body.
Most concealed threat detection systems use heat and energy naturally emitted from the human body to detect the presence of concealed weapons by looking for anomalies in a captured image. Other concealed threat detection systems use radio frequency illumination and analyze the reflection and absorption of this illumination to detect the presence of concealed weapons.
Subjects will be asked to don the appropriate model threat object and stand in front of a concealed threat detection system while their image is collected. Threat objects will contain only secondary explosives and no initiators will be used. This proposed activity has been reviewed and approved by the Sandia Explosives Safety Committee.
The screening procedure is as follows: (1) subject stands at some distance (typically 3 to 5 meters) in front of the detection system, (2) the detection system either captures an image of the individual to be analyzed or emits and captures specific frequency illumination for analysis, (3) the system operator is notified of the presence of a concealed threat by either audible alarm or indication on the captured image.
Several concealed threat detection systems will be evaluated to determine characteristics such as probability of detection, false alarm rate, throughput, etc. This evaluation will be held at Sandia National Laboratories (SNL) and will be conducted by SNL personnel. Since this work involves the use of explosives, only appropriately trained personnel will don model threat objects and be imaged. Subjects will be volunteers from the organization involved in this project.
Images collected from concealed threat detection systems will be stored locally on the control computer for the system that acquired it. Sample images may be included in a final report that will be handed over to Department of Homeland Security (DHS) upon completion of the work.
Only images of the subject will be collected and retained. No personal information will be collected during this work. SNL team members will have access to the images collected for analysis purposes. After completion of the evaluation, some example images will be given to DHS in the form of a final report.
All data will be maintained on computers with standard Sandia access protection and/or stored in a locked filing cabinet in a secure building at SNL for the retention period required by Federal law. After that time has elapsed, if it is determined there is no longer a need for retention in the current study, data will be stored or destroyed using standard Sandia protocol for the storage or destruction of sensitive materials.
"Development of a Medical Screening Program for Former Workers from Sandia National Laboratories"
Principal Investigator: Dr. Maureen F. Cadorette, Johns Hopkins Bloomberg School of Public Health
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: Sandia National Laboratories
Most recent approval: 06/20/06
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 2006
Type(s) of Human Subjects Involvement:
The purpose of this program is to identify former Sandia National Laboratories (SNL) workers at increased risk of occupational disease due to past work there, and offer a one-time examination consisting of history, physical and targeted laboratory tests.
Procedure:
1. Contact former SNL workers through mailings and invite them to participate in this medical examination program.
2. Conduct a confidential interview with former SNL workers who agree to participate in this program. The interview involves the completion of an exposure and medical history questionnaire (EQ2).
3. Perform a medical examination for former SNL workers at one of four sites chosen by the participant.
4. Send all records to Baltimore, MD after the examination session. Once the blood tests, the beryllium lymphocyte proliferation test (BeLPT), and the audiometry results are completed they will be added to the former worker's record. These records are stored in locked file cabinets within a locked private office that are exclusively accessed by approved members of the Baltimore Program Team.
5. Send results packets to the former workers, with copies of all test results and our recommendations for follow-up to the primary care provider. Johns Hopkins physicians will generally be responsible for review of results and preparation of results letters.
The risks involved with this program are the risks involved with routine medical examinations and testing. The medical exams are focused to evaluate health outcomes related to exposures to asbestos, beryllium, lead, noise, radiation, and solvents. The medical tests include spirometry, audiometry, blood tests (complete blood count with differential, blood urea nitrogen, creatinine, thyroid stimulating hormone, and BeLPT), a hemocult test of stool, and a chest x-ray. Not all former workers receive all these exams and tests. The chest x-ray is one view only and the radiation received is the same as that received during a routine medical chest x-ray.
At the request of DOE, we are obtaining consent from participants to place their de-identified data in the DOE Comprehensive Epidemiological Data Resource (CEDR) Database and to send DOE the current mailing address of the participant.
All records, test results, and x-rays are kept in Baltimore in locked files. Access to these files is limited to the Principal Investigator and selected members of the program team. Reports sent to DOE contain group data. No individual is identified in these reports. A unique identification number identifies the participant and is used on all blood samples and tests. No personal identifiers are used. Program records and data are maintained in locked files and password protected databases. No information is given to anyone without the written permission of the former worker. Certain laws or a subpoena may alter the confidentiality of these records. This information is in all of the program consent forms.