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

PROTOCOL TITLE: fMRI Studies of Working Memory and Cognitive Control 
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PROTOCOL TITLE:
fMRI 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
4/30/21
Revised COVID-19 precautions
no
4
8/24/2021
Added New COVID-19 Precautions
yes
5 
2/21/2023
Added community recruitment to section 13.1
No
6
5/11/2023
Added earplug risk information to section 15.1
Yes
7
6/28/2024
Added recruitment site
no
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Table of Contents
1.0
Study Summary ........................................................................................................3
2.0
Objectives* ...............................................................................................................4
3.0
Background*.............................................................................................................4
4.0
Study Endpoints*......................................................................................................4
5.0
Study Intervention/Investigational Agent.................................................................4
6.0
Procedures Involved* ...............................................................................................5
7.0
Data and Specimen Banking*...................................................................................5
8.0
Sharing of Results with Subjects* ............................................................................6
9.0
Study Timelines*......................................................................................................6
10.0
Inclusion and Exclusion Criteria* ............................................................................6
11.0
Vulnerable Populations*...........................................................................................6
12.0
Local Number of Subjects ........................................................................................7
13.0
Recruitment Methods................................................................................................7
14.0
Withdrawal of Subjects*...........................................................................................7
15.0
Risks to Subjects*.....................................................................................................7
16.0
Potential Benefits to Subjects* .................................................................................8
17.0
Data Management* and Confidentiality...................................................................8
18.0
Provisions to Monitor the Data to Ensure the Safety of Subjects*...........................8
19.0
Provisions to Protect the Privacy Interests of Subjects ............................................9
20.0
Compensation for Research-Related Injury..............................................................9
21.0
Economic Burden to Subjects...................................................................................9
22.0
Consent Process........................................................................................................9
23.0
Process to Document Consent in Writing...............................................................12
24.0
Setting.....................................................................................................................13
25.0
Resources Available ...............................................................................................13
26.0
Multi-Site Research* ..............................................................................................13
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1.0
Study Summary
Study Title
fMRI 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 functional magnetic resonance imaging 
(fMRI).
Secondary 
Objective(s)
Research 
Intervention(s)/ 
Investigational 
Agent(s) 
NA
IND/IDE # 
Study Population
Healthy young adults
Sample Size
400
Study Duration for 
individual 
participants
1-2 hours
Study Specific 
Abbreviations/ 
Definitions 
fMRI – functional magnetic resonance imaging
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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 functional magnetic resonance 
imaging (fMRI). fMRI is a well-established, non-invasive technique 
used by thousands of labs around the world to study brain function.
2.2
State the hypotheses to be tested.
We hypothesize that areas in the prefrontal cortex (PFC) and 
posterior parietal cortex (PPC) are active during working memory 
and cognitive control. We hypothesize that activity in these regions 
directs the selection, retention, and manipulation of representations 
elsewhere in the brain.
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.
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.
fMRI is one of the best non-invasive tools that researchers have for 
studying human brain function. The ability to 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 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
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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 use 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.   While performing the proposed tasks, MRI data will be 
collected. Subjects will be screened by the MR technologist, and will 
be excluded if they meet any exclusion criteria. Subjects will be 
given instructions about the task and the MRI scanning environment. 
If there is any concern about claustrophobia, participants will be 
encouraged to try the mock scanner before entering the MRI scanner. 
The mock scanner is located next door to the MRI scanner and 
provides a simulated MRI environment. If they are uncomfortable 
with the enclosed environment (at any time), they can exit the study 
and receive compensation for their time. Otherwise, participants will 
then be given a short practice session on the task either before 
entering the scanner, or during collection of preliminary and/or 
structural images. After being positioned in the scanner by the 
technologist, the technologist will acquire initial calibration scans. A 
structural image of the head and brain may be acquired before or 
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after the functional imaging data. The remaining time in the scanner 
will be used to collect functional imaging data while subjects 
perform the task. Response time and accuracy data will be recorded 
during the task. We will relate these measures to the fMRI data from 
the scanner, in order to understand the relationships between neural 
activity and behavioral performance. For some studies, eye tracking 
will be performed. This will involve positioning a camera focused 
over one of the eyes and recording video of eye position. Such data 
will be useful to monitor eye position and pupil dilation. Knowledge 
of eye position is important in tasks that utilize spatial stimuli (e.g. 
location) and when mapping out areas of the brain that respond to 
stimuli as a function of their position on the eyes (e.g. visual cortex).
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 
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 
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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 
a.
In this task, participants will switch among 
two or more tasks of the nature described 
above.
o
Retinotopic mapping 
a.
In this task, stimuli will be used to map out 
the visual field within the brain. Stimuli will 
consist of high contrast checkboard images 
that efficaciously recruit visual cortex. 
Stimuli will be moved around the visual 
field such that mapping between visual 
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location and brain location can be 
determined.
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
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 MRI. 
Participants will also be screened such that 
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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 
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
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 while scanning. 
We will stop testing or administer breaks if participants feel 
frustrated or tired. Additional risks and preventions include: 1) 
Magnetic field attracting ferromagnetic objects: Subjects will 
be screened for metallic objects prior to entering the scan room 
to minimize this risk and anyone with a questionable history of 
metal will not be allowed to enter the scanner room. 2) 
Claustrophobia: Any participant reporting the experience of 
claustrophobia will be removed from the magnet immediately, 
debriefed, and given compensation for their time. 3) Noise: All 
participants will be required to wear ear plugs to shield them 
from scanner noise while allowing communication from the 
technician. If the noise is overly bothersome to the subjects, 
they will be removed from the magnet immediately. Please 
note: The occurrence of any adverse events associated with this 
study and its procedures, as well as any changes in risk level 
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will be monitored by the principal investigator and 
coinvestigators of this study, as well as the scanner technician.
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. 

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."
To implement this COVID-19 vaccination option, we will make 
a note in our study records for each prospective subjects and 
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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 while being tested in the 
MRI scanner.
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*
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 
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subject’s primary care physicians) and if so, describe how the results 
will be shared.
The MRIF contracts with The Mind Research Network (MRN) for 
screening of all subjects. To this end, subjects electing to partake in 
the IF program will have their T1 and T2 weighted scan data sent to 
MRN via encrypted data link. Other scans such as Susceptibility 
Weighted Images (SWI), Diffusion Weighted Images (DWI), and 
Fluid-attenuated Inversion Recovery (FLAIR) can also be send to 
MRN for review, if needed.
The MRN Contracted Radiologists will review images provided to 
them, and do not have access to additional clinical information. The 
MRI scans are collected under research protocols and are not 
obtained for clinical purposes.
The research MRI scans are not a substitute for a clinical scan and 
might not show problems that may be picked up by a clinical scan. If 
MRNs find an abnormality that requires follow-up, they may also 
mail a copy of the report to the subject, or contact them (with their 
permission), to help answer questions.
All MRN radiology reviews are completed within 30 days and are 
forwarded as a de-identified report directly to the MRI Technologist. 
All reports are then printed and mailed via US Postal Service to the 
subject’s mailing address. They are provided with the contact 
information of the MRI Technologist in case they have questions. 
Any returned reports will be recorded and the hard copy destroyed.
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.
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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 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 
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.
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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. Because of the visual presentation of 
stimuli, participants will need to have normal or corrected-to-normal 
vision. Exclusion: Left-handed people will be excluded. Many brain 
functions are lateralized (e.g. language is often processed by the left 
hemisphere). While such lateralization is typically very consistent in 
right-handers, brain lateralization is less predictable in left-handers 
which can confound localization of function. Participants must pass 
the MRI screening protocol, excluding people who have metal in any 
portion of the body, have medical complications, cardiac pacemaker 
cochlear implant, aneurysm clip, IUD shrapnel, history of metal 
fragments in eyes, neurostimulators, weight over 300 pounds, known 
problems of claustrophobia, history of psychiatric illness and/or 
neurological illness, or illicit drug use. Because alcohol has a 
transient effect on neural activity, subjects will be screened to have 
not consumed alcohol for the past 24 hours via self-report. 
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
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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 
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 MRI 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.)
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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.
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 
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of the risks. Consider physical, psychological, social, legal, and 
economic risks.
Risks for the study include:
Frustration from poor performance on the task, fatigue, or 
eye-strain
Probing for personal or sensitive information in surveys, 
interviews, or questionnaires.
Risks from MRI:
o
Magnetic field attracting ferromagnetic objects. 
There is a potential risk of the main magnet field 
attracting ferromagnetic/metallic objects towards 
the magnet.
o
Claustrophobia. The magnet is a small enclosed 
space that can induce feelings of claustrophobia.
o
Noise. The scanner makes a bothersome/loud noise 
during the course of data collection. This can 
damage hearing if measures are not taken to protect 
the ears.
o
Earplug risk. Risk of trauma from the earplugs in cases 
where participants have cerumen (earwax) accumulated in 
their ears.
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.
NA
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.
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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 
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 
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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.

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.
NA
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 and the 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 
passes the first phase of screening and remains interested in 
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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. Steps that will be taken to minimize 
the possibility of coercion or undue influence.

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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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 fMRI 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 
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MRI scanner is 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 MRI scanner and eye tracker where 
participants will perform fMRI experiments.

Describe the availability of medical or psychological resources 
that subjects might need as a result of an anticipated 
consequences of the human research.
A first aid kit is 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 and shadowing trained researchers.
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
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