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
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
Number of Human Subjects Projects reported: 13
Project Identifier: SNL-94-01
Project Title:
Personal Status Monitor
Principal Investigator:
Mr. Jerry Love
Project started in: 1994
This project ended in Fiscal Year 1997.
Project Funding Information:
Project did not receive funding in Fiscal Year 1997.
Project did not use human subjects in Fiscal Year 1997.
Explanation:
Project was not funded for FY97, so no additional subjects were studied.
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 1997 (10/1/96 - 9/30/97): 0
Type of Human Subjects Involvement:
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.
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
Project Funding Information:
Project received funding in Fiscal Year 1997.
Project used human subjects in Fiscal Year 1997.
Funding Sources:
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 1997 (10/1/96 - 9/30/97): 1
Type of Human Subjects Involvement:
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.
Consent: Subjects will be provided with a "Research Subject Information Form" in lieu of signing a consent form. The requirement to document informed consent has been waived by HSB since this project has basically no risk and is not a procedure for which consent is normally required, i.e., giving feedback on computer software improvements. Subject responses will be tabulated by computer and stored under an ID code provided by the subject.
Project Identifier: SNL-95-06
Project Title:
Acoustic Data Acquisition From Human Subjects
Principal Investigator:
Ms. Ann M. Bouchard
Project started in: 1995
This project ended in Fiscal Year 1997.
Project Funding Information:
Project received funding in Fiscal Year 1997.
Project used human subjects in Fiscal Year 1997.
Funding Sources:
Project does not involve use of multiple protocols/subprojects.
IRB Review:
Type of Review: Expedited
Most Recent Approval: May 27, 1997
Number of Human Subjects who participated in this project/protocol during
FY 1997 (10/1/96 - 9/30/97): 6
Type of Human Subjects Involvement:
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.
Subjects signed a consent form and were given a copy of what they signed. Each subject was assigned a number (which could not be linked to the individual, except through a table of names and subject numbers, which was kept separately as private information). As data was acquired, data files were stored by subject number. The consent forms and subject name-number table are kept in a locked drawer or filing cabinet while not in use.
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
This project ended in Fiscal Year 1997.
Project Funding Information:
Project received funding in Fiscal Year 1997.
Project used human subjects in Fiscal Year 1997.
Funding Sources:
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 1997 (10/1/96 - 9/30/97): 56
Type of Human Subjects Involvement:
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 New Mexico State University (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.
Subjects signed a consent form and were given a copy of what they signed. Each subject was assigned a number (which could not be linked to the individual, except through a table of names and subject numbers, which was kept as private information). As data was acquired, data files were stored by subject number. The consent forms and subject name-number table are kept in a locked drawer or filing cabinet while not in use.
Project Identifier: SNL-95-11
Project Title:
Radar Detection of Concealed Weapons
Principal Investigator:
Mr. John Aurand
Project started in: 1995
This project ended in Fiscal Year 1997.
Project Funding Information:
Project did not receive funding in Fiscal Year 1997.
Project did not use human subjects in Fiscal Year 1997.
Explanation:
Project was never started due to lack of funding.
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 1997 (10/1/96 - 9/30/97): 0
Type of Human Subjects Involvement:
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.
Since funding was never obtained this project was not started, and the IRB approval was terminated during FY97.
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
This project ended in Fiscal Year 1997.
Project Funding Information:
Project received funding in Fiscal Year 1997.
Project used human subjects in Fiscal Year 1997.
Funding Sources:
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 1997 (10/1/96 - 9/30/97): 2
Type of Human Subjects Involvement:
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 that 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 that records the output voltage as a function of molecule drift time. A typical IMS drift time cell is 6 to 8 centimeter (cm) long with an electric field gradient of 200 V/cm; under these conditions, the drift time of a 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 CAM 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 cm 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 CAM which will be the device used for testing. There are also no known risks in any of the study procedures.
Privacy / Confidentiality / Consent
Volunteers will be provided with information about the project and will be asked to sign an informed consent form. The data base used for data reduction and reporting will not contain any names or any other data that can be used to relate any performance information to an individual. Volunteers will be asked about their feelings on the device, but these survey results will be reported without any reference to any individual.
Project Identifier: SNL-96-03
Project Title:
Remote Vital Sign Detection Utilizing Micropower Impulse Radar Technology
Principal Investigator:
Mr. Mark D. Ladd
Project started in: 1996
This project ended in Fiscal Year 1997.
Project Funding Information:
Project received funding in Fiscal Year 1997.
Project used human subjects in Fiscal Year 1997.
Funding Sources:
Project does not involve use of multiple protocols/subprojects.
IRB Review:
Type of Review: Expedited
Most Recent Approval: February 05, 1997
Number of Human Subjects who participated in this project/protocol during
FY 1997 (10/1/96 - 9/30/97): 2
Type of Human Subjects Involvement:
Objective
DOE/OSS (Department of Energy/Office of Safeguards and Security) and the TSWG (Technical Support Work Group) of the National Security Council's Policy Coordinating Committee on Terrorism/Counterterrorism have tasked Sandia to research and develop a new generation of sensors with the potential of remotely and unobtrusively detecting the presence, absence, or variation of one or more human vital signs such as heart rate, respiration, temperature, etc., to identify abnormal levels of tension and anxiety that may be indicative of elevated stress or malevolent intention. The ability to remotely detect such abnormal vital signs has potential application to access control systems, crowd control systems, airport security, prisons security, and other government and industrial security applications where it is desirable to remotely recognize personnel that are a high risk and take appropriate preemptive measures prior to the occurrence of a security incident. This specific proposal is for the research of Micropower Impulse Radar (MIR) technology developed at Lawrence Livermore National Laboratories.
Methodology
The operating principle of the MIR sensors are based on a novel form of radar known as ultra-wideband (UWB) impulse radar. A very short electromagnetic pulse is propagated from the sensor and only the echoes that reflect from a defined range are detected. One application of the MIR is that of an organ motion sensor. The microradar organ motion sensor, or heart monitor, is a motion sensor that is claimed to detect cardiac contractions, as well as detect arterial wall motion, respiration (from a distance), and vocal cord activity. It has also been claimed that motion signatures can be detected almost everywhere in the body, such as from the carotid, brachial and femoral arteries, and from the cranium. Each of these effects will have to be tested as to sensitivity, reliability, and quality of information obtained. Since each vital sign (cardiac activity, respiration, pulse rate) has its own characteristics, a "normal" range needs to be established for comparison to any readings that might be obtained in the field.
Initially, the application may be limited towards a Remote Vital Sign detector that can reliably assess the presence, absence, or variation of one or more vital signs. Several units could be used to identify specific signatures of these vital signs. A signal processor would analyze the signal and determine the individual's current vital signs. Use of this technology may lead to more complex applications. These applications may be comprised of providing advanced warning as to elevated anxiety or malicious intent of screened personnel. The ability to detect such abnormal states, either remotely or as a subject passes through a portal or housing of some sort, would lead to the prevention of contemplated acts of violence and subterfuge, and provide greater security to the public as well as to government officials.
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 seek as many as 20 volunteers who can participate in this project during their normal work day. They will be told how the MIR devices work and will be given an opportunity to ask questions about the MIR devices. They will be tested with the device as often as possible until we establish a suitable data base. The length of time needed to perform each test is estimated to be a maximum of 15 minutes, with an estimated total for all tests of 6 hours, spread over the 3 month period. All of the tests will be monitored by an investigator within the laboratory to facilitate collection of system performance data.
After signing in, volunteers will enter the laboratory where they will be asked to stand up and/or sit down for several minutes at a time while a radar measurement is being made. They will not be asked to exercise or in any way elevate their heart or respiration rates, except for an occasional deep breath. The plastic micropower radar housing may be strapped or taped to the volunteer or be held toward the volunteer, but skin contact with the plastic microwave radar housing will not happen because a non-conductive shield will be between the skin and the device. During the measurement period, they will be exposed to low-level microwave radiation and their heartbeat and blood pressure will be checked occasionally while they are being exposed to the radiation. The heart rate and blood pressure measurements will be recorded to compare with the data obtained from the MIR devices. Micropower radar pulses will be directed into various parts of the body, and echoes will be recorded by a data acquisition system connected to the output of the MIR devices. These samples include radar echoes detected externally from the heart, lungs, tongue and throat region, arterial system, skull and skeleton, and full body echoes.
All tests conducted in this research project are considered experimental since this method of using micropower pulsed radar to detect human vital signs is currently not a standard medical technique.
Possible Risk/Discomforts
There are no known risks associated with the use of the MIR devices which will be used for testing. There are also no known risks in any of the study procedures. Exposure to microwave or non-ionizing radiation can be hazardous at high levels of incident power density, and is strictly regulated by an international standard ('IEEE Standard for Safety Levels with Respect to Human Exposure to Radio Frequency Electromagnetic Fields, 3 kHz to 300 GHz,' IEEE C95.1-1991). However, this MIR study will use very low levels of power.
For the broadband frequency range of use for these measurements, 1 to 3 GHz, the maximum permissible exposure (MPE) limit is 3.33 to 10 mW/cm2 respectively. The MPE's refer to exposure values obtained by spatially averaging over an area equivalent to the vertical cross-section of the human body. The MPE refers to values averaged over any 6-minute period for frequencies less than 15 GHz. Within the human presence laboratory, the worst-case exposure level will be 1 uW/cm2, which is 3,333 to 10,000 times smaller than the permitted exposure level. These are very small microwave power densities, and are based on currently published health standards, there is no risk whatsoever associated with direct exposure to these levels of microwave radiation.
For comparison purposes, consider the typical radiated power density in front of a microwave oven when it is operating: 2 mW/cm2 at a distance of 20 cm in front of the oven door. This is 1.67 to 5 times lower than the permissible exposure level, but at least 2000 times stronger than the worst-case exposure level for this project.
Privacy / Confidentiality / Consent
Volunteers will be provided with a consent process and asked to sign an informed consent form. Individual identity and performance data will not be included in any of the test results. Test results will be reported as rates/levels, with no reference to individual performance information. Any reports, additional data, or information pertaining to a specific individual will not contain the individual's identity.
Project Identifier: SNL-96-04
Project Title:
Commuter Aircraft Visual Inspection Reliability
Principal Investigator:
Mr. Floyd W. Spencer
Project started in: 1996
This project ended in Fiscal Year 1997.
Project Funding Information:
Project did not receive funding in Fiscal Year 1997.
Project did not use human subjects in Fiscal Year 1997.
Explanation:
Human subject tasks ended in Sept '96; FY97 work involved only data analysis and followup.
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 1997 (10/1/96 - 9/30/97): 0
Type of Human Subjects Involvement:
The Federal Aviation Administration (FAA) has established the Airworthiness Assurance Nondestructive Inspection Validation Center (AANC) managed by Sandia. The AANC is located in a maintenance hangar facility at 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.
Project Identifier: SNL-96-05
Project Title:
Visual Observer Tests
Principal Investigator:
Mr. Steve Tucker
Project started in: 1996
This project ended in Fiscal Year 1997.
Project Funding Information:
Project received funding in Fiscal Year 1997.
Project used human subjects in Fiscal Year 1997.
Funding Sources:
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 1997 (10/1/96 - 9/30/97): 5
Type of Human Subjects Involvement:
Objective: Determine the ability and efficacy of visual observers to visually detect aircraft in various lighting and meteorological conditions.
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.
Privacy / confidentiality / consent: Volunteers will be provided with information and procedures and asked to sign an informed consent form. Volunteers' identity will be treated as confidential, and no results will give the volunteers' names or other identifiable references to the individuals.
Project Identifier: SNL-97-01
Project Title:
3D Ultrasound Imaging for Diagnostic Imaging. II.
Principal Investigator:
Mr. Charles Q. Little
Project started in: 1997
This project ended in Fiscal Year 1997.
Project Funding Information:
Project received funding in Fiscal Year 1997.
Project used human subjects in Fiscal Year 1997.
Funding Sources:
Project does not involve use of multiple protocols/subprojects.
IRB Review:
Type of Review: Expedited
Most Recent Approval: February 07, 1997
Number of Human Subjects who participated in this project/protocol during
FY 1997 (10/1/96 - 9/30/97): 6
Type of Human Subjects Involvement:
The objective of this study is to create high resolution images from ultrasound data. The methodology uses a commercial ultrasound scanner with an array transducer, such as seen in prenatal ultrasound scanners in an obstetrician's office. The human is subjected to low-level ultrasound, a non-ionizing radiation. Our setup has a water bath tank that allows the human to put one leg in. The water bath contains only the human's leg and a foot rest. The transducer is coupled through a window from outside the tank, along with all mechanical parts to rotate the tank. The scan area is limited to below the knee to above the ankle. A seat and handlebar provide support. The scanning head is rotated around the leg, and data is collected over a 20 minute period. After this, the human subject is done; no other chemicals or procedures are used. Post processing of the data generates the high resolution composite images. The data is presented much like computed tomography (CT) data in that there is data in 3 dimensions. Subjects will be provided with an informed consent process and form, and will be identified only by an 8-character alphanumeric code in order to assure confidentiality.
Project Identifier: SNL-97-05
Project Title:
Sandia's Explosives Detection Portal
Principal Investigator:
Dr. Kevin L. Linker
Project started in: 1997
This project ended in Fiscal Year 1997.
Project Funding Information:
Project received funding in Fiscal Year 1997.
Project used human subjects in Fiscal Year 1997.
Funding Sources:
Project does not involve use of multiple protocols/subprojects.
IRB Review:
Type of Review: Expedited
Most Recent Approval: June 17, 1997
Number of Human Subjects who participated in this project/protocol during
FY 1997 (10/1/96 - 9/30/97): 2,400
Type of Human Subjects Involvement:
The Federal Aviation Administration (FAA) has provided funding to Sandia National Laboratories (SNL) through the Department of Energy (DOE) to support the FAA's program of research and development in explosives detection for airport physical security. SNL has recently completed the design and fabrication of a prototype demonstration portal that uses vertical airflow sampling, large volume preconcentrators and a cross flow ion mobility spectrometer for the analysis and detection of explosives. This system is of interest to the FAA because of the congressional mandate for deploying portals in the near future that can screen personnel for explosives. Currently, there are no commercially available portals that can detect plastic explosives through a non-invasive method and is, therefore, unique in this respect. The final phase of the portal development is an actual field test of the portal with volunteers in the Albuquerque International Airport.
a. Objectives. The intent of the portal test is purely technical to determine the performance limits of the prototype unit. Volunteers will not derive any direct benefit from the test nor will any benefit be derived by any specific group. The FAA is interested in several objectives for field testing this portal. These objectives include: human factors, throughput rate, reliability, environmental background, passenger background, detection capabilities, and recovery rate.
b. Methodology. The method for obtaining the project objectives is to process 2000 volunteers during a two week duration at the Albuquerque International Airport.
c. Human subjects were not exposed to ionizing radiation, radioactive substances, or chemical substances.
d. Involvement of Human Subjects.
1. Test subjects will be passed through the portal on a voluntary basis. Random selectee volunteers will be solicited by hired screening personnel standing in front of the portal. All volunteers will be 18 years or older per Sandia’s Human Studies Board. A generic script might include the following:
Greeting: Excuse me sir/madam. We are conducting a test of a new security device developed for the FAA by Sandia National Laboratories. If you have a moment to spare, would you please consider passing through this portal.
Explanation: This portal screens personnel for the presence of explosives. When you enter the portal, turn to the left and place your feet on the footprints outlined on the floor, with your heels on the red stripe. You will stay in this position for approximately four seconds, and you will feel two sampling air flows: a vertical flow running down from the top of the portal towards your feet, and a horizontal pulse from the nozzles between your lower chest and upper legs. You will be advised when you can exit the portal, and an answer concerning any detection will be obtained within a few seconds.
Appeal: We would like to get your impressions of this device. This information is crucial to the continued improvements being made in airline security.
Visual diagrams will be posted to help explain both the purpose of the portal and the choreography of screened individuals. Since we hope to maintain a short queue of people waiting to go through the portal at many times, it will not be necessary to repeat the above dialogue to every screened person.
2. There are no known risks associated with the explosives detection portal to the general public. There are also no known risks in the test protocol.
3. None of the published results will contain individual performance or identification of any kind. Because of logistics, essentially no risk and voluntary participation, Sandia’s HSB determined that informed consent was impracticable and could be waived in accordance with Federal regulations.
Project Identifier: SNL-97-06
Project Title:
Wall Breaching Tests
Principal Investigator:
Mr. Dave J. Swahlan
Project started in: 1997
Project Funding Information:
Project received funding in Fiscal Year 1997.
Project used human subjects in Fiscal Year 1997.
Funding Sources:
Project does not involve use of multiple protocols/subprojects.
IRB Review:
Type of Review: Expedited
Most Recent Approval: July 10, 1997
Number of Human Subjects who participated in this project/protocol during
FY 1997 (10/1/96 - 9/30/97): 5
Type of Human Subjects Involvement:
This abstract defines the proposed research, including a description of the risks and benefits. The proposed testing will be the breaching of three and four foot thick reinforced concrete walls as targets by the use of explosives and necessary hand/thermal tools. The tests will include an adversary team and an explosives team.
· The adversary team is comprised of volunteers from the Special Operations Command (SOCOM) out of Fort Bragg, North Carolina. Because of the nature of their work, the team itself is comprised strictly of volunteers.
· The explosive handlers will be Sandia explosives experts from the Area III sled track.
The adversary team will consist of trained personnel from the Grizzly Hitch command that will place inert explosive packages on, or in front of, the targets. This activity will be timed. Once the adversary team positions their inert package, the explosives team will remove the inert package and replace it with a live device. Operations with live explosives will not be timed, but they will be performed in accordance with all safety documentation for the use of explosives at the sled track. The explosives team will then detonate the package. If more than one explosive sequence is required, the previous process will be repeated. Once the air clears and the range is declared safe, the adversary team will continue to attack the target with hand/thermal tools until they breach the target. At this point the test will be over.
The foreseen risks involved in these tests are as follows: 1) sharp points/edges from protruding concrete and rebar, 2) airborne dust/dirt particles, 3) hot points/spots from protruding rebar, and 4) medium exertion. Risks will be minimized through the use of protective clothing; gloves, coveralls, hard hats, etc. The members of the Special Forces team are thoroughly trained to perform such tasks as a routine part of their activities.
These tests will benefit any agencies that require vulnerability analysis (e.g. SNL, DOE, DOD) for protection of high value assets. The testing will also benefit the Special Forces team which will receive valuable experience in breaching massive concrete structures.
All volunteers from the DOD Special Forces team will be required to read (and if agreeable) sign the Research Subject Consent Form prior to participating in any of the timed activities. All of the Special Forces activities will be recorded on video tape and with still photos. The volunteers will be given the option of wearing a "ski mask" to protect their identity, if they so choose.
Project Identifier: SNL-97-08
Project Title:
The Effects of a Four-Week Walking Program on the Blood Lipid Profiles
Principal Investigator:
Ms. Raquel Williams
Project started in: 1997
Project Funding Information:
Project received funding in Fiscal Year 1997.
Project used human subjects in Fiscal Year 1997.
Funding Sources:
Project does not involve use of multiple protocols/subprojects.
IRB Review:
Type of Review: Expedited
Most Recent Approval: August 12, 1997
Number of Human Subjects who participated in this project/protocol during
FY 1997 (10/1/96 - 9/30/97): 76
Type of Human Subjects Involvement:
Previous research has demonstrated a positive relationship between coronary artery disease (CAD) and total blood cholesterol. Increased levels of HDL cholesterol and decreased levels of LDL cholesterol have been reported to reduce the risk of developing CAD. Experimental data suggests that aerobic exercise training can increase HDL and reduce total cholesterol levels. However, training intensity and duration of exercise needed to effect these changes has not been clearly defined. Therefore, the purpose of this study was to determine what training intensity level is most effective in reducing total cholesterol and increasing HDL cholesterol for Sandia National Laboratory (SNL) employees.
The study was conducted for 4 weeks at the SNL Security Fitness facility's (Bldg 956) outdoor running track. Pre- and Post-assessment tests were as follows: total blood cholesterol measured by a standard fasting blood chemistry analysis involving actual blood draw of one tube (9ccs) with a needle from a vein in the arm (executed at Medical Bldg 831), and estimated maximal oxygen consumption (VO2 max) determined by the Rockport Walk test. The equation used by Rockport to determine VO2 max uses the following components: age, gender, weight, post exercise heart rate, and one mile completion time.
Subjects were randomly assigned to either 65%, or 75% of their heart rate reserve. The training protocol was performed three times per week: a 10 min warm-up consisting of 1 lap walking, followed by 5 min standardized stretching program; 30 minutes of walking at the required intensity and a 5 min cool-down. The subjects will be instructed on how to monitor their own heart rate. A one-way analysis of variance will be used to determine group differences and the Tukey test will be used to determine where those differences exist. The significance level will be set at p >.05. The predicted results are as follows: (1) total cholesterol will not significantly change for any group; (2) however, HDL cholesterol will significantly increase in the 75% training group; (3) VO2max will significantly increase for both training groups. This data may suggest that training at specific intensity levels will be most effective in increasing HDL cholesterol and VO2max for the SNL employees.
Prior to participation, subjects reviewed and signed the informed consent. This document contained complete detail on protocol, possible risks and confidentiality. The possible risks associated with participation include: shortness of breath, leg and arm fatigue, dizziness and loss of consciousness. The results of the study, including laboratory or any other data, may be published for scientific purposes but will not give the subject's name or any identifiable references.