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: 15
| SNL-03-0221 | "Integrated Microfluidic System for Oral Diagnostics" |
| SNL-05-14 | "Computational Economics Human Decision Experiments" |
| SNL-05-36 | "Ethnographic Observation of Intelligence Analysts for Collaborative Environment and Tool Design" |
| SNL-05-37 | "Patterns of Communication and Information Seeking within Software Development" |
| SNL-06-04 | "Developing Ethical Practices for Genetic Testing in the Workplace " |
| 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-06-44 | "Development of a Medical Screening Program for Former Workers from Sandia National Laboratories" |
| SNL-07-03 | "Medical Surveillance for Former DOE Workers at Lawrence Berkeley National Laboratory, Lawrence Livermore National Laboratory, and Sandia Livermore. Phase II." |
| SNL-07-04 | "Development of Sandia National Laboratories-Specific Human Reliability Program (HRP) MMPI-2 Population Norms With Descriptive Statistics and Comparative Analyses of the Validity and Clinical Scales" |
| SNL-07-0659 | "Managers Responses to Poor Performance" |
| SNL-07-07 | "Adaptable Computing Environment Usability Study" |
| SNL-07-13 | "Using Infrared Video to Detect Humans and to Improve Nuisance Alarm Rejection" |
"Integrated Microfluidic System for Oral Diagnostics"
Principal Investigator: Dr. Anup K. Singh, Sandia National Laboratories
Project started in: 2003
Status of the Research this Fiscal Year:
Study enrollment is permanently closed, participants have completed research-related interventions, and long-term follow-up is completed. The remaining research activities are limited only to data analysis.
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: 12/06/06
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 0
Reporting period for number of human subjects:
Other: 07/01/06 to 06/30/07
Explanation:
Project cycle specified by National Institute of Dental and Craniofacial Research. No new subjects participated. Study continues for data analysis only.
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 background. 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.
"Computational Economics Human Decision Experiments"
Principal Investigator: Dr. Andrew J. Scholand, Sandia National Laboratories
Project started in: 2005
This project ended in fiscal year 2007.
Status of the Research this Fiscal Year:
Current study is completed.
This project does not involve the use of multiple protocols/subprojects.
Institutional Review Board (IRB) Review:
Type of Review:
Expedited
Approving Institution: Sandia National Laboratories
Most recent approval: 02/27/06
Explanation of IRB approval:
IRB approval was valid until 2/26/07. Project was closed before approval expired.
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 0
Reporting period for number of human subjects:
Fiscal Year 2007
Type(s) of Human Subjects Involvement:
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 principal investigators. The simulation record and the transcribed data will contain no personally identifiable information.
"Ethnographic Observation of Intelligence Analysts for Collaborative Environment and Tool Design"
Principal Investigator: Dr. Laura A. McNamara, Sandia National Laboratories
Project started in: 2005
This project ended in fiscal year 2007.
Status of the Research this Fiscal Year:
Current study is completed.
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: 08/23/07
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 0
Reporting period for number of human subjects:
Fiscal Year 2007
Type(s) of Human Subjects Involvement:
This 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 observational 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.
"Patterns of Communication and Information Seeking within Software Development"
Principal Investigator: Ms. Alisa Bandlow, Sandia National Laboratories
Project started in: 2005
Status of the Research this Fiscal Year:
Study is no longer enrolling and participants have completed all research-related interventions. The study remains active only for long-term follow-up.
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: 07/26/07
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 0
Reporting period for number of human subjects:
Fiscal Year 2007
Type(s) of Human Subjects Involvement:
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.
"Developing Ethical Practices for Genetic Testing in the Workplace"
Principal Investigator: Dr. Teddy D. Warner, University of New Mexico
Project started in: 2006
Status of the Research this Fiscal Year:
Study enrollment is permanently closed, participants have completed research-related interventions, and long-term follow-up is completed. The remaining research activities are limited only to data analysis.
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: 11/15/06
IRB approval number: N/A
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 40
Reporting period for number of human subjects:
Fiscal Year 2007
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, and 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 onto 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 person completing the survey. 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. Kevin R. Dixon, Sandia National Laboratories
Project started in: 2006
This project ended in fiscal year 2007.
This is an international project.
Foreign Subjects No
Foreign Data No
Foreign Specimens No
Foreign Collaborators Yes
Foreign IRB No
Status of the Research this Fiscal Year:
Current study is completed.
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: 01/16/07
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 24
Reporting period for number of human subjects:
Fiscal Year 2007
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.) are 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
Status of the Research this Fiscal Year:
Recruitment and/or enrollment of new participants or review of records/specimens continue.
Funding for Human Subjects Research:
This project does not involve the use of multiple protocols/subprojects.
Institutional Review Board (IRB) Review:
Type of Review:
Full Board
Approving Institution: Sandia National Laboratories
Most recent approval: 01/30/07
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 42
Reporting period for number of human subjects:
Fiscal Year 2007
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. Cynthia L. Nelson, Sandia National Laboratories
Project started in: 2006
This project ended in fiscal year 2007.
Status of the Research this Fiscal Year:
Study protocol is inactive.
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: 01/23/07
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 0
Reporting period for number of human subjects:
Fiscal Year 2007
Type(s) of Human Subjects Involvement:
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
This project ended in fiscal year 2007.
Status of the Research this Fiscal Year:
Current study is completed.
This project does not involve the use of multiple protocols/subprojects.
Institutional Review Board (IRB) Review:
Type of Review:
Expedited
Approving Institution: Sandia National Laboratories
Most recent approval: 02/01/06
Explanation of IRB approval:
IRB approval was valid until 1/31/07. Study was closed out prior to that expiration date.
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 0
Reporting period for number of human subjects:
Fiscal Year 2007
Type(s) of Human Subjects Involvement:
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 synchronous 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 were 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.
"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
This project ended in fiscal year 2007.
Status of the Research this Fiscal Year:
Current study is completed.
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: 06/19/07
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 220
Reporting period for number of human subjects:
Other: 07/01/06 to 09/30/07
Explanation:
Cumulative total since study began.
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.
"Medical Surveillance for Former DOE Workers at Lawrence Berkeley National Laboratory, Lawrence Livermore National Laboratory, and Sandia Livermore. Phase II."
Principal Investigator: Dr. Lewis D. Pepper, Sandia National Laboratories
Project started in: 2007
This project ended in fiscal year 2007.
Status of the Research this Fiscal Year:
Current study is completed.
This project does not involve the use of multiple protocols/subprojects.
Institutional Review Board (IRB) Review:
Type of Review:
Expedited
Approving Institution: Sandia National Laboratories
Most recent approval: 06/19/07
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 0
Reporting period for number of human subjects:
Fiscal Year 2007
Type(s) of Human Subjects Involvement:
See note at #11 above.
"Development of Sandia National Laboratories-Specific Human Reliability Program (HRP) MMPI-2 Population Norms With Descriptive Statistics and Comparative Analyses of the Validity and Clinical Scales"
Principal Investigator: Dr. Tony J. Kreuch, Sandia National Laboratories
Project started in: 2007
Status of the Research this Fiscal Year:
Study enrollment is permanently closed, participants have completed research-related interventions, and long-term follow-up is completed. The remaining research activities are limited only to data analysis.
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: 11/06/06
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 369
Reporting period for number of human subjects:
Fiscal Year 2007
Type(s) of Human Subjects Involvement:
The purpose of the study is to develop population norms for the Sandia National Laboratories (SNL) Human Reliability Program (HRP) Minnesota Multiphasic Personality Inventory-2 (MMPI-2), using the existing HRP MMPI-2 database. The study will provide MMPI-2 validity and clinical scale norms for three major Sandia employee groups currently participating in the program: Scientists/Engineers, Security Officers, and Materials Handlers. In addition, the study will also establish mean profiles for HRP participants in good standing, participants with restrictions, and former participants permanently removed and compare all groups (Occupational and Program Status) with prior similar groups from previous studies, such as airline pilots and law enforcement personnel. The SNL population will also be compared with the normative sample from the 1989 re-standardization of the MMPI. Establishment of these population norms will be useful from the perspective of identification of population parameters, evaluation of predictive utility of the MMPI-2 for HRP, and assisting with longitudinal assessment of the psychological evaluation component of HRP.
The methodology for the study will include descriptive statistics and comparisons of all groups for significance, in addition to comparison with reference groups and the MMPI re-standardization normative sample. Intercorrelations of scales for profile trends will also be completed. The study uses data that have already been collected as part of the current HRP psychological evaluation process with data coded using unique identifiers.
The only potential risk to human subjects for this study is potential breach of confidentiality with that risk mitigated by appropriate coding of data. Potential benefits of the study include contributing to the existing knowledge in the field of MMPI-2 research in occupational settings and providing specific information to enhance the predictive utility of the test with the SNL HRP population.
"Managers Responses to Poor Performance"
Principal Investigator: Dr. Tamara Cagney, Sandia National Laboratories
Project started in: 2007
Status of the Research this Fiscal Year:
Study enrollment is permanently closed, participants have completed research-related interventions, and long-term follow-up is completed. The remaining research activities are limited only to data analysis.
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: 09/17/07
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 53
Reporting period for number of human subjects:
Fiscal Year 2007
Type(s) of Human Subjects Involvement:
This research will investigate the variables that influence management referrals to employee assistance programs (EAPs) by exploring management perceptions of poorly performing employees, how managers explain employee behavior, and how these explanations or attributions impact their referral patterns and influence responses to poor performance.
There is a dynamic interplay between employees' performance problems and management's willingness to confront them. The EAP is a worksite-based program designed to assist in addressing productivity issues and in identifying and resolving personal concerns including, but not limited to, health, marital, family, financial, alcohol, drug, legal, emotional, stress, or other issues that may affect job performance.
For any given supervisor-subordinate problem situation, there is a rich milieu of responses for managing, or not managing, the problem. The increasing reliance on self-referrals casts some doubts on the ability of EAPs to locate and bring into their orbit those employees whose denial is such that some type of constructive confrontation is necessary. Because management referral is widely considered to be the backbone of employee assistance programs' unique services, there have been attempts to address the universal problem of low management EAP referrals. These efforts either attempt to profile the troubled employee or examine the characteristics and referral patterns of management.
Managerial responses to poor performance would be expected to vary based on the attribution the manager makes as to its cause. This study will investigate features of attribution theory, which examines how we explain the behavior of others. An understanding of how the attributions that managers make affect their willingness to refer would be helpful in understanding management responses to poor performance and use of EAPs.
Participants will be recruited from a pool of managers working at Sandia's Livermore, CA site. Recruitment will take place through a brief presentation at the TriLevel managers meeting, followed up by email distribution of the instrument. There are currently 109 managers at that site. To obtain a 5 percent margin of error with a 95 percent confidence level, the target sample size is 86 respondents.
Managers will be informed that the purpose of the study is to examine how managers analyze and deal with subordinate behavior and that their responses will remain anonymous and confidential. All subjects will be asked to review and sign a consent form and to have that signature witnessed before returning the signed form to the principal investigator via mail.
Participants will then access the online survey via the link provided and answer the questions from the point of view of a manager in charge of this department.
Scenarios will be modeled after those developed by Struthers and Weiner that describe an employee who has performed poorly on an important job-related task. The manager will be presented with different personnel decisions ranging from taking no action to termination. In addition, possible mediators of these decisions will be examined with ratings obtained for expectancy, responsibility, anger, and sympathy.
This study will gather evidence as to what factors contribute or detract from manager referrals of employees with performance problems. The demonstration of attributions as a mediating link between subordinate performance and manager behavior beyond just rating behavior has important implications for organizations. This information can be used to modify, improve, and target training for managers that can increase management referrals to employee assistance programs as proactive interventions, earlier in the development of behavioral health problems, thereby reducing reliance on reactive interventions related to crisis. It sheds light on erroneous attribution. When managers make erroneous attributions for subordinate performance, their intervention or response may be inappropriate. For example, if managers believe that ability, a stable cause, produced the unwanted outcome, that level of performance (high or low) would be expected to continue, regardless of the leaders efforts. If, in fact, lack of ability was not the cause of the subordinate's poor performance, the supervisor may either miss an opportunity to help a person who could perform well or sit back and watch a previously successful person struggle. This may mean that greater attention should be devoted to helping managers learn better techniques to avoid misattributions that would result in poor choices of leadership behavior and could promote an increase in appropriate targeted referrals to employee assistance programs.
"Adaptable Computing Environment Usability Study"
Principal Investigator: Dr. Ann M. Bouchard, Sandia National Laboratories
Project started in: 2007
This project ended in fiscal year 2007.
Status of the Research this Fiscal Year:
Study protocol is inactive.
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: 11/06/06
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 0
Reporting period for number of human subjects:
Fiscal Year 2007
Type(s) of Human Subjects Involvement:
Sandia National Laboratories is developing the Adaptable Computing Environment (ACE). This software system enables users to create and store information in books on bookcases (rather than in a hierarchical tree of folders), record and find actions they've taken in the system, and create programs in English-like sentences, without knowledge of any programming language.
A series of prototypes focuses on the capability to create, store, find, retrieve, and analyze data in tabular form. That is, the books and bookcases record and find, and English-like programming will all be added in stages, but the user will only be able to deal with tables of data, not databases, Microsoft Word documents, or other formats.
The developers of the ACE attempted to design a software system that is intuitive to use for each task it supports. The purpose of this study is to determine to what extent this design goal was achieved. Specifically, the goals of the study are, first of all, to determine whether the interface is easy to understand and use in general, and to identify aspects that are difficult or confusing. Another important goal is to determine if English-like programming increases productivity in analyzing tabular data relative to other tabular analysis software (e.g., Excel). Third, we seek user input on priorities for changes, fixes for bugs, and additional features.
At each evaluation session, the subject will be seated at a computer, with the session facilitator seated beside him/her, and one or more observers listening in and observing what the subject types, clicks, etc., on a second monitor connected to the subject's computer. The facilitator will follow a script, explaining the goal, the process, and the particular task the subject is being asked to accomplish with the ACE. Tasks will be things like "open the red book and turn to page 8," "make a new book," or "find all the rows of this table with a date of June 8, 2006." The subject will attempt to complete the task, 'thinking out loud' as he does so. When the task is completed (or aborted if the subject wants to stop for some reason), the subject will be asked to share his experience with the software (easy, fun, confusing, frustrating, etc.).
The risks subjects may encounter in this study are no greater than risks they encounter when interacting with computer software. The first anticipated users of the ACE will be security analysts at Sandia. The user base is then expected to expand to other DOE sites, then to other government agencies. These users will benefit directly from this study, in that it will lead to improved software. In addition, there is a high potential to transfer this technology to industry.
Due to management re-direction, the usability portion of this activity was abandoned and no human subjects were involved.
"Using Infrared Video to Detect Humans and to Improve Nuisance Alarm Rejection"
Principal Investigator: Dr. Mark W. Koch, Sandia National Laboratories
Project started in: 2007
This project ended in fiscal year 2007.
Status of the Research this Fiscal Year:
Study is not currently enrolling subjects or enrollment of participants is currently suspended, but may resume in the future.
Funding for Human Subjects Research:
This project does not involve the use of multiple protocols/subprojects.
Institutional Review Board (IRB) Review:
Type of Review:
Expedited
Approving Institution: Sandia National Laboratories
Most recent approval: 05/09/07
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 2007
Type(s) of Human Subjects Involvement:
The intent of this study is to investigate ways to lower the nuisance alarm rate and thereby improve the utility of the Virtual Perimeter Extended Defense system and technologies for a wide range of Homeland Security Department customers and applications.
We intend to use three primary sources of data. The first is benchmark video imagery using existing, publicly available data and data available internally at SNL. The second is data to be collected from people entering and exiting a facility. The infrared video camera will be far enough away that people cannot be uniquely identified. The third source is scripted data collections in which subjects will walk, run, and crawl along a sandy track outdoors. Infrared video imagery will be gathered at various view angles and various distances from the subject to get 20 to 200 pixels on a person. Imagery will contain the subject partially occluded by long grass, temporarily occluded by trees or bushes, and in the clear. Subjects will be given a description of the project, encouraged to ask questions, and asked to sign a consent form.
It is expected that each subject will only need to participate in one multi-person session of about an hour in length.
Human subjects were not exposed to any chemical substances or radiation.
There were no risks or discomforts associated with the study outside those normally experienced in participating in an outdoor activity and being video taped:
Slips, trips, falls, scratches, and cuts. The terrain in the test area includes small animal holes, short dirt slopes, tumbleweeds, cacti, occasional barbed wire, and numerous other tripping hazards. While this terrain is typical of Sandia mountain range low foothills and presents no extraordinary challenges or barriers, there is a risk of sustaining injury from slipping, tripping, or falling. To mitigate this risk, subject activity will be constrained to the dirt roads at the test site, and subjects are asked to wear closed-toed footwear as a condition for participation. Subjects participating in the crawling activity will be provided with gloves and knee pads. All subjects were cautioned to be wary of obstructions, uncertain footing, and other hazards.
Wildlife. The area surrounding the test site is home to a variety of wildlife. There have been sightings of coyotes and tarantulas, and the presence of rattlesnakes is possible as well. While these animals are rarely encountered, a moderate amount of caution will be sufficient to avoid any interaction with them. In the unlikely event that subjects need medical care due to an animal-inflicted injury, such medical care will be provided.
Exposure. The study will only be conducted only if the weather is appropriate to outdoor activities. This includes comfortable temperatures (e.g., within the 50°F to 90°F range) and the absence of any significant precipitation or lightning. Potential weather-related problems will be mitigated by conducting tests early in the morning (in summer). Sunscreen and a cooler of bottled water will be available for subjects and the project team. Subjects will be instructed to notify the principal investigator immediately if they feel physically uncomfortable. They will be able to take a break or terminate the session at their discretion. Vehicles with air conditioning/heating will be available for breaks.
Exertion. Traversing unlevel terrain can be physically demanding. Subjects will be advised that if they become fatigued at any point during the study, they may rest or withdraw. If subjects need medical care due to overexertion, such care will be provided.
There are no direct benefits or any financial compensation to subjects for participating in this study. The research team may receive project funding and visibility as a result of subjects participating in the project. Potential benefit for Military and Homeland Security personnel, will be lower nuisance alarm rates and thereby improved utility of the Virtual Perimeter Extended Defense system and technologies for a wide range of Homeland Security Department customers and applications.
The only data to be collected in this study are infrared video imagery of the subjects participating in various activities in an outdoor environment. No personal information about subjects will be gathered or linked to the imagery. The video imagery will reside on a password protected computer to which only authorized project personnel will have access.