Evaluation of Post-Exposure Sauna Treatment of Firefighters - A Pilot Study, Institutional Review Board# 1801201082
Phase: NA
Conditions: Post-fire Rehabilitation of Firefighters in Sauna
Sponsor: University of Arizona

 
 
 
 
 
 
 
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PROJECT 
TITLE: 
Evaluation of Post-Exposure Sauna 
Treatment of Firefighters – A Pilot Study 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
STUDY PROTOCOL 
 
NCT NUMBER: NCT03429348 
 
DOCUMENT DATE:  MAY 14, 2018 

 
 
 
 
 
 
 
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1) Background 
Firefighters are at increased risk of cancer, and both inhalation and dermal routes contribute to 
overall exposure to carcinogens, including polycyclic aromatic hydrocarbons (PAHs).  PAHs can be 
measured in urine samples so urine sampling has been shown to be a good measurement of 
exposure to toxicants. 
Training fires are performed as part of fire suppression continuing education and/or training events 
scheduled by fire departments to review or present new departmental concepts in fire suppression 
activities under closely monitored safety conditions.  The National Fire Protection Agency (NFPA) 
requires fire department to annually test active firefighters for competency in fire suppression.  This 
can be done using training fires.   
Two types of structure training fires are flashover and burn room fires.  Flashover training fires are 
fires that simulate the transitional phase of a structure fire between the growth stage and the fully 
developed stage of a fire.  During a flashover, ignition of the room contents are ignited at once, 
includes smoke, and the entire space is consumed by fire. Burn room training fires simulate fires that 
burn wood, straw, excelsior, hay, wood pallets, generating enough heat for fire training purposes.   
After fighting a fire, the standard operating procedures for fire department require a post-fire 
rehabilitation to prevent the risk of injury that may result from extended field operations under 
adverse conditions.  At the Fire Department, the rehabilitation consists of:  1) assessment of vital 
signs; 2) revitalization p rest, hydration, refreshments, and temperature regulation; 3) medical 
evaluation and treatment of injuries, if needed; 4) transportation for those requiring treatment at 
medical facilities, and 5) reassignment as needed. 
 
Sauna post-fire incident exposure detoxification was performed post 9-11 and studied in research 
published in 2006 by Cecchini, etal., (article attached) but the results of the study are incomplete 
and were not controlled.  Crinnion, 2007, as director of the Environmental Medicine Center of 
Excellence at the Southwest College of Naturopathic Medicine in Tempe, Arizona, summarized that 
saunas, “…can be used very effectively for certain cardiovascular problems and as a means to 
enhance the mobilization of fat-soluble xenobiotics.  When saunas are used to reduce blood 
pressure and enhance blood flow and cardiac functioning, only short sauna sessions (15 minutes) are 
necessary. 
 
A traditional sauna generates heat by heating rocks to heat the air, adding in steam to heat the skin, 
and generally operate at 180-190 deg F.  An infrared sauna uses light to create heat that warms your 
body directly without warming the air and operate at lower temperatures, 110-140 deg F. A Mayo 
Clinic Consumer Health report by Dr. Brent A Bauer, MD, accessed 12/21/2017 (attached) reported 
“…no adverse effects have been reported with infrared saunas.” 
 
The purpose of the current study is to determine if treatment in an infrared sauna: a) affects 
absorption of PAHs as measured by urinary metabolites; and b) changes core body temperature and 
heart rate. Infrared exposure from the sauna treatment is expected to increase the core body 
temperature, which may have a detrimental effect on the firefighter performance; heart rate will be 
used as a measurement of stress. There is sparse literature concerning the subject of using infrared 
sauna as a post-exposure treatment.  

 
 
 
 
 
 
 
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2) Purpose 
The purpose of the current study is to determine if post-fire training exercise treatment in an 
infrared sauna as compared to the standard post-fire treatment:  
a) Affects absorption of PAHs as measured by urinary metabolites. (Aim 1) 
b) Changes core body temperature and heart rate. (Aim2) 
 
These two aims will be achieved by the following objectives: 
a. Coordinating with the Fire Department to recruit and consent firefighters scheduled for 
training fires to participate 
b. Obtaining 12 hour pre and post-fire urine samples, along with dermal samples. 
c. Monitoring core body temperature and heart rate at baseline, during fire response, and for 8 
hours after 
d. Splitting the post-fire post-standard Rehab firefighters into 2 groups:  no additional treatment 
group or sauna rehab group. 
e. Answering a survey to gather demographic information and information about recent 
exposures that might affect the results of the urine results and information about their 
participation in the fire 
 
The results of the biological samples may tell us if sauna post-fire rehab is an effective means for 
increasing the body’s removal of toxic chemicals during post-fire rehab with less than a 102 degree 
core body temperature increase.  
 
3) Lay Summary (approximately 400 words) 
The fire department chosen is a career fire department with approx. 260 active firefighters on staff.  
They respond to fire incidents and other medical emergencies in a 184 square mile area.  They train 
recruits to become firefighters and annually proving drill training in various skills, such as live fire 
training.  Following live fire responses (including training fires) their standard operating procedure 
includes a rehabilitation requirement to insure that no firefighter will be permitted to continue 
emergency operations beyond safe levels of physical or mental exertion (rehab).   
 
They would like to add the use of a sauna post-fire response to their rehab SOP and have supported 
the UA study team lead by Dr. Jeff Burgess to compare a chemical commonly excreted after 
firefighting to compare the value of adding sauna to rehab post-fire and monitoring the heart rate 
and temperature using a core body temperature/heart rate monitor data recorder. Urine will be 
collected for 12 hours immediately before the scheduled training fire and for 12 hours afterwards.  
 
The core body temperature/heart rate monitor works by having the firefighter swallow a sensor 
shaped like a pill that the data recorder senses the temperature.  The pill passes thru the gut and is 
removed with bowel movement, approximately in 24 hours, depending on the normal excretion 
timing of the person.  A Polar heart rate belt that is worn around the body in the chest area and 
records the heart rate/pulse of the person wearing it.  The firefighter will swallow the sensor and put 
on the Polar heart rate belt and the UA study team will start the data recorder before the firefighter 
enters the training fire and will continue to wear it for up to 8 hours afterwards. 
 

 
 
 
 
 
 
 
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After the fire, the firefighter will perform the standard rehab.  During this time, the UA study team 
will randomly select half of the firefighters to and additional sauna rehab and the other half of the 
firefighters to no additional rehab.  Dermal (skin) wipe samples will be taken off the calf, arm, and 
neck before the fire, before standard rehab, and after sauna/no additional treatment.  
 
If it is available, a personal air monitor will be worn to assess the air quality in the fire.  A post-fire 
survey will be administered to gather demographic information, pre-fire exposure information, job 
duties in the training fire, and other information. 
 
The UA study team will perform the urine PAH-OH analysis, download the air monitor data (if 
performed), results of the surveys, skin wipe analysis (if performed) , and download and compare 
the core body temperature and heart rate data between the sauna rehab and the no additional 
treatment groups. 
 
4) Setting of the Human Research 
The recruitment, consenting, and training fire exercises will take place at the fire department’s main 
office, stations, and training centers used to train firefighters to respond to live-fires.  The University 
of Arizona (UA) study team will be responsible for recruiting and consenting interested firefighters 
and in collecting samples and surveys before and after the training fire.  The fire department 
personnel are responsible for the training and safety of the firefighters with regard to the fire 
training exercise. At the University of Arizona, data and sample analysis and manuscript writing will 
be done at Drachman Hall, Office 317C or A241, at the Medical Research Building Lab 130, or Keating 
Building, Lab 402.  The UA study team are trained in human subjects protection, sample collection, 
processing, transportation, and analysis.  
 
5) Resources available to conduct the Human Research  
The fire department has fire training for both flashover and burn room fires as standard operating 
training exercises.   Making space available to the UA study team to recruit, consent, and collect 
samples has not caused undue problems to their department as is evidenced in their support letter. 
The supplies needed for the UA study team’s research will be funded by the PI’s fixed price complete 
account, or alternate sources as determined by the PI.   
The sauna already belongs to the fire department and it is NOT being purchased for this research.   
6) Study Population 
The study will seek participation from the fire department firefighters assigned or soon to be 
assigned to a training fire exercise.  To test the best type of training fire exercise (flashover or burn 
room) we will need four for each group; this is referred to as Stage 1 in section 1, page 3 of this 
document.  They may be the same firefighters or different, depending on the fire department 
schedule and the firefighters consent preferences.   
After the training fire type is chosen (flashover or burn-room) up to 24 firefighters already scheduled 
to participate in a training fire as part of their continuing education will be selected as participants in 
the study exercise referred to as Stage 2 involving urine collection, skin wipes, core body 
temperature monitoring, survey collection, etc.  They will be selected based on the availability of the 
UA study team to be present during their training fire exercise and their consent preferences.  This 
group of 20-up to 24 firefighters may consist of the same firefighters who participated in the Stage 1 

 
 
 
 
 
 
 
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fire(s) or may be different, depending on the fire department training fire schedules and the 
firefighters consent preferences. 
The fire department employees can be included in the study if they: 
1) Are employed as an active fire responder by the fire department 
2) Are scheduled for a training fire exercise by the fire department in the next year. 
3) Are currently a non-smoker (including cigarettes, cigars and e-cigarettes) 
4) Cannot have any contraindications to the core temp pill, which are: 
a. Do you weigh less than eighty (80) pounds? 
b. Do you have any known or suspected obstructive disease of the gastrointestinal tract, 
including but not limited to diverticulitis and inflammatory bowel disease? 
c. Do you exhibit or have a history of disorders or impairment of the gag reflex? 
d. Have you had a previous gastrointestinal surgery? 
e. Do you have any diseases or disorders of the esophagus? 
f. Will you be undergoing Nuclear Magnetic Resonance (NMR) or MRI scanning less than 
3 days after swallowing the sensor? 
g. Do you have a low motility disorder of the gastrointestinal tract including but not 
limited to ileus? 
h. Do you have a cardiac pacemaker or other implanted electromedical device? 
i. Do you have a swallowing disorder? (problems swallowing) 
 
In order to insure we have enough firefighters consented for the scheduled training fires, we will 
plan to consent more than 24 firefighters, requesting approval for up to 40 firefighters.   There is no 
power analysis planned for the recruitment of the firefighters. 
7) Recruitment Methods and Consenting Process 
a. Recruitment Process: We will recruit using a recruiting flyer that may be distributed at the fire 
department’s main office, stations, newsletters, and list-serves.    
b. Informed Consent:   
We will consent firefighters, individually, who are interested in participating in a private area 
prior to the training fire exercise.  Consent will be a written version, signed by the firefighter and 
administered by the UA study team who are well versed in the proper consenting process.  The 
consenting process may be over the phone to facilitate urine collection prior to the training day. 
If consent is obtained over the phone, a signature will be obtained, in person, prior to the 
firefighter turning in the urine sample, or otherwise participating in any part of the research.  
Each page of the consent form will be individually discussed with the firefighter and will provide 
the firefighter with an opportunity to ask questions.  Coercion and undue influence will be 
avoided by ensuring the voluntary nature of this study is stressed.  Additionally, no supervisors 
will be involved in the consenting process.   
As a condition of employment, all fire department firefighters are adults, fluent in English so all 
information and consenting materials will be presented in English.  Only non-smoking firefighters 
(including cigarettes, cigars and e-cigarettes) will be recruited, to minimize smoke exposure not 
associated with live-fire training.   
 

 
 
 
 
 
 
 
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8) Research procedures involved in the Human Research 
Stage 1: An initial four firefighters will be evaluated for change in PAHs associated with standard fire 
department flashover training to determine if urinary PAH metabolites increase following exposure, 
comparing baseline urine samples before training to a repeat sample collected after cessation of 
training. If a significant increase is not seen, then repeat testing with four additional firefighters will 
be completed using alternate burn room training fire.  Prior to starting the training fire, the subjects 
will provide a 12-hour pre-fire urine sample, swallow a core temperature probe and wear a monitor 
and heart rate belt for recording both their core temperature and heart rate. In addition, dermal 
wipes will be collected prior to the training fire. Firefighters may wear a personal air monitor to 
capture the quality of the air during the training exercise. Post-fire dermal wipe samples will be 
collected after the firefighter removes turnout gear.  Post-fire 12 hour urine samples will be 
collected in the same manner as the pre-fire urine samples. Subjects will also be asked to complete 
the exposure assessment survey. Specific procedures as explained in more detail below.   
 
Stage 2: Once a measurable increase in post-fire urinary PAH has been documented, the associated 
training fire (flashover training or burn room training), testing will be carried out in up to 24 subjects.   
Urine, core temperature, heart rate, dermal wipe and air monitoring samples will be collected as in 
Stage 1 collection.  
In addition, following the standard rehab, the firefighters will be randomly selected to either sauna-
treatment or no additional treatment as explained in the “Sampling Protocol Timeline” below.   
 
The Sampling Protocol Timeline for the Stage 1 and Stage 2 training fires: 
1. Beginning of sampling period: The UA study team will meet each firefighter at the training 
fire facility prior to beginning their training fire.  Firefighters will have already been consented 
and their contraindications forms completed at an earlier date as described in the “Informed 
Consent” and “Risks to Subjects” sections. The UA study team will read the contraindicated 
form to the participant one more time to confirm that they have not experienced any of the 
contraindications.  If they answer ‘yes’ to any of the contraindications, they will be excluded 
from the study.  If the firefighter consented by phone, the consent form will be signed by the 
firefighter before continuing. 
2. If the firefighter answered ‘no’ to all contraindications, the UA study team will instruct the 
firefighter to swallow the core thermo pill (the sensor will pass through the body and 
excreted with their normal bowel movement at the subject’s normal rate of motility, which is 
typically 24-36 hours).   
3. The UA study team will accept the urine sample collection the firefighter began collecting 
approximately 12 hours before the anticipated start of the fire. If one of the 12 hour urine 
samples has not yet been collected by the firefighter, a “zero” hour baseline sample will be 
collected at the time of the scheduled training. 
4. The Polar heart rate belt will be donned by the firefighter and three dermal skin wipes (calf, 
arm, and neck) will be collected prior to the firefighter donning the turnout gear.   

 
 
 
 
 
 
 
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5. 
When the fire department personnel say that it is time for the firefighter to don their turnout 
gear, the UA study team will turn on the core body/heart rate monitor data recorder. Next, 
the UA study team will place the core body/heart rate monitor data recorder in the 
firefighter’s inner pocket of their turnout jacket.  The UA study team will make sure the data 
is recording by pressing the “run” button to see that it registers a digital reading.  After the 
firefighter is in full gear, the placement of the heart rate monitor/data recorder will be 
accessed for firefighter activity safety (not impeding movement) and a personal air monitor 
may be attached to the outside of the turnout gear jacket in an unobtrusive location. 
6. 
The firefighter will enter the training fire room as instructed by standard fire department 
protocol for the standard period of time for participation in the training fire.  Following 
cessation of the training fire, the subjects will follow their standard fire department 
procedures for post-fire treatment (rehab).   
7. The UA study team will remove the personal air monitor from the firefighter’s turnout jacket 
(if applicable).The firefighters will remove their turnout gear at this time. The heart rate/core 
body temperature monitor data recorder will be transferred from the turnout jacket inner 
pocket to a pants pocket.  A dermal wipe (a gauze pad moistened with alcohol) of the left 
calf, arm, and neck will be obtained prior to cleaning their skin with their standard rehab 
baby wipes (part of the standard fire department procedures for post-fire treatment.) 
8. (For Stage 2 fires only) The subjects will then be randomized to either an infrared sauna 
treatment, or no additional treatment following their fire department protocols.  The 
firefighters will be randomized by the UA study team as such:  Firefighters will pull a piece of 
paper out of a helmet; if it says “sauna” they will participate in the sauna treatment.  If it is 
blank, they will participate in no additional post-fire treatment.  “Sauna treatment” consists 
of a firefighter entering the sauna for 20 minutes as soon as the fire department has 
completed their standard rehab.  
 
9. Following the sauna treatment or no additional treatment time period, dermal wipes of the 
left calf, arm, and neck will be repeated and the subjects will complete a survey and return to 
work. The dermal wipe samples will be transported under Arizona Department of 
Transportation guidelines for transportation of samples to the University of Arizona. 
 
10. Core temperature and heart rate will continue to be monitored for up to 8 hours after 
training scenario.  At the end of the 8 hour period, the firefighter will turn the monitor off by 
pressing the “stop” button and the “On/Off” button.   
 
11. The subjects will collect all their urine after the fire training for a period of up to 12 hours in 
the same manner that urine was collected prior to the fire training.  
 
12. End of sampling period: At the end of the sampling period, the UA study team will, again, 
meet the firefighters at the fire department to collect the data recorder/heart rate monitor 
data recorder, Polar Heart Rate belt, and urine samples.  
 
13. The urine will be stored at the Medical Research Building at -80 deg C until analyzed for 
urinary PAH metabolites and potentially other toxicants from the fire, and, dependent on the 
available budget, similar evaluations may be carried out on the skin wipes.  The core 

 
 
 
 
 
 
 
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temperature and heart rate data will be downloaded from the data recorder onto a password 
protected computers and will be analyzed for comparison to the pre-fire data.  The personal 
air monitors will be downloaded in the same manner and analyzed for air quality. 
 
 
 
We would like to take pictures during the activities such as wearing the monitors, performing skin 
wipes, going into or coming out of the training fires or sauna, including cleaning up gear, for possible 
use in manuscripts, presentations, posters, and/or brochures to present a visual description of the 
activities involved in the training fire study.  The subjects will be asked to agree or decline being in 
photos. 
Specific Sampling Protocols for Stage 1 and Stage 2 training fires: 
Urine sampling: before and after the fire: 
For each urine sample collected, the total amount of each voided sample will be collected in a 200ml 
sample collection container and stored in an ice chest until picked up by the UA study team.  The 
subjects will collect all their urine after the fire training for a period of up to 12 hours in the same 
manner as they collected their urine prior to the fire training.   
Core body/heart rate monitoring before and after the fire: 
The monitor that records their core temperature and heart rate is a small instrument, approximately 
the size of a double deck of playing cards (3/4” x 1 ¾” x 4 ¾”) in a fabric protective pouch that can be 
worn on a belt or placed into a jacket pocket.  The monitor will be turned on before the firefighter 
enters the training room fire and not turned off until up to 8 hours after the fire. 
The heart rate belt is a 3/4“strap (T31 Polar Transmitter) that is worn around the body in the chest 
height area. It will be donned by the firefighter before the monitor is turned on and not removed 
until the monitor is turned off. 
Monitoring of the core body temperature and the heart rate by the UA study team begins before the 
fire and continues for up to 8 hours after the fire so that a comparison between the standard post-
fire and the sauna post-fire methods can be compared for core body temperature return to normal 
and heart rate return to normal. 
Dermal wipes: before and after the fire: 
Dermal wipes are 2x4” alcohol wipes.  They will be collected by the UA study team from the right 
calf, right arm, and right neck before the firefighter dons turnout gear (before entering the training 
room fire.)  To collect the samples, the UA study team member will gently wipe the area of the right 
calf (midway between the back of the knee and the heel) in a 2x4” rectangle gently but firmly in 2 up 
and down wiping directions.  This process will be repeated on the opposite calf, arm, and neck after 
the fire when the firefighter removes the turnout gear and before the firefighter wipes his skin off 
with the standard rehab baby wipes, and again right after exit from the sauna (if in the sauna 
treatment group) or at the same time post-fire (if in the standard treatment group—the no-sauna 
group.)   
 
9) Cost to subjects  

 
 
 
 
 
 
 
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There will be no monetary cost to the subjects.  The fire department has given their support for the 
time required to recruit and consent firefighters individually.  The department has also given support 
for allowing the firefighters the time to participate in the research portions of the training exercise. 
 
 
10) Risks to subjects 
• Biological and Air Sampling:  There is no risk to the firefighter to self-collect urine samples or skin 
wipes, or to wearing a personal air monitor.  
 
• Survey: There are no known risks with filling out survey questions; the firefighters will be informed 
that any section can be left unanswered if unknown or stressful.  Individual participant’s answers to 
the questions will not be made available to the fire department.  
 
• Flashover or Burn Room Training:  The fire training itself is a part of the job and is a continuing 
education event required by fire department for active firefighters.  According to NFPA (National Fire 
Protection Agency) 1001, fire departments must develop recurring proficiency cycles for fighting 
structure fires with the goal of preventing skill degradation and potential for injury and death of 
members and an annual skill check to verify minimum professional qualifications of its members.  
The firefighter may be required by the fire department to have training in the burn room and/or 
flashover training. If the firefighter is not scheduled for a specific training, the fire department will 
not schedule them. As documented in the supporting letter from the fire department, there is no risk 
to the firefighter’s job for not participating in the study.   
 
• Infrared Sauna:  No adverse effects have been reported with infrared saunas 
 
• Core Body Temperature/Heart Rate monitoring:  In accordance with the CorTemp User Manual, page 
6, use of the CorTemp ingestible temperature sensor is contraindicated for the following conditions: 
• In any subject whose body weight is less than eighty (80) pounds. 
• In the presence of any known or suspected obstructive disease of the gastrointestinal 
tract, including but not limited to diverticulitis and inflammatory bowel disease. 
• In any subject exhibiting or having a history of disorders or impairment of the gag reflex. 
• In any subject with previous gastrointestinal surgery. 
• In any subject having felinization* of the esophagus. 
• In any subject who might undergo Nuclear Magnetic Resonance (NMR)/Magnetic 
Resonance Imaging (MRI) scanning during the period that the CorTemp Core Body 
Temperature Sensor is within the body. 
• In any subject with hypomotility disorders of the gastrointestinal tract, including but no 
limited to ileus. 
• In any subject having a cardiac pacemaker or other implanted electromedical device. 
 
*Felinization=Transient transverse folds of the esophageal mucosa as seen by barium 
esophagography and on endoscopic examination have been termed “felinization.” This finding has 
been considered a normal variant or has been associated with reflux esophagitis. No symptoms have 
been associated with its presence. 
 

 
 
 
 
 
 
 
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Additionally, the CorTemp Core Body Temperature Sensor may not be appropriate in individuals who 
have experienced swallowing disorders.  If an individual experiences difficulty swallowing the sensor, 
they may not be a candidate for the study. 
 
The minimal risk will be mitigated by having all participants complete a contraindications form at the 
time of consenting and then reviewing their form prior to swallowing the pill.  Any firefighter who 
indicates they suffer from one or more of the contraindications will be excluded from the study.  The 
contraindications form has been clinically verified by Dr. Jeff Burgess and found to be an adequate 
screening tool to ensure the safety of study participants.  Additionally, if any participants experience 
difficulty swallowing the sensor, they will be excluded from the study. 
 
11) Potential benefits to subjects and/or society 
There is no direct benefit to the participants in this study.  However, there are very few studies to 
actually monitor a firefighters core body temperature in a post-fire sauna detoxification period.  This 
study is expected to aid in a better understanding if infrared sauna treatment reduces absorbed 
toxicants from the fire and if it results in an increased core body temperature. 
 
12) Provisions to protect the privacy of subjects and the confidentiality of data 
a. Protection of subject privacy: Subjects will be consented individually, under private conditions.  
Fire department officers responsible for scheduling training fires will have access to a list of 
firefighters who consented to participate in the study so that they may be efficiently scheduled for 
the training fires. 
In order to protect the privacy of participants, the consent forms, and contraindication forms will be 
accessible only to the UA study team.  When not in use, they will be kept in a locked drawer in the 
Medical Research Building, Lab 130.   Urine samples and skin wipes will be identified only by a 
subject ID number and whether baseline or post-fire collections.  Survey answers, personal air 
monitors, and the core body temperature/heart rate data downloaded will be identified by subject 
ID number only.   
b. Protection of data confidentiality: As described above, all personally identifiable information will 
either be kept in a locked cabinet or on a password protected computer.  The final report to fire 
department and any manuscripts or publications will contain aggregate and statistical representation 
of the study population.  If pertinent to discuss individual results in the report, random anonymous 
numbers (subjected ID numbers) will be assigned to each study participant and any results discussing 
individuals will be referenced by such an anonymous identifier.   
 
13) Subject compensation 
Subjects will not be compensated. 
14) Medical care and compensation for injury  
There are no funds set aside for injury to the subjects.  If the subject suffers an injury from 
participating in this study, they are advised in the consent form to seek treatment and that the 
University of Arizona has no funds set aside for the payment of treatment expenses for this study.  
 
15) Monitoring for subject safety  

 
 
 
 
 
 
 
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The fire department’s training fire is a required training exercise, but the research concerns the 
comparison of the post-fire sauna treatment versus the standard (no-sauna) treatment post-fire.  The 
data from the core body temperature/heart rate monitor data recorder will be downloaded within 48 
hours and examined for excessive core body temperature rise (above 102 Deg F) by the PI, Dr. Jeff 
Burgess.  The firefighter, after exiting the sauna, will have blood pressure pulse readings taken and 
documented as part of the fire department’s post-fire treatment protocols.  Firefighters who do not 
participate in the sauna treatment will be monitored and the data downloaded in a likewise time 
period, but the data will not be examined by Dr. Burgess until the data are analyzed by statistical 
methods as the standard treatment is not being changed by the study from what the fire department 
normally performs on its firefighters during their normal annual fire training exercises.  
 
16)  Withdrawal of subjects 
It will be made clear to the firefighters that their participation is voluntary and that they may 
withdraw on their own volition at any time.  It is not anticipated that the PI or other UA study team 
members will have to withdraw a subject after the consent and verification of the contraindication 
form.  However, there is potential that the firefighter may become not medically fit for duty for an 
unrelated reason between the consenting and sampling period.  This situation would result in the 
subject being withdrawn from the study.   
 
In addition, in order to adequately achieve the end total of up to 24 firefighter participating in the 
Stage 2 exercise, it may become imperative to consent more than 24 firefighters.  When the time is 
reached that 24 firefighters have been evaluated for the Stage 2 training fire testing, additional 
testing of firefighters who consented but haven’t been tested will be stopped and the untested 
firefighters will be withdrawn from the study.   
 
17) Sharing of results with subjects  
Firefighters will not be given individual results to the urine analysis for PAHs, their dermal wipe 
analyses, nor their core body/heart rate data analysis, nor any comparison of their individual survey 
results to the other firefighters in the study.  However, aggregate results will be shared with the fire 
department, a report will be prepared for distribution via the fire department newsletter, and 
potential manuscripts, publications or PowerPoints may be prepared for presentation at meetings 
and conferences. 
18) Future use and long-term storage of data or specimens 
Urine samples will be stored by subject ID number and baseline or post-fire sampling methods until 
the end of the study or longer, if space is available for storage.  Subjects will be asked if their samples 
can be used for other testing during the consenting process.  We have no immediate plans for future 
research for the stored urine or dermal samples, but if there are samples remaining after the pilot 
study urine or dermal analysis is complete, we will store the samples in accordance with the 
selection chosen by the subject in the consent form.  Data from the core body temperature analysis 
will be kept indefinitely for future firefighter related occupational toxic chemical, heat, or infrared 
exposure research