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: 15
"Manhattan Project Plutonium Workers Health Study"
Principal Investigator: Dr. George L. Voelz, 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: 02/14/00
IRB approval number: 91 LANL 06
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 16
Reporting period for number of human subjects:
Fiscal Year 2000 (10/1/99-9/30/2000)
Type(s) of Human Subjects Involvement:
MANHATTAN PROJECT PLUTONIUM WORKERS HEALTH STUDY
This project involves long term medical and dosimetry follow-up of 26 workers exposed to plutonium in 1944-1945. Periodic medical examinations, urinalyses for plutonium, and chest counts have been done in the past at five (5) year intervals. The last examinations were done in 1997. Since then, annual follow-up has been done using a simple questionnaire to update their addresses, telephone numbers, and major health problems. The death of three (3) study members in 1998 reduced the number of living persons in the cohort to 16 persons. No deaths occurred in 1999. The 2000 update questionnaire is in progress now. In 2000 and 2001, no work will be done on these men personally so no risks will be involved except for keeping records confidential.
"Acceptance Testing for Air-Line Supplied Air-Suits"
Principal Investigator: Mr. Bruce D. Reinert, 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: 02/14/00
IRB approval number: 90 LANL 07
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 8
Reporting period for number of human subjects:
Fiscal Year 2000 (10/1/99-9/30/2000)
Type(s) of Human Subjects Involvement:
ACCEPTANCE TESTING FOR AIR-LINE SUPPLIED-AIR SUITS
A. OBJECTIVES: This program primarily provides testing of air-supplied suits 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 these suites is maintained.
B. 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.
C. 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%.
D. 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 testing are kept confidential. Reports on test results do not contain the identity of test subjects. All test 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.
"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
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: 91 LANL 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 2000 (10/1/99-9/30/2000)
Type(s) of Human Subjects Involvement:
Abstract:
OBJECTIVES: 1) to use human neutrophils to study the binding of a fluorescent peptide to a cell surface receptor. 2) To use this binding interaction as a system for improving flow cytometric instrumentation.
METHODOLOGY: Neutrophils are isolated by centrifugation from fresh human blood (50 mls). Investigations are performed on the isolated cells by flow cytometry.
HUMAN SUBJECTS: Healthy volunteers donate blood by routine venipuncture. An informed consent is read and signed by each donor. Risks are limited to minimal discomfort from drawing the blood sample.
PROGRESS: The National Flow Cytometry Resource (NFCR) has been funded through the period July 1, 1997 to June 30, 2002. The human cells will be an important part of the core Research and Development activities of the NFCR. We expect the project to increase its activities with the arrival of new personnel and instrumentation in the winter of 2000.
"The Development of Improved Methods for the Detection of Individual Sensitivity to Beryllium"
This project is being conducted at multiple sites. See also: ORAU-99-LANL-1_V
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: 02/14/00
IRB approval number: 96 LANL 05
Additional IRB approvals from other institutions:
Type of Review: Full Board
Approving Institution: ORAU/ORNL (Oak Ridge National Laboratory)
Most recent approval: 12/01/99
IRB approval number: LANL-1
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 180
Reporting period for number of human subjects:
Fiscal Year 2000 (10/1/99-9/30/2000)
Type(s) of Human Subjects Involvement:
Abstract:
Los Alamos National Laboratory will become the primary facility within the DOE weapon complex for beryllium work. A state-of-the art Beryllium Technology Facility has been developed and will open this year. The facility will integrate into the workplace the most advanced methods for monitoring airborne beryllium and for minimizing personal exposure. Strict exposure controls are deemed necessary because 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.
a. Objectives
The near term objective of our proposed research plan is to develop cellular and genetic biomarker assays for detecting beryllium sensitivity in beryllium-exposed workers. The longer term objective is to develop new tests that predict beryllium hypersensitivity in exposed individuals and then apply these tests so that individuals who are susceptible to the adverse health effects of beryllium inhalation may be identified before exposure.
b. Methodology
In FY00, we propose to continue to test the LANL beryllium worker cohort 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.
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-LPT are given in terms of the percentage of proliferating cells in a particular (CD4+ or CD8+) lymphocyte subset.
As part of the Immuno-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-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.
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 analysis that we will carry out on the LANL beryllium cohort will be to look for genetic correlates to beryllium sensitivity as measured by the 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 Activation (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 research for the presence of specific variations in the HLA genes will not be reported to the worker.
Subjects in this study may be asked to give a repeat sample if the results on the Immuno-LPT 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.
c. Human subjects will not be exposed to any chemical or radioactive substances as a part of this project.
d. 1. A peripheral blood sample from each subject will be acquired as part of the project procedure.
2. The risks are minimal, and will be those normally associated with blood withdrawal.
3. The researchers receive only a subject or patient number on the sample. The Immuno-Be-LPT results involving LANL subjects are provided to Dr. Smith, who will de-code them and give them to the subject. The results of the genetic biomarker research study are kept in the laboratory in HRL-1 and are not disclosed to the worker.
See project NIOSH-95-015.
Project Identifier: LANL-97-02_V
Project Title: "Prevention of Stress and the Health Consequences of Workplace Downsizing and Reorganization"
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"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
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: 98 LANL 01
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 10
Reporting period for number of human subjects:
Fiscal Year 2000 (10/1/99-9/30/2000)
Type(s) of Human Subjects Involvement:
We propose to develop a non-invasive Intracranial Pressure (ICP) measurement system that could be used by paramedics to monitor the
intracranial pressure of combat casualties while they are being
transported to an appropriate medical facility. Medication or other
treatment required to regulate the patient's ICP could be administered during transport, thereby improving the survival rate of head trauma cases. The ICP sensor could also be designed to work within the framework of a more general patient status system that would provide vital signs and other data to medical facility personnel via telemetry.
During the first year of the proposed study, we will use a combination of ultrasonic tests, to be conducted on both phantom heads and human subjects' heads, and finite element analysis to determine the most viable frequency range for application of the Swept Frequency Acoustic Interferometry (SFAI) technique to non invasive ICP measurement. We will primarily be examining low ultrasonic frequencies between 40 kHz and 1MHz. The goal is to identify the specific frequency range that produces response spectra that can be most readily associated with intracranial pressure variations. The LANL head model will be used to simulate the
ultrasonic tests and provide an understanding of the mechanisms
associated with the various response modes. The maximum spatial
resolution of the LANL head model is 2mm, indicating that the model could resolve wavelengths about 10mm. Given a sound speed of 2920m/s in the human skull (F. A. Duck, 1990), a 10mm wavelength implies a frequency of about 250 kHz. Thus, the upper limit of frequency that could be directly simulated by the LANL head model is about 250 kHz. This limit will tend to focus our interest on the lower frequency portion of the ultrasonic range to be investigated.
The number of human subjects to be tested has been set at 10 in order to provide a good measure of human variability without duly burdening the project with massive data collection and processing requirements.
Subjects for the second year of testing will be selected from among the ten individuals who participated in the first year of testing. For the sake of convenience, those individuals most closely affiliated with the noninvasive ICP project will be preferred in the selection process.
We intend to minimize the risk to human participants in this study by
using an ultrasonic power level that is about 19 times less than the FDA 1974 limit. The output power of our sensors will be limited to 5 mW/cm2. There will be no danger of electrical shock during our tests because the transducer employs a maximum nine-volt signal and no high voltages or currents are generated anywhere in the instrument. Furthermore, the transducer is electrically isolated from the test subjects head during the tests and is electrically grounded.
The test subject should suffer no discomfort from the ultrasonic pulse; the lowest frequency to be used (40 kHz) is two times greater than the highest frequency that can be heard by humans and the power level is too low to be felt by the subject.
Initially, each participant will be scheduled for two test sessions. These sessions will take place on two separate days. Dr. Wray
will conduct the testing in his office at TA-46, Bldg. 217/218, Rm 122. Each test session will take approximately 20 minutes. Two small
piezoelectric transducers, about the size of a nickel, will be placed on the participant's head, and held in place by an elastic band or a small amount of ultrasound gel. The participant will be asked to lie down on a small rollaway bed and relax for 5 minutes. After a five-minute rest period, Dr. Sinha will take a reading with the test device. The time required for each reading is approximately 20 seconds. It may be necessary to repeat a reading two or three times to obtain a satisfactory result. In any case, the total ultrasound exposure time in the supine position will not exceed two minutes. After completion of testing in the supine position, the whole procedure will then be repeated while the participant is in a sitting position and then in a standing position. The total ultrasound exposure will not exceed six minutes total per test session.
After completion of the two scheduled test sessions, the participants may be invited back for up to a maximum of three additional sessions. These additional test sessions will be requested only if there is a real need for additional data.
All identifying information concerning human subjects will be kept in a locked file drawer in Dr. Wray's office (TA-46, Bldg. 217/218, Rm. 122). Actual test data will reside on a desktop computer, but subjects will be identified only through a key that will be kept in the locked file drawer. No publication or any other report of test results, whether written or verbal, will disclose the identity of any subject who participates in the study.
"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: 02/14/00
IRB approval number: 98 LANL 02
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 4
Reporting period for number of human subjects:
Fiscal Year 2000 (10/1/99-9/30/2000)
Type(s) of Human Subjects Involvement:
Objectives: We are currently completing the LANL Superconducting Imaging Surface (SIS) whole-head Magnetoencephalography (MEG) system. The system currently has 64 channels installed of the total 155 expected. In addition, the forward physics problem (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 2000 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.
Methodology: Since the focus of the experiment was determining system response based on well known neurological responses, the methodology was a very simple stimulus (such as a simple median nerve stimulation). 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 FY 2001 with the new forward physics mode.
This experiment is completely non-invasive and involves absolutely no use of ionizing radiation, chemicals, or biological substances.
Human subjects involved were researchers involved in the technical aspects of the project. All were not only well appraised of the procedure, but also involved in designing and carrying out the experimental design. Each subject read and signed the release form no attempt to identify data sets was made except to identify the data with the technical system and data excision parameters. Subject identification was unnecessary since we are not concerned with neurological studies at this stage of the project.
"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
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: 98 LANL 04
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 2000 (10/1/99-9/30/2000)
Type(s) of Human Subjects Involvement:
USE OF HUMAN PERIPHERAL BLOOD SAMPLES IN STRUCTURAL BIOLOGY OF BACTERIAL TOXINS
Bacterial toxin superantigens and bipartite toxins 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 MHC 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. Bipartite AB5 toxins like those produced by E. coli and Vibrio Colerae mediate their effects upon binding to specific receptors (ganglioside receptors, GM1) on target intestinal epithelial cells, resulting in an excessive stimulation of adenyl cyclase and a pathologic production of cyclic adenosine monophosphate (cAMP). With both types of toxins, the initial step in the mediation of their disease-causing effects requires binding to specific receptors.
OBJECTIVE: In a project funded by DARPA (entitled "Structural Biology of Bacterial Toxins"), we are developing non-pathogenic mimics of superantigens and AB5 toxins that should serve as competing, but pathogenically inactive ligands for receptor structures that are recognized as binding sites by the toxins. The goal here is to develop therapeutic strategies that will inhibit the binding of superantigens to their cell receptors and thereby prevent their toxic effects.
METHODOLOGY: To date, three rationally designed superantigens mimics have been synthesized. Using human lymphocytes, we have found that mimics can inhibit both the superantigen (SEB)-stimulated production of Interleukin-2 and the T cell proliferative response. These mimics are being further optimized structurally, and we are generating new mimics to inhibit the toxic actions of other superantigens. As indicated above, we are assessing the ability of the mimics to interfere with superantigen-induced T cell proliferation and the production of Interleukin-2.
HUMAN TREATMENTS: None. Human subjects are only used as a source of peripheral blood to obtain mononuclear leukocytes for in vitro testing.
HUMAN SUBJECTS: Human peripheral blood is sampled by conventional phlebotomy. Mononucleated white blood cells are obtained using density gradient centrifugation. Cells are cultured in the presence of superantigens and mimics. Cell counts are performed. Cell proliferation is also determined by flow cytometry to assess the percentages of cells in S and G2M phases of the cell cycle. Interleukin-2 concentrations in cell culture supernatants are determined by immunoassay.
RISKS: The project poses no risks other than those that may be encountered by conventional, routine phlebotomy.
CONSENT: Participants are volunteers. Before phlebotomy, volunteers are advised about the project's objectives and how their blood will be used. The volunteers must sign an informed consent form before participating in the project as blood donors. Individual identities of the volunteers are irrelevant to the project's objectives.
See project JHUSHP-97-DE-FC03-98SF21541.
Project Identifier: LANL-98-98-LANL-E5_V
Project Title: "Medical Surveillance for Former Department of Energy Workers"
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"Anthropometric Profile of Glovebox Operators"
Principal Investigator: Mr. Jeffery N. Hollander, Los Alamos National Laboratory
Project started in: 1999
This project ended in fiscal year 2000.
Funding for Human Subjects Research:
This project does not involve the use of multiple protocols/subprojects.
Institutional Review Board (IRB) Review:
Type of Review: Expedited
Approving Institution: Los Alamos National Laboratory
Most recent approval: 10/12/99
IRB approval number: LANL 99-04
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 110
Reporting period for number of human subjects:
Fiscal Year 2000 (10/1/99-9/30/2000)
Type(s) of Human Subjects Involvement:
Anthropometry is the study of the range of human physical dimensions such as size (e.g., height), breadth (e.g., shoulder width), and distance between anatomical points (e.g., upper arm length). This information is valuable in determining appropriate dimensions for optimum fit between people and the work environment.
Specific anthropometric information can be derived from published tables, formulae and formula proportions.
There are, however, caveats associated with the use of such published sources. Chief among these is that the data are derived from specific race/gender groups. The analyst considers the population used in the creation of the reference table/formula values in order to make the best decisions on design parameters. Anthropometric data are thus viewed as significant information which is limited in accuracy by the reference table/formula population, the changing norms in body size, and by the variations within race/gender combinations which make up the population being designed for.
The newest Laboratory glovebox specifications are 15-20 years old. The oldest glovebox designs still in use are 40+ years old. Anecdotal data seem to suggest that the variations within race/gender combinations of the population of Lab glovebox operators have changed significantly over this period of time. It is believed the population has become increasingly race and gender diverse. Furthermore, this trend is expected to continue, as it is a stated management goal. An accurate anthropometric profile of today's Laboratory glovebox worker population, the purpose of this study, will best serve those undertaking design changes and improvements to glovebox features and the specification including glovebox gloves. It will also serve as a baseline against which a changing glovebox population can be compared.
The physical measurements of over 100 voluntarily participating Nuclear Materials Technology glovebox operators were recorded in a database. The human subject's stood or sat while physical dimensions were measured directly or by videotape (hands only. There were no risks to the subject's and there are no names or other personal identifying information associated with the data collected.
See project NIOSH-95-004.
Project Identifier: LANL-99-05_V
Project Title: "Leukemia Case-Control Study"
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"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
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
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 8
Reporting period for number of human subjects:
Fiscal Year 2000 (10/1/99-9/30/2000)
Type(s) of Human Subjects Involvement:
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.
Magnetic 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 radiowaves 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 of 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.
"Electromagnetic Mapping of Cardiac Function in the Human Heart"
Principal Investigator: Dr. Robert H. Kraus, Jr., Los Alamos National Laboratory
Project started in: 2000
Funding for Human Subjects Research:
This project does not involve the use of multiple protocols/subprojects.
Institutional Review Board (IRB) Review:
Type of Review: Expedited
Approving Institution: Los Alamos National Laboratory
Most recent approval: 03/06/00
IRB approval number: LANL 00-01
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 2000 (10/1/99-9/30/2000)
Type(s) of Human Subjects Involvement:
Instrument development still in progress.
Proposed Research Summary:
Magnetic field mapping of the heart is a completely noninvasive technique that enables an early and cost-effective diagnosis with a potentially much better reliability for localizing the sites of aberrant and/or impeded electrical activity. We propose to use the same techniques that were developed by the Biophysics group for magnetoencephalography (MEG): magnetic field mapping of extraordinarily small signals using Superconducting Quantum Interference Devices (SQUIDs) and model-based inverse solvers for electrical source localization. We would propose to use electrical myocardial models developed at UCSD and low-field measurement expertise at UCB with the SQUID measurement capabilities and inverse solvers developed by our group. This technique will enable practitioners to observe electrical function of the myocardium with a few millimeters spatial and millisecond temporal resolution.
We propose to build a SQUID-based MCG system to noninvasively measure the magnetic fields resulting from cardiac electrical activity and generate a model-based image of the electrical currents flowing in the heart. We will work with well known cardiologists Michael Crawford and Dr. Milton Icenogle at the University of New Mexico Hospital who will conduct clinical studies utilizing the LANL developed system under their own IRB approved protocol. Colleagues at the University of California (San Diego and Berkeley) will provide needed cardiac model and sensor support to this project. Our goal is to prove the efficacy of a SQUID sensor system based on the LANL-patented SIS concept and to establish a sufficient preliminary database to successfully apply for a NIH grant to study specific conditions in patients at a clinical facility (eg. UNMH). Subsequently, we will work with cardiologists to begin utilizing the MCG system in clinical trials.
"Research Study: LANL Intern Program Evaluation"
Principal Investigator: Dr. Elaine Seymour, University of Colorado-Boulder in collaboration with LANL
Project started in: 2000
Funding for Human Subjects Research:
This project does not involve the use of multiple protocols/subprojects.
Institutional Review Board (IRB) Review:
Type of Review: Expedited
Approving Institution: Los Alamos National Laboratory
Most recent approval: 07/27/00
IRB approval number: LANL 00-02
Additional IRB approvals from other institutions:
Type of Review: Expedited
Approving Institution: University of Colorado at Boulder
Most recent approval: 07/25/00
IRB approval number: 0700.06
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 110
Reporting period for number of human subjects:
Fiscal Year 2000 (10/1/99-9/30/2000)
Type(s) of Human Subjects Involvement:
LANL STUDENT PROGRAMS EVALUATION 2000
OBJECTIVES:
1. To identify and categorize the essential elements of good undergraduate and graduate research experiences, the learning gains they produce over time; the conditions and processes by which these occur; and their relative significance in the achievement of outcomes valued by students and faculty.
2. To prepare analysis, results, implications and recommendations based on the findings through interviews with students and existing survey data.
METHODOLOGY:
1. Planning
· Review and analysis of existing survey materials
· Determine best strategy for rapid and accurate access to student population at LANL
· Prepare sample matrix of student - future work to include mentors
· Access students for interviews and conduct interviews using approved protocol and mutually agreeable interview questions
· Determine the research design and identify research questions
· Plan for dissemination for initial findings to Educational Initiatives Council (EIC) in 12/00
2. Research and Data Collection
· Notification and scheduling of interview target groups based on selected methods and strategies
· Preparation of protocol and obtaining appropriate approvals through HRC
· Conduct the interviews based on approved protocols and design
3. Analysis
· Transcribing all recorded interviews
· Tabulating and organizing data - qualitative and quantitative
· Utilize THE ETHNOGRAPH software to decipher the complex data set
· Code development
4. Report findings
· Data will provide useful insights into the research question
· Findings will be written and submitted and presented to EIC I 12/00
· Findings will include results, recommendations and implications
5. Follow Through
· Thorough explanation & use of report findings
· Develop next steps and strategies
INVOLVEMENT OF HUMAN SUBJECTS: Based on the demographics of the LANL Student Programs, a matrix was developed to select a diverse sampling of students who participate in the LANL student programs (UGS and GRA.) All students were randomly selected and notified of their selection. Students were scheduled for a 55-minute interview session with a University of Colorado trained interviewer. Protocol was adopted and questions were designed to determine the ultimate impact of the LANL Student Programs on the student s and on the institution. All interviews were audiotaped to be transcribed at a later date. All student selected remain anonymous in the final report findings. All students were asked to read and sign the HRC approved consent form. All interviews were held in a private space to protect the identity of each subject. There are no known risks to the subjects due to the project design and approved protocol as implemented. Data collected through the interview interaction is specifically for the use in this research project. Subjects were not exposed to any ionizing radiation as a result of this study. All participants/students were 18 years of age or older.
"Aircrew Process/MOPP Exchange Testing"
Principal Investigator: Dr. Bruce D. Reinert, Los Alamos National Laboratory
Project started in: 2000
Funding for Human Subjects Research:
This project does not involve the use of multiple protocols/subprojects.
Institutional Review Board (IRB) Review:
Type of Review: Expedited
Approving Institution: 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: 9
Reporting period for number of human subjects:
Fiscal Year 2000 (10/1/99-9/30/2000)
Type(s) of Human Subjects Involvement:
OBJECTIVES: The objective 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.
METHODOLOGY: The testing is conducted in accordance with Los Alamos National Laboratory proposals Aircrew Processing/MOPP Exchange Testing R-2224-99-0 and R-2224-00-0.
EXPOSURE TO CHEMICALS: The risks to the test subjects are minimal. The UV 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 1,500 mg/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.
INVOLVEMENT OF HUMAN SUBJECTS: 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 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 subjects photographed under ultra violet light to determine if any of the florescent 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.
Data will be stored in locked files at the R&D Team facility and transferred to the sponsor as appropriate. Data will be released only to the Naval Air Warfare Center Project officer. Test subjects will be identified only by the ESH-5, R&D team human subject numbers.