cTBS/fMRI Study of Hierarchical Control in the PFC
Phase: NA
Conditions: Transcranial Magnetic Stimulation
Sponsor: Florida State University

PROTOCOL TITLE: TMS Studies of Working Memory and Cognitive Control  
 
 
Page 1 of 31 
Revised: December 1, 2018 
PROTOCOL TITLE: 
TMS Studies of Working Memory and Cognitive Control  
PRINCIPAL INVESTIGATOR: 
Derek Evan Nee  
Psychology  
850-644-1963  
nee@psy.fsu.edu 
VERSION NUMBER/DATE: 
Include the version number and date of this protocol. 
REVISION HISTORY 
 
Revision 
# 
Version Date 
Summary of Changes 
Consent 
Change? 
1 
9/30/19 
Previously approved protocol changed to 
RAMP 
no 
2 
6/10/20 
Added COVID-19 precautions 
yes 
3 
12/15/20 
Added follow-up procedures 
yes 
4 
4/30/2021 
Revised COVID-19 precautions 
no 
5 
7/26/2021 
Added NDA surveys 
no 
6 
8/16/2021 
Revised Section 6.0 
no 
7 
8/24/2021 
Added New COVID-19 precautions 
yes 
8 
5/16/2022 
Added dizziness, lightheadedness, and syncope 
to risks 
yes 
9 
2/21/2023 
Added community recruitment to section 13.1 
no 
10 
6/28/2024 
Added recruitment site 
no 
 
 
 

PROTOCOL TITLE: TMS Studies of Working Memory and Cognitive Control  
 
 
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Table of Contents 
1.0 
Study Summary ........................................................................................................ 3 
2.0 
Objectives* .............................................................................................................. 4 
3.0 
Background* ............................................................................................................ 4 
4.0 
Study Endpoints* ..................................................................................................... 5 
5.0 
Study Intervention/Investigational Agent ................................................................ 5 
6.0 
Procedures Involved*............................................................................................... 5 
7.0 
Data and Specimen Banking* ................................................................................ 15 
8.0 
Sharing of Results with Subjects* ......................................................................... 15 
9.0 
Study Timelines* ................................................................................................... 16 
10.0 Inclusion and Exclusion Criteria* .......................................................................... 16 
11.0 Vulnerable Populations* ........................................................................................ 18 
12.0 Local Number of Subjects ..................................................................................... 18 
13.0 Recruitment Methods ............................................................................................. 18 
14.0 Withdrawal of Subjects* ........................................................................................ 20 
15.0 Risks to Subjects* .................................................................................................. 20 
16.0 Potential Benefits to Subjects* .............................................................................. 25 
17.0 Data Management* and Confidentiality ................................................................ 25 
18.0 Provisions to Monitor the Data to Ensure the Safety of Subjects* ........................ 26 
19.0 Provisions to Protect the Privacy Interests of Subjects .......................................... 27 
20.0 Compensation for Research-Related Injury ........................................................... 28 
21.0 Economic Burden to Subjects ................................................................................ 28 
22.0 Consent Process ..................................................................................................... 28 
23.0 Process to Document Consent in Writing .............................................................. 30 
24.0 Setting .................................................................................................................... 30 
25.0 Resources Available............................................................................................... 31 
26.0 Multi-Site Research* ............................................................................................. 31 
 
 
 

PROTOCOL TITLE: TMS Studies of Working Memory and Cognitive Control  
 
 
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1.0 
Study Summary 
 
Study Title 
TMS Studies of Working Memory and Cognitive Control 
Study Design 
Experimental/Control Design 
Primary Objective 
The purpose of the proposed research is to identify brain 
areas that correlate with working memory and cognitive 
control using transcranial magnetic stimulation (TMS). 
Secondary 
Objective(s) 
 
Research 
Intervention(s)/ 
Investigational 
Agent(s)  
NA 
IND/IDE #  
NA 
Study Population 
Healthy young adults 
Sample Size 
400 
Study Duration for 
individual 
participants 
1-2 hours 
Study Specific 
Abbreviations/ 
Definitions  
TMS – transcranial magnetic stimulation 
 
 

PROTOCOL TITLE: TMS Studies of Working Memory and Cognitive Control  
 
 
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2.0 
Objectives* 
2.1 Describe the purpose, specific aims, or objectives. 
The purpose of the proposed research is to further our understanding 
in the mechanistic operations of working memory and cognitive 
control. We are interested in the brain mechanisms underlying 
working memory and cognitive control abilities. Our goal is to 
identify brain areas that directly correlate with working memory and 
cognitive control through the use of transcranial magnetic 
stimulation (TMS). TMS is a well-established, non-invasive 
technique used by thousands of labs around the world to study causal 
aspects of brain function. 
2.2 State the hypotheses to be tested. 
We will test the hypothesis that brain regions that are shown to 
correlated with a cognitive process are causally relevant to that 
process such that stimulating those brain regions produces a change 
in behaviors reflective of the cognitive process. 
3.0 
Background* 
3.1 Describe the relevant prior experience and gaps in current 
knowledge. 
Cognitive control refers to the ability to align behaviors in 
accordance with goals and contextual circumstances. This ability 
often depends upon maintaining information (e.g. instructions, goals) 
when it is no longer available to the senses – referred to as working 
memory. Cognitive control and working memory are central to 
higher-level cognition, but their mechanistic operations are poorly 
understood. In particular, little causal data is available regarding 
whether and how particular brain regions support cognitive control 
and working memory. The purpose of the proposed study is to 
further our understanding of these abilities. 
3.2 Describe any relevant preliminary data. 
NA 
3.3 Provide the scientific or scholarly background for, rationale for, and 
significance of the research based on the existing literature and how 
will it add to existing knowledge. 
TMS is a well-established, non-invasive technique used by hundreds 
of labs around the world to study causal aspects of brain function. 
Also, TMS is one of the few non-invasive causal tools that 
researchers have for studying human brain function. The ability to 
causally associate brain regions with cognition is of central 
importance for our understanding of mental and neural function. 
Furthermore, basic understanding of mental and neural function will 

PROTOCOL TITLE: TMS Studies of Working Memory and Cognitive Control  
 
 
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improve our understanding of impairments observed in psychiatric 
and neurological disorders. 
4.0 
Study Endpoints* 
4.1 Describe the primary and secondary study endpoints. 
NA 
4.2 Describe any primary or secondary safety endpoints. 
NA 
5.0 
Study Intervention/Investigational Agent 
1.1 Description: Describe the study intervention and/or investigational 
agent (e.g., drug, device) that is being evaluated. 
NA 
5.1 Drug/Device Handling: If the research involves drugs or device, 
describe your plans to store, handle, and administer those drugs or 
devices so that they will be used only on subjects and be used only by 
authorized investigators. 
NA 
5.2 If the drug is investigational (has an IND) or the device has an IDE 
or a claim of abbreviated IDE (non-significant risk device), include 
the following information: 
 
NA 
 
6.0 
Procedures Involved* 
6.1 Describe and explain the study design. 
In the proposed research, we will used computer-based tasks that 
engage cognitive control and/or working memory. Typical 
paradigms will involve presenting stimuli such as words, letters, 
pictures, or sounds. In tasks involving working memory, participants 
will be asked to retain in mind some aspect of the stimulus after it is 
no longer present on the monitor. In tasks involving working 
memory and/or cognitive control, participants will make decisions 
on stimuli that are based on previous instruction and previous 
stimuli. Since cognitive control interacts with the reward system (i.e. 
to motivate cognitive control), we will also examine reward-related 
tasks either in tandem with cognitive control, or in isolation. 
TMS will be delivered in one of two modes: 1) In "online" studies, 
TMS will be time-locked to the task (for example, a single pulse may 
be delivered 20, 60, or 100 ms after the onset of the stimulus) and we 
will investigate the critical period of involvement of a given region. 
Such studies will involve either single pulses of TMS or short burst 

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of pulses. Bursts will contain 5 or fewer pulses with bursts spaced by 
intervals of 3 seconds or more. All studies will conform to the safety 
limits established by Rossi et al. (2009). 2) In "offline" studies, 
longer duration TMS will be administered prior to the task. This 
TMS will transiently suppress or excite the region resulting in 
decreased or increased performance on the task. Three types of 
offline designs may be used: A) Continuous Theta-Burst stimulation 
(TBS), which is one of the most widely used offline techniques in 
which 600 pulses are delivered in bursts of 3 pulses (at 50 Hz) 
repeated at a rate of 5 Hz. This technique was introduced in 2005 by 
Huang et al. and has been used in hundreds of studies since. B) 
Intermittent TBS, which is another widely used offline technique 
introduced by Huang et al., 2005. As in continuous thetaburst 
stimulation, 600 pulses are delivered in 50 Hz bursts every 5 Hz. 
However, in intermittent TBS, 2 seconds of stimulation is alternated 
with 8 seconds of no stimulation. Hence, the entire set of pulses is 
delivered over 190 seconds. C) 1 Hz stimulation for at most 30 
minutes. This technique was considered standard until the invention 
of TBS and has been used in hundreds of studies too. Again, all 
procedures will conform to safety limits established by Rossi et al. 
(2009). It is important to note that these stimulation parameters differ 
from those that are typically used to treat patients (e.g. depression) in 
clinical settings. These stimulation parameters are for research 
purposes designed at producing transient, not chronic, effects and to 
ensure the safety of the participant. With the exception of TBS, all of 
our stimulation protocols fall under the heading of either single pulse 
or low frequency rTMS, for which adverse effects are rare (classified 
as Class 3, low risk under Rossi et al., 2009). The versions of TBS 
that we administer are short lasting and have especially low rates of 
adverse effects (Oberman et al., 2011). In general, analyses will 
focus on the accuracy and speed with which participants performed 
the task. The critical analyses will compare these variable as a 
function of TMS parameters (e.g. timing, location, frequency).    
In order to dose appropriately the TMS stimulation, it is necessary to 
determine an individual’s sensitivity to TMS. This is done by 
delivering TMS to the motor cortex to affect muscle activity in the 
hand in order to record the motor threshold (MT). MT is the standard 
in the field for determining the intensity of TMS for each individual 
to ensure participant safety. 
MT will be determined in one of two ways: 1) Recording 
electromyography (EMG) of the first dorsal interosseus muscle of 
the hand contralateral to TMS to monitor muscle activity. In this 
case, persistent muscle activity will be elicited by having the 
participant activate the muscle using the appropriate flexion 
movement, and the effect of TMS on the muscle will be observed as 
a brief cessation of EMG activity. This is referred to as the active 

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motor threshold (AMT). 2) Observing a visually-identified hand 
twitch in the hand contralateral to TMS (e.g. if applying TMS to the 
left hemisphere of the brain, a twitch will be observed in the right 
hand). This is referred to as the resting motor threshold (RMT). In 
most cases, the AMT will be determined. However, if EMG cannot 
be recorded due to technical issues (e.g. the participant’s hand is too 
sweaty to record a strong signal), RMT will be recorded. In both 
cases, the scalp region producing the largest hand twitch will be 
identified. To identify this region, TMS will be set to 30% of the 
maximal stimulator output, which is well below the motor threshold 
for most, if not all, individuals. TMS will be delivered to a scalp 
location approximating the location of motor cortex based upon 
surface features using the nose and ears as landmarks. From this 
initial location, TMS will be delivered. If ineffective to produce a 
hand twitch, the TMS coil will be moved to a new, nearby site, 
which will subsequently be tested. This process will continue until a 
grid of locations has been tested around the starting location, 
approximating 5 cm2. If a hand twitch has not been produced, this 
indicates that the stimulation is below threshold and the stimulator 
output will be raised by 5% of the maximum stimulator output. The 
process will then repeat until the maximal hand twitch at a given 
stimulation level is observed, thereby indicating the location of 
interest. During this process, the participant will be closely 
monitored and periodically asked whether the stimulation is 
producing any discomfort or unusual symptoms (e.g. dizziness). At 
the scalp location of interest, the lowest TMS intensity able to elicit 
5 visible cessations of EMG activity in 10 trials (AMT), or 5 visible 
twitches in 10 trials (RMT) at this site will be determined. Individual 
MT will be used to determine the intensity of stimulation for each 
individual, as recommended by safety guidelines. This procedure 
usually takes about 5 minutes and also serves the purpose of 
acquainting participants to TMS stimulation. Once MT is 
determined, TMS will be administered within the limits of the safety 
guidelines recently updated in Rossi et al., 2021. An additional 12 
years of research using TBS ranging between 80% and 100% RMT 
was examined to determine the continued efficacy of previously 
established guidelines in Rossi et al., 2009. Since the 2009 
publication, the scientific community has gained a better 
understanding of safety risks and the rarity of adverse events (such 
as seizure) associated with TMS. To reflect current safety guidelines 
for offline studies using TBS, TMS will never exceed 100% of RMT 
or 120% of AMT. For offline studies using 1Hz stimulation, TMS 
will never exceed 110% of RMT or 130% of AMT. For online 
studies, TMS will never exceed 110% of RMT or 130% of AMT. 
Electroencephalography (EEG) will be used to either guide TMS 
frequencies and/or targets, measure changes in brain activity 

PROTOCOL TITLE: TMS Studies of Working Memory and Cognitive Control  
 
 
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following TMS, or both. The EEG assesses electrical brain activity 
through surface recording disks (electrodes) which are placed near 
the participant's head. The electrodes transmit the signals, which are 
then amplified (via an 8 channel Brain Vision LiveAmp) and stored 
on a computer. The procedure is entirely non-invasive. 
An electrode cap will be placed on the participant's head. In order to 
record brain activity, these disks need to be filled will a gel which 
allows the electrodes to better record brain activity at the scalp. 
Therefore, the participants in this study will need to clean their hair 
after participation. The gel is completely water soluble, and the 
procedure is painless. The MRI facility has sinks and towels, and the 
investigators will help to make sure the participant has thoroughly 
rinsed all the gel from their hair. After an accurate signal is assured, 
the signal derived from the electrode cap is then amplified, 
transmitted to a computer, and stored for later analysis. 
In addition to the EEG recording, muscle activity from around the 
eyes may be recorded from the subjects. Muscle activity from around 
the eyes is recorded by two small sensors that will be placed below 
the participant’s left eye, as well as behind the ears. These 
procedures are completely noninvasive and painless. 
6.2 Provide a description of all research procedures being performed 
and when they are performed, including procedures being performed 
to monitor subjects for safety or minimize risks. 
Below is a description of the kinds of tasks that participants may 
perform in a piecemeal fashion. It is likely that elements from 
multiple such tasks will be combined into a single task. Hereafter, 
stimuli will refer to letters, numbers, words, pictures, or sounds. 
Unless otherwise specified, stimuli will be affectively neutral. In 
general, tasks will range in duration from 5-10 minutes to 1-2 hours. 
Breaks will be given every 5-10 minutes. Multiple sessions may be 
performed. Based upon performance on the tasks, we may contact 
participants to perform other related tasks. Returning to perform 
other tasks will be optional and have no bearing upon the tasks the 
participants have already completed.  
• Computer-based Tasks  
o Short-term memory  
a. In this task, participants are presented with a 
set of stimuli to remember. After a delay, 
participants will receive a test item. The test 
item can either be an old/new stimulus 
requiring a recognition decision (i.e. was the 
stimulus a member of the set?) or it can be a 
stimulus to be transformed to match a 

PROTOCOL TITLE: TMS Studies of Working Memory and Cognitive Control  
 
 
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stimulus in the set (e.g. rotate a grating until 
it matches a grating in memory).  
o Span  
a.  In this task, participants will be presented 
with a list of stimuli to remember. In some 
cases, they will be asked to make judgments 
in-between the presentation of memoranda 
(e.g. assess the validity of a simple 
arithmetic expression). Upon termination of 
the list, participants will be asked to 
reproduce the list.  
o Change-detection  
a.  In this task, participants will see a 
collection of stimuli, followed by another 
collection of stimuli. They will respond with 
whether the collection changed or not.  
o Sequence Memory 
a. In this task, participants will learn a 
predefined stimulus sequence. Participants 
will make judgements regarding whether the 
presented stimuli follow the predefined 
sequence or not. 
o Alternative forced choice  
a.  In this task, participants will judge the 
categorical status of stimuli. Categories 
include word/non-word judgements, 
semantic judgements, number judgements 
(e.g. is the number odd or even), object 
category judgments (e.g. face, scene), and 
spatial judgments (e.g. which direction does 
an arrow point). 
o Cued attention  
a. In this task, participants will be directed to 
attend to a particular stimuli, regions of 
space, or location of sound. Participants will 
make either alternative forced choice or 
memory judgements regarding the attended 
stimuli. 
o Task-switching  

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a. In this task, participants will switch among 
two or more tasks of the nature described 
above. 
o Doors Task  
a. Participants will be shown graphics 
depicting doors, and will be asked to choose 
a door. After picking a door, participants 
receive feedback on the screen indicating 
whether they have won or lost on that trial. 
The participants’ goal is to do their best to 
win as much money as possible. In this task, 
participants will receive a monetary bonus 
for correct guesses, which will total between 
$0.00 and $10.00 depending on how many 
correct guesses they make. This task will 
take approximately 5-10 minutes. 
o Motivated Behavior Task  
a. Participants will be given the opportunity to 
complete a specified number of trials for a 
specified reward. Trials will entail trials of 
the tasks described above or other simple 
cognitive tasks such as arithmetic. 
• Written tasks 
o DSM-5 Crosscutting Assessment (Adult) 
a. This is an assessment requested by the NDA 
for clinical studies. This assessment in 
particular is used to assess a participant for 
any psychiatric diagnoses that the study can 
impact. The version being used asks adult 
participants if certain symptoms related to 
psychiatric disorders have been bothering 
them in the past two weeks. 
o WHODAS 2.0 
a. This is an assessment requested by the NDA 
for clinical studies. This assessment in 
particular is used to determine the disability 
status of a participant. The questionnaire 
asks the participant about difficulties due to 
a health condition. Health conditions include 
injuries, mental/emotional issues, and 
substance use issues. The questions are 
answered in the perspective of difficulty 

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completing a specific task within the past 30 
days. 
o PHQ-9 
a. This is an assessment requested by the NDA 
for clinical studies. This assessment in 
particular is used to determine the severity 
of Major Depressive Disorder if present in 
the participant. The questionnaire asks about 
behavior trends from the past two weeks in 
the form of a Likert scale. 
o GAD-7 
a. This is an assessment requested by the NDA 
for clinical studies. This assessment in 
particular is used to determine the severity 
of anxiety if present in the participant. The 
questionnaire asks about behavior trends 
from the past two weeks in the form of a 
Likert scale. 
o Raven’s Progressive Matrices 
a. In this standardized measure of intelligence, 
participants decide which among several 
images completes a logical matrix of images 
o Self-reported tasks 
a. At the end of an experimental session, we 
may ask participants to answer questions 
regarding their strategic approach to tasks. 
Examples of questions include whether 
participants verbally rehearsed material to 
themselves, whether they named images, 
and whether they maintained vigilance. In 
all cases, questions will be about task 
performance. No personal information will 
be requested for these tasks. 
o Screening 
a. Participants will be screened to be fluent in 
English, between the ages of 18-30, and to 
have no contraindications for TMS. 
Participants will also be screened such that 
they do not belong to populations vulnerable 
to the Coronavirus Disease (COVID-19) and 
have not been exposed. They will also be 
asked to indicate whether they have received 

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a full FDA-authorized COVID-19 
vaccination series, the specific vaccine 
product they received, and the date of 
complete vaccination. 
o Demographics  
a. Demographic information including age, 
gender, race, and ethnicity will be collected. 
This information will be used for reporting 
purposes to demonstrate fair inclusion. 
Participants will be informed that providing 
this information will be optional. This 
information has no direct bearing upon the 
research to be performed 
o Follow-up Form 
a. One month after the last TMS session, 
participants will be contacted and asked to 
fill out a follow-up form. This form inquires 
about possible experiences the participant 
may have had that may be attributable to 
TMS. This information will be used to 
assess any possible risks of TMS.  
6.3 Describe: 
• 
Procedures performed to lessen the probability or magnitude 
of risks. 
• 
All drugs and devices used in the research and the purpose of 
their use, and their regulatory approval status. 
• 
The source records that will be used to collect data about 
subjects. (Attach all surveys, scripts, and data collection 
forms.) 
To lessen the probability or magnitude of risks, researchers will 
stop testing or administer breaks if participants feel frustrated, 
tired, and/or uncomfortable. Additionally, the occurrence of 
any adverse events associated with this study and its 
procedures, as well as any changes in risk level, will be 
monitored by the principal investigator and co-investigators. 
The most severe risk is that of seizure. The risk of seizure will 
be minimized in two ways 1) Using stimulation parameters that 
are within the safety guidelines reported by Rossi et al., 2009, 
and 2) Excluding participants at increased risk for seizure as 
indicated in the exclusion criteria. Within the stimulation 
parameters to be used in the present protocol, no seizures have 
been reported resulting from TMS in the populations that we 

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will study. Personnel who administer TMS will be trained to 
recognize a potential seizure event and to act as first responders 
in order to administer appropriate initial care. In addition, all 
study personnel will be trained in CPR usage. However, we 
wish to emphasize that there are no known cases where 
individuals required the use of CPR during a TMS session. The 
major physical signs the study personnel will look out for in 
detecting a potential seizure include chewing movements, 
convulsions/tremor/shaking, difficulty talking, a blank stare, 
eyes rolling up, and profuse sweating. If any of these signs are 
observed, study personnel will stop the research procedure and 
inquire whether the subject feels okay. If the subject is 
unresponsive (and therefore likely experiencing a seizure), 
first-aid will be supplied. The first-aid response consists of 
making sure the subject is physically safe for the duration of 
the seizure. This involves moving the subjects out of the TMS 
chair and onto the floor lying down on their left side. The 
subject will be kept lying down on their left side, while the 
staff call emergency medical help, via a 911 call. Resources 
available in the laboratory include a first-aid kit and immediate 
phone access. In the extremely unlikely event of an actual 
occurrence of a seizure, it will be immediately reported to the 
IRB. To minimize headaches and/or other forms of discomfort, 
the experimenter will encourage participants to report any form 
of discomfort during the procedure. The experimenter will 
periodically directly query the participant regarding whether or 
not they are experiencing discomfort. In addition, an arm will 
be used to help support the coil to reduce downward pressure 
on the subject that could lead to neck discomfort. The 
experimental procedure will be immediately terminated 
whenever anyone reports experiencing discomfort. To prevent 
adverse effects on hearing due to the sound produced by TMS, 
all experimental participants will wear ear plugs. 
In order to ensure that personnel are qualified to administer 
TMS, all personnel to be added to this protocol will receive a 
minimum of 10 hours of training with an experienced TMS 
administrator. In addition to training, personnel will be 
required to read safety documentation consisting of Rossi et al., 
2009, and Oberman et al., 2011. Prior to being permitted to 
administer TMS, all personnel will meet with Dr. Derek Nee to 
ensure understanding of the TMS procedure and all potential 
contraindications. All personnel will receive CPR training and 
CITI training. Additionally, all personnel will be instructed on 
how to deal with a seizure. 

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The source records that will be used to collect data about 
subjects will be retained in digital format. Digital information 
will be stored on password protected local machines, or on 
secure cloud-based services such as Google Docs, also 
requiring a password. 
Due to the COVID-19 national emergency and pandemic, in 
cases where participants or study staff have not completed a 
full FDA-authorized vaccination series at least 14 days before 
the study session, researchers will also apply the following 
precautions in conducting this research:  
• 
No persons deemed as higher risk by the CDC will be 
included in the study. Participants will be screened such 
that they meet these requirements.  
• 
COVID-19 related risks will be mitigated as much as 
possible. This will be done through screening for exposure 
to COVID-19, regular cleaning and disinfecting study 
areas, reducing in-person interactions, and use of personal 
protection equipment.  
• 
To prevent the spread of pathogens during TMS, 
participants may be given a disposable face mask. 
Administered masks will contain no metal so as to be 
compatible with TMS. 
• 
Unvaccinated participants will be unable to participate in 
this study if they have tested positive or if they were in 
close contact with a positive COVID-19 case within the last 
ten days.  
For in-person study activities involving prospective subjects and 
study staff, we will as part of our screening and eligibility 
procedures implement the option of informing subjects and staff 
that their voluntary disclosure of their full COVID-19 
vaccination status is an alternative to the requirement for 
COVID-19 precautions such as social distancing, use of masks, 
and other safety precautions. In doing so, we will use the 
following language: “In order to protect against COVID-19 or 
Coronavirus, if you come to the lab we are required to follow 
certain precautions like social distancing and use of masks. 
However, we don’t have to do this for persons who have 
completed a full COVID-19 vaccination. You may if you’d like 
share with us information about your COVID-19 vaccination, 
but this is your decision and is not required. You can still come 
to the lab and we will follow our usual COVID-19 precautions." 

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To implement this COVID-19 vaccination option, we will make 
a note in our study records for each prospective subjects and 
staff who choose to disclose their COVID-19 vaccination 
information.  
 
 
6.4 What data will be collected during the study and how that data will 
be obtained. 
The data that will be collected during the study includes identifying 
information. Additionally, brain activations, accuracies and reaction 
times to tasks will be collected. The data will be obtained using 
computerized-based tasks or written tasks. 
6.5 If there are plans for long-term follow-up (once all research related 
procedures are complete), what data will be collected during this 
period.  
In some cases, performance in some tasks will trigger eligibility for 
other tasks. In these cases, procedures will be identical to those 
described above. 
6.6 For Humanitarian Use Device (HUD) uses provide a description of 
the device, a summary of how you propose to use the device, 
including a description of any screening procedures, the HUD 
procedure, and any patient follow-up visits, tests or procedures. 
NA 
7.0 
Data and Specimen Banking* 
7.1 If data or specimens will be banked for future use, describe where 
the specimens will be stored, how long they will be stored, how the 
specimens will be accessed, and who will have access to the 
specimens. 
NA 
7.2 List the data to be stored or associated with each specimen. 
NA 
7.3 Describe the procedures to release data or specimens, including: the 
process to request a release, approvals required for release, who 
can obtain data or specimens, and the data to be provided with 
specimens. 
NA 
8.0 
Sharing of Results with Subjects* 

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8.1 Describe whether results (study results or individual subject results, 
such as results of investigational diagnostic tests, genetic tests, or 
incidental findings) will be shared with subjects or others (e.g., the 
subject’s primary care physicians) and if so, describe how the results 
will be shared. 
9.0 
Study Timelines* 
9.1 Describe: 
• 
The duration of an individual subject’s participation in the 
study. 
• 
The duration anticipated to enroll all study subjects. 
• 
The estimated date for the investigators to complete this study 
(complete primary analyses) 
The duration for each individual’s participation will be between 1 
and 2 hours per session. Participants will participate in at least 1, and 
potentially several sessions. It may take up to several weeks to 
complete an entire task. The duration anticipated to enroll all study 
subjects is 72 months. 
10.0 Inclusion and Exclusion Criteria* 
10.1 Describe how individuals will be screened for eligibility. 
Participants will be screened in order to minimize risks associated 
with TMS. Screening will proceed in two phases. First, the screening 
form will be sent to the participant via e-mail (see Appendix). The 
participant will be asked to respond with whether the answer to any 
question on the screening form is “yes.” At this phase, the participant 
does not need to indicate to which question the answer is “yes.” If 
the response is “yes” to any question, the participant will be 
excluded. If the participant passes the first phase of screening and 
remains interested in participating, the participant will be invited to 
perform the study. Participants will read the consent form and any 
questions will be answered. After answering questions, the 
participant will once again be presented with the screening form. In 
this case, the participant will fill-out the screening form. If the 
answer is “yes” to a given question, the participant may be asked to 
elaborate. A “yes” response may occur in the second screening, but 
not the first, if circumstances changed since the initial screening. The 
individuals included in this study will be adults from ages 18 to 30. 
We will also exclude from study individuals who are vulnerable to or 
may have come in contact with COVID-19. We will include 
individuals who have completed a full FDA-authorized vaccination 
series at least 14 days before the study session, and individuals who 
have not been fully vaccinated provided that they pass the screening 
process. As with the other screening forms, the COVID-19 screening 

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form will be sent to the participant via e-mail (see Appendix). The 
participant will be asked to respond with whether the answer to 
question #1 on the form is “yes” or if, alternatively the answer to #1 
is “no” and the answer to any other question on the screening form 
(#2 through #8) is “yes.” Question #1 asks participants to indicate if 
they have received a complete vaccination series, the specific FDA-
approved vaccine product they received, and the date of vaccination. 
At this phase, the participant does not need to indicate which to 
which of the other questions the answer is “yes.” If the response is 
“yes” to any questions including #2 through #8, the participant will 
be excluded. If the participant passes the first phase of screening and 
remains interested in participating, the participant will be invited to 
perform the study. Participants will read the consent form and any 
questions will be answered. After answering questions, the 
participant will once again be presented with the screening form. In 
this case, the participant will fill-out the screening form. If the 
answer is “no” to #1 and “yes” to any of the other questions (#2 
through #8), the participant may be asked to elaborate. A “yes” 
response may occur in the second screening, but not the first, if 
circumstances changed since the initial screening. 
 
10.2 Describe the criteria that define who will be included or excluded in 
your final study sample. 
Inclusion: Because we are interested in the mental function of adults 
prior to any age-related decline, participants will be between the ages 
of 18-30. Participants will also need to be fluent in English and have 
acquired fluency prior to the age of 6 since English is required to 
understand the instructions and some tasks will use English 
words/letters as stimuli.  
Exclusion: Left-handed people will be excluded. Many brain 
functions are lateralized (e.g. language is often processed by the left 
hemisphere).  
Based on recommendations of the International Workshop on the 
Safety of Repetitive Transcranial Magnetic Stimulation (reported in 
Wassermann, 1998), as well as the recommendations of Rossi et al., 
2009, we will exclude subjects on any of the following grounds: 
Metal anywhere in the head, excluding the mouth, History of 
seizures, Family history of epilepsy, Vascular, traumatic, tumoral, 
infectious, or metabolic lesion of the brain, Stroke, Chronic, or 
transient insomnia (e.g. jet lag), Alcoholism, Severe headaches, 
Cardiac pacemakers, Current use of medication for neurological or 
psychiatric conditions, Tinnitus, and Pregnancy. While the health 
risks to the fetus are unknown, magnetic field strength decreases 
approximately with the cube-root of the distance from the magnetic 

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coil. Therefore, a coil located on the scalp will have little direct 
effect on the abdomen, though changes in neural firing or emotional 
stress levels could in theory have distal impact. Nevertheless, any 
person who is pregnant will be excluded from the study. 
Additionally, people with the following will be excluded: hearing 
impairments and permanent retainers on the top portion of their jaw. 
A screening form (attached) will be used to assess each subject's 
eligibility for participation. 
10.3 Indicate specifically whether you will include or exclude each of the 
following special populations: (You may not include members of the 
above populations as subjects in your research unless you indicate 
this in your inclusion criteria.) 
• 
Adults unable to consent 
• 
Individuals who are not yet adults (infants, children, teenagers) 
• 
Pregnant women 
• 
Prisoners 
Special populations will not be studied. 
11.0 Vulnerable Populations* 
11.1 If the research involves individuals who are vulnerable to coercion 
or undue influence, describe additional safeguards included to 
protect their rights and welfare. 
NA 
12.0 Local Number of Subjects 
12.1 Indicate the total number of subjects to be accrued locally. 
The total number of subjects to be accrued locally is 400. 
12.2 If applicable, distinguish between the number of subjects who are 
expected to be enrolled and screened, and the number of subjects 
needed to complete the research procedures (i.e., numbers of 
subjects excluding screen failures.) 
NA 
13.0 Recruitment Methods 
13.1 Describe when, where, and how potential subjects will be recruited. 
Recruitment will be conducted at Florida State University at least 
one hour before testing. Potential subjects will be recruited via 
voluntary responses to flyers posted around campus and responses to 
approved electronic postings (see Appendix). Flyers will also be 
posted around local areas (e.g. coffee shops, restaurants). 
Additionally, flyers will be given to participants who have 

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volunteered for similar studies. (A paper flyer will be given to 
participants who have volunteered for similar studies after they have 
completed the study. These participants will have completed a study 
in a lab at Florida State University that uses similar methods to us 
and has agreed to hand out flyers for our studies to their 
participants). Volunteers will email or call a trained research 
technician who will screen the subject by the stated criteria. Potential 
subjects will be instructed to meet either in the Nee lab in the 
Psychology Building, Hajcak lab in the Psychology Building, or the 
MRI facility at the College of Medicine. All of these are private and 
secure locations requiring key card access. 
13.2 Describe the source of subjects. 
The source of subjects will be from Florida State University or the 
local community as long as subjects are eligible based on inclusion 
and exclusion criteria. 
13.3 Describe the methods that will be used to identify potential subjects. 
The methods used to identify potential subjects include the inclusion 
criteria and “no” responses to TMS screening questions. 
13.4 Describe materials that will be used to recruit subjects. (Attach 
copies of these documents with the application. For advertisements, 
attach the final copy of printed advertisements. When advertisements 
are taped for broadcast, attach the final audio/video tape. You may 
submit the wording of the advertisement prior to taping to preclude 
re-taping because of inappropriate wording, provided the IRB 
reviews the final audio/video tape.) 
Materials to recruit subjects include an online advertisement and 
recruitment advertisements posted throughout Florida State 
University. These documents are attached, along with a sample 
recruitment email response from a researcher. 
13.5 Describe the amount and timing of any payments to subjects. 
Participants will receive $15 per hour or credit hours associated with 
the undergraduate Psychology course. Paid participants may also 
receive a performance-based bonus as incentive to perform the task 
to the best of their ability. Such incentives will only be available to 
paid participants and will be based upon accuracy and speed on the 
tasks and will tend to total $0-$5 per hour. In the event of a 
multisession study, paid participants may also receive a completion 
bonus. Participants that withdraw from the study prior to completion 
will receive prorated compensation (either monetary or credit hours) 
commensurate with the duration of participation. Lastly, monetary 
compensation or credit hours will be awarded once the study is 
complete, or after the subject withdraws from the study. 

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14.0 Withdrawal of Subjects* 
14.1 Describe anticipated circumstances under which subjects will be 
withdrawn from the research without their consent. 
Anticipated circumstances under which subjects will be withdrawn 
from the research without their consent include inattentiveness, 
damage to research equipment, clear misunderstanding of task 
instructions, and inappropriate behavior such as yelling or swearing. 
14.2 Describe any procedures for orderly termination. 
NA 
14.3 Describe procedures that will be followed when subjects withdraw 
from the research, including partial withdrawal from procedures 
with continued data collection. 
Procedures that will be followed when subjects withdraw from the 
research, including partial withdrawal from procedures with 
continued data collection, include appropriate compensation for their 
time and safekeeping of their data in appropriate records. Identifying 
information will be retained in digital format. Digital information 
will be stored on password protected local machines, or on secure 
cloud based services such as Google Docs also requiring a password. 
15.0 Risks to Subjects* 
15.1 List the reasonably foreseeable risks, discomforts, hazards, or 
inconveniences to the subjects related the subjects’ participation in 
the research. Include as may be useful for the IRB’s consideration, a 
description of the probability, magnitude, duration, and reversibility 
of the risks. Consider physical, psychological, social, legal, and 
economic risks. 
Risks for the study include: 
GENERAL INFORMATION TMS is applied through a magnetic 
stimulator. This device consists of a set of electrical capacitors which 
can store and rapidly discharge electricity into a coil of electrical 
wire that is encased in shielded plastic. We will use MagPro X100 
Magnetic Stimulator equipped for a figure 8 (i.e. butterfly) coil 
(MCF-B65) and a flex arm for coil positioning. The stimulator is 
manufactured by MagVenture, which is one of the most established 
manufacturers of TMS equipment with arguably the best currently 
available products and an excellent safety record. The coil is placed 
adjacent to the scalp above the targeted region. As the electrical 
current flows through the coil, a magnetic field is generated. The 
field passes through the skin and skull, inducing a brief change in the 
electrical flow of current in the brain. The magnetic pulse briefly 
alters neural activity in brain areas lying directly beneath the coil, 
presumably by causing discharge of neurons to a depth of 1.5 to 2.0 

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cm below the scalp. TMS has been used in a large number of 
laboratories worldwide for over 30 years. When administered within 
documented safety guidelines, adverse effects associated with TMS 
are rare. The risk of such adverse effects depends greatly on the form 
of stimulation employed. Below, various risks and side effects are 
described with an account of the likelihood of each effect under the 
proposed stimulation conditions. The primary sources for this 
information come from the recommendations of the International 
Workshop on the Safety of Repetitive Magnetic Stimulation, June 
57, 1996 (reported in Wassermann, 1998). A new set of guidelines 
was published in 2009 (Rossi et al., 2009) based on a consensus 
conference which took place in Certosa di Pontignano, Siena (Italy) 
in 2008. Our proposed studies fall firmly within these established 
safety guidelines. There are no known long-term health risks to the 
use of TMS per se when operated within consensus safety guidelines 
(Rossi et al., 2009). In 2008, the FDA approved the use of high 
frequency TMS in the treatment of depression. Also in 2008, an 
international consensus conference on safety guidelines for TMS 
met. Their report (Rossi et al., 2009) systematically reviewed the 
thousands of healthy subjects and patients who have undergone TMS 
in order to allow for a better assessment of relative risks. The relative 
infrequency of adverse events using TMS was noted. They 
concluded that in the case of Class 3 studies (studies involving 
indirect benefit and low risk in normal subjects and patients that are 
expected to yield important data on brain physiology or safety, but 
have no immediate relevance to clinical problems), normal 
volunteers should be permitted to participate in TMS research. They 
also concluded that this research can be performed in a nonmedical 
setting (i.e., psychology labs, robotics labs, research institutions, etc. 
as opposed to a hospital or appropriately equipped outpatient clinic). 
The Rossi et al. (2009) consensus report went on to suggest safety 
guidelines based on the now rather extensive international 
experience with TMS. These guidelines include the TMS intensity 
and timing parameters considered safe, training, and planning for 
and managing emergencies. We will follow these guidelines, and 
have incorporated them into our screening and session procedures. 
The consensus safety guidelines (Rossi et al., 2009) are included as a 
supporting document attachment with this IRB application. 
The PI on this project (Dr. Nee) has extensive experience with TMS 
during both graduate school and post-doctoral studies. He received 
formal training in the administration of TMS through an intensive 
course offered by Harvard Medical School 
(http://tmslab.org/educationintensive.php) lead by Dr. Alvaro 
Pascual-Leone, a world leader in non-invasive brain stimulation. He 
has delivered or directly supervised over 100 sessions of TMS with 
no serious adverse effects. Over the course of these sessions, one 

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participant withdrew from the study due to discomfort in a muscle 
near the stimulation site, and another withdrew due to dizziness. No 
other side effects have been reported. It is important to note that 
TMS protocols in the literature differ with respect to stimulation 
intensity, frequency, and duration. Adverse effects increase as each 
of these variables increases. The TMS protocols to be used in this 
study are reflective of the PI’s previous studies and are suggestive of 
a low incidence of adverse effects with the planned stimulation 
parameters. Here I list the documented risks associated with TMS: 
Seizure. Seizure is a theoretical risk with TMS. In a workshop 
convened by the National Institute for Neurological Disorders and 
Stroke (NINDS) in 1996, researchers in the field agreed upon a set of 
TMS consensus safety guidelines, including recommended 
stimulation parameters and contraindications (Wasserman, 1998), 
and these consensus guidelines have been recently updated (Rossi et 
al., 2009). Widespread adherence to the 1996 guidelines has resulted 
in the virtual elimination of inadvertent seizures in TMS studies 
(Rossi et al., 2009). The levels of stimulation used in this protocol 
are well within safety guidelines (Rossi et al., 2009; Wassermann et 
al. 1998). In the Rossi et al. (2009) report it was stated that "the 
occurrence of seizures has been extremely rare, with most of the few 
new cases receiving rTMS protocols exceeding previous guidelines, 
often in patients under treatment with drugs which potentially 
lowered the seizure threshold. A total of 16 seizure cases have been 
identified to date (from tens of thousands on participants tested). 
Seven of these cases were included in the previous 1998 safety 
guidelines and 9 had been reported subsequent to the 1996 report. 
The majority of the seizures were induced in studies 1) using 
parameters outside the safety guidelines 2) examining patients with 
neurological or psychiatric conditions taking pro-epileptogenic 
medications, or 3) both. Our protocol excludes patients taking pro- 
epileptogenic medications and uses stimulation parameters that are 
well within the safety guidelines (Rossi et al., 2009). Four of the new 
seizures (two following single-pulse and two following repetitive 
TMS, rTMS) appear to have been induced in studies using "safe" 
stimulation parameters. The two rTMS incidents involved patients 
with either major depression (Figiel et al., 1998) or tinnitus (Nowak 
et al., 2006). The single-pulse incidents involved a patient with 
multiple sclerosis (Haupts et al., 2004) and a patient with bipolar 
depression (Tharayil et al., 2005). In summary, all of the new seizure 
incidents involved patients that would be excluded by our protocol, 
and in three of the cases, the patients were TAKING 
proepileptogenic medications. Since 2009, only one more seizure has 
been reported (Katz et al., 2011). This occurred in a healthy subject 
who developed symptoms of a seizure after single pulse TMS during 
initial motor threshold estimation. The initial stimulation setting was 

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at 50% of the maximum stimulator output (MSO) and produced a 
very large motor evoked potential signal (peak-to-peak amplitude 9.2 
mV), with observable movement of the whole right hand. The 
stimulation was lowered until the movements were restricted to the 
fingers. The subject then reported nausea and became unresponsive 
with involuntary limb movements and loud breathing. These 
reactions persisted for about 90 s. Given the unusual nature of this 
case, it has been questioned whether this reaction should be 
considered a seizure (Alonso-Alonso et al., 2011). The event lacks 
unequivocal features to be diagnosed as a seizure, and may be better 
considered as convulsive syncope. In summary, with over 30 years 
of data, it is clear that the risk of seizure in protocols similar to the 
one used by us is exceedingly low. Moreover, the few cases that 
have been reported involve patients with neurological or psychiatric 
conditions taking proepileptogenic. The stimulation parameters to be 
used in the proposed studies have never been reported to induce a 
seizure and are well within the limits recommended by the 
guidelines established at the consensus conference (Rossi et al., 
2009). Personnel who administer TMS will be trained to recognize a 
potential seizure event and to act as first responders in order to 
administer appropriate initial care. In addition, all study personnel 
will be trained in CPR usage. However, we wish to emphasize that 
there are no known cases where individuals required the use of CPR 
during a TMS session. The major physical signs the study personnel 
will look out for in detecting a potential seizure include chewing 
movements, convulsions/tremor/shaking, difficulty talking, a blank 
stare, eyes rolling up, and profuse sweating. If any of these signs are 
observed, study personnel will stop the research procedure and 
inquire whether the subject feels okay. If the subject is unresponsive 
(and therefore likely experiencing a seizure), first-aid will be 
supplied. The first-aid response consists of making sure the subject is 
physically safe for the duration of the seizure. This involves moving 
the subjects out of the TMS chair and onto the floor lying down on 
their left side. The subject will be kept lying down on their left side, 
while the staff call emergency medical help, via a 911 call. 
Resources available in the laboratory include a first-aid kit and 
immediate phone access. In the extremely unlikely event of an actual 
occurrence of a seizure, it will be immediately reported to the IRB. 
Local pain, headache, or discomfort. The most commonly reported 
side effect of TMS is headache. This headache is typically of a 
muscle-tension type. It usually develops during or immediately after 
the stimulation and may last for minutes to hours following the end 
of the stimulation. It is typically limited to the day of stimulation. 
Neck pain or scalp pain may also occur. Both are usually managed 
easily with over-the-counter analgesics. The experimental procedure 
will be immediately terminated whenever anyone reports 

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experiencing discomfort. There are no reports of any such effects 
recurring. For many scalp locations, TMS feels only like a sudden 
tap on the scalp accompanied by a clicking sound. For other scalp 
locations, TMS can cause face or limb twitches. These twitches are 
not painful, but can feel odd or disquieting when first experienced. 
On some occasions, TMS might cross the threshold to the point 
where it would actually be described as producing a slightly painful 
scalp sensation. We will closely monitor subjects' comfort and will 
request them to tell us if the stimulation ever feels painful. If this 
occurs, we will immediately decrease TMS intensity to a level that is 
not painful. It is important to note that the likelihood of headache 
and other discomfort depends upon the stimulation parameters. 
Parameters for clinical applications for depression note a rate of 28% 
for pain, which is greater than the 16% observed for sham (i.e. no 
true stimulation; Loo et al., 2008). However, for TBS, the rate is less 
than 3% (Oberman et al., 2011). In many cases, discomfort can be 
due to neck pain resulting from holding one’s head still against the 
coil. The figure 8 coil (MCF-B65) is lightweight compared to most 
coils and will be supported by an arm for positioning that alleviates 
downward pressure on the subject. Therefore, we anticipate rates of 
adverse effects due to pain and discomfort will be low and in 
accordance with the PI’s previous history with the technique. 
Transient hearing changes. TMS produces an audible clicking noise 
when the current passes through the coil. This click can result in 
tinnitus and transient decreased hearing if no protection is used. To 
prevent this adverse effect, all experimental participants will wear 
ear plugs. Animal and human studies have demonstrated that 
earplugs can effectively prevent the risk of hearing disturbances or 
discomfort due to TMS. 
Participants may experience lightheadedness or dizziness. In rare 
cases, a syncope may occur (Rossi et al., 2021). Participants will be 
verbally queried for any feelings of lightheadedness or dizziness 
immediately after stimulation. Since these symptoms typically result 
from cerebral hypoperfusion (i.e. reduced blood flow to the brain), 
steps will be taken to facilitate cerebral perfusion including 
hydration (offering the participant water), cold compress to reduce 
vasodilation, and lowering the head of the participant. The procedure 
chair can recline to facilitate the latter. In the event of dizziness, 
experimental procedures will be paused until symptoms resolve. In 
the rare event of a syncope, participants will be monitored until they 
regain consciousness. Experimental procedures will be terminated, 
and the IRB will be informed. 
The experimenters will also be provided with ear protection devices 
to minimize any discomfort they might experience from the clicks. 
Transient cognitive/neuropsychological changes. Some repetitive 
TMS protocols have been shown to affect cognitive processing for 

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up to one hour following stimulation. Specifically, this is the case for 
"offline" techniques such as 1 Hz stimulation and theta-burst 
stimulation (TBS; Huang et al., 2005). These changes are small, but 
could in theory affect the subject's ability to drive home safely. 
However, our use of offline TMS always precedes the actual 
experimental task that subjects are performing. Since the effects of 
the TMS parameters we are proposing to use have never been 
observed to last more than 1 hour, the potential cognitive effects of 
TMS are expected to have worn off by the time the testing session is 
concluded. Participants may experience frustration from poor 
performance on the task. Another potential risk is probing for 
personal or sensitive information in surveys, interviews, or 
questionnaire. 
15.2 If applicable, indicate which procedures may have risks to the 
subjects that are currently unforeseeable. 
NA 
15.3 If applicable, indicate which procedures may have risks to an 
embryo or fetus should the subject be or become pregnant. 
While the health risks to the fetus are unknown, magnetic field 
strength decreases approximately with the cube-root of the distance 
from the magnetic coil. Therefore, a coil located on the scalp will 
have little direct effect on the abdomen, though changes in neural 
firing or emotional stress levels could in theory have distal impact. 
15.4 If applicable, describe risks to others who are not subjects. 
NA 
16.0 Potential Benefits to Subjects* 
16.1 Describe the potential benefits that individual subjects may 
experience from taking part in the research. Include as may be 
useful for the IRB’s consideration, the probability, magnitude, and 
duration of the potential benefits. 
No direct benefit. 
16.2 Indicate if there is no direct benefit. Do not include benefits to 
society or others. 
No direct benefit. 
17.0 Data Management* and Confidentiality 
17.1 Describe the data analysis plan, including any statistical procedures 
or power analysis. 
Data analysis will follow standard procedures detailed in the relevant 
literature including frequentist tests and Bayesian statistics when 
applicable. Power analyses will be performed on relevant past and/or 

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preliminary data to inform planned sample sizes. If such data are no 
available, power analyses will be performed based on anticipated 
effect sizes. 
17.2 Describe the steps that will be taken to secure the data (e.g., 
training, authorization of access, password protection, encryption, 
physical controls, certificates of confidentiality, and separation of 
identifiers and data) during storage, use, and transmission. 
The steps that will be taken to secure the data (e.g., training, 
authorization of access, password protection, encryption, physical 
controls, certificates of confidentiality, and separation of identifiers 
and data) during storage, use, and transmission include retaining 
information in digital format. Digital information will be stored on 
password protected local machines, or on secure cloud based 
services such as Google Docs also requiring a password. 
17.3 Describe any procedures that will be used for quality control of 
collected data. 
NA 
17.4 Describe how data or specimens will be handled study-wide: 
• 
What information will be included in that data or associated 
with the specimens? 
• 
Where and how data or specimens will be stored? 
• 
How long the data or specimens will be stored? 
• 
Who will have access to the data or specimens? 
• 
Who is responsible for receipt or transmission of the data or 
specimens? 
• 
How data or specimens will be transported? 
NA 
18.0 Provisions to Monitor the Data to Ensure the Safety of Subjects* 
This section is required when research involves more than Minimal Risk 
to subjects. 
18.1 Describe: 
• 
The plan to periodically evaluate the data collected regarding 
both harms and benefits to determine whether subjects remain 
safe.  The plan might include establishing a data monitoring 
committee and a plan for reporting data monitoring committee 
findings to the IRB and the sponsor. 
• 
What data are reviewed, including safety data, untoward 
events, and efficacy data. 

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• 
How the safety information will be collected (e.g., with case 
report forms, at study visits, by telephone calls with 
participants). 
• 
The frequency of data collection, including when safety data 
collection starts. 
• 
Who will review the data. 
• 
The frequency or periodicity of review of cumulative data. 
• 
The statistical tests for analyzing the safety data to determine 
whether harm is occurring. 
• 
Any conditions that trigger an immediate suspension of the 
research. 
 
The primary safety risk of TMS is seizure. Any seizures resulting 
from TMS will be reported to the IRB. The incidences of seizures 
will be monitored. If it appears that the incidences of seizures 
observed in the study are statistically higher than those reported in 
the literature (e.g. through the use of a chi-square test), the IRB 
will be alerted and the safety protocol will be revisited. 
19.0 Provisions to Protect the Privacy Interests of Subjects 
19.1 Describe the steps that will be taken to protect subjects’ privacy 
interests. “Privacy interest” refers to a person’s desire to place 
limits on whom they interact or whom they provide personal 
information. 
The steps taken to protect subjects’ privacy interests include testing 
in a private and secure location requiring keycard access. Subjects 
will be consented and screened individually in a testing room, where 
he or she will have contact with trained personnel identified in this 
application.  During the consenting process, the participant will only 
have contact with trained personnel identified in this application. 
19.2 Describe what steps you will take to make the subjects feel at ease 
with the research situation in terms of the questions being asked and 
the procedures being performed. “At ease” does not refer to 
physical discomfort, but the sense of intrusiveness a subject might 
experience in response to questions, examinations, and procedures. 
Subjects will be able to stop or leave at any moment. Additionally, 
trained personnel will deliver instructions and provide information 
regarding where to go if they have questions. 
19.3 Indicate how the research team is permitted to access any sources of 
information about the subjects. 
The research team is permitted to access any sources of information 
about the subjects using the digital formats storing subject 
information. Researchers will need to know the passwords or have 
access to view the information. 

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20.0 Compensation for Research-Related Injury 
20.1 If the research involves more than Minimal Risk to subjects, describe 
the available compensation in the event of research related injury. 
None 
20.2 Provide a copy of contract language, if any, relevant to 
compensation for research-related injury. 
Routinely, FSU, its agents, or its employees do not compensate for 
or provide free care for human subjects in the event that any injury 
results from participation in a research project.  If you become ill or 
injured as a direct result of participating in this study, contact your 
regular medical provider.  If you have insurance, your insurance 
company may or may not pay for these costs. If you do not have 
insurance, or if your insurance company refuses to pay, you will be 
billed. Funds to compensate for pain, expenses, lost wages and other 
damages caused by injury are not routinely available. 
21.0 Economic Burden to Subjects 
21.1 Describe any costs that subjects may be responsible for because of 
participation in the research. 
NA 
22.0 Consent Process 
22.1 Consent will be obtained: 
• 
In person, onsite in the Nee lab or Hajcak lab, prior to the 
collection of data. 
• 
There will be no waiting period available between informing 
the prospective subject and obtaining consent. 
• 
There will be no process to ensure ongoing consent 
• 
HRP-090 consent will not be used. 
• 
The individuals listed in the application will tell subjects that 
the purpose of the study is to understand the mental processes 
involved in retaining information in mind when it is no longer 
available to the senses, and using retained information to guide 
behavior. The participants will also be informed of the duration 
of the experiment, use of TMS, use of EEG, and inclusion and 
exclusion criteria. 
• 
Additionally, participants will be screened in order to minimize 
risks associated with fMRI. Screening will proceed in two 
phases. First, the screening form will be sent to the participant 
via email (see Appendix). The participant will be asked to 
respond with whether the answer to any question on the 
screening form is “yes”. If the response is “yes” to any 
question, the participant will be excluded. If the participant 

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passes the first phase of screening and remains interested in 
participating, the participant will be invited to perform the 
study. Participants will read the consent form and any 
questions will be answered. After answering questions, the 
participant will once again be presented with the screening 
form. If the answer is “yes” to a given question, the participant 
may be asked to elaborate. A “yes” response may occur in the 
second screening, but not the first, if circumstances changed 
since the initial screening.  
• 
Consent discussion will occur prior to data collection. Data 
collection will not occur until subjects understand the study 
outlines and protocol. 
• 
Researchers will inform subjects that participation is voluntary 
and they can leave at any moment. 
• 
Researchers will ask participants questions regarding 
understanding of the study before proceeding. 
• 
The consenting process will take as long as any subject needs 
to understand the experiment. 
• 
Steps that will be taken to minimize the possibility of coercion 
or undue influence include understanding the task and a formal 
signature on the consent document before proceeding with data 
collection. 
 
Non-English Speaking Subjects 
• 
NA 
Waiver or Alteration of Consent Process (consent will not be 
obtained, required information will not be disclosed, or the 
research involves deception) 
• 
NA 
Subjects who are not yet adults (infants, children, teenagers) 
• 
NA 
Cognitively Impaired Adults 
• 
NA 
Adults Unable to Consent 
• 
NA  

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Revised: December 1, 2018 
Adults Unable to Consent 
• 
NA 
23.0 Process to Document Consent in Writing 
23.1 Describe whether you will be following “SOP: Written 
Documentation of Consent (HRP-091).” If not, describe whether and 
how consent of the subject will be documented in writing. 
Yes, written consent will be obtained. 
23.2 If your research presents no more than minimal risk of harm to 
subjects and involves no procedures for which written 
documentation of consent is normally required outside of the 
research context, the IRB will generally waive the requirement to 
obtain written documentation of consent. 
23.3 (If you will document consent in writing, attach a consent document. 
If you will obtain consent, but not document consent in writing, 
attach a consent script. Review “CHECKLIST: Waiver of Written 
Documentation of Consent (HRP-411)” to ensure that you have 
provided sufficient information. You may use “TEMPLATE 
CONSENT DOCUMENT (HRP-502)”to create the consent 
document or script.) 
A consent document is attached. 
24.0 Setting 
24.1 Describe the sites or locations where your research team will 
conduct the research. 
• 
Identify where your research team will identify and recruit 
potential subjects. 
• 
Identify where research procedures will be performed. 
• 
Describe the composition and involvement of any community 
advisory board. 
• 
For research conducted outside of the organization and its 
affiliates describe: 
o 
Site-specific regulations or customs affecting the 
research for research outside the organization. 
o 
Local scientific and ethical review structure outside the 
organization. 
 
The research team will identify and recruit potential subjects in the 
Nee lab or Hajcak lab in the Psychology Building at Florida State 
University. Consent and TMS screening will occur in the Nee lab 
or Hajcak lab in the Psychology building at Florida State 
University. The research procedures will be performed in the 
College of Medicine at Florida State University. This is where the 

PROTOCOL TITLE: TMS Studies of Working Memory and Cognitive Control  
 
 
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Revised: December 1, 2018 
TMS and EEG equipment are housed. There will be no 
composition and involvement of any community advisory board. 
25.0 Resources Available 
25.1 Describe the resources available to conduct the research: For 
example, as appropriate: 
• 
Justify the feasibility of recruiting the required number of 
suitable subjects within the agreed recruitment period. For 
example, how many potential subjects do you have access to? 
What percentage of those potential subjects do you need to 
recruit? 
Much of the student population of Florida State University will 
be eligible for our studies. This is a large pool from which to 
draw which will ensure the ability to recruit and test the 
required number of participants. 
• 
Describe the time that you will devote to conducting and 
completing the research. 
The research will be conducted over the next several years 
• 
Describe your facilities. 
The Nee lab and Hajcak lab are equipped with testing rooms 
with computers designated for testing subjects and privacy for 
consenting and screening participants. The College of 
Medicine houses the TMS equipment where TMS studies will 
be performed. 
• 
Describe the availability of medical or psychological resources 
that subjects might need as a result of an anticipated 
consequences of the human research. 
A CPR kit and AED are available at the TMS suite. Emergent 
medical care is available through standard sources (e.g. 911). 
• 
Describe your process to ensure that all persons assisting with 
the research are adequately informed about the protocol, the 
research procedures, and their duties and functions. 
All persons assisting with the research are adequately informed 
about the protocol, the research procedures, and their duties 
and functions by completing the Human Subjects Research 
training offered by CITI, shadowing trained researchers, and 
training in seizures and CPR. 
26.0 Multi-Site Research* 
26.1 
Study-Wide Number of Subjects* 
If this is a multicenter study, indicate the total number of subjects to be 
accrued across all sites. 
NA