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: 8
Project Identifier: SNL-97-06
Project Title:
Advanced Attack Methods (formerly Wall Breaching Tests)
Principal Investigator:
Mr. Edward J. Schaub
Project started in: 1997
This project ended in Fiscal Year 1998.
Project Funding Information:
Project received funding in Fiscal Year 1998.
Project used human subjects in Fiscal Year 1998.
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 1998 (10/1/97 - 9/30/98): 4
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
This project ended in Fiscal Year 1998.
Project Funding Information:
Project received funding in Fiscal Year 1998.
Project did not use human subjects in Fiscal Year 1998.
Explanation:
During FY 98 no new subjects were enrolled, data analysis only
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 1998 (10/1/97 - 9/30/98): 37
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) VO2 max 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.
Project Identifier: SNL-98-01
Project Title:
Border Warning/Intrusion Detection Radar
Principal Investigator:
Mr. Martin W. Sandoval
Project started in: 1998
Project Funding Information:
Project received funding in Fiscal Year 1998.
Project did not use human subjects in Fiscal Year 1998.
Explanation:
Project was behind schedule, no human enrollment occurred
Funding Sources:
Project does not involve use of multiple protocols/subprojects.
IRB Review:
Type of Review: Expedited
Most Recent Approval: November 13, 1997
Number of Human Subjects who participated in this project/protocol during
FY 1998 (10/1/97 - 9/30/98): 0
Type of Human Subjects Involvement:
Project Purpose: The purpose of the Border Warning Radar Detection Project tests are 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. Sandia has been tasked to test and evaluate the radar detection/video assessment system. 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.
Methodology: This portable radar and automatic assessment system will be temporarily set up in an open field in the Northwest corner of Sandia's Exterior Sensor Testbed. The boundaries of the detection area will be clearly indicated with appropriate signs and markers. Operating procedures established in conjunction with ES&H requirements and the SNL Industrial Hygiene Department will be adhered to.
The subject will be directed to advance towards the detector from a given point, at different speeds and approaches. The radar detector should be capable of detecting the intruder once within the detection envelope and automatically provide appropriate assessment capability to the operator.
Human Subject Testing: Sandia volunteers (subjects) with approval of the SNL Human Studies Board 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 that the 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, etc. Human subjects are necessary for this test because this system depends both on the radar cross section and motion of the intruder for detection. It would not be practical to build human robots that would have the same radar characteristics and motions to conduct these types of tests. The purpose of this study is not to determine how detection depends upon various human attributes across a "population" of human subjects. Identification information is recorded by the principal investigator in such a manner that the subjects cannot be identified, either directly or through identifiers linked to the subjects. For the purposes of 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 the subject was detected or not.
Safety Concerns: 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 has been established by SNL Industrial Hygiene Department to comply with ANSI/IEEE C95.1-1991. The nighttime IR illuminator has been designed for minimal laser power output. 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.
Risks and Benefits: 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. Consent forms will be available to sign after reviewing the operating procedure established for this project.
Project Identifier: SNL-98-02
Project Title:
Access Delay Technology Base Support
Principal Investigator:
Mr. Dave Swahlan
Project started in: 1998
Project Funding Information:
Project received funding in Fiscal Year 1998.
Project used human subjects in Fiscal Year 1998.
Funding Sources:
Project does not involve use of multiple protocols/subprojects.
IRB Review:
Type of Review: Expedited
Most Recent Approval: January 12, 1998
Number of Human Subjects who participated in this project/protocol during
FY 1998 (10/1/97 - 9/30/98): 2
Type 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 testing operation that will allow testing and evaluation of new tools and techniques as they appear on the commercial market or as they are raised by security analysts. The project will support the identification, selection, evaluation and testing of any applicable commercial tools available, but will focus on the fire/rescue, mining, and construction industries. A standard series of target materials will be defined to ensure valid comparisons of tools and cutting rates both now and in the future. It is anticipated that two or three new tools can be tested in any given year. Over a four or five year period enough data will be obtained to update a significant portion of the Access Delay Technology Transfer Manual with current, relevant, tool descriptions and rate data.
No test subjects will be exposed to ionizing radiation or radioactive or chemical substances.
All phases of testing will involve minimum risk because the participants will be well trained in the use of the equipment being tested. The minimal hazards involved (dust, heat, loud noises) are similar to those encountered in using common portable tools. Participants will be provided with, and required to use, appropriate safety equipment during the training and testing.
The results of the study may be published for scientific purposes but will not give individuals' names. Subjects will be photographed and/or videotaped during the testing activities, so individuals might be identifiable by photographs or videotapes, but this has been clearly explained to volunteers.
Project Identifier: SNL-98-03
Project Title:
Hepatitis C Research Study
Principal Investigator:
Mr. Alan Zelicoff
Project started in: 1998
Project Funding Information:
Project received funding in Fiscal Year 1998.
Project used human subjects in Fiscal Year 1998.
Funding Sources:
Project does not involve use of multiple protocols/subprojects.
IRB Review:
Type of Review: Expedited
Most Recent Approval: February 11, 1998
Number of Human Subjects who participated in this project/protocol during
FY 1998 (10/1/97 - 9/30/98): 1,000
Type of Human Subjects Involvement:
The Biological and Toxin Weapons Convention (BTWC) is an international agreement prohibiting the stockpiling of biological materials for hostile purposes. The Convention entered into force in 1975 without a monitoring regime. States Parties to the Convention have recognized that violations have occurred; hence, there has been considerable political pressure to establish a monitoring regime to enhance compliance. Yet, the difficulties inherent in monitoring such a treaty are recognized widely.
In 1995, with the full participation of the United States, the Parties to the Convention agreed to begin work on a legally binding regime to strengthen the BTWC. There are three essential political demands that must be addressed by this regime: (1) enhanced deterrence to proliferation among States Parties; (2) substantive progress on sharing of biotechnology among signatories to the Protocol; and (3) cost-effectiveness.
One measure under consideration is the reporting of disease outbreaks. Such a measure would address both of the political requirements for a protocol by increasing the likelihood that experiments or accidents involving dangerous biologicals would be detected while at the same time adding to world-wide knowledge of emerging diseases including information relevant to the mitigation of disease outbreaks. The vast majority of disease outbreaks would have no association with biological weapons development; nonetheless, the practice of epidemiologic surveillance is cost-effective and highly sensitive to disease outbreaks. Thus, a protocol incorporating disease monitoring would provide incentives to all States Parties to join the putative BTWC protocol.
The Cooperative Epidemiology and Disease Monitoring (CEMD) Project was envisioned to test the hypothesis that non-specialist physicians operating in disparate cultures in widely separated rural regions could contribute to the knowledge of poorly understood, novel disease, in this case Hepatitis C. This disease, while arguably of absolutely no significance to biological weapons proliferation, is a newly emerging public health problem of enormous importance to physicians and government officials in Russia and the United States, as well as other countries. Russia and the US have a long and bitter history of accusation and counter-accusation of violation of the BTWC. Thus, CEMD seeks to evaluate the utility of epidemiologic monitoring in these two countries to serve as model for a similar measure now under consideration in the formal negotiations on the legally binding regime in Geneva.
CEMD is sponsored by the US Department of Energy, under the Office of the Assistant Secretary for National Security and Non-Proliferation. The project has the following specific goals:
· Organizing physicians in rural New Mexico hospitals and the hospital at the Russian closed city of Chelyabinsk-70 (Snezinsk) to perform a high-quality, randomized epidemiology study of the prevalence and risk factors for Hepatitis C virus among healthy members of the population. Approximately 4000 patients (2000 on each side) will be surveyed using a jointly developed survey instrument, along with advice of Hepatitis C experts at the World Health Organization and the University of New Mexico School of Medicine.
· Exchanging data in a completely transparent manner using web-based INTERNET tools.
· Resolving problems and analyzing data by use of INTERNET tools, including videoconferencing and other better known modalities (e-mail, file transfer).
· Producing a joint-authored paper on the results of the study.
· Providing a briefing on the study design, results, and future work to the plenary of negotiators in Geneva who are currently considering measures to strengthen the BTWC under the Protocol as described above.
To date (10/16/98), approximately 1000 patients (700 from US Hospitals in Alamagordo, Los Alamos and Silver City in NM, 300 from Snezinsk) have entered into the study. Laboratory technicians in Snezinsk have analyzed blood for presence of Hepatitis C antibody, and the NM Department of Health's State Laboratory Division (SLD) has performed the same analysis on NM patients' samples. The physicians at all four hospitals have met using a multi-point internet videoconferencing tool (CuSeeMe), and have discussed mutual concerns and problems which have been resolved based on the experience of physicians in each of the four centers.
Data is entered to a web site (www.cmc.sandia.gov/HEP_C) at Sandia's Cooperative Monitoring Center by staff at each participating hospital. This data is immediately made available to participants. As adequate numbers of patients' data become available, statistical analysis of results will proceed on both sides, with comparison of results during weekly vidoeconference meetings among all physicians and nurses.
The project should be complete by December 1998, owing in part to some delays in Russian customs for transfer of Hepatitis C analytic equipment to Russian physicians in Snezinsk.
Project Identifier: SNL-98-04
Project Title:
Performance Evaluation of the DKL Model 2.0 Lifeguard
Principal Investigator:
Mr. Dale W. Murray
Project started in: 1998
This project ended in Fiscal Year 1998.
Project Funding Information:
Project received funding in Fiscal Year 1998.
Project used human subjects in Fiscal Year 1998.
Funding Sources:
Project does not involve use of multiple protocols/subprojects.
IRB Review:
Type of Review: Expedited
Most Recent Approval: March 06, 1998
Number of Human Subjects who participated in this project/protocol during
FY 1998 (10/1/97 - 9/30/98): 1
Type of Human Subjects Involvement:
Sandia National Laboratories was asked by the DOE Office of Safeguards and Security, NN-51, to perform a basic evaluation of the DKL LifeGuard (Model 2) from DielectroKinetic Laboratories, LLC (DKL) human presence detector and tracker. This device has been advertised by the manufacturer to be capable of detecting living human beings at distances of up to 500 meters through any material. The existence of such a device could be a tremendous help in the areas of search and rescue, law enforcement, and security. Needless to say, the announcement of such a device has gained attention in government circles. The question posed to Sandia was simply: Does the device work?
To begin the trial, the Test Operations Manager (TOM) escorts everyone present except the Test Target and the Test Set-up Manager (TSM) into the instrument trailer. The TSM uses a sealed, random test schedule, provided for this test, to direct the target to a specific crate to occupy. When the target is placed, the TSM checks carefully to see that no indication is present of the set up. The TSM then knocks on the instrument trailer door, invites all inside to step outside, and then the TSM enters the trailer and does not observe the outcome of the trial.
The operator then uses the DKL device to determine which crate contains the target. The Test Recorder notes which crate was indicated by the DKL operator, using the form provided to note results. The TOM verifies that the test proceeds appropriately, and then he escorts the same group back to the instrument trailer for the next trial. The TOM leaves the instrument trailer as the others enter, without being informed of the test results and proceeds to set up the next trial.
No ionizing radiation, or radioactive or chemical substances were used in the test. The only risks associated with this test were the normal risks associated with outdoor activity in New Mexico. The only information that could be potentially gained about the target would be his location (presence) during the course of the test. This testing is very similar to tests of passive infrared motion sensors that are routinely performed by this center. Nothing about the individual that could identify him as the test target could be learned from the trial, and no medical or personal information was collected. The individuals who participated in this test were all volunteers who were briefed in the nature of the information that could be gained by the testing and risks associated with the activity.
Project Identifier: SNL-98-07
Project Title:
Development and Evaluation of a Stress-Based Health Promotion Model in an Organizational Setting Using Structural Equation Modeling
Principal Investigator:
Ms. Judy Boswell
Project started in: 1998
This project ended in Fiscal Year 1998.
Project Funding Information:
Project received funding in Fiscal Year 1998.
Project used human subjects in Fiscal Year 1998.
Funding Sources:
Amount reflects payment for questionnaires
Project does not involve use of multiple protocols/subprojects.
IRB Review:
Type of Review: Expedited
Most Recent Approval: June 04, 1998
Number of Human Subjects who participated in this project/protocol during
FY 1998 (10/1/97 - 9/30/98): 297
Type of Human Subjects Involvement:
The purpose of the proposed research will be to develop and evaluate two competing stress-based health promotion models hypothesizing the relationships between organizational stress, individual strain and coping resources and individual performance and the number of sick days taken in the past six months in an occupational setting.
Objectives of the proposed research include: 1) construct two structural equation models, (SEM) Model 1 hypothesizing the relationships between occupational stress and strain, and their relationships to individual performance and number of sick days taken by the participant in the past six months and Model 2 identical to Model 1 with the addition of a coping resource variable; 2) test the extent to which the measured variables for each factor in Model 1 and Model 2 actually measure what they are intended to measure using confirmatory factor analysis (CFA); 3) compare the results of the CFA on the occupational stress factor and the strain factor in Model 1 to the results of the CFA on the same factors in the Occupational Stress Inventory; 4) using SEM, examine the degree and nature of relationships between variables in Model 1 and Model 2 using sample data from Sandia National Laboratories; and 5) evaluate the goodness of fit (GOF) of Model 1 and Model 2 using GOF indices.
Potential participants will be randomly selected from the population of individuals employed by Sandia National Laboratories in Albuquerque, NM, and invited, via cover letter and informed consent, to complete the 140-item Occupational Stress Inventory (OSI) (Osipow & Spokane, 1992). Waves of letters/packets will be generated every two weeks until 350 participants have agreed to participate in the study. Additionally, with the written consent of the participant, the researcher will obtain the number of sick days taken by the participant in the past six months, and the participant's last performance rating.
Packets inviting participation will include a pre-addressed UCI envelope for return of the completed questionnaire and consent form to ensure confidentiality. The researcher will mail a copy of the signed consent form back to the participant via interoffice mail in a UCI envelope.
Data will be analyzed using descriptive statistics to describe the population and response rates, confirmatory factor analysis to assess how well each of the measured variables describes each latent variable, and structural equation modeling to describe the nature and degree of relationships between occupational stress and strain, sick days and performance, with and without a coping variable.
Minimal or no adverse risks are associated with the collection of this confidential data. However, as with any self-reflection activity, uncomfortable feelings may arise. The participant is free to stop participation in the study at any time, and may write concerns or questions on the back of the questionnaire or contact the researcher via the phone number provided in the cover letter. The researcher will respond to all comments or questions upon receipt of the questionnaire. No promises are made to the participant that any benefits will be obtained from participating in the research. However, participation in the research will be valuable in defining which stress-based health promotion model would be the best as far as planning stress management programs and interventions in an occupational setting.
Data collected for this project will be kept on file in a locked file cabinet in the office of the researcher for three years.