Mr. John R. Gustafson
LANL Public Info. Grp., PA 1
P. O. Box 1663, MS C177
Los Alamos, NM 87544
Phone: 505-665-9197
Fax: 505-665-3910
Email: POGO@lanl.gov
Projects are approved by an IRB located at: Los Alamos National Laboratory.
The approving IRB operates under a Multiple Project Assurance (MPA) recognized by DOE or by the Department of Health and Human Services (HHS).
MPA number of the IRB: DOE/LANL 93-96
Number of Human Subjects Projects reported: 7
Project Identifier: LANL-76-90LANL07
Project Title:
Acceptance Testing Procedures for Air-Supplied Suits
Principle Investigator:
Mr. Bruce D. Reinert
Project started in: 1976
Project Funding Information:
Project received funding in Fiscal Year 1995.
Project used human subjects in Fiscal Year 1995.
Funding Sources:
Project does not involve use of multiple protocols/subprojects.
IRB Review:
Type of Review: Full Board
Most Recent Approval: April 13, 1995
IRB Approval Number: 90LANL07
Number of Human Subjects in the Last Reporting Period for this Project: 8
(Reporting periods vary.)
Type of Human Subjects Involvement:
For evaluation of air-supplied suits
Air-supplied suits are used at Department of Energy facilities to protect workers from radioactive materials that pose an inhalation and skin hazard. All air-supplied suits accepted for use at DOE facilities are subjected to testing to determine the level of respiratory protection provided. Testing to determine whether aerosols will penetrate the suit and associated equipment is conducted in a 16 cubic meter chamber. A test atmosphere containing a di(2-ethylhexyl) sebacate aerosol with a mass median aerodynamic diameter of approximately 0.5 micrometers and a concentration of 25 +/- 1.3 milligrams per cubic meter. The aerosol concentration is measured with a TSI Model 8587 laser photometer.
The subject will perform eight exercises: normal breathing, touching toes, running in place, raising arms above the head, squatting, crawling, folding arms across the chest, and torso twisting.
These exercises require approximately 15-20 minutes total per test. Possible risks include an exposure of the subject to a 10% penetration of the test aerosol into the suit. There should be no health risks associated with a 10% penetration. The test is terminated at this level because a suit that leaks that much is unacceptable. Some persons who are sensitive to the sebacate may experience mild skin irritation with prolonged contact to high concentrations. The test subject may experience a feeling of claustrophobia. Some test subjects have reported a warm, clammy feeling within the suit. Physically, there are no risks.
Tests are terminated upon test subject's request, operator's observation of unacceptable test conditions (such as malfunction of the monitoring system, torn suit, low pressure alarm from the self-contained breathing apparatus), or if the penetration of the aerosol into the interior of the suit exceeds 10%.
Project Identifier: LANL-82-90LANL08
Project Title:
Prolonged Refrigerated Storage of Human Red Blood Cells
Principle Investigator:
Dr. Mark W. Bitensky
Project started in: 1982
Project Funding Information:
Project received funding in Fiscal Year 1995.
Project did not use human subjects in Fiscal Year 1995.
Explanation:
Human blood was purchased from local blood bank.
Funding Sources:
Project does not involve use of multiple protocols/subprojects.
IRB Review:
Type of Review: Full Board
Most Recent Approval: April 13, 1995
IRB Approval Number: 90LANL08
Number of Human Subjects in the Last Reporting Period for this Project: 0
(Reporting periods vary.)
Type of Human Subjects Involvement:
The purpose of this project is to understand the biochemistry and physiology of human red blood cells. Blood used in this project (90-100 units) was purchased from a local blood bank. Experiments were conducted on isolated cells, and no human subjects were directly involved. Investigators at Los Alamos do not know the identities of the blood donors.
Project Identifier: LANL-91-90LANL04
Project Title:
Neuromagnetic Mapping of Multiple Visual Areas in Humans
Principle Investigator:
Dr. Cheryl J. Aine
Project started in: 1991
Project Funding Information:
Project received funding in Fiscal Year 1995.
Project used human subjects in Fiscal Year 1995.
Funding Sources:
Project does not involve use of multiple protocols/subprojects.
IRB Review:
Type of Review: Full Board
Most Recent Approval: April 13, 1995
IRB Approval Number: 90LANL04
Number of Human Subjects in the Last Reporting Period for this Project: 7
(Reporting periods vary.)
Type of Human Subjects Involvement:
Noninvasive neuromagnetic measures (along with electroencephalography (EEG) readings in some cases) are recorded from the surface of the head with the goal of identifying and characterizing multiple visual areas in the human brain. Subjects view small stimuli on a TV screen while SQUIDs (Superconducting Quantum Interference Devices) record the magnetic fields evoked by the brain in response to the stimuli.
Mathematical models are applied to these data with the goal of localizing each of the neural generators in visual cortex which have contributed to the signals at the surface of the head. The locations of the sources, in head-centered x,y,z coordinates, are located on the magnetic resonance (MR) imaging (anatomical brain images) to identify the cortical structures generating these signals. The long term goal of these studies is to map visual cortex, i.e., to identify those regions which are processing color and medicating motion, as a couple of examples. There are no risks to the subjects. Most of our subjects are associated with the grant (i.e., PI, co-investigators, technicians, etc.).
These measures (magnetoencephalography and electroencephalography) are routinely used in research and the clinic. Magnetic resonance images are also acquired for most of the subjects at the VA Hospital in Albuquerque, NM.
Project Identifier: LANL-91-91LANL03
Project Title:
Ligand-Receptor G Protein Dynamics and Neutrophil Response
Principle Investigator:
Dr. Larry A. Sklar
Project started in: 1991
Project Funding Information:
Project received funding in Fiscal Year 1995.
Project did not use human subjects in Fiscal Year 1995.
Explanation:
This protocol is kept active but no subjects are currently being used.
Funding Sources:
Project does not involve use of multiple protocols/subprojects.
IRB Review:
Type of Review: Full Board
Most Recent Approval: April 13, 1995
IRB Approval Number: 91LANL03
Number of Human Subjects in the Last Reporting Period for this Project: 0
(Reporting periods vary.)
Type of Human Subjects Involvement:
OBJECTIVES: The binding kinetics of fluorescent ligands to human neutrophils and cell responses are studied by flow cytometry.
METHODOLOGY: Neutrophils are isolated from freshly drawn anticoagulated human blood. The cells are isolated by centrifugation. The cell preparations are used in biochemical and biophysical characterization of the molecular pathways of neutrophil activation. Fresh blood is used because the properties of the cells change dramatically if the cells age.
SUBSTANCES: None.
INVOLVEMENT OF SUBJECTS: Human subjects are volunteers. An informed consent document is read and signed by each donor. The procedure involves routine venipuncture of the arm and withdrawal of up to 50 milliliters (ml) of blood. Risks are limited to minimal discomfort from drawing the blood sample.
Project Identifier: LANL-92-92LANL03
Project Title:
Performance Testing of Level A and Level B Suits for Protection Against Hazardous Materials
Principle Investigator:
Mr. Bruce D. Reinert
Project started in: 1992
Project Funding Information:
Project received funding in Fiscal Year 1995.
Project used human subjects in Fiscal Year 1995.
Funding Sources:
Project does not involve use of multiple protocols/subprojects.
IRB Review:
Type of Review: Full Board
Most Recent Approval: April 13, 1995
IRB Approval Number: 92LANL03
Number of Human Subjects in the Last Reporting Period for this Project: 4
(Reporting periods vary.)
Type of Human Subjects Involvement:
evaluate hazardous materials handlers suits
Conducting this research in a safe environment prior to actual use or need is necessary to assess the fit and protection these suits will afford personnel who must wear them on jobs that often require them to enter environments where hazardous materials are present. Such research allows for a better understanding of materials, suit construction, and design configurations of suits that will afford the best protection for personnel.
For this test, a human subject will wear the suit in an atmosphere containing di-(ethylhexyl) sebacate. The penetration of the test agent into the interior of the covering of the device will be measured with a TSI model 8587 laser photometer as the subject carries out dexterity, simulated work exercise, and standard exercise tests.
While wearing the suit and self contained breathing apparatus (SCBA), the subject will, in three test sessions, perform the following: Dexterity tests which include an eye test, reading, writing, manipulating small bolts and nuts, and using a cylinder repair kit; simulated work tests, which include crawling, sealing large drum containers, building a concrete-block wall, climbing a ladder, and opening an overhead valve; and standard exercise tests which include normal breathing, toe touching, flagging arms overhead, raising arms above the head while looking upward, squatting, and crawling.
Risks include exposure of the subject to a 10 percent penetration of di-(ethylhexyl) sebacate into the suit, which poses no health risk. The test subject may experience feelings of claustrophobia. Some test subjects have reported a warm, clammy feeling within the suit. The tests are terminated upon test subject's request, operator's observation of unacceptable test conditions (such as malfunction of the monitoring system, torn suit, SCBA low pressure alarm, or if the penetration of the aerosol into the interior of the suit exceeds 10 percent. The test is terminated at this level because a suit that leaks that much is unacceptable.
Project Identifier: LANL-93-90LANL05
Project Title:
Personnel Verification/Identification Based on Iris Patterns -Bartas Iris Verification
Principle Investigator:
Dr. Roger G. Johnston
Project started in: 1993
Project Funding Information:
Project received funding in Fiscal Year 1995.
Project used human subjects in Fiscal Year 1995.
Funding Sources:
Project does not involve use of multiple protocols/subprojects.
IRB Review:
Type of Review: Full Board
Most Recent Approval: April 13, 1995
IRB Approval Number: 90LANL05
Number of Human Subjects in the Last Reporting Period for this Project: 36
(Reporting periods vary.)
Type of Human Subjects Involvement:
The objective of this research is to learn if people can be identified by video images of their irises. Conventional and custom pattern matching algorithms, combined with standard statistical tests are used to determine whether people can be identified by iris patterns. The subject's eye is NOT touched because the instrument (video camera) is located two feet away from the subject. Standard video illumination is used. No unusual illumination is used -- no lasers, no ultraviolet (UV) light, no high intensity. The situation is nearly identical to camcorder video recording at home. There are no known risks. The Bartas Iris Verification system is named for the French poet Signeur du Bartas who first called the eyes the windows of the soul.
Project Identifier: LANL-95-95LANL01
Project Title:
Stabilization of Hemoglobin for Prolonged Refrigerated Storage of Red Blood Cells
Principle Investigator:
Dr. Mark W. Bitensky
Project started in: 1995
Project Funding Information:
Project did not receive funding in Fiscal Year 1995.
Project did not use human subjects in Fiscal Year 1995.
Explanation:
In vivo study was not ready to start by the end of FY 95.
Project does not involve use of multiple protocols/subprojects.
IRB Review:
Type of Review: Full Board
Most Recent Approval: April 13, 1995
IRB Approval Number: 95LANL01
Number of Human Subjects in the Last Reporting Period for this Project: 0
(Reporting periods vary.)
Type of Human Subjects Involvement:
The objective of this study is to provide definitive verification of our protocols for storing human blood by using in vivo measurements to quantify the 24-hour survival of red blood cells. The Food and Drug Administration currently requires that at least 75 percent of the transfused cells survive for at least 24 hours.
Blood donated by volunteers is stored using various protocols for varying periods of time. Before the blood is returned to the original donor through a transfusion, the red blood cells are labeled with radioactive substances (51-Cr and 99m-Tc), and excess radioactive materials are washed from the blood. Several times during the first 24 hours following the transfusion, blood samples are taken from the donor, and the survival rate of red blood cells is measured.
The radiation dose from this procedure will be about 10 millirems (much less than a chest x-ray). The procedure entails a measurable risk of bacterial contamination, but this is virually eliminated by culturing the blood for bacteria for several days before transfusion. Blood is also tested for HIV (human immunodeficiency virus) and for hepatitis B and C.
The risk of receiving the wrong blood is minimized through the use of careful identification procedures and a limit on the number of transfusions to only one a day. In over 220 procedures, no bacterial or blood identification problems have occurred.