Ms. Kathy L. Delucas
Los Alamos National Laboratory
Public Affairs Office (PA)
P. O. Box 1663, MS C177
Los Alamos, NM 87544
Phone: 505-667-1455
Fax: 505-665-3910
E-mail: duke@lanl.gov
Number of Human Subjects projects reported: 24
"Manhattan Project Plutonium Workers Health Study"
Principal Investigator: Dr. Hugh N. Smith, Los Alamos National Laboratory
Project started in: 1952
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: Full Board
Approving Institution: Los Alamos National Laboratory
Most recent approval: 01/22/01
IRB approval number: LANL 91-06
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:
MANHATTAN PROJECT PLUTONIUM WORKERS HEALTH STUDY
Twenty-six white male workers, who did the original plutonium research and development work on Manhattan Engineer's Project Y (Los Alamos) in 1944-1945, have been examined periodically since 1952. Their effective doses, as of 1996, range from 0.11 to 7.2 Sv; the median effective dose is 1.3 Sv. The study objective is to identify possible health effects due to internal plutonium depositions. The principal study methods include comprehensive medical examinations, sputum cytology, urinalysis for plutonium content, and in vivo lung counts. Cytogenetic studies were also performed at 27, 32, and 47 years after exposure. Risks to these volunteers are minimal; they include transportation risks during their return to Los Alamos, medical diagnostic x-rays, and collection of blood samples. Medical records are retained in storage cabinets in a locked room. Each volunteer has read and signed a study permit form approved by the LANL IRB/HSR. The last complete examinations were done in 1966-97. Nineteen of the 26 workers were alive at that time; their median age was 74. The types and number of malignancies recorded in living and deceased subjects include cancers (4), lung (4), bone, colon, bladder, and skin (malignant melanoma). Two individuals were diagnosed with two separate malignancies each. All four individuals with lung cancer were moderate to heavy cigarette smokers throughout much of their adulthood. Since 1997, annual questionnaires have been sent to each participant to confirm addresses and telephone numbers, and to obtain self-reported major health developments.
Conclusion: This study of workers exposed to plutonium, above and below current radiation protective standards, documents their long-term health histories. The data has consistently shown that the mortality rates for all causes of deaths and for all cancers are not elevated, compared with either U.S. white males or unexposed Los Alamos male workers with comparable hire dates. This information may be useful in assessing individual risks after plutonium exposure and to help counsel workers after future plutonium exposures.
LA-UR - 01-5609
Los Alamos National Laboratory, an affirmative action/equal opportunity employer, is operated by the University of California for the U. S. Department of energy under contract W-7405-ENG-36. By acceptance of this article, the publisher recognized that the U. S. Government retains a nonexclusive, royalty-free license to publish or reproduce the published form of this contribution, or to allow others to do so, for U. S. Government purposes. Los Alamos National Laboratory requests that the publisher identify this article as work performed under the auspices of the U. S. Department of Energy. Los Alamos National Laboratory strongly supports academic freedom and a researcher's right to publish; as an institution, however, the Laboratory does not endorse the viewpoint of a publication or guarantee its technical correctness.
"Acceptance Testing for Air-Line Supplied Air-Suits"
Principal Investigator: Mr. Michael T. Brandt, Los Alamos National Laboratory
Project started in: 1976
Funding for Human Subjects Research:
This project does not involve the use of multiple protocols/subprojects.
Institutional Review Board (IRB) Review:
Type of Review: Full Board
Approving Institution: Los Alamos National Laboratory
Most recent approval: 01/22/01
IRB approval number: LANL 90-07
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 12
Reporting period for number of human subjects:
Fiscal Year 2001
Type(s) of Human Subjects Involvement:
ACCEPTANCE TESTING FOR AIR-LINE SUPPLIED-AIR SUITS
OBJECTIVES: This program primarily provides testing of air-supplied suites used to protect workers in environments containing plutonium and tritium. It is conducted at Los Alamos because air-supplied suits are not eligible for National Institute of Occupational Safety and Health (NIOSH) testing and certification. The program has been operational since 1974. Suites will continue to be retested to ensure that the continued quality and performance of theses suites is maintained.
METHODOLOGY: Air-supplied suit testing is conducted in accordance with "Acceptance Testing Procedures for Air-Line Supplied-Air Suit", Los Alamos report LA-10156-MS, June 1984.
EXPOSURE TO CHEMICALS: Subjects may be exposed to diethylhexylsebecate (DEHS) up to but not to exceed 10% of the chamber concentration. Individuals sensitive to DEHS may experience mild skin and eye irritation. Subjects may be exposed to elevated levels of carbon dioxide in the suites: these levels are not allowed to exceed 5%.
INVOLVEMENT OF HUMAN TEST SUBJECTS: Testing consists of having the test subjects don a suit and enter a chamber that contains an aerosol environment and measuring the amount of aerosol that penetrates into the suit. The test subjects conduct moderate stress exercises while in the chamber to simulate movements of workers using the suit at DOE sites. Another test involves turning the air supply to the suit off while the test subjects are running in-place and monitoring oxygen and carbon dioxide levels in the breathing zones of the test subjects. The air supply is turned on when the oxygen level in the suit reaches 16%.
All records of the testing are kept confidential. Reports on test results do not contain the identity of test subjects. All tests subjects are briefed on the testing, their rights as test subjects, the consent form is read and signed, and all questions are answered before testing begins.
LA-UR - 01-5589
Los Alamos National Laboratory, an affirmative action/equal opportunity employer, is operated by the University of California for the U. S. Department of energy under contract W-7405-ENG-36. By acceptance of this article, the publisher recognized that the U. S. Government retains a nonexclusive, royalty-free license to publish or reproduce the published form of this contribution, or to allow others to do so, for U. S. Government purposes. Los Alamos National Laboratory requests that the publisher identify this article as work performed under the auspices of the U. S. Department of Energy. Los Alamos National Laboratory strongly supports academic freedom and a researcher's right to publish; as an institution, however, the Laboratory does not endorse the viewpoint of a publication or guarantee its technical correctness.
"Ligand-Receptor G Protein Dynamics and Neutrophil Response"
Principal Investigator: Dr. Larry A. Sklar, Univ. of New Mexico, Collaboration with LANL
Project started in: 1991
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: Full Board
Approving Institution: Los Alamos National Laboratory
Most recent approval: 01/22/01
IRB approval number: LANL 91-03
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:
Abstract:
We have used primary cultures of neutrophils to develop methods for the study of molecular assemblies involved in receptor mediated signal transduction. In particular, we used the responses of neutrophils to fluorescent analogues of bacterial metabolites to test and characterize new rapid kinetic flow cytometry instrumentation. In the past several years, engineered animal cell lines have been developed that retain many of the essential features of primary human neutrophil preparations. These cell lines will be used for tests in the future.
LA-UR - 01-5610
Los Alamos National Laboratory, an affirmative action/equal opportunity employer, is operated by the University of California for the U. S. Department of energy under contract W-7405-ENG-36. By acceptance of this article, the publisher recognized that the U. S. Government retains a nonexclusive, royalty-free license to publish or reproduce the published form of this contribution, or to allow others to do so, for U. S. Government purposes. Los Alamos National Laboratory requests that the publisher identify this article as work performed under the auspices of the U. S. Department of Energy. Los Alamos National Laboratory strongly supports academic freedom and a researcher's right to publish; as an institution, however, the Laboratory does not endorse the viewpoint of a publication or guarantee its technical correctness.
"The Development of Improved Methods for the Detection of Individual Sensitivity to Beryllium"
This project is being conducted at multiple sites.
Principal Investigator: Dr. Babetta L. Marrone, Los Alamos National Laboratory
Project started in: 1996
Funding for Human Subjects Research:
This project does not involve the use of multiple protocols/subprojects.
Institutional Review Board (IRB) Review:
Type of Review: Full Board
Approving Institution: Los Alamos National Laboratory
Most recent approval: 01/22/01
IRB approval number: LANL 96-05
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 359
Reporting period for number of human subjects:
Fiscal Year 2001
Type(s) of Human Subjects Involvement:
The Development of Improved Methods
for the Detection of Individual Sensitivity to Beryllium
ABSTRACT
Background
Los Alamos National Laboratory is the primary facility within the DOE weapon complex for beryllium work. Respiration of beryllium particles can lead to a cell-mediated immune response in susceptible individuals. This response has been linked to the occurrence of Chronic Beryllium Disease (CBD), an interstitial lung disease. CBD occurs in about 2-5% of all beryllium-exposed workers. One feature of CBD that is believed to be an early marker is the development of cellular hypersensitivity to beryllium. In a sensitive individual, the lymphocyte cell fraction in a peripheral blood sample will increase within 5-7 days after a challenge with soluble beryllium. This test is termed the Beryllium Lymphocyte Proliferation Test (Be-LPT), and it is currently being used throughout the DOE complex and in industry to test for beryllium sensitivity in the former and current beryllium worker population. Although there is an active medical surveillance program for LANL beryllium workers the Be-LPT was only recently added to the LANL medical surveillance program.
About 11-50% of individuals testing positive on the Be-LPT progress to have physical symptoms of CBD (the exact percentage is not known or readily available). In addition, there is often disagreement in the results from the three commercial laboratories that perform the Be-LPT currently. The high "false positive" rate has prompted Los Alamos to explore the development of more accurate measures of beryllium sensitivity. Specifically, because CBD is a disease of the immune system, the LANL Be-LPT will measure beryllium hypersensitivity in specific lymphocyte subsets. In addition, research on the genetic mechanisms underlying the individual development of beryllium hypersensitivity will be pursued in conjunction with the Be-LPT sampling.
Objective
The overall objective is to improve the prediction of beryllium disease in beryllium-exposed individuals. The approach is to develop improved methods for detecting beryllium sensitivity and genetic susceptibility and to apply these new methods as part of the beryllium worker medical surveillance program.
Methodology
In FY02, we propose to continue to test the LANL beryllium workers using a Be- LPT done by flow cytometry. We will also continue to test other beryllium workers, from other sites including Lawrence Livermore National Laboratory, Lawrence Berkeley National Laboratory, Brush-Wellman Inc., Starmet, Inc. Former beryllium workers who are a part of beryllium medical surveillance programs at National Jewish Center, or the Oak Ridge Associated Universities Former Beryllium Worker Medical Surveillance Program, or other programs will also be included as part of this study. Individuals with CBD or with diagnosed beryllium sensitivity will be asked to participate in this study to serve as positive controls. Workers from other sites where beryllium work is done may also be added to the study during this year. Testing of workers from additional sites, other than LANL, involves coordination with the IRB of the collaborating institution.
The test uses total lymphocytes isolated from a heparinized blood sample by Ficoll gradient. The isolated lymphocytes are then cultured in complete medium in the presence of serum (either commercial human serum, fetal calf serum, or patient's own serum) or plasma. The Be-LPT that we have developed (termed the Immuno-Be-LPT) measures the growing cell fraction of specific lymphocyte subsets in response to a 6- day challenge with soluble beryllium (beryllium sulfate, beryllium fluoride, etc.). Additional samples may be used to test the growing cell fraction in response to beryllium alloys (beryllium aluminum, beryllium copper, etc.). The growing cell fraction is measured by labeling the cultured cells with either a DNA-binding dye (to analyze cell cycle stage by total DNA content) or with bromo-deoxyuridine (BrDU) incorporation by cell labeling with antibodies to BrDU (to measure cells in the process of DNA synthesis). In either case, the labeled cells are then measured by multiparameter flow cytometry and compared to negative (no beryllium) and positive (tetanus- activated) control samples from the same individual. The cells are also labeled with antibodies for lymphocytes subsets: CD4 (T helper), CD8 (T suppresser/cytotoxic); or others in order to interpret the growing cell fraction measure in the context of a specific lymphocyte subset. The CD4+ subset is believed to be the beryllium-responsive cell in CBD. The results of the Immuno-Be-LPT are given in terms of the percentage of proliferating cells in a particular (CD4+ or CD8+) lymphocyte subset.
As part of the Immuno-Be-LPT, a sample of blood is analyzed on the day of collection for baseline immunophenotype. This is done by a Complete Blood Count, followed by immunolabelling for lymphocyte subsets (usually CD3, CD4, CD8, and CD56) and multiparameter flow cytometry. The results are given as percentages and absolute numbers of lymphocytes in each subset. Immunophenotyping results falling outside of the normal ranges are indication of an underlying immune system disorder, which may influence the Immuno-Be-LPT results, and should be taken into consideration for follow-up in the worker's medical surveillance program. The research goals of the immunophenotyping are to better understand the role of lymphocyte subsets in beryllium sensitivity, and to determine whether immunophenotyping information can be used diagnostically in CBD. Immuno-Be-LPT results are given to Dr. Smith in ESH-2. Dr. Smith tells the worker the results of their test.
In addition, we use peripheral blood samples from the same individuals to develop other methods for detecting beryllium sensitivity even earlier in the course of its development. Specifically, there is evidence that there may be a genetic susceptibility to CBD. Specific genetic factors may combine with the environmental factor of beryllium exposure to make certain individuals who carry these inherited genetic factors more susceptible to development of beryllium sensitivity and CBD. One test that we will carry out on LANL beryllium workers will be to look for genetic correlates to beryllium sensitivity as measured by the Immuno-Be-LPT. This will be done by determining the DNA sequence of specific regions that may be involved in the etiology of CBD. In particular, one region of the genome that codes for immune responses, called the Human Leukocyte Antigen (HLA) region, will be explored in detail using automated DNA sequencing technology. From our previous work, we now know that certain variations of the HLA gene, HLA-DPB1, have high associations with CBD. The results of genetic testing for the presence of specific variations in the HLA-DPB1 gene have not been reported to the individual or to ESH-2 while the aggregate results of the study were being analyzed
Finally, we ask each subject to complete a 1-page questionnaire at the time of blood draw. The questionnaire includes questions about lifestyle habits, ethnicity, pharmaceuticals, or other medical conditions. The questionnaire is important because we still do not know how these factors affect outcome on the Immuno-Be-LPT or are correlated with the genetic biomarkers for susceptibility to development of CBD. The results will be used to help interpret any unusual findings on the Immuno-Be-LPT and to gain additional descriptive information about the study population.
Subjects in this study may be asked to give a repeat sample if the results on either the Immuno-Be-LPT or genetic biomarker test are not interpretable, due to laboratory error; or if the results are of scientific interest and the subject warrants additional, in depth study. All repeat testing will be coordinated through Dr. Smith and the ESH-2 staff.
Involvement of Human Subjects
Human subjects are not be exposed to any chemical or radioactive substances as a part of this project. A peripheral blood sample from each subject is acquired as part of the project procedure. Participants are asked to answer questions on a questionnaire as part of the procedure. The risks are minimal, and are those normally associated with blood withdrawal. The researchers receive only a subject or patient number on the sample and the questionnaire. The Immuno-Be-LPT results involving LANL subjects are provided to Dr. Smith, who de-codes them and gives them to the subject. Each subject signs an informed consent form before blood withdrawal. A copy of the signed consent form is given to the subject at the time of blood withdrawal. The original signed forms are kept in ESH-2.
Outcome
The anticipated outcome of this study will be an improved process for determining individual sensitivity to beryllium and individual genetic risk for developing CBD, which can eventually be integrated into the beryllium medical surveillance program. The study will be completed when results from a sufficient number of positive controls (individuals with CBD or beryllium sensitivity) have been obtained to allow us to repeat previously published results. This number is approximately 30 more individuals.
Conclusion
The benefit of this study will be the development of new tools that will help to prevent the occurrence of CBD, by integrating the Immuno-Be-LPT and genetic screening methods into current practices.
LA-UR - 01-5608
Los Alamos National Laboratory, an affirmative action/equal opportunity employer, is operated by the University of California for the U. S. Department of energy under contract W-7405-ENG-36. By acceptance of this article, the publisher recognized that the U. S. Government retains a nonexclusive, royalty-free license to publish or reproduce the published form of this contribution, or to allow others to do so, for U. S. Government purposes. Los Alamos National Laboratory requests that the publisher identify this article as work performed under the auspices of the U. S. Department of Energy. Los Alamos National Laboratory strongly supports academic freedom and a researcher's right to publish; as an institution, however, the Laboratory does not endorse the viewpoint of a publication or guarantee its technical correctness.
"Development and Testing of A Fieldable Prototype Noninvasive Intracranial Pressure Measurement System"
Principal Investigator: Dr. William O. Wray, Los Alamos National Laboratory
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: Full Board
Approving Institution: Los Alamos National Laboratory
Most recent approval: 01/22/01
IRB approval number: LANL 98-01
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 2
Reporting period for number of human subjects:
Fiscal Year 2001
Type(s) of Human Subjects Involvement:
Development and Testing of A Fieldable Prototype Non-Invasive Intracranial Pressure Measurement System (ICP Final Summary)
William O. Wray, B-4
Ten healthy human subjects were tested in the Laboratory of Dr. Dipen Sinha on October 27, 1999. Vibrational resonance scans were taken on each subject in the seated and in the supine position. The data was later evaluated to see if the change in position, which is known to cause variations in intracranial pressure (ICP), led to changes in the frequency of the resonant maxima. This data proved to be inconclusive because other effects associated with shifting from a seated to a supine position were also associated with significant changes in the frequency of resonant maxima. In particular, when one shifts from a seated to a supine position while the piezoelectric transducers are held in place by a headband, the orientation of the head and the transducers with respect to the gravitational field are changed by roughly 90°. The change in orientation relative to the gravitational field causes the vibration modes of the head/transducer system to undergo small changes, which in turn leads to shifts in the resonant mode frequencies. Thus it became apparent that, in order for the vibrational resonance system to be able to detect ICP variations, the position of the subject or patient must remain unchanged.
Follow-up tests were performed on the Principal Investigator, William O. Wray, in a common area just outside his office at TA-46 during the summer of 2000. Vibrational resonance scans were taken immediately after lying down from a standing position and again five minutes later. The two scans showed that certain resonant frequencies shifted to lower values after a five minute wait. This shift is consistent with a reduction in ICP after the body has reached equilibrium following the abrupt shift from a standing to a supine position.
A second set of measurements were made on Wray as he lay in a supine position and alternately relaxed and strongly exerted himself by pressing his palms together in front of his chest. The scans showed that some resonant maxima shifted to higher frequencies during exertion and returned to lower frequencies during relaxation. This data indicates that the vibrational resonance system is capable of detecting the increase in ICP associated with exertion and the subsequent decrease in ICP associated with relaxation. Unfortunately, all of the data from the tests conducted on William Wray during the summer of 2000 were lost to the Cerro Grande fire.
Clinical tests of the vibrational resonance ICP measurement system were conducted in the intensive care unit at the Medical College of Virginia on December 9th and 10th, 2000. The tests were conducted by Dr. Aury Nagy under a separate Institutional Review Board approval process. Seventeen resonant ultrasound scans were performed on a single patient over a two day period. Intracranial pressure was monitored continuously during this period using a conventional ventricular catheter system, and the patients ICP was found to vary from a low of 12 mm Hg to a high of 31 mm Hg. The location of resonant maxima in the resonant ultrasound scans exhibited no clear correlation with the measured ICP values. Although it may be possible to detect changes in the location of resonant maxima using a higher resolution scanning procedure, this procedure would also be more sensitive to frequency excursions associated with extraneous sources such as patient movement, etc. Since there are no resources available for continuing the investigation at this time, and because substantial additional work may be required to develop a resonant ultrasound system that is operationally effective, it has been decided to terminate the project.
All records are confidential and may not be disclosed without the subject's written permission with the exception that the FDA and/or funding agencies may inspect the records. Documented informed consent is obtained from all subjects in a manner compliant with all federal regulations.
LA-UR - 01-5607
Los Alamos National Laboratory, an affirmative action/equal opportunity employer, is operated by the University of California for the U. S. Department of energy under contract W-7405-ENG-36. By acceptance of this article, the publisher recognized that the U. S. Government retains a nonexclusive, royalty-free license to publish or reproduce the published form of this contribution, or to allow others to do so, for U. S. Government purposes. Los Alamos National Laboratory requests that the publisher identify this article as work performed under the auspices of the U. S. Department of Energy. Los Alamos National Laboratory strongly supports academic freedom and a researcher's right to publish; as an institution, however, the Laboratory does not endorse the viewpoint of a publication or guarantee its technical correctness.
"Neuromagnetic Mapping of Functional Centers in the Human Brain"
Principal Investigator: Dr. Robert H. Kraus, Jr., Los Alamos National Laboratory
Project started in: 1998
Funding for Human Subjects Research:
This project does not involve the use of multiple protocols/subprojects.
Institutional Review Board (IRB) Review:
Type of Review: Full Board
Approving Institution: Los Alamos National Laboratory
Most recent approval: 01/22/01
IRB approval number: LANL 98-02
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:
NEUROMAGNETIC MAPPING OF FUNCTIONAL CENTERS IN THE HUMAN BRAIN
ROBERT H. KRAUS JR
Background - We have completed construction of a novel whole-head superconducting image sensor system for Magnetoencephalography (MEG) of the human brain. We have completed experimental calibration and validated the system using physical phantoms. We are currently demonstrating system efficacy by direct comparison with a commercial whole-head MEG array with the same physical phantoms. A cost-effective whole-head system that employs new physics principals will provide important capabilities for noninvasive functional human brain measurements for both clinical applications and basic research. MEG directly measures a physical effect of neuronal currents with temporal resolution not limited by the sluggish vascular response; unlike PET and MRI that measure hemotological changes associated with neuronal activity. High temporal resolution is particularly important for studying neurological disorders such as epilepsy where temporal information is a major diagnostic, and for fundamental studies of synchronization and oscillatory brain activity.
Objectives - We have recently completed the LANL Superconducting Imaging Surface (SIS) whole-head Magnetoencephalography (MEG) system. The system has 149 channels installed and tested. In addition, a new Finite-Element-Method (FEM) forward physics model (required for source localization for functional localization in the brain) has been developed over the past fiscal year. The primary objective continues to be demonstrating efficacy for this new instrument. Human studies were performed to obtain representative data for the new SIS MEG system. The focus through FY 2001 was to obtain temporal data for well known and thoroughly investigated paradigms. The most simple evoked response experiments were performed (for example, somatosensory response paradigms) to evoke a primary somatosensory cortex response. This data was compared to well known time-domain response for healthy subjects to confirm the outstanding temporal and signal-to-noise performance of our new instrument. We intend to complete the Los Alamos phase of the work as soon as the complete set of electronics arrive from the vendor. We will continue the study using the same human subjects at the VA Hospital in Albuquerque and are currently acquiring required joint IRB approvals.
Methodology - Since the focus of the experiment was determining system response based on well-known neurological responses, the methodology was a very simple median nerve stimulation, and data in and around the N20 and P100 to P150 responses were examined and compared to prior investigators for temporal response and general location. Source localization will be performed in FY2001 with the new forward physics mode. This experiment is completely non-invasive and involves absolutely no use of ionizing radiation, chemicals, or biological substances. In the future, different evoked response experimental paradigms that have been long established in functional brain research will be used. These paradigms include visual evoked response, somatosensory, and motor paradigms. Visual stimuli include gray scale patterns at one position, numerous different positions, with varying duration, and stationary or moving. Somatosensory stimuli include median nerve stimulation with varying stimulus duration, interval, and randomization of pulse intervals. Finally, motor paradigms include finger tapping using one or multiple fingers, "knocking" (wrist motion), toe tapping, etc. Although more complex paradigms (such as facial patterns) have been studied, the complexity of these evoked responses are such that they are unlikely to be used to test our system efficacy. Specific paradigms are developed in collaboration with neuroscientists such as Chris Wood (LANL, Biophysics Group), Cheryl Aine and Roland Lee (VA Hospital and UNM).
Initial experiments have focused on signal quality comparing features of signal-to-noise and temporal details of the signal. The evoked response for the paradigms noted above have been extensively studied and typical signal amplitude fluctuations and temporal features of the various responses are generally reproducible. An example is the large "N20" peak from a somatosensory stimulation of the median nerve followed by a bipolar depression in the signal 20-40 milliseconds after the peak and a return to the nominal baseline. These features are important to verify proper performance of the individual MEG sensors in the system. Acquisition of simultaneous data from all channels to perform source localization using analysis methods developed in the LANL Biophysics Group is currently stalled by availability of all electronics from the vendor. Source localizations are anticipated in late calendar 2001 and will be compared to expected results.
Involvement of Human Subjects - Human subjects involved were researchers involved in the technical aspects of the project. All were not only well apprised of the procedure, but involved in designing and carrying out the experimental design. Each subject read and signed the consent form. No attempt to identify data sets was made except to identify the data with the technical system and data acquisition parameters. Subject identification was unnecessary since we are not concerned with neurological studies at this stage of the project.
Outcome - Initial physical phantom work has clearly demonstrated performance of the LANL whole-head MEG system far beyond anything available (by a factor of 5 in localization precision). We anticipate demonstrating significant improvements with human subjects using established paradigms in the near future.
LA-UR - 01-5606
Los Alamos National Laboratory, an affirmative action/equal opportunity employer, is operated by the University of California for the U. S. Department of energy under contract W-7405-ENG-36. By acceptance of this article, the publisher recognized that the U. S. Government retains a nonexclusive, royalty-free license to publish or reproduce the published form of this contribution, or to allow others to do so, for U. S. Government purposes. Los Alamos National Laboratory requests that the publisher identify this article as work performed under the auspices of the U. S. Department of Energy. Los Alamos National Laboratory strongly supports academic freedom and a researcher's right to publish; as an institution, however, the Laboratory does not endorse the viewpoint of a publication or guarantee its technical correctness.
"Use of Human Peripheral Blood Samples in Structural Biology of Bacterial Toxins"
Principal Investigator: Dr. Bruce E. Lehnert, Los Alamos National Laboratory
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: Full Board
Approving Institution: Los Alamos National Laboratory
Most recent approval: 02/14/00
IRB approval number: LANL 98-04
Explanation of IRB approval:
Study changed from expedited to exempt. No human subject involvement for FY 2001
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 0
Reporting period for number of human subjects:
Year prior to last IRB approval date
Type(s) of Human Subjects Involvement:
STRUCTURAL BIOLOGY OF BACTERIAL TOXINS
BRUCE E. LEHNERT
Bacterial toxin superantigens continue to pose a major health problem. Superantigens such as the Staphylococcal enterotoxins (SEA, SEB, SEC1-3, SED, and SEE), which are single unit proteins, can simultaneously interact with class II MCH receptors present on antigen presenting cells (APC) and T cell receptors present on the surfaces of T lymphocytes. Direct outcomes of such binding include the excessive release of the cytokine interleukin-2 (IL-2) and the proliferation of T cells. Subsequent cytokine effects and downstream cytokine networks then medicate a variety of clinical symptoms, e.g., fever, shock.
In this project, we set out to develop non-pathogenic mimics of superantigens designed to serve as competing, but pathogenically inactive ligands for receptor structures that are recognized as binding sites by the toxins. The goal was to develop therapeutic strategies that will inhibit the binding of superantigens to their cell receptors and thereby prevent their toxic effects. The project required the use of human peripheral blood white cells.
We have completed the first phase of our investigations in which a receptor decoy molecule was designed and shown to interfere with Staphylococcus enterotoxin B superantigens-induced T cell proliferation and interleukin-2 production.
Over the last year, we have transitioned from using blood obtained from LANL volunteers in our receptor mimic work to purchasing human peripheral white blood cells from a commercial supplier (Clonetics). Accordingly, we request that LANL's Institutional Review Board on Human Subjects re-categorize our work to that of an "exempt study" status.
LA-UR - 01-5605
Los Alamos National Laboratory, an affirmative action/equal opportunity employer, is operated by the University of California for the U. S. Department of energy under contract W-7405-ENG-36. By acceptance of this article, the publisher recognized that the U. S. Government retains a nonexclusive, royalty-free license to publish or reproduce the published form of this contribution, or to allow others to do so, for U. S. Government purposes. Los Alamos National Laboratory requests that the publisher identify this article as work performed under the auspices of the U. S. Department of Energy. Los Alamos National Laboratory strongly supports academic freedom and a researcher's right to publish; as an institution, however, the Laboratory does not endorse the viewpoint of a publication or guarantee its technical correctness.
See project JHUSHP-97-DE-FC03-98SF21541.
Project Identifier: LANL-98-05_IRB
Project Title: "Medical Surveillance for Former Department of Energy Workers"
Go to list of projects at Los Alamos National Laboratory
"Neutron Extremity Dosimetry Based on Monte Carlo Computations of Magnetic Resonance Images"
Principal Investigator: Dr. Michael W. Mallett, Los Alamos National Laboratory
Project started in: 2000
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: Los Alamos National Laboratory
Most recent approval: 09/21/00
IRB approval number: LANL 00-03
Explanation of IRB approval:
The IRB was notified by the principal investigator that the study was closed effective 9/12/01. Therefore no further study review was indicated.
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 11
Reporting period for number of human subjects:
Fiscal Year 2001
Type(s) of Human Subjects Involvement:
NEUTRON EXTREMITY DOSIMETRY BASED ON MONTE CARLO COMPUTATIONS OF MRI IMAGES
MICHAEL W. MALLETT
A computer model of the human body will be developed using magnetic resonance images. These images will map the geometry and material compositions of the various tissues. The model will then be used in transport calculations.
Magnet resonance images are obtained for the human subjects volunteers. The volunteers lie on their back inside the MRI unit and remain motionless for the approximately 30 minutes required for the imaging. The MRI unit features a static 1.5-Tesla magnetic field to which the volunteer is exposed. Additionally, electromagnetic radio waves are transmitted into the body of the volunteer. This represents the principal health hazard to the individual. The health effects of exposure to electromagnetic fields has not been quantified. However, the U.S. EPA has approved exposure to magnetic fields less than 4 Tesla in strength.
All data generated by this project are treated as confidential, personal medical records and are thus protected from distribution.
LA-UR - 01-5611
Los Alamos National Laboratory, an affirmative action/equal opportunity employer, is operated by the University of California for the U. S. Department of energy under contract W-7405-ENG-36. By acceptance of this article, the publisher recognized that the U. S. Government retains a nonexclusive, royalty-free license to publish or reproduce the published form of this contribution, or to allow others to do so, for U. S. Government purposes. Los Alamos National Laboratory requests that the publisher identify this article as work performed under the auspices of the U. S. Department of Energy. Los Alamos National Laboratory strongly supports academic freedom and a researcher's right to publish; as an institution, however, the Laboratory does not endorse the viewpoint of a publication or guarantee its technical correctness.
"Aircrew Process/MOPP Exchange Testing"
Principal Investigator: Dr. Bruce D. Reinert, Los Alamos National Laboratory
Project started in: 2000
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: Los Alamos National Laboratory
Most recent approval: 10/12/00
IRB approval number: LANL 99-03
Explanation of IRB approval:
Original approval date is 10/12/99. This study was reviewed and approved for continuation 10/12/00
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 6
Reporting period for number of human subjects:
Fiscal Year 2001
Type(s) of Human Subjects Involvement:
AIRCREW PROCESSING / MOPP EXCHANGE TESTING
OBJECTIVES: The purpose of Aircrew Processing testing is to evaluate the current Navy, Marine, Army, and Air Force aviation Nuclear, Biological and Chemical (NBC) garments/ensembles with respect to removal and design concerns.
This testing will aid in determining the desirable design features of each of the configurations that negate the transfer of contamination from the outer layers of the garments to the individual. Differences in the transfer of agent from a protective outer-garment vice a protective under-garment will also be reported. The results of this testing will be directly employed in the development of the Joint Protective Aircrew Ensemble (JPACE), an NBC garment for all the services' aviation communities.
METHODOLOGY: The testing involves having a human subject don the ensemble, including the appropriate accessories such as survival vest, protective mask and helmet normally worn with the particular ensemble. The subject then enters a chamber where a fluorescent powder previously sprayed into the chamber will settle on to the test subject. Since each ensemble being tested includes a respiratory protection system, the test subject will not be exposed to inhalation of the airborne powder while in the chamber. The subject then exits the chamber and undergoes removal of the ensemble using the methods specified for that ensemble. After removal is complete, the test subject is photographed under ultra violet light to determine if any of the fluorescent powder was transferred to the test subject. The test subject will in all cases wear an undergarment that does not fluoresce under ultra violet light. At the end of the testing the subject will be asked to fill out a questionnaire on the ensemble worn during the test.
The tests to be conducted are similar in most respects to the Contaminated Suit Removal Test that is used in the Acceptance Testing of Air-Supplied Suits project. The test differs only in the protective ensembles being tested, the type of fluorescent powder, the method of spraying the fluorescent powder and the ensemble removal procedures. The new fluorescent powder is necessary because the powder we previously used is no longer available.
Data collection will include photographs of all the test runs prior to testing and post ensemble removal; video of all the tests; and data collection from the subjects using a questionnaire. Important data points include the following:
Where the transfer occurred
The relative size of the contamination
Ensemble removal time per subject
Subject body measurements
Observations on removal procedures and recommendations for improvement
IONIZING RADIATION, RADIOACTIVE SUBSTANCES, OR CHEMICAL SUBSTANCES: The risks to the test subjects are minimal. The new powder includes 0.02% formaldehyde by weight. The formaldehyde is polymerized to itself so there is no chance of any gaseous formaldehyde being present during testing. To exceed the TLV for formaldehyde, a concentration of the powder in air would need to be greater than 1,500mg/m3. the concentration of powder in the chamber during our tests will not exceed 500 mg/m3 and the test subjects will be wearing respiratory protection while in the chamber. The respirator will continue to be worn until all outer garments that are covered with the fluorescent powder have been removed. ESH-5 personnel who will help the test subjects in doffing the ensembles will wear respirators. At any time during the testing if there are any unforeseen events or the subject requests termination of the test, the subject twill be removed from the ensemble. The test subject may experience claustrophobia due to the close-fitting suit and restricted visibility.
INVOLVEMENT OF HUMAN SUBJECTS: Testing was conducted at TA-52, RD-1. The subjects were asked to read the form and sign it before each test. Any questions that the test subject may have were answered before the beginning of the test. (Refer to details above under Methodology Section).
Subjects were briefed on their role and the purpose of the testing. They had an opportunity to walk through the test chamber lay out and were asked to sign a consent form before testing. The subjects donned black polyester long underwear over their own underwear and were photographed with a digital camera under a black light before the test to assure that no contamination is present. Navy personnel dressed the subject in the NBC ensemble including the mask assembly. The subject was responsible for checking the seal of the mask.
The subject entered the contamination chamber after the powder stimulant has been released. They were instructed to turn in the chamber and wave their arms up and down during the one-minute exposure time.
Three subjects were required to test each garment configuration, one run by each subject. With four NBC configurations being tested a total of twelve trials were completed. Subjects are identified only by a number assigned to them by the Los Alamos Research and Development Team. A total of six different test subjects were used for the testing. Four test subjects were male and two were female. All test subjects were medically cleared and had a stress EKG within the last 12 months.
LA-UR - 01-5590
Los Alamos National Laboratory, an affirmative action/equal opportunity employer, is operated by the University of California for the U. S. Department of energy under contract W-7405-ENG-36. By acceptance of this article, the publisher recognized that the U. S. Government retains a nonexclusive, royalty-free license to publish or reproduce the published form of this contribution, or to allow others to do so, for U. S. Government purposes. Los Alamos National Laboratory requests that the publisher identify this article as work performed under the auspices of the U. S. Department of Energy. Los Alamos National Laboratory strongly supports academic freedom and a researcher's right to publish; as an institution, however, the Laboratory does not endorse the viewpoint of a publication or guarantee its technical correctness.
"SLEEP TREATMENTS FOR CERRO GRANDE FIRESTORM VICTIMS"
Principal Investigator: Dr. BARRY KRAKOW, Los Alamos National Laboratory, Univ. of New Mexico & Sleep & Human Health Institute, Albuquerque NM
Project started in: 2001
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: Full Board
Approving Institution: Los Alamos National Laboratory
Most recent approval: 01/18/01
IRB approval number: LANL 01-01
Additional IRB approvals from other institutions:
Type of Review: Expedited
Approving Institution: University of NEW Mexico
Most recent approval: 07/11/01
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 104
Reporting period for number of human subjects:
Fiscal Year 2001
Type(s) of Human Subjects Involvement:
SLEEP TREATMENTS FOR CERRO GRANDE FIRESTORM VICTIMS
The design of this study utilized Sleep Dynamics Therapy (SDT), an approach focusing on sleep disturbances in the victims of the Cerro Grande firestorm, May 2000. We hypothesized that six weekly SDT sessions, two hours each, would promote improvement in several qualities, including insomnia, nightmares, post traumatic distress, depression, and sleep quality, and that these improvements would be maintained over time. Results displayed significant improvement on a variety of measures, both immediately following the treatment and 12 weeks after the initial session. The positive results implicate broad application potential in survivors of traumatic events. The focus on sleep disturbances provides an effective alternative approach to conventional psychological / pharmacological treatment methods for the victims.
Some individual were allowed to take home an Autoset (home sleep monitoring device), which measure breathing disturbances and oxygen desaturations. These individuals returned the device and consulted with on of the authors in analyzing the data
NOTE: No individuals were recruited from the LANL clinic, nor were any LANL facilities utilized for this study. There is no continuing activity with LANL regarding this study.
LA-UR - 01-5940
Los Alamos National Laboratory, an affirmative action/equal opportunity employer, is operated by the University of California for the U. S. Department of energy under contract W-7405-ENG-36. By acceptance of this article, the publisher recognized that the U. S. Government retains a nonexclusive, royalty-free license to publish or reproduce the published form of this contribution, or to allow others to do so, for U. S. Government purposes. Los Alamos National Laboratory requests that the publisher identify this article as work performed under the auspices of the U. S. Department of Energy. Los Alamos National Laboratory strongly supports academic freedom and a researcher's right to publish; as an institution, however, the Laboratory does not endorse the viewpoint of a publication or guarantee its technical correctness.
"LANL TRAVEL STUDY"
Principal Investigator: Mr. ROBERT WARLING, Los Alamos National Laboratory
Project started in: 2001
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: Los Alamos National Laboratory
Most recent approval: 01/24/01
IRB approval number: LANL 01-02
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 40
Reporting period for number of human subjects:
Fiscal Year 2001
Type(s) of Human Subjects Involvement:
LANL TRAVEL STUDY - ENJOYING THE ADVENTURES OF INTERNATIONAL TRAVEL BY LEARNING THE INHERENT RISKS OF THE JOURNEY
The purpose of our study was to heighten the awareness of environmental health and safety issues among our employees involved in international travel. Whether for business or pleasure, more of us experience the joys and difficulties associated with international travel. Exposures to health hazards markedly increase when we visit countries where health and safety standards fail to compare to Hometown USA. A poster session presented findings from a "repeated measure" survey that assessed responses of international travelers. We administrated the survey questionnaire before and after the employee traveled to their international locations. The findings helped assess the employee's preparedness for the conditions and environment each encountered.
Prior to traveling, employees were informed of a variety of recognized Internet web sites offering current and reliable travel information, some with precautionary advisories concerning specific countries and geographical regions. We compared pre-and post-responses and analyzed the findings by gender, age groups, frequency of travel, and whether the trip was for business of pleasure. Our results suggest the need to tailor travel consultation by purpose, country, personal factors, and duration of stay. Prospective travelers gain valuable insight from others having recently visited the intended destination. Adhering to common sense approaches and offering access to information on current, regional health and safety issues prevent injuries and illnesses among employees.
LA-UR - 01-5595
Los Alamos National Laboratory, an affirmative action/equal opportunity employer, is operated by the University of California for the U. S. Department of energy under contract W-7405-ENG-36. By acceptance of this article, the publisher recognized that the U. S. Government retains a nonexclusive, royalty-free license to publish or reproduce the published form of this contribution, or to allow others to do so, for U. S. Government purposes. Los Alamos National Laboratory requests that the publisher identify this article as work performed under the auspices of the U. S. Department of Energy. Los Alamos National Laboratory strongly supports academic freedom and a researcher's right to publish; as an institution, however, the Laboratory does not endorse the viewpoint of a publication or guarantee its technical correctness.
"CATARACTS IN RADIATION WORKERS WITH TRANSURANIUM BODY BURDEN"
Principal Investigator: Dr. BARUCH S. JACOBSON, Washington State Univ., U.S. Transuranium and Uranium Registries
Project started in: 2001
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: Los Alamos National Laboratory
Most recent approval: 10/04/00
IRB approval number: LANL 00-06
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 20
Reporting period for number of human subjects:
Fiscal Year 2001
Type(s) of Human Subjects Involvement:
CATARACTS IN RADIATION WORKERS WITH TRANSURANIUM BODY BURDENS
The study is being conducted using the medical records of USTUR and LANL registrants who have given permission to access their medical records. The object is to determine whether radiation-induced cataracts are occurring. These cataracts would be predominately posterior sub-capsular cataracts (PSC) in contrast to the common age-related cataracts, which are predominately of the nuclear-cortical type. An excess of the PSC type cataracts would suggest a radiation effect. In order to do this, I contacted the subjects' ophthalmologists, with information obtained from the subjects. The ophthalmologists are supplied with copies of the registrant's signed consent forms and queried regarding the diagnosis of cataract and the type of cataract.
While it may not be possible to identify all the individuals with cataracts, I will attempt to ascertain whether there is an excess of posterior cortical cataracts, as compared to the common types, and whether this effect its related to radiation exposure or body burden of radionuclides.
It is necessary to identify registrants by name when contact ophthalmologists. Other wise, name of individuals will be kept confidential within USTUR, in accordance with our establish procedures. Our files are not accessible to the public. Results will be presented to the scientific community.
Justification for the study: The ocular radiation protection standards formulated by National Council on Radiation Protection (NCRP) and the International Council on Radiation Protection (ICRP) are predicated on the assumption that radiation cataracts only appear when a high dose threshold is exceeded. However, several lines of evidence from experimental and epidemiological studies suggest otherwise. If this is the case, the radiation safety standards set for workers as well as the general population may be inadequate. Furthermore, if radiation cataract is proven stochastic - implying that some fraction of a population will develop them at even low doses - its utility for dose reconstruction will be enhanced. Therefore, it is important for the risk assessment community to know whether cataract formation is indeed a stochastic response to radiation. There is no apparent risk to the registrants, all of whom have freely decided to make their radioisotope-related records available. Informed consent documents are on hand.
LA-UR - 01-5875
Los Alamos National Laboratory, an affirmative action/equal opportunity employer, is operated by the University of California for the U. S. Department of energy under contract W-7405-ENG-36. By acceptance of this article, the publisher recognized that the U. S. Government retains a nonexclusive, royalty-free license to publish or reproduce the published form of this contribution, or to allow others to do so, for U. S. Government purposes. Los Alamos National Laboratory requests that the publisher identify this article as work performed under the auspices of the U. S. Department of Energy. Los Alamos National Laboratory strongly supports academic freedom and a researcher's right to publish; as an institution, however, the Laboratory does not endorse the viewpoint of a publication or guarantee its technical correctness.
"DOSE ASSESSMENTS FOR VETERANS WHO PARTICIPATED IN BROKEN ARROWS FOR ARMOA/SGOR, BOLLING AFB, DC"
Principal Investigator: Ms. SANDRA E. WAGNER, Los Alamos National Laboratory
Project started in: 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: Full Board
Approving Institution: Los Alamos National Laboratory
Most recent approval: 11/16/00
IRB approval number: LANL 00-05
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:
DOSE ASSESSMENTS FOR VETERANS WHO PARTICIPATED IN BROKEN ARROWS FOR ARMOA/SGOR, BOLLING AFB, DC
The purpose of this work is for LANL to: provide collection containers and appropriate shipping packaging to the Department of Veteran's Administration Regional Hospitals on request, provide directions for collection to the veteran, provide directions for return shipping for the VA, receive these urine samples, analyze for Pu-239 in the urine, and provide a committed dose estimate for each of the veterans. Approximately 1600 people participated in the Palomares, Spain Broken Arrow and approximately 600 people participated in the Thule, Greenland Broken Arrow. This project anticipates a phased response starting with an assumption that a minimum of 200 people from the Palomares Broken Arrow will respond and require dose assessments. (Included in this 200 will be 20 individuals from the Thule Broken Arrow as well.) A continuing incremental schedule will be extended to continue this service based on each additional 100 veterans that require dose estimates.
LA-UR - 01-5873
Los Alamos National Laboratory, an affirmative action/equal opportunity employer, is operated by the University of California for the U. S. Department of energy under contract W-7405-ENG-36. By acceptance of this article, the publisher recognized that the U. S. Government retains a nonexclusive, royalty-free license to publish or reproduce the published form of this contribution, or to allow others to do so, for U. S. Government purposes. Los Alamos National Laboratory requests that the publisher identify this article as work performed under the auspices of the U. S. Department of Energy. Los Alamos National Laboratory strongly supports academic freedom and a researcher's right to publish; as an institution, however, the Laboratory does not endorse the viewpoint of a publication or guarantee its technical correctness.
"HAZARD ASSESSMENT / RISK MANAGEMENT SURVEY"
Principal Investigator: Ms. RITA J. HENINS, Los Alamos National Laboratory
Project started in: 2001
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: Los Alamos National Laboratory
Most recent approval: 11/28/00
IRB approval number: LANL 00-06
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 20
Reporting period for number of human subjects:
Fiscal Year 2001
Type(s) of Human Subjects Involvement:
HAZARD ASSESSMENT / RISK MANAGEMENT SURVEY STUDY
The objective of this survey research is to evaluate LANSCE personnel perceptions regarding the effectiveness of any hazard assessment / risk management tools currently used by persons who are responsible for developing or using hazard control plans related to their programmatic work.
METHODOLOGY: This study is a non-experimental study. Instead, this study uses a survey tool that will be presented in a structured interview format, to volunteer subjects. A research assistant will receive Letters of Consent, interview questions, and two legal envelopes from the principal investigator (PI). In addition, the PI will review the purpose of each question with the research assistant. The research assistant will contact each volunteer and arrange to complete the survey with him or her. The structured interview will take place at the convenience of the volunteer, research assistant, and survey responder. Each volunteer will be given a letter of consent before the arranged interview, which they will be asked to sign to indicate their voluntary participation in the study. One copy of the signed consent letter will remain with the participant. The second copy will be placed in a legal envelope, where it will remain until after the study is completed and the resulting paper is submitted to the interested parties. The consent letter will provide each participant with an understanding of the study, their involvement, their ability to withdraw at any time, and their rights to refuse participation in the study. Participants will be further informed that the final report, including the de-identified / summarized data, will be made available to all groups that participated in the project. Each participant will also receive a copy of the "Los Alamos National Laboratory's Experimental Subject's Bill of Rights".
The research assistant will then use the survey questions as interview questions. Participants will be allowed to ask clarifying questions. Responses will be recorded verbatim, in short hand. Responses will be placed in a second legal envelope. At intervals to be determined by the research assistant, the interview transcripts will be transposed to longhand. When all surveys are completed, the entire set of surveys will be hand delivered to the PI. All other interview records will be destroyed, except the envelope containing the signed consent letters. All survey data is maintained in one location until the end of the collection period to protect the volunteer's confidentiality. The holding period will further prevent the PI from making any connections between responses and the respondents.
The PI will then complete an analysis of the data and finalize the project report. The report will be submitted to Central Missouri State University Graduate School in partial fulfillment of a Master of Science degree in Industrial Safety Management. The report will also be submitted to the LANSCE Division Office and the facility manager.
The required data set is 30-35 complete surveys. Each interview should last about one hour. The final report should be completed by March 2001.
HUMAN SUBJECT INVOLVEMENT: Subjects will consist of approximately 30 volunteers who work at TA-53, commonly known as LANSCE. The project PI will send an invitation for participation in the research project by electronic mail to the entire LANSCE facility. The electronic mail will briefly describe the project objective, the research methodology, and the time required of each participant. The electronic mail will ask interested persons to contact the project research assistant.
The research assistant will then arrange with each respondent to mail the volunteers a consent form to review. The research assistant will follow up approximately one week later to inquire about arranging a time to meet with each volunteer to complete the survey.
The research assistant will meet with each volunteer to answer any questions related to the study, review and sign the consent form, and complete the survey. No identifying information will be included on the survey, with the exception of the volunteer's work classification (e.g., "maintenance technician", etc.). When every survey has been completed, the entire package of surveys will be hand delivered to the PI for analysis.
No other information is collected. No participant is exposed to any hazardous energy or hazardous substance. No samples of human tissue or other data is collected.
LA-UR - 01-5601
Los Alamos National Laboratory, an affirmative action/equal opportunity employer, is operated by the University of California for the U. S. Department of energy under contract W-7405-ENG-36. By acceptance of this article, the publisher recognized that the U. S. Government retains a nonexclusive, royalty-free license to publish or reproduce the published form of this contribution, or to allow others to do so, for U. S. Government purposes. Los Alamos National Laboratory requests that the publisher identify this article as work performed under the auspices of the U. S. Department of Energy. Los Alamos National Laboratory strongly supports academic freedom and a researcher's right to publish; as an institution, however, the Laboratory does not endorse the viewpoint of a publication or guarantee its technical correctness.
"POLARIZED ELASTIC SCATTERING SPECTROSCOPY SYSTEM"
Principal Investigator: Dr. JUDITH R. MOURANT, Los Alamos National Laboratory
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: Los Alamos National Laboratory
Most recent approval: 12/07/00
IRB approval number: LANL 00-07
Additional IRB approvals from other institutions:
Type of Review: Full Board
Approving Institution: University of New Mexico
Most recent approval: 06/06/01
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:
POLARIZED ELASTIC SCATTERING SPECTROSCOPY SYSTEM
Objectives: The aim of this study is to test a new technology to diagnose cervical cancer. Although current methods of screening for cervical cancer have made a huge impact on the prevalence of cervical cancer, the current methods have some significant drawbacks. The current tests are not very accurate - at a recent talk by an NIH program manager, the sensitivity and specificity of the Pap smear were both given as about 50%. Secondly, there is a delay in finding out the results of a Pap smear. This delay in addition to the fact that a portion of the population frequently does not return for follow-up means that some people do not get treatment. We are developing a non-invasive optical technique that we hope will reduce the first problem and eliminate the second.
Methodology: A fiber optic probe is placed in contact with the tissue. Light passes down the probe - through a polarizer that is part of the probe into the tissue where it is scattered. Some of the light returns to the tissue surface, this light is collected with information about its location and polarization. The intensity and wavelength dependence of the collected light provides information about the tissue structure on the scale of microns and smaller. The protocol and specifics of the instrumentation of this study have been reviewed by the FDA and the FDA has found that the proposed clinical investigation is a nonsignificant risk device.
There is no exposure to ionizing radiation, radioactive substances or chemical substances.
Involvement of human subjects. A slender fiber optic fiber optics tube will be placed against the surface of the cervix while the light reading device processes the light scattering from cervical tissue. A small piece of tissue will then be removed to be analyzed by a pathologist. The findings of the pathologist will be used to determine the sensitivity and accuracy of the light reading process. There are no known risks or side effects related to the light probe. The most common side effects of cervical biopsy include anxiety, minimal cramping, pain of bleeding during the biopsy and vaginal spotting afterwards. Tissue will be stored for future testing. At this time it has not been determined what these further tests may be, however, all testing of the tissue will relate directly to this study. Once the study is no longer acquiring information the tissue will be discarded. Only study personnel and oversight committees will have access to study information, which will be kept in a secure area. Patient/participant names will not be used in any publications.
In order to participate in the study, patients will have to sign a consent form. The consent form describes, the purpose and background, the procedures, possible risks and discomforts, benefits of participation, and confidentiality of the study. All records are confidential and may not be disclosed without the subject's written permission with the exception that the FDA and/or funding agencies may inspect the records. Documented informed consent is obtained from all subjects in a manner compliant with all federal regulations.
LA-UR - 01-5166
Los Alamos National Laboratory, an affirmative action/equal opportunity employer, is operated by the University of California for the U. S. Department of energy under contract W-7405-ENG-36. By acceptance of this article, the publisher recognized that the U. S. Government retains a nonexclusive, royalty-free license to publish or reproduce the published form of this contribution, or to allow others to do so, for U. S. Government purposes. Los Alamos National Laboratory requests that the publisher identify this article as work performed under the auspices of the U. S. Department of Energy. Los Alamos National Laboratory strongly supports academic freedom and a researcher's right to publish; as an institution, however, the Laboratory does not endorse the viewpoint of a publication or guarantee its technical correctness.
"A STUDY OF THE PATTERNS OF ELECTRONIC MAIL USE IN ORGANIZATIONAL COMMUNICATION"
Principal Investigator: Ms. DENISE DERKACS, Los Alamos National Laboratory
Project started in: 2001
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: Los Alamos National Laboratory
Most recent approval: 12/07/00
IRB approval number: LANL 00-08
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 85
Reporting period for number of human subjects:
Fiscal Year 2001
Type(s) of Human Subjects Involvement:
A STUDY OF THE PATTERNS OF ELECTRONIC MAIL USE IN ORGANIZATIONAL COMMUNICATION NETWORKS
This research project, A Study of the Patterns of Electronic Mail Use in Organizational Communication Networks, was being done at Los Alamos National Laboratory in connection with a University of New Mexico graduate-level, communication research methods course.
The purpose of this research was to examine the use of e-mail in various communication exchanges, identify the factors that influence the use of e-mail, and compare usage patterns with current media-use theories in organizational communication. From a practical perspective, this research can assist Laboratory employees in understanding the choice of e-mail for certain communication exchanges, but not for others. An understanding of communication media choices can promote more effective communication at the Laboratory.
This research involved a survey of a convenience sample of approximately 150 employees in three groups/offices at the Laboratory. Approximately half, 85 employees, returned the questionnaires. Permission was obtained from the program director in IBD and the group leaders in MST-6 and IM-1 to distribute the questionnaire their employees. The survey questionnaire was distributed by interoffice mail and returned by interoffice mail. Completion of the questionnaire was estimated to take no more than 15 minutes. There were no known risks associated with this research project.
Participants were asked to sign an informed consent form, which was included with the questionnaire, but separated from the completed questionnaire, upon receipt, before results were tallied. Returned questionnaires were not be crosschecked against distribution lists. The consent form explained that participation in the survey was completely voluntary, that management would not receive information about their participation, and that participants were free to not complete the questionnaire, or not answer any particular question(s).
Responses to the questions were be entered into a statistical software package and analyzed. The data set was stored on a computer disk, kept with the consent forms, and completed questionnaires in a file cabinet in investigator's office. These items will be kept for five years and then destroyed. The investigator will be the only person with access to the consent forms, the questionnaires, and the data set. A report was written on the results of the research. Names were not associated with the survey responses. Data are presented in summary form, and others will see only the summary of the data in the research report.
LA-UR - 01-5596
Los Alamos National Laboratory, an affirmative action/equal opportunity employer, is operated by the University of California for the U. S. Department of energy under contract W-7405-ENG-36. By acceptance of this article, the publisher recognized that the U. S. Government retains a nonexclusive, royalty-free license to publish or reproduce the published form of this contribution, or to allow others to do so, for U. S. Government purposes. Los Alamos National Laboratory requests that the publisher identify this article as work performed under the auspices of the U. S. Department of Energy. Los Alamos National Laboratory strongly supports academic freedom and a researcher's right to publish; as an institution, however, the Laboratory does not endorse the viewpoint of a publication or guarantee its technical correctness.
"PEOPLE MISTREATMENT IN THE CULTURALLY DIVERSE ORGANIZATION"
Principal Investigator: Ms. DENISE DERKACS, Los Alamos National Laboratory
Project started in: 2001
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: Los Alamos National Laboratory
Most recent approval: 12/19/00
IRB approval number: LANL 00-10
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 69
Reporting period for number of human subjects:
Fiscal Year 2001
Type(s) of Human Subjects Involvement:
PEOPLE MISTREATMENT IN THE CULTURALLY DIVERSE ORGANIZATION
Purpose of the Project: The purpose of the project is to examine people mistreatment at Los Alamos National Laboratory (LANL). Specifically, we want to define people mistreatment and potentially offer ways to resolve and reduce people mistreatment. We frame the project with face-negotiation theory (Ting-Toomey & Kurogi, 1998; Ting-Toomey & Oetzel, in press). Face is the claimed sense of favorable social self-worth and/or projected other-worth in a public situation (Ting-Toomey & Kurogi, 1998). Essentially, face is our image concerns during interactions. Face is especially problematic in uncertainty situations (such as interacting with diverse others) when the situated identities of the communicators are called into question. During interactions with others, we negotiate our image in order to create a positive regard for self and our group identities (e.g., cultural group). Face is associated with respect, honor, status, reputation, credibility, competence, family/network connection, loyalty, trust, relational indebtedness, and obligation issues. People mistreatment represents a critical situation for an individual's face. Face is relevant during people mistreatment encounters because an individual is not certain where s/he stands with the other person (or organization). His/her perceived worth (i.e., identity goals) is called into question and s/he must choose various strategies to (re)negotiate boundaries and self-worth. S/he may choose to withdraw from the situation (e.g., quitting) or confront the other party. Either way, the identity negotiation-taking place likely has a negative effect on the individual's personal satisfaction and effort on the job (i.e., s/he doesn't feel respected by others).
Human Subject Involvement: Participants are LANL employees. In Phase I (interviews), the Diversity Office will select possible participants from the Diversity Council, Employee Advisory Council, Science and Engineering Advisory Council, Laboratory Fellows, and others to invite them to participate. All invitees will be given the option to turn down the request for interviews at two points-during the initial contact and directly before the interview begins. We want to conduct approximately 75 interviews. There will be at least five participants from each of the cultural groups of interest in the current study: (a) ethnicity, (b) gender, (c) age, (d) job position, and (e) sexual orientation. Our intention is to include people from a variety of backgrounds, but not limit their focus to any one of these aspects in discussing people mistreatment. We will not exclude any group from participation, but will take special efforts to include people from a variety of ethnic/cultural groups.
Methods and Procedures: The proposed study will be conducted in two phases: (1) interviews and (2) survey/questionnaire.
Phase I Interviews: The first phase is to conduct interviews. The purpose of question one is to establish rapport with the participant and begin a dialogue. Questions two through five are designed to provide a definition and concrete examples of people mistreatment. Questions six through eight examine appropriate resolutions for people treatment. Question nine is for demographics, while question ten provides an opportunity for final thoughts from the participants. The questions are designed to be open-ended and not leading. The protocol was pilot tested with students at the University of New Mexico (to determine clarity and effectiveness of questions, length of time of the interview, and appropriate probes for the questions) and one employee of LANL. After completing the pilot test, we shared the revised protocol with LANL staff (primarily the Diversity Office) to obtain their approval. Two research assistants from our team will conduct the interviews. They are trained in interview techniques and will take steps to conduct the interviews in a consistent manner. All interviews will take place in an unsecured, but private, area at LANL. The interviewers will follow the interview protocol. Interviews will be scheduled at a rate of one per hour-30-45 minutes for each interview and 15 minutes for the interviewers to complete notes after the interview. The interviewers will provide an introduction to the purpose of the interviews and obtain a signature on a consent form from each participant prior to beginning the interviews. All interviews will remain anonymous. The interviewers will ask permission of the participants to take notes. The data will be transcribed from the notes and analyzed to identify underlying themes
Phase II Survey: The second phase is a survey for the purpose of relating the concept of people mistreatment to individual goal achievement. For this phase, people mistreatment is the independent variable. The dependent variables are task, relational, and identity goals. The open-ended responses from the interviews will be used to operationalize people mistreatment. That is, items will be created to match the themes identified in Phase I. In this manner, we will be able to associate people mistreatment with individual goals, such as effort (task goal), commitment (relational goal), and self-worth (identity goal) at LANL. The questionnaire for this phase will be created after the completion of Phase I. We will likely utilize existing measures of effort and commitment (Oetzel, 1998c) and self-worth (Ting-Toomey & Oetzel, in press). We will submit the final questionnaire for approval by LANL staff before its implementation. We anticipate that the instrument will contain approximately 50 items and take 10-15 minutes to complete. There will be approximately 500 participants for this phase. We will work with LANL staff to acquire a randomly selected participant list. The questionnaire will be distributed via the LANL Intranet (with the help of LANL staff) and data will be automatically collected in a spreadsheet for later analysis. The questionnaire will be completed with anonymity. A statistical package (SPSS) will then be used to provide descriptive data (means and standard deviations) and associations (correlation and regression).
Personal Data - Collection, Storage, Disposal, and Confidentiality: The data will be collected with protecting anonymity. In Phase I, the transcriptions of interviews will not be attached to individual names. Data will only be presented in summary form-that is, we will identify common themes about the data without noting individuals. In Phase II, the questionnaire will not ask for name or other identifying information. In both phases, demographic characteristics will be asked for. Participants will have the option to not complete demographic information. Additionally, we will not link individuals to their demographic information. In the interviews, the data will be collected by taking notes about the interview. These notes will be transcribed for use in data analysis. In the survey, data will collected via the Intranet and will be transferred to a data file. Raw data will be stored at the University of New Mexico-on one computer and in one office (Professor John Oetzel). It will be kept for 5 years and then destroyed. The reason for storing for 5 years is that the data are to be published and proof of data must be maintained in case the publication is challenged. The raw data will not be made available to LANL staff. We will present the data in summary form (via a written and oral report). Both the publication and reports are listed in the informed consent form for participants.
Risks and Benefits: The benefit of the project is meeting information needs described by LANL's Diversity Office. Specifically, we will provide a concrete definition of people mistreatment and a measure of the degree to which people mistreatment is affecting individual goals that are relevant to LANL. This information can be useful as it can be utilized in training in an effort to have zero incidents of people mistreatment at LANL. The risks of the information are minimal. Self-report of people mistreatment may lead to the remembering of painful experiences for participants (e.g., being discriminated against). However, participants have the right not to participate, not to answer any particular question, and/or stop the interview/survey at any time. Thus, the risks are minimized.
LA-UR - 01-5597
Los Alamos National Laboratory, an affirmative action/equal opportunity employer, is operated by the University of California for the U. S. Department of energy under contract W-7405-ENG-36. By acceptance of this article, the publisher recognized that the U. S. Government retains a nonexclusive, royalty-free license to publish or reproduce the published form of this contribution, or to allow others to do so, for U. S. Government purposes. Los Alamos National Laboratory requests that the publisher identify this article as work performed under the auspices of the U. S. Department of Energy. Los Alamos National Laboratory strongly supports academic freedom and a researcher's right to publish; as an institution, however, the Laboratory does not endorse the viewpoint of a publication or guarantee its technical correctness.
"RAPID SYNDROME EVALUATION PROJECT (RSVP)"
Principal Investigator: Dr. DAVID W. FORSLUND, Los Alamos National Laboratory
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: Los Alamos National Laboratory
Most recent approval: 01/18/01
IRB approval number: LANL 01-05
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:
RAPID SYNDROME EVALUATION PROJECT (RSVP)
This project is seeking to collect syndromic data, which would be an indication of infectious disease in a person, such as an influenza-like illness.
OBJECTIVES: We seek to collect data to better characterize the syndromes associated with influenza and how they might be distributed in the population
METHODOLOGY: We are using a web-based application that requires no keyboard use by a healthcare provider. Data is entered by checking appropriate selection boxes. The information collected will be analyzed to determine the frequency of certain symptoms and correlations between those symptoms. We also check for combinations of syndromes that might indicate a reportable disease and send the information to the Office of Epidemiology in the New Mexico Dept. of Health. They, then, can contact the local provider immediately to get further information if they believe the event does constitute a reportable disease.
IONIZING RADIATION, RADIOACTIVE SUBSTANCE, OR CHEMICAL SUBSTANCES: there is no ionizing radiation, radioactive substances, or chemical substances involved.
INVOLVEMENT OF HUMAN SUBJECTS: this project at most involves "invitro" information from lab tests that would be taken in a normal course of patient treatment. We are simply trying to collect the clinical results to better establish the baseline of influenza. If we need to link a lab data report to the syndromic collection, we will use a one-way hash code that lets us uniquely link the lab data to the syndromic data, but does not allow us to identify the patient. Because we have no patient identifiable information, we are protecting the patient privacy and confidentiality. There is not risk for physical injury or disease because we are not changing the patient treatment procedure in any way.
LA-UR - 01-5594
Los Alamos National Laboratory, an affirmative action/equal opportunity employer, is operated by the University of California for the U. S. Department of energy under contract W-7405-ENG-36. By acceptance of this article, the publisher recognized that the U. S. Government retains a nonexclusive, royalty-free license to publish or reproduce the published form of this contribution, or to allow others to do so, for U. S. Government purposes. Los Alamos National Laboratory requests that the publisher identify this article as work performed under the auspices of the U. S. Department of Energy. Los Alamos National Laboratory strongly supports academic freedom and a researcher's right to publish; as an institution, however, the Laboratory does not endorse the viewpoint of a publication or guarantee its technical correctness.
"EARLY DETECTION OF INFLUENZA STRAINS"
Principal Investigator: Dr. JOHN P. NOLAN, Los Alamos National Laboratory
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: Full Board
Approving Institution: Los Alamos National Laboratory
Most recent approval: 02/08/01
IRB approval number: LANL 01-06
Additional IRB approvals from other institutions:
Type of Review: Full Board
Approving Institution: University of New Mexico
Most recent approval: 03/14/01
IRB approval number: HRRC: 01-078
Explanation of additional approval:
Exempt approval by the Universtiy of New Mexico
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 5
Reporting period for number of human subjects:
Fiscal Year 2001
Type(s) of Human Subjects Involvement:
EARLY DETECTION OF INFLUENZA STRAINS
The process to sequence the small, 15 kb genome of influenza virus isolates is being done in collaboration with Dr. Steven Young, Technical Director, Microbiology/Virology, TriCore Reference Laboratories (2811 Stanford, NE, Albuquerque NM 87107). TriCore is a non-profit organization that provides analytical data for clinical samples (including influenza) for three hospitals in Santa Fe and Albuquerque). TriCore propagates putative influenza samples in mammalian tissue cultures and routinely isolates RNA from these samples using commercial RNA isolation kits (guanadinium lysis and spin columns: Qiagen, Inc.). This process results in the isolation and purification of the negative RNA strand that is not infectious. This is the material that will be forwarded to our laboratories at LANL.
At LANL, our basic protocol will be the reverse transcription of the RNA samples and subsequent PCR amplification of the 8 "segments" of the influenza genome. These amplified products will then be sequenced using standard protocols within the Production Sequencing Facility or other smaller sequencing units within LANL. The RNA sequence will be analyzed to identify distinguishing characters that define evolutionary relationships among strains. A microsphere-based genotyping assay will be developed to detect these identifying characters to enable rapid, nucleic acid-based influenza surveillance.
Samples will be coded to indicate the date and location of collection and will not be associated with identifying information.
In many cases, samples are collected by collaborating institutions under informed consent approved by local IRBs with approval of the LANL IRB, and provided to us anonamized with all identifying information removed. In other cases, samples will be obtained with documented informed consent obtained from all subjects in a manner compliant with all federal regulations. In all cases, all records are confidential and may not be disclosed without the subject's written permission with the exception that the FDA and/or funding agencies may inspect the records.
LA-UR - 01-5593
Los Alamos National Laboratory, an affirmative action/equal opportunity employer, is operated by the University of California for the U. S. Department of energy under contract W-7405-ENG-36. By acceptance of this article, the publisher recognized that the U. S. Government retains a nonexclusive, royalty-free license to publish or reproduce the published form of this contribution, or to allow others to do so, for U. S. Government purposes. Los Alamos National Laboratory requests that the publisher identify this article as work performed under the auspices of the U. S. Department of Energy. Los Alamos National Laboratory strongly supports academic freedom and a researcher's right to publish; as an institution, however, the Laboratory does not endorse the viewpoint of a publication or guarantee its technical correctness.
"RAMAN SPECTROSCOPY FOR CANCER DIAGNOSIS AND MONITORING"
Principal Investigator: Dr. JUDITH R. MOURANT, Los Alamos National Laboratory
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 Insti