Mr. Rod
Geer
Sandia National Laboratories
Employee Communications & Media Relations
PO Box 5800, MS 0167
Albuquerque, NM 87185-0167
Phone: 505-844-6601
Fax: 505-844-6367
E-mail: WRGEER@SANDIA.GOV
Number of Human Subjects projects reported: 6
Project Identifier:
SNL-98-01
Project Title:
"Border Warning/Intrusion Detection Radar"
Principal Investigator: Mr. Martin W. Sandoval, Sandia National Laboratories
Project started in: 1998
Funding for Human Subjects Research: No Funding Sources Reported
This project does not involve the use of multiple protocols/subprojects.
Institutional Review Board (IRB) Review:
Type of Review: Expedited
Most recent IRB approval: 11/20/98
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 1999 (10/1/98-9/30/99)
Type(s) of Human Subjects Involvement:
The purpose of this project is to evaluate the ability of a border warning/intrusion detection system to detect the approach of 1 or 2 people and automatically train an assessment video camera on such intruders. This testing will mostly involve detection sensitivity in terms of required radar cross section and target velocity, ease of use, reliability, etc. However, its ability to detect human intruders must also be tested.
This portable radar and automatic assessment system will be temporarily set up in an open field in the Northwest corner of Sandia's Exterior Sensor Testbed. The boundaries of the detection area will be clearly indicated with appropriate signs and markers. Operating procedures established in conjunction with ES&H requirements and the SNL Industrial Hygiene Department will be adhered to.
Subject(s) will be directed to advance towards the detector from a given point, at different speeds and approaches. The radar detector should be capable of detecting the intruder once within the detection envelope and automatically provide appropriate assessment capability to the operator.
After approval of the protocol by the Sandia Human Studies Board (HSB), volunteers (subjects) will be asked to perform the expected movements of possible intruders. These intruders may be walking, running, jumping, or crawling, but for the purpose of the Sandia testing, the tasks will be selected so that there will be only minimal physical stress on the subjects. These detection tests will be run both day and night. At night, an eye-safe laser illuminator will be used to allow the use of a low-light-level video camera for assessment. These cameras will use a wide-angle lens, so subject identification will not be possible. The intent of the testing is only to be able to verify that the equipment being evaluated is capable of classifying intrusions as human and not animals, tumble weeds, or other moving objects.
Human subjects are necessary for this test because this system depends both on the radar cross section and motion of the intruder for detection. It would not be practical to build human robots that would have the same radar characteristics and motions to conduct these types of tests. The purpose of this study is not to determine how detection depends upon various human attributes across a "population" of human subjects. Identification information is recorded by the principal investigator in such a manner that the subjects cannot be identified, either directly or through identifiers linked to the subjects. For this test, it is only important to know when the subject is present, where subject is in the coverage field, about how fast the subject is moving, and whether or not the subject was detected.
The principal investigator will complete all appropriate safety courses prior to conducting this test. The radar radiation is far below the ES&H-required maximum levels, and the SNL Industrial Hygiene Department has determined that it complies with ANSI/IEEE C95.1-1991. The nighttime IR illuminator has been designed for minimal laser power output, and the SNL Laser Safety Officer has calculated and established appropriate procedures to comply with ANSI A136.1-1993. Temporary barricades with required signs will be erected around the identified hazard area, and the principal investigator will be responsible for controlling access to the test area.
There are no health risks or benefits to the human subjects. Identity of subjects is not necessary and will be treated as confidential upon request.
Project Identifier:
SNL-98-02
Project Title:
"Power and Thermal Tool Testing"
Principal Investigator: Mr. Dave Swahlan, Sandia National Laboratories
Project started in: 1998
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
Most recent IRB approval: 12/15/98
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 1
Reporting period for number of human subjects:
Fiscal Year 1999 (10/1/98-9/30/99)
Type(s) of Human Subjects Involvement:
This is a broad-based project that will enable the Access Delay Technology Department to resume basic research, testing, and assessment of evolving security threats. This project involves setting up a small operation that will allow testing and evaluation of new tools and techniques as they appear on the commercial market or as they are raised by security analysts. The project will support the identification, selection, evaluation, and testing of any applicable commercial tools available, but will focus on the fire/rescue, mining, and construction industries. A standard series of target materials will be defined to ensure valid comparisons of tools and cutting rates both now and in the future. It is anticipated that two or three new tools can be tested in any given year. Over a four or five year period enough data will be obtained to update a significant portion of the Access Delay Technology Transfer Manual with current, relevant, tool descriptions and rate data.
No test subjects will be exposed to ionizing radiation or radioactive or chemical substances.
All phases of testing will involve minimum risk because the participants will be well trained in the use of the equipment being tested. The minimal hazards involved (dust, heat, loud noises) are similar to those encountered in using common portable tools. Participants will be provided with, and required to use, appropriate safety equipment during the training and testing.
The results of the study may be published for scientific purposes, but will not give individuals' names. Subjects will be photographed and/or videotaped during the testing activities, so individuals might be identifiable by photographs or videotapes, but this has been clearly explained to volunteers.
Project Identifier:
SNL-98-03
Project Title:
"Hepatitis C Research Study"
Principal Investigator: Mr. Alan Zelicoff, Sandia National Laboratories
Project started in: 1998
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
Most recent IRB approval: 02/11/99
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 2000
Reporting period for number of human subjects:
Fiscal Year 1999 (10/1/98-9/30/99)
Type(s) of Human Subjects Involvement:
The Biological and Toxin Weapons Convention (BTWC) is an international agreement prohibiting the stockpiling of biological materials for hostile purposes. The Convention entered into force in 1975 without a monitoring regime. States Parties to the Convention have recognized that violations have occurred; hence, there has been considerable political pressure to establish a monitoring regime to enhance compliance. Yet, the difficulties inherent in monitoring such a treaty are recognized widely.
In 1995, with the full participation of the United States, the Parties to the Convention agreed to begin work on a legally binding regime to strengthen the BTWC. There are three essential political demands that must be addressed by this regime: (1) enhanced deterrence to proliferation among States Parties; (2) substantive progress on sharing of biotechnology among signatories to the Protocol; and (3) cost-effectiveness.
One measure under consideration is the reporting of disease outbreaks. Such a measure would address both of the political requirements for a protocol by increasing the likelihood that experiments or accidents involving dangerous biologicals would be detected while at the same time adding to world-wide knowledge of emerging diseases including information relevant to the mitigation of disease outbreaks. The vast majority of disease outbreaks would have no association with biological weapons development; nonetheless, the practice of epidemiologic surveillance is cost-effective and highly sensitive to disease outbreaks. Thus, a protocol incorporating disease monitoring would provide incentives to all States Parties to join the putative BTWC protocol.
The Cooperative Epidemiology and Disease Monitoring (CEMD) Project was envisioned to test the hypothesis that non-specialist physicians operating in disparate cultures in widely separated rural regions could contribute to the knowledge of poorly understood, novel disease, in this case Hepatitis C. This disease, while arguably of absolutely no significance to biological weapons proliferation, is a newly emerging public health problem of enormous importance to physicians and government officials in Russia and the United States, as well as other countries. Russia and the US have a long and bitter history of accusation and counter-accusation of violation of the BTWC. Thus, CEMD seeks to evaluate the utility of epidemiologic monitoring in these two countries to serve as model for a similar measure now under consideration in the formal negotiations on the legally binding regime in Geneva.
CEMD is sponsored by the US Department of Energy, under the Office of the Assistant Secretary for National Security and Non-Proliferation. The project has the following specific goals:
- Organizing physicians in rural New Mexico hospitals and the hospital at the Russian closed city of Chelyabinsk-70 (Snezhinsk) to perform a high-quality, randomized epidemiology study of the prevalence and risk factors for Hepatitis C virus among healthy members of the population. Approximately 4000 patients (2000 on each side) will be surveyed using a jointly developed survey instrument, along with advice of Hepatitis C experts at the World Health Organization and the University of New Mexico School of Medicine.
- Exchanging data in a completely transparent manner using web-based INTERNET tools.
- Resolving problems and analyzing data by use of INTERNET tools, including videoconferencing and other better known modalities (e-mail, file transfer).
- Producing a joint-authored paper on the results of the study.
- Providing a briefing on the study design, results, and future work to the plenary of negotiators in Geneva who are currently considering measures to strengthen the BTWC under the Protocol as described above.
To date (9/30/99), approximately 3000 patients (2000 from US Hospitals in Alamagordo, Los Alamos and Silver City in NM, 1000 from Snezhinsk) have entered into the study. Laboratory technicians in Snezhinsk have analyzed blood for presence of Hepatitis C antibody, and the NM Department of Health's State Laboratory Division (SLD) has performed the same analysis on NM patients' samples. The physicians at all four hospitals have met using a multi-point internet videoconferencing tool (CuSeeMe), and have discussed mutual concerns and problems which have been resolved based on the experience of physicians in each of the four centers.
Data is entered to a web site (www.cmc.sandia.gov/HEP_C) at Sandia's Cooperative Monitoring Center by staff at each participating hospital. This data is immediately made available to participants. As adequate numbers of patients' data become available, statistical analysis of results will proceed on both sides, with comparison of results during weekly vidoeconference meetings among all physicians and nurses.
The project should be complete by December 1998, owing in part to some delays in Russian customs for transfer of Hepatitis C analytic equipment to Russian physicians in Snezhinsk.
Note: Participation of subjects concluded 6/1/99.
Project Identifier:
SNL-98-07
Project Title:
"Development and Evaluation of a Stress-Based Health Promotion Model in an Organizational Setting Using Structured Equation Modeling"
Principal Investigator: Ms. Judy Boswell, Sandia National Laboratories
Project started in: 1998
This project ended in fiscal year 1999.
Funding for Human Subjects Research: No Funding Sources Reported
This project does not involve the use of multiple protocols/subprojects.
Institutional Review Board (IRB) Review:
Type of Review: Expedited
Most recent IRB approval: 06/04/98
Explanation of IRB approval:
IRB approval expired 6/3/99.
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 1999 (10/1/98-9/30/99)
Type(s) of Human Subjects Involvement: Abstract:
The purpose of the proposed research was to develop and evaluate two competing stress-based health promotion models hypothesizing the relationships between organizational stress, individual strain and coping resources, and individual performance and the number of sick days taken in the past six months in an occupational setting.
Objectives of the proposed research include:
(1) construct two structural equation models (SEMs), Model 1 hypothesizing the relationships between occupational stress and strain, and their relationship to individual performance and number of sick days taken by the participant in the past six months, and Model 2, identical to Model 1 with the addition of a coping resource variable
(2) test the extent to which the measured variables for each factor in Model 1 and Model 2 actually measure what they are intended to measure using confirmatory factor analysis (CFA)
(3) compare the results of the CFA on the occupational stress factor and the strain factor in Model 1 to the results of the CFA on the same factors in the Occupational Stress Inventory
(4) using SEMs, examine the degree and nature of relationships betwen variables in Model 1 and Model 2 using sample data from Sandia National Laboratories (SNL)
(5) evaluate the goodness of fit (GOF) of Model 1 and Model 2 using GOF indices.
Potential participants will be randomly selected from the population of individuals employed by SNL in Albuquerque, NM, and invited, via cover letter and informed consent, to complete the 140-item Occupational Stress Inventory. Waves of letters/packets will be generated every two weeks until 350 participants have agreed to participate in the study. Additionally, with the written consent of the participant, the researcher will obtain the number of sick days taken by the participant in the past six months, and the participant's last performance rating.
Packets inviting participation will include a pre-addressed Unclassified Controlled Information (UCI) envelope for return of the completed questionnaire and consent form to ensure confidentiality. The researcher will mail a copy of the signed consent form back to the participant via interoffice mail in a UCI envelope.
Data will be analyzed using descriptive statistics to describe the population and response rates, confirmatory factor analysis to assess how well each of the measured variables describes each latent variable, and structural equation modeling to describe the nature and degree of relationships between occupational stress and strain, sick days, and performance with and without a coping variable.
Minimal or no adverse risks are associated with the collection of this confidential data. However, as with any self-reflection activity, uncomfortable feelings may arise. The participant is free to stop participation in the study at any time, and may write concerns or questions on the back of the questionnaire or contact the researcher via the phone number provided in the cover letter. The researcher will respond to all comments or questions upon receipt of the questionnaire. No promises are made to the participant that any benefits will be obtained from participating in the research. However, participation will be valuable in defining which stress-based health promotion model would be the best as far as planning stress management programs and interventions in an occupational setting.
Data collected for this project will be kept on file in a locked file cabinet in the office of the researcher for three years.
Project Identifier:
SNL-99-06
Project Title:
"Visual Inspection Reliability Program"
Principal Investigator: Ms. Caren A. Wenner, Sandia National Laboratories
Project started in: 1999
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
Most recent IRB approval: 08/31/99
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 1
Reporting period for number of human subjects:
Fiscal Year 1999 (10/1/98-9/30/99)
Type(s) of Human Subjects Involvement:
The Federal Aviation Administration (FAA) has established the Airworthiness Assurance Nondestructive Inspection Validation Center (AANC) managed by Sandia National Laboratories and located in a maintenance hangar at the Albuquerque International Airport. AANC facilitates the development and introduction of new nondestructive inspection (NDI) techniques into aircraft maintenance by providing testbeds for the development of techniques, as well as for the validation of inspection techniques. Validation programs rely on blind experiments where the operator of any NDI equipment does not know of the existence (and/or locations) of flaws in the test specimens.
Currently, the most pervasive method of inspection in the airline industry is visual, and is guided by written instructions. Previous efforts (approved by the Human Studies Board [HSB] as SNL9604) were conducted to obtain benchmark performance levels for both major and commuter airline inspectors. This program is designed to establish a quantitative assessment of visual inspection performance for typical aircraft visual inspection tasks as related to the fundamental instructions given to the inspector. The effect of instructions on both performance and search strategies will be determined.
This program will use representative inspectors from the airline industry to perform two days worth of inspection on the Boeing 737 testbed. All inspectors will be experienced with this type of aircraft, and the inspections they will perform are a subset of tasks they routinely perform in their day-to-day jobs. Inspectors will be videotaped during the inspections, and monitors will be present to record the inspectors' defect findings on the aircraft. The videotape will provide a backup to the recording of the faults and a means for objective comparisons of individual inspection techniques across the subjects. Inspectors will also be asked to provide background data concerning their past experience and training. Visual acuity tests will also be administered.
This study is expected to begin in August 1999, and continue until August 2000. Forty-three participants will be solicited from airlines and other maintenance facilities, and will be scheduled at their convenience. Members of various airline groups will ask for volunteers from within the inspection and maintenance personnel in their organizations.
A number of airlines have been contacted to solicit volunteers for this study, and the SNL project manager attended a committee meeting of the Air Transport Association to present this research proposal to airline maintenance supervisors on July 15, 1999. In addition, the Final ATA Proposal was provided to each committee member to further explain the project.
There has been little quantification of the impact of inspection instructions on performance in the aircraft maintenance domain. The results will benefit the FAA and the entire airline industry, since what is learned in this program can be applied to instructions written by the aircraft manufacturers, airlines, and other maintenance facilities. Monitoring an individual inspector's actions will enable an objective comparison of inspector behaviors that can influence performance levels.
The risks to the individuals participating in this program are minimal and do not exceed the normal risks faced in their daily employment. Inspectors will be briefed on safety and standard operating procedures in effect at the AANC Hangar prior to their working in the facility, and adherence to those procedures will be enforced during their inspections of the aircraft. Individual inspection results will not be linked to any names and no direct feedback, other than statistical summary, will be given to the inspector's employer or the FAA.
Project Identifier:
SNL-99-08
Project Title:
"Facilal Verification System Evaluation"
Principal Investigator: Mr. Timothy H. Buckle, Sandia National Laboratories
Project started in: 1999
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
Most recent IRB approval: 09/13/99
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 58
Reporting period for number of human subjects:
Fiscal Year 1999 (10/1/98-9/30/99)
Type(s) of Human Subjects Involvement:
The purpose of this study is to evaluate the performance of a facial verification system. The Department of Energy's Office of Safeguards and Security (OSS) is funding this work. OSS is interested in characterizing the performance of automated biometric devices, including facial verification systems, to determine their applicability for physical access control. Human subjects are needed to conduct this evaluation.
Facial verification systems use distinguishing characteristics of the face to verify a person's identity. Briefly, the facial verification process is performed as follows. An image of the face is captured using a video camera. Distinguishing features are extracted from the image and compared with previously stored features. If the two match within a specified tolerance, a positive identity verification results and the person is allowed to enter the facility.
The target sample size for the test is 50-100 people. Each participant will be assigned a personal identification number (PIN) and then enrolled on the system with the help of the tester. The system consists of a wall-mounted face terminal and a computer. The face terminal, which is the primary interface between the system and the user, includes a small, recessed video camera, a keypad, and an LCD display. Enrollment consists of turning on an overhead light, entering the PIN on the keypad, and standing in place while the system takes two pictures, which are stored on the computer as reference images.
Once enrolled, the participant will be asked to use the face verification system to simulate requesting access to a locked room. This entails turning on the overhead light, entering the PIN on the keypad, standing in place while the system takes a picture, and waiting for a response on the display. The participant will perform verification trials on the device once or twice a day for 3-4 weeks (desired number of trials is at least 20 per participant). Verification trials will include both enrolled user and imposter attempts (e.g., non-enrolled users or enrolled users with erroneous PINs).
Test subjects will be recruited from employees and contractors of Sandia. Although there are no inclusion/exclusion criteria, recruitment of subjects will likely be limited to personnel who work in building 821 or regularly travel through that facility. Participation will be voluntary, and there will be no financial compensation for participating in the study. DOE will benefit from the study by obtaining information that allows it to determine the suitability of this technology for particular applications. There are no known health or personal safety risks associated with use of the facial verification system.
The identity of test subjects in the study will be treated as confidential. Only test project personnel will have access to information that ties image and performance data to particular subjects. Computer database files will be password protected.
Test subjects will read and sign a consent form describing the project and acknowledging that they understand the information and are participating freely. Participants will be asked to provide their height and whether or not they wear glasses. This information is required to understand how these factors might impact the performance of the system.
System performance will be characterized in terms of error rates (false reject rate and false accept rate), verification and enrollment times, and user acceptance.
· Scores resulting from verification attempts will be used to determine estimates of the false reject and false accept rates.
· Verification and enrollment times will be measured manually. All enrollments and a subset of all verifications will be timed.
· User acceptance will be measured via a short survey administered to the participants at the end of the test.