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: 14
Project Identifier: LANL-52-91 LANL 06
Project Title:
Manhattan Project Plutonium Workers Health Study
Principal Investigator:
Dr. George L. Voelz
Project started in: 1952
Project Funding Information:
Project received funding in Fiscal Year 1997.
Project used human subjects in Fiscal Year 1997.
Funding Sources:
The project involves only human subjects so the total funds received are reported in 12.c above.
Project does not involve use of multiple protocols/subprojects.
IRB Review:
Type of Review: Full Board
Most Recent Approval: January 23, 1997
IRB Approval Number: 91 LANL 06
Number of Human Subjects who participated in this project/protocol during
FY 1997 (10/1/96 - 9/30/97): 19
Type of Human Subjects Involvement:
The research program, Manhattan Project Plutonium Workers Health Study, involves medical examinations of persons who did the pioneering work on the chemistry and metallurgy of plutonium from 1944-45 at Los Alamos. By 1952, Drs. Wright Langham and Louis Hempelmann had selected 28 workers who were judged to have the highest internal deposition of plutonium. Letters were sent to each of these workers (most of whom had left Los Alamos by 1948) to inform them of the purpose of a proposed medical examination program and asking for their voluntary cooperation. Two men did not wish to participate so the medical follow-up study consisted of 26 men.
About every five years since 1953, the surviving members of the group (19 at the present time) have had voluntary medical examinations. The principal objective of the study since its inception is to identify possible late effects from exposure to plutonium. The primary methods of follow-up consists of comprehensive medical examinations which include blood biochemical tests and x-rays of the chest and selected bones. From 1953 to 1965, these examinations were done at or near their home community by their private physicians or one selected by Dr. Hempelmann. Since 1972, the men have returned to LANL for their examinations. Additional bioassay sampling, in vivo chest counts, and other special medical studies (e.g., sputum cytology and cytogenetic studies) were done at LANL to assess their retention of plutonium and improve our knowledge of the biological behavior of this metal.
Although the study involved a very small number of men, an epidemiologic component was added to the study in 1980. Standardized mortality analyses were performed comparing the death rates of this small exposed cohort with those of their co-workers who had no plutonium exposure, and with white males in the U.S. general population. The selection criteria for the internal comparison group are Los Alamos male workers who were hired from 1943 to 1945, born within the same range of birth years of the exposed workers, and have no history of plutonium exposure. This internal comparison cohort consists of 876 workers.
The risks in this study are the same as those involved in the medical diagnostic examinations, plus the hazards of traveling. Each person undergoing examination signs a volunteer permission form for this study. The names of the participants are kept confidential and their records are medically confidential. Copies of their medical records are made available to the plutonium exposed persons in the clinical program, or more often their personal physicians upon receiving a signed medical release permit. Published reports from the study do not reveal the identity of the volunteer. All records are retained either in LANL’s medical records system or in the records of the epidemiology section of the Occupational Medicine Group. All records are under controlled access.
Project Identifier: LANL-76-90 LANL 07
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 1997.
Project used human subjects in Fiscal Year 1997.
Funding Sources:
$200,000 is an estimated amount with funding shared between projects 90 LANL 07 and 92 LANL 03.
Project does not involve use of multiple protocols/subprojects.
IRB Review:
Type of Review: Full Board
Most Recent Approval: January 23, 1997
IRB Approval Number: 90 LANL 07
Number of Human Subjects who participated in this project/protocol during
FY 1997 (10/1/96 - 9/30/97): 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 .5 um and a concentration of 25(+/-) 1.3 mg/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 1997.
Project used human subjects in Fiscal Year 1997.
Funding Sources:
Project does not involve use of multiple protocols/subprojects.
IRB Review:
Type of Review: Full Board
Most Recent Approval: January 23, 1997
IRB Approval Number: 90 LANL 04
Number of Human Subjects who participated in this project/protocol during
FY 1997 (10/1/96 - 9/30/97): 1
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 1997.
Project did not use human subjects in Fiscal Year 1997.
Explanation:
Funding Sources:
Project does not involve use of multiple protocols/subprojects.
IRB Review:
Type of Review: Full Board
Most Recent Approval: January 23, 1997
IRB Approval Number: 91 LANL 03
Number of Human Subjects who participated in this project/protocol during
FY 1997 (10/1/96 - 9/30/97): 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-92-92 LANL 03
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 1997.
Project used human subjects in Fiscal Year 1997.
Funding Sources:
$200,000 is an estimated amount and funding is shared between projects 90 LANL 07 and 92 LANL 03.
Project does not involve use of multiple protocols/subprojects.
IRB Review:
Type of Review: Full Board
Most Recent Approval: January 23, 1997
IRB Approval Number: 92 LANL 03
Number of Human Subjects who participated in this project/protocol during
FY 1997 (10/1/96 - 9/30/97): 3
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-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 did not receive funding in Fiscal Year 1997.
Project did not use human subjects in Fiscal Year 1997.
Explanation:
This project is on hold pending outcome of other research.
Funding Sources:
Project does not involve use of multiple protocols/subprojects.
IRB Review:
Type of Review: Full Board
Most Recent Approval: January 23, 1997
IRB Approval Number: 94 LANL 02
Number of Human Subjects who participated in this project/protocol during
FY 1997 (10/1/96 - 9/30/97): 0
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 materials suit.
The Standard Exercise and Simulated Work conditions will require the test subject to enter a test chamber that will be 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 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 a 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-95-97 LANL 02
Project Title:
The Employee Effects of Downsizing in the Nuclear Industry
Principal Investigator:
Dr. Lewis D. Pepper
Principal Investigator's Institution: Boston University School of Public Health
Project started in: 1995
Project Funding Information:
Project received funding in Fiscal Year 1997.
Project used human subjects in Fiscal Year 1997.
Funding Sources:
Project does not involve use of multiple protocols/subprojects.
IRB Review:
Type of Review: Expedited
Most Recent Approval: March 24, 1997
IRB Approval Number: 97 LANL 02
Number of Human Subjects who participated in this project/protocol during
FY 1997 (10/1/96 - 9/30/97): 300
Type of Human Subjects Involvement:
Objectives: The National Institute for Occupational Safety and Health funded project "The Employee Effects of Downsizing in the Nuclear Industry" has two overarching objectives. The project will (1) identify individual and organizational factors which will form the basis of a program to prevent the adverse consequences of downsizing, and (2) describe the consequences of downsizing, particularly as related to organizational climate, health, and performance effects.
Methodology: This project is a cross-sectional study of hourly and salaried workers at DOE facilities which are or will be affected by organizational restructuring and/or downsizing. Multiple methods are being used to complement the study design and fill out the picture of differences in employee effects among various sites. These include the use of archival data, ethnographic data, and survey data.
Archival data to be collected at each site includes, but is not limited to, objective information about organizational climate (i.e., work site policies and procedures, organizational charts) health and performance indicators (i.e., union grievances, occupational injuries and illnesses, medical unit visits, and any site recognized measures of performance.)
Ethnographic data, or descriptive information uncovering the ways and patterns of the employee culture, provides an important research strategy for studying questions and populations that may be inaccessible using other research techniques. Ethnographic methods produce qualitative data that provides depth and detail through direct quotation and careful description of situations, events, people, interactions and observed behaviors. Interviews with key informants, work site observations and focus group discussions permit the researcher to understand the world as seen by the respondent within the context of the respondent’s everyday life.
Individual survey data will be collected to answer, by statistical means, the study questions. A number of survey scales that measure organizational climate (level of work demands, worker control, and support) and health are being used for this study, although, final selections will follow discussions between the cooperating parties as outlined in the project agreement. In addition, ethnographic material will be used to tailor interments. This design step has proved invaluable in improving instrumentation and scale reliabilities in other research that considered similar study variables.
Involvement of Human Subjects: A participant may be asked to take part in one of three activities. They may fill out a questionnaire, take part in a focus group, participate in an interview, participate in a pilot testing of the survey instrument, or take part in the final survey. Potential participants are not required to answer any questions which they do not wish to answer or to take part in any of these activities.
Risks: There is little risk in participating in the project. Subjects may be inconvenienced by the time spent answering the questionnaire and participating in the interview.
Confidentiality: All records associated with this project will be confidential and will be kept in a locked file in Dr. Pepper’s office. Project staff reviewing records will not reveal an individual’s identity. Any records collected by project staff will not contain personal identity. A participant’s identity will not be revealed in publications or reports resulting from the study. Potential subjects who do not wish to participate in the study will not suffer adverse consequences.
Informed consent: An informed consent is discussed with all research participants. The informed consent contains an introduction, the procedures to follow, risks and benefits, confidentiality, and a statement associated with signature of consent. The consent is signed prior to participation.
Little is known about the health effects of downsizing on workers even though the economic and social implications seem obvious. The question of health effects for workers who remain is an important one given the possibility of doing more work with less resources, increasing demands, and the likelihood for a changeover in the skills and tasks that the job requires. A study of the health effects of downsizing, in terms of better or worse ways to implement it, is vitally important to ameliorating the adverse consequence. Although the subject will not directly benefit from participation in the project, the information developed from this project may help guide future policy in this area.
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
This project ended in Fiscal Year 1997.
Project Funding Information:
Project received funding in Fiscal Year 1997.
Project used human subjects in Fiscal Year 1997.
Funding Sources:
Project does not involve use of multiple protocols/subprojects.
IRB Review:
Type of Review: Full Board
Most Recent Approval: January 23, 1997
IRB Approval Number: 96 LANL 02
Number of Human Subjects who participated in this project/protocol during
FY 1997 (10/1/96 - 9/30/97): 10
Type of Human Subjects Involvement:
THE PROJECT ENDED SEPTEMBER 30, 1997.
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 Committed Effective Dose Equivalent (CEDE)s exceeding 100 mrem in the year of intake.
During FY97, 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 the 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 (fallout 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 distribution 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 03
Project Title:
Heat Stess and Durability Testing, Frahm-Tex Cool Suit
Principal Investigator:
Mr. Bruce D. Reinert
Project started in: 1996
This project ended in Fiscal Year 1997.
Project Funding Information:
Project received funding in Fiscal Year 1997.
Project used human subjects in Fiscal Year 1997.
Funding Sources:
These funds were used to complete the required testing for 1997.
Project does not involve use of multiple protocols/subprojects.
IRB Review:
Type of Review: Full Board
Most Recent Approval: January 23, 1997
IRB Approval Number: 96 LANL 03
Number of Human Subjects who participated in this project/protocol during
FY 1997 (10/1/96 - 9/30/97): 4
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 that 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 a false reading. The subject will stand with arms hanging along the sides of the body. A hose with a 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, showering, and debriefing. Showering 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 will 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 1997.
Project used human subjects in Fiscal Year 1997.
Funding Sources:
Funding for this project was shared with 90 LANL 07, 92 LANL 03, 94 LANL 02, and 96 LANL 04. All four projects were approved by the IRB/HSR committee.
Project does not involve use of multiple protocols/subprojects.
IRB Review:
Type of Review: Full Board
Most Recent Approval: January 23, 1997
IRB Approval Number: 96 LANL 04
Number of Human Subjects who participated in this project/protocol during
FY 1997 (10/1/96 - 9/30/97): 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 subject's heart rate reaching the 90% 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 subsequent 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 1997.
Project used human subjects in Fiscal Year 1997.
Funding Sources:
Project does not involve use of multiple protocols/subprojects.
IRB Review:
Type of Review: Full Board
Most Recent Approval: August 22, 1997
IRB Approval Number: 96 LANL 05
Number of Human Subjects who participated in this project/protocol during
FY 1997 (10/1/96 - 9/30/97): 60
Type of Human Subjects Involvement:
Los Alamos National Laboratory (LANL) is the primary facility, within the DOE weapon complex, involved in beryllium work. A state-of-the art facility is being developed that 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 1-5% 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 FY98 research, we hope to gain an improved understanding of the mechanisms underlying individual sensitivity to beryllium.
A. Objectives: The overall objective of our research is to develop in vitro 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 FY98, we propose to continue testing the LANL beryllium workers using an LPT by flow cytometry. The LANL LPT measures proliferation of specific lymphocyte subsets in response to beryllium. 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. 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 in vitro test for screening workers before beryllium exposure.
C. Substances: Human subjects are not exposed 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.
Project Identifier: LANL-96-96 LANL 06
Project Title:
Optical Physiological Monitoring of the Brain
Principal Investigator:
Dr. Judith R. Mourant
Project started in: 1996
This project ended in Fiscal Year 1997.
Project Funding Information:
Project received funding in Fiscal Year 1997.
Project used human subjects in Fiscal Year 1997.
Funding Sources:
Project does not involve use of multiple protocols/subprojects.
IRB Review:
Type of Review: Full Board
Most Recent Approval: January 23, 1997
IRB Approval Number: 96 LANL 06
Number of Human Subjects who participated in this project/protocol during
FY 1997 (10/1/96 - 9/30/97): 2
Type of Human Subjects Involvement:
Background: The idea of noninvasive, optical monitoring of the brain has developed quickly in the last few years and progress in this area continues to be rapid. Several groups have demonstrated that near-infrared (NIR) light passes through both bone and brain tissue and have used it to noninvasively probe the brain. Optical methods show promise for real-time monitoring of physiologically important parameters as well as for answering some fundamental questions about brain function and metabolism. Clinical applications include monitoring of hemoglobin saturation during times of risk for neonates and during surgical procedures such as cardiopulmonary bypass surgery. The appropriateness of optical techniques for studying aspects of brain function identification are demonstrated in a recent paper in Science where signals arising from microcirculation are used to map brain function.
Objectives: To measure a change in either oxygenated or deoxygenated concentration upon stimulation of the motor cortex with a noninvasive optical technique.
Methodology: The approach taken here is to make measurements of light transport through the brain using fiber optics placed on the head. All measurements will be made with a continuous wave (cw) technique.
Measurements will be made over the spectral range of 600-1100 nm. The light source is a Tungsten-Halogen lamp. The light output from the optical fibers to be placed in contact with the skull is >100 mW. The diameter of this probe will be about 1 mm for low light levels (~5 mW) and about 1 cm for the high light levels, corresponding to a power density of ~30 mW/cm2. To assure good contact between the optical fibers and the skull, both the delivery and the collection fibers will be spring loaded. Light collection is performed by bundles of 200 um fibers separated by a few centimeters from the delivery fibers. When small numbers of fibers are used, the fibers will be encased in epoxy. The diameter of the probe will be at least one millimeter to assure that the probe can not puncture the skin. The light collection fibers conduct the light to a spectrometer and CCD array.
Measurements may be made on any region of the head, but initially we will focus on the motor and visual cortex. Stimulations for the motor cortex will consist of moving various parts of the body such as the fingers. Stimulations for the visual cortex will consist of screens of black and white squares with the image reversing colors as a function of time.
Ionizing Radiation, Radioactive Substances, Chemical Substances: No ionizing radiation, radioactive substances, or chemical substances were used as a part of this study.
Involvement of Human Subjects: The subjects wore a modified motorcycle helmet. This helmet was outfitted with spring loaded optical fiber that contracted the subjects skull over the motor cortex. During the measurements the subjects either sat or performed a finger opposition task that consists of alternately touching each finger to the thumb of the same hand.
There were no risks to the subjects.
The identity of each subject was kept confidential. The study was explained to each participant and an informed consent was signed prior to involvement in the research.
Project Identifier: LANL-97-97 LANL 01
Project Title:
Human Subject Aerosol Penetration Testing of 3M Abrasive Blasting Hoods
Principal Investigator:
Mr. Bruce D. Reinert
Project started in: 1997
Project Funding Information:
Project did not receive funding in Fiscal Year 1997.
Project did not use human subjects in Fiscal Year 1997.
Explanation:
Project will be funded FY98
Funding Sources:
Project does not involve use of multiple protocols/subprojects.
IRB Review:
Type of Review: Full Board
Most Recent Approval: January 23, 1997
IRB Approval Number: 97 LANL 01
Number of Human Subjects who participated in this project/protocol during
FY 1997 (10/1/96 - 9/30/97): 0
Type of Human Subjects Involvement:
The penetration of the test agent, DEHS, in the form of an aerosol, will be monitored and recorded by the subject, during standardized and simulated work exercises.
Abstract: 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 if the 3M Model 8100 Whitecap II abrasive-blasting supplied-air respirator, a W2907 air regulating valve in conduction with W9435 compressed air hose, and the 3M Model 8100 Whitecap II abrasive-blasting respirator, utilizing a W3200 Whitecap powered air purifier, 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 Subjects: Testing will require four different subjects: a representation of at least three distinct sizes and one subject that has a large lung capacity. The three physical sizes that shall be represented are of the following heights: (1) small-168 to 176 cm (5ft 6 in. to 5ft 9 in.), (2) medium-177 to 188 cm (5ft 10 in. to 6 ft 2 in.), and (3) large-191 to 198 cm (6 ft 3 in. to 6 ft 6 in.) The height, weight, arm length, leg length, and breadth of each subject shall be determined before start of testing.
Medical Examination: Before a person participates in any of these tests, he/she will be required to have passed a maximum stress test administrated by medical personnel. This test assesses the work load that the heart can safely accommodate. This test will reveal the subject’s maximum heart rate from which 90% of maximum will be calculated. This stress EKG test will determine if the person can participate and to what level. Once a person is accepted as a subject and the 90% level has been established, the 90% level will not be exceeded during testing.
Informed Consent: All subjects will receive a complete briefing on the program, including its purpose, requirements, possible discomforts, risks, and possible complications which might arise. A condensed version of this briefing will be repeated each time the subject comes in for testing. After the briefing and before each test, the subject will be asked to sign an informed consent form. The form states that the subject has been briefed and that all of his/her questions have been answered. The form also notifies the subjects that they can stop a test at any time or quit the program at any time without any adverse consequences.
Test Chamber: A 16 cubic meter 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-faced Metricel membrane filters, 25mm, 0.8um, and weighed on an ATI CAHN, Model C-33, microbalance. The chamber will be adjusted to maintain a measured concentration of 15-20 mg/m3.
Hood Modification: 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 feed-through is used for sampling aerosol particles inside the hood at the breathing zone of the subject. All feed-throughs are sealed and leak checked before the start of human subject testing.
Breathing-Air: Breathing-air flow is measured using a Teledyne Hastings-Raydist mass flowmeter, Model AHL-25. Each hood will be tested at breathing-air flows of no less than 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 05454-000, 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 concentrations are checked before each test session.
Exercises: Each test subject will don the hood as outlined in the Clemco operating manual, and perform the following exercises for two minutes each with a 15 second rest period between exercises: 1. Subject standing on feet: normal breathing, bending at waist and touching toes with fingers, raising arms above head, bending at the knees, twisting at waist while holding rod in both hands and raising/lowering arms, marching in place, and normal breathing. 2. Subject lying on back (abrasive blasting movements): hands together - move hands from side to side, hands together-moving hands from above head to waist, roll from side to side, and roll from back onto belly and back again - repeatedly. 3. Subject lying on belly: with hands in front of subject, move hands up and down.
Sound Pressure Levels: Levels will be measured inside the helmet at all manufacture's specified breathing-air flows. These sound pressure levels will be monitored as the flow is increased to ensure that test subjects will not be exposed to sound pressure levels above 80 dBA.
The subjects will not be required to perform any exercises more stressful than running in place during this testing.
Risks: The subject will encounter minimal 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 air flow rate, monitoring equipment malfunction, or test laboratory power failure.
Project Identifier: LANL-97-97 LANL 03
Project Title:
Heat Stress and Aerosol Testing of the Bechtel-Hanford Suits
Principal Investigator:
Mr. Bruce D. Reinet
Project started in: 1997
This project ended in Fiscal Year 1997.
Project Funding Information:
Project received funding in Fiscal Year 1997.
Project used human subjects in Fiscal Year 1997.
Funding Sources:
This project had several parts, only one which required human subjects.
Project does not involve use of multiple protocols/subprojects.
IRB Review:
Type of Review: Expedited
Most Recent Approval: April 08, 1997
IRB Approval Number: 97 LANL 03
Number of Human Subjects who participated in this project/protocol during
FY 1997 (10/1/96 - 9/30/97): 5
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.
Statement of Purpose: This protocol has been written to describe heat stress and aerosol testing of the Bechtel Hanford Inc. protective suits. Data will be collected on six different configurations of suits now in use, and in a safe environment prior to actual use. Two sets of data will be taken, body temperature, and aerosol penetration. This data will then be compared, suit to suit, to determine the characteristics of the suits. Such research allows for a better understanding of materials, construction, and design configurations of this type of clothing.
Testing of the Bechtel Hanford reusable coverall type garments will be conducted using the Research and Development Section’s environmental chamber. The R&D Section is a part of the Industrial Hygiene and Safety Group/Environmental Safety and Health Division.
Test Subjects: Testing will require four different subjects: a representation of at least three distinct sizes. The three physical sizes that shall be represented are of the following heights: (1) small-168 to 176 cm (5ft 6 in. to 5ft 9 in.), (2) medium-177 to 188 cm (5ft 10 in. to 6 ft 2 in.), and (3) large-191 to 198 cm (6 ft 3 in. to 6 ft 6 in.)
Medical Examination: Before a person participates in any of these tests, he/she will be required to have passed a maximum stress test administrated by medical personnel. This test assesses the work load that the heart can safely accommodate. This test will reveal the subject’s maximum heart rate from which 90% of maximum will be calculated. This stress EKG test will determine if the person can participate and to what level. Once a person is accepted as a subject and the 90% level has been established, the 90% level will not be exceeded during testing.
Subjects will be required to wear an air-purifying respirator during these tests. Due to this test requirement, all subjects must posses an up to date LANL respirator card.
Risks and Discomforts: The risks involved with this testing are minimal. Minimal risks may include the subject's heart rate reaching the 90% of maximum level, a rapid increase in body core temperature of equal to but not greater than 0.5 degree C per minute. (NOTE: either of these items would cause the test to be stopped immediately.) The subject may become nauseous if this occurs. The possibility exists of rashes or abrasions caused by a reaction to the heart rate patches, test leads, or the wet clothing. Discomforts associated with these tests will include wearing the anti C type clothing soaked with the individual’s perspiration, wearing the heart rate patches or their removal which is equivalent to removing a very good surgical tape, and the possibility of heat rash due to the hot humid conditions inside the clothing.
Informed Consent: All subjects will receive a complete briefing on the program, including its purpose, requirements, possible discomforts, risks, and possible complications that might arise. A condensed version of this briefing will be repeated each time the subject comes in for testing. After the briefing and before each test the subject will be asked to sign an informed consent form. The form states that the subject has been briefed and all of his/her questions have been answered. The form also notifies the subjects that they can stop a test at any time or quit the program at any time without any adverse consequences.
Garment Configuration: Garments to be tested will all be of the coverall type without a face cover.
Exercises: A protocol of exercises has been developed that should not stress the individual subject above the heart rate limit of 90% maximum. These exercises will be of a simulated work type. Tests will be stopped immediately if a subject’s heart rate reaches 90% of maximum, a core temperature of 39 degree C is reached, or the rate of rise of the core temperature is equal to 0.5 degree C/min. Tests will be stopped immediately upon the subject’s request, or if the operator detects any equipment malfunction, or any unacceptable test condition.
Exercises will include: crawling on elbows and knees on an abrasive surface (Army style), building a block wall with cement blocks, climbing a ladder, removing and replacing the lid and sealing ring on a 55 gallon drum, turning an overhead valve wheel, deep knee squats, and 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 rest time of 63 minuets.