Clinical trial NCT03593044
Conditions: Myopia
Keywords: atropine photophobia pupil reading speed myopia Surveys and Questionnaires
Sponsor: Jeffrey J. Walline, OD PhD
Start date: 2018-07-23; Completion date: 2019-01-17
Enrollment: 31 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This study will perform several objective and subjective measurements of the eye and vision before and after a week of using 0.01% concentration atropine drops. These measurements will help to obtain a comprehensive understanding of the side effects of this concentration of atropine and determine if the drops would be tolerated as a possible preventative treatment for nearsightedness.

Detailed description:
Atropine drops are commonly used to dilate the eye and prevent the ability to focus and also slow the progression of nearsightedness. Low concentration (0.01%) atropine slows the progression of myopia 60% to 83% while causing less side effects than high concentration (1.0%) atropine though still showing an effect on pupil size and pupil response.This study is a prospective cohort study in which several objective and subjective measurements will be taken before and after the use of 0.01% atropine for a week to determine the effect of this concentration on 1. vision at distance and near; 2. pupil size; 3. focusing ability, accuracy, and change; 4. symptoms, including subjective vision, headaches, light sensitivity, drop comfort; and 5. pressure in the eye. This will allow us to determine the effect these drops have on the eye and whether or not patients would be willing to use them as a possible preventative treatment for nearsightedness. The investigators expect to find that the drops will not affect vision, will increase pupil size, decrease focusing ability and accuracy (but not clinically meaningfully), cause some light sensitivity, and have no effect on eye pressure. The investigators expect that patients would be willing to use these drops to control nearsightedness even after experiencing the side effects.

Arms: arm 1: 0.01% concentration atropine drops
Interventions: intervention 1: 0.01% concentration atropine drops
Intervention descriptions: intervention 1: One drop of 0.01% concentration atropine in each eye at night for seven days.

Protocol documents:
Prot_SAP_002.pdf: 
Page 1 of 6 
Side Effects of Atropine (SEA) Study 
NCT03593044 
November 23, 2021 
 
 


Page 2 of 6 
Research Protocol 
Side Effects of Atropine (SEA) Study 
Version 1.0 
I. Objectives 
The purpose of this study is to determine whether there are any changes in subjective or objective measures of eye 
comfort or vision. Specifically, we will monitor for the following changes: 
1. High contrast distance, high contrast near, and low contrast distance visual acuity 
2. Pupil size 
3. Ability to focus the eyes for near work 
4. Reading speed 
5. Subjective comfort and vision issues 
6. Headaches 
7. Intraocular pressure 
We hypothesize that pupil size will increase significantly, but no other measures will change clinically meaningfully. 
 
II. Background and Rationale 
1.0% atropine is routinely used to dilate pupils and knock out the ability to focus the eyes to see close objects clearly, 
and it also slows the progression of nearsightedness. Many eye care practitioners are now using 0.01% atropine to slow 
the progression of nearsightedness because it slows the progression of nearsightedness by 60%1 to 83%,2 and it causes 
much fewer side effects than 1.0% atropine. One study compared myopia progression and side effects of 0.01%, 0.1%, 
and 0.5% atropine in children. While 0.5% atropine slowed myopia progression significantly more than 0.01% atropine, 
there were no other differences in myopia progression over two years, and there were fewer side effects with 0.01% 
atropine (Table 1), so many eye care practitioners now use 0.01% atropine to slow the progression of nearsightedness. 
 
Table 1. Ocular changes after taking various concentrations of atropine. 
 
0.01% 
0.1% 
0.5% 
p‐value 
Accommodative amplitude (D) 
‐4.6 
‐10.1 
‐11.8 
<0.001 
Pupil size in dim light(mm) 
1.15 
2.71 
3.56 
<0.001 
Pupil size in bright light (mm) 
0.75 
2.24 
3.11 
<0.001 
Distance visual acuity (logMAR) 
‐0.02 
+0.01 
‐0.01 
0.44 
Near visual acuity (logMAR) 
‐0.02 
+0.06 
+0.25 
<0.001 
Asked for glasses to improve near vision (% yes) 
6 
61 
70 
<0.001 
 
Another study examined the changes in visual function and symptoms of young adults while taking daily drops of 0.01% 
atropine for five days. Only pupil size and pupil response exhibited a significant change over that time period (Table 2). 
 
Table 2. The change in vision function while taking 0.01% atropine for five days. 
 
Day 1 
Day 3 
Day 5 
p‐value 
Distance VA (logMAR, OD) 
‐0.10 ± 0.10 
‐0.08 ± 0.07 
‐0.08 ± 0.05 
0.55 
Near point of accommodation (D) 
10.2 ± 1.42 
10.0 ± 1.39 
9.1 ± 2.12 
0.08 
Pupil size (mm, OD) 
5.51 ± 1.74 
6.55 ± 1.12 
6.82 ± 0.61 
0.04 
Pupil response 
3.0 ± 0.0 
2.8 ± 0.5 
1.1 ± 0.9 
<0.01 
Reading speed (words per second) 
3.36 ± 0.55 
3.16 ± 0.54 
3.25 ± 0.45 
0.12 
Near point of convergence (cm) 
6.8 ± 2.4 
7.0 ± 2.2 
8.0 ± 3.2 
0.25 


Page 3 of 6 
 
We plan to examine a wider range of objective measures of visual function and symptoms than previous investigations, 
including investigate the changes in vision, pupil size, the ability to focus the eyes for near work, reading speed, comfort 
of the drops, subjective visual effects, presence and severity of headaches, and whether or not someone would be 
willing to take the drops long‐term if they delayed the onset of nearsightedness. 
 
III. Procedures 
A. Research Design 
This is a prospective cohort study in which we will compare pre‐treatment measures to post‐treatment measures 
after taking the treatment for approximately one week. The subjects will serve as their own controls. This will allow 
us to see the changes to be expected while taking the eye drop. Because the half‐life of the drug is approximately 4 
hours and maximum cycloplegia (eyes can’t focus for near work) occurs in less than one hour, a longer period of 
time is not required. 
 
B. Sample 
We will examine adults between the ages of 21 and 30 years. We are not examining the effects in children because 
adults will give a more accurate description of the side effects they experience than children. Because children 
typically complain less about eye comfort and vision issues than adults,3 we strongly believe that we will obtain data 
that would be considered the worst case scenario for children. The specific entry criteria are listed in Table 3. 
 
Table 3. Entry criteria 
Age 
21 to 30 years, inclusive 
Accommodation 
No known history of accommodative issues or therapy 
 
All subjects in the age range specified with no known accommodative (focusing) issues will undergo consent and be 
enrolled. 
 
Most of this experiment is hypothesis generating, but we can estimate a sample size based on a two measures, 
assuming α= 0.05 and power = 80%. We aim to detect a change in pupil size of 1.0 mm because this is approximately 
what was reported in previous studies and what may begin to be clinically meaningful. We conservatively estimate a 
SD of change of 1.0. We also aim to detect a change in visual acuity of 0.1 logMAR, which is one line of visual acuity, 
a clinically meaningful change, with a standard deviation change of 0.2. The sample size required for pupil size is 
eight subjects and the sample size for visual acuity is 31 subjects. We will aim to enroll a sample sufficient to detect 
both the pupil size and visual acuity change. Assuming a 10% drop out rate, we estimate a sample size of 35, and we 
include five extra subjects who may be ineligible, for a total sample size of 40 subjects. 
 
C. Measurement / Instrumentation 
Manifest Refraction 
This is a standard clinical procedure used to measure glasses prescriptions during clinical examinations. Cycloplegic 
autorefraction, the standard measure of eye prescription in many studies, is not necessary because we are not 
measuring the change in prescription over time. 
 
Phoria 
We will measure phoria at near in order to determine whether low concentration atropine affects how the two eyes 
work together Modified Thorington is a more repeatable and less subjective method of measuring phoria than 
alternating cover test. 
Visual Acuity 
We will measure the high contrast (black letters) visual acuity at distance and near and the low contrast (grey 
letters) at distance using logMAR visual acuity charts and scoring on a letter basis. These measures of vision are 
standard protocols for vision research. 
 


Page 4 of 6 
Pupil Size 
We will measure the pupil size with the NeurOptics VIP‐200 Pupillometer (NeurOptics, Inc., Irvine, CA) in bright and 
dim light. For the dim light condition, the subject will stand with his or her back toward the wall‐mounted visual 
acuity chart with the room lights off except for the incandescent lamp pointed straight down over the examination 
chair at the opposite end of the room. For the bright condition, the subject will stand with his or her back toward the 
wall‐mounted visual acuity chart, and the visual acuity chart illumination should be turned on and be the same as 
when taking visual acuity measurements (approximately 75 – 120 cd/m2 or 9.3‐9.9 EV). 
 
Focusing Ability 
A detailed target on a stick will be too near the eyes to read the letter. The stick will be pulled away from the subject 
until the subject reads the letter. The distance between the forehead and the stick will be measured to determine 
the ability to focus. 
 
Lag of Focus 
While wearing full vision correction, the prescription will be measured ten times while looking at distance target 
using the Grand Seiko WAM‐5500 Binocular Autorefractor/Keratometer (AIT Industries, Bensenville, IL). A target will 
then be placed at 33 cm, and the subject will be told to keep the target clear while measuring the prescription five 
times. The prescription at distance will be subtracted from the prescription at near, and that result will be 
subtracted from 3.0 D, which is the focusing demand. 
 
Reading Speed 
Reading Speed will be measured using the Rate of Reading Test. This test contains the same 15 simple words, 
repeated on each line and presented in random order. It is meant to serve as a test of reading speed pre‐ and post‐
intervention. 
 
Ability to Shift Focus 
Subjects will view a card held at 40 cm. Flippers with +2.50 D lenses on one side and –2.50 D lenses on the other side 
will be placed in front of the subject, and the subject will report when the letters become clear. The lenses will be 
flipped, and the subject will again report when the print is clear. This will be continued for 1 minute, and the number 
of flips will be counted. This is a routine clinical measure of the ability to change focus from distance to near. 
 
Surveys 
We will survey subjects about light sensitivity, drop comfort, likelihood of taking the drop to delay the onset of 
nearsightedness, vision symptoms, headaches, and comfort of the proparacaine eye drop and an artificial tear eye 
drop (for comparison of drop comfort to low concentration atropine). We will use the following format to collect 
survey data (using different questions and anchors as necessary): 
 
Overall, what did you think of your vision during the past three days?  
1 
2 
3 
4 
5 
6 
7 
8 
9 
10 
 
Good 
Perfect  
 
Pressure in the Eye 
We will measure the pressure in the eye using a Tonopen, a clinical measure that is performed during routine eye 
examinations. This requires a drop of 1% proparacaine in each eye to numb the eye. This drop is also used during 
routine eye examinations. 
 
D. Detailed Study Procedures 
Manifest Refraction 
The examiner will measure glasses or perform retinoscopy to get a starting point for the refraction. The refraction 
will be performed using Jackson crossed cylinder, binocular blur balance, and maximum‐plus‐to‐maximum‐acuity to 
obtain the final refraction. 
 


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Phoria 
The subject holds the Maddox rod horizontally in front of the right eye for 30 seconds before testing. Hold the near 
Muscle Imbalance Measure (MIM) card 40cm from the subject. Encourage the subject to keep the letters and 
numbers on the card clear, and shine the penlight through the hole in the center of the card. Ask the subject 
whether the red line is on the side of the red triangle (esophoria) or the blue circle (exophoria), and have the subject 
to tell you the number the line goes through. The card is marked with even numbers only, so if the subject states 
that the line is between two numbers, record the number between them (for example, if the line is between the 2 
and the 4 on the red triangle side of the card, record 3pd esophoria). Record the finding using a positive sign (+) to 
indicate eso deviations and a negative sign (–) to indicate exo deviations. 
 
Visual Acuity 
Bailey‐Lovie logMAR charts will be calibrated to 9.3 to 9.9 EV (75 to 120 cd/m2). The subject stands 4 meters from 
the chart and reads the first letter on each line, continuing down the chart until the first letter is missed. She starts 
two lines above the missed letter and reads five letters from every line. If she misses a letter on the first line, she 
continues up the chart until she reads all five letters correctly. She must guess five letters on each line until three or 
more letters is missed in a single line. If she gets 3 or more correct on the bottom line, move to 6 meters and repeat. 
If she does not get all five letters correct on the top line, move the subject to 2 meters and repeat. The total number 
of letters read correctly and the final test distance are recorded for each visual acuity measurement. 
 
Pupil Size 
Press the OD button to activate the unit. Bring the unit up in front of the subject’s right eye with the eye cup resting 
against the subject’s face and hold down the OD button continuously. When the pupil is marked with a green circle, 
release the button to initiate the measurement. Hold the unit still during the few seconds of the measurement. Take 
care that the eyelids do not cover the pupil. If the green measurement circle was not centered over the pupil, delete 
the measurement by using the Eraser icon at the right side of the three‐icon Tool menu. Repeat the measurement 
until the green measurement circle is centered over the pupil. Record the pupil size to the nearest 0.1 millimeter on 
the examination form. Repeat steps 6‐9 while the lights are in the mesopic condition. 
 
Focusing Ability 
A letter target on a stick is placed against the nose, in front of the eyes. Tell the subject the stick will be moved 
slowly away until the subject can first read the letter correctly. The subject should say the letter as soon as s/he can 
read it. The distance from the forehead to the stick is measured to the nearest cm and recorded. 
 
Lag of Focus 
Place the manifest correction used for visual acuity in a trial frame, minimizing the number of lenses used in the trial 
frame. Place an occluding trial lens in the trial frame well over the left eye so that the subject will only view targets 
with the right eye. Place the 33cm near rod in the central slot to measure accommodative lag in primary gaze only. 
Place the subject’s chin on the chinrest and forehead against the forehead rest. Obtain a view of the eye on the 
screen. The white keratometry circle should be in focus. Centered the pink reticule within the white keratometry 
ring. Encourage the subject to keep the letters as clear as possible throughout the measurement and have the 
subject focus on a specific letter to ensure the subject is attentive and accommodating. Obtain at least five readings 
without the “retry” message. When in doubt, take additional measurements to ensure that at least 5 measurements 
exist. Press Print and tape the printout in the location indicated on the exam form. 
 
Reading Speed 
Tell the subject you want him/her to read the random words on a page as quickly as possible without making any 
mistakes. If you make a mistake, just continue reading the card. You will read for one minute. I will tell you when to 
start and when to stop. Have the subject hold Test A at 40 cm. Tell the subject to being and immediately begin the 
stop watch. Put a line through each mistake. Circle the last word read correctly and record the number of words 
read correctly. If more than five mistakes occurred, have the subject read for another minute and continue until the 
subject makes five or fewer mistakes. 
 


Page 6 of 6 
Ability to Shift Focus 
Subjects hold the near visual acuity card at 40 cm. Flippers with +2.00 D lenses on one side and –2.00 D lenses on 
the other side will be placed above the subject’s eyes. Tell the subject to say “now” as soon as the letters on the 
card are clear after each flip of the lenses. This will be timed for one minute, and the number of cycles will be 
recorded. Begin with the +2.00 D lenses and measure binocularly. 
 
Surveys 
Subjects will be told to circle the number that corresponds to their perception that answers each question, noting 
the descriptions at each end of the numbers. 
 
Pressure in the Eye 
Place one drop of 1.0% proparacaine in each eye of the subject, and have him/her answer the three questions about 
eye comfort after receiving the drop. Place a sheath on the measurement tip of the Tonopen. Have the subject view 
a distant object while holding the eye open. Press the button on the Tonopen and wait until the green light turns on. 
Lightly tap the Tonopen on the cornea, until a final “beep” sounds. If the screen has a “95” in the bottom right 
corner, then the measure is valid and can be recorded. If anything else is displayed, repeat the procedure. 
 
Compounding of the 0.01% Atropine 
The drug will be compounded by the Central Ohio Compounding Pharmacy. They will dissolve 0.1 g atropine sulfate 
USP monohydrate powder in 1000 mL sterile water to a final concentration of 0.01%, and add Benzalkonium 
Chloride as preservative. 
 
E. Internal Validity 
We will measure the potential side effects of low concentration atropine in adults rather than children, although 
children will ultimately receive low concentration atropine for myopia control. We are not examining the effects in 
children because adults will give a more accurate description of the side effects they experience than children. 
Because children typically complain less about eye comfort and vision issues than adults,3 we strongly believe that 
we will obtain data that would be considered the worst case scenario for children. 
 
We will use a pre‐ post‐test format in order to examine the changes to be expected over a short period of time. The 
first week of experience will typically guide the likelihood of long‐term commitment to the treatment.4,5 We 
therefore want to know how much administration of low concentration atropine will have on subjects’ vision. 
 
F. Data Analysis 
We will perform repeated measures t‐tests to determine whether there are significant changes over time for 
normally distributed variables and Wilcoxon signed‐rank tests to determine whether there are significant changes 
over time for non‐normally distributed variables.  
 
IV. Bibliography 
1. 
Chia A, Chua WH, Cheung YB, et al. Atropine for the treatment of childhood myopia: safety and efficacy of 0.5%, 
0.1%, and 0.01% doses (Atropine for the Treatment of Myopia 2). Ophthalmology. 2012;119(2):347‐354. 
2. 
Clark TY, Clark RA. Atropine 0.01% Eyedrops Significantly Reduce the Progression of Childhood Myopia. J Ocul 
Pharmacol Ther. 2015;31(9):541‐545. 
3. 
Greiner KL, Walline JJ. Dry eye in pediatric contact lens wearers. Eye Contact Lens. 2010;36(6):352‐355. 
4. 
Lang JM. The use of a run‐in to enhance compliance. Stat Med. 1990;9(1‐2):87‐93; discussion 93‐85. 
5. 
Pablos‐Mendez A, Barr RG, Shea S. Run‐in periods in randomized trials: implications for the application of results 
in clinical practice. JAMA. 1998;279(3):222‐225. 
 

ICF_004.pdf: 
Side Effects of Atropine (SEA) Study 
NCT03593044 
July 6, 2018


CONSENT & 
AUTHORIZATION 
 
 
 
IRB Protocol Number: 
2018H0224 
IRB Approval date:  7/6/2018 
Version:  1.0 
 
 
Page 2 of 7 
Form date: 07/18/16  
 
 
The Ohio State University Combined Consent to Participate in 
Research and HIPAA Research Authorization 
 
Study Title: 
Side Effects of Atropine (SEA) Study 
Principal Investigator: 
Jeffrey J. Walline, OD PhD 
Sponsor:  
The Ohio State University College of Optometry 
 
 This is a consent form for research participation.  It contains important information 
about this study and what to expect if you decide to participate.  Please consider the 
information carefully. Feel free to discuss the study with your friends and family and 
to ask questions before making your decision whether or not to participate. 
 Your participation is voluntary.  You may refuse to participate in this study.  If you 
decide to take part in the study, you may leave the study at any time.  No matter what 
decision you make, there will be no penalty to you and you will not lose any of your 
usual benefits.  Your decision will not affect your future relationship with The Ohio 
State University.  If you are a student or employee at Ohio State, your decision will 
not affect your grades or employment status. 
 You may or may not benefit as a result of participating in this study.  Also, as 
explained below, your participation may result in unintended or harmful effects for 
you that may be minor or may be serious depending on the nature of the research. 
 You will be provided with any new information that develops during the study 
that may affect your decision whether or not to continue to participate.  If you 
decide to participate, you will be asked to sign this form and will receive a copy of the 
form.  You are being asked to consider participating in this study for the reasons 
explained below.   
 
1.   Why is this study being done? 
This study is being done to determine the possible side effects of 0.01% atropine used 
every night for seven days. 1.0% atropine is approved by the United States Food and 
Drug administration, and it is typically used to make the pupil of the eye bigger or to 
decrease the ability to focus the eye for long periods of time. It is available only by a 
prescription. The risks of atropine when used for these purposes are well known, but this 
study will evaluate the side effects when it is given in a much lower dose and used for a 
different purpose. 
 
2.   How many people will take part in this study? 
Up to 40 people will participate in this study. 
 


CONSENT & 
AUTHORIZATION 
 
 
 
IRB Protocol Number: 
2018H0224 
IRB Approval date:  7/6/2018 
Version:  1.0 
 
 
Page 3 of 7 
Form date: 07/18/16  
 
3.   What will happen if I take part in this study? 
If you take part in this study, you will come to two visits, a week apart, for less than one 
hour each time. In between visits, you will put 0.01% atropine eye drops in both eyes 
every night. During each of the visits, we will measure your vision, pupil size, eye 
focusing, reading speed, eye pressure, and ask you about your vision and eye comfort 
 
4.   How long will I be in the study? 
There are two visits, one week apart. The first visit lasts about one hour, and the second 
will be shorter. 
 
5. Can I stop being in the study? 
You may leave the study at any time.  If you decide to stop participating in the study, 
there will be no penalty to you, and you will not lose any benefits to which you are 
otherwise entitled. Your decision will not affect your grades or your relationship with The 
Ohio State University or the College of Optometry. 
 
6.   What risks, side effects or discomforts can I expect from being in the study? 
0.01% atropine may cause blurry vision or light sensitivity, or the drops may sting slightly 
for a short time when put in the eyes. If you experience blurry vision at near, we will 
provide you with glasses to improve your vision. If you experience light sensitivity, we 
will provide you with disposable sunglasses. 
 
7.   What benefits can I expect from being in the study? 
You will not gain any individual benefits by being in the study, but you will help us 
understand what side effects to expect if taking 0.01% atropine on a daily basis.  
 
8.   What other choices do I have if I do not take part in the study? 
You may choose not to participate without penalty or loss of benefits to which you are 
otherwise entitled. 
 
9. What are the costs of taking part in this study? 
There are no costs for taking part in this study. 
 
10. Will I be paid for taking part in this study? 
By law, payments to subjects are considered taxable income. You will receive $10 cash 
for each visit attended. You will also receive a free parking pass if necessary. 
 
11. What happens if I am injured because I took part in this study? 
If you suffer an injury from participating in this study, you should notify the researcher or 
study doctor immediately, who will determine if you should obtain medical treatment at 
The Ohio State University Wexner Medical Center.   
 


CONSENT & 
AUTHORIZATION 
 
 
 
IRB Protocol Number: 
2018H0224 
IRB Approval date:  7/6/2018 
Version:  1.0 
 
 
Page 4 of 7 
Form date: 07/18/16  
 
The cost for this treatment will be billed to you or your medical or hospital insurance. The 
Ohio State University has no funds set aside for the payment of health care expenses for 
this study.  
 
12. What are my rights if I take part in this study? 
If you choose to participate in the study, you may discontinue participation at any time 
without penalty or loss of benefits.  By signing this form, you do not give up any personal 
legal rights you may have as a participant in this study. 
You will be provided with any new information that develops during the course of the 
research that may affect your decision whether or not to continue participation in the 
study. 
 
You may refuse to participate in this study without penalty or loss of benefits to which 
you are otherwise entitled. 
 
An Institutional Review Board responsible for human subjects research at The Ohio State 
University reviewed this research project and found it to be acceptable, according to 
applicable state and federal regulations and University policies designed to protect the 
rights and welfare of participants in research. 
 
13. Will my study-related information be kept confidential? 
Efforts will be made to keep your study-related information confidential.  However, there 
may be circumstances where this information must be released.  For example, personal 
information regarding your participation in this study may be disclosed if required by state 
law.   
 
Also, your records may be reviewed by the following groups (as applicable to the 
research): 
 
Office for Human Research Protections or other federal, state, or international 
regulatory agencies; 
 
U.S. Food and Drug Administration; 
 
The Ohio State University Institutional Review Board or Office of Responsible 
Research Practices; 
 
The sponsor supporting the study, their agents or study monitors; and 
 
Your insurance company (if charges are billed to insurance). 
 
A description of this clinical trial will be available on http://www.ClinicalTrials.gov, as 
required by U.S. law.  This website will not include information that can identify you.  At 
most, the website will include a summary of the results.  You can search the website at 
any time.  


CONSENT & 
AUTHORIZATION 
 
 
 
IRB Protocol Number: 
2018H0224 
IRB Approval date:  7/6/2018 
Version:  1.0 
 
 
Page 5 of 7 
Form date: 07/18/16  
 
14. HIPAA AUTHORIZATION TO USE AND DISCLOSE INFORMATION 
FOR RESEARCH PURPOSES  
I. What information may be used and given to others? 
 Past and present medical records; 
 Research records; 
 Records about phone calls made as part of this research; 
 Records about your study visits; 
 Information that includes personal identifiers, such as your name, or a number 
associated with you as an individual; 
 Records about any study drug you received; 
 Records about the study device; and  
II. Who may use and give out information about you? 
Researchers and study staff.   
 
III. Who might get this information? 
 The sponsor of this research.  “Sponsor” means any persons or companies that are: 
 working for or with the sponsor; or  
 owned by the sponsor. 
 Authorized Ohio State University staff not involved in the study may be aware that 
you are participating in a research study and have access to your information; 
 If this study is related to your medical care, your study-related information may be 
placed in your permanent hospital, clinic or physician’s office record; 
 Others: Jeffrey J. Walline and Ben Cyphers. 
 
IV. Your information may be given to: 
 The U.S. Food and Drug Administration (FDA), Department of Health and Human 
Services (DHHS) agencies, and other federal and state entities; 
 Governmental agencies in other countries; 
 Governmental agencies to whom certain diseases (reportable diseases) must be 
reported; and  
 The Ohio State University units involved in managing and approving the research 
study including the Office of Research and the Office of Responsible Research 
Practices. 
 
V. Why will this information be used and/or given to others? 
 To do the research;  
 To study the results; and  
 To make sure that the research was done right.   
 
VI. When will my permission end? 
There is no date at which your permission ends. Your information will be used 
indefinitely. This is because the information used and created during the study may be 
analyzed for many years, and it is not possible to know when this will be complete. 


CONSENT & 
AUTHORIZATION 
 
 
 
IRB Protocol Number: 
2018H0224 
IRB Approval date:  7/6/2018 
Version:  1.0 
 
 
Page 6 of 7 
Form date: 07/18/16  
 
 
VII. May I withdraw or revoke (cancel) my permission? 
Yes. Your authorization will be good for the time period indicated above unless you 
change your mind and revoke it in writing. You may withdraw or take away your 
permission to use and disclose your health information at any time. You do this by 
sending written notice to the researchers. If you withdraw your permission, you will not 
be able to stay in this study. When you withdraw your permission, no new health 
information identifying you will be gathered after that date. Information that has already 
been gathered may still be used and given to others. 
 
VIII. What if I decide not to give permission to use and give out my health 
information? 
Then you will not be able to be in this research study and receive research-related 
treatment.  However, if you are being treated as a patient here, you will still be able to 
receive care. 
 
IX. Is my health information protected after it has been given to others? 
There is a risk that your information will be given to others without your permission. Any 
information that is shared may no longer be protected by federal privacy rules. 
 
X. May I review or copy my information? 
Signing this authorization also means that you may not be able to see or copy your study-
related information until the study is completed.   
 
15. Who can answer my questions about the study? 
For questions, concerns, or complaints about the study, or if you feel you have been 
harmed as a result of study participation, you may contact Jeffrey J. Walline: 
walline.1@osu.edu or 614-247-6840. 
 
For questions related to your privacy rights under HIPAA or related to this research 
authorization, please contact  Cathy Beatty: beatty.22@osu.edu or 614-247-6190. 
 
For questions about your rights as a participant in this study or to discuss other study-
related concerns or complaints with someone who is not part of the research team, you 
may contact Ms. Sandra Meadows in the Office of Responsible Research Practices at 1-
800-678-6251. 
 
If you are injured as a result of participating in this study or for questions about a study-
related injury, you may contact Jeffrey J. Walline: walline.1@osu.edu or 614-247-6840.


CONSENT & 
AUTHORIZATION 
 
 
 
IRB Protocol Number: 
2018H0224 
IRB Approval date:  7/6/2018 
Version:  1.0 
 
 
Page 7 of 7 
Form date: 07/18/16  
 
Signing the consent form 
 
I have read (or someone has read to me) this form and I am aware that I am being asked to 
participate in a research study.  I have had the opportunity to ask questions and have had them 
answered to my satisfaction.  I voluntarily agree to participate in this study.  
 
I am not giving up any legal rights by signing this form.  I will be given a copy of this 
combined consent and HIPAA research authorization form. 
 
 
 
 
 
Printed name of subject 
 
Signature of subject 
 
 
 
 
 
AM/PM 
 
 
Date and time 
 
 
 
 
 
 
 
 
 
Printed name of person authorized to consent for subject 
(when applicable) 
 
Signature of person authorized to consent for subject  
(when applicable) 
 
 
 
 
 
AM/PM 
Relationship to the subject 
 
Date and time 
 
 
 
 
Investigator/Research Staff 
 
I have explained the research to the participant or his/her representative before requesting the 
signature(s) above.  There are no blanks in this document.  A copy of this form has been given 
to the participant or his/her representative. 
 
 
 
 
 
Printed name of person obtaining consent 
 
Signature of person obtaining consent 
 
 
 
 
 
AM/PM 
 
 
Date and time 
 
 
Witness(es) - May be left blank if not required by the IRB 
 
 
 
 
 
Printed name of witness 
 
Signature of witness 
 
 
 
 
 
AM/PM 
 
 
Date and time 
 
 
 
 
 
Printed name of witness 
 
Signature of witness 
 
 
 
 
 
 
AM/PM 
 
 
Date and time