Investigating Accelerated Learning and Memory in Healthy Subjects Using a Face Name Memory Task
Phase: NA
Conditions: Healthy Adults
Sponsor: The University of Texas at Dallas

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Project Title: Investigating Transcranial Direct Current Stimulation (tDCS) in accelerating learning in healthy subjects 
Application for Expedited or Full Board Review 
Institutional Review Board 
Office of Research Compliance 
 
 
Please submit this completed form, along with finalized copies of all recruitment materials (e.g., telephone scripts, fliers, etc.), tests, surveys, 
interviews, and copies of human participants training completion certificates for all investigators and key personnel to the IRB. This training 
can be found at http://www.utdallas.edu/research/orc/irb/required_training/. 
 
If you require further assistance in completing this form or need additional information, please contact Office of Research Compliance at 
extension 4575 or by E-mail amanda.boone@utdallas.edu. 
 
 
 
Principal Investigator (PI) 
Name (Last name, First name, MI) 
Highest Earned Degree 
Vanneste Sven 
PhD 
University Title
Department 
Professor 
BBS 
Campus Phone No. 
E-mail Address 
972.883.7277 
sven.vanneste@utdallas.edu 
Campus Mailing Address 
Campus Mail Station 
BSB 
  Faculty 
Staff 
Student 
Other: 
 
 
Co-Principal Investigator 
Faculty Sponsor 
Name (Last name, First name, MI) 
Highest Earned Degree 
University Title 
Department 
Campus Phone No. 
E-mail Address 
Campus Mailing Address 
Campus Mail Station 
Faculty 
Staff 
Student 
Other: 
 
 
 
 
Primary Contact Person 
Name 
Campus Phone No. 
E-Mail Address 
To Wing Ting 
9728837275 
wingting.to@utdallas.edu 

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Other Study Personnel: 
Name (Last Name, First Name, MI) 
Role in Study 
Wing Ting To 
subject recruitment, subject screening, data collection, data 
analysis 
Anusha Mohan, Clisha Dsouza, Edgar De La Concha, Hye 
Bin Yoo, Ian Abenes, Jeff Hullfish, Natalie Garcia, Ratjith 
Idiculla, Sahil Sinha, Samantha Long, Shaheen Ahmed, 
Tiffany Kao, Venkata Esanakarra, Yuefeng Huang 
subject recruitment, subject screening, data collection 
 
Are study personnel outside UTD and its affiliated institutions involved in this study? 
 Yes  
 No 
 
Non-Affiliated Study Personnel: 
Name (Last Name, First Name, MI) 
Institution 
Role in Study 
 
Study Funding and Other Support 
 
Is this study funded? 
 Yes  
  No 
Please select all appropriate funding sources for this project, including sources of pending support: 
  Federal 
  Industry - For Proft 
  Private - Non Profit 
  Public - State of Texas 
  Public - Local 
  Academic 
  Internal - Departmental 
 
Have all PIs, Co-PIs, and Faculty Sponsors provided a Conflict of Interest Disclosure within the last 12 months? Student researchers 
should complete and submit the attached Student Conflict of Interest Disclosure along with this application. 
 Yes  
  No 
Please Note: Final approval will be withheld until all Conflict of Interest Disclosures have been received and reviewed by the Office 
of Research Compliance. 
 
Federal Grant Information: 
Granting Agency: 
Grant Status: 
 Awarded
 Pending 
 Not Yet Submitted 
Grant Title: 
Principal Investigator: 

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Performance Sites 
Mark all UTD affiliated sites where research-related activities will be conducted and the relevant activities performed at each site: 
Performance Site 
Recruitment 
Procedures 
Data Analysis 
Richardson Main Campus 
 
 
 
Callier Campus - Richardson 
 
 
 
Callier Campus - Dallas 
 
 
 
Center for BrainHealth 
 
 
 
Center for Vital Longevity 
 
 
 
TX Biomedical Device Center - Dallas 
 
 
 
 
If applicable, please indicate all performance site(s)/institution(s) that are non-UTD affiliated: 
Site Name 
Research Related Activity 
 
Does the non-UTD affiliated institution have an IRB? 
 Yes  
  No 
If yes, has IRB approval been obtained? 
  Yes  
 No 
Note: A copy of the IRB approval letter is required. If the site/institution does not have an IRB, a Letter of Support/Permission 
from an equivalent entity or an authorized institutional official may be accepted. 
 
Which methods will this study include? (check all that apply) 
 Descriptive 
 Oral History 
 Qualitative 
 Experimental/Control Design 
 Quantitative 
 Ethnographic 
 Formative 
 Longitudinal
 Other, specify: 
 
 
Estimated Study Duration 
Please indicate the estimated length of research study: 
Between 1 and 2 years 
 
 
Publication of Results 
Please identify all methods in which you may publicly disseminate the results of your study (academic journal, academic conference, 
a thesis or dissertation for one of your students, etc.). 
 Academic journal 
 Academic conference paper 
 Public poster session 
 Book or chapter 
 Thesis 
 Dissertation 
 Class project 
 Other: 

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Instructions: 
Use non-professional language and address each part separately to describe your protocol. Attaching sections of a grant application 
or proposal is not an acceptable substitute. Provide sufficient information for effective review by all members of the IRB, including 
non-specialists. Define all abbreviations and terms that are not part of common language. 
 
 
Describe the objective(s) of the proposed research: 
Describe why this research project will be carried out. Clearly state the overall objectives, specific aims, hypotheses (research 
questions), and rationale for performing the study. 
 
The overall objective of this study is to explore whether transcranial Direct Current Stimulation (tDCS) can accelerate 
associative learning and boost associative memory in healthy subjects. 
 
The aim of this study is to investigate the effects of transcranial Direct Current Stimulation (tDCS) stimulating the 
greater occipital nerve (more specifically the C2 area) during a face-name association memory task and to determine if 
tDCS targeting the C2 may be used as a way to enhance brain plasticity during a face-name association memory task to 
optimize long-term associative memory performance. We hypothesize that participants who received real tDCS will have 
a better long-term associative memory performance compared to participants who received sham tDCS. 
 
 
Describe previous studies that form the basis for the proposed research: 
 
Associative memory refers to remembering the association between two items, such as a face and a name or a word in 
English and the same word in another language. It is not only important for learning and for navigating daily life, but it 
is also one of the first aspects of memory performance that is impacted by aging and by Alzheimer׳s disease. For 
decades, neuroscientists have investigated associative learning and memory and ways to enhance associative learning 
and memory. This knowledge contributes to a better basic understanding of learning and memory. 
 
In the last decade, non-invasive neuromodulation, such as transcranial direct current stimulation (tDCS), have been 
introduced to modulate cortical brain areas (Nitsche et al. 2008; Matsumoto et al. 2010; Nitsche and Paulus, 2011; 
Zaehle et al. 2011; Polanìa et al. 2011; Stagg and Nitsche 2011; Brunoni et al. 2012a) as well as the greater occipital 
nerve area (more specifically the C2 area) (Plazier et al. 2015). Transcranial direct current stimulation (tDCS) is a form 
of neurostimulation which uses constant, low current delivered directly to the brain or the occipital nerve area using two 
electrodes. TDCS has been proposed as a therapeutic procedure in various diseases (e.g. Hoy and Fitzgerald 2010; Zyss; 
2010; Benninger et al. 2010; Freitas et al. 2011; Brunelin et al. 2012; Brunoni et al. 2012b; Berlim et al 2013) and tDCS 
in healthy adults have demonstrated to improve cognitive and memory performance (e.g. Floel et al., 2008; De Vries et 
al., 2010; Fiori et al., 2011; Fregni et al., 2005), but few tDCS studies have investigated its impact on associative 
memory. By targeting the occipital nerve area we want to introduce a safer and easier-to-use non-invasive 
neuromodulation procedure. The greater occipital nerve is known to be connected to the locus coeruleus via the 
trigeminal nerve complex and the nucleus of tractus solitarius which is associated with enhancing brain plasticity. 
Therefore, we aim to increase our understanding of the effects of transcranial Direct Current Stimulation (tDCS) 
targeting the greater occipital nerve (C2) during a face-name associative memory task and determine if tDCS may be 
used as a way to enhance brain plasticity during an associative memory task to optimize long-term associative memory 
performance. In an ongoing study in our lab, we have preliminary evidence that tDCS targeting the greater occipital 
nerve (C2) during a verbal associative memory task is able to accelerate learning and improve memory performance in 
healthy subjects. In this study we aim to validate these findings for a non-verbal associative memory task, namely a 
face-name associative memory task. Furthermore, we want to ensure that tDCS is accelerating learning by enhancing 
brain plasticity (through the described pathway of C2 connected to locus coeruleus via the trigeminal nerve complex and 
the nucleus of tractus solitarius) during an associative memory task and not influencing stress or mood levels that might 
mediate learning and memory. Hence, we will add pupil dilation as an indication for brain plasticity as it is an assumed 
to be a proxy measure for locus coeruleus activity (Murphy et al., 2014). Furthermore, we will explore the salivary alpha 
amylase (biological marker of endogenous noradrenaline), salivary cortisol and mood levels before and after the tDCS 
procedure, as cortisol is known as a stress hormone and noradrenaline is known as one of the primary transmitters to 
mediate synaptic communications between the brain structures that process memory (McIntyre et al., 2012). 
 
 
What information do you expect to obtain and how will the obtained knowledge be applied: 
To investigate the effects of tDCS on associative memory performance, we will measure associative memory 
performance in a group that receives active tDCS and a group that receives sham tDCS. Furthermore, to ensure that 
PROTOCOL SUMMARY 

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tDCS is strictly accelerating learning by enhancing brain plasticity during an associative memory task and not influencing 
stress or mood levels that might mediate learning and memory, additional assessments will be done right before and 
right after the tDCS procedure. 
 
Associative memory performance will be measured using a computerized face-name association memory task, which 
includes learning faces and the associated names. We will base our task on an experiment published by Jacobs and 
colleagues (2015) where all information is provided to conduct the face-name association memory task. tDCS will be 
performed during the encoding and consolidation phase of the face-name association memory task right before the 
retrieval phase. We hypothesize that participants who receive real tDCS during the face-name association memory task 
will show better performance when compared to participants who received sham tDCS. 
 
Possible brain plasticity changes through the described pathway of C2 connected to locus coeruleus via the trigeminal 
nerve complex and the nucleus of tractus solitarius, will be measured by changes in pupil dilation (proxy measure for 
locus coeruleus activity) and salivary alpha amylase (biological marker of endogenous noradrenaline which is released by 
the coeruleus activity) right before and right after the tDCS procedure. We hypothesize that participant who receive real 
tDCS during the face-name association memory task will show increased pupil dilation and increased noradrenaline level 
when compared to participants who received sham tDCS. 
To ensure that possible improved performance in the face-name association memory task is due to tDCS enhancing 
brain plasticity during an associative memory task and not due to stress or mood changes, salivary cortisol and mood 
levels will be measured before and after the tDCS procedure as control measures. We hypothesize that participant who 
receive real tDCS during the face-name association memory task will not demonstrate decreased cortisol levels (i.e. be 
more relaxed) or significant changes in mood as measured by the POMS, when compared to participants who will 
receive sham tDCS. 
The knowledge gained from this study will provide evidence as to whether or not tDCS is possible in improving 
associative memory. 

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Number of Participants 
Please indicate the maximum number of participants that will be involved in the research project at UTD affiliated sites: 
50 healthy subjects will be enrolled (consented) in the study 
 
Will participants from non-UTD affiliated site be included? 
 Yes  
  No 
If yes, please indicate how many participants are anticipated at each site. 
 
 
Characteristics of Participants 
 
To which of the following categories do the participants in this research belong? 
 
 Adults 
 UTD Students/Staff 
 Babies and Toddlers (0-3) 
 Children in Daycare 
 Young Children (4-10) 
 Children in School 
 Youth (11-12) 
 Teachers or Staff in Schools 
 Adolescents (13-18) 
 Clinic or Hospital Patients 
 Elderly (>65) 
 Clinic or Hospital Staff 
 Families (Parents w/ Child) 
 Institutional residents 
 Prisoners or parolees 
 
 Person with language/hearing disability 
 Person with emotional disability 
 Cancer patients 
 Non-English speaker 
 Person with cognitive disability 
 Terminally ill 
 Person with physical disability 
(If you checked one of the boxes above and are in need of assistance in accommodating a person with disabilities during the 
research activities, please contact the IRB office.) 
 
 Pregnant women 
 Women undergoing in vitro fertilization 
 Fetuses 
 Other: 
 
 
Will any vulnerable participants be included? 
Participants can be vulnerable for multiple reasons. Some examples of vulnerable participant include: children, the elderly, pregnant 
women, fetuses, cognitively impaired individuals, emotionally impaired persons, terminally ill patients, institutional residents, 
prisoners, parolees, non-English speaking participants, and UTD students/staff. 
 Yes  
  No 
If yes, what is the justification for the inclusion of each vulnerable group named? 
We want to include a homogeneous sample (regarding educational attainment and IQ) of students and young 
professionals, since we want to investigate learning and memory performance in young healthy adults. 
STUDY POPULATION 

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Inclusion/Exclusion Criteria 
Equitable inclusion of both men and women of all ages, and individuals from diverse racial/ethnic backgrounds, is important to 
assure that they receive an equal share of the benefits of research and that they do not bear a disproportionate share of its burdens. 
Participation of adult participants of both genders and diverse racial/ethnic backgrounds should not be restricted without medical or 
scientific justification. 
 
Describe the selection criteria and justification for participant inclusion (for instance, if only women are included, explain the 
rational for excluding men). 
1. Age between 18 and 35 
2. Currently not using any medication 
3. Native English speaker 
4. Capable of understanding and signing an informed consent 
 
Describe criteria and justification for any participant exclusion (for instance, if mentally ill participants are to be excluded 
from the procedure, state why, what steps will be taken to determine mental status). 
1. Severe disease e.g. cancer, fibromyalgia, migraine,... 
2. Mental illness 
3. Cardiac history 
4. History of severe head injuries 
5. History of epileptic insults or family member with epilepsy or history of seizures 
6. Any implanted devices such as pace maker, neurostimulator 
7. Pregnancy 
 
What are the qualifications and training of the staff who will determine inclusion and exclusion? 
Staff will have a briefing/training before the start of the study. All personnel involved at the study will have undergone 
form research and ethical training at UTD 
 
Selection procedures 
Will participants be fully informed about the selection criteria and the selection procedure? 
 Yes 
 No 
If no, please explain: 
 
 
Will a Control Group be used? 
 Yes 
 No 
If yes, 
 Participants will be informed that they may be a member of a control group. 
 The individual participants will not be informed that they are part of a control group. 
Explain: 

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The identification and recruitment of participants must be ethically and legally acceptable and free of coercion. Procedures used to 
recruit participants should be designed to reach diverse populations. For example, vulnerable participants, such as persons in nursing 
homes or institutions, should not be recruited merely for the sake of convenience. 
 
Recruitment Methods 
 Advertisement 
  Phone solicitations 
 Verbal scripts for face-to-face meeting 
  E-Mail 
 Letters to potential participants 
  Web-Based
 Other, please explain: Flyer, UTD Psych Research Sign-Up System 
Please describe the recruitment procedures including: 1) how participants will be identified; 2) the steps for recruiting 
participants; and 3) who will have responsibility for recruitment: 
1) We are recruiting healthy subjects between the ages of 18 to 35 years old for our study, which overlaps with the 
overall UTDallas student and staff population 
2) In order to recruit participants flyers will be handed out and publicly displayed at the main campus of UTD at 
Richardson and the Center for Brain Health. Furthermore, the research study will be posted on the UTD Psych Research 
Sign-Up System of the School of Behavioral and Brain Sciences at UTDallas participants. 
 
Please describe how the timing of the recruitment and consenting process will provide potential participants ample 
opportunity to consider whether or not to participate in the study: 
Prospective participants who meet the preliminary inclusion/exclusion criteria on the flyer can contact the research 
personnel through the contact information on the flyer, if they are interested. They will be contacted by phone for more 
information about the study and they will be screened if they are still interested to participate in the study. If they are 
eligible, they have the choice to schedule for an appointment right away or to contact us back to schedule an 
appointment to give them more time to consider a possible participation in the study. Once scheduled, we will be sent 
an electronic copy of the Consent Form. This will allow prospective participants to read and gather any questions about 
the study at their own pace. Note: Prospective participants will be asked to sign the Consent Form only at the UTDallas 
main Campus 
Please describe the measures that will be taken to minimize the potential for undue influence: 
As standard lab protocol, we ask the following questions before any prospective participant signs the Consent Form: 
 
1 Can you tell me the main purpose of the study, and why you are involved? 
2. Can you tell me the main components of the study that require your participation? 
3. Do you understand that signing this Consent Form does NOT mean that you have been officially included in the study, 
but rather, inclusion into the study will be determined based on outcomes on additional screening measures? 
4. If you decide to not participate in the study at any time, what should you do? 
5. If you experience any discomfort or symptoms associated tDCS, what should you do? 
 
 
Payment for Participation 
 
Will participants be paid an incentive for participation in research? 
 Yes 
 No 
If yes, please complete the following (mark all that apply): 
 SONA system credit(s) 
 Cash 
 Gift card 
 Other: 
Please note: 1) payment amount; 2) payment schedule; 3) will the incentive be pro-rated based on participant's early 
withdrawal? 
1) $30 or 2 SONA credits, 2) payment at the completion of the study, 3) participants get $5 but no SONA credits 
if the study procedure is not finished 
Will participants be reimbursed for parking, travel, or other expenses related to participation in the research? 
 Yes 
 No 
If yes, please describe: 
RECRUITMENT OF PARTICIPANTS 

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In research involving more than minimal risk, when capacity to consent is unclear, the capacity to consent must be determined by a 
physician, clinical psychologist, or by other qualified professionals. Individuals who lack the capacity to consent may participate in 
research only if consent is given on their behalf by a legally authorized representative. 
 
Will you obtain written, signed informed consent from each participant/participant's representative? 
 Yes 
 No 
 
Will your study involve the use of any language other than English for Informed Consent forms, data collection instruments, 
or recruitment materials? 
 Yes 
 No 
If “Yes,” after the IRB has notified you of the approval of the English version of your forms, you must then submit the foreign 
language versions along with an English translation for each. 
Specify all foreign languages: 
Who will be authorized to obtain informed consent? Identify by name and training the individual(s) authorized to describe the 
research and obtain consent form from participants or their legal representatives. 
Sven Vanneste, Ph.D. – Associate Professor in BBS, study PI 
Wing Ting To, Ph.D. - research scientist in BBS 
 
Will the participants be informed about which information is recorded and stored? 
 Yes  
 No 
If no, explain: 
 
 
Who will provide written informed consent/permission/assent? (Attach copies of all versions that will be used) 
 Adult Participants (him/herself) 
 Legally Authorized Representative 
 Parents (Permission for Minor) 
 Children (Assent) 
 
For studies involving the use of children as research participants, please describe how assent will be obtained in a manner 
that is sensitive to the developmental stage of the participants: 
/ 
INFORMED CONSENT 

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Process of Consent 
Consider: a) the environment and location where informed consent will be solicited; b) the timing of the process (for instance the 
stress that may be associated with the situation); c) the involvement of someone other than the investigators to help explain the 
research; and d) opportunity for the prospective participants or their legal representatives to discuss participation in the research with 
family, friends, or their advisors before signing the consent form. 
 
Where will the consent process take place? 
a) all participants will sign the consent form in dr. Vanneste's lab in Erik Jonsson Academic Center JO.3112 
 
How--and by whom--will it be determined whether the participants or their legally authorized representatives understand the 
information provided? This section should clearly document that the investigator has an adequate plan in place to assure existence 
of an acceptable level of comprehension before consent is documented. 
The study personnel who administer the consent form will follow strict lab protocol by asking the aforementioned 
questions about the study (see above on minimizing undue influence) to each participant before they sign the consent 
form 
 
 
Waiver of Informed Consent Process (complete only if you are requesting a waiver of consent) 
Explain why the use presents no more than minimal risk to the participants? 
 
 
 
Explain why a waiver of informed consent will not adversely affect the rights and welfare of the participants? 
 
 
 
Why could the research not practicably be carried out with an informed consent from the participants? 

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Mark one or more of the following that apply: 
 
 Interviews 
 Standardized assessments 
 Survey/questionnaire 
 Deception 
 Behavioral observation 
 
Describe each activity in which participants will be involved: 
Attach surveys, instruments, interview questions, etc. Describe the frequency and duration of procedures, psychological tests, 
educational tests, and experiments; including screening, intervention, follow-up etc. 
Participant’s Review of Inclusion/Exclusion Criteria: Prospective participants will initially review general inclusion and 
exclusion criteria about the study on the flyer where there is contact information to contact a researcher for more 
detailed information about the study. Interested individuals will be screened through a standard phone screen script. 
Their continued interest in the study confirms that they have met basic inclusion/exclusion criteria (via self-report). 
 
Administration of Consent Form: When the Consent form is administered, participants will have already acknowledged 
that they have met the criteria and have expressed continued interest in participating in the study. If, at that time, they 
feel that they do not meet the criteria, or have specific questions about these criteria, they will be asked to inform the 
research team member administering the consent form. If they again meet these criteria to the best of their knowledge, 
a second set of study screening procedures will be administered to evaluate whether or not they qualify for the study. 
All of the remaining screening and study procedures described hereinafter will be administered only if the participant has 
provided consent to participate (i.e., signed the consent form). 
 
PRE-assessments – approximately 30 minutes: 
At the lab, the participants will be asked to perform the Mini Mental State Examination as a screening measure for 
general cognitive performance and to complete some questionnaires such as a demographic questionnaire, a 
neuromodulation screening questionnaire, the Beck Depression Inventory, the Beck Anxiety Inventory and the Profile of 
mood states. Furthermore, saliva will be collected in a tube and pupillometry will performed. 
 
TDCS procedure – approximately 20-45 minutes (actual tDCS stimulation=15 minutes): 
After completing the questionnaires, the participant will be set up with the tDCS material that will start real or sham 
stimulation during the encoding and consolidation phase of the face-name association memory task. The two electrodes 
of the tDCS will be placed over the left and right C2 nerves dermatomes. For a real stimulation the electrical current will 
be initially increased in a ramp-like fashion over several seconds (5 seconds) until reaching 1.5mA and stimulation will 
be maintained for the duration of the task until it ramps down (5 seconds). For a sham stimulation, the electrical current 
will be increased in a ramp-like fashion over several seconds (5 seconds) until reaching 1.5mA to mimic the sensation 
present during the first 5 seconds of real stimulation and then stimulation will be stopped without the participant 
knowing. The total duration of the sham tDCS will be maintained for the duration of the task to be able to appropriately 
blind the procedure. To allocate participants in the different simulation groups in a fair way, participants will be assigned 
randomly to different groups. 
 
While the real or sham tDCS stimulation started, the “Encoding phase” of the computerized face-name association 
memory task where participants will be presented with 60 neutral faces in black-white in the middle of the screen 
accompanied with a name (Jacobs et al., 2015). Participants will be asked to memorize the face-name association and 
assess the gender of the person, to keep them focused on the task. Each face-name association was shown for 5 
seconds to provide sufficient encoding time. After the encoding phase there will be a “consolidation phase” of 10 
minutes where the participant will be asked to relax and think about nothing in particular. The “retrieval phase” starts 
after the consolidation phase. In this phase participant will be presented with 60 old and 60 new faces and they will 
have to decide whether they have seen this face during encoding. For faces that are judged as old, participants will 
further be asked to indicate the correct name out of 4 options. 
 
To allocate participants in the different groups in a fair way, participants will be assigned randomly to one of two 
groups. One group will receive real tDCS paired with face-name association memory task and the second group will get 
sham tDCS paired with face-name association memory task. 
 
POST-assessments – approximately 30 minutes: 
After the tDCS procedure, the participants will be asked to complete the Profile of mood states questionnaire again and 
saliva collection and pupillometry will be performed again. 
 
At the end of the session, participants will need to fill out a tDCS questionnaire. 
METHODS AND PROCEDURES FOR THE COLLECTION OF NEW DATA 

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Will archival data be used? 
 Yes  
 No 
If yes, please continue 
 
Describe the records: medical, educational, employment existing data set, or pathological specimens: 
 
 
Do you have permission to access the records or specimens? 
 Yes, these sources are publicly available. Identify the source (e.g., database name, website address, etc.) 
 
 Yes, other. Identify the source and describe how you have permissible access to the records. 
 
 No 
Number of records or specimens to be used: 
 
 
Will the records you receive be stripped of all identifiers that would make it possible for you to identify a participant? 
 Yes 
 No 
Describe the identifying information to which you will have access to prior to recording data: 
 
 
Describe the identifying information you will record: 
 
 
Confirm that the data/specimens you wish to review already exist. 
 The data set exists 
 The data set does not already exist 
 
Confirm that you will not have access to, or create a link, which would make it possible to identify participants. 
 I will not have access to, or create a link. 
 I will have access to a link, explain: 
If this record or specimen became publicly available, could it have negative psychological, physical, economic, 
sociological or legal consequences for the participant from which it originated? 
 Yes 
 No 
If yes, describe the potential negative consequences. 
METHODS AND PROCEDURES FOR THE USE OF ARCHIVAL DATA 

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A reasonable person would consider it to be important to know the risk of harm or discomfort when deciding whether to participate 
in the research project. 
 
Potential Risks 
Are there risks of physical harm or discomfort associated with the research? 
 Yes  
 No 
If yes, describe: - The most common side-effect of neurostimulation is temporally local redness of the skin direct 
under the electrode. This disappears within 1 hour. 
 
- Itching at the site of the electrode, passing within the hour 
 
- Slight feeling of dizziness when starting the stimulation occurs in a small number of patients. 
This takes only a few seconds and does not affect balance after stimulation 
 
- Very rarely, temporary skin damage may occur under the electrode. This gives a darkening of 
the skin, which normalizes after a weeks and heals. The size of such etch is a few millimeters. 
This is harmless, however, with the current that we will handle, this risk is minimal. 
 
On the safety of tDCS in healthy volunteers, in 2005 a well-conducted study published in the 
Journal of Neurology. There is a group of 103 people total tDCS stimulation given to 2 mA. 
Outside redness and itching they describe a transient slight improvement in language fluency 
(pronouncing words) or a transient slight delay in language fluency. The technique is seen as 
safe. 
 
Are there risks of psychological harm or discomfort associated with the research procedure? 
 Yes  
 No 
If yes, describe: 
 
Are there risks of social harm to the participants associated with the research? 
 Yes  
 No 
If yes, describe: 
 
Are there economic risks associated with the research? 
 Yes  
 No 
If yes, describe: 
 
What is your assessment of the overall risk classification of this research? 
 Minimal 
 Greater than Minimal Risk and the study presents the prospect of direct benefit to the participants 
 Greater than Minimal Risk and the study presents no prospect of direct benefit to the participants, but will likely yield 
generalizable knowledge about the study question. 
 
Minimizing Risks 
 
How will you minimize risks or discomfort? 
 Monitor the experiments by professional staff. 
 Provide opportunities for rest or breaks. 
 Withdrawal of participant based on specific criteria, explain: : All participants who are terminated from the study 
will have the reason for their termination documented. 
Reasons for termination may include: lost-to-follow- 
up, participant-initiated withdrawal, staff-directed 
withdrawal, completion of study. 
 Remind participant of his/her opportunity to stop or withdraw. 
 Modification of process, explain: 
 Other, describe: 
 
Potential Benefits 
Benefits to participants do NOT include monetary incentives paid in return for participation. 
RISK/BENEFIT ASSESSMENT 

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Please describe any direct benefits anticipated for the individual participants in this study: 
None 
 
Please describe any potential benefits to society: 
Knowledge gained from this study can be used in aging and patient populations, such as patients with Mild Cognitive 
Impairment or Alzheimer's disease, where memory performance is one of the first aspects to be impacted. 

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The principal investigator/faculty sponsor is responsible for taking all necessary steps to maintain confidentiality of data. This 
includes coding data and choosing appropriate and secure ways to store data to prevent unauthorized access to the data. 
 
Will identifiers or links to an identifier of the participants be stored? 
 Yes  
 No 
If yes, what information that could be linked to the participants will be recorded? 
All data collected in this study will be coded. Identifying information, such as name, DOB, physical and contact 
email addresses and phone numbers, which link a particular participant to their coded data, will be kept in a 
locked file cabinet in Dr. Vanneste’s lab 1at BSB 4.604. This information will be stored alongside the signed 
consent forms. All coded data will be kept in a separate locked file in dr. Vanneste's lab BSB 14.604 
Please explain the procedure for de-identifying or anonymizing the data: 
All data collected during the experimental procedures used in the study will consist of only coded identifiers 
 
Will you obtain any information containing personally identifying information? 
 Yes  
 No 
If yes, please continue with the following questions. 
 
If information with personal identifiers will be accessed, will the participants provide consent for storing of personal 
data or biological specimens in connection with the research? 
 Yes 
 No 
If no, provide justification for a waiver of informed consent: 
 
 
Will anyone other than the specified study team, have access to the study records or data? If so, please specify each person's 
name, role on this study, and affiliation. 
No 
 
If coded or identified data will be released outside of UTD or its affiliated institutions, please specify the persons/agencies to 
which the information will be released. Please also indicate the precautions that will be taken to assure that confidentiality 
will be maintained during transmission of the data. 
 
 
Will your study involve obtaining individually identifiable health information from health care plans, health care 
clearinghouses, or health care providers? 
 Yes   
 No   
 Not Applicable 
If "Yes," describe the procedures you will use to comply with the HIPAA Privacy Rule: 
 
 
Where, how long, and in what format (such as paper, digital or electronic media, video, audio, or photographic) will data be 
kept? In addition, describe what security provisions will be taken to protect this data (password protection, encryption, etc.). 
All hard-copy clinical and research data, as well as electronic data, collected during this study will be kept in locked file 
cabinets or on password-protected computers in the laboratory of Dr. Vanneste. Data will be stored indefinitely. 
 
 
What will happen to the data after the data analysis is complete? 
 
 Data will be destroyed 
years after completion of the study 
 Data will be stored an unspecified length of time 
DATA PRIVACY & CONFIDENTIALITY 

Page 16 of 17 
Last Revised 01/2016 
 
ASSURANCES 
 
THIS SECTION MUST BE COMPLETED 
The DHHS and other Federal Regulations require that the IRB is responsible for determining whether the proposed data collection 
meets the federal definition of research. 
 
Federal regulations state all activities classified as research must be submitted for IRB review and approval. 
 
Expedited category of review is reserved for research that involves minimal risk and satisfies one or more of following seven 
categories defined by Federal Regulation (Department of Health and Human Services). All other research involving humans must be 
reviewed by the FULL BOARD of the IRB. 
 
Please mark all that apply: 
 
 Category 1 - Study of drugs or devices that do not require an IND application, are used consistent w/ label 
 Category 2 - Blood samples by finger/stick or venipuncture from healthy and non-pregnant adults <550ml 
 Category 3 - Prospective biological specimens for research by non-invasive means (ex. hair or nail clippings) 
 Category 4 - Non-invasive procedure used in routine clinical practice 
 Category 5 - Materials collected previously (archival data) 
 a) for non-research purposes 
 b) for another research protocol 
 Category 6 - Collection of data from voice, video, digital or other recordings for research purposes. 
 Category 7 - Research on individuals or groups using surveys, interviews, or program evaluation, etc. 
 
 
 
My signature below certifies that: 
 
I agree to comply fully with the ethical principles and regulation regarding the protection of human subjects in research. 
 
I agree that the information provided in this form and all other supporting documents and forms are accurate and complete. 
Copies of all required documentation of consent and any data related to this research are securely stored at: 
UTD Building 
Office Number 
 
 
 
 
 
 
 
Principal Investigator's Signature 
Date 
 
 
 
 
 
 Co-Principal Investigator 
 Faculty Sponsor 
Date 
IRB REVIEW CATEGORY 

Page 17 of 17 
Last Revised 01/2016 
 
Student Conflict of Interest Disclosure 
for Non-Exempt IRB Application 
Office of Research Compliance 
 
 
The purpose of this form is to assist UTD undergraduate and graduate students conducting human subjects research that requires 
approval by the UTD Institutional Review Board to comply with the terms of UT System Policy 175. Please contact Conor 
Wakeman (conor.wakeman@utdallas.edu, 972-883-4718) if you have any questions about this form. 
 
STUDENT INFORMATION 
Name: 
Program: 
 
UTD Research Conflict of Interest Policy requires annual conflict of interest disclosures from all individuals who 
contribute significantly to research conducted at UTD. As an investigator on a human subjects research protocol, you 
are required to disclose the following interests related to your research at UTD that may constitute a significant 
outside interest: 
 
1) Compensation, travel reimbursement or royalty income that exceeds $5,000 in the previous 12 months. 
2) An equity interest that represents more than $5,000 in fair market value, more than 10% voting or participating 
interest, a controlling interest, or any interest (>0%) in a privately held business entity. 
3) A gift that represents more than $250 in value (excluding gifts from family members). 
4) A fiduciary interest in a business or non-profit entity. 
 
 
Yes 
No 
Do you have a significant outside interest related to your research at UTD that you need 
to disclose? 
If yes, you will be provided instructions by the Conflict of Interest Manager to complete a full disclosure. 
 
Certification 
In submitting this form, I certify that the above information is true to the best of my knowledge and that I have read and understand 
the policy on Research Conflict of Interest. I also certify that I will comply with conditions or restrictions imposed by UTD to 
manage, reduce or eliminate actual or potential conflicts of interest. Furthermore, I supply this information for confidential review 
by the University and I do not authorize release of it for any other use. 
Signature 
Date 
 
For Internal Use Only - Office of Research Review 
Sanaz Okhovat 
Date 
Assistant Vice President, Office of Research Compliance 
Rafael Martin 
Associate Vice President for Research 
No Conflict 
Full Disclosure Required