NASA INSTITUTIONAL REVIEW BOARD (IRB)

CONSENT TO BE A PART OF A RESEARCH STUDY

ABOUT THIS RESEARCH CONSENT FORM

You may be eligible to take part in a research study.

A research study is carefully planned and designed to increase scientific knowledge.

This NASA IRB Consent form describes important information related to participation in a research
study including the purpose, planned procedures, and potential risks.
Please take time to review this information carefully. Talk to the researchers about the study and
ask any questions you have. Make sure you fully understand what will be expected of you and
the risks associated with participating in this study. You may also wish to talk to others (for
example, your friends, family, or doctors) about your participation in this study. If and when you
decide to be a participant, you will be asked to sign this form and you will be given a copy.

Taking part in this study is completely voluntary. The decision to participate is yours. You may
also leave the study at any time. If you leave the study before it is finished, there will be no penalty
to you.

This NASA IRB Consent form provides a detailed description regarding essential information
including, but not limited to, how, when, where, and by whom a signed informed consent will be
obtained.

Note: Failure to disclose pre-existing medical conditions may place you at greater risk for
injury or other adverse events resulting from your participation in this study.

1. GENERAL INFORMATION

1.1 Your study title is: Human Exploration Research Analog (HERA) Campaign 2

1.2 Your study team includes a Principal Investigator, Co-Investigator, Key-Personnel (names,
degrees, affiliations):

Principal Investigator
Ronita L. Cromwell, PhD
Project Scientist, NASA Flight Analogs
Universities Space Research Association
Phone: (281) 483-7261
Email: ronita.l.cromwell@nasa.gov

Co-investigator: Patrice O. Yarbough, PhD

Deputy Project Scientist, NASA Flight Analogs
Universities Space Research Association
Phone: (281) 483-6052
Email: patrice.o.yarbough@nasa.gov

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 Co-investigator
Kimberly A. Seaton, PhD
Clinical Psychologist
UTMB/ Wyle Integrated Science and Engineering
Phone: (281) 212-1394
Email: kimberly.seaton@nasa.gov

Key Personnel:
Carolyn Y Parsons
Wyle- Integration Coordinator
1290 Hercules
Houston, TX 77058
carolyn.y.parsons@nasa.gov
Office: 281-244-1447
Screening Cell: 713-825-0583

1.3 This study is sponsored or funded by: Human Research Program

2. PURPOSE OF THIS STUDY (History and Background)

2.1 You are being asked to join this study because:

The HERA serves as an analog for the NASA Human Research Program (HRP) to study and
evaluate impacts due to isolation, remoteness and confined habitation. Investigators will be looking
at psychological, human factor and physiological impacts and the development and verification of
countermeasures to reduce or mitigate those impacts. Each HERA mission will simulate space
exploration scenarios. You will participate in various investigators studies as listed below:

This second HERA Campaign (HERA C2) will include up to four (4) 14-Day missions.
This HERA Campaign will pursue the following objectives:

Dr Mathias Basner will test a comprehensive neurocognitive toolkit to evaluate a full range
of cognitive functions affected by fatigue and other space exploration risk factors.
Cognition refers to your mental abilities including attention, memory, judgement and
problem solving skills. Language analysis to derive psycho-social well-being of the crew
will be performed by Dr Eduardo Salas. Dr. Salas will also study key team and social roles
that influence team function; he is interested in how personality relates to success in a team
role. Dr Steve Kozlowski will investigate reaction to and adjustment by the crew to the
conditions of isolation, confinement and extremes of a spaceflight analog by analysis of
surveys and questionnaires referred to the team. Dr. Pete Roma will assess features of team
cohesion. Drs Dinges and Metaxas will study an optical system for detection of facial signs
of negative emotions and fatigue in the crew. In order to determine the impact of
communication delays on the team, Dr Ute Fischer will assess task performance in
simulated scenarios where the crew interact in a delayed way with mission control. Dr.

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Scott Tannenbaum will examine team composition variables that are necessary for team
collaboration and resilience during long duration space exploration.

Dr Zwart and Dr Wotring will gather information on food intake and medication use,
respectively, via an iPad application. Dr Sherry Thaxton will look at ways to assess
habitability and human factors in an operational setting. Dr. Zwart will use an iPAD to
track dietary intake and Dr. Wotring will use an iPAD to track medication use. Dr. Goel
will evaluate various biomarkers to predict susceptibility to stressors such as sleep
deprivation in spaceflight. Dr. Allen will conduct an environmental study to diagnose
hazardous noise levels. Dr. Schrenghosts study will develop and assesses a method of
allocating work between human operators and automation. Automation of procedures
around units of work such as steps improves human performance of procedures over
manual performance. The overall objective is to develop countermeasures to risks of
inadequate design of human/automation integration. Dr. Burkes research is to determine
how shared leadership behaviors impact team processes and performance under long
duration and isolated contexts. The study will identify how shared leadership enables
team autonomy and the dynamic nature of shared leadership behaviors over the course of
a teams lifespan.

3. STUDY PARTICIPANTS

3.1 In order to be eligible to participate, you may be asked to undergo the following screening
tests or procedures:

- You will go through a medical screening at the JSC Test Subject Screening (TSS). Your
age is between 26 and 55 years, and your height is not more than 74 inches. You must
demonstrate professionally technical skills.
- You will go through a psychological assessment with a clinical psychologist to qualify
you for participation in this study. You will be asked to sign a consent form for the
psychological assessment. The information from your interview and tests will become
part of the NASA LSDA Life Sciences Database.

- You will not be currently taking sleep medications or have taken that type of medication
during the past 30 days.
- You will be asked to complete the International Personality Item Tool. This tool will be
used to assess your personality and determine your suitability for the HERA missions.
- You will be asked to complete the short pre-mission questionnaire that includes a few
personal habit items.

3.2 You are one of __16___subjects. Persons with prior HERA and/or Habitat Demonstration
Unit (HDU) experience are not allowed to participate.

4. STUDY PARTICIPANTS

4.1 You are provided a schedule that includes the following: (Check applicable boxes)
X Chart or calendar as a possible addition to the explanation of the tests;
X Duration of the study, and when the study is to be complete (14 days)

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 X Amount of time for each test, frequency of testing, and whether testing is continuous
or intermittent;
X Need for follow-up examinations or tests: to be determined
X Location of the testing: JSC B220

X The amount of blood, urine, saliva, other biological samples and/or tissue to be taken and
how often;
X Detailed explanation of each test, including what data will be collected
Whether joining this study limits your chance to join other studies;
X Whether standard medical procedures are included in the study;
How your other activities may be affected by the study (exercise, diet, medications,
physical activities, etc.).

4.2 You are being told if the study you are joining includes one of the following categories:

Randomized means that you are put into a group by chance (e.g., like flipping a
coin). Neither you nor the principal investigator will choose what group you will be
in. You will have a chance of being placed in any group.
Blinded means you (blinded) will not know what group you are in.
Double-Blinded means that neither you nor the Principal Investigator (double-
blinded) will know what group you are in.
Placebo means a pill with no medicine. In a placebo-controlled study, you may be
given a study medication and it will contain either (name of drug) or placebo (pills with
no medicine).

4.3. You are being told how the study is organized:

This second HERA Campaign (Campaign 2) will include up to 4 missions. Each HERA "run" will
simulate a space exploration mission and you will participate in activities planned for the simulated
mission, as well as in the measures needed for each investigation. Communication delay and
workload will vary across the mission days as appropriate, according to a predesigned schedule.

4.4 You are being given an explanation of the study procedures and tests:

This study includes activities/operational tasks that parallel flight. Meaningful work
activities (including training tasks) are based on the ISS workday and general
housekeeping and maintenance. The operational tasks are designed to evaluate crew
interaction with flight-like hardware. In some cases physiological data will be collected
during the technology demonstration. Blood pressure, heart rate and a record of your
movements (actigraphy) are examples of data that would be available to PIs. Categories
of operational tasks are: flight simulations, emergency simulations, team planning tasks,
physiological data capture, maintenance and systems checks, environmental monitoring,
and research tasks. Activities that involve schedule changes will consist of: extended
work days and variable workloads, communication delays, unclear procedures, and
confusing communications. In addition, you will take part in routine exercise sessions of
low intensity cycle ergometry (exercise bicycle) and resistive exercises or calisthenics.
Time will be allowed for stowage and hygiene after the session.

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Depending on the portion of the mission in which you participate, you will be asked to
complete some or all of the following tests. The tests you will participate in will be
described to you during the consent briefing.You will be audio and video recorded
throughout the study. A test schedule is attached to this consent form. Some variation of
testing dates may be necessary.

Lexical Indicators: you will participate in digital audio recordings of mission verbal
communication (along with video recordings for comparison), recordings that will then
be transcribed with high fidelity software in written form. In addition, you will be asked
to complete a brief pen-and-paper questionnaire assessing emotional state at various
points of the mission.

Cognition: is a test battery that consists of 10 different cognitive tests that are administered
with the Cognition software. The battery will start with a brief questionnaire, followed by
administration of the 10 cognitive tests. We ask you to perform the Cognition battery (all
10 tests) during this study on three pre-mission days, daily during the HERA mission, and
three days post-mission. The Cognition test schedule will be part of the HERA mission
schedule. The total administration time for one battery (questionnaire plus all 10 tests) will
be between 20 and 30 minutes. The Cognition software will be installed on the HERA
computers. Test data will be encrypted and uploaded to a secure server.

Optical Computer Recognition: you will conduct mission work and requirements as
outlined by the mission protocol while facial video footage will be collected from HERA
facility cameras.
The investigators want to also collect morning and evening report ratings of sleep
duration, timing and quality, as well as your mood state. These self-report questionnaires
will be administered in paper form and part of a self-report diary for each individual
crewmember. One days combined morning and afternoon testing sessions will require a
total of 5 minutes time.

Team Cohesion: you will take part in a primary computer-based activity. Team
Performance Task (TPT) runs will be embedded. In this task you earn points by using
the computer mouse to drag blocks from a Resource area into a Target bin without
hitting any barriers. You can see some barriers, but they are invisible to the rest of the
group. You can reveal your barriers to the rest of the group through click-and-hold action
with the mouse. For the majority of the session you will work at an individual computer
station. You will complete a single TPT run before, in the middle, and after each
mission. We will collect data on all of the behaviors you perform within the TPT task as
well as recording verbal and non-verbal behaviors with microphones and cameras.
You will also be required to donate saliva samples throughout the study for each TPT
session before (pre) and during the mission, every other day. You will give a sample
before and during the mission. It should take about 1-3 minutes to collect each sample.
The total donation over the course of the study can be up to 10 teaspoons. These samples
will be used to measure stress hormones. All samples will be labeled with your ID
number and only accessible by research staff.

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Before each mission, you will first complete a pre-study questionnaire asking about your
recent medication use, drug use, sleep, and menstrual cycle phase (if female). Before, in
the middle, and after each mission, you will be asked to complete a questionnaire asking
about your mood. After each mission, you will be asked to complete a questionnaire
asking your opinions on your Crew as a whole and the other individual members of your
Crew. After the study is over you will be asked to complete similar opinion
questionnaires online.

Team Cohesion (ANSMET): You will participate in several surveys at four different
stages during the study: an introductory survey (about 40 minutes) of background and
personality questions, to be completed at the beginning of the expedition; daily reports
(about 5-10 minutes) about your reactions to your team and the mission, to be completed
daily during the expedition; interaction quality reports (about 2 minutes) taken multiple
times daily; an exit survey (about 15 minutes) of questions asking you to reflect about
your overall experience.

Team Collaboration: You will be asked to complete surveys and participate in a task with
other team members for the duration of the HERA study. You will complete these tasks
and at several points, you will complete a set of measures asking about your experiences
during the task. You will be audio and video recorded throughout this study.

Asynchronus Communications: On two days of the simulated 14-day mission, we will

record your voice or text-based communications with remote partners (i.e., participants
acting as astronauts if you will take on the role of flight controller, or participants acting
as flight controllers if your role will be that of an astronaut) for communication analysis.
You will also be video recorded as visual data provide contextual information facilitating
communication analysis.
On one of the days, communications with remote partners will be voice-based; on the
other day (as for the remaining days of the mission) you will also be able to use a texting
tool.
At each day of the 14-day mission, you will receive a short questionnaire (5 to 10 min) to
provide feedback on your communications with remote partners.

ISS FIT: You will be asked to try out the ISS FIT App to record your food intake during
the mission. The App has a database of space foods that will be available during the
mission, and there are many options for entering data (checklist, barcode, voice
recognition, etc). This is designed to be easy to use, to take very little time, and to
provide some real time feedback of your intake day-to-day. Once your mission is
complete, your nutrient content during the mission will be analyzed. You will be asked to
provide feedback on ease of use of the ISS FIT App and to provide any suggestions you
may have. You will conduct a 30-minutes debrief after your mission to get your
feedback about the App. The App also allows for comments to be submitted along with
the food information.

Dose Tracker: While in the HERA habitat, you will use the Dose Tracker iPad
Application (App) daily in the context of a simulated medical condition scenario that will

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be presented to you (or you will be free to create your own). You will be asked to record
your simulated medical symptoms, medication usage, what prompted you to take the
medication, dose, frequency of use, perceived efficacy, and any side affects you may
have experienced. You will be asked to complete at least one simulated medical scenario
each day while in the HERA habitat. However, you are free to complete as many entries
as you would like each day, time permitting. Each simulated medical scenario will
require only a few minutes to complete each time. After the mission, you will be
requested to complete a 30 minute debrief with one of the Dose Tracker iPad App studys
representatives. This is for you to provide feedback for any suggested changes identified
during the HERA mission, prior to the use of Dose Tracker iPad App in an International
Space Study (ISS) study.
Allocating Tasks for Performance: This study will investigate the hypothesis that
selecting units of work to automate based on procedures written for humans will improve
human-automation designs. You will participate in studies performed in HERA to
investigate human-automation performance, ease of human learning, and generalization
to situations beyond those explicitly and completely covered in a procedure.
Leadership Fellowship: You will answer questions about your personality and how you
work in teams. You will complete surveys and participate in a task with other team
members for the duration of the study. You will complete a set of measures asking about
your experiences during the tasks. You will be audio and video recorded throughout the
study.
Dynamic Team Role: You will complete surveys and participate in a task with other
team members for the duration of the study. You will complete a set of measures asking
about your experiences during the tasks. You will be audio and video recorded
throughout the study.

Biomarkers as Predictors of Resiliency and Susceptibility to Stress in Space Flights:

The biomarkers to be collected include: cardiovascular measures (blood pressure, stroke volume,
cardiac output, heart rate and heart rate variability), cortisol, catecholamines (dopamine,
noradrenaline, and adrenaline), C Reactive Protein (an inflammatory marker), metabolomic
markers (small molecules) and microRNAs (small regulators of gene expression). Biomarkers will
be collected by echocardiography, heart rate and blood pressure monitors, saliva, or blood.
During part of your time in mission, in order to create stress and sleep loss conditions, you will
participate in a five-day experiment. This experiment will consist of two baseline nights of 8
hours in bed each followed by neurobehavioral and cognitive testing while awake; these
baseline nights will be followed by one night of acute total sleep loss (during which you must
remain awake all night) followed by longer, more intense neurobehavioral and cognitive testing
as well as a mock interview and completion of arithmetic problems while awake; this sleep loss
night will be followed by one night of recovery of 10 hours time in bed and a second night of
recovery of 8 hours time in bed each followed by neurobehavioral and cognitive testing while
awake.
Biomarkers will be collected at seven (7) assessment time points:

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 1) immediately before the mission
2) during the mission at baseline (after two nights of fully-rested conditions)
3) after a night of total sleep loss before daytime stress testing
4) immediately before the stress testing during the daytime following total sleep loss
5) immediately after the stress testing during the daytime following total sleep loss
6) following recovery (after two nights of fully-rested conditions)
7) immediately after the mission.
Assessments will be taken at the same time of day (in the morning before eating), except for the
two stress assessments which will be taken during the daytime.The neurobehavioral testing you
will perform will consist of tests measuring reaction time, throughput and memory and
subjective scales measuring sleepiness, fatigue, vigor and mood as well as subjective ratings of
sleep quality and estimates of sleep duration. You will also perform a cognitive test battery that
covers a wide range of cognitive domains (e.g., vigilance, memory, spatial orientation).
In addition to these tests, you will be asked to wear an actiwatch for the duration of the mission
to monitor your sleep-wake behavior. The actiwatch provides us with information about your
sleep-wake behavior by continuously measuring ambient light levels and accelerations induced
by your wrist movements. You are asked to wear the actiwatch 24 hours a day (day and night)
except when showering.
Your total time commitment is approximately 26.5 hours.
During the pre-mission day, approximately 30 minutes will be required. We will draw a
blood sample. Up to 6 hours is needed on pre-mission day to train the crew on equipment
and procedures.
During the 5-day experiment in-mission, various biomarker measurements will be taken.
You will perform various neurobehavioral and cognitive tasks. Approximate time
commitments for each day are:
o Day 1/Baseline 1: neurobehavioral test battery for 30 minutes every 2 hours (total
of 3 hours of testing) and performing a cognitive test battery for space flight for 30
minutes.
o Day 2/Baseline 2 (extended day due to total sleep loss): about 30 minutes to
collect biomarker measurements, drawing a blood sample, neurobehavioral test
battery for 30 minutes every 2 hours (total of 6 hours of testing) and a cognitive
test battery for space flight for 30 minutes.
o Day 3/Total Sleep Deprivation day: neurobehavioral test battery for 1 hour every 2
hours (total of 5 hours of testing) and a cognitive test battery for space flight for 30
minutes. There is a mock interview and arithmetic problems which will take
approximately 30 minutes. Biomarker measurements are collected 3 times
requiring about 90 minutes. There are 3 blood draws.
o Day 4/Recovery 1: neurobehavioral test battery for 30 minutes every 2 hours (total
of 3 hours of testing) and a cognitive test battery for space flight for 30 minutes.
o Day 5/Recovery 2: Approximately 30 minutes to collect all biomarker
measurements. There is a blood draw. There is a neurobehavioral test battery for
30 minutes every 2 hours (total of 3 hours of testing) and a cognitive test battery
for space flight for 30 minutes.

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 During the post-mission day, about 30 minutes is needed to collect all biomarker
measurements. There is a blood draw.
5. DRUGS, BIOLOGICS, and MEDICAL DEVICES

5.1 You will be told if the study uses drugs, blood or blood components, allergenic substances,
vaccines, medical devices or other similar products used to investigate human anatomy or
physiology, or to prevent or treat disease or injury.

_X _No study drug, biologic, or medical device product is used.

_____Yes, the study drug or biologic is _________________.

____This drug or biologic is FDA approved.

____This is an investigational drug or biologic, with the FDA IND number _______.

_X____Yes, the study medical device is ___________________

Omron BP791IT, 10 series Plus Blood Pressure Monitor with ComFit TM Cuff
(Omron Healthcare, Lake Forest, Illinois)
eMotion Faros (Mega Electronics Ltd, Kuopio, Finland)
VIVID e system (General Electric Healthcare, Wauwatosa, Wisconsin)

____This is an investigational medical device, with the FDA IDE number _________.

____This is an investigational non-significant risk device, with IRB approval for use. A
document providing full and informed disclosure is provided for your review.

6. INFORMATION ABOUT RISKS AND HAZARDS

6.1 You are joining a study that is:

Minimal risk means that the probability and magnitude of harm or discomfort
anticipated in the research is not greater in and of themselves than those ordinarily
encountered in daily life or during the performance of routine physical or
psychological examinations or tests.
X Greater than minimal risk means that the probability and magnitude of harm or
discomfort anticipated in the research is greater in and of themselves than those
ordinarily encountered in daily life or during the performance of routine physical or
psychological examinations or tests, but that the risks of harm or discomfort are
considered to be acceptable when weighed against the anticipated benefits and the
importance of the knowledge to be gained from the research.

6.2 You are told that the risks of joining the study and the steps taken to protect against harm
include:

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 HERA Facility Risks
Risk Mitigation
Electrical shock HERA is grounded; handheld electrical devices are
COTS and UL approved
Falling Railings are in place and training on climbing ladders
will be provided
Cutting yourself Sharp edges are controlled
Hitting your head Training on precautions to take when traveling through
mock-up hatches
Unforseen medical problems A medical team and AED are located in close proximity.

- Risk of loss of privacy:

o You might be uncomfortable if other people see what you report. Precautions will be
taken to de-identify data before sharing it and follow protocol for safe storage of
identifiable data. Data will be de-identified and no names or identities will be used in
any published reports of the research. Only research personnel identified in this form
will have access to the key linking individual subjects ID to their names.

-Team Cohesion: There are no more than slight risks associated with strain on your eyes and
muscles from remaining seated in the same position for a prolonged period of time using a
computer monitor, keyboard, and mouse. There may also be possible boredom or frustration
associated with the tasks and study schedule, or very mild and temporary discomfort associated
with obtaining physiological measures. Refraining from caffeine during study sessions may
cause some discomfort, such as headaches, feeling jittery, or difficulty concentrating.
All of the technologies used for the physiological and behavioral measurements are currently
used in a wide variety of laboratory and field research settings, are painless and temporary, and
pose no known short-term or long-term health risks to you.
Because one session will be conducted overnight you will probably become sleepy during the
study. A member of the study staff will be available at all times to assist you in remaining awake.
Should you feel that you are unable to remain awake, as at other times during the course of the
study, you are free to withdraw your consent to participate in this project.
Continuous wakefulness for 24-36 hours may increase symptoms of fatigue and reduce cognitive
(thinking) processing speed; however, research has shown that clinically relevant psychiatric
symptoms such as hallucinations do not emerge until the fourth consecutive night of sleep
deprivation (about 100 hours of continuous wakefulness). In fact, even after 2 nights (56 hours)
of sleep deprivation, significant increases on clinical scales of somatic (physical) complaints,
anxiety, depression, and paranoia still remain within normal/healthy limits, with no effects on
symptoms of anxiety-related disorders, manic symptoms, or borderline, schizophrenic, and
antisocial features. All physical, cognitive, and psychological consequences of acute sleep
deprivation are helped by adequate recovery sleep, and resuming normal sleep (8-10 hours)
produces recovery from the effects of sleep deprivation following 24-36 hours of continuous
wakefulness. There are no known lasting adverse physical or psychological effects from
remaining awake for 24-36 hours.

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Biomarkers as Predictors of Resiliency and Susceptibility to Stress in Space Flight:
o You will probably become sleepy during some segments of the study when you are asked
to remain awake. This experience is similar to that of a shift worker when he/she works
the night shift. Should you feel that you are unable to remain awake, you are free to
withdraw your consent to participate in this experiment and then go to sleep. There are no
known lasting adverse effects from missing nighttime sleep.
o During this study, you will be required to perform a variety of alertness and mental
performance tasks on a computer. These tests may become difficult to perform when you
are sleepy and may, therefore, produce some distress. There is the potential you may
develop a headache during the study due to the amount of computer work. Should you
feel that you are unable to perform these tasks during the course of the study, you are free
to withdraw your consent to participate in this experiment and then go to sleep.
o This study will ask you to perform a behavioral task that may induce stress. You will be
asked to maintain your best effort. If you feel upset and emotional discomfort while
participating in the study, you may contact the PI. Should you feel that you are unable to
complete the task during the course of the study, you are free to withdraw your consent to
participate in this experiment.
o This study will ask you to restrain from eating for a period of 10 hours (overnight) which
may be uncomfortable if you become hungry, however you will be able to drink water
during this time.
o This study involves the collection of blood samples. There may be some discomfort
associated with the collection of the blood samples, including possible bruising of the
arm, dizziness, fainting, and a small risk of infection. To minimize risk, sterile disposable
hardware will be used by experienced technical personnel for all procedures. In the event
of fainting during the blood draw procedure, you will have a medical evaluation by a
physician; you will be able to continue the study if you are medically cleared. To
minimize risks, a spotter will be present, and food and drink will be available.
o This study involves measuring your blood pressure. There is minimal risk associated with
measuring blood pressure. Some minor discomfort may occur as the cuff inflates.
o This study involves measuring your body movement using an actigraph (wActiSleep-BT
Monitor, ActiGraph, Pensacola, FL). There is minimal risk associated with wearing an
actigraph. This device is powered by batteries that pose no risk to you. The actigraph
worn on your wrist may cause some minor discomfort and/or skin irritation. You may
remove the actiwatch from the irritated arm and wear it on your other arm if skin
irritation occurs.
o This study involves measuring your heart activity (electrocardiogram, ECG). There is
minimal risk associated with measuring ECG. This device is powered by batteries that
pose no risk to you. The electrodes attached to your chest may cause some minor
discomfort and/or skin irritation; you should notify staff if discomfort occurs. The
monitoring device (eMotion Faros, Mega Electronics Ltd., Kuopio, Finland) attached to
the electrodes is electrically approved and conforms to hospital standards for electrical
safety.
o This study involves measuring your cardiac output and stroke volume using
echocardiography. The echocardiograph device (VIVID e system, General Electric
Healthcare, Wauwatosa, WI) is an ultrasound system that is commercially available and
poses no risk to you. We will place non-toxic gel on the skin of your chest wall to aid in
ultrasound wave transmission. Mild and transient discomfort may result from the need to
apply pressure on the transducer and thus your chest wall to obtain ultrasound images.
You should notify the person conducting the echocardiography if discomfort occurs.

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- There is a risk of frustration due to the time-delayed communication. You will have the
opportunity to provide feedback on your experience to help us minimize negative impacts of
time-delay on team interactions in future space exploration missions.
7. TREATMENT, INJURY AND COMPENSATION INFORMATION

7.1 Even though researchers have taken steps to minimize the risks, you may experience problems
or side effects. In the event of physical injury resulting from this study, NASA will provide or
cause to be provided, the necessary immediate action or treatment. NASA will pay for any
claims of injury, loss of life or property damage to the extent required by the Federal
Employees Compensation Act or the Federal Tort Claims Act. Your agreement to participate
shall not be construed as a release of NASA or any third party from any future liability, which
may arise from, or in connection with, the test procedures.

7.2 For International Partner subjects:

In the event of injury resulting from this study, I understand that I will receive medical
attention and available treatment. I also understand that I will be compensated for any
injuries to the extent permitted under current (insert agency name) laws and
regulations and the provisions of the contract between me and (insert agency name) .
My agreement to participate shall not be construed as a release of (insert agency name)
or any third party liability which may arise from, or in connection with, the above
procedures.

Include the HRMRB Multinational consent form

8. BENEFITS INFORMATION

8.1 Participation in NASA studies generally result in no direct benefit to you as an individual. It
is hoped that the information learned from this research study will help NASA learn more
about human physiological changes for future space flight missions.

Statements of Disclosure:

1. The Group for Organizational Effectiveness (GOE), Dr. Scott Tannenbaum,

President, Dr. George Alliger, Rebecca Beard, Jamie Donsbach, Dr. William
Baetz, Christopher Cerasoli
As part of the research they will employ a debriefing architecture for
which the company, The Group for Organizational Effectiveness Inc., has
intellectual property rights. They will use the architecture since it provides
a ready-to-use shell, however all the debriefing content used to populate
the shell has been designed specifically for this research effort with
NASA.
2. Dr Pete Roma, co-inventor of the TPT/PoC assay
The TPT/PoC assay tested throughout this project could eventually be
patented and commercialized. The co-inventor of the assay could
potentially gain financially in the form of royalties and/or bonus pay based
on product sales. However, financial gains can only be realized if the

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 product is scientifically validated by accurate, meaningful, and replicable
data.

9. NEW FINDINGS

9.1 If new information is obtained during the study after you have joined, you will be informed.
You may change your mind about continuing in the study. You may be asked to sign a new
consent form that includes the new information.

10. STUDY WITHDRAWAL and/or TERMINATION

10.1 You may withdraw from the study at any time. If you decide to leave before the study is
finished, please tell the investigator or study staff. Your refusal will be honored, except in
cases when the responsible physicians opinion is that study termination could have undesired
consequences for your health and/or the health of other subjects. You will be told if there
could be any harm to you if you decide to leave before the study is finished. If you tell the
researchers your reasons for leaving the study, that information will be part of the study
record.

10.2 Your withdrawal or refusal to participate in the study will not result in any penalty or loss
of benefits to which you are otherwise entitled.

10.3 If you decide not to join the study, you may be eligible to participate in other studies.

10.4 Researchers may need to stop your participation in the study even if you want to continue
participation. Some examples of this scenario include: (Check applicable boxes)
X The researcher believes that it is not in your best interest to stay in the study
X There is any problem with following study related instructions
X There is any problem with procedures regarding the HERA and JSC
X There is any serious complication during the study
X There is inappropriate behavior
X The study is suspended or canceled
X The subjects information is or becomes unusable for any reason
X Events beyond NASAs control occur, for example: fire, explosion, disease, weather,
floods, terrorism, wars, insurrection, civil strife, riots, government action, or failure of
utilities
X Existing data reveal answers earlier than expected

11. COST and FINANCIAL INFORMATION

11.1 There are no costs or bills to you for participation in this study.

12. PAYMENT and REIMBURSEMENT

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12.1 You will be paid to participate in the study as follows:
___ Is the total dollar amount for the study, including pro-rating (if you do not
complete the study or if there is a bonus payment at the end of the study).

___ No payment if you are a NASA, non-NASA, federal civil servant employee,
contractor, or International Partner crewmember participating in ESA,
JAXA, CSA, or NASA-sponsored studies.

If you are not a civil servant or a JSC contractor subject, you will be reimbursed for time
spent participating in the mission for up to 16 hours per day at $10 per hour. Time spent
participating in screening, training and other pre- or post-mission activities will be
reimbursed at $10 per hour.

If you are a civil servant or active duty military, you must have management approval to
participate. Civil Servants will be required to be on annual leave during the confinement
period and will not be reimbursed for participation unless it is determined by their
management (with concurrence by the NASA legal office) to be in scope with their
current position. In this case, the civil servant will charge up to 40 hours a week to their
nominal charge code.

If you are a Bioastronautics JSC contractor participant, you must have management
approval. You will be reimbursed for a nominal eight- (8) hour day during the
confinement period. If participation falls within your nominal scope of work, the nominal
charge number will be used. If participation does not fall within the nominal scope of
work, a Flight Analogs Project Labor Authorizing Document (LAD) will be provided.

If you are a JSC contractor participant who is not on the Bioastronautics contract, you
must have management approval. If participation falls within your nominal scope of
work, the nominal charge number will be used for a nominal eight (8) hour day during
the confinement period. If participation does not fall within the nominal scope of work,
you will be required to take leave and will be reimbursed for time spent participating in
the mission for up to 16 hours per day at $10 per hour. All screening, training and other
pre- or post-mission activities will be reimbursed on an hourly basis.

13. SUBJECT RECORD CONFIDENTIALITY AND AUTHORIZATION TO RELEASE

PROTECTED HEALTH INFORMATION (PHI)

13.1 Your privacy and the confidentiality of data collected as a part of this research study will be
protected from unauthorized disclosure according to applicable federal law.

13.2 Your protected health information may be used or shared with others during the research.
This may include:
Existing medical records;
Video and photographic materials;
New information created from study-related tests, procedures, visits, and/or
questionnaires.

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13.3 Your protected information may be used or shared by NASA offices of research oversight or
quality assurance, medical monitors, and researchers for the reasons below:
To conduct and oversee the research;
To make sure the research meets NASA requirements;
To conduct monitoring activities (including situations where you or others may be at
risk of harm or reporting of adverse events);
To become part of your medical record, if necessary, for your medical care;
To review the safety of the research.
To support NASA Clinical Summit activities where clinical experts evaluate relevant
medical and research data to recommend clinical practice guidelines specifically for
astronauts. These data will not include names or other information that explicitly link
the information to you.

13.4 Every effort will be made to maintain the confidentiality of your study records. There are
many reasons why information about you may be used or seen by the researchers or others
during or after this study. Examples include:
The researchers may need the information to make sure you can take part in the study.
NASA and other government officials may need the information to make sure that the
study is done in a safe and proper manner. These agencies may include the Department
of Health and Human Services (DHHS), the Food and Drug Administration (FDA), the
National Institutes of Health (NIH), and/or the Office for Human Research Protections
(OHRP) or other domestic or foreign government bodies if required by law and/or
necessary for oversight purposes.
The FDA may need to review the information if the study involves the use of an
experimental drug or device.
Safety monitors, medical personnel, or safety committees may review your research
data and/or medical records for the purposes of medical safety or for verification of
research procedures.
A data and safety monitoring board (DSMB) may oversee the research, if applicable.
The results may be used by the research team and possibly be presented/published at
scientific conferences and/or in an article, but would not include information that
would identify you without your consent.

13.5 You have the right to withdraw your consent for the researchers to use or share your protected
health information. The researchers will not be able to withdraw all the information that already
has been used or shared with others to carry out related activities such as oversight, or to ensure
quality of the study. To withdraw your consent, you must do so in writing by contacting the
researcher.

13.6 You have the right to request access to your study records after the study is completed. To
request this information, you must do so in writing by contacting the researcher.

13.7 If physiologic data (including but not limited to standard measures, laboratory data,
psychological, or physiological measurements) are obtained from you for this study, they
may become the property of NASAs Life Science Data Archive. These data may be used in
this research, may be used in other research, and may be shared with other organizations. All

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 federal regulations concerning the privacy and confidentiality of these data will be followed.
Records stored in this archive will not include names, registration numbers, or other
information that explicitly links the information to you.

14. CONTACT INFORMATION

14.1 You may contact the Principal Investigator to:

Obtain more information about the study;
Ask a question about the study procedures;
Report an illness, injury, or other problem;
Leave the study before it is finished;
Express a concern about the study.

Principal Investigator: ___Ronita Cromwell, PhD___________________

Email Address: _________ronita.l.cromwell@nasa.gov_____________________
Mailing Address: _______2101 NASA Parkway, Mail Code SK__________________
Telephone: ___________281- 483-7261___________________

Study Coordinator: _______Patrice O. Yarbough, PhD__________________

Email Address_______ patrice.o.yarbough@nasa.gov_______________________
Mailing Address: ______2101 NASA Parkway, Mail Code SK ____________________
Telephone: ___________281-483-6052__________________________

You may express a concern about this study by contacting the NASA JSC Institutional Review
Board (IRB) listed below:
Office of Research Assurance: Research Integrity & Protection of Human Subjects
2101 NASA Parkway
Mail Code SA
Houston, Texas 77058
Telephone: (281) 212-1228
E-mail: NASA-IRB@nasa.gov

15. RECORD of INFORMATION PROVIDED

15.1 Your signature in the next section means that you have received copies of all of the following
documents:
This NASA IRB Consent to be Part of a Research Study document;

Video, Audio, and Photo Consent;

Other (specify): ________________________________

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16. SIGNATURES
Research Subject:
I understand the information printed on this form. I have discussed this study, its risks and potential
benefits, and my other choices with Dr Yarbough or Dr Cromwell. My questions so far have been
answered. I understand that if I have more questions or concerns about the study or my
participation as a research subject, I may contact the study team. I understand that I will receive a
copy of this form at the time I sign it and later upon request.
Signature of Subject: __________________________________ Date: ________________
Name (Print legal name): ___________________________________________________________

Video, Audio, and Photo:

I understand that this study will utilize video and/or still photography to analyze study results and I
consent for the use of these materials.
I accept
I do not accept
Signature: _____________________________

Video, Audio, and Photo for Media Release:

I understand that this study may utilize video, audio and/or still photography for media release
purposes
I accept
I do not accept
Signature: _____________________________

Principal Investigator (or Designee):

I have given this subject information about this study. I believe this to be accurate and complete.
The subject has indicated that he or she understands the nature of the risks and benefits of
participating in this study.
Name: ____________________________________ Title: ___________________________
Signature: _________________________________ Date: ___________________________

Witness (optional):
I observed the above subject sign this consent document.
Name: ________________________________
Signature: _____________________________ Date: _________________________

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