Investigating the Neural Correlates in Memory Retrieval After HD-tDCS
Phase: NA
Conditions: Healthy Adults
Sponsor: The University of Texas at Dallas

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Project Title: Investigating the neural correlates in memory retrieval during HD-tDCS 
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 
CD 
  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 
Shaheen Ahmed 
972-883-7275 
sxa176730@utdallas.edu 

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Other Study Personnel: 
Name (Last Name, First Name, MI) 
Role in Study 
Yuefeng Huang 
subject recruitment, subject screening, data collection 
Wing Ting To 
subject recruitment, subject screening, data collection 
Hye Bin Yoo 
subject recruitment, subject screening, data collection 
Shaheen Ahmed 
subject recruitment, subject screening, data collection 
Jeffrey Hullfish 
subject recruitment, subject screening, data collection 
Ian Abenes 
subject recruitment, subject screening, data collection 
Clisha DSouza 
subject recruitment, subject screening, data collection 
Anusha Mohan 
subject recruitment, subject screening, data collection 
Tiffany Kao 
subject recruitment, subject screening, data collection 
Stephanie Royer 
subject recruitment, subject screening, data collection 
Natalie Garcia 
subject recruitment, subject screening, data collection 
Venkata Esanakarra 
subject recruitment, subject screening, data collection 
Aaron Duque 
subject recruitment, subject screening, data collection 
Samantha Long 
subject recruitment, subject screening, data collection 
Juan Francisco Silva Riquelme 
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: 

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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 to 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 investigate the neural correlate in recognition memory task. 
 
The aim of the study is to understand the undergoing changes in late positive ERP component during recognition 
memory task when stimulating the posterior cingulate cortex (PCC) with High Definition Transcranial Direct Current 
Stimulation (HD-tDCS). We hypothesize that participants who received active HD-tDCS will have larger late positive 
component compared to participants received sham HD-tDCS. 
Describe previous studies that form the basis for the proposed research: 
Recognition memory is supported by distinct retrieval process known as recollection and familiarity. These two process 
have been associated with distinct event related potentials (ERPs). At the time of retrieval, familiarity is associated with 
modulation of the FN400, an enhanced positivity for old items relative to new items observed from approximately 
400-600ms post stimulus onset. The FN400 tends to have mid-frontal scalp distribution which can extend to left and 
right frontal areas and central midline regions. In contrast, recollection has been linked with modulation of positive going 
waveform that emerges approximately 600ms post stimulus and is typically maximal over parietal sites (Curran et. al. 
2000; Rugg et.al. 1998) and referred to as late positive component (LPC). In addition, FN400 is found to increase 
gradually as a function of item recognition confidence whereas LPC is limited to high confidence recognition response. 
 
High Definition transcranial Direct Current Stimulation (HD-tDCS ) is a newly developed non-invasive neuromodulation 
technic. Compared to the standard bipolar montage used by the conventional tDCS, it uses arrays of smaller, specially 
designed electrodes to deliver a constant and low current directly to the cortical brain areas to increase the spatial 
focality. Studies show that the cortical area undergoing stimulation with HD-tDCS is more restricted compared to the 
standard bipolar montage of conventional tDCS (Datta et al. 2009). 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 no HD- 
tDCS study have investigated its impact on recognition memory. By targeting the PCC area by HD-tDCS, we want to 
introduce a safer, easier-to-use and more accurate non-invasive neuromodulation procedure. The dysfunctions of 
posterior cingulate cortex are been linked to a range of psychiatric and neurological condition such as Alzheimer’s 
disease, schizophrenia, autism, depression and attention deficit hyperactivity disorder, as well as aging. It shows 
increased activity when subject retrieve autobiographical memories suggests its internal orientated function. PET and 
ERP combined studies have shown greater blood flow medial temporal lobe with a brief late positive ERP component in 
PCC (Duzel et. al.1998). Therefore, in this study we aim to understand whether HD-tDCS targeting the PCC can 
modulate the late positive ERP component. 
 
 
What information do you expect to obtain and how will the obtained knowledge be applied: 
To investigate the effects of HD-tDCS on recognition memory task we will measure the late positive ERP component 
performance in a group receiving active HD-tDCS and a group receiving sham HD-tDCS. 
 
Recognition memory task will be measured using a computerized recognition memory task, which includes learning face 
and word stimuli. We will base our task on an experiment published in NeuroImage by Ruggs (2012) and Neurobiology 
by Jacobs (2015) where all information is provided to conduct the face and word learning test. 
 
The knowledge gained from this study will provide evidence as to whether or not HD-tDCS modulates the late positive 
component during retrieval process and in improving the recognition memory. 
PROTOCOL SUMMARY 

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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: 
75 healthy subjects will screened, consented and enrolled for 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 homogeneous sample (regarding educational attainment and IQ) of students and young 
professionals, since we want to investigate how ERP correlates with recognition memory retrieval 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. 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 
2. Mental illness 
3. Cardiac history 
4. History of severe head injuries 
5. History of epileptic seizures 
6. Any implanted devices such as pacemaker, 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 
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. 
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: Clincard 
Please note: 1) payment amount; 2) payment schedule; 3) will the incentive be pro-rated based on participant's early 
withdrawal? 
1) payment of $30 in Clincard at the completion of the study, OR 2) Two SONA credits after completion of study 
(participants can decide) , 3) participants get $5 in Clincard 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 
Shaheen Ahmed, PhD – Research Associate 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 Green Hall GR 2.404 or in BSB 14.604 at UTD Main 
Campus. 
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. 
Participants 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 the researcher for more 
detailed information about the study. Interested individual will be screened through a standard phone screen script. 
Their continued interest confirms that they have met the basic inclusion/exclusion criteria (via self-report). 
 
Administration of Consent Form: When the consent form is administered, participants will have already acknowledged 
that they meet the criteria and have expressed continued interest for participating in the study. If at that time they feel 
that they do not meet the criteria or have specific question about the mentioned 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). 
 
Experimental Procedures: At the lab the participants will be asked to complete questionnaire such as demographic 
questionnaire, neuromodulation screening questionnaire, MMSE memory study,Beck Depression Inventory, and Beck 
Anxiety Inventory. 
 
Baseline Testing and Learning Phase:The participants will be presented with "face" and "word" stimuli. No stimulation 
using tDCS or EEG will be performed. 
 
Stimulation phase: After this the participant will be allowed to relax for 10min. The participant will be set up with the 
3x1 HD-tDCS configuration by STARSTIM system that will start the active or sham stimulation. The anode electrode of 
the HD-tDCS will be placed over the posterior cingulate cortex dermatomes (PZ) and the other three cathode electrodes 
will be placed on OZ, PO7 and PO8 positions. For an active stimulation the electrical current will be initially increased in 
a ramp-like fashion until reaching 1.0mA and stimulation will be maintained for the duration of the task until it ramps 
down. For a sham stimulation, the electrical current will be increased in a ramp-like fashion until reaching 1.0mA to 
mimic the sensation present during the real stimulation and then stimulation will be stopped and ramp down without the 
participant knowing. The total duration of the sham HD-tDCS will be maintained for the duration of the task to be able 
to appropriately blind the procedure. 
 
Retrieval phase: After the application of active or sham stimulation, the EEG cap and the electrode will be affixed on the 
head. Once connected the participant will be represented the face or words again with the instruction of not responding 
to it when they see on the screen. The participant will respond after 90sec. The ERP data will be collected during the 
retrieval phase. 
 
After the completion of study the participant will need to fill out the 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 
participants. 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 at BSB 14.604. The signed consent forms will be stored in another 
locked cabinet in Dr. Vanneste’s lab at BSB 14.604. All coded data will be kept in another 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 

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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 

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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