Mr. James R. Fallin
Los Alamos National Laboratory
Public Affairs Office, CER-20
P. O. Box 1663, MS C177
Los Alamos, NM 87545-
Phone: 505-667-1455
Fax: 505-665-3910
E-mail: jfallin@lanl.gov
Number of Human Subjects projects reported: 25
| LANL-52-91 LANL 06 | "Manhattan Project Plutonium Workers Health Study" |
| LANL-98-02 | "Neuromagnetic Mapping of Functional Centers in the Human Brain. Formerly Titled: Initial Efficacy Study of a New Whole-Head Magnetoencephalography System " |
| LANL-01-07 | "Polarized Elastic Scattering Spectroscopy System" |
| LANL-01-11 | "Biosurveillance Analysis Feedback Evaluation and Response. Formerly titled: Rapid Syndrome eValuation Project (RSVP)" |
| LANL-01-12 | "Early Detection of Influenza Strains" |
| LANL-01-13 | "Raman Spectroscopy for Cancer Diagnosis and Monitoring" |
| LANL-01-14 | "Advanced Leukemia Diagnostics" |
| LANL-01-15 | "Optical Biosensor for the Early Detection of Breast Cancer" |
| LANL-01-16 | "Joint Protective Air Crew Ensemble, JPACE. Formerly known as Air Warrior Dirty Doffing Test" |
| LANL-01-17 | "Transmission and Viral Dynamics of Drug Resistant HIV-1" |
| LANL-02-02 | "Application of a High-Geometry, Low-Energy Photon Detector, and Simple Sample Preparation Techniques for Rapid Analysis of Bioassay Samples" |
| LANL-02-05 | "Reliability Test of a Self-Efficacy Scale" |
| LANL-02-10 | "Facilitation and Support for the Design and Testing of a Relevant HIV-1 Vaccine Candidate " |
| LANL-02-11 | "Bioassay Analysis for the Determination of Plutonium in Atomic Veterans " |
| LANL-03-01 | "Spatiotemporal Imaging of Human Visual Systems Processing. Specific Aim 2: Optimize Integration of fMRI/MEG/EEG Data " |
| LANL-03-02 | "New Human DNA Fingerprinting Method Demonstration Project" |
| LANL-03-03 | "Bio-Surveillance Analysis Feedback Evaluation and Response (B-SAFER)" |
| LANL-03-04 | "HIV Compartmentalization in Women: Virus and CTL Response" |
| LANL-03-05 | "Retaining Radiation Safety Personnel for Mission-Critical Positions" |
| LANL-03-06 | "Electromagnetic Studies of the Fetal Heart at the Los Alamos National Laboratory" |
| LANL-03-07 | "Use of Nuclear Medicine Patients to Determine the Response of Radiation Detections System" |
| LANL-03-08 | "Los Alamos National Laboratory Employee Assistance Program (EAP) Employee Opinion Survey" |
| LANL-03-10 | "HIV Molecular Epidemiology Survey" |
| LANL-03-11 | "MOSIS Remote Biometric Sensing" |
| LANL-03-12 | "Emergency Department and Pre-Hospital Surveillance and Analysis Protocol " |
Other projects of interest associated with this site:
| JHUSHP-97-DE-FC03-98SF21541 | "Medical Surveillance for Former Department of Energy Workers" |
| NIOSH-95-004 | "Leukemia Case-Control Study" |
"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: 02/11/03
IRB approval number: LANL 91-06
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 14
Reporting period for number of human subjects:
Fiscal Year 2003
Type(s) of Human Subjects Involvement:
Study Title: Manhattan Project Plutonium Workers Study
The study of Manhattan Project Plutonium Workers was begun in 1952 by Louis Hemplemann and Wright Langham. The study identified the 26 Manhattan Project Workers who had the highest exposures to plutonium (Pu) at Los Alamos during WWII. The health and estimated plutonium deposition of these workers have been followed at approximately five-year intervals since 1952. At many of these intervals the workers returned to Los Alamos for complete medical and dental exams. Now due to the advanced age of the surviving members of the cohort, travel to Los Alamos is no longer feasible. In addition to other medical/dental examinations, workers have provided urine samples for plutonium dosimetry analyses. These analyses have been used to better estimate the doses of these workers and also to improve the techniques used to monitor plutonium deposition among exposed individuals. The workers have participated in many other projects, such as a chromosome analysis, whole body dosimetry, and other medical and research projects. Mortality follow-up of the cohort has been ongoing from 1952 to the present. In the most recent contact with these workers, the workers provided new urine samples for analyses and recent medical records and histories.
The updated information on the medical condition of the surviving cohort members will be completed. Questionnaire data obtained last year from contacts (by mail) will be analyzed and used for an updated publication. The individuals and their data will not be identified in this publication. Mortality analyses comparing the mortality experience of this cohort with the expected mortality based on US death rates will be conducted and included in the paper(s) describing this study. Internal comparisons of mortality among the study cohort with mortality among an internal comparison cohort, which was selected based on similar work history and age, will be conducted. Mortality follow-up for the comparison cohort will be updated through an agreement with the National Death Index. Comparing mortality among the study group with mortality among the internal comparison group should reduce the impact of the healthy worker effect or other selection bias. This mortality follow-up of the comparison population has been conducted in previous updates of this study and has been reported in previous papers.
Urine bioassay samples have historically been collected from the subjects in the Manhattan District workers cohort at LANL during the entire period that the study has been ongoing. The latest samples were collected from surviving subjects in autumn 2002. These samples were analyzed for plutonium content using either alpha spectrometry or the more sensitive thermal ionization mass spectrometry (TIMS) method. These and previous bioassay samples are being used to estimate the radiation doses for each of the workers in the population.
It is anticipated that additional samples will be collected in the future from the cooperating survivors in this study. Since previous samples were collected about every six years, more frequent sampling is desirable, but not more than once yearly. An important scientific question that can be addressed with additional samples is whether age-related osteoporosis results in an increase in the rate of Pu urinary excretion. Because current biokinetic models do not take this possibility into account, it is important to document whether the phenomenon occurs. It is anticipated that at least two reports will be prepared as a result of these efforts. One report will deal with the results of the review of medical conditions and mortality analyses and the other will deal with the improved, updated dose assessments.
LA-UR-03-8082
"Neuromagnetic Mapping of Functional Centers in the Human Brain. Formerly Titled: Initial Efficacy Study of a New Whole-Head Magnetoencephalography System"
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: 02/11/03
IRB approval number: LANL 98-02
Additional IRB approvals from other institutions:
Type of Review: Expedited
Approving Institution: University of New Mexico Medical Center Dept of Radiology, VA Hospital, Albuq/Magnetic Source Center
Most recent approval: 03/04/03
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 2003
Type(s) of Human Subjects Involvement:
Study Title: Neuromagnetic Mapping of Functional Centers in the Human Brain
Background – We have completd construction of a novel whole-head superconducting image sensor system for magnetoencephalography (MEG) of the human brain. We have recently added new background sensor channels and developed computational algorithms to subtract background in post-processing. We have also developed real-time background rejection to provide researchers with real-time results of measurements. The experimental calibration and validation of the system using physical phantoms has been completed. We have demonstrated 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 positron emission tomography (PET) and functional magnetic resonance imaging (fMRI) 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 MEG system and implemented unique background noise rejection hardware and software. The system has 149 primary channels installed and tested for measuring brain signals. In addition, 15 sensors have been installed to simultaneously measure background noise for rejection of this noise from primary channels. The new finite-element method (FEM) forward physics model (required for source localization for functional localization in the brain) has been improved and optimized. The primary objective continues to be demonstrating efficacy and improving performance for this new instrument. Human studies were performed to obtain representative data for the new SIS MEG system. The focus through FY 2003 was to obtain temporal data for well-known and thoroughly investigated paradigms. The most simple evoked response experiments were performed (for example, somatosensory and auditory response paradigms) to evoke a primary somatosensory cortex and primary auditory response. These data were compared to well-known time-domain responses for healthy subjects to confirm the outstanding temporal and signal-to-noise performance of the new instrument. We have used the same human subjects at the Veteran's Administration (VA) Hospital in Albuquerque for this study to compare the commercial MEG system at the VA with the Los Alamos system. IRB approvals at both institutions were coordinated and approved.
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 intermixed with a simple auditory "click." The data in and around the N20 and P100 to P150 responses were examined and compared to prior investigators for temporal response and general location. In addition, the relative locations of somatosensory response were correlated with the location of the auditory response (primary auditory cortex). Extremely good agreement was found between the LANL SIS-MEG system and the VA Hospital commercial system. Problems with data acquired at the VA have prevented comparison of all subject data. 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 auditory, visual evoked response, somatosensory, and motor paradigms. Auditory stimuli include simple "clicks" presented at a low but audible level (dB was not measured, however sound was very slightly above subject recognition threshold). Visual stimuli include gray-scale patterns at one position, numerous different positions, with varying time duration, and stationary or moving location. 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 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 the University of New Mexico).
Experiments in FY2003 have focused on signal quality improvement by noise rejection methods, comparing features of signal-to-noise and temporal details of the signal, localization reliability and accuracy, and comparison between LANL and VA systems. 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 reproducible. We have developed noise rejection better than any reported in the literature. The noise rejection reduces ambient field noise in the brain signal by a factor of more than 10,000. The residual noise in the primary brain signal sensors is at or near the inherent noise level of the sensors themselves. The forward model (FEM) discussed above is being integrated with state-of-the art source localization procedures. We have reported very good results with our data (from the LANL SIS-MEG system).
Involvement of Human Subjects – Human subjects involved were researchers involved in the technical aspects of the project or related projects. All were not only well-apprised of the procedure, but have been either directly involved in designing and carrying out the experimental design or work on closely related efforts. Each subject read and signed the consent form. In order to compare data between LANL and VA systems, data sets were correlated with subject identity using an encrypted computer generated code. Confidentiality is preserved by keeping any linkage between subject and data in a locked administrative vault.
Outcome – Excellent agreement between LANL and VA systems was observed for all data with high integrity from the VA. All data obtained with the LANL system provided good correlation between primary somatosensory and primary auditory locations. Noise rejection dramatically improved the quality of the LANL SIS-MEG data. Real time algorithms to provide researchers (and ultimately clinicians) the opportunity to review data while the subject is still available in the instrument is progressing well.
LA-UR-03-8082
"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: 11/30/02
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: 04/23/03
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 2003
Type(s) of Human Subjects Involvement:
Study Title: Polarized Elastic Scattering Spectroscopy System
a. 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 presentation by an NIH program manager the sensitivity and specificity of the Pap smear were both given as about 50 percent. 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.
b. 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.
c. Risk: There is no exposure to ionizing radiation, radioactive substances or chemical substances. 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 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 from bleeding during the biopsy, and vaginal spotting afterwards.
d. Involvement of human subjects. In order to participate in the study patients will have to sign a consent form. This consent form describes, the purpose and background, the procedures, possible risks and discomforts, benefits of participation, and confidentiality of the study. The following information was taken from the consent form. A slender 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. 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.
At this stage in the study, the expected results are an understanding of the reproducibility of the measurement system and preliminary correlations with pathology. These results will be used to improve our experimental measurement system and the study design. The criteria for success or failure for the study is ultimately the correlation with pathology. If sensitivities and specificities of 85 percent or higher are obtained the study will be a success, if lower specificities and sensitivities are obtained then the study will either have to be terminated or redesigned.
LA-UR-03-8082
"Biosurveillance Analysis Feedback Evaluation and Response. Formerly titled: Rapid Syndrome eValuation Project (RSVP)"
Principal Investigator: Dr. Edward L. Joyce, Los Alamos National Laboratory
Project started in: 2001
This project ended in fiscal year 2003.
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: 02/11/02
IRB approval number: LANL 01-05
Explanation of IRB approval:
LANL closed this phase of the study 02/11/03.
Additional IRB approvals from other institutions:
Type of Review: Expedited
Approving Institution: University of New Mexico
Most recent approval: 06/25/03
IRB approval number: FWP20020032E
Explanation of additional approval:
UNM continued work on this phase of the project.
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 2003
Type(s) of Human Subjects Involvement:
Abstract:
Study Title: Biosurveillance Analysis Feedback Evaluation and Response
Formerly Titled: Rapid Syndrome eValuation Project (RSVP)
Study closed 2/11/03 - no renewal, no activity.
RSVP was a collaborative effort between Los Alamos National Laboratory, Sandia National Laboratory, the University of New Mexico School of Medicine, and the New Mexico Department of Health. Clinical/syndromic data were gathered in hospital emergency rooms with the intent of identifying a bio-terrorist event from a physician examination.
LA-UR - 03-8082
"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: 02/11/03
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: 03/21/01
IRB approval number: HRRC: 01-078
Explanation of additional approval:
Exempt approval by the University of New Mexico
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 2003
Type(s) of Human Subjects Involvement:
Study Title: The 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, N. E. 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. We will also culture selected isolates obtained from TriCore at Los Alamos in order to prepare RNA locally.
At LANL our basic protocol will be the reverse transcription of the ribonucleic acid (RNA) samples and subsequent polymerase chain reaction (PCR) amplification of the eight "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.
The total number of samples to be collected will be in the range of 20 to 50 samples per year, depending on availability. Samples will be coded to indicate the date and location of collection and will not be associated with identifying information. Samples obtained from TriCore are collected through the New Mexico Department of Health influenza surveillance activities, and as such, have no consent form associated with them. These activities were reviewed by the University of New Mexico IRB and are approved as Exempt (but as Expedited by the LANL IRB). It is anticipated that as the project progresses we will obtain samples from additional collaborators. In these cases we will provide the IRB the necessary information regarding our collaborators' IRB approval and informed consent, as appropriate.
LA-UR-03-8082
"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 Institution: Los Alamos National Laboratory
Most recent approval: 03/29/03
IRB approval number: LANL 01-07
Additional IRB approvals from other institutions:
Type of Review: Full Board
Approving Institution: Swedish Medical Center, Seattle, Washington
Most recent approval: 02/01/03
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 2003
Type(s) of Human Subjects Involvement:
Study Title: Raman Spectroscopy for Cancer Diagnosis
a. Objectives: The detection of cancer at its earliest stages is crucial, for it greatly improves the likelihood of successful treatment. Traditional methods of diagnosis have relied on physical removal of a portion of tissue and microscopic assessment of morphology. The need for tissue removal reduces the area of tissue that can be sampled. A non-invasive technique would eliminate this problem. Furthermore, a non-invasive technique has the potential to allow treatment to begin during the same endoscopic procedure used for diagnosis and reduce other complications associated with tissue removal such as tissue handling and increased risk of infection to the patient. Our general objective is to enable the application of vibrational spectroscopy to cancer diagnosis and treatment monitoring. Vibrational spectroscopy is a non-invasive method of obtaining information on the chemical constituents of tissue. We will focus on developing Raman spectroscopy for detection of precancerous conditions in patients with Barrett's esophagus. Barrett's esophagus is a pathology in which the squamous epithelial lining is replaced by a specialized metaplastic epithelium and the likelihood of adenocarcinoma is increased. Because the microscopic changes of dysplasia are difficult to observe, the entire area of metaplastic epithelium should be sampled. Therefore, Barrett's esophagus is well-suited for a non-invasive diagnostic technique. The methods and techniques developed in this proposal may also find application in other tissues such as the cervix. The second objective of our work is to develop Raman spectroscopy as a method for assessing the effects of treatment. Current methods for monitoring the response of an individual tumor to therapy are unreliable and often difficult to implement during the course of therapy. Development of non-invasive or minimally invasive optical methods to reliably identify regions of apoptosis and necrosis would provide a simple method for assaying tumor response in each individual cancer patient. Consequently, treatments could be customized.
b. Methodology: The project is expected to be five years in duration. The first two years will be primarily used to understand the vibrational signatures of viable cell suspensions and will not involve human subjects. After we have gained experience with well-controlled cell cultures, we will make measurements of tissue. We will only measure excised tissue specimens. These measurements will be samples normally removed during the course of examination and possibly a biopsy site believed to be non-cancerous/non-dysplastic. Raman instrumentation will be taken to the clinical site (Swedish Medical Center). We will set up the instrumentation in the clinical rooms where the normal biopsy procedures are performed. When a biopsy is taken, it will be immediately measured by the Raman system prior to being placed in formalin. The measurement will consist of placing a fiber optic probe in contact with the tissue. Red light will be emitted out of the end of the probe. The light is intense enough that if you stare at it, eye damage may occur. (The exact intensity of the light is not known at this time, because we are still developing the Raman system. The light hazard issue should be readdressed before clinical trials begin.) All operators of the instrumentation will be made aware of the potential light hazard and told never to point the probe at a patient or at anyone's eyes. After measurement by the Raman system each biopsy specimen will be placed in an individual container labeled such that a later correlation between our spectroscopy and the histopathological diagnosis can be performed. 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.
c. Ionizing Radiation, Radioactive Substances, or Chemical Substances: None.
d. Involvement of Human Subjects: Please see the Methodology section.
Initial work for this study will involve examination of biopsy samples. We aim to determine whether there is a relationship between the biochemical information we obtain and the pathology for those samples. If a relationship is found, then we will attempt to modify our protocol so that we can perform in vivo studies.
LA-UR-03-8082
"Advanced Leukemia Diagnostics"
Principal Investigator: Dr. John P. Nolan, Los Alamos National Laboratory
Project started in: 2001
This project ended in fiscal year 2003.
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: 05/31/02
IRB approval number: LANL 01-08
Explanation of IRB approval:
Study closed, not renewed.
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:
Study Title: Advanced Leukemia Diagnositics
Study Closed 5/31/03.
In this study researchers in Bioscience Division worked on the development of new approaches to solve critical biological problems. One of the areas of interest is disease diagnostics. To this end, we have developed a new method to identify chimeric mRNAs (messenger RNA) resulting from chromosomal translocations associated with leukemia. Using microspheres and flow cytometry, we are able to rapidly determine the type of the translocation as well as the specific junction variant.
The method involves isolation of ribonucleic acid (RNA) from the cells of interest, production of coding DNA (cDNA) using reverse transcriptase (a protein that catalyzes and synthesizes DNA from an RNA template), and polymerase chain reaction (PCR) amplification of the chimeric mRNA. The PCR amplified target is then interrogated with a panel of synthetic oligonucleotide (a synthetic single strand of DNA) probes that are then analyzed by flow cytometry (a method for the optical analysis of small particles). Initial studies were performed using cell lines and synthetic DNA templates. To validate our method on actual clinical samples we will work with Dr. Carl Stewart of the Roswell Park Cancer Institute (RPCI), whose laboratory is a leader in flow cytometry-based leukemia diagnostics.
Dr. Stewart's lab isolated RNA from a number of patient's samples and sent them to Los Alamos for testing. All identifiers were removed from the samples sent to Los Alamos, and there was no way for LANL researchers to associate the results with identity of the original donor. The samples were collected using protocols approved by the RPCI IRB.
LA-UR-03-8082
"Optical Biosensor for the Early Detection of Breast Cancer"
Principal Investigator: Dr. Basil I. Swanson, 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: 07/27/03
IRB approval number: LANL 01-09
Additional IRB approvals from other institutions:
Type of Review: Full Board
Approving Institution: City of Hope National Medical Center
Most recent approval: 04/08/03
IRB approval number: 00080
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 2003
Type(s) of Human Subjects Involvement:
Study Title: Optical Biosensor for the Early Detection of Cancer
The overarching objective is to develop a sensor system that could be used for the early detection of antigenic markers for breast cancer to aid in the diagnosis and monitoring of cancer. Currently, the diagnosis of breast cancer is limited to self-exam, clinical exam, and mammography. Mammography is the best of these diagnostic tools and yet it is quite expensive and has significant problems with both false positives and false negatives. The development of a quick, simple diagnostic tool based on the detection of a panel of tumor markers would greatly improve the management of this disease. The biosensor platform and assays are being developed at Los Alamos and the clinical study is being performed at the City of Hope National Medical Center. The human patient studies are being conducted under the auspices of the City of Hope IRB (Protocol 00080), as well as the Los Alamos National Laboratory Human Subject Protocol 01-09.
In the R21 phase we will demonstrate the optical biosensor for the detection of carcinoembrionic antigen (CEA) and in the R33 phase we will fully develop assays for three tumor markers including CEA, Her2/neu, and cancer antigen CA15.3. All patients that are eligible for the study will have been referred to the City of Hope clinic as a result of an abnormal mammogram on one breast. These patients are eligible for our study and have either benign breast disease or are diseased subjects with unilateral breast cancer. Those with benign breast disease provide controls that will allow us to differentiate CEA levels in secretions from breasts containing cancerous and benign tumors. In addition, each patient with unilateral breast disease provides an internal control.
Secretions will be collected on nipple filters from both the healthy and the biopsied breast so that each patient provides a control allowing us to establish CEA levels in secretions from normal and cancerous breast tissue. The intra-patient variability in CEA levels detected on nipple filters will be determined by collecting replicate samples from the same patient as described in the City of Hope protocol. Sample collection will not interfere with the patients' treatment schedule. When allowed for by the treatment schedule, replicate samples will be collected with at least a two-day interval prior to the patient's treatment (surgery/biopsy). In addition, nipple blots will be collected from patients 30-day post treatment at the regular follow-up examination. When possible duplicate post-treatment nipple blots will be collected with a two-day interval. Data from these replicate samples are examined statistically as described in Section VIII.B of the City of Hope protocol. Specifically, reproducibility of the nipple blot CEA assay will be assessed using data from replicate samples within each group (cancerous breast, benign diseased breast, and bilateral healthy breast) by the intra-class correlation coefficient (ICC).
Blood samples (10 mL) will be drawn from each patient and tumor marker levels will be determined by enzyme immunoassay (EIA) and by the biosensor analysis. Nipple blots will be obtained from each breast on each patient. All of the data will be coded and used for this study only. The risks to the patient are minimal. Routine blood draws carry a small risk of a transient hematoma. We know of and anticipate no risk associated with obtaining the nipple blot. If a rash or other problem develops, we will treat the patient with an appropriate ointment. The patients' names and study results will be coded and kept confidential. The data will be retained by the PI in a locked file drawer in his office.
LA-UR-03-8082
"Joint Protective Air Crew Ensemble, JPACE. Formerly known as Air Warrior Dirty Doffing Test"
Principal Investigator: Mr. Fredric N. Bolton, 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: 10/10/02
IRB approval number: LANL 01-11
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 2003
Type(s) of Human Subjects Involvement:
Study Title: Joint Protective Air Crew Ensemble (JPACE)
(Formerly: "Air Warrior Dirty Doffing")
Scientific Context and Objectives:
This study is a continuation of work performed for JPACE Testing during FY2002. One of the JPACE objectives is that the selected garment be capable of providing protection to both the wearer and assistants during the doffing process following completion of a military mission. The objective of this phase of the study is to determine how the effectiveness of the protective garments may be improved during post-mission doffing and decontamination.
Hypothesis:
The hypothesis to be tested is that the protection afforded to the wearer and assistants can be greatly improved through a combination of decontamination methods and doffing technique.
Experimental Design:
The selection of test subjects, as well as experimental design and study conduct, are very similar to previous JPACE work. This phase of the study involves similar combinations of protective garments and equipment, and test subjects previously identified for JPACE work will be asked to participate. A variety of methods of decontamination (dry removal, wetting garment surfaces, etc.) will be employed to determine which combinations of decontamination method and doffing technique appear to provide better overall protection from contamination transfer to bare skin.
Procedures Involving Human Subjects:
As with previous JPACE work, human subjects will be dressed in the appropriate combination of protective garment and equipment. Once dressed in the military garb, the subjects will be exposed to a tracer (e.g., fingerprint powder), which will be used to visually track the transfer of contamination to the wearer’s skin during the doffing process. The known risks to human subjects include:
· Brief inhalation exposure to airborne tracer materials (e.g., fingerprint powder) while fully garbed in military protective gear (including respiratory protection).
· Potential contact between the tracer material and unprotected skin (e.g., neck, wrists, and ankles).
· Slightly elevated risk of heat stress (a combination of the protective clothing and respirator).
· Slightly elevated risk of cold stress arising from the use of wet decontamination methods.
· Potential for brief exposure to ultraviolet light during test evaluation (post-doffing) and digital imaging.
Anticipated Results, Criteria for Success, and Study Termination:
The main record of interest for this phase of JPACE continues to be the digital images collected after the military garb has been doffed. Key to success of the work is the ability to qualitatively discern the differences in performance between different combinations of decontamination method and doffing technique. The study is expected to result in information that will be useful to military planners in establishing appropriate decontamination and doffing procedures for potentially contaminated air crew members and assistants. The study will be terminated when the final JPACE garment design has been accepted by the DoD.
LA-UR-03-8082
"Transmission and Viral Dynamics of Drug Resistant HIV-1"
Principal Investigator: Dr. Alan S. Perelson, 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: 09/10/03
IRB approval number: LANL 01-12
Additional IRB approvals from other institutions:
Type of Review: Full Board
Approving Institution: The Rockefeller University
Most recent approval: 07/03/03
IRB approval number: MMA-0340-0703
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 2003
Type(s) of Human Subjects Involvement:
Abstract:
Study Title: Transmission and Viral Dynamics of Drug Resistant HIV-1
Objectives: This is an NIH-funded project aimed at understanding the virological determinants that govern the transmission, fitness, and in vivo replication dynamics of multi-drug resistant human immunodeficiency virus-type 1 (HIV-1). The project has three specific aims:
1. Use genotypic and phenotypic methods to determine whether drug resistant HIV-1 variants are being transmitted with increasing prevalence.
2. Determine how the replicative characteristics and relative fitness of drug resistant viruses may affect the transmission of HIV-1 infection.
3. Use intervention-based clinical studies to define the replication dynamics of drug resistant variants of HIV-1 in vivo.
Methodology: To accomplish Aim 1, blood will be drawn and HIV isolated and tested for resistance to antiretroviral drugs.
To accomplish Aim 2, wild-type and drug resistant virus will be grown in cell culture. By measuring the fraction of viruses in culture that are drug-resistant at different times, one can compute the fitness of the drug-resistant virus relative to the wild-type.
In Aim 3, the concentration of HIV-1 in plasma will be measured as a function of time patients have been on antiretroviral drug therapy. Mathematical models of HIV-1 replication in individuals undergoing drug therapy will be used to analyze the data obtained from the study subjects. From such an analysis one can deduce how fast subjects are clearing HIV from their blood stream and how rapidly the virus is killing infected cells. We are interested in learning how these rates change in patients infected with drug-resistant virus versus wild-type virus.
Ionizing Radiation, Radioactive Substances, or Chemical Substances: None.
Involvement of Human Subjects: Work at LANL will only involve statistical analysis and mathematical modeling of data obtained elsewhere. The data will be sent to LANL with patients identified in coded form. The data will include patient coded identification numbers, time since start of therapy, HIV RNA/ml CD4 count, and the fraction of the HIV RNA that is wild-type or drug resistant. No personal information about the patients will be obtained.
LA-UR-03-8082
"Application of a High-Geometry, Low-Energy Photon Detector, and Simple Sample Preparation Techniques for Rapid Analysis of Bioassay Samples"
Principal Investigator: Dr. Raymond A. Guilmette, Los Alamos National Laboratory
Project started in: 2002
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: 12/20/02
IRB approval number: LANL 02-02
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 2003
Type(s) of Human Subjects Involvement:
Study Title: Application of a High-Geometry, Low-Energy Photon Detector, and Simple Sample Preparation Techniques for Rapid Analysis of Bioassay Samples
This project aims to improve the timeliness of incident-related dose assessments by providing radiometric measurements of actinides in fecal samples with in 24 to 48 hours after a worker inhalation exposure, which is up to two weeks sooner than is currently possible using existing radiochemical methods for analyzing urine bioassay samples. The methods to be developed involve using a specialized photon detector that can measure small amounts of Pu, Am, Cm in minimally processed fecal samples. To do this study, human fecal samples obtained from unexposed volunteers are needed. To date, such samples have been obtained from five volunteers. The samples were obtained without any labeling or personal identifiers, and are maintained frozen as anonymous samples until needed for the study. Because of problems encountered with the performance of the photon detector, this project will be extended for another one-year period. During this period, more fecal samples may be required. To date, a method for reducing the volume of fecal samples by 75 percent has been identified. This is adequate to allow the entire sample to be counted within the active volume of the photon counter. As before, there is no risk to the volunteers who contribute fecal samples.
LA-UR-03-8082
"Reliability Test of a Self-Efficacy Scale"
Principal Investigator: Ms. Anne E. Khoury, Los Alamos National Laboratory
Project started in: 2002
This project ended in fiscal year 2003.
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: 02/21/02
IRB approval number: LANL 02-05
Explanation of IRB approval:
Study closed at LANL, not renewed. Employee terminated from LANL and is now conducting study with new employer, LLNL.
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 86
Reporting period for number of human subjects:
Fiscal Year 2003
Type(s) of Human Subjects Involvement:
Study Title: Reliability Test of a Self-Efficacy Scale
Study closed at LANL 2/12/03; not renewed.
Objective: Determine the reliability of the Self-Efficacy Scale for Los Alamos National Laboratory (LANL) leaders.
Methodology: In FY2002 100 LANL managers were selected by the LANL Leadership Center Staff to receive the Self-Efficacy Scale survey. The 100 managers were selected from the population of alumni of the Laboratory Leadership and Management Institutes. Sample participants were emailed the 23-item questionnaire by Leadership Center Staff. Responses were returned to the researcher through LANL mail to protect the identity of the respondents. No demographic data were collected so the data had no personal identifiers attached.
Human Subjects Involvement. See Methodology.
LA-UR-03-8082
"Facilitation and Support for the Design and Testing of a Relevant HIV-1 Vaccine Candidate"
Principal Investigator: Dr. Bette T. Korber, Los Alamos National Laboratory
Project started in: 2002
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: 07/23/03
IRB approval number: LANL 02-10
Additional IRB approvals from other institutions:
Type of Review: Full Board
Approving Institution: Massachusetts General Hospital
Most recent approval: 12/24/02
IRB approval number: MGH: 2001-P-001941
Type of Review: Full Board
Approving Institution: NYU School of Medicine
Most recent approval: 11/11/02
IRB approval number: H 9430-03 A
Type of Review: Full Board
Approving Institution: Massachusetts General Hospital, Boston Massachusetts
Most recent approval: 04/25/03
IRB approval number: 2000-P-001150
Type of Review: Full Board
Approving Institution: Massachusetts General Hospital, Boston Mass.
Most recent approval: 02/05/03
IRB approval number: 2001-P-000012
Type of Review: Full Board
Approving Institution: Massachusetts General Hospital, Boston Mass.
Most recent approval: 01/08/03
IRB approval number: 2002-P-000063
Type of Review: Expedited
Approving Institution: Massachusetts General Hospital, Boston Mass.
Most recent approval: 11/21/02
IRB approval number: 2002-P-000132
Type of Review: Full Board
Approving Institution: Massachusetts General Hospital, Boston Mass.
Most recent approval: 01/08/03
IRB approval number: 2002-P-000133
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 200
Reporting period for number of human subjects:
Fiscal Year 2003
Type(s) of Human Subjects Involvement:
Study Title: Facilitation and Support for the Design and Testing of a Relevant HIV-1 Vaccine Candidate
This is a study of HIV immune responses in populations with differences in host immune genes and differences in the infecting virus. The NIH funded this contract to explore the host immune response to HIV in populations that are likely vaccine sites. The baseline information will help both in the design of optimal vaccines for particular populations, and in interpretation of vaccine trial immunogenicity results.
Whereas Europe and America have mainly HIV1 subtype B, eastern Africa has predominantly subtypes A and D. Southern Africa on the other hand has mostly subtype C. Because of this viral variation, and differences in highly variable, immunologically important human genes in different regions of the world, a vaccine that is best for one location might not be optimal for another.
We do not do any experimental work in the Theoretical Division at Los Alamos. The NIH specified that the basic immunological information gained through this contract will be incorporated into the NIH-DOE sponsored database at Los Alamos, to facilitate HIV vaccine design in the developing world. Part of our task is to make the appropriate information concerning the immunologically reactive parts of the virus in the Barbados, and in South Africa, available to HIV researchers through our LANL based HIV immunology database. Prior to public release of the data, we will work with our co-authors and assist them in analyzing the data and writing the publication, then the published data will be made available to other researchers.
Blood is drawn from HIV positive patients attending participating clinical locations in the US, South Africa, and Barbados. Patients are asked if they would mind giving a blood sample to be used for the research study; this work may help to design an HIV vaccine and appropriate tests for vaccine trials in the region. Local IRB approved consent forms are used; copies of the consent forms and the initial IRB approvals were provided to the LANL/DOE IRB when the project was approved. There is no direct benefit to the patient, only possible benefit to their community and society. The patient is already attending the clinic and is known to be HIV positive. Technology transfer is bringing immunology assays to South Africa and Barbados, and immunological testing is done on site. A small amount of the blood sample is shipped to Harvard University and to the University of Washington. Host immune response genes are characterized, the viral sequence is obtained, the amount of virus in the sample is measured, and the immune response is measured. Viruses may be cultured or cells may be cultured for testing the immune response on site or at Harvard.
Minimal clinical records accompany the samples, essentially just the CD4 T-cell count, viral load, and treatment status. The patient is given a coded identifier for the purpose of the study and communication between investigators. Only the patient's physician can break the code. The kind of data we are collecting is often found in scientific publication. The patient is being treated for being HIV positive, and this study does not compromise treatment or privacy. The primary risk involved is associated with the blood draw, and patients are fully informed concerning the research nature of the study. Their treatment is not influenced in any way by their choice to participate or not.
LA-UR-03-8082
"Bioassay Analysis for the Determination of Plutonium in Atomic Veterans"
Principal Investigator: Dr. Samuel E. Glover, Los Alamos National Laboratory
Project started in: 2002
This project ended in fiscal year 2003.
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: 09/05/02
IRB approval number: LANL 02-11
Explanation of IRB approval:
Study was completed May 2003.
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 24
Reporting period for number of human subjects:
Fiscal Year 2003
Type(s) of Human Subjects Involvement:
Study Title: Bioassay Analysis for the Determination of Plutonium in Atomic Veterans
Study closed 5/2003.
In this study Los Alamos National Laboratory (LANL) determined the plutonium content of human urine from veterans for the Defense Threat Reduction Agency (DTRA). LANL will utilize standard Thermal Ionization Mass Spectrometry (TIMS) protocols currently in use for its plutonium bioassay program to conduct these measurements. Each veteran will submit two 24-hour bioassay samples.
The intent of this study is to improve the internal dose estimate for these veterans using the most sensitive methods available. Each of these veterans previously participated in a follow-up study conducted at Brookhaven National Laboratory using fission track analysis. Consent for participation was obtained from volunteers. All personal information and bioassay results were kept confidential according to Privacy Act regulations. Each veteran was provided two 24-hour bioassay kits standard to the LANL bioassay program. Each kit consisted of eight 500 mL polyethylene bottles with tamper-proof containers and detailed instructions. The bottles were then placed in the box provided and sealed upon completion. Both kits were then placed in a shipping container and transported to a designated Veterans Administration (VA) hospital. The contents were then inspected by the VA representative for completeness and shipped to LANL for analysis.
All samples were processed in accordance with the standard procedures of the Department of Energy Laboratory Accreditation Program (DOELAP) accredited Los Alamos National Laboratory Bioassay Program. The samples were divided into three batches. One quality control sample and one blank were analyzed with each batch. Quality control samples were provided by the Oak Ridge National Laboratory in keeping with the standard practices of the Bioassay Quality Assurance Program. Samples were poured into two liter Teflon containers, weighed, the specific gravity determined, and temperature measured. National Institute of Standards and Technology (NIST) traceable 242Pu tracer was then added to each sample which was then co-precipitated as the alkaline phosphate, digested, and the plutonium isolated using anion exchange chromatography. The samples were then electrodeposited and 238Pu and 239+240Pu determined using alpha spectrometry.
The samples were then submitted for chemistry in preparation for analysis by TIMS. The plutonium was stripped from the disks and separated using two micro anion exchange columns. The final eluant was then electrodeposited onto a rhenium filament and the plutonium determined by TIMS. LANL completed the analyses of 24 bioassay samples provided as part of the program entitled “Bioassay Analysis for the Determination of Plutonium in Atomic Veterans” (IACRO # 02-41031) with the Defense Threat Reduction Agency (DTRA). This work was conducted in accordance to Institutional Review Board (IRB) LANL 02-11. Results of study were submitted to DTRA 5/15/03 by S. E. Glover (LA-UR-03-3245).
LA-UR-03-8082
"Spatiotemporal Imaging of Human Visual Systems Processing. Specific Aim 2: Optimize Integration of fMRI/MEG/EEG Data"
Principal Investigator: Dr. John S. George, Los Alamos National Laboratory
Project started in: 2003
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: 10/31/02
IRB approval number: 03-01
Additional IRB approvals from other institutions:
Type of Review: Full Board
Approving Institution: Massachusetts General Hospital
Most recent approval: 10/24/02
IRB approval number: Assurance #1331
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 2003
Type(s) of Human Subjects Involvement:
Study Title: Spatiotemporal Imaging of Human Visual System Processing
Background: This work is part of the competing renewal of an NIH-sponsored R01 project: Spatiotemporal Imaging of Human Visual System Processing lead by Dr. John Belliveau of the Massachusetts General Hospital (MGH) Martinos Imaging Center (formerly NMR Center), and Harvard University. The Los Alamos Lead Investigator, Dr. John George was a collaborator on the first phase of this project and has been involved in several other collaborations with Belliveau and colleagues over the last decade.
a. Objectives: The objectives of this project are to further develop and apply experimental and analytical techniques for dynamic imaging of human brain function. The approach involves the integration of anatomical and functional magnetic resonance imaging (fMRI) which provides information on brain anatomy, connectivity (wiring), and localization of function, together with magnetoencephalography (MEG) and electroencephalography (EEG), which provide information on the large-scale dynamics of brain function. In addition to continuing technical development, the work will develop new methods for brain modeling incorporating information on brain connectivity and will begin to more aggressively apply these methods to study the processing of visual information in the human brain.
b. Methodology: Experimental procedures employed at MGH include anatomical and functional MRI, MEG, and EEG. These techniques are non-invasive and entail minimal risk. The activities performed at LANL involve computational analysis and modeling intended to localize sources of neural activity and to describe the dynamics of activation.
c. Ionizing radiation, radioactive substances, or chemical substances: Human subjects are not exposed to any ionizing radiation, radioactive substances, or chemical substances.
d. Involvement of human subjects.
1. Procedures involving human subjects: Experimental data will be collected at facilities of the Martinos Imaging Center at MGH, under protocols reviewed and approved by the Institution. The LANL contribution to this project is to develop, evaluate, and apply computational models of the physical processes that give rise to MEG and EEG signals at the head surface. This will include boundary-element and finite-difference calculations that incorporate data from human MRI studies. We may also analyze MEG and EEG data collected in these studies.
2. Potential Risk: The activities performed at LANL involve computational analysis and modeling and pose no risk except for the potential to identify study participants.
3. Privacy/confidentiality/consent issues: All of the experimental data used at LANL are cataloged by the project PI so that subjects cannot be identified, directly or through identifiers linked to the subject. Analysis and modeling procedures will not generate personally identifiable tags. We acknowledge the potential concern that volumetric MRI data might be used to generate a recognizable rendering of the research subject. Solutions to this problem are presently being studied by the National Institutes of Health sponsored BioInformatic Research Network (BIRN) on structural anatomy, as well as working groups in the Human Brain Project and elsewhere. As an interim measure, no realistic renderings or complete image datasets will be stored on publicly accessible databases, and technical solutions to prevent identification of individuals will be adopted as they become available.
e. Results: These studies are intended to develop methods for integration of multiple imaging modalities, applicable to a wide range of functional neuroimaging studies. In addition to the immediate application to basic neuroscience studies (of human visual processing in this case), these studies will have applications in neurology, mental health, and other areas of human brain science. Current term of the project is four years, but we anticipate application for future funding to address new issues raised by this work.
LA-UR-03-8082
"New Human DNA Fingerprinting Method Demonstration Project"
Principal Investigator: Dr. Jose A. Olivares, Los Alamos National Laboratory
Project started in: 2003
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: 12/16/02
IRB approval number: 03-02
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 2003
Type(s) of Human Subjects Involvement:
Study Title: New Human DNA Fingerprinting Method Demonstration Project
Study closed FY2003; the study was concluded by September 2003.
We are developing an analysis process for human DNA fingerprinting that requires below one hour in total analysis, ie, from sample swab-to-answer. The procedure was developed using commercial kits and reagents for lysing, purification, polymerase chain reaction (PCR) amplification, and electrophoretic analysis. The method exploits sensitivity and speed the new LANL ImaGene electrophoresis system. The work performed under this study demonstrates that human samples can be analyzed within one hour. Human samples were collected from four individuals. Saliva sputum, skin (fingerprint on sticky tape), and hair samples were collected within the laboratory facilities with the consent of volunteer donors. The volunteers were asked to provide 0.5-1.0 milliliters of saliva into a vial, 10 to 40 hairs (0.5-1.0 inch long) from the head, arms, or legs (by choice of the donor), and skin cells from a finger by pressing on sticky tape. The volunteers were not subjected to any ionizing radiation, radioactive, or chemical substances. The volunteers faced minimal, if any risks, from the sample collection procedure. Since DNA fingerprint studies were to be made on the individual samples, and in order to best maintain complete confidentiality on the individuals, a waiver of signed consent was granted under 45 CFR 46.117.c and an information sheet regarding the project was given to volunteers.
The study determined that it is possible to perform human DNA fingerprinting using these types of samples and our new procedure could be completed well within one hour for a total analysis.
LA-UR-03-8082
"Bio-Surveillance Analysis Feedback Evaluation and Response (B-SAFER)"
Principal Investigator: Dr. Edward L. Joyce, Los Alamos National Laboratory
Project started in: 2003
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: 02/11/03
IRB approval number: LANL 03-03
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 99762
Reporting period for number of human subjects:
Fiscal Year 2003
Type(s) of Human Subjects Involvement:
Study Title: Bio-Surveillance Analysis Feedback Evaluation and Response (B-SAFER)
The goal of B-SAFER is to develop a modular, scalable surveillance information system that can serve at a local level and can be integrated into regional, state, and national surveillance systems including the Centers for Disease Control and Prevention (CDC) Public Health Information Network (PHIN) and National Electronic Disease Surveillance System (NEDSS).
Specific aims include prospective demonstration of the effectiveness of syndromic surveillance, identification of data source(s) and data elements with the greatest utility for early detection, identification of analytic methods with sensitivity for early detection of events and specificity to avoid false-positive alarms, and development and evaluation of modeling tools for prediction of the evolution of an outbreak to guide response.
B-SAFER was fielded in Albuquerque, New Mexico in October 2002 and received data until May 2003. This project completed taking data on May 31, 2003 and is now performing analysis on that data and publishing results as appropriate.
LA-UR-03-8082
"HIV Compartmentalization in Women: Virus and CTL Response"
Principal Investigator: Dr. Carla L. Kuiken, Los Alamos National Laboratory
Project started in: 2003
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: 02/13/03
IRB approval number: LANL 03-04
Additional IRB approvals from other institutions:
Type of Review: Full Board
Approving Institution: New York State Department of Health
Most recent approval: 07/10/03
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 2003
Type(s) of Human Subjects Involvement:
Study Title: HIV Compartmentalization in Women: Virus and CTL Response
a. Objectives: to characterize the extent of differences between human immunodeficiency virus (HIV) variants found in the blood and genital tract of women, and to investigate the role of the immune system in driving these differences.
b. Methodology: Women displaying differences between virus found in the blood and that from the genital tract will be identified. The role of the host immune response will be investigated by characterizing the ability of immune cells to recognize variants from the two compartments.
c. Risk: Not applicable.
d. Involvement of Human Subjects: Samples will be obtained from the two compartments, and the virus found will be characterized using sequencing of the pol and env genes. The risk is pain and possibility of infection from the blood draw. All women are seen within the framework of a larger cohort study, and their privacy is guaranteed. They are asked to sign an informed consent form prior to participating in the study.
e. Anticipated results: We expect to be able to draw definite conclusions about the relationship between immunological pressure and the existence and nature of compartment-specific variation in HIV. The study will be terminated when sufficient samples have been obtained to draw these conclusions.
LA-UR-03-8082
"Retaining Radiation Safety Personnel for Mission-Critical Positions"
Principal Investigator: Ms. Michelle B. Lee, Los Alamos National Laboratory
Project started in: 2003
This project ended in fiscal year 2003.
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: 03/06/03
IRB approval number: LANL 03-05
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 207
Reporting period for number of human subjects:
Fiscal Year 2003
Type(s) of Human Subjects Involvement:
Study Title: Retaining Radiation Safety Personnel for Mission-Critical Positions
The purpose of this study was to (1) investigate possible causes of turnover among radiological control technicians (RCTs) at Los Alamos National Laboratory (LANL) and (2) make recommendations to management to increase RCT retention. The goals of this study are to (1) increase awareness, respect, and appreciation of the RCTs’ many important functions and (2) recognize the RCTs’ necessary contribution to missions of the Department of Energy’s Nuclear Weapons Complex.
The study was carried out by means of an anonymous survey mailed to RCTs at LANL - both currently employed RCTs (stayers) and former RCTs that transferred to another position at the laboratory (leavers). The survey used the following factors to assess the RCTs’ work environment: commitment, job satisfaction (work, pay, promotion, policy, co-workers, customers, and supervisors), and distributive justice. The Organizational Commitment Questionnaire, Job Satisfaction Survey, and Distributive Justice Index measured these job factors respectively. The Mann-Whitney U-test measured differences between stayers and leavers. Spearman’s rank-order correlation established relationships among factors for leavers and stayers.
Results revealed statistically significant differences between leavers and stayers for organizational commitment and promotional opportunities. These differences suggested that leavers had lower commitment than stayers and perceived more limited opportunities for promotion. Results for both stayers and leavers indicated that commitment exhibits a positive relationship with policy, fairness, pay, supervisors, and promotion. Also, stayers and leavers both associated distributive justice with supervisors, policy, promotion, and pay. This study presents several practical recommendations for management to increase workplace retention among RCTs. The underlying theories for these recommendations include Abraham Maslow’s Hierarchy of Needs and Albert Bandura’s Social Cognitive Theory.
LA-UR-03-8082
"Electromagnetic Studies of the Fetal Heart at the Los Alamos National Laboratory"
Principal Investigator: Dr. Michelle A. Espy, Los Alamos National Laboratory
Project started in: 2003
This project ended in fiscal year 2003.
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: 05/01/03
IRB approval number: LANL 03-06
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 1
Reporting period for number of human subjects:
Fiscal Year 2003
Type(s) of Human Subjects Involvement:
Study Title: Electromagnetic Studies of the Fetal Heart at the Los Alamos National Laboratory
This work was a research study of the electromagnetic signals generated by the fetal human heart. The heart muscle produces tiny electrical control signals and larger (though still tiny) electrical “waves" that propagate across the human heart. This is true in adults as well as fetal hearts. Abnormalities in the development of the fetal heart can result in errant electrical signals. We are researching a new completely non-invasive method to detect and localize these errant electrical signals in the heart. Using sensitive magnetic sensors known as Superconducting Quantum Interface Devices (SQUIDs), fetal electrical heart signals can be measured passively from outside the mother’s body. This method is particularly important as beyond week 20 the fetus is electrically isolated from the outside world and the only way to access the electrical information is by magnetic filed measurements. No other technique known can achieve these measurements. Fetal magnetocardiography has been measured since the 1960s. Signals from the fetal heart are relatively small compared to signals from the maternal heart and ambient magnetic noise from nearby sources such as the electrical wiring in a room. We want to investigate hardware and software techniques that will greatly improve our sensitivity to the small signal from the fetal heartbeat, and provide the clearest information about its electrical structure. The measurement technique is passive and requires nothing more that the mother lying under a sensor array. The sensors will not touch her body. The magnetic measurements taken from outside the mother will be analyzed with a computer to remove the maternal heart signal and any ambient magnetic noise. Our method is a completely passive technique, the sensors only record, and it uses absolutely no energy sources outside your body (such as those used in ultrasound, MRI, or x-rays). There are no known risks to the mother or fetus. Data obtained from this study will be owned by the University of California under this research program. Data will be correlated with subjects using a subject code available only to the program Principal Investigator and will be kept confidential at all times. Data will not be released to anyone unless required by law. Our goal was to optimize the measurement and data analysis methods to enable doctors to understand details of the electrical activity in the fetal heart. The study was terminated in May after successful data collection from one subject.
LA-UR-03-8082
"Use of Nuclear Medicine Patients to Determine the Response of Radiation Detections System"
Principal Investigator: Mr. Brian G. Rees, Los Alamos National Laboratory
Project started in: 2003
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: 05/01/03
IRB approval number: 03-07
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 2003
Type(s) of Human Subjects Involvement:
Study Title: Use of Nuclear Medicine Patients to Determine the Response of Radiation Detections Systems
Radiation detection systems are being installed at large numbers of locations to detect the illicit movement of radioactive materials. These detection systems routinely detect patients that have recently received nuclear medicine treatments. There is considerable interest in obtaining detailed radiation detection data from patients who receive nuclear medicine treatments. Typically patients that are detected by a system are released as soon as practicable after the source of the radiation is confirmed. Follow-on measurements are not sought due to the operational nature of the installation. It is not practicable from a number of perspectives to administer radiopharmaceuticals to people in order to conduct measurements.
LANL employee volunteers will be solicited at the nuclear medicine department of local hospitals or other suitable locations by the use of information that will be provided to them after administration of treatment. Their medical conditions will not be solicited; however, they will be requested to provide information on the nuclide, time of administration, activity at administration, and chemical formulation. Their individual identification number or name will not be recorded on measurement datasheets or associated with the measurements. Additional information will include any voiding since administration, age, weight, height, and gender. Volunteers will be placed at various distances and angles from fixed and portable radiation detectors, and may be asked if they can walk or drive (government vehicles) near fixed or portable instruments.
In addition to the measurements that could be conducted, this is an opportunity to ensure patients are aware of their responsibilities regarding thermo luminescent dosimeters (TLDs), etc.
Risks: There are no risks imposed on people by their participation in this study. Any measurements in the presence of other radioactive material will be conducted in such a manner as to result in less than 5 mrem from the additional material so that a TLD will not be required for the patient. All personnel conducting measurements will wear TLDs.
Benefits: The response of radiation detection instruments to people with nuclear medicine treatments will be better understood. This will improve the ability to detect illicit movement of radioactive materials, and possibly minimize the unnecessary delay of nuclear medicine patients in locations with radiation detection systems.
LA-UR-03-8082
"Los Alamos National Laboratory Employee Assistance Program (EAP) Employee Opinion Survey"
Principal Investigator: Dr. Thomas P. Locke, Los Alamos National Laboratory
Project started in: 2003
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: 05/01/03
IRB approval number: LANL 03-08
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 422
Reporting period for number of human subjects:
Fiscal Year 2003
Type(s) of Human Subjects Involvement:
Los Alamos National Laboratory Employee Assistance Program (EAP) “Employee Opinion Survey”
An employee survey was designed to assess the factors contributing to workers use of the LANL Employee Assistance Program. A random sample of 1,358 employees (10 percent) from University of California employees and six major subcontractors received by mail an anonymous and confidential questionnaire. Employees were encouraged to complete the questionnaire and return it to the investigators in enclosed envelopes without identifying information. Thirty-one percent (422) of the questionnaires were returned. Preliminary analysis of the data is underway.
Anonymity was assured with the destruction of the returned survey forms. Data analysis based on any demographic values will be done only if 10 or more respondents selected a particular variable. Risk to the subjects was categorized as “none or very minimal.”
Results will be used to improve the delivery of EAP services and to clarify employee reluctance to utilize counseling services because of concern for clearances. Findings from the study will be reported during CY2004.
LA-UR-03-8082
"HIV Molecular Epidemiology Survey"
Principal Investigator: Mr. Brian K. Gaschen, Los Alamos National Laboratory
Project started in: 2003
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: 08/18/03
IRB approval number: 03-10
Additional IRB approvals from other institutions:
Type of Review: Full Board
Approving Institution: Chinese Government
Most recent approval: 05/10/02
Explanation of additional approval:
The project is reviewed in China every two years and is funding related (the project is funded for two-year periods).
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 200
Reporting period for number of human subjects:
Fiscal Year 2003
Type(s) of Human Subjects Involvement:
Study Title: HIV Molecular Epidemiology Survey
A human immunodeficiency virus (HIV) sequence database containing HIV-1 (the primary type of human immune deficiency virus infecting humans) sequences from China is being designed and developed as a collaborative project between the International HIV Database Group, located at Los Alamos National Laboratory, and the laboratory of Dr. Yiming Shao, the director of Division of Research on Virology and Immunology at the Chinese Center for Disease Control and Prevention (China’s CDC). Initial design and development of the database is being conducted in the Theoretical Biology and Biophysics Division at Los Alamos. The database, when completed, will house HIV sequences collected from known HIV-1 infected individuals throughout China and will contain sequence information, clinical information (patient CD4 counts, CD8 counts, and HLA types), and epidemiological information, which will be collected by Chinese health authorities using an approved survey form. CD4 and CD8 are types of lymphocyte (white blood cells) used to monitor disease progression; HLA (human leukocyte antigen protein) types reflect genetically determined ability of the immune system to recognize "self" as opposed to "foreign" cells in the body. After development, the master database will be housed and updated in China, while the Los Alamos database group will obtain database updates, which will be made publicly available to researchers worldwide. No personally identifiable information on patients will be kept in the Los Alamos copy of the database, and patients participating in the investigation have voluntarily agreed to participate by signing an approved consent form. Data maintained in the database can be used to model HIV transmission throughout China, and predict the future spread of the disease. An important beneficiary of the work will be researchers involved in vaccine design, who will have ready access to previously unavailable sequence, clinical data, and epidemiological information.
LA-UR-03-8082
"MOSIS Remote Biometric Sensing"
Principal Investigator: Mr. Mervyn J. Kellum, Los Alamos National Laboratory
Project started in: 2003
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: 08/27/03
IRB approval number: 03-11
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 1
Reporting period for number of human subjects:
Fiscal Year 2003
Type(s) of Human Subjects Involvement:
Study Title: MOSIS Remote Biometric Sensing
This purpose of this research study is to perform reflectance of light experiments on human subjects. For almost fifty years the medical community has conducted low-level, ultra-violet (UV) and infrared (IR) photographic imaging of human subjects for the purposes of quick, non-invasive diagnostics for a variety of medical conditions. Because of the nature of these photographic methods, these experiments have, in the past, been conducted in dark, controlled conditions. The newly developed multi-mode optical spectral imaging sensor (MOSIS) digital camera system promises researchers the ability to perform some of these same experiments in normal, room light conditions. We anticipate the MOSIS system will be able to capture and separate images resulting from the illumination of different sources of light. As this is a preliminary research study, a criterion for success or failure is being developed. At this time, we do not know when the study will be terminated.
During this experiment, subjects are illuminated with light emitting diodes (LEDs). The subject’s image is recorded using a digital camera that is attached to a laptop computer where the image is stored. Subjects are not exposed to any chemical or radioactive substances or ionizing radiation. Subjects taking part in this study do so voluntarily. Subjects may choose not to take part at all. If a person decides to be in this study, the indivdual can stop participating at any time. Subjects will be provided with any significant new findings developed during the course of this study.
Pursuant to the 2002 Threshold Limit Values (TLVs) and Biological Exposure Indices published by ACGIH (American Conference of Governmental Industrial Hygienists) Worldwide, pp. 153-160: the TLVs for occupational exposure to broad-band light are generally required only if the luminance of the source exceeds 1 cd/ cm2. Since the intensities of the illumination sources are below the TLVs there are no foreseeable risks from being in this study.
Subjects' identities in this study are treated as confidential. Any published results of the study will not give subjects' name or include any identifiable references to the subjects. Any records or data obtained as a result of this study will be kept private insofar as permitted by law. Data obtained by this study will be secured by physical lock and by secure password access on the computer on which they are stored. No personal health information will be used during this study.
LA-UR-03-8082
"Emergency Department and Pre-Hospital Surveillance and Analysis Protocol"
Principal Investigator: Dr. Edward L. Joyce, Los Alamos National Laboratory
Project started in: 2003
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: 09/05/03
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 3054
Reporting period for number of human subjects:
Fiscal Year 2003
Type(s) of Human Subjects Involvement:
Study Title: Emergency Department and Pre-Hospital Surveillance and Analysis Protocol
Emergency Department and Pre-Hospital Surveillance and Analysis (EDPSA) is a research and development collaboration between Los Alamos National Laboratory (LANL), Albuquerque Ambulance Service (AAS), Presbyterian Hospital Services (PHS), and the New Mexico Department of Health (NMDOH). The goal is to collect both emergency department and pre-hospital care data to assist public health officials in monitoring its population via routine surveillance (diabetes, childhood asthma rates, trauma), and to look for indicators that will quickly detect and analyze disease outbreaks (including a biological or chemical attack).
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