USDOE Human Subjects Research Database, Fiscal Year 1996

Sandia National Laboratories

Public Information Contact:

Mr. Rod Geer
Sandia National Laboratories
Employee Communications & Media Relations
PO Box 5800
Albuquerque, NM 87185-0167

Phone: 505-844-6601
Fax: 505-844-6367
Email: WRGEER@SANDIA.GOV

Institutional Review Board (IRB):

Projects are approved by an IRB located at: Sandia National Laboratories.
The approving IRB operates under a Multiple Project Assurance (MPA) recognized by DOE or by the Department of Health and Human Services (HHS).
MPA number of the IRB: DOE.MPA.SNL96-2000

Human Subjects Projects:

Number of Human Subjects Projects reported: 14

SNL-92-02
3D Ultrasound Imaging for Diagnostic Imaging (formerly Non-Invasive Scanning Techniques for Prosthetic Applications)
SNL-93-06
Mathematical Modeling Approach to Quantitative Retrospective Exposure Assessment of Potential Occupational Exposures to Mixed Organic Solvents at Sandia National Laboratories, NM.
SNL-94-01
Personal Status Monitor
SNL-94-12
Calibration and Benchmarking Data for Machine Vision and Image Classification
SNL-95-12
Human Presence Detection Utilizing a Chemical Agent Monitor
SNL-95-02
Evaluation of the Performance of the IriScan Biometric Identity Device
SNL-95-05
Evaluation of the Performance of the Facial Image Biometric Identifiers
SNL-95-06
Acoustic Data Acquisition From Human Subjects
SNL-95-09
Performance Evaluations of Biometric Identification Devices II
SNL-95-10
Video and Acoustic Data Acquisition From Human Subjects for Personnel Identity Verification
SNL-95-11
Radar Detection of Concealed Weapons
SNL-95-13
Evaluation of the performance of Voice Verification Devices
SNL-96-04
Commuter Aircraft Visual Inspection Reliability
SNL-96-05
Visual Observer Tests

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Project Identification:

Project Identifier: SNL-92-02

Project Title:

3D Ultrasound Imaging for Diagnostic Imaging (formerly Non-Invasive Scanning Techniques for Prosthetic Applications)

Principal Investigator: Mr. Alan K. Morimoto

Project started in: 1992
This project ended in Fiscal Year 1996.


Fiscal Year 1996 Funding for Research on Human Subjects:

Project Funding Information:
Project did not receive funding in Fiscal Year 1996.
Project did not use human subjects in Fiscal Year 1996.

Explanation:

No human studies took place during FY96 -- IRB approval expired in February '96, so study was closed out.

Funding Sources:

Non-DOE Federal: Defense Advanced Research Projects Agency
Amount: $0


Information on Use of Human Subjects:

Project does not involve use of multiple protocols/subprojects.

IRB Review:
Type of Review: Expedited
Most Recent Approval: February 14, 1995

Number of Human Subjects who participated in this project/protocol during FY 1996 (10/1/95 - 9/30/96): 0

Type of Human Subjects Involvement:

Instrument/Device/Product Testing or Man-Machine Studies:

Use of human subjects to develop/test instruments, materials, devices, or objects.

Abstract:
(a. Objectives, b. Methodology, c. Ionizing Radiation, Radioactive Substances, or Chemical Substances to which human subjects are exposed, d. Involvement of Human Subjects [d.1. procedures used, d.2. risks if any])

a. Development of a new ultrasound based scanner.

b. Scanner is based on approved commercially available ultrasound machine and will be used to define skin and bone surface geometry of human limbs (legs and arms). Scanner can be used for study of amputee limbs, limbs that have suffered injury or disease and are completely encased in skin or sterile sheath, and normal limbs. Information gathered on the limb will be used for fabrication of prostheses; in the case of the amputee, for refinement of the scanning platform for diagnostic image generation; and for studies of comparative anatomy. Uniqueness is use of ultrasound for high resolution three-dimensional images similar in format to x-ray computed tomography without suffering hazards of ionizing radiation.

d. Individual places leg (or arm) into water bath, used as transmission medium for ultrasound. Tank that surrounds water houses the ultrasound probe which takes images of the leg as the tub rotates around the leg. Procedure lasts approximately 20 seconds. Energy levels and duration of exposure are below Food and Drug Administration (FDA) limits and do not pose any known health risks.


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Project Identification:

Project Identifier: SNL-93-06

Project Title:

Mathematical Modeling Approach to Quantitative Retrospective Exposure Assessment of Potential Occupational Exposures to Mixed Organic Solvents at Sandia National Laboratories, NM.

Principal Investigator: Ms. Lisa Hooper

Project started in: 1993
This project ended in Fiscal Year 1996.


Fiscal Year 1996 Funding for Research on Human Subjects:

Project Funding Information:
Project did not receive funding in Fiscal Year 1996.
Project did not use human subjects in Fiscal Year 1996.

Explanation:

Project is an in-house dissertation research project with no specific funding for human subjects work. Data used in modeling was collected prior to FY96. Dissertation was completed in FY96 and project closed out.

Information on Use of Human Subjects:

Project does not involve use of multiple protocols/subprojects.

IRB Review:
Type of Review: Expedited
Most Recent Approval: June 09, 1995

Number of Human Subjects who participated in this project/protocol during FY 1996 (10/1/95 - 9/30/96): 0

Type of Human Subjects Involvement:

Questionnaires, Surveys, Epidemiological Studies:

Use of personally identifiable data from questionnaires, surveys, or epidemiological studies.

Abstract:
(a. Objectives, b. Methodology, c. Ionizing Radiation, Radioactive Substances, or Chemical Substances to which human subjects are exposed, d. Involvement of Human Subjects [d.1. procedures used, d.2. risks if any])

Study to develop a mathematical retrospective exposure modeling method appropriate for the variables at Sandia National Laboratories, New Mexico (SNL/NM) and apply it to potential occupational organic solvent exposures. Hypothesis is that in a diverse work environment with limited historical air monitoring data, a mathematical exposure model can be developed to perform retrospective exposure assessments resulting in significantly less misclassification of study subjects, with respect to airborne exposure, than semi-quantitative and qualitative models. The study will include development and application of three models that provide qualitative, semi-quantitative, and quantitative assessments of occupational exposure to neurotoxic organic solvents. The exposure intensity values generated by all three models will be used to establish cumulative exposures for the SNL/NM worker study population. The data used to complete the models are existing aggregate data that were collected for other purposes such as compliance air monitoring (exposure data for groups of people, for example, those working in a certain laboratory during a certain period). The cumulative exposures values will be compared to similar values from published epidemiology studies that look at sub-clinical neurotoxic effects. There are no risks to human subjects from actions taken in support of this project.


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Project Identification:

Project Identifier: SNL-94-01

Project Title:

Personal Status Monitor

Principal Investigator: Mr. Jerry Love

Project started in: 1994


Fiscal Year 1996 Funding for Research on Human Subjects:

Project Funding Information:
Project received funding in Fiscal Year 1996.
Project used human subjects in Fiscal Year 1996.

Funding Sources:

DOE: SNL LDRD
Amount: $15,000 (Est.)


Information on Use of Human Subjects:

Project does not involve use of multiple protocols/subprojects.

IRB Review:
Type of Review: Expedited
Most Recent Approval: April 12, 1996

Number of Human Subjects who participated in this project/protocol during FY 1996 (10/1/95 - 9/30/96): 50

Type of Human Subjects Involvement:

Instrument/Device/Product Testing or Man-Machine Studies:

Use of human subjects to develop/test instruments, materials, devices, or objects.

Abstract:
(a. Objectives, b. Methodology, c. Ionizing Radiation, Radioactive Substances, or Chemical Substances to which human subjects are exposed, d. Involvement of Human Subjects [d.1. procedures used, d.2. risks if any])

Objective: To develop and understand the sensor/human interface of a Personal Status Monitor (PSM) for ambulatory patients that will record blood pressure, heart rate, respiration, and core body temperature for routine patient monitoring in hospitals, for outpatients, and for home care.

Methodology: Vital signs will be measured at the superficial middle temporal portion of the external carotid artery in front of the ear, or on an orbital anterior auricular branch of this artery. This artery is readily compressed because it lies on bone. Compression of the artery to determine blood pressure requires a headband type platform to provide an opposing force, or an ear canal platform where a squeezing force can be applied. Either platform permits the mounting of sensors for measuring other parameters, i.e., core body temperature, which can be measured in the ear canal. Other suitable sensor sites included in the study are wrist and finger. No electrical contact with tissue is required. The desired vital signs can be determined with an infrared (IR) and red sensor, a pressure transducer, and a temperature transducer. Non-occlusive techniques to indirectly determine blood pressure will also be explored.

Involvement of Human Subjects: Subjects will be used to obtain measurement and calibration data for the development of this project--only the basic concept has been developed. No known risk is involved with human subjects. All techniques use conventional measurement and control techniques, e.g., compression of an artery to determine blood pressure.


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Project Identification:

Project Identifier: SNL-94-12

Project Title:

Calibration and Benchmarking Data for Machine Vision and Image Classification

Principal Investigator: Mr. Gordon C. Osbourn

Project started in: 1994


Fiscal Year 1996 Funding for Research on Human Subjects:

Project Funding Information:
Project received funding in Fiscal Year 1996.
Project used human subjects in Fiscal Year 1996.

Funding Sources:

DOE: Defense Programs
Amount: $10,000 (Est.)


Information on Use of Human Subjects:

Project does not involve use of multiple protocols/subprojects.

IRB Review:
Type of Review: Expedited
Most Recent Approval: October 09, 1996

Number of Human Subjects who participated in this project/protocol during FY 1996 (10/1/95 - 9/30/96): 7

Type of Human Subjects Involvement:

Instrument/Device/Product Testing or Man-Machine Studies:

Use of human subjects to develop/test instruments, materials, devices, or objects.

Abstract:
(a. Objectives, b. Methodology, c. Ionizing Radiation, Radioactive Substances, or Chemical Substances to which human subjects are exposed, d. Involvement of Human Subjects [d.1. procedures used, d.2. risks if any])

Objectives: To collect human perception data (that does not exist in the vision science literature) to improve, calibrate, and benchmark the performance of machine vision and image classification algorithms.

Methodology: Video images will be presented to subjects and subjects will report what they perceive by responding to multiple choice questions.

Involvement of Human Subjects: Subjects will view images on a video monitor and describe what they see by typing responses on a computer keyboard. The responses will be tabulated by computer and stored with an identification code. Response time will also be measured; uncertain responses (associated with longer response times) often occur for image parameters at the important "transitions" between two possible perceptions. There are no known risks to the subjects.


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Project Identification:

Project Identifier: SNL-95-12

Project Title:

Human Presence Detection Utilizing a Chemical Agent Monitor

Principal Investigator: Mr. Mark D. Ladd

Project started in: 1995


Fiscal Year 1996 Funding for Research on Human Subjects:

Project Funding Information:
Project did not receive funding in Fiscal Year 1996.
Project did not use human subjects in Fiscal Year 1996.

Explanation:

Funding was cut for FY96 by DOE Office of Safeguards & Security but will be funded in FY97

Information on Use of Human Subjects:

Project does not involve use of multiple protocols/subprojects.

IRB Review:
Type of Review: Expedited
Most Recent Approval: October 09, 1996

Number of Human Subjects who participated in this project/protocol during FY 1996 (10/1/95 - 9/30/96): 0

Type of Human Subjects Involvement:

Instrument/Device/Product Testing or Man-Machine Studies:

Use of human subjects to develop/test instruments, materials, devices, or objects.

Abstract:
(a. Objectives, b. Methodology, c. Ionizing Radiation, Radioactive Substances, or Chemical Substances to which human subjects are exposed, d. Involvement of Human Subjects [d.1. procedures used, d.2. risks if any])

Objective

DOE (Department of Energy) /OSS (Office of Safeguards and Security) has tasked Sandia to research and develop a new generation of sensors with the potential of identifying unique life-form characteristics such as breathing patterns, heartbeat patterns, body odors, etc. Sensors that can differentiate between life-form characteristics and other uncontrollable environmental stimuli would represent a significant progress in the nuisance and false alarm arena. This specific proposal is for the research of the IMS (Ion Mobility Spectrometry) technology incorporated into a portable hand-held Chemical Agent Monitor (CAM).

Methodology

The CAM could be used as a possible human body odor detector. The possibility of identifying chemicals emitted from human bodies will be researched using the ion mobility spectrometry technology. Human bodies exude organic chemicals and inorganic gases as part of respiration via lungs and presumably through skin. By utilizing the CAM, the identification of major product ions provided by human subjects may be achieved. The CAM has a small suction pump which uses a nozzle to absorb a volume of air carrying the subject’s molecules into the IMS. In the ion mobility spectrometer, the analyte molecules in the air sample are negatively ionized using a beta source and then passed into a drift cell through a shutter which opens periodically over a specific interval. Within the drift region, the ionized species move down an electric field gradient against a counterflow of an inert gas. In doing so, the molecules separate by weight, with the lightest species, with their smaller cross-sections, progressing more quickly upstream than the more massive species. At the end of the drift region the ions strike a Faraday plate which records the output voltage as a function of molecule drift time. A typical IMS drift time cell is 6 to 8 cm. long with an electric field gradient of 200 V/cm; under these conditions, the drift time of human’s body chemicals/gases can be determined. Coupling with a gas chromatograph is not necessary for identification of the analyte since the time-of-flight separation achieved in the drift region provides specificity.

Ionizing Radiation

There are no chemical or radioactive substances or ionizing radiation to which the human subjects will be exposed.

Involvement of Human Subjects

We will seek as many as 20 volunteers. All of the participation will occur as part of the volunteer’s normal work day. They will be informed of the use of the CAM device and will be given the opportunity to become familiar with its operation. We will then ask that they be tested with the device as often as possible until we establish a suitable data base. This phase is expected to last a maximum of 2 months. The total length of time it will take to perform all of the tests is estimated to be less than two hours. All of the tests will be monitored to facilitate collection of system performance data. None of these procedures are experimental.

A sign in sheet will be located outside the laboratory. Prior to entering, they will sign their name, date, and time. The Chemical Agent Monitor will be set on a desk top and the human samples will be "sniffed" using the CAM. The subject will hold parts of the body approximately 1 centimeter away from the sampling orifice on the anterior end of the CAM. These body parts will include forearms, scalps, and cheeks. The sampling will last approximately 30 seconds to 1 minute as the CAM samples the ambient temperature air about each subject. The spectra will be saved on a 3.5" floppy disk in a personal computer so the results could be analyzed and printed at a later date. After the elapsed time, the subject will exit the laboratory.

Possible Risk / Discomforts:

There are no known risks associated with the use of the Chemical Agent Monitor which will be the device used for testing. There are also no known risks in any of the study procedures.


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Project Identification:

Project Identifier: SNL-95-02

Project Title:

Evaluation of the Performance of the IriScan Biometric Identity Device

Principal Investigator: Mr. Frank Bouchier

Project started in: 1995
This project ended in Fiscal Year 1996.


Fiscal Year 1996 Funding for Research on Human Subjects:

Project Funding Information:
Project received funding in Fiscal Year 1996.
Project used human subjects in Fiscal Year 1996.

Funding Sources:

DOE: Office of Safeguards and Security
Amount: $4,000 (Est.)


Information on Use of Human Subjects:

Project does not involve use of multiple protocols/subprojects.

IRB Review:
Type of Review: Expedited
Most Recent Approval: February 22, 1995

Number of Human Subjects who participated in this project/protocol during FY 1996 (10/1/95 - 9/30/96): 90

Type of Human Subjects Involvement:

Instrument/Device/Product Testing or Man-Machine Studies:

Use of human subjects to develop/test instruments, materials, devices, or objects.

Abstract:
(a. Objectives, b. Methodology, c. Ionizing Radiation, Radioactive Substances, or Chemical Substances to which human subjects are exposed, d. Involvement of Human Subjects [d.1. procedures used, d.2. risks if any])

The U.S. Department of Energy (DOE) has tasked Sandia National Laboratories (SNL) to evaluate commercial state-of-the-art entry control technology devices, and part of this task is to evaluate new and developing biometric identification devices to determine their applicability for use in DOE sites. Biometric identification devices are capable of identifying a person based on some measurable, unique characteristic of the individual. Prototype device to be evaluated uses the irises of individual eyes. Verification of identity is accomplished by matching the measured characteristic with a reference measurement obtained from a previous enrollment.

Volunteers will be trained in the use of the device and will use it as often as possible until a suitable database of transactions is established. The number of false rejects will be compared to the number of transactions. Then all volunteers' templates will be deleted from the device, and each volunteer will try the device several times. During this time, the volunteer's biometric data will be compared against a database of 400 other user templates; researchers will be looking for false accepts and will calculate error rate.

None of the published results will contain individual performance or identification of any kind. There are no known risks associated with the use of the biometric identification device to be studied, and there are no known risks in any of the study procedures.


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Project Identification:

Project Identifier: SNL-95-05

Project Title:

Evaluation of the Performance of the Facial Image Biometric Identifiers

Principal Investigator: Mr. Frank Bouchier

Project started in: 1995
This project ended in Fiscal Year 1996.


Fiscal Year 1996 Funding for Research on Human Subjects:

Project Funding Information:
Project did not receive funding in Fiscal Year 1996.
Project did not use human subjects in Fiscal Year 1996.

Explanation:

Project ended in early October 1995

Funding Sources:

DOE: Office of Safeguards and Security
Amount: $0


Information on Use of Human Subjects:

Project does not involve use of multiple protocols/subprojects.

IRB Review:
Type of Review: Expedited
Most Recent Approval: April 25, 1995

Number of Human Subjects who participated in this project/protocol during FY 1996 (10/1/95 - 9/30/96): 0

Type of Human Subjects Involvement:

Instrument/Device/Product Testing or Man-Machine Studies:

Use of human subjects to develop/test instruments, materials, devices, or objects.

Abstract:
(a. Objectives, b. Methodology, c. Ionizing Radiation, Radioactive Substances, or Chemical Substances to which human subjects are exposed, d. Involvement of Human Subjects [d.1. procedures used, d.2. risks if any])

Prototype devices to be evaluated use the unique characteristic of individual facial images for biometric identification. Both these systems acquire digital images of people's faces, and verification of identity is accomplished by matching the image with a reference image obtained from a previous enrollment. Characterizing the performance of these devices in terms of error rates, length of time required for verification, user acceptability, vulnerability to attack, and identification of categories of people who might not be able to use these devices is the purpose of this test.

Volunteers will be trained in the use of the devices and will use them as often as possible until a suitable database of transactions is obtained. The number of false rejects will be compared to the number of transactions to establish the false reject rate. Then volunteers' templates will be deleted and each volunteer will try the devices several times. Error rates (for example, false matches) will be calculated, and observations during the test and user surveys following the test will address the other performance considerations.

None of the published results will contain individual performance or identification of any kind. There are no known risks associated with the use of the biometric identification devices to be tested, and there are no known risks to any of the study procedures.


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Project Identification:

Project Identifier: SNL-95-06

Project Title:

Acoustic Data Acquisition From Human Subjects

Principal Investigator: Ms. Ann M. Bouchard

Project started in: 1995


Fiscal Year 1996 Funding for Research on Human Subjects:

Project Funding Information:
Project received funding in Fiscal Year 1996.
Project used human subjects in Fiscal Year 1996.

Funding Sources:

DOE: LDRD: information
Amount: $50,000 (Est.)


Information on Use of Human Subjects:

Project does not involve use of multiple protocols/subprojects.

IRB Review:
Type of Review: Expedited
Most Recent Approval: June 07, 1996

Number of Human Subjects who participated in this project/protocol during FY 1996 (10/1/95 - 9/30/96): 4

Type of Human Subjects Involvement:

Instrument/Device/Product Testing or Man-Machine Studies:

Use of human subjects to develop/test instruments, materials, devices, or objects.

Abstract:
(a. Objectives, b. Methodology, c. Ionizing Radiation, Radioactive Substances, or Chemical Substances to which human subjects are exposed, d. Involvement of Human Subjects [d.1. procedures used, d.2. risks if any])

The goal of this project is to research and develop a new biometric identity verification system based on the acoustic signature of the individual's ear canal and/or voice. Subjects will be asked to listen to sound in a frequency range from 20 Hertz (Hz) to 50 kilohertz (kHz), and will provide speech samples to a modified telephone handset. All acoustic signal levels will be comparable to or less than typical telephone volume levels. There are no known risks to the human subjects.


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Project Identification:

Project Identifier: SNL-95-09

Project Title:

Performance Evaluations of Biometric Identification Devices II

Principal Investigator: Mr. Jose Rodriguez

Project started in: 1995
This project ended in Fiscal Year 1996.


Fiscal Year 1996 Funding for Research on Human Subjects:

Project Funding Information:
Project received funding in Fiscal Year 1996.
Project did not use human subjects in Fiscal Year 1996.

Explanation:

The human subject data was collected during FY95, but the data analysis was performed during FY96

Funding Sources:

DOE: Office of Safeguards and Security
Amount: $10,000 (Est.)


Information on Use of Human Subjects:

Project does not involve use of multiple protocols/subprojects.

IRB Review:
Type of Review: Expedited
Most Recent Approval: August 18, 1995

Number of Human Subjects who participated in this project/protocol during FY 1996 (10/1/95 - 9/30/96): 0

Type of Human Subjects Involvement:

Instrument/Device/Product Testing or Man-Machine Studies:

Use of human subjects to develop/test instruments, materials, devices, or objects.

Abstract:
(a. Objectives, b. Methodology, c. Ionizing Radiation, Radioactive Substances, or Chemical Substances to which human subjects are exposed, d. Involvement of Human Subjects [d.1. procedures used, d.2. risks if any])

Objective: Determine operating characteristics of commercially available biometric identification devices used in entry control applications. Devices to be evaluated use one of the following characteristics: voice dynamics, hand geometry, fingerprint, or signature.

Methodology: Each volunteer will be given a unique personal ID number (PIN) and will be trained in the use of the device; then volunteers will each use the device at least 20 times. By analyzing the number of false rejects compared to the number of transactions, first error level will be established. Volunteers will then be asked to use their biometric feature against other valid PINs, with a resulting error rate calculation.

Involvement of Human Subjects: There will be a single controlled database that correlates PIN numbers to volunteers' names. None of the published results will contain individual performance or identification of any kind.

There are no known risks associated with the use of any of the biometric identification devices, and there are no known risks to any of the study procedures.


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Project Identification:

Project Identifier: SNL-95-10

Project Title:

Video and Acoustic Data Acquisition From Human Subjects for Personnel Identity Verification

Principal Investigator: Ms. Ann M. Bouchard

Project started in: 1995


Fiscal Year 1996 Funding for Research on Human Subjects:

Project Funding Information:
Project received funding in Fiscal Year 1996.
Project used human subjects in Fiscal Year 1996.

Funding Sources:

DOE: LDRD: Information
Amount: $40,000 (Est.)


Information on Use of Human Subjects:

Project does not involve use of multiple protocols/subprojects.

IRB Review:
Type of Review: Expedited
Most Recent Approval: October 09, 1996

Number of Human Subjects who participated in this project/protocol during FY 1996 (10/1/95 - 9/30/96): 100

Type of Human Subjects Involvement:

Instrument/Device/Product Testing or Man-Machine Studies:

Use of human subjects to develop/test instruments, materials, devices, or objects.

Abstract:
(a. Objectives, b. Methodology, c. Ionizing Radiation, Radioactive Substances, or Chemical Substances to which human subjects are exposed, d. Involvement of Human Subjects [d.1. procedures used, d.2. risks if any])

The identification of personnel through biometric measurements (e.g. retinal scans, hand/finger geometry scans, voice, face scans, fingerprint scans) has numerous security and surety applications, including control of entry to restricted areas, restricting access to sensitive or private information, or recognizing criminal or terrorist suspects. A related industrial need is to replace the proliferating use of PIN numbers for authenticating financial and medical transactions. The need to memorize many different PIN numbers is becoming impractical, and many users compromise the security of their accounts by using the same PIN number for multiple purposes and by carrying the PIN number(s) in wallets/purses. However, in order for biometric technologies to meet this broad need, improvements must be made in reliability, cost, and acceptability to users.

In this project, we propose a minimally intrusive biometric system, based on the fusion of multiple coarse biometric features to distinguish and identify individuals. Specifically, we will simultaneously acquire images of the hand and face (front view as well as profile), acoustic recordings of the voice, and other physical measurements, such as height and weight. From this data, we will extract coarse measurements, such as the length and width of fingers, the curvature of the nose profile, or characteristic frequencies or patterns in the voice. We will then investigate what combinations of such features can be used to recognize individuals most reliably.

This system is "minimally intrusive" in that all of the data can be acquired without physical contact (e.g., via images or voice recordings) and without exposing the individual to unusual or uncomfortable conditions (e.g., putting his/her eye close to a scanner). As a result, wide user acceptance is expected. By using measurements from several different physical features, we hope to enhance reliability, both in improving distinguishability of individuals and by making the system less vulnerable to defeat by impostors. Finally, through inexpensive cameras, acoustic sensors, and personal computer hardware, the system can be made at a reasonable cost.

The purpose of this human study is to collect data from volunteers in each of the procedures described below, in order to (1) investigate which measurements enable the recognition of individuals, and (2) test and refine the measurements, and (3) evaluate the system for reliability and user acceptance.

Each data acquisition procedure is described in the following:

Hand: A volunteer will be asked to place his/her hand on a designated surface or hold his/her hand out at a designated location and orientation while a video camera captures images of the individual's hand.

Face: A volunteer will be asked to face a designated direction while video cameras capture images of the front and/or profile views of the individual's face.

Voice: A volunteer will be asked to say designated phrases or word sequences while his/her voice is recorded.

Height: A volunteer will be asked to stand at a designated location while a video camera captures an image of the individual's head (the height measurement will be inferred from the location, orientation, etc. of the camera).

Weight: A volunteer will be asked to stand on a scale while his/her weight is recorded.

In addition, volunteers will be asked to comment on how comfortable they feel about each of the data acquisition procedures.

We will use up to 200 Sandia employee volunteers and up to 200 NMSU student, faculty, and staff volunteers for the study. We will acquire extensive data from a small number of volunteers (the members of the team). From additional volunteers, we will acquire data up to five times per week, for about 5 minutes each session, with the entire test period covering a number of months.


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Project Identification:

Project Identifier: SNL-95-11

Project Title:

Radar Detection of Concealed Weapons

Principal Investigator: Mr. John Aurand

Project started in: 1995


Fiscal Year 1996 Funding for Research on Human Subjects:

Project Funding Information:
Project did not receive funding in Fiscal Year 1996.
Project did not use human subjects in Fiscal Year 1996.

Explanation:

This was to be a Tech Transfer project, but the expected external funding was not obtained during FY96. Funding is still being sought.

Information on Use of Human Subjects:

Project does not involve use of multiple protocols/subprojects.

IRB Review:
Type of Review: Full Board
Most Recent Approval: January 23, 1996

Number of Human Subjects who participated in this project/protocol during FY 1996 (10/1/95 - 9/30/96): 0

Type of Human Subjects Involvement:

Instrument/Device/Product Testing or Man-Machine Studies:

Use of human subjects to develop/test instruments, materials, devices, or objects.

Other use of human subjects:

Use of very low-level non-ionizing microwave radiation to detect concealed firearms.

Abstract:
(a. Objectives, b. Methodology, c. Ionizing Radiation, Radioactive Substances, or Chemical Substances to which human subjects are exposed, d. Involvement of Human Subjects [d.1. procedures used, d.2. risks if any])

The proposed research involving human subjects would be done as part of a Technology Transfer project. The goal of this project will be to examine the possibility of using microwave radar techniques in a law-enforcement device to detect concealed firearms on suspects. This project would require direct exposure of human subjects to very low-level microwave (non-ionizing) radiation. Experimental data on microwave scattering from personnel with and without a variety of firearms would be acquired in two different facilities, over a period of several weeks. The two facilities are the Sandia National Laboratories' Time-Domain Radar Facility, Department 9323, and the Compact Range RCS Measurement Facility, Department 2343.

Exposure of personnel to non-ionizing microwave radiation is governed by an IEEE Standard, IEEE C95.1-1991. The worst-case exposure, even with direct illumination in either facility, will be at least 50,000 times lower than the permissible level. In addition, their exposure time will be limited to the minimum time required to acquire the desired backscatter data. Both facilities have controlled-access capability, and this will be utilized (as is normally done anyway) to prevent uninformed or unauthorized personnel from being exposed to the microwave radiation.


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Project Identification:

Project Identifier: SNL-95-13

Project Title:

Evaluation of the performance of Voice Verification Devices

Principal Investigator: Mr. Tim Buckle

Project started in: 1995
This project ended in Fiscal Year 1996.


Fiscal Year 1996 Funding for Research on Human Subjects:

Project Funding Information:
Project received funding in Fiscal Year 1996.
Project used human subjects in Fiscal Year 1996.

Funding Sources:

DOE: Defense Programs
Amount: $50,000 (Est.)


Information on Use of Human Subjects:

Project does not involve use of multiple protocols/subprojects.

IRB Review:
Type of Review: Expedited
Most Recent Approval: November 06, 1996

Number of Human Subjects who participated in this project/protocol during FY 1996 (10/1/95 - 9/30/96): 208

Type of Human Subjects Involvement:

Questionnaires, Surveys, Epidemiological Studies:

Use of personally identifiable data from questionnaires, surveys, or epidemiological studies.

Instrument/Device/Product Testing or Man-Machine Studies:

Use of human subjects to develop/test instruments, materials, devices, or objects.

Abstract:
(a. Objectives, b. Methodology, c. Ionizing Radiation, Radioactive Substances, or Chemical Substances to which human subjects are exposed, d. Involvement of Human Subjects [d.1. procedures used, d.2. risks if any])

Objectives

This research project is designed to evaluate the performance of several commercial voice verification devices. These devices attempt to verify the identity of a person based on his/her unique voice characteristics while speaking prompted phrases. The outcome of the evaluation will help in determining the effectiveness of these systems for identification purposes and will also help to identify areas that need improvement. Appropriate recordings of human voices were required to carry out the evaluation, hence the need for human test subjects.

Methodology

Voice recordings were collected from participants via telephone. Some of the voice recordings were used to build voice templates for each individual. The remaining recordings were used as test utterances. The voice verification devices make acceptance and rejection decisions based on comparing the test utterances with the voice templates. Sometimes they make the wrong decision, hence the error rates of these devices provide a prime method of characterizing device performance. Other important considerations include the length of time required for verification, user acceptability, and classes of people that may not be able to use the device. Characterizing the performance of these devices was a primary purpose of this test. A secondary test purpose was the collection of a voice database. A voice database will permit appropriate comparisons between the devices currently selected for evaluation and future devices.

Approximately 200 volunteers were recruited for the voice collection effort. These volunteers were recruited from several population groups to examine possible device performance differences among these groups. The literature suggests that the ability of a voice verification device to correctly identify a subject varies with gender, age, native language, and physical impairments/health disorders. Test subjects were recruited to obtain some variability within these categories.

Procedure

Each participant filled out a form giving their name, gender, age, native language, whether or not they smoke, and describing any disorders or physical impairments of the mouth or throat. This information was required to understand how these factors might affect the performance of the systems. A personal identification number (PIN) and a telephone number were provided for calling in. Participants were requested to call this number twice a day, once from their work phone and once from another phone, until 24 calls had been made within a three-week period. Speaker phones, portable phones, and cellular phones were not allowed for call in. Touch tone (rather than rotary dial) phones were required. During each phone call, the participants were prompted for all required information. The data collected included: date and time (from the system), participant PIN, phone number calling from, a current condition report, and multiple repetitions of each of several phrases. Each phone call lasted about three to four minutes.

Possible Risk/Discomforts

Participants made calls using telephones -- there are no known health or personal safety risks associated with this common activity. There are also no known health or personal safety risks in any of the study procedures.


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Project Identification:

Project Identifier: SNL-96-04

Project Title:

Commuter Aircraft Visual Inspection Reliability

Principal Investigator: Mr. Floyd W. Spencer

Project started in: 1996


Fiscal Year 1996 Funding for Research on Human Subjects:

Project Funding Information:
Project received funding in Fiscal Year 1996.
Project used human subjects in Fiscal Year 1996.

Funding Sources:

Non-DOE Federal: Department of Transportation
Amount: $85,000 (Est.)
Comments:
Amount does not include Principal Investigator's time as this program was one of several in which he was involved.


Information on Use of Human Subjects:

Project does not involve use of multiple protocols/subprojects.

IRB Review:
Type of Review: Expedited
Most Recent Approval: June 06, 1996

Number of Human Subjects who participated in this project/protocol during FY 1996 (10/1/95 - 9/30/96): 11

Type of Human Subjects Involvement:

Questionnaires, Surveys, Epidemiological Studies:

Use of personally identifiable data from questionnaires, surveys, or epidemiological studies.

Instrument/Device/Product Testing or Man-Machine Studies:

Use of human subjects to develop/test instruments, materials, devices, or objects.

Abstract:
(a. Objectives, b. Methodology, c. Ionizing Radiation, Radioactive Substances, or Chemical Substances to which human subjects are exposed, d. Involvement of Human Subjects [d.1. procedures used, d.2. risks if any])

The Federal Aviation Administration has established the Airworthiness Assurance Nondestructive Inspection Validation Center (AANC) managed by Sandia. The AANC is located in a maintenance hangar facility on the Albuquerque International Airport. The major emphasis of the AANC is to facilitate the development and introduction of new nondestructive inspection (NDI) techniques into aircraft maintenance. The AANC provides testbeds for the development of techniques, as well as for the validation of inspection techniques. The validation programs rely on blind experiments where the operators 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. Inspectors look at the aircraft structure aided only by flashlights, mirrors, and magnifiers to locate structural flaws and other airworthiness issues. This program was designed to benchmark performance levels of inspectors currently employed in the commuter industry using a Fairchild Metro II aircraft. Industry groups (Regional Airline Association, Metro Operators Group) expressed interest in the program and their member organizations provided the inspectors used in the benchmark.

This program used representative inspectors from the airline industry to perform two days worth of inspection on the Fairchild Metro II testbed to provide a benchmark for performance levels. All the inspectors were experienced with this type of aircraft and the inspections they performed were a subset of tasks that they routinely perform in their day-to-day jobs. The inspectors were monitored and videotaped during their inspections. The videotape provided a backup to the recording of the faults and also provided a means to objectively compare individual inspection techniques across the subjects. The inspectors also provided background data concerning their past experience and training. Visual acuity tests were also administered.

The benchmark inspections were completed during the summer of 1996, but analysis of the results is on-going. All subjects were provided by various airline companies from within their inspection and maintenance personnel.

Expected Benefits and Risks

There has been little quantification of visual inspection performance in general, and even less within the commuter airline industry. This program will benefit the FAA and the commuter industry, by providing an objective benchmark quantification of performance levels. The monitoring of inspector’s actions will enable an objective comparison of inspector behaviors that can influence performance levels.

The risks to the individuals cooperating in this program were minimal and did not exceed the normal risks faced in their daily employment. The work that they performed is the same work that they do on a routine basis as part of their jobs. The inspectors were briefed on safety and standard operating procedures in effect at the AANC Hangar prior to their working in the facility. Their adherence to those procedures was 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.


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Project Identification:

Project Identifier: SNL-96-05

Project Title:

Visual Observer Tests

Principal Investigator: Mr. Steve Tucker

Project started in: 1996


Fiscal Year 1996 Funding for Research on Human Subjects:

Project Funding Information:
Project received funding in Fiscal Year 1996.
Project used human subjects in Fiscal Year 1996.

Funding Sources:

Non-DOE Federal: Air Force Space Command
Amount: $3,500 (Est.)


Information on Use of Human Subjects:

Project does not involve use of multiple protocols/subprojects.

IRB Review:
Type of Review: Expedited
Most Recent Approval: July 18, 1996

Number of Human Subjects who participated in this project/protocol during FY 1996 (10/1/95 - 9/30/96): 9

Type of Human Subjects Involvement:

Other use of human subjects:

Perception research

Abstract:
(a. Objectives, b. Methodology, c. Ionizing Radiation, Radioactive Substances, or Chemical Substances to which human subjects are exposed, d. Involvement of Human Subjects [d.1. procedures used, d.2. risks if any])

Objective: Determine the ability and efficacy of visual observers to visually detect aircraft.

Methodology: Two series of tests are run. In one the observer is cued as to aircraft position via a feed from the FAA radar by the test monitor. In the second test, the observer will not be cued. In both tests, the number of actual aircraft vs. detected aircraft will be recorded. Additional data includes: range, meteorological data and time. A histogram of range vs detection efficacy for various conditions will be produced.

Risks: Observers will be outdoors and have the risk of sunburn and cold temperatures. Sunscreen and coats are provided.


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