Mr. Rod Geer
Sandia National Laboratories
Media Relations and Communications
PO Box 5800, MS 0165
Albuquerque, NM 87185-0165
Phone: 505-844-6601
Fax: 505-844-0645
E-mail: wrgeer@sandia.gov
Number of Human Subjects projects reported: 10
"Border Warning/Intrusion Detection System"
Principal Investigator: Mr. Martin W. Sandoval, Sandia National Laboratories
Project started in: 1998
This project ended in fiscal year 2001.
Funding for Human Subjects Research:
This project does not involve the use of multiple protocols/subprojects.
Institutional Review Board (IRB) Review:
Type of Review: Expedited
Approving Institution: Sandia National Laboratories
Most recent approval: 11/20/99
Explanation of IRB approval:
Project was completed before expiration of IRB approval on 11/19/00.
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 3
Reporting period for number of human subjects:
Fiscal Year 2001
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 Sandia's Exterior Sensor Testbed. The boundaries of the detection area will be clearly indicated, and all applicable ES&H operating procedures will be adhered to.
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 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.
"Power and Thermal Tool Testing"
Principal Investigator: Mr. David J. Swahlan, Sandia National Laboratories
Project started in: 1998
This project ended in fiscal year 2001.
Funding for Human Subjects Research:
This project does not involve the use of multiple protocols/subprojects.
Institutional Review Board (IRB) Review:
Type of Review: Expedited
Approving Institution: Sandia National Laboratories
Most recent approval: 11/20/99
IRB approval number: N/A
Explanation of IRB approval:
Project was completed before expiration of IRB approval on 11/16/00.
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 2001
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.
"Genetic Markers for Early Onset Familial Breast Cancer"
Principal Investigator: Dr. Jeffery K. Griffith, University of New Mexico
Project started in: 2000
This project ended in fiscal year 2001.
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
Approving Institution: Sandia National Laboratories
Most recent approval: 05/16/00
IRB approval number: N/A
Explanation of IRB approval:
Study was completed prior to expiration of IRB approval on 5/15/2001.
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 144
Reporting period for number of human subjects:
Fiscal Year 2001
Type(s) of Human Subjects Involvement:
Germline mutations in the BRCA1 gene are responsible for an estimated 5 to 10% of all breast cancers, and a higher proportion of cases in women with a family history of breast cancer. The Hispanic and Nonhispanic white populations of New Mexico provide a unique opportunity to study BRCA1 sequence variations in different racial groups who live in the same geographic area. Reports from other locations indicate that Hispanics in general have a lower frequency of familial breast cancer than Caucasians. A reduction in BRCA1 mutation frequencies in New Mexico Hispanics could contribute to the observed breast cancer rates. To test this hypothesis, genomic DNA from Hispanic women with a familial history of breast cancer was analyzed for BRCA-1 sequence variations by automated DNA sequencing. No mutations were detected in exons comprising 93% of known mutations. Of the nine polymorphic alleles identified, a novel association was observed with the two alleles, 4427T/C and S1613A/G, and women diagnosed with breast cancer before age 45. Women with the T/C-A/G genotype and C/C-G/G genotypes are diagnosed 7.8 years and 10.5 years earlier, respectively, than women with the T/T-A/A genotype (p=0.036). These preliminary data indicate that women with the T/C-A/G and C/C-G/G genotypes are 4.9 times and 7.7 times more likely, respectively, to be diagnosed with breast cancer before age 45 than women with the T/T-A/A genotype (1). We hypothesize that the frequencies of these alleles differs significantly with ethnicity and affects the age of breast cancer onset in Hispanic New Mexican Women.
The objective of this pilot project is to determine whether specific BRCA1 alleles affect the age of breast cancer onset in Hispanic New Mexican Women. The objectives will be accomplished through the following Specific Aims.
· Oral lavage will be optimized as a source of DNA for allele-specific polymerase chain reaction (PCR) analysis of BRCA1 alleles that have been previously linked to age of breast cancer onset.
· A preliminary investigation of the frequencies of the BRCA1 alleles will be performed in Hispanic and Nonhispanic white populations with and without breast cancer.
Experimental Design: There are two phases to the study. In the first phase, we will optimize methods for analyzing the specified BRCA1 mutations using allele specific PCR and DNA obtained by oral lavage with mouthwash. In the second phase of the study, we will compare the frequency and distribution of the specified BRCA1 alleles in Hispanic and Nonhispanic white women with and without past or present breast cancer.
Study Population: Hispanic and Nonhispanic white women with and without past or current breast cancer will be studied. Approximately 240 women (total) will be enrolled into the study. We expect 50 to 100 volunteers from Sandia National Laboratories (SNL).
Tissue Collection: Buccal cells will be collected after oral lavage by mouthwash samples donated at various locations around SNL.
DNA Purification: DNA will be purified from buccal cells using the QIAmp Tissue kit, as described the supplier (Qiagen Corp., Chatsworth, CA). The quantity and quality of the purified DNA will be functionally assessed by agarose gel electrophoresis.
Note: The specimens collected for this study will also be used for SNL0011, which runs concurrently.
This protocol was approved by the UNM Human Research Review Committee (HRRC) on 3/6/2000.
"Genetic Susceptibility to Asthma"
Principal Investigator: Dr. Jeffrey K. Griffith, University of New Mexico
Project started in: 2000
This project ended in fiscal year 2001.
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
Approving Institution: Sandia National Laboratories
Most recent approval: 05/16/00
IRB approval number: N/A
Explanation of IRB approval:
Study was completed prior to expiration of IRB approval on 5/15/2001.
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 218
Reporting period for number of human subjects:
Fiscal Year 2001
Type(s) of Human Subjects Involvement:
Many respiratory diseases, such as asthma and lung cancer, result from complex interactions between substances in the environment (e.g. allergies, radioactive materials, xenobiotics), and the hosts' responses to them (e.g. immune response, DNA repair, detoxifying systems). While geographic, economic, and cultural factors affect individuals' exposure to these substances, there is mounting evidence that individuals' susceptibility to disease is also influenced by allelic variation (polymorphism) in the genes encoding the hosts' responses. This pilot project is based on the hypothesis that the frequency of allelic variation for these genes differs significantly with ethnicity and affects the incidence of respiratory disease in Native American populations.
The primary objective of this pilot project is to demonstrate the feasibility of performing genetic analysis of respiratory disease susceptibility in Native Americans in New Mexico. State-of-the-art molecular technologies for discriminating between allelic variants are currently available through the Center for Genetics in Medicine (CGM) at the University of New Mexico School of Medicine. These analyses can be performed on DNA obtained from minimal quantities of fresh or archival tissue. However, cultural concerns make research with blood or tissue specimens problematic for many Native American communities, which may also distrust, fear or see little benefit in genetic research (1). Issues that must be addressed include fully informed Tribal and IRB review and approval, fully informed individual consent, confidentially and anonymity of data, security and respectful handling of specimens, potential stigmatization, and special cultural values and concerns related to the use of blood and other tissues. The objective will be accomplished through the following Specific Aims.
1. Buccal cells collected after oral lavage will be optimized as a source of DNA for polymerase chain reaction (PCR) analysis of four polymorphic genes that have been previously linked to asthma: the genes encoding IL-4, the a-subunit of the IL-4 receptor, the high affinity IgE receptor and the b-2 adrenergic receptor.
2. Appropriate protocols for the collection, storage, and use of specimens for genetic susceptibility testing will be developed and implemented in cooperation with Jemez Tribal Councils and IRB.
3. A preliminary investigation of the frequencies of the allelic variants of the genes encoding IL-4, the a-subunit of the IL-4 receptor, the high affinity IgE receptor and the b-2 adrenergic receptor will be performed in Native American (Jemez), Hispanic, and Nonhispanic white populations.
Note: This study used the specimens collected for SNL0010. No new specimens were collected for this study.
This protocol was approved by the UNM Human Research Review Committee (HRRC) on 7/21/1999.
"Pedomass Personnel Tracker"
Principal Investigator: Mr. Kurt Wessendorf, Sandia National Laboratories
Project started in: 2000
Funding for Human Subjects Research:
This project does not involve the use of multiple protocols/subprojects.
Institutional Review Board (IRB) Review:
Type of Review: Expedited
Approving Institution: Sandia National Laboratories
Most recent approval: 09/04/01
IRB approval number: N/A
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 4
Reporting period for number of human subjects:
Fiscal Year 2001
Type(s) of Human Subjects Involvement:
There are a variety of applications for a small, portable, self-contained system that can measure and record personnel movement. The goal is to develop a sensor suite, algorithms, computational hardware, and memory storage to implement such a system. The initial concept is to use an accelerometer to determine movement (which might be used like a pedometer to count steps as a person walks) and a compass to determine direction. Then by counting steps and knowing direction, one could tell how far and where an individual went. Memory would be included to store this information for later download (e.g., to a personal computer).
This project proposes using human subjects to walk around typical SNL work areas with small, lightweight sensor packages to provide data required for the development and implementation of this device. Data will be collected on human locomotion and algorithms will be developed to allow conversion of the sensor data into distance and direction information.
The benefits of this activity are that it develops a new capability that has a high level of interest from several customer groups. Physical risks to human subject participants are minimal and the activities are not out of the ordinary (walking).
Phase I
To obtain initial data, human subjects will walk within a lab room carrying small (<1lb.) sensor packages. Sensor data will be recorded via an umbilical cord to standard lab equipment. (The umbilical cord is a multi-strand small gauge wire bundle weighing only a couple pounds and about 20 feet long.) Sensor packages and wiring will be insulated to shield subject from the power supply, and cord will be held up off floor and will be kept from being a tripping hazard via careful handling. All system voltages used are to be 5 V or less. Sensors include an accelerometer and an electronic compass, and data will be used to establish baseline sensor patterns of typical human locomotion, in particular walking. Baseline data will be used to develop micro-controller software algorithms to interpret later sensor data. Subjects will walk for a few seconds at a time over distances of approximately 15 feet. This activity will be limited to walking around the lab space and hallways.
Phase II
Phase II development will include a fully self-contained sensor/computer package. This will be a battery-powered, small (~fanny pack size) unit worn by subject in a fanny-pack type pouch or carried in a briefcase. Subjects will walk around various areas (e.g., within buildings, outside, and around Tech Area I, weather permitting) for periods of an hour or less. System memory will then be downloaded and a map of the subject's travels made. The battery pack will be sealed and insulated from the wearer by using plastic containment boxes.
Phase III
Future enhancements might include the inclusion of additional sensors (such as auditory, chemical, etc.) to the sensor suite. Also additional miniaturization will occur to eventually reduce the system to a size of the order of a pager.
Physical risks to the human subject participants are minimal. Electrical power applied to the sensors is low (<5 volts, and the current in the insulated umbilical cord, and the portable battery device is in the low millampere range), so that there is minimal shock hazard. The device to be carried or attached to subject is light weight (<3 lbs.), so there is no danger from the stress of transporting heavy objects. The system would be contained in something like a fanny pack or smaller, and thus there is no mechanical pinch or other danger to the subjects. The proposed activities are routine for the subject population (i.e., walking through typical pedestrian traffic areas), so no additional risk is imposed on the participants. The potential enhancements via additional sensors will pose no additional risk as they will be non-hazardous in form and function.
"Facial Verification System Evaluation"
Principal Investigator: Mr. Larry J. Wright, Sandia National Laboratories
Project started in: 2000
Funding for Human Subjects Research:
This project does not involve the use of multiple protocols/subprojects.
Institutional Review Board (IRB) Review:
Type of Review: Expedited
Approving Institution: Sandia National Laboratories
Most recent approval: 08/08/01
IRB approval number: N/A
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 45
Reporting period for number of human subjects:
Fiscal Year 2001
Type(s) of Human Subjects Involvement:
Facial verification systems use distinguishing characteristics of the face to verify a person's identity in automated entry control applications. 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.
Although facial systems have been proposed and studied for a number of years, commercial systems have only been available for the last few years. Developers have had to overcome two difficult problems: (1) wide variations in the presentation of the face (head tilt and rotation, presence or absence of glasses, facial hair changes, facial expression changes, etc.) and (2) lighting variations (day vs. night, location A vs. location B, etc.).
The purpose of the test is to determine the performance of the Lau Technologies Portal, a commercial face verification system configured for physical access control. Performance will be characterized in terms of false reject rate, false accept rate, and enrollment and verification times. In addition, user acceptance of the device will be measured by administering a survey to the test participants. Other important characteristics to be observed during the test include ease of setup, resistance to spoofing (attempts to defeat the system), template storage requirements, and system cost. As configured for the test, the system consists of a face terminal, a processor/controller for the portal, and controlled lighting.
Test subjects will be recruited from employees and contractors of Sandia. Although there are no inclusion/exclusion criteria, recruitment of subjects will be limited to a convenience sample of personnel who work in building 821 or regularly travel through that facility. Subjects will be recruited by posted announcement. If this fails to achieve the target sample size of 50-100 people, additional subjects will be recruited through e-mail (to building 821 occupants) using an electronic copy of the IRB-approved posted announcement. If needed, an announcement will be made in the Sandia Daily News using an abbreviated version of the posted announcement.
Subject participation is voluntary, and there will be no implicit or explicit coercion. Also, there will be no financial compensation for participating in the study. There are no known health or personal safety risks associated with use of the facial verification system.
The activities involved in this study are similar to using an automated teller machine. Test subjects will be asked to read a three-page Informed Consent form, ask any questions they might have regarding the study, then sign the form acknowledging that they understand the information and are participating freely.
Positive measures will be taken to protect the privacy of subjects and the confidentiality of the data. Only test project personnel will have access to information that ties image and performance data to particular test subjects, and computer database files will be password protected. The results of the study, may be published for scientific purposes, but such results will be limited to summary data only and will not provide name, picture, or any identifiable references to subjects. However, any records or data obtained in this study may be inspected by the sponsor, by any relevant governmental agency (e.g., DOE), by the Sandia Human Studies Board, or by the persons conducting this study, provided that such inspectors are legally obligated to protect any identifiable information from public disclosure, except as otherwise authorized or required by law.
Participants will be asked to provide their height and whether or not they wear glasses. This participation is required to understand how these factors might impact the performance of the system.
The identity of test subjects in the study will be protected. Only test project personnel will have access to information that ties image and performance data to particular test subjects. Computer database files will be password protected. The database record for the test subject includes name, ID card number, phone number, date enrolled, expiration date (of access), and comments (e.g., height, whether glasses are worn). Once a record has been activated, the test subject's face is enrolled.
Once a person has been enrolled, verification is as follows:
1. Test subjects stand in front of the face terminal and present an ID card to the proximity reader to identify themselves to start the ID verification process. The proximity ID card is used in lieu of a personal identification number (PIN). A mark on the floor will provide a suggested standing location for reliable image capture.
2. The system captures a picture after the ID card read, extracts necessary features, and compares them with the stored template. A match would allow the access request to be honored.
Verification time will be determined during the evaluation. Image capture is passive. The system provides lighting for proper facial illumination during image capture. The proximity card reader emits a low power electric field to activate and read the ID card.
Note: The original PI for this project was Timothy Buckle, who has since left Sandia. He was succeeded by Larry Wright.
"Computer Architecture for Telemedicine Health Care Delivery Systems"
Principal Investigator: Mr. Richard Craft, Sandia National Laboratories
Project started in: 2000
This project ended in fiscal year 2001.
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
Approving Institution: Sandia National Laboratories
Most recent approval: 08/16/00
IRB approval number: N/A
Explanation of IRB approval:
Study was closed on the expiration of IRB approval (8/15/01).
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 2001
Type(s) of Human Subjects Involvement:
Telemedicine has the potential to improve both the quality and accessibility of health care with its ability to deliver access to needed care "anywhere, anytime." However, before this promise can be realized, certain barriers must be overcome, including device incompatibilities, high system costs, and patient data security and privacy issues in an Internet-enabled world.
Commercial telemedicine systems are increasingly functional, incorporating diagnostic and therapeutic peripherals, video-conferencing, patient education, medication reminders, and a host of other services. However, current systems typically do not address interoperability and security issues, due to factors such as limited use and closed system designs.
Sandia began the development of a Telemedicine Reference Architecture to address both hardware and software compatibility and standardization issues. SNL is currently working to define the architectural interfaces between each of six service areas and the "Backplane," a collection of hardware and software building blocks that allow the various elements within a telemedicine device to interact with one another.
The goal of the architecture is to standardize the interfaces, allowing needed plug-and-play mechanisms and distributed operations to be built into system elements. This should significantly improve the cost effectiveness and improve the quality and security of telemedicine devices and systems.
In its initial phase, the telemedicine system will collect a simple suite of measurements as needed for demonstration purposes in discussions to be held with NATO and the DoD. Measurements to be taken include heart and lung sounds, blood pressure, body temperature, pulse rate, blood oxygen saturation level, weight, and EKG data. These data will be collected using a telemedicine system capability (commercial medical instruments integrated with a commercial PC) developed by Sandia and will not require any special preparation, such as fasting, on the part of the subjects. All physiological data collected will be associated to fictitious names and demographic information, and no personally identifiable information will be associated in the database with any subject.
The subject pool includes male and female adults between the ages of 18 and 75 years old. Subjects will constitute a convenience sample recruited primarily out of Centers 6200 and 6500, who are Sandia personnel working on this project and will be in good general health (as self-identified) and have no physical disabilities that would increase risk of harm. Subjects have no medical/clinical training, and will be recruited verbally for all three phases.
The initial suite of medical instruments used to collect data for this project will consist of non-invasive monitors of various sorts designed for use with a computer, none of which delivers any significant level of radiation and all of which are FDA-approved. The risks the potential for harm/discomfort is less than or equal to daily life or the performance of routine physical or psychological exams/tests.
There is no financial compensation to subjects for participation in this research project. There is no personal benefit other than humanitarian (the satisfaction of knowing that you are helping to develop a set of standards that could increase accessibility and lower cost of health care to the public at large).
"Performance Evaluation of Biometric Verification Systems"
Principal Investigator: Mr. Larry Wright, Sandia National Laboratories
Project started in: 2001
Funding for Human Subjects Research:
This project does not involve the use of multiple protocols/subprojects.
Institutional Review Board (IRB) Review:
Type of Review: Expedited
Approving Institution: Sandia National Laboratories
Most recent approval: 12/19/00
IRB approval number: N/A
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 65
Reporting period for number of human subjects:
Fiscal Year 2001
Type(s) of Human Subjects Involvement:
Objectives: The objective of this research is to determine the performance characteristics of three biometric verification systems based on iris recognition, hand geometry, and voice recognition.
Methodology: Test subjects will be enrolled on the system and then asked to make two to three verification attempts each day for approximately five weeks. After the verification-testing phase is completed, each subject will be asked to attempt to verify (as an imposter) against the other templates in the system.
No ionizing radiation, radioactive substances, or chemical substances are involved in this study.
Involvement of human subjects: See Methodology section
Privacy considerations: All subjects are enrolled on each system by identification number only. The list associating ID numbers with names is treated as Unclassified Controlled Information (UCI) and only project personnel have access to the list.
Risks to subjects were minimal.
"An Exploratory Study of Uranium and Thorium Isotopic Detection by ICP-MS and Its Applications"
Principal Investigator: Dr. Amir H. Mohagheghi, Sandia National Laboratories
Project started in: 2001
Funding for Human Subjects Research:
This project does not involve the use of multiple protocols/subprojects.
Institutional Review Board (IRB) Review:
Type of Review: Expedited
Approving Institution: Sandia National Laboratories
Most recent approval: 06/26/01
IRB approval number: N/A
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 100
Reporting period for number of human subjects:
Fiscal Year 2001
Type(s) of Human Subjects Involvement:
Uranium and thorium are naturally occurring isotopes to which people are exposed daily through the water they drink and the food they eat. Sandia National Laboratories (SNL) currently collects urine bioassay samples to monitor individuals for possible exposure to total uranium and thorium as part of ongoing medical surveillance of employees. However, there are several areas where this monitoring can be improved. In case of accidents or exposure to people who are not routinely monitored, the optimum window for collecting urine samples may be missed. In addition, background levels vary significantly from one person to the next and also change for the same individual over time. This is caused by variations in food and drink, metabolism, physical activity, illness, and age among many other factors. Establishing comprehensive background distributions that take into account all the important parameters is a massive task and is beyond the scope of this study. However, even a limited knowledge of background variations will be a valuable aid in determining actions levels for follow up studies.
A new analytical method in isotopic detection is developed by employing an Inductively Coupled Plasma Mass Spectrometer (ICP-MS), which allows for more accurate and distinct data retrieval on individual isotopes. Using the ICP method, this study proposes to:
· establish the accuracy of the U-235 to U-238 isotopic ratio measurement in real bioassay samples (determination of exposure source),
· investigate the use of hair for exposure monitoring (in lieu of urine),
· determine a preliminary background distribution of U-235, U-236, U-238, and Th-232 isotopes in hair, urine, and typical drinking water (an exploratory understanding of the nature of the statistics governing the background variation), and
· investigate the existence of any correlation for each isotope between the three sample types.
Three specimens will be collected from each participant: hair, urine, and typical drinking water. Each subject will receive a sample kit containing: two 80ml plastic bottles, one for urine collection and one for drinking water collection; a small plastic bag for hair collection ; and instructions on collecting and returning specimens. Subjects will also receive verbal instructions. Participants will be expected to return urine and water samples as soon as possible (within three days) to maintain sample integrity. Hair samples are expected to be returned within four weeks to accommodate different collection circumstances (i.e., waiting for a hair cut or gathering enough hair in hairbrush). Participants will not be given any kind of radioactive or non-radioactive material for internal or external use in or on the body.
No other information will be collected from any subject, participants will not be asked to use more than one kit.
There is no physical risk to participants, and other risks are no greater than an average person encounters when donating a specimen for a standard, non-invasive bioassay.
The primary benefits are the option of viewing summary results on the SNL internal web site, and the satisfaction of helping to establish a new method of monitoring potential exposure to uranium 235/238 and thorium 232. There is no financial compensation for participation.
"Adaptive Awareness for Personal and Small Group Decision Making"
Principal Investigator: Dr. Carmen M. Pancerella, Sandia National Laboratories
Project started in: 2001
Funding for Human Subjects Research:
This project does not involve the use of multiple protocols/subprojects.
Institutional Review Board (IRB) Review:
Type of Review: Expedited
Approving Institution: Sandia National Laboratories
Most recent approval: 09/05/01
IRB approval number: N/A
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 7
Reporting period for number of human subjects:
Fiscal Year 2001
Type(s) of Human Subjects Involvement:
Objectives:
Many situations call for the use of sensors to monitor physiological and environmental data. In these situations, it is beneficial to have intelligent agents analyze the large amounts of sensor data, recognize cues from the data, and communicate the results to humans and other computers. This project will pilot an awareness and warning tool, comprised of heterogeneous sensors, small light-weight processors, embedded intelligent software, and a wireless network connecting these processors and computers. This tool has broad applicability to emergency teams, military squads, individual exercise and fitness monitoring, health monitor for sick and elderly, and environmental monitoring in public places.
Methodology:
To realize this tool, researchers propose to develop a sensor-independent architecture for integrating self-awareness information across a distributed team (e.g. military squads, approximately 10 soldiers working together in a relatively small geographical distance) and the design approaches, concepts, and software agents for a tool that supports squad-level decision making.
Involvement of Human Subjects:
Actual testing of the system with humans will be limited to ensuring that the sensor is functioning correctly. All intelligent algorithm training and testing will be done with simulated data. As such, the time that the sensor will be attached to subjects will be short, perhaps 5 minutes or less, as required for the software/hardware development and testing. The subject will attach the sensor as required to determine that the sensor interface is correctly transmitting the data. However, no personally identifiable information will be collected on any subject. Actual personal sensor data will not be archived in the system.
The risks associated with this study are minimal (no greater than those encountered in daily life).