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/MPA-LANL96-2000
Number of Human Subjects Projects reported: 11
Project Identifier: LANL-76-90LANL07
Project Title:
Respirator Studies, Acceptance Testing Procedures for Air-Line Supplied Air-Suits
Principal Investigator:
Mr. Bruce D. Reinert
Project started in: 1976
Project Funding Information:
Project received funding in Fiscal Year 1996.
Project used human subjects in Fiscal Year 1996.
Funding Sources:
$500,000 is an estimated amount with funding shared between projects 90 LANL 07, 92 LANL 03, 94 LANL 02, and 96 LANL 04. All four (4) projects were approved by LANL's IRB.
Project does not involve use of multiple protocols/subprojects.
IRB Review:
Type of Review: Full Board
Most Recent Approval: January 25, 1996
IRB Approval Number: 90 LANL 07
Number of Human Subjects who participated in this project/protocol during
FY 1996 (10/1/95 - 9/30/96): 7
Type of Human Subjects Involvement:
The penetration of the test agent, DEHS, in the form of an aerosol, will be monitored and recorded as the subject carries out standardized and simulated work exercises.
DOE air-supplied suit fit factor testing is conducted on all devices that are to be accepted for use at DOE Facilities.
The test subject will be required to perform five types of tests for each sequence. These tests will include sound pressure levels, O2, CO2, aerosol penetration, air-hose to suit covering pull, and escape. Aerosol penetration will be monitored and recorded during these tests.
Penetration testing and air-hose to suit covering pull test of the air-supplied suit and its associated equipment is performed in a 16M3 test chamber. A polydispenser test atmosphere of Di(2)ethylhexylsebacate (DHES) is generated at an approximate size of.5um and a concentration of 25(+/-) 1.3mg.m(3). This atmosphere is used to determine the level of respiratory protection provided by the suits.
The test subject will perform nine exercises: (1) normal breathing, (2) touching toes, (3) running in place, (4) raising arms above the head, (5) squatting, (6) crawling, (7) folding arms across the chest, (8) torso twisting, and (9) normal breathing.
These exercises will be continued for two minutes each, with a fifteen second rest between each test, and will require approximately 21 minutes total per test.
Risks may include an exposure of the subject to a 10% penetration of the test aerosol. The test subject may be aware of 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, or if the penetration of the aerosol into the interior of the suit reaches 10%. Unacceptable test conditions would include equipment malfunction, aerosol concentration out of tolerance, breathing air settings to low or high.
Project Identifier: LANL-91-90 LANL 04
Project Title:
Neuromagnetic Mapping of Multiple Visual Areas in Humans
Principal Investigator:
Dr. Cheryl J. Aine
Project started in: 1991
Project Funding Information:
Project received funding in Fiscal Year 1996.
Project used human subjects in Fiscal Year 1996.
Funding Sources:
Project does not involve use of multiple protocols/subprojects.
IRB Review:
Type of Review: Full Board
Most Recent Approval: January 25, 1996
IRB Approval Number: 90 LANL 04
Number of Human Subjects who participated in this project/protocol during
FY 1996 (10/1/95 - 9/30/96): 6
Type of Human Subjects Involvement:
This proposal is aimed at identifying and characterizing multiple visual areas in the human brain through the use of neuromagnetic measurements, in conjunction with magnetic resonance imaging techniques. Although previous noninvasive studies have shown evidence of crude retinotopy in the human brain (i.e., point-to-point mapping from the visual field onto striate and extrastriate cortical regions), a more thorough description of this retinotopy is lacking. There have been no studies which have systematically examined the arrangement of the visual field representations nor the specific functions of these areas. The experiments proposed here, using transient evoked response techniques, will be carried out in two phases: 1) retinotopic mapping and 2) functional characterization of visual areas.
Retinotopic mapping will be performed by measuring neuromagnetic field distributions from the surface of the head, using Superconducting Quantum Interference Devices (SQUIDs) while subjects view small stimuli on a TV screen. These stimuli are placed in different regions of the visual field (e.g., in the central and peripheral visual field along the vertical and horizontal meridia). Functional characterization of visual areas will focus on manipulations of color since this parameter has been successful in differentiating between visual areas in nonhuman primates. The chromatic contrast and luminance of sinusoidal gratings will be manipulated in order to preferentially activate the color/form system. The goal here is to map visual cortex, e.g., to identify those cortical regions which process colored stimuli as opposed to gray stimuli.
There are no risks to the subjects. All of our subjects are associated with the grant itself (i.e., the PI, co-investigators, technicians, postdoctoral students, etc.).
The long-term goal of the project is the delineation of specific information processing pathways in the human brain. The functional characterization of the different visual areas will ultimately aid in a better understanding of higher cognitive functions.
Project Identifier: LANL-91-91 LANL 03
Project Title:
Ligand-Receptor G Protein Dynamics and Neutrophil Response
Principal Investigator:
Dr. Larry A. Sklar
Project started in: 1991
Project Funding Information:
Project received funding in Fiscal Year 1996.
Project did not use human subjects in Fiscal Year 1996.
Explanation:
Funding Sources:
Project does not involve use of multiple protocols/subprojects.
IRB Review:
Type of Review: Full Board
Most Recent Approval: January 25, 1996
IRB Approval Number: 91 LANL 03
Number of Human Subjects who participated in this project/protocol during
FY 1996 (10/1/95 - 9/30/96): 0
Type of Human Subjects Involvement:
OBJECTIVES: 1)To use human neutrophils to study the binding of a fluorescent peptide to a cell surface receptor. 2) To use this binding interaction as a system for improving flow cytometric instrumentation.
METHODOLOGY: Neutrophils are isolated by centrifugation from fresh human blood (50 mls). Investigations are performed on the isolated cells by flow cytometry.
SUBSTANCES: None.
INVOLVEMENT OF SUBJECTS: An informed consent document is read and signed by each donor. No data is released which identifies the donor, therefore the confidentiality of the participants is maintained. Healthy volunteers donate blood. The procedure involves routine venipuncture of the arm. Risks are limited to minimal discomfort from drawing the blood sample.
Project Identifier: LANL-92-92LANL03
Project Title:
Acceptance Testing of Hazardous Material Level "A" and Level "B" Suits
Principal Investigator:
Mr. Bruce D. Reinert
Project started in: 1992
Project Funding Information:
Project received funding in Fiscal Year 1996.
Project used human subjects in Fiscal Year 1996.
Funding Sources:
$500,000 is an estimated amount and funding is shared between projects 90 LANL 07, 92 LANL 03, 94 LANL 02, and 94 LANL 04. All four (4) projects were approved by the LANL IRB
Project does not involve use of multiple protocols/subprojects.
IRB Review:
Type of Review: Full Board
Most Recent Approval: January 25, 1996
IRB Approval Number: 92 LANL 03
Number of Human Subjects who participated in this project/protocol during
FY 1996 (10/1/95 - 9/30/96): 2
Type of Human Subjects Involvement:
This research 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, constructions, and design configurations of these suits.
The test subject shall wear the Hazardous Materials suit that is supplied with breathing air from a self contained breathing apparatus (SCBA).
Subjects will be required to perform tests that will evaluate the level of respiratory and skin protection, noise generated by the flow of air through a hazardous materials suit, reading and writing ability, a dexterity assessment, the ability to use cylinder repair kits, contaminated suit removal, and escape from a hazardous material suit.
The standard exercise and simulated work conditions will require the test subject to enter a test chamber that will have a self-contained, pre-programmed environment. The temperature and humidity can be programmed in this chamber. Temperature extremes may be used so that the test subject will need to be prepared for moderate to fairly stressful exercises in a -32 degree F to +90 degree atmosphere. The chamber will contain a test atmosphere of polydispersed aerosol, di(2)ethylhexylsebecate (DEHS), to determine the level of protection provided by the hazardous material suit. A chamber concentration of (15-30 mg/m3) will be used. The penetration of the test agent into the interior of the device shall be measured as the subject carries out standardized and simulated work exercises.
DESCRIPTION of STANDARD EXERCISES: The test subject will perform the following standard exercises: (1) Standing still, arms hanging downward along the sides of the body, normal breathing, (2) bending forward and touching toes repeatedly, (3) flagging arms overhead repeatedly, (4) raising arms above head looking upward repeatedly, (5) bending knees and squatting repeatedly, (6) crawling on hands and knees, and (7) standing still, arms hanging downward along the sides of the body, normal breathing.
All exercises will be continued for a period of two minutes each with a one minute standing rest after each exercise.
DESCRIPTION of SIMULATED WORK: The test subject will perform the following simulated work exercises; (a) crawling on an abrasive surface; (b) sealing large drum containers; (c) building a block wall with concrete blocks; (d) climbing a ladder, and (e) opening an overhead valve. These exercises simulate activities that hazardous response personnel encounter in routine field work within hazardous environments.
All tasks will be continued for a period of three minutes each, with a one-minute standing rest after each task.
ANTICIPATED DURATION and RESPONSE: These standard exercises and work simulations will require approximately 1.5 hours each for the test subject to complete. While performing these exercises, the test subject can expect to feel the heat and humidity generated in the suit by the exertion required to operate within the suit. The internal atmosphere of the suit may resemble that of a sauna.
RISKS: Possible risks include exposure of the subject to a 10% penetration of the test aerosol. The subject may also experience feeling claustrophobic.
Project Identifier: LANL-93-90 LANL 05
Project Title:
Personnel Verification/Identification Based on Iris Patterns-Bartas Iris Verification
Principal Investigator:
Dr. Roger G. Johnston
Project started in: 1993
This project ended in Fiscal Year 1996.
Project Funding Information:
Project did not receive funding in Fiscal Year 1996.
Project did not use human subjects in Fiscal Year 1996.
Explanation:
Project is completed.
Project does not involve use of multiple protocols/subprojects.
IRB Review:
Type of Review: Full Board
Most Recent Approval: January 25, 1996
IRB Approval Number: 90 LANL 05 (96)
Number of Human Subjects who participated in this project/protocol during
FY 1996 (10/1/95 - 9/30/96): 0
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-94-94 LANL 02
Project Title:
Testing of Hazmat Level "A" Suits with the NASA Liquid-Air Breathing System
Principal Investigator:
Mr. Bruce D. Reinert
Project started in: 1994
Project Funding Information:
Project received funding in Fiscal Year 1996.
Project used human subjects in Fiscal Year 1996.
Funding Sources:
$500,000 is an estimated amount with funding shared between projects 90 LANL 07, 92 LANL 03, 94 LANL 02, and 96 LANL 04. All four (4) projects were approved by the LANL IRB.
Project does not involve use of multiple protocols/subprojects.
IRB Review:
Type of Review: Full Board
Most Recent Approval: January 25, 1996
IRB Approval Number: 94 LANL 02
Number of Human Subjects who participated in this project/protocol during
FY 1996 (10/1/95 - 9/30/96): 5
Type of Human Subjects Involvement:
The penetration of the test agent, (DEHS), into the interior of the suit, shall be measured as the subject carries out standardized and simulated work exercises.
This testing is an addition to research on Level A fully encapsulating suits (92LANL03) that are used in hazardous materials operations. The research to be conducted will require human subject participation. This additional research is necessary to determine the performance of the NASA liquid-air breathing system when used in Level A suits.
This research 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, constructions, and design configurations of these suits when used with a NASA liquid-air breathing system.
Subjects will be required to perform tests that will evaluate the level of respiratory and skin protection, the noise generated by the flow of air through a hazardous materials suit, reading and writing ability, a dexterity assessment, the ability to use cylinder repair kits, contaminated suit removal, and escape from a hazardous material suit.
The Standard Exercise and Simulated Work conditions will require the test subject to enter a test chamber that will be a self-contained, per-programmed environment. The temperature and humidity can be programmed in this chamber. Temperature extremes may be used so that the test subject will need to be prepared for moderate to fairly stressful exercises in a -32 degree F to +90 degree F atmosphere. The chamber will contain a test atmosphere of polydispersed aerosol, di(2)ehtylhexylsebecate (DEHS), to determine the level of protection provided by the Hazardous Materials suit. An aerosol concentration of (15-30 mg/m3) will be used. The penetration of the test agent into the interior of the suit shall be measured as the subject carries out standardized and simulated work exercises.
DESCRIPTION of STANDARD EXERCISES: The test subject will perform the following standard exercises: (1) Standing still, arms hanging downward along the sides of the body, normal breathing, (2) bending forward and touching toes repeatedly, (3) flagging arms overhead, (4) raising arms above head looking upward repeatedly, (5) bending knees and squatting repeatedly, crawling on hands and knees, and (6) standing still, arms hanging downward along the sides of the body, normal breathing.
All exercises will be continued for a period of two minutes each, with a one minute standing rest after each exercise.
DESCRIPTION of SIMULATED WORK: The test subject will perform the following simulated work exercises: (a) crawling on an abrasive surface, (b) sealing large drum containers, (c) building a block wall with concrete blocks, (d) climbing a ladder, and (e) opening an overhead valve. These exercises simulate activities that hazardous response personnel encounter in routine field work within hazardous environments as well as in emergency response operations.
All tasks will be continued for a period of three minutes each, with a one-minute standing rest after each task.
ANTICIPATED DURATION and RESPONSE: These standard exercises and work simulations will require approximately 1.5 hours each for the test subject to complete. While performing these exercises, the test subject can expect to feel the heat and humidity generated within the suit by the exertion required to operate within the suit. The internal atmosphere of the suit may resemble that of sauna.
RISKS: Possible risks include exposure of the subject to a 10% penetration of the test aerosol The subject may also experience feeling claustrophobia.
Project Identifier: LANL-96-96-LANL-02
Project Title:
Applications of Mass Spectrometry to the Detection of Plutonium Intakes
Principal Investigator:
Dr. William C. Inkret
Project started in: 1996
Project Funding Information:
Project received funding in Fiscal Year 1996.
Project used human subjects in Fiscal Year 1996.
Funding Sources:
Project does not involve use of multiple protocols/subprojects.
IRB Review:
Type of Review: Expedited
Most Recent Approval: May 13, 1996
IRB Approval Number: 96 LANL 02
Number of Human Subjects who participated in this project/protocol during
05/13/96 - 09/30/96: 40
Type of Human Subjects Involvement:
DESCRIPTION OF THE PROBLEM: The historically accepted method for detecting intakes and assessing the dosimetric consequences of plutonium inhalation is by radiochemical evaluation of urine samples collected from the individual. The radiochemistry and alpha spectrometry (RAS) techniques used at LANL from 1943 to the present do not meet current DOE regulations that require the detection of all occupationally related CEDEs exceeding 100 mrem in the year of intake.
During FY96, this project established a viable urine bioassay program using thermal ionization mass spectrometry (TIMS) for detecting very-low occupational levels of plutonium.
The purpose of the analysis on the two-stage TIMS is to develop a TIMS measurement capability that has sensitivities comparable to the induced fission track method (FTM) at approximately ½ of the cost. The two-stage TIMS technique will provide a faster sample turn-around-time than FTM and a direct measure of the chemical yield.
OBJECTIVES: Establish a data set of urine assay results to construct a Bayesian prior distribution for assessment of individuals with environmental exposures. Continue to establish interactions with outside funding sources and use information and capabilities derived from the project to enhance applications for outside funding. Establish a variable and cost effective plutonium bioassay program for evaluation of urine samples from individuals with intakes from occupational and environmental sources (fall out and remediation projects).
METHODOLOGY: Collect and analyze (on the single-stage TIMS) twenty (20) 24-hour urine samples from an individual with no history of occupational exposure to plutonium. Collect and analyze (on the two-stage TIMS) twenty (20) 24-hour urine samples from an individual with no history of occupational exposure to plutonium. Use single-stage measurement information to establish lower limit of detection and Bayesian prior for non-occupational exposure to plutonium on current production system. Use two-stage measurement information to investigate the potential to achieve another order of magnitude in sensitivity.
SUBSTANCES: None
RISKS: None
Project Identifier: LANL-96-96 LANL 01
Project Title:
Air Line Abrasive Blast Respirators
Principal Investigator:
Mr. Bruce D. Reinert
Project started in: 1996
This project ended in Fiscal Year 1996.
Project Funding Information:
Project received funding in Fiscal Year 1996.
Project used human subjects in Fiscal Year 1996.
Funding Sources:
Project does not involve use of multiple protocols/subprojects.
IRB Review:
Type of Review: Full Board
Most Recent Approval: February 21, 1996
IRB Approval Number: 96 LANL 01
Number of Human Subjects who participated in this project/protocol during
FY 1996 (10/1/95 - 9/30/96): 6
Type of Human Subjects Involvement:
The penetration of the test agent (DEHS in aerosol form) into the interior of the suit shall be measured as the subject carries out standardized and simulated work exercises.
Purpose: OSHA requires a third party laboratory measured fit factor of at least 20,000 (penetration of 0.005%) to allow a respiratory device of this type to be used with lead based products. This laboratory measured fit factor of 20,000 would allow the device to be assigned a working fit factor of 1,000 which is the requirement. The purpose of this study is to determine whether or not the Clemco Apollo Model 20 and 60 hoods are capable of providing this range of user protection. The benefits would be that workers who purchase these devices could be assured that they will be protected.
TEST DESCRIPTION: A 16m(3) test chamber is used for aerosol respirator fit testing. Air flow through the chamber is approximately 75 CFM. A challenge aerosol of di(2)ethyl hexyl sebecate will be used with the majority of particles of submicron size. Aerosol concentrations are measured gravimetrically before and after each test. Samples are collected on open-face Metricel membrane filters, 25mm, 0.8um, and weighted on an ATI CAHN, Model C-33, microbalance. The chamber will be adjusted to maintain these measured concentration 15 - 20 mg/m (3).
Each hood is modified for sampling by drilling two 0.250" holes through the face shield for measuring pressure and aerosol penetration. One penetration is extended inside the hood to a position at the side of the subject’s head at the jaw line in order to measure pressure. The second feedthrough is used for sampling aerosol particles inside the hood at the breathing zone of the subject. All feedthroughs are sealed and leak checked before the start of human subject testing.
Breathing-air flow is measured using a Teledyne Hastings-Raydist mass flowmeter, Model AHL-25. Each hood will be tested at 6 cfm (170 lpm). Air pressure inside the hood is measured with a Validyne DP-45 differential pressure transducer connected to a Validyne, Model cd-15, carrier demodulator. The data is recorded on a Linear, Model 05454-0000, strip chart recorder. Aerosol particles are measured using a TSI Laser Photometer, Model 8587, at a sample flow of 2 lpm. Instrument background and chamber aerosol concentration are checked before each test session.
Each test subject will don the hod as outlined in the Clemco operating manual provided to the participants. The test subjects will perform the following exercises for two minutes each with a 15 second rest period between exercises:
SUBJECT STANDING ON FEET:
1. Normal breathing
2. Bending at waist and touching toes with hands
3. Raising arms above head
4. Twisting at waist while holding rod in both hands and raising and lowering
arms
5. Running in place
6. Normal breathing.
SUBJECT LYING ON BACK (abrasive blasting movements):
7. With hands together, move hands from side to side
8. With hands together, move hands from waist to above head
9. Roll side to side
10.Roll over onto belly and back.
SUBJECT LYING ON BELLY:
11. With hands in front of subject, move hands up and down.
Sound pressure levels measured at 6 CFM inside the Clemco helmet indicated that test subjects will not be exposed to sound pressure levels above 80dBA.
The subjects will not be required to perform any exercises more stressful than running in place during this testing.
RISKS: The subject will encounter no risks during this testing. Testing will be stopped if the penetration of aerosol into the helmet reaches a level of 10%. The test subject may stop the test at any time for any reason. The test operator will stop the test if any event occurs that is not according to the test protocol, for example, a drop in the breathing rate, monitoring equipment malfunction, or test lab power failure.
Project Identifier: LANL-96-96 LANL 03
Project Title:
Heat Stess and Durability Testing, Frahm-Tex Cool Suit
Principal Investigator:
Mr. Bruce D. Reinert
Project started in: 1996
Project Funding Information:
Project received funding in Fiscal Year 1996.
Project used human subjects in Fiscal Year 1996.
Funding Sources:
Project does not involve use of multiple protocols/subprojects.
IRB Review:
Type of Review: Expedited
Most Recent Approval: September 23, 1996
IRB Approval Number: 96 LANL 03
Number of Human Subjects who participated in this project/protocol during
FY 1996 (10/1/95 - 9/30/96): 2
Type of Human Subjects Involvement:
This testing will determine the amount of body heat captured by the Frahm-Tex cool suit. The durability of these garments will be evaluated during the testing. Data will also be collected on several configurations of the anti-C clothing that is now in use. These two sets of data will then be compared to determine if the Frahm-Tex device is a good replacement for the present anti-C's. Such research allows for a better understanding of materials, constructions, and design configurations of this clothing.
The subject will don the garment configuration to be tested exactly as instructed during the briefing. The testing subjects will be required to wear a heat stress monitor which will monitor his/her heat rate, body temperature, and the air temperature inside the suit between the covering and the subject's body. The subjects must wear a rectal probe temperature sensor. The sensor is approximately one eighth inch in diameter and must be inserted to a depth of approximately five inches. The subjects will be trained to insert these probes themselves. Selected subjects will be asked to restrict some items from their diet before the test, and on the day of the test.
When the subject is completely dressed, the test operator will take a pretest core temperature and heart rate. This data will be logged as physiological baseline measurements. The subject will enter the chamber, accompanied by a monitor. The subject will perform exercises at his/her own pace but the operator may at times give instructions to speed up or slow down.
BODY HEAT: An exercise protocol has been developed that should not stress the individual subject above the heart rate requirement of 90% of maximum. These exercises will be of simulated work type based on requirements of workers.
EXERCISES WILL INCLUDE: (1)Crawling on elbows and knees on an abrasive surface (Army style), (2) building a block wall with cement blocks, (3) climbing a ladder, (4) removing and replacing the lid and sealing ring on a 55 gallon drum, (5) turning an overhead valve wheel, (6) deep knee squats, and (7) running in place.
Each of these exercises will be performed for two minutes with a one minute rest period between each exercise. The entire set will be repeated three times for a total test time of 60 minutes.
Tests will be stopped immediately upon the subject's request, the operator detects equipment malfunction, or the occurrence of any unacceptable test condition.
When the test is completed the monitor will escort the subject out and provide him/her with two cups of cool water to drink and a towel to dry the face and hands. The operator will insist the subject drink all the water provided.
DURABILITY TESTING: This test will be conducted during the body heat testing. The suit material will be subjected to abrasive surfaces as the exercises require the subject crawl, pick up cement blocks to build a wall, and use the tools required to remove and replace the 55 gallon drum.
WATER TEST: This test will determine worn areas of the suit by allowing water to pass through the material. After the subject has showered and donned clean dry blue coveralls, and Frahm-Tex coveralls, he/she will return to the test area. A water spray test will be conducted as rapidly as possible to prevent perspiration from giving the test false reading. The subject will stand with arms hanging along the sides of the body. A hose with spray nozzle attached will be used to direct a stream of water at the knees, elbows, buttocks, and stomach areas of the suit. The exterior of the Frahm-Tex suit will be wiped dry. The Frahm-Tex suit will be removed and the blue coveralls will be inspected for wet spots, specifically at those areas where the water was directed.
TEST DURATION: Each test will require approximately two hours of the subject's time. This will include 30 minutes for the briefing, paper work, and dressing; one hour for the testing in the chamber, and 30 minutes for undressing, shower, and debriefing. Shower and dressing facilities are available at the test site.
RISKS and DISCOMFORTS: The risks involved with this testing are minimal. Minimal risks may include a high heart rate, or a rapid increase in body core temperature. The subject may develop rashes or abrasions caused by a reaction to the heart rate patches, test leads, or the wet clothing. Discomforts that the subject may experience associated with these tests well include wearing the anti-C clothing soaked with the individual's perspiration.
Project Identifier: LANL-96-96 LANL 04
Project Title:
Evaluation of Sensors and Methods for Auditory Canal Temperature Measurements
Principal Investigator:
Mr. Bruce D. Reinert
Project started in: 1996
Project Funding Information:
Project received funding in Fiscal Year 1996.
Project used human subjects in Fiscal Year 1996.
Funding Sources:
$500,000.00 shared between 90 LANL 07, 92 LANL 03, 94 LANL 02, and 96 LANL 04. All four (4) projects were approved by the IRB/HSR Comm.
Project does not involve use of multiple protocols/subprojects.
IRB Review:
Type of Review: Expedited
Most Recent Approval: September 23, 1996
IRB Approval Number: 96 LANL 04
Number of Human Subjects who participated in this project/protocol during
FY 1996 (10/1/95 - 9/30/96): 5
Type of Human Subjects Involvement:
While the temperature of the tympanic membrane might be ideal and is often measured in clinical settings, there is no instrument presently on the market, that would fit and stay in a precise location in the ear of an active working individual. Auditory canal temperatures, on the other hand, can be measured readily with small sensors mounted in special ear plugs.
While, in theory, these measurements give useful data, there are a number of practical and theoretical questions that must be answered: (1) what sensor to use, (2) how long does it take for the temperature to stabilize when the sensor is installed, (3) what is the best way to hold the sensor in the ear canal, (4) what is the effect of ambient temperature on sensor temperature, and (5) how should the data be interpreted.
The following program using human subjects is designed to answer these questions as fully as possible. When a subject arrives, a foam ear plug containing a temperature sensor will be installed in one or both ears. These ear plugs have been molded individually for each subject who will participate. The subject will insert a rectal temperature probe and don the heart rate monitor and transmitter. A protocol of exercise using a treadmill has been developed that should not stress the individual subject above 90% of their maximum heart rate. All test subjects have been screened by a cardiologist with a physical evaluation and a treadmill stress test prior to participation in the project.
These exercises will require the subject to walk on a treadmill at four miles per hour and 0 degrees incline for five minutes. The treadmill will then be raised three degrees of incline every three minutes up to a maximum of 15 degrees. The speed will remain constant at four miles per hour. The treadmill will then be lowered to 0 degrees incline, and three miles per hour. The subject will continue for three minutes. The subject will continue to wear the sensors, and the operator will monitor the physiological data until it has returned to pretest levels.
This test protocol will be performed in both ambient conditions and in the environmental test chamber which will generate the required higher and lower ambient temperatures. Temperatures to be considered for this testing may range from a low of 30 degrees F to high of 110 degrees F.
These exercises will also be conducted with the subject wearing coveralls, coveralls with the hazmat suit, and a SCBA breathing device.
Duration of testing will require approximately two hours of the subjects time.
The risks involved with this testing are minimal. These risks may include the subjects heart rate reaching the 90% if maximum level, a rapid increase in body core temperature not to exceed 0.5 degree C/min., or a core temperature of 39 degrees C. The possibility of rashes or abrasions caused by reaction to the heart rate patches, test leads, or the ear plugs is possible.
Discomforts associated with these tests will include wearing the ear plugs in one or both ears for extended periods. Wearing the heart rate patches and their removal which is equivalent to removing a very good surgical tape. Wearing the rectal temperature probe may be uncomfortable for some test subjects.
Project Identifier: LANL-96-96 LANL 05
Project Title:
Improved Methods for Detection of Beryllium Sensitivity
Principal Investigator:
Dr. Babetta L. Marrone
Project started in: 1996
Project Funding Information:
Project received funding in Fiscal Year 1996.
Project did not use human subjects in Fiscal Year 1996.
Explanation:
Funding in FY 96 was for test development. Testing will be done in FY97. (Note: IRB approval was 09/24/96
Funding Sources:
Project does not involve use of multiple protocols/subprojects.
IRB Review:
Type of Review: Full Board
Most Recent Approval: September 24, 1996
IRB Approval Number: 96 LANL 05
Number of Human Subjects who participated in this project/protocol during
FY 1996 (10/1/95 - 9/30/96): 0
Type of Human Subjects Involvement:
Los Alamos National Laboratory (LANL) is the sole facility, within the DOE weapon complex, involved in beryllium work. A state-of-the art facility is being developed which will integrate into the workplace the most advanced methods for monitoring airborne beryllium and for minimizing personal exposure. Strict exposure controls are necessary because respiration of beryllium particles can lead to a cell-mediated immune response in susceptible individuals. This response has been linked to the occurrence of Chronic Beryllium Disease (CBD), an interstitial lung disease. CBD occurs in about 2-5% of all beryllium-exposed workers. One feature of CBD that is believed to be an early marker is the development of cellular hypersensitivity to beryllium. In a sensitive individual, the lymphocyte cell fraction in a peripheral blood sample will increase within 5-7 days after a challenge with soluble beryllium. This test termed the Lymphocyte Proliferation Test (LPT) is currently being used throughout the DOE complex and in industry to test for sensitivity in former and current beryllium workers. LANL has an active medical surveillance program for their beryllium workers, but the LPT is not used to test for sensitivity for this population.
Physical symptoms of CBD occur in approximately 20% of individuals testing positive on the LPT. In addition, there is often disagreement in the results from the three (3) commercial laboratories that currently perform the LPT. The high "false positive" rate has prompted LANL to explore the development of more accurate measures of beryllium sensitivity. Through the proposed FY97 research, we hope to gain an improved understanding of the mechanisms underlying individual sensitivity to beryllium.
A. OBJECTIVES: The overall objective of our research proposal is to develop cellular and molecular biomarker assays for detecting beryllium sensitivity in exposed workers. Additional objectives include applying these tests to individuals who are susceptible to beryllium sensitivity through inhalation and to identify individuals before exposure.
B. METHODOLOGY: In FY97, we propose to test the LANL beryllium workers using an LPT by flow cytometry. In addition, we propose to use peripheral blood samples from the same individuals to develop other methods for detecting beryllium sensitivity even earlier during its development. Specifically, there is evidence that there may be a genetic susceptibility to CBD. One test that we will carry out on the LANL beryllium group will be to look for a genetic correlate to beryllium sensitivity as measured by the LPT. Another test that we will apply will examine a possible functional endpoint of the genetic susceptibility factor measured by flow cytometry as a cellular metabolic response. We will analyze the results of LPT, cellular response and genotype in relation to a beryllium exposure history. If our results support a genetic susceptibility to beryllium sensitivity, then a future goal will be to develop and apply a simple test for screening workers before beryllium exposure.
C. SUBSTANCES: There are no exposes, to human subjects, to any chemical or radioactive substances as a part of this project.
D. RISKS: The project requires an initial peripheral blood sample from each subject and a completed work history questionnaire. The risks are minimal and will be those normally associated with blood withdrawal. Test subjects review and sign informed consent forms before the Occupational Medical Group at LANL obtains blood samples. Blood samples receive a code before being sent to the PI. The PI does not know the identity of the test subjects involved in the study, thereby maintaining the confidentiality of the participants.
The proposed research plan developed through collaborative interactions with the Occupation Medicine Group at LANL. Additional input was obtained from the following LANL organizations: The National Flow Cytometry Resource Group; the Life Sciences Division and Human Genome Project investigators for cell cycle kinetics, pulmonary toxicology, molecular biology, and genomics; and the Environmental, Safety, and Health Division investigators for epidemiology and industrial hygiene.