Clinical trial NCT03523988
Conditions: NSAID Pain Management
Keywords: Pre-emptive analgesics Acetaminophen Ibuprofen
Sponsor: University of Washington
Start date: 2017-05-02; Completion date: 2017-08-01
Enrollment: 73 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study is designed to determine if the preemptive use of a combination of acetaminophen and ibuprofen is more effective in reducing pain following orthodontic tooth movement when compared to the use of acetaminophen and ibuprofen alone.

Detailed description:
This study is designed to determine if the preemptive use of a combination of acetaminophen and ibuprofen is more effective in reducing pain following orthodontic tooth movement when compared to the use of acetaminophen and ibuprofen alone. Before their orthodontic appointment, participants will be administered acetaminophen (650mg), ibuprofen (400mg), or acetaminophen (650mg) + ibuprofen (400mg). Participants will be asked to record their pain intensity using a numerical (0-10) visual analog scale (VAS) during rest, light biting, and while chewing paraffin wax during the following time intervals: immediately following drug administration, 6 hours after, the morning after, and the second morning after orthodontic treatment.

Arms: arm 1: Acetaminophen 650mg powder in gel capsule taken by mouth before entering appointment arm 2: Ibuprofen 400mg powder in gel capsule taken by mouth before entering appointment arm 3: Acetaminophen 650mg and Ibuprofen 400mg powder in gel capsule taken by mouth before entering appointment
Interventions: intervention 1: Acetaminophen intervention 2: Ibuprofen
Intervention descriptions: intervention 1: Acetaminophen gel capsule intervention 2: Ibuprofen gel capsule

Protocol documents:
ICF_005.pdf: 
Study Title:
Effects of preoperative combined use of acetaminophen and ibuprofen on the control of pain following orthodontic treatment 
 
Approved on: 4/26/2017
Last updated: 4/26/2017
 
NCT #03523988


UNIVERSITY OF WASHINGTON
CONSENT FORM
Pre-emptive Use of Analgesics for Orthodontic Pain Reduction
Researchers: Andrew Keith – Lead researcher; University of Washington School of Dentistry 
Email: akeith@uw.edu  Phone #: (206) 616-4338
Dr. Anne-Marie Bollen, DDS – Faculty Advisor; University of Washington Dept. of 
Orthodontics
Researchers’ statement
We are asking you to be in a research study.  The purpose of this consent form is to give you the 
information you will need to help you decide whether to be in the study or not.  Please read the 
form carefully.  You may ask questions about the purpose of the research, what we would ask 
you to do, the possible risks and benefits, your rights as a volunteer, and anything else about the 
research or this form that is not clear.  When we have answered all your questions, you can 
decide if you want to be in the study or not.  This process is called “informed consent.”  We will 
give you a copy of this form for your records.
PURPOSE OF THE STUDY
Orthodontic treatment creates an inflammatory process, which allows for the reshaping of bone 
around the teeth.  The inflammation may also be a source for pain or discomfort during treatment 
that peaks within the first few days after treatment and is usually resolved within a week.  
Analgesics are medications that are used to relieve pain.  Commonly used analgesics are 
acetaminophen (a.k.a. Tylenol®) and ibuprofen (a.k.a. Advil®).  These drugs work by 
specifically inhibiting cyclooxygenase (COX) enzymes, which weakens the inflammatory 
response and therefor reduces the discomfort caused by orthodontic treatment.
Acetaminophen and ibuprofen have both been shown in numerous studies to reduce the peak 
level and duration of discomfort associated with orthodontic treatment when taken before the 
appointment when compared to a placebo (sugar pill).  The combination of both acetaminophen 
and ibuprofen is a widely accepted standard for mild to moderate dental pain relief.  However, to 
our knowledge, the combination of acetaminophen and ibuprofen taken pre-emptively has not 
yet been investigated for pain reduction during orthodontic treatment.
This study is recruiting 180 participants in order to determine if orthodontic patients can benefit 
from decreased peak levels of discomfort and shorter duration of discomfort with pre-emptive 
administration of a combination of acetaminophen and ibuprofen compared to a single dose of 
each individual medication.
STUDY PROCEDURES
As a participant of this study, you will be given a brown envelope that contains two capsules.  
The contents of the two capsules will be one of the following:
Acetaminophen (a.k.a. Tylenol®) (650mg), 
Ibuprofen (a.k.a. Advil®) (400mg), 
Acetaminophen (a.k.a. Tylenol®) (650mg) + ibuprofen (a.k.a. Advil®) (400mg)
 
     Approved 
     4/26/2017
     UW HSD IRB


Before the start of your appointment, you will be asked to take the provided medication, record 
the date and time, and answer a few short questions, which should take less than a minute.
You have the option to be given a paper workbook or online version that consists of visual 
analogue scales (VAS) which will help you record your level of discomfort at four different time 
points over the next few days.  Each recording can be completed in one to two minutes.  For your 
convenience, the requested dates and times for the recordings will be written on the top of each 
page:
Immediately following drug administration
6 hours after the appointment
The morning after the appointment
The 2nd morning after the appointment
For each recording you will mark the horizontal line circle the appropriate number that 
corresponds to your level of discomfort.  You may use the provided facial expressions, or written 
descriptions to help you determine an appropriate recording.
Each time interval will ask you to record your level of discomfort during three different 
scenarios:
At rest: The teeth should be not touching and the jaw should be relaxed
Lightly close: Gently bring your back teeth together until they touch
Chewing: Chew a small piece of wax (~1/2 inch) for 5 seconds
During the study you will be asked to not take any additional analgesics.  If you absolutely must 
take additional analgesics please record what you took, how much, when you took it, and if it 
was for dental pain.
If you have completed the paper version of the workbook, please bring it to your next 
appointment at the University of Washington and return it to the front desk upon check-in.  
Participation in this study will have no effect on your treatment and you are not obligated to 
answer or complete any portion of the study against your will.  You are free to refuse any portion 
of the study.
RISKS, STRESS, OR DISCOMFORT
The medication given to you will be randomly determined and will include one of the following:
Acetaminophen (a.k.a. Tylenol®) (650mg), 
Ibuprofen (a.k.a. Advil®) (400mg), 
Acetaminophen (a.k.a. Tylenol®) (650mg) + ibuprofen (a.k.a. Advil®) (400mg)
The doses are determined from the U.S. Food and Drug Administration (FDA) recommended 
doses for each medication for ages 12+ and over 88 lbs.  If you have not taken one of the 
medications before, there may be unanticipated side effects.  These commonly taken medications 
 
     Approved 
     4/26/2017
     UW HSD IRB


are available over-the-counter and side effects are often associated with long-term use at high 
doses.  Although rare, it is possible that you may experience: 
Anemia
Kidney failure
Liver failure
Edema
Dizziness
Blurred vision
Headache 
Rash
Heartburn
Nausea
Cardiovascular 
thrombotic events
Ulcers
Bronchospasms
Adverse effects typically occur in patients over the age of 60 or with one of the following 
conditions:
Impairment of the heart, kidney, or liver
History of peptic ulcer
History of hypersensitivities to NSAIDs or acetaminophen
Asthma
Systemic lupus erythematosus
BENEFITS OF THE STUDY
The medication that you will be given may reduce your peak pain level and shorten the duration 
of discomfort associated with your orthodontic treatment.
CONFIDENTIALITY OF RESEARCH INFORMATION
The workbook that will be given to you will have a unique number associated with it that can be 
used at the conclusion of the study to determine which drug was administered.  No personal 
identifiers will be recorded and your responses will be kept anonymous.
OTHER INFORMATION
You may refuse to participate and you are free to withdraw from this study at any time without 
penalty or loss of benefits to which you are otherwise entitled.
If you would like to enter the raffle for one of four gift cards, please tear off the raffle ticket on 
the last page of your workbook.  If you completed the online version of the workbook, then your 
contact information will be automatically entered into the raffle once you have submitted your 
last recording.  Fill out your contact information and return it to the front-desk of the Department 
of Orthodontics.  At the conclusion of the study, four tickets will be randomly drawn to 
determine who will receive the $50 Visa gift cards, and contacted approximately at the end of 
June 2017.  Prizes can be claimed at the front-desk of the Department of Orthodontics when 
convenient.
 
     Approved 
     4/26/2017
     UW HSD IRB


RESEARCH-RELATED INJURY
If you think you have a medical problem or illness related to this research, contact Andrew Keith 
right away at (206) 616-4338. He will treat you or refer you for treatment. 
Printed name of study staff obtaining consent*
Signature*
Date*
Subject’s statement
This study has been explained to me.  I volunteer to take part in this research.  I have had a 
chance to ask questions.  If I have questions later about the research, or if I have been harmed by 
participating in this study, I can contact one of the researchers listed on the first page of this 
consent form.  If I have questions about my rights as a research subject, I can call the Human 
Subjects Division at (206) 543-0098 or call collect at (206) 221-5940.  I will receive a copy of 
this consent form.
Printed name of subject
Signature of subject
Date
When subject is a minor:
Printed name of parent
Signature of parent
Date
Copies to:
Researcher
Subject
 
     Approved 
     4/26/2017
     UW HSD IRB

SAP_004.pdf: 
Study Title:
Effects of preoperative combined use of acetaminophen and ibuprofen on the control of pain following 
orthodontic treatment 
Last updated: 5/1/2018
NCT #03523988


Statistical Analysis Plan
Data analysis was performed blinded for the medication groups.  Descriptive statistics were 
determined for the pain scores at each time interval for the three experimental groups.  A one-way 
analysis of variance (ANOVA) and Tukey’s post-hoc test was used to determine the differences in 
mean pain scores at each time interval among the three groups.  Results were determined to be 
statistically significant at P<0.05.
A similar study1 found the combined mean pain scores of acetaminophen and ibuprofen to be 
24.8mm±17.1 (mean±SD) and 20.1mm±13.5, respectively, when measured using a 100-mm VAS. 
Clinical significance was established by a difference in mean pain scores of 10mm or greater.  Each 
group must have a sample size of 46 participants in order to demonstrate a statistical significance using 
the described data at α=0.05 and power=80%.  
1Bradley R, Ellis P, Thomas P, Bellis H, Ireland A, Sandy J. A randomized clinical trial comparing the 
efficacy of ibuprofen and paracetamol in the control of orthodontic pain. Am J Orthod Dentofacial 
Orthop. 2007;132:511–7.

Prot_003.pdf: 
Study Title:
Effect  of preopertive combined u e of tcettminopeen tnd ibuprofen on tee control of ptin follo inw 
orteodonic trettment 
Approved on: 4/19/2017
Lt t updtted: 4/19/2017
NCT #03523988
ZIPLINE APPLICATION: IRB Protocol
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ZIPLINE APPLICATION: IRB Protocol
INSTRUCTIONS

If you are requestin a determiiatoi
 
  tbout  eeteer your tcivity i  eumtn  ubject  re etrce or qutlife  for exempt  tttu , 
you mty  kip tll que ion  except teo e mtrked  ite t          . For extmple 1.1  mu t be tn  ered.

Aiswer all questois
 
 . If t que ion i  not tpplictble to your re etrce or if you believe you etve tlretdy tn  ered t que ion 
el e eere in tee tppliction,  ttte “NA” (tnd if tpplictble, refer to tee que ion  eere you provided tee informtionn. If you 
do not tn  er t que ion, tee IRB doe  not kno   eeteer tee que ion  t  overlooked or  eeteer it i  not tpplictble. Tei  
mty re ult in unnece  try “btck tnd forte” for cltrifction. U e non-tecenictl ltnwutwe t  muce t  po  ible. 

To ceeck t box, pltce tn “X” in tee box. To fll in t text box, mtke  ure your cur or i   itein tee wrty text box btr before 
typinw or pt inw text.

Tee  ord “you” refer  to tee re etrceer tnd tll member  of tee re etrce tetm, unle   oteer i e  pecifed. 

For colltbortive re etrce, de cribe only tee informtion tett i  relevtnt to you unle   you tre reque inw tett tee UW IRB 
provide tee revie  tnd over iwet for your colltborttor  t   ell. 

You mty reference oteer document  ( uce t  t wrtnt tpplictionn if teey provide tee reque ted informtion in non-tecenictl 
ltnwutwe. Be  ure to provide tee document ntme, ptwe( n, tnd  pecifc  ecion , tnd uplotd it to Zipline. Al o, de cribe tny 
cetnwe  tett mty etve occurred  ince tee document  t   riten (for extmple, cetnwe  tett you’ve mtde durinw or tfer tee 
wrtnt revie  proce  n. In  ome ct e , you mty need to provide tddiiontl dettil  in tee tn  er  ptce t   ell t  referencinw t 
document. 
INDEX
1 Overvie 
6 Ceildren (Minor n tnd Ptrenttl Permi  ion
10 Ri k / Beneft A  e  ment
2 Ptriciptnt 
7 A  ent of Ceildren (Minor n
11 Economic Burden to Ptriciptnt 
3 Interntiontl Re etrce Setnw
8 Con ent of Adult 
12 Re ource 
4 Recruiinw tnd Screeninw Ptriciptnt 
9 Privtcy tnd Confdenitlity
13 Oteer Approvtl , Permi  ion , tnd 
Rewulttory I  ue 
5 Procedure 
1 OVERVIEW
Study Title:
Effects of preoperative combined use of acetaminophen and ibuprofen on the control of pain 
following orthodontic treatment 
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1.1 Home iisttutoi. Idenify tee eome in ituion of tee letd re etrceer t  li ted on tee IRB tppliction. Provide tny 
eelpful expltnttory informtion.  
In general, the home instttton is the instttton (1) that provides the researcher’s paycheck and that considers him/her to be 
a paid employee, or (2) at which the researcher is a matrictlated sttdent. Scholars, factlty, fellows, and sttdents who are 
visitng the UW and who are the lead researcher  identfy yotr home instttton and describe the ptrpose and dtraton of yotr  
UW visit, as well as the UW department/center with which yot are afliated while at the UW.
Note that many UW clinical factlty members are paid employees of non-UW insttttons.
The UW IRB provides IRB review and oversight for only those researchers who meet the criteria described in the POLICY: Use 
of the UW IRB.
University of Washington - School of Dentistry
1.2 Coisultatoi history. Htve you con ulted  ite tnyone tt HSD tbout tei   tudy?
It is not necessary to obtain advance constltaton. If yot have  answering this qteston will help enstre that the IRB is aware 
of and considers the advice and gtidance yot were provided.  
X
No
Yes
 If ye , briefly de cribe tee con ulttion: tpproximtte dtte,  ite  eom, tnd meteod (e.w., by emtil, 
peone ctll, in-per on meeinwn.
     
1.3 Similar aid/or related studies. Are teere tny reltted IRB tppliction  tett provide context for tee propo ed 
tciviie ?
Examples of sttdies for which there is likely to be a related IRB applicaton  Using samples or data collected by another sttdy; 
recrtitng stbjects from a registry established by a colleagte’s research actvity; condtctng Phase 2 of a mtlt-part project, or 
condtctng a contntaton of another sttdy; serving as the data coordinatng center for a mtlt-site sttdy that incltdes a UW 
site.
Providing this informaton (if relevant) may signifcantly improve the efciency and consistency of the IRB’s review.
X
No
Yes
 If ye , briefly de cribe tee oteer  tudie  or tppliction  tnd eo  teey reltte to tee propo ed 
tciviie . If tee oteer tppliction   ere revie ed by tee UW IRB, plet e tl o provide: tee UW IRB 
number, tee  tudy itle, tnd tee letd re etrceer’  ntme.
ZIPLINE APPLICATION: IRB Protocol
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1.4 Exterially-imposed urneicy or tme deadliies. Are teere tny externtlly-impo ed detdline  or urwency tett tffect 
your propo ed tcivity?
HSD recognizes that everyone wotld like their IRB applicatons to be reviewed as qtickly as possible. To enstre fairness, it is 
HSD policy to review applicatons in the order in which they are received. However, HSD will assign a higher priority to 
research with externally-imposed trgency that is beyond the control of the researcher. Researchers are encotraged to 
commtnicate as soon as possible with their HSD staf contact person when there is an trgent sittaton (in other words, before 
stbmitting the IRB applicaton). Examples  a researcher plans to test an experimental vaccine that has jtst been developed for 
a newly emerging epidemic; a researcher has an tnexpected opporttnity to collect data from sttdents when the end of the 
school year is only fotr weeks away. 
HSD may ask for doctmentaton of the externally-imposed trgency. A higher priority shotld not be reqtested to compensate 
for a researcher’s failtre to prepare an IRB applicaton in a tmely manner. Note that IRB review reqtires a certain minimtm 
amotnt of tme; withott stfcient tme, the IRB may not be able to review and approve an applicaton by a deadline. 
No
X
Yes
 If ye , briefly de cribe tee urwency or detdline t   ell t  tee ret on for it.
The proposed activity is to be completed as part of a 4th year dental student research-focused 
curriculum.  The dates for the student to conduct the clinical trials range from March 27th to June 
16th, 2017.
1.5 Objectves U inw lty ltnwutwe, de cribe tee purpo e,  pecifc tim , or objecive  tett  ill be met by tei   pecifc 
project. If eypotee e  tre beinw te ted, de cribe teem. You  ill be t ked to de cribe tee  pecifc procedure  in t 
ltter  ecion.
If your tppliction involve  tee u e of t HUD “eumtnittritn” device: de cribe  eeteer tee u e i  for “on-ltbel” 
clinictl ptient ctre, “off-ltbel” clinictl ptient ctre, tnd/or re etrce (collecinw  tfety tnd/or effecivene   dtttn.
Orthodontic tooth movement induces an inflammatory response that can cause patients mild to moderate pain, 
especially within the first few days after forces have been applied.  It has been shown that the use of over-the-
counter analgesics such as acetaminophen and NSAIDs (i.e. ibuprofen) can be used effectively in the treatment of 
mild to moderate pain caused by orthodontic tooth movement.  When such analgesics are taken preemptively to 
the introduction of orthodontic forces, a greater reduction in postoperative pain has been reported. 
The combined use of acetaminophen and ibuprofen has been shown to have an additive relationship in the control 
of mild to moderate dental pain following tooth extractions.  While each drug can individually reduce pain, the 
combination has been shown to be even more efficacious.  
This study is designed to determine if the preemptive use of a combination of acetaminophen and ibuprofen is 
more effective in reducing dental pain following orthodontic treatment when compared to the use of 
acetaminophen and ibuprofen alone.
Hypothesis:
Patients taking a combination of acetaminophen and ibuprofen prior to orthodontic treatment will report less pain 
when compared to those that premedicate with acetaminophen or ibuprofen alone.
1.6 Study desini. Provide t one- entence de cripion of tee wenertl  tudy de iwn tnd/or type of meteodolowy.  
Yotr answer will help HSD in assigning applicatons to reviewers and in managing workload. Examples  a longittdinal 
observatonal sttdy; a dotble-blind, placebo-controlled randomized sttdy; ethnographic interviews; web scraping from a 
convenience sample of blogs; medical record review; coordinatng center for a mtlt-site sttdy.
Double-blind randomized control study
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1.7 Iiteit. Ceeck tll tee de criptor  tett tpply to your tcivity. You mu t pltce tn “X” in tt let t one box.
This qteston is essental for enstring that yotr applicaton is correctly reviewed. Please read each opton careftlly.
Descriptor
1. Clt   project or oteer tcivity  eo e purpo e i  to provide tn eductiontl experience for tee re etrceer 
(for extmple, to letrn tbout tee proce   or meteod  of doinw re etrcen.
X
2. Ptrt of tn in ituion, orwtniztion, or prowrtm’  o n interntl opertiontl monitorinw.
3. Improve tee qutlity of  ervice provided by t  pecifc in ituion, orwtniztion, or prowrtm.
4. De iwned to exptnd tee kno ledwe bt e of t  cienifc di cipline or oteer  ceoltrly feld of  tudy, tnd 
produce re ult  tett:

Are expected to be tpplictble to t ltrwer popultion beyond tee  ite of dttt collecion or tee  pecifc 
 ubject   tudied, or

Are intended to be u ed to develop, te t, or  upport teeorie , principle , tnd  tttement  of 
reltion eip , or to inform policy beyond tee  tudy.
X
5. Develop informtion tbout t druw or device terouwe it  pro pecive u e tnd t  iwnment to  ubject ,  eice 
 ill teen be  ubmited to tee Food tnd Druw Admini trtion (FDAn in  upport of t mtrkeinw or re etrce 
tppliction for tn inve iwtiontl druw or device, or for cetnwe  to tee purpo e, popultion, or do e for tn 
tlretdy-tpproved druw or device.
6. Focu  directly on tee  pecifc individutl  tbout  eom tee informtion or bio pecimen  tre collected 
terouwe ortl ei tory, journtli m, biowrtpey, or ei torictl  ceoltr eip tciviie , to provide tn tccurtte tnd 
evidence-bt ed portrtytl of tee individutl .
7. A qutlity improvement or prowrtm improvement tcivity conducted to improve tee implementtion 
(delivery or qutlityn of tn tccepted prtcice, or to collect dttt tbout tee implementtion of tee prtcice 
for clinictl, prtcictl, or tdmini trtive purpo e . Tei  doe  not include tee evtlution of tee efctcy of 
different tccepted prtcice , or t comptri on of teeir efctcy.
8. Public eetlte  urveilltnce tciviie  conducted, reque ted, or tuteorized by t public eetlte tuteority for 
tee  ole purpo e of idenifyinw or inve iwtinw potenitl public eetlte  iwntl  or imely t trene   tnd 
priority  etnw durinw t  itution tett teretten  public eetlte.
9. Prelimintry, explorttory, or re etrce development tciviie  ( uce t  pilot tnd fet ibility  tudie , or 
relitbility/vtlidtion te inw of t que ionntiren
10. Exptnded tcce   u e of t druw or device not yet tpproved for tei  purpo e
11. U e of t Humtnittritn U e Device
12. Oteer. Expltin:
     
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1.8 Backnrouid, experieice, aid prelimiiary work. An  er tei  que ion oily if your propo ed tcivity et  one or 
more of tee follo inw cetrtcteri ic . Tee purpo e of tei  que ion i  to provide tee IRB  ite informtion tett i  
relevtnt to it  ri k/beneft tntly i .

Involve  more tetn minimtl ri k (pey ictl or non-pey ictln

I  t clinictl tritl, or

Involve  etvinw tee  ubject  u e t druw, biolowictl, bottnictl, nutriiontl  upplement, or medictl 
device.
“Minimal risk” means that the probability and magnittde of harm or discomfort antcipated in the research are not greater 
than those ordinarily encotntered in daily life or dtring the performance of rottne physical or psychological examinatons or 
tests.
a. Btckwround. Provide tee rtiontle tnd tee  cienifc or  ceoltrly btckwround for your propo ed tcivity, bt ed 
on exi inw litertture (or clinictl kno ledwen. De cribe tee wtp  in current kno ledwe tett your project i  
intended to tddre  .
Do not provide scholarly citatons. Limit yotr answer to less than one page, or refer to an atached doctment with 
backgrotnd informaton that is no more than three pages long.
Pain associated with orthodontic tooth movement is generated by an inflammatory process.  This 
hyperalgesic result can reduce patient compliance and may be a deterrent for treatment for some 
individuals.  Prostaglandins are one of the primary mediators of this inflammatory response and are 
synthesized by the enzyme cyclooxygenase (COX), which exists as two forms: COX-1 (constitutive), 
and COX-2 (inducible).  The use of non-steroidal anti-inflammatory drugs (NSAIDs) have been 
shown to inhibit the activity of COX, thus achieving some of its analgesic effect by its anti-
inflammatory properties.1
Numerous studies have shown the use of analgesics, such as NSAIDs and acetaminophen, to be 
effective in the control and management of pain induced by orthodontic tooth movement.2, 3, 4  Pre-
emptive administration of analgesics an hour before the placement of orthodontic separators has 
been shown to have a greater reduction in pain than analgesic administration following the 
procedure.5, 6, 7  Acetaminophen (650mg) and ibuprofen (400mg) have been shown to be similarly 
effective as a pre-emptive analgesic for the control of dental pain following separator and initial 
archwire placement.4, 8, 9  
The combined use of acetaminophen and ibuprofen has been demonstrated to be more effective 
than either medication alone for the treatment of post-operative dental pain.10, 11, 12  The combination 
of acetaminophen with NSAIDs has been shown to have a synergistic relationship in reducing 
visceral pain in a rat model.13 It has been suggested that the simultaneous use acetaminophen and 
NSAIDs has held an additive analgesic effect against other prostaglandin mediated pain such as 
osteoarthritis, dental surgery, and other surgical procedures.14
To our knowledge, there is no research that has been done that investigates the pre-emptive use of a 
combination of acetaminophen and ibuprofen for the control of dental pain associated with orthodontic 
treatment.  We are interested in discovering if the recommended use of a combination of analgesics for the 
control of dental pain can be used pre-emptively in the orthodontic setting.
References:
1. Krishnan V; Orthodontic pain: from causes to management—a review. Eur J Orthod 2007; 29 (2): 170-179. doi: 10.1093/ejo/cjl081.
2. Sudhakar V, Vinodhini T S, Mohan A M, Srinivasan B, Rajkumar B K. The efficacy of different pre- and post-operative analgesics in the management of pain after orthodontic separator 
placement: A randomized clinical trial. J Pharm Bioall Sci 2014;6, Suppl S1:80-4.
3. Simmons KE,  Brandt M. Control of orthodontic pain. Journal of the Indiana Dental Association, 1992, vol. 71 (pg. 8-10).
4. Ngan P,  Wilson S,  Shanfeld J,  Amini H. The effect of ibuprofen on the level of discomfort in patients undergoing orthodontic treatment. American Journal of Orthodontics and Dentofacial 
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Orthopedics, 1994, vol. 106 (pg. 88-95).
5. Steen Law SL,  Southard KA,  Law AS,  Logan HL,  Jakobsen JR. An evaluation of preoperative ibuprofen for treatment of pain associated with orthodontic separator placement. American 
Journal of Orthodontics and Dentofacial Orthopedics, 2000, vol. 118 (pg. 629-633).
6. Bernhardt MK,  Southard KA,  Batterson KD,  Logan HL,  Baker KA,  Jakobsen JR. The effect of preemptive and/or postoperative ibuprofen therapy for orthodontic pain. American Journal 
of Orthodontics and Dentofacial Orthopedics, 2001, vol. 120 (pg. 20-27).
7. Polat O,  Kararam AI,  Durmus E. Effects of preoperative ibuprofen and naproxan sodium on orthodontic pain. The Angle Orthodontist , 2005, vol. 75 (pg. 791-796).
8. Zarif Najafi H, Oshagh M, Salehi P, Babanouri N, Torkan S. Comparison of the effects of preemptive acetaminophen, ibuprofen, and meloxicam on pain after separator placement: a 
randomized clinical trial. Progress in Orthodontics. 2015;16:34. doi:10.1186/s40510-015-0104-y.
9. Bird S, Williams K, Kula K. Preoperative acetaminophen vs ibuprofen for control of pain after orthodontic separator placement. Am J Ortho Dentofacial Orthop. 2007;132:504–10. doi: 
10.1016/j.ajodo.2006.11.019
10. Merry AF, Gibbs RD, Edwards J, et al. Combined acetaminophen and ibuprofen for pain relief after oral surgery in adults: a randomized controlled trial. BJA: British Journal of 
Anaesthesia. 2010;104(1):80-88. doi:10.1093/bja/aep338.
11. Bailey E, Worthington HV, van Wijk A, Yates JM, Coulthard P, Afzal Z. Ibuprofen and/or paracetamol (acetaminophen) for pain relief after surgical removal of lower wisdom teeth. 
Cochrane Database Syst Rev. 2013 Dec 12;(12):CD004624. doi:10.1002/14651858.CD004624.pub2.
12. Moore PA, Hersh EV. Combining ibuprofen and acetaminophen for acute pain management after third-molar extractions: translating clinical research to dental practice. Journal of 
American Dental Association. 2013 Aug;144(8):898-908.
13. Miranda HF, Puig MM, Prieto JC, Pinardi G. Synergism between paracetamol and nonsteroidal anti-inflammatory drugs in experimental acute pain. Pain. 2006 Mar;121(1-2):22-8. Epub 
2006 Feb 9. doi: 10.1016/j.pain.2005.11.012.

14. Altman RD. A rationale for combining acetaminophen and NSAIDs for mild-to-moderate pain. Clinical and Experimental Reumatology, 22 (2004), pp. 110–117.
b. Experience tnd prelimintry  ork. Briefly de cribe experience or prelimintry  ork or dttt (if tnyn tett you or 
your tetm etve tett  upport  tee fet ibility tnd/or  tfety of tei   tudy.  
It is not necessary to stmmarize all disctssion that has led to the development of the sttdy protocol. The IRB is interested 
only in short stmmaries abott experiences or preliminary work that stggest the sttdy is feasible and that risks are 
reasonable relatve to the benefts. Examples  Yot have already condtcted a Phase 1 sttdy of an experimental drtg which  
stpports the Phase 2 sttdy yot are now proposing to do; yot have already done a small pilot sttdy showing that the 
reading skills interventon yot plan to tse is feasible in an afer-school program with classroom aides; yot have 
experience with the type of strgery that is reqtired to implant the sttdy device; yot have a sttdy coordinator who is 
experienced in working with stbjects who have signifcant cognitve impairment.
The Orthodontics Graduate Clinic currently recommends the use of analgesics for pain management.  
1.9 Supplemeits. Ceeck tll boxe  tett tpply, to idenify Supplement  you  eould complete tnd uplotd to tee 
Supportin Documeits SmtrtForm in Zipline.
This secton is here instead of at the end of the form to redtce the risk of dtplicatng informaton in this IRB Protocol form that  
yot will need to provide in these Stpplements.
Check all 
That Apply
Type of Research
Supplemeit Name
Departmeit of Defeise
Tee re etrce involve  Deptrtment of Defen e fundinw, ftciliie , dttt, or 
per onnel.
ZIPLINE
 
  SUPPLEMENT: 
 
 
Deptrtment of Defen e
Departmeit of Eierny
Tee re etrce involve  Deptrtment of Enerwy fundinw, ftciliie , dttt, or 
per onnel.
ZIPLINE
 
  SUPPLEMENT: 
 
 
Deptrtment of Enerwy
Drun, biolonic, botaiical, supplemeit
Procedure  involve tee u e of tny druw, biolowic, bottnictl or 
 upplement, even if tee item i  not tee focu  of your re etrce
ZIPLINE
 
  SUPPLEMENT: 
 
 
Druw 
X
Emerneicy exceptoi to iiformed coiseit 
Re etrce tett require  tei   pecitl con ent  tiver for re etrce involvinw 
more tetn minimtl ri k
ZIPLINE
 
  SUPPLEMENT: 
 
 
Excepion from Informed 
Con ent for Emerwency 
Re etrce (EFICn
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Geiomic data shariin
Genomic dttt tre beinw collected tnd  ill be depo ited in tn externtl 
dtttbt e ( uce t  tee NIH dbGtP dtttbt en for  etrinw  ite oteer 
re etrceer 
ZIPLINE
 
  SUPPLEMENT: 
 
 
Genomic Dttt Setrinw
Medical device
Procedure  involve tee u e of tny medictl device, even if tee device i  
not tee focu  of your re etrce, except  een tee device i  FDA-tpproved 
tnd i  beinw u ed terouwe t clinictl ftcility in tee mtnner for  eice it i  
tpproved
ZIPLINE
 
  SUPPLEMENT: 
 
 
Device 
Mult-site study
(You tre t kinw tee UW IRB to revie  one or more  ite  in t muli- ite 
 tudy.n
ZIPLINE
 
  SUPPLEMENT: 
 
 
Ptriciptinw Site in Muli-
Site Re etrce
Partcipait results shariin
Individutl re etrce re ult   ill be  etred  ite  ubject .
ZIPLINE
 
  SUPPLEMENT: 
 
 
Ptriciptnt Re ult  
Setrinw
None of tee tbove
2 PARTICIPANTS
2.1 Partcipaits. De cribe tee wenertl cetrtcteri ic  of tee  ubject popultion  or wroup , includinw twe rtnwe, 
wender, eetlte  tttu , tnd tny oteer relevtnt cetrtcteri ic .
Males and females aged 12-59 in good health currently in orthodontic treatment.
2.2 Iiclusioi aid exclusioi criteria. De cribe tee  pecifc criterit you  ill u e to decide  eo  ill be included in your 
 tudy from tmonw intere ted or potenitl  ubject . Defne tny tecenictl term  in lty ltnwutwe.
Include:
-Age 12-59
Exclude patient with:
-History of taking an analgesic in the past six hours
-Hypersensitivity to ibuprofen or acetaminophen
-Aspirin-sensitive asthma
-Renal or liver impairment
-History of GI bleeding or ulcers
-Cardiovascular disease, recent myocardial infarction, heart failure, or coronary artery bypass graft surgery
-Currently taking antibiotics or other medications for a chronic systemic disease
-Bleeding disorder
-Pregnant or nursing
2.3 Prisoiers. IRB tpprovtl i  required in order to include pri oner  in re etrce, even  een pri oner  tre not tn 
intended ttrwet popultion.
a. Will you recruit or obttin dttt from individutl  tett you kno  to be pri oner ?
For records reviews  if the records do not indicate prisoner statts and prisoners are not a target poptlaton, select “No”. 
See the WORKSHEET  Prisoners for the defniton of “prisoner”.  
X
No
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Yes
 If ye , tn  er tee follo inw que ion  (i   ivn.
i. De cribe tee type of pri oner , tnd  eice pri on /jtil :
     
ii. One concern tbout pri oner re etrce i   eeteer tee effect of ptriciption on pri oner ’ 
wenertl livinw condiion , medictl ctre, qutlity of food, tmeniie , tnd opportunity for 
etrninw  in pri on  ill be  o wrett tett it  ill mtke it difcult for pri oner  to tdequttely 
con ider tee re etrce ri k . Wett  ill you do to reduce tee cetnce  of tei ?
     
iii. De cribe  ett you  ill do to mtke  ure tett (tn your recruitment tnd  ubject  elecion 
procedure   ill be ftir to tll eliwible pri oner  tnd (bn pri on tuteoriie  or oteer pri oner   ill 
not be tble to trbitrtrily prevent or require ptricultr pri oner  from ptriciptinw.
     
iv. If your re etrce  ill involve pri oner  in federtl ftciliie  or in  ttte/loctl ftciliie  out ide of 
Wt einwton Sttte: ceeck tee box belo  to provide your t  urtnce tett you  ill (tn not 
encourtwe or ftcilittte tee u e of t pri oner’  ptriciption in tee re etrce to influence ptrole 
deci ion , tnd (bn cletrly inform etce pri oner in tdvtnce (for extmple, in t con ent formn 
tett ptriciption in tee re etrce  ill etve no effect on ei  or eer ptrole.
Coifirmed
b. I  your re etrce likely to etve  ubject   eo become pri oner   eile ptriciptinw in your  tudy?  
For example, a longittdinal sttdy of yotth with drtg problems is likely to have stbjects who will be prisoners at some 
point dtring the sttdy.
X
No
Yes
 If ye , if t  ubject become  t pri oner  eile ptriciptinw in your  tudy,  ill you coninue tee 
 tudy procedure  tnd/or dttt collecion  eile tee  ubject i  t pri oner?
No
Yes
 If ye , de cribe tee procedure  tnd/or dttt collecion you  ill coninue  ite 
pri oner  ubject 
     
2.4 Protected populatois. IRB tpprovtl i  required for tee u e of tee  ubject popultion  li ted eere. Ceeck tee boxe  
for tny of tee e popultion  tett you  ill purpo efully include in your re etrce. (In oteer  ord , beinw t ptrt of 
tee popultion i  tn inclu ion criterion for your  tudy.n
The WORKSHEETS describe the criteria for approval btt do not need to be completed or stbmited.  
Populatoi
Worksheet
Ceildren
WORKSHEET: Ceildren
Ceildren  eo tre  trd 
WORKSHEET: Ceildren
Fetu e  in utero
WORKSHEET: Prewntnt Women
Neontte  of uncerttin vitbility
WORKSHEET: Neontte 
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Non-vitble neontte 
WORKSHEET: Neontte 
Prewntnt  omen
WORKSHEET: Prewntnt Women
“Children” are defned as individtals who have not atained the legal age for consent to treatments or procedtres involved in 
the research and its specifc setting. This will vary according to the locaton of the research (that is, for diferent states and 
cotntries).
a. If you ceeck tny of tee boxe  tbove, u e tei   ptce to provide tny informtion you teink mty be relevtnt for 
tee IRB to con ider. 
     
2.5 Natve Americais or ioi U.S. iidineious populatois. Will you tcively recruit from Ntive Americtn or non-U.S. 
indiwenou  popultion  terouwe t tribe, tribe-focu ed orwtniztion, or  imiltr community-bt ed orwtniztion?
Indigenots people are defned in internatonal or natonal legislaton as having a set of specifc rights based on their historical 
tes to a partctlar territory and their ctlttral or historical distnctveness from other poptlatons that are ofen politcally 
dominant. 
Examples   a reservaton school or health clinic; recrtitng dtring a tribal commtnity gathering
X
No
Ye
s
 If ye , ntme tee tribe, tribtl-focu ed orwtniztion, or  imiltr community bt ed orwtniztion. Tee 
UW IRB expect  tett you  ill obttin tribtl/indiwenou  tpprovtl before bewinninw your re etrce.
     
2.6 Third party subjects. Will you collect privtte ideniftble informtion tbout other individtals from your  ubject ? 
Common extmple  include: collecinw medictl ei tory informtion or conttct informtion tbout ftmily member , 
friend , co- orker .
“Identfable” means any direct or indirect identfer that, alone or in combinaton, wotld allow yot or another member of 
yotr research team to readily identfy the person. For example, stppose that yot are sttdying immigraton history. If yot ask 
yotr stbjects several qtestons abott their grandparents btt yot do not obtain names or other informaton that wotld allow 
yot to readily identfy the grandparents, then yot are not collectng private identfable informaton abott the grandparents. 
X
No
Yes
 If ye , tee e individutl  tre con idered eumtn  ubject  in your  tudy. De cribe teem tnd  ett 
dttt you  ill collect tbout teem.
     
2.7 Number of subjects. Ctn you predict or de cribe tee mtximum number of  ubject  (or  ubject unit n you need to 
complete your  tudy, for etce  ubject wroup?
Stbject tnits mean tnits within a grotp. For most research sttdies, a grotp will consist of individtals. However, the tnit of 
interest in some research is not the individtal. Examples   

Dyads stch as caregiver-and-Alzheimer’s patent, or parent and child

Families

Other tnits, stch as sttdent-parent-teacher
Stbject grotp means categories of stbjects that are meaningftl for yotr research. Some research has only one stbject grotp – 
for example, all UW sttdents taking Introdtctory Psychology. Some common ways in which stbjects are grotped incltde 
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
By interventon – for example, an interventon grotp and a control grotp.

By stbject poptlaton or setting – for example, trban versts rtral families

By age – for example, children who are 6, 10, or 14 years old. 
The IRB reviews the ntmber of stbjects yot plan to sttdy in the context of risks and benefts. Yot may stbmit a Modifcaton 
to increase this ntmber at any tme afer yot receive IRB approval. If the IRB determines that yotr research involves no more 
than minimal risk  yot may exceed the approved ntmber and it will not be considered non-compliance. If yotr research 
involves more than minimal risk  exceeding the approved ntmber will be considered non-compliance. 
No
 If no, provide your rtiontle in tee box belo . Al o, provide tny informtion you ctn tbout tee 
 cope/ ize of tee re etrce. You do not need to complete tee ttble.
Example  yot may not be able to predict the ntmber of stbjects who will complete an online strvey 
advertsed throtgh Craigslist, btt yot can state that yot will post yotr strvey for two weeks and the ntmber 
who respond is the ntmber who will be in yotr sttdy.
     
X
Yes
 If ye , for etce  ubject wroup, u e tee ttble belo  to provide your e imtte of tee mtximum 
de ired number of individutl  (or oteer  ubject unit,  uce t  ftmilie n  eo  ill complete tee 
re etrce.
Group iame/descriptoi
Maximum desired iumber of iidividuals (or other 
subject uiit, such as families) who will complete 
the research
*For clinical trials: provide numbers for your site and 
for the study-wide total number
Acetaminophen/Ibuprofen 
60
Acetaminophen
60
Ibuprofen
60
3 INTERNATIONAL RESEARCH SETTING
Aiswer the questois ii this sectoi ONLY if your research will occur at sites outside of the Uiited 
States
3.1 Reasoi for sites. De cribe tee ret on( n  ey you  elected tee  ite   eere you  ill conduct tee re etrce.
     
3.2 Local coitext. Culturtlly-tppropritte procedure  tnd tn under ttndinw of loctl context tre tn importtnt ptrt of 
protecinw  ubject . De cribe tny  ite- pecifc culturtl i  ue , cu tom , belief , or vtlue  tett mty tffect your 
re etrce or eo  it i  conducted.
Examples  It wotld be ctlttrally inappropriate in some internatonal settings for a woman to be directly contacted by a male 
researcher; instead, the researcher may need to ask a male family member for permission before the woman can be 
approached. It may be appropriate to obtain permission from commtnity leaders prior to obtaining consent from individtal 
members of a grotp.
This federal site maintains an internatonal list of htman research standards and reqtirements 
 htp //www.hhs.gov/ohrp/internatonal/index.html 
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3.3 Site-specific laws. De cribe tny loctl lt   tett mty tffect your re etrce (e pecitlly tee re etrce de iwn tnd 
con ent procedure n. Tee mo t common extmple  tre lt   tbout:

Specimeis   for extmple,  ome countrie   ill not tllo  bio pecimen  to be ttken out of tee country.

Ane of coiseit   lt   tbout  een tn individutl i  con idered old enouwe to be tble to provide con ent vtry 
tcro    ttte , tnd tcro   countrie .  

Lenally authorized represeitatve   lt   tbout  eo ctn  erve t  t lewtlly tuteorized repre enttive (tnd  eo 
et  priority  een more tetn one per on i  tvtiltblen vtry tcro    ttte  tnd countrie .

Use of healthcare records   mtny  ttte  (includinw Wt einwton Sttten etve lt   tett tre  imiltr to tee 
federtl HIPAA lt  but tett etve tddiiontl requirement .
     
3.4 Site-specific admiiistratve or ethical requiremeits. De cribe loctl tdmini trtive or eteictl requirement  tett 
tffect your re etrce. 
Example  A school district may reqtire yot to obtain permission from the head district ofce as well as school principals 
before approaching teachers or sttdents; a factory in China may allow yot to interview factory workers btt not allow yot to 
pay them. 
     
4 RECRUITING aid SCREENING PARTICIPANTS
4.1 Recruitin aid Screeiiin. De cribe eo  you  ill idenify, recruit, tnd  creen  ubject . Include informtion tbout: 
eo ,  een,  eere, tnd in  ett  etnw. Idenify  eo (by po iion or role, not ntmen  ill tpprotce tnd recruit 
 ubject , tnd  eo  ill  creen teem for eliwibility.  
Patients of the University of Washington Department of Orthodontics that are scheduled for archwire adjustments 
from March to June 2017 will be screened for this study.  Upon check in for their appointment, the clinic will be 
instructed to provide the patient with a recruitment flyer regarding the study.  Interested participants will return the 
flyer to the front desk and the principal investigator will meet with them before the scheduled appointment to 
review the consent form.  Participants will be asked if they meet all of the eligibility requirements that are outlined 
on the application.  The consent form will have a description of the study included in it and will be used to help 
answer any questions that the participant may have.
4.2 Recruitmeit materials. 
a. Wett mtteritl  (if tnyn  ill you u e to recruit tnd  creen  ubject ?
Examples  talking points for phone or in-person conversatons; video or atdio presentatons; websites; social media 
messages; writen materials stch as leters, fyers for postng, brochtres, or printed advertsements; qtestonnaires flled 
ott by potental stbjects.
Recruitment flyers will be available for the front office staff of the clinic.  The front office staff is able to view 
the reason for the appointment and will distribute the recruitment flyer when the patient checks in. 
The consent form will be used to help explain the details of the study as well as answer any questions.
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b. Uplotd de cripion  of etce type of mtteritl (or tee mtteritl  teem elve n to tee Coiseit Forms aid 
Recruitmeit Materials SmtrtForm of Zipline. If you  ill  end leter  to tee  ubject , tee leter  eould include t 
 tttement tbout eo  you obttined tee  ubject’  ntme, conttct informtion, tnd tny oteer  ubject- pecifc 
informtion ( uce t  t eetlte condiionn tett i  menioned in tee leter. 
HSD encotrages researchers to consider tploading descriptons of most recrtitment and screening materials instead of the 
materials themselves. The goal is to provide the researchers with the fexibility to change some informaton on the materials  
withott stbmitting a Modifcaton for IRB approval of the changes. Examples 

Yot cotld provide a list of talking points that will be tsed for phone or in-person conversatons instead of a script.  

For the descripton of a fyer, yot might incltde the informaton that it will provide the sttdy phone ntmber and the 
name of a sttdy contact person (withott providing the acttal phone ntmber or name). In doing so, yot wotld not 
need to stbmit a Modifcaton if/when the sttdy phone ntmber or contact person changes. Also, instead of listng the  
incltsion/excltsion criteria, yot might state that the fyer will list one or a few of the major incltsion/excltsion 
criteria.

For the descripton of a video or a website, yot might incltde a descripton of the possible vistal elements and a list 
of the content (e.g., sttdy phone ntmber; sttdy contact person; top three incltsion/excltsion criteria; payment of 
$50; sttdy name; UW researcher). 
4.3 Relatoiship with partcipait populatoi. Do tny member  of tee  tudy tetm etve tn exi inw reltion eip  ite 
tee  tudy popultion( n? 
Examples  a sttdy team member may have a dtal role with the sttdy poptlaton (for example, being their clinical care 
provider, teacher, laboratory directory or tribal leader in additon to recrtitng them for his/her research).
X
No
Yes
 If ye , de cribe tee ntture of tee reltion eip.
     
4.4 Paymeit to partcipaits. De cribe tny ptyment you  ill provide, includinw:

Tee tottl tmount/vtlue

Weeteer ptyment  ill be “pro-rtted”  o tett ptriciptnt   eo tre untble to complete tee re etrce mty  ill 
receive  ome ptrt of tee ptyment
The IRB expects the consent process or sttdy informaton provided to the stbjects to incltde informaton abott the ntmber 
and amotnt of payments, and especially the tme when stbjects can expect to receive payment. One of the most freqtent 
complaints received by HSD is from stbjects who expected to receive cash or a check on the day that they completed a sttdy 
and who were angry or disappointed when payment took 6-8 weeks to reach them. 
Do not incltde a descripton of any expenses that will be reimbtrsed. 
When the participants return the completed workbook they will be able to enter a raffle for one of four $50 VISA 
gift cards.  The participant will tear off the provided card on last page of their workbook, write their contact 
information, and place it in a locked collection box.  Participants that elected to complete the electronic version of 
the workbook will be entered into the raffle when their last entry has been submitted.  At the conclusion of the 
study, four of the raffle tickets will be randomly drawn.  The winners will be contacted and instructed to claim 
their prize at the front office at their next appointment or at an agreed upon time.
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4.5 Noi-moietary compeisatoi. De cribe tny non-monettry compen tion you  ill provide. Extmple: extrt credit 
for  tudent ; t toy for t ceild. If you  ill be offerinw clt   credit to  tudent , you mu t provide (tnd de criben tn 
tlterntte  ty for tee  tudent  to etrn tee extrt credit  iteout ptriciptinw in your re etrce. 
     
4.6 Coiseit for recruitin aid screeiiin. Will you obttin con ent for tny of tee recruiinw tnd  creeninw procedure ? 
(Secion 8: Con ent of Adult  t k  tbout con ent for tee mtin  tudy procedure n.
“Consent” incltdes  consent from individtals for their own partcipaton; parental permission; assent from children; consent 
from a legally atthorized representatve for adtlt individtals who are tnable to provide consent.
Examples   

For a sttdy in which names and contact informaton will be obtained from a registry  the registry shotld have consent  
from the registry partcipants to release their names and contact informaton to researchers.

For a sttdy in which possible stbjects are identfed by screening records  there will be no consent process. 

For a sttdy in which individtals respond to an annotncement and call into a sttdy phone line  the sttdy team person 
talking to the individtal may obtain non-writen consent to ask eligibility qtestons over the phone. 
X
No
 If no, you mu t  ill tn  er questoi 
 
 4.7
 
  belo .
Yes
 If ye , de cribe tee con ent proce  .
     
a. Documenttion of con ent. Will you obttin t  riten or veriftble electronic  iwntture from tee 
 ubject on t con ent form to document con ent for tll of tee recruitin aid screeiiin 
procedures?
No
 If no, de cribe tee informtion you  ill provide durinw tee con ent proce   tnd 
for  eice procedure .
     
Yes
 If ye , uplotd tee con ent form to tee Coiseit Forms aid Recruitmeit Materials 
ptwe of Zipline.
4.7 Data aid specimeis for recruitin aid screeiiin. For  tudie   eere you  ill obttin con ent, de cribe tny dttt 
tnd/or  pecimen  (includinw tny PHIn you  ill obttin for recruiinw tnd  creeninw (prior to obttininw con entn tnd 
 eeteer you  ill rettin it t  ptrt of tee  tudy dttt. 
Obtain means to possess or record in any fashion (writng, electronic doctment, video, email, voice recording, etc.) for 
research ptrposes and to retain for any length of tme.
Examples  names and contact informaton; the informaton gathered from records that were screened; restlts of screening 
qtestonnaires or screening blood tests; Protected Health Informaton (PHI) from screening medical records to identfy 
possible stbjects.
The front office staff that will be distributing the recruitment flyers will not obtain any additional data from this 
study than they normally would.  The research team will not obtain any data until the participant has expressed 
interest.
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5 PROCEDURES
5.1 Study procedures. U inw lty ltnwutwe, provide t complete de cripion of tee  tudy procedure , includinw tee 
 equence, intervenion or mtnipultion (if tnyn, ime required, tnd  etnw/loction. If it i  tvtiltble tnd you teink 
it  ould be eelpful to tee IRB: Uplotd t  tudy flo   eeet or ttble to tee Supportin Documeits SmtrtForm in 
Zipline. 
For sttdies comparing standards of care  It is important to acctrately identfy the research procedtres. See UW IRB POLICY: 
Risks of Harm from Standard Care and the draf gtidance from the federal Ofce of Htman Research Protectons, “Guidance 
on Disclosing Reasonably Foreseeable Risks in Research Evaluatng Standards of Care”;
 
  October 20, 2014.
There will be three groups of medication: acetaminophen (650mg); ibuprofen (400mg); and 
acetaminophen (650mg) + ibuprofen (400mg). The medications will be prepared by the Kelley-Ross 
Compounding Group (Seattle, WA) to make each medication similar in appearance in order to prevent 
recognition of the medication by the investigator or participant. The medications will be placed in individual 
vials and labeled as either A, B, or C.  A sealed document will be sent with the medications that can properly 
identify which medications were assigned to each group, and this document will not be opened until the 
conclusion of the study.
During the informed consent process, participants will be asked if they meet all of the eligibility 
requirements that are outlined on the recruitment flyer.  After reviewing and signing the informed consent, 
each eligible patient will be given a workbook that has a pre-designated participant number.  A master list 
will be made in Microsoft Excel that uses a random number generator to randomly assign each participant 
number to Group A, B, or C, which will correspond to the indicated medication that is to be delivered.  The 
appropriate medication will be administered with a 3 oz. paper cup of water.  The patient will give the 
provider the first page of the workbook to complete.  The provider will record the patient’ age, gender, and 
give a brief description of the treatment that will be completed at the appointment.  Once completed, the 
information will be returned to the principal investigator at the front desk.
Pain intensity will be measured using a numerical visual analog scale (VAS) immediately following 
drug administration, 6 hours after orthodontic treatment, the next morning after orthodontic treatment, the 
second morning after orthodontic treatment.  At the aforementioned time periods, the participant will record 
their pain on the VAS for each of the following scenarios: teeth at rest, back teeth lightly touching, and when 
chewing a small piece (~0.5 inch) of provided wax.  Participants will be instructed to not use other analgesics 
during the week if they can help it.  If the participant must use an analgesic, they should record the time, 
name, and amount taken.
The participant will have the option to complete the recordings digitally through the website Catalyst.  
If the participant does not wish to complete the submissions online, then they will be given paper copies of 
the workbook to take home with them.  Once completed, the patient can return the workbook at their next 
appointment.  When returning the completed workbook, participants have the option of tearing off the last 
page of their workbook, writing their contact information, and entering it into a raffle for one of four $50 gift 
cards.  Participants electing to complete the recordings digitally will be entered into the raffle upon 
submission of their last recording.   
The recordings from the VAS workbooks will becompiled in Microsoft Excel.
There will be three groups of medication: acetaminophen (650mg); ibuprofen (400mg); and 
acetaminophen (650mg) + ibuprofen (400mg). The medications will be prepared by the Kelley-Ross 
Compounding Group (Seattle, WA) to make each medication similar in appearance in order to prevent 
recognition of the medication by the investigator or participant. The medications will be placed in 
individual vials and labeled as either A, B, or C.  A sealed document will be sent with the medications 
that can properly identify which medications were assigned to each group, and this document will not be 
opened until the conclusion of the study.
During the informed consent process, participants will be asked if they meet all of the eligibility 
requirements that are outlined on the recruitment flyer.  After reviewing and signing the informed 
consent, each eligible patient will be given a workbook that has a pre-designated participant number.  A 
master list will be made in Microsoft Excel that uses a random number generator to randomly assign 
each participant number to Group A, B, or C, which will correspond to the indicated medication that is to 
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be delivered.  The appropriate medication will be administered with a 3 oz. paper cup of water.  The 
patient will give the provider the first page of the workbook to complete.  The provider will record the 
patient’ age, gender, and give a brief description of the treatment that will be completed at the 
appointment.  Once completed, the information will be returned to the principal investigator at the front 
desk.
Pain intensity will be measured using a numerical visual analog scale (VAS) immediately 
following drug administration, 6 hours after orthodontic treatment, the next morning after orthodontic 
treatment, the second morning after orthodontic treatment.  At the aforementioned time periods, the 
participant will record their pain on the VAS for each of the following scenarios: teeth at rest, back teeth 
lightly touching, and when chewing a small piece (~0.5 inch) of provided wax.  Participants will be 
instructed to not use other analgesics during the week if they can help it.  If the participant must use an 
analgesic, they should record the time, name, and amount taken.
The participant will have the option to complete the recordings digitally through the website 
Catalyst.  If the participant does not wish to complete the submissions online, then they will be given 
paper copies of the workbook to take home with them.  Once completed, the patient can return the 
workbook at their next appointment.  When returning the completed workbook, participants have the 
option of tearing off the last page of their workbook, writing their contact information, and entering it into 
a raffle for one of four $50 gift cards.  Participants electing to complete the recordings digitally will be 
entered into the raffle upon submission of their last recording.   
The recordings from the VAS workbooks will be compiled in Microsoft Excel.
5.2 Data variables. De cribe tee  pecifc dttt you  ill obttin (includinw t de cripion of tee mo t  en iive item n. If 
you  ould prefer, you mty uplotd t li t of tee dttt vtritble  to tee Supportin Documeits SmtrtForm in tetd of 
de cribinw tee vtritble  belo .
Age, sex, description of treatment during the appointment, did the patient take any additional pain medications 
during the study, and pain scores during rest, light biting, and chewing at several time points (immediately 
following drug administration, 6 hours, the next morning, and the second morning after orthodontic treatment.
5.3 Data sources. For tll type  of dttt tett you  ill tcce   or collect for tei  re etrce: Idenify  eeteer you tre 
obttininw tee dttt from tee  ubject  (or  ubject ’  pecimen n or  eeteer you tre obttininw tee dttt from  ome 
oteer  ource (tnd idenify tee  ourcen.
If yot have already provided this informaton in Qteston 5.1, yot do not need to repeat the informaton here.
Patient appointments for the University of Washington Department of Orthodontics clinic during March to June 
2017 will be screened for arch wire adjustment appointments.  The applicable appointments will be given a 
recruitment flyer.
Patients will be given a paper or online workbook to record their pain on a visual analogue scale (VAS) to return 
at their next scheduled appointment and their provider will complete a short questionnaire.  
5.4 Retrospectve/prospectve. For tll type  of dttt tnd  pecimen  tett you  ill tcce   or collect for tei  re etrce: 
De cribe  eice dttt tre:

Retro pecive (i.e., exi t tt tee ime  een you  ubmit tei  tpplictionn

Pro pecive (i.e., do not yet exi t tt tee ime  een you  ubmit tei  tpplictionn

Bote retro pecive tnd pro pecive (for extmple, pt t tnd future  ceool record n
Prospective: Workbook of pain recordings and questionnaire
Both: Patient appointments for archwire adjustments
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5.5 Ideitfiability of data aid specimeis. An  er tee e que ion  ctrefully tnd completely. Tei   ill tllo  HSD to 
tccurttely determine tee type of revie  tett i  required tnd to t  i t you in idenifyinw relevtnt complitnce 
requirement . Revie  tee follo inw defniion  before tn  erinw tee que ion :
Access means to view or perceive data, btt not to possess or record it. See, in contrast, the defniton of “obtain”.
Identiable means that the identfy of an individtal is or may be readily (1) ascertained by the researcher or any other 
member of the sttdy team from specifc data variables or from a combinaton of data variables, or (2) associated with the 
informaton. 
Direct identiers are direct links between a stbject and data/specimens. Examples incltde (btt are not limited to)  name, date  
of birth, medical record ntmber, email or IP address, pathology or strgery accession ntmber, sttdent ntmber, or a collecton 
of yotr data that is (when taken together) identfable. 
Indirect identiers are informaton that links between direct identfers and data/specimens. Examples  a stbject code or 
psetdonym.  
Key refers to a single place where direct identfers and indirect identfers are linked together so that, for example, coded data  
can be identfed as relatng to a specifc person. Example  a master list that contains the data code and the identfers linked 
to the codes.
Obtain means to possess or record in any fashion (writng, electronic doctment, video, email, voice recording, etc.) for 
research ptrposes and to retain for any length of tme. This is diferent from accessing, which means to view or perceive data. 
a. Will you or tny member  of your tetm etve tcce   to tny direct or indirect idenifer ?
Yes
 If ye , de cribe  eice idenifer  tnd for  eice dttt/ pecimen . 
  
X
No
 If no,  elect tee ret on( n  ey you (tnd tll member  of your tetmn  ill not etve tcce   to 
direct or indirect idenifer .
Teere  ill be no idenifer . 
X
Idenifer  or tee key etve been (or  ill etve beenn de troyed before you etve tcce  . 
You etve (or  ill etven entered into tn twreement  ite tee eolder of tee idenifer  (or 
keyn tett proeibit  tee relet e of tee idenifer  (or keyn to you under tny 
circum ttnce .  
Yot shotld be able to prodtce this agreement for IRB tpon reqtest. Examples  a Data Use 
Agreement, Repository Gatekeeping form, or doctmented email.
Teere tre  riten policie  tnd procedure  for tee repo itory/dtttbt e/dttt 
mtntwement center tett proeibit tee relet e of tee idenifer  (or idenifyinw linkn. Tei  
include   itution  involvinw tn Hone t Broker.
Teere tre oteer lewtl requirement  proeibiinw tee relet e of tee idenifer  or key to 
you. De cribe teem belo .  
     
b. Will you obttin tny direct or indirect idenifer ?
X
Yes
 If ye , de cribe  eice idenifer  tnd for  eice dttt/ pecimen .
Participants may opt to sign up for text/email reminders to complete the recordings which 
would make it necessary for the research team to obtain the patient’s phone number or 
email address.
Patients may elect to be entered into a raffle at the end of their participation in the study.  
Participants can record their contact information on a blank card that will have no 
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identifiers to their data.  
No
 If no,  elect tee ret on( n  ey you (tnd tll member  of your tetmn  ill not obttin direct or 
indirect idenifer .
Teere  ill be no idenifer . 
Idenifer  or tee key etve been (or  ill etve beenn de troyed before you etve tcce  . 
You etve (or  ill etven entered into tn twreement  ite tee eolder of tee idenifer  (or 
keyn tett proeibit  tee relet e of tee idenifer  (or keyn to you under tny 
circum ttnce .  
Yot shotld be able to prodtce this agreement for IRB tpon reqtest. Examples  a Data Use 
Agreement, Repository Gatekeeping form, or doctmented email.
Teere tre  riten policie  tnd procedure  for tee repo itory/dtttbt e/dttt 
mtntwement center tett proeibit tee relet e of tee idenifer  (or idenifyinw linkn. Tei  
include   itution  involvinw tn Hone t Broker.
Teere tre oteer lewtl requirement  proeibiinw tee relet e of tee idenifer  or key to 
you. De cribe teem belo .  
     
c. If you obttin tny idenifer , indictte eo  tee idenifer   ill be  tored (tnd for  eice dtttn.
You  ill  tore tee idenifer   ite tee dttt. De cribe tee dttt to  eice tei  tpplie :
     
You  ill  tore idenifer  tnd  tudy dttt  eptrttely but you  ill mtinttin t link 
bet een tee idenifer  tnd tee  tudy dttt (for extmple, terouwe tee u e of t coden. 
De cribe tee dttt to  eice tei  tpplie :
X
 Participants electing to receive notifications to complete the submissions will have the 
provided contact information (phone number or email) recorded.  The contact 
information will be recorded on a separate computer file than the data but linked with a 
participant number. 
You  ill  tore idenifer   eptrttely from tee  tudy dttt,  ite no link bet een tee 
idenifer  tnd tee  tudy dttt. De cribe tee dttt to  eice tei  tpplie :
X
All data will be returned to the front office.  There will be a locked box in the front 
office for participants to enter their contact information into.
d. Research collaboratoi. Will individutl   eo provide you  ite coded informtion or  pecimen  for your 
re etrce tl o colltbortte on oteer tciviie  for tei  re etrce? If ye , idenify tee tciviie  tnd provide tee 
ntme of tee colltborttor’  in ituion/orwtniztion.
Examples incltde btt are not limited to  (1) sttdy, interpretaton, or analysis of the data that restlts from the coded 
informaton or specimens; and (2) atthorship on presentatons or mantscripts related to this work.
     
5.6 Newbori dried blood spots. Will you u e ne born dried blood pot  collected in tee United Sttte  on or tfer 
Mtrce 18, 2015?
X
No
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Ye
s
 If ye , i  tei  re etrce  upported by tny federtl fundinw (includinw tny fello  eip or ctreer 
development t trd tett provide   tltry  upportn?
No
Yes
 If ye , de cribe eo  you  ill en ure tett tee blood pot   ere collected  ite 
ptrenttl permi  ion (in complitnce  ite t 2015 lt  tett tpplie  to federtl-funded 
re etrcen.
     
5.7 Protected Health Iiformatoi (PHI). Will you tcce  , obttin, u e, or di clo e t ptriciptnt’  ideniftble PHI for tny 
ret on (for extmple, to idenify or  creen potenitl  ubject , to obttin  tudy dttt or  pecimen , for  tudy follo -
upn tett doe  not involve tee cretion or obttininw of t Limited Dttt Set?
PHI is individtally-identfable healthcare record informaton or clinical specimens from an organizaton considered a “covered 
entty” by federal HIPAA regtlatons, in any form or media, whether electronic, paper, or oral.
No
 If no,  kip tee re t of tei  que ion; wo to que ion
 
  5.8
 
 
X
Yes
 If ye , tn  er tll of tee que ion  belo .
a. De cribe tee PHI you  ill tcce   or obttin, tnd tee ret on for obttininw it. Be specifc.
Ptient tppointment informtion  ill be tcce  ed for tee UW-Orteodonic  clinic for tll ptient  
for tee durtion of tee  tudy (April   June 2017n tnd  ill include ntme, peone number, tnd 
ret on for vi it.
b. I  tny of tee PHI loctted in Wt einwton Sttte?
No
X
Yes
c. De cribe eo  you  ill tcce   or obttin tee PHI. Be specifc.
Ween tee ptient ceeck -in for teeir tppointment tt tee Orteodonic  clinic, tee front ofce  ttff 
member   ill be tble to  ee tee ptient’  ntme, peone number, tnd ret on for teeir vi it.  If tee 
ret on for tee vi it for tee ptient involve  trce ire tdju tment teen tee front ofce  ttff  ill 
etnd tee ptient t recruitment flier.
If tee ptient i  intere ted in more informtion tbout ptriciption in tee  tudy teen tee ptient 
 ill noify tee front ofce tnd  ill be wreeted by tee principtl inve iwttor.  
d. For  eice PHI  ill you obttin HIPAA tuteoriztion from tee  ubject  by etvinw teem  iwn t HIPAA 
Auteoriztion form, before obttininw tnd u inw tee PHI? 
None
Confrm by ceeckinw tee box tett you  ill u e tee UW Medicine HIPAA Auteoriztion form 
mtinttined on tee HSD  eb ite if you  ill tcce  , obttin, u e, or di clo e UW Medicine PHI.
X
Coifirmed
e. For  eice PHI  ill you NOT obttin HIPAA tuteoriztion from tee  ubject ?
Patient appointment information.
Provide tee follo inw t  urtnce  by ceeckinw tee boxe .
Tee PHI  ill not be reu ed or di clo ed to tny oteer per on or enity, except t  required by 
lt , for tuteorized over iwet of tee re etrce  tudy, or for oteer re etrce for  eice tee u e or 
     X
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di clo ure of PHI  ould be permited.
You  ill fulfll tee HIPAA “tccouninw for di clo ure ” requirement. See UW Medicine Privtcy 
Policy #25. THIS IS ONLY FOR UW RECORDS.
 
     X
Teere  ill be ret ontble  tfewutrd  to protect twtin t idenifyinw, directly or indirectly, tny 
ptient in tny report of tee re etrce.
     X
5.8 Geiomic data shariin. Will you obttin or wenertte wenomic dttt (t  defned tt 
htps //gds.nih.gov/13faqsogds.htmln?
X
No
Yes
 If ye , tn  er tee que ion belo .
a. I  tei  re etrce funded by NIH terouwe t wrtnt or contrtct tppliction  ubmited to NIH on or 
tfer Jtnutry 25, 2015?
No
Yes
 If ye , you mu t comply  ite tee NIH Genomic Dttt Setrinw policy. Complete 
tee ZIPLINE
 
  SUPPLEMENT Geiomic Data Shariin
 
  tnd uplotd it to tee 
Supportin Documeits SmtrtForm of Zipline.
5.9 Data aid specimei shariin/baikiin. Do you pltn to  etre  ome or tll of tee dttt,  pecimen , or  ubject conttct 
informtion  ite oteer re etrceer  or t repo itory/dtttbt e, or to btnk teem for your o n future un pecifed 
re etrce u e ? You are stroinly eicouraned to coisider the broadest possible future plais you minht have, aid 
whether you will obtaii coiseit iow from the subjects for future shariin or uispecified uses. An  er NO if 
your only  etrinw  ill be terouwe tee NIH Genomic Dttt Setrinw de cribed in que ion 5.8.
Many federal grants and contracts now reqtire data or specimen sharing as a conditon of ftnding, and many jotrnals reqtire  
data sharing as a conditon of ptblicaton. “Sharing” may incltde  informal arrangements to share yotr banked 
data/specimens with other investgators; establishing a repository from which yot formally share with others throtgh writen 
agreements; or sending yotr data/specimens to a third party repository/archive/entty stch as the NIH dbGaP database, the 
Social Science Open Access Repository (SSOAR), or the UCLA Ethnomtsicology Archive.  
X
No
Ye
s
 If ye , tn  er tll of tee que ion  belo .
a. De cribe  ett  ill be  tored, includinw  eeteer tny direct or indirect (e.w.,  ubject code n 
idenifer   ill be  tored. 
     
b. De cribe  ett  ill be  etred, includinw  eeteer direct idenifer   ill be  etred tnd (for 
 pecimen n  ett dttt  ill be relet ed  ite tee  pecimen . 
     
c. Weo  ill over ee tnd/or mtntwe tee  etrinw?. 
     
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d. De cribe tee po  ible future u e , includinw limittion  or re tricion  (if tnyn on future u e  or 
u er . A   ttted tbove, con ider tee brotde t po  ible u e .
Examples  data will be tsed only for cardiovasctlar research; data will not be tsed for research on 
poptlaton origins.
     
e. Con ent. Will you obttin con ent no  from  ubject  for tee btnkinw tnd/or future  etrinw? 
No
Yes
 If ye , be  ure to include tee informtion tbout tei  con ent proce   in tee 
con ent form (if teere i  onen tnd in your tn  er  to tee con ent que ion  in 
Secion 6.
f. Witedrt tl. Will  ubject  be tble to  itedrt  teeir dttt/ pecimen  from btnkinw or  etrinw? 
No
Yes
 If ye , de cribe eo , tnd  eeteer teere tre tny limittion  on  itedrt tl.
Example  data can be withdrawn from the repository btt cannot be retrieved afer they 
are released.
     
n. Awreement  for  etrinw or relet e. Confrm by ceeckinw tee box tett you  ill comply  ite UW 
(tnd, if tpplictble, UW Medicinen policie  tett require t formtl twreement bet een you tnd 
tee recipient for relet e of dttt or  pecimen  to individutl  or eniie  oteer tetn federtl 
dtttbt e .  
Data Use Agreements or Gatekeeping forms are tsed for data; Material Transfer Agreements are tsed 
for specimens (or specimens plts data. Do not atach yotr template agreement forms; the IRB neither 
reviews nor approves them
Coifirmed
5.10 Commuiicatoi with subjects duriin the study. De cribe tee type  of communiction (if tnyn you  ill etve  ite 
tlretdy-enrolled  ubject  durinw tee  tudy. Provide t de cripion in tetd of tee tctutl mtteritl  teem elve .  
Examples  email, texts, phone, or leter reminders abott appointments or abott rettrning sttdy materials stch as a 
qtestonnaire; reqtests to confrm contact informaton. 
If reque ted, ptriciptnt   ill receive emtil or text me  twe noifction  t  reminder  to complete tee 
 ubmi  ion .
5.11 Future coitact with subjects. Do you pltn to rettin tny conttct informtion you obttin for your  ubject   o tett 
teey ctn be conttcted in tee future?
No
X
Yes
 If ye , de cribe tee purpo e of tee future conttct, tnd  eeteer u e of tee conttct informtion  ill 
be limited to your tetm; if not, de cribe  eo el e could be provided  ite tee conttct informtion. 
De cribe your criterit for tpprovinw reque t  for tee informtion.
Examples  inform stbjects abott other sttdies; ask stbjects for additonal informaton or medical record 
access that is not ctrrently part of the sttdy proposed in this applicaton; obtain another sample.
Upon completion of the study, the participant will write their contact information on a raffle 
ticket and drop it into a locked box at the front desk of the clinic.  Four raffle tickets will be 
drawn at the conclusion of the study and the respective individuals will be contacted and 
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notified to claim their prize at the front desk at a convenient time or their next appointment. 
All raffle tickets will be destroyed.
5.12 Alteriatves to partcipatoi. Are teere tny tlterntive procedure  or trettment  tett miwet be tdvtnttweou  to 
tee  ubject ?
If there are no alternatve procedtres or treatments, select “No”. Examples of advantageots alternatves  earning extra class 
credit in some tme-eqtivalent way other than research partcipaton; obtaining stpportve care or a standard clinical 
treatment from a health care provider instead of partcipatng in research with an experimental drtg. 
X
No
Yes
 If ye , de cribe tee tlterntive .
     
5.13 Upload to the Supportin Documeits SmtrtForm of Zipline tll dttt collecion form  (if tnyn tett  ill be directly 
u ed by or  ite tee  ubject , tnd tny  cript /ttlkinw point  you  ill u e to collect tee dttt. Do not include dttt 
collecion form  tett  ill be u ed to tb trtct dttt from oteer  ource  ( uce t  medictl or tctdemic record , or 
video recordinw .

Examples  strvey, qtestonnaires, stbject logs or diaries, focts grotp qtestons.

NOTE: Sometmes the IRB can approve the general content of strveys and other data collecton instrtments rather than 
the specifc form itself. This prevents the need to stbmit a modifcaton reqtest for ftttre minor changes that do not add 
new topics or increase the sensitvity of the qtestons. To reqtest this general approval, tse the text box below to identfy 
the qtestonnaires/strveys/ etc. for which yot are seeking this more general approval. Then briefy describe the scope of 
the topics yot will cover and the most personal and sensitve qtestons. The HSD staf person who screens this applicaton  
will let yot know whether this is stfcient or whether yot will need to provide more informaton.

For materials that cannot be uploaded  tpload screenshots or writen descriptons that are stfcient to enable the IRB to 
tnderstand the types of data that will be collected and the nattre of the experience for the partcipant. Yot may also 
provide URLs (website addresses) or writen descriptons below. Examples of materials that tstally cannot be tploaded  
mobile apps; comptter-administered test; licensed and restricted standardized tests.

For data that will be gathered in an evolving way  This refers to data collecton/qtestons that are not pre-determined 
btt rather are shaped dtring interactons with partcipants in response to observatons and responses made dtring those 
interactons. If this applies to yotr research, provide a descripton of the process by which yot will establish the data 
collecton/qtestons as yot interact with stbjects, how yot will doctment yotr data collecton/qtestons, the topics yot 
plan to address, the most sensitve type of informaton yot will plan to gather, and the limitatons (if any) on topics yot 
will raise or ptrste.
U e tei  text box (if de iredn to provide:

Seort  riten de cripion  of mtteritl  tett ctnnot be uplotded,  uce t  URL 

A de cripion of tee proce   you  ill u e for dttt tett  ill be wtteered in tn evolvinw  ty.

Tee wenertl content of que ionntire ,  urvey  tnd  imiltr in trument  for  eice you tre  eekinw wenertl 
tpprovtl. (See tee NOTE bullet point in tee in trucion  tbove.n
T
The online version of the workbook is in the format of a Catalyst quiz.  The online 
version asks for the participant number, the level of discomfort in the same three 
scenarios as the paper version of the workbook, and if the participant used any 
additional pain medications.  All of the questions have an option of “I wish to skip 
this question.”
T
https://catalyst.uw.edu/webq/survey/akeith/328766
5.14 Seid HSD a Coifideitality Anreemeit if you  ill obttin or u e tny privtte ideniftble UW record   iteout 
 ubject’   riten con ent (for extmple,  creeninw medictl record  or clt   wrtde  to idenify po  ible  ubject n.
The Confdentality Agreement form mtst be completed, printed, signed, and mailed to the Htman Stbjects Division at Box 
359470. Yotr IRB applicaton cannot be approved tntl we receive the Confdentality Agreement.
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6 CHILDREN (MINORS) aid PARENTAL PERMISSION
6.1 Iivolvemeit of miiors. Doe  your re etrce include minor  (ceildrenn?    
Miior or child metn   omeone  eo et  not yet tttined tee lewtl twe for con ent for tee re etrce procedure , t  
de cribed in tee tpplictble lt   of tee juri dicion in  eice tee re etrce  ill be conducted. Tei  mty or mty not 
be tee  tme t  tee defniion u ed by fundinw twencie   uce t  tee Ntiontl In itute  of Hetlte.

In Wt einwton Sttte tee weneric twe of con ent i  18, metninw tett tnyone under tee twe of 18 i  
con idered t ceild. 

Teere tre  ome procedure  for  eice tee twe of con ent i  muce lo er in Wt einwton Sttte. See tee 
WORKSHEET: Childrei for dettil .  

Tee weneric twe of con ent mty be different in oteer  ttte , tnd in oteer countrie . 
No
 If no, wo to Secion 8.
X
Yes
 If ye , provide tee twe rtnwe of tee minor  ubject  for tei   tudy tnd tee lewtl twe for con ent in 
your popultion( n. If teere i  more tetn one tn  er, expltin.  
12+ year old
Doi’t kiow
Tei  metn  i  it not po  ible to kno  tee twe of your  ubject . For extmple, tei  mty be 
true for  ome re etrce involvinw  ocitl medit, tee Internet, or t dttt et tett you obttin 
from tnoteer re etrceer or from t wovernment twency. Go to Secion 8.
6.2 Pareital permissioi. Pareital permissioi metn  tcively obttininw tee permi  ion of tee ptrent . Tei  i  not tee 
 tme t  “pt  ive” or “opt out” permi  ion  eere it i  t  umed tett ptrent  tre tllo inw teeir ceildren to 
ptriciptte bectu e teey etve been provided  ite informtion tbout tee re etrce tnd etve not objected or 
returned t form indictinw teey don’t  tnt teeir ceildren to ptriciptte.
a. Will you obttin ptrenttl permi  ion for:
All of your re etrce procedure 
 Go to questoi 
 
 6.2b.
 
 
X
None of your re etrce procedure 
 U e tee ttble belo  to provide your ju ifction, tnd  kip 
que ion 6.2b.
Some of your re etrce procedure 
 U e tee ttble belo  to idenify tee procedure  for  eice you  ill 
not obttin  riten ptrenttl permi  ion.
Be stre to consider all research procedtres and plans, incltding screening, ftttre contact, and sharing/banking of data and 
specimens for ftttre work.
Childrei 
Group1
Describe the procedures or 
data/specimei collectoi (if aiy) for 
which there will be NO pareital 
permissioi
Reasoi why you will iot 
obtaii pareital 
permissioi
Will you iiform 
them about the 
research?2
YES
NO
     
     
     
     
     
     
     
     
     
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Table footnotes
1.
If yotr answer is the same for all children grotps or all procedtres, yot can collapse yotr answer across the grotps and/or 
procedtres.
2.
Will yot inform them abott the research beforehand even thotgh yot are not obtaining actve permission?
b. Indictte by ceeckinw tee tppropritte box(e n your pltn for obttininw ptrenttl permi  ion
Bote ptrent , unle   one ptrent i  decet ed, unkno n, incompetent, or not ret ontbly tvtiltble; or  een 
only one ptrent et  lewtl re pon ibility for tee ctre tnd cu tody of tee ceild
One ptrent, even if tee oteer ptrent i  tlive, kno n, competent, ret ontbly tvtiltble, tnd  etre  lewtl 
re pon ibility for tee ctre tnd cu tody of tee ceild. 
   X
This is all that is reqtired for minimal risk research.
If you ceecked bote boxe , expltin:
     
6.3 Childrei who are wards. Will tny of tee ceildren be  trd  of tee Sttte or tny oteer twency, in ituion, or enity?
X
No
Yes
 If ye , tn tdvoctte mty need to be tppointed for etce ceild  eo i  t  trd. Tee tdvoctte mu t be in 
tddiion to tny oteer individutl tcinw on beetlf of tee ceild t  wutrditn or in loco ptreni . Tee 
 tme individutl ctn  erve t  tdvoctte for tll ceildren  eo tre  trd .
De cribe  eo  ill be tee tdvoctte( n. Your tn  er mu t tddre   tee follo inw point :

Btckwround tnd experience

Willinwne   to tct in tee be t intere t  of tee ceild for tee durtion of tee re etrce

Independence of tee re etrce, re etrce tetm, tnd tny wutrditn orwtniztion
     
7 ASSENT OF CHILDREN (MINORS)
Go to Secton 8 if yotr research does not involve children (minors).
7.1 Asseit of childrei (miiors). Teouwe ceildren do not etve tee lewtl ctptcity to “con ent” to ptriciptte in 
re etrce, teey  eould be involved in tee proce   if teey tre tble to “t  ent” by etvinw t  tudy expltined to teem 
tnd/or by retdinw t  imple form tbout tee  tudy, tnd teen wivinw teeir verbtl ceoice tbout  eeteer teey  tnt to 
ptriciptte. Teey mty tl o provide t  riten t  ent if teey tre older. See WORKSHEET: Childrei for circum ttnce  
in  eice t ceild’  t  ent mty be unnece  try or intppropritte.  
a. Will you obttin t  ent for:
All of your re etrce procedure  tnd ceild wroup 
 Go to questoi 
 
 7.2
 
 . 
    X
None of your re etrce procedure  tnd ceild wroup 
 U e tee ttble belo  to provide your 
ju ifction, teen  kip to que ion 7.5.
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Some of your re etrce procedure  tnd ceild wroup 
 U e tee ttble belo  to idenify tee 
procedure  for  eice you  ill not obttin 
t  ent. 
Be stre to consider all research procedtres and plans, incltding screening, ftttre contact, and sharing/banking of data and 
specimens for ftttre work.
Childrei 
Group1
Describe the procedures or 
data/specimei collectoi (if aiy) for 
which asseit will NOT be obtaiied
Reasoi why you will iot obtaii asseit
     
     
     
     
     
     
     
     
     
     
     
     
     
     
     
Table footnotes
1.
If yotr answer is the same for all children grotps or all procedtres, yot can collapse yotr answer across the grotps and/or 
procedtres.
7.2 Asseit process. De cribe eo  you  ill obttin t  ent, for etce ceild wroup. If your re etrce involve  ceildren of 
different twe , tn  er  eptrttely for etce wroup. If tee ceildren tre non-Enwli e  petker , include t de cripion of 
eo  you  ill en ure tett teey compreeend tee informtion you provide.
If the patient indicates that they would like to participate in the study, I will read the assent form to the child and 
answer any questions the child, or parent, may have.  If the child would like to continue, I will have them sign the 
assent form.
7.3 Disseit or resistaice. De cribe eo  you  ill idenify t ceild’  objecion or re i ttnce to ptriciption (includinw 
non-verbtl indiction n durinw tee re etrce, tnd  ett you  ill do in re pon e. 
If at any point the child does not wish to continue I will let them know that they are free to drop out of the study at 
no penalty. 
7.4 Documeitatoi of asseit.  Weice of tee follo inw  tttement  de cribe   eeteer you  ill obttin documenttion of 
t  ent?
None of your re etrce procedure  tnd ceild wroup 
 U e tee ttble belo  to provide your 
ju ifction, teen wo to que ion 7.4.t.
All of your re etrce procedure  tnd ceild wroup 
 Go to questoi 
 
 7.4.a
 
 , do not complete tee 
ttble
X
Some of your re etrce procedure  tnd/or ceild wroup 
 Complete tee ttble belo  tnd teen to wo 
que ion 7.4.t
Childrei
Group1
Describe the procedures or data/specimei 
collectoi (if aiy) for which asseit will 
NOT be documeited
Reasoi why you will iot documeit asseit
     
     
     
     
     
     
     
     
     
     
     
     
     
     
     
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Table footnotes
1.
If yotr answer is the same for all children grotps or all procedtres, yot can collapse yotr answer across the grotps and/or 
procedtres.
a. Describe how you will documeit asseit. If tee ceildren tre funciontlly illitertte or tre not fluent in Enwli e, 
include t de cripion of  ett you  ill do.
I will have the child sign the assent form. 
b. Upload all asseit materials (ttlkinw point , video , form , etc.n to tee Coiseit Form aid Recruitmeit 
Materials SmtrtForm of Zipline. A  ent mtteritl  tre not required to provide tll of tee  ttndtrd element  of 
tdult con ent; tee informtion  eould be tppropritte to tee twe, popultion, tnd re etrce procedure . Tee 
document   eould be in Word, if po  ible.
7.5 Childrei who reach the lenal ane of coiseit duriin partcipatoi ii loinitudiial research. 
Ceildren  eo  ere enrolled tt t younw twe tnd coninue for mtny yetr : It i  be t prtcice to re-obttin t  ent (or 
to obttin it for tee fr t ime, if you did not tt tee bewinninw of teeir ptriciptionn. 
Ceildren  eo retce tee lewtl twe of con ent: You mu t obttin informed con ent from tee no -tdult  ubject for (1n 
tny onwoinw intertcion  or intervenion   ite tee  ubject , or (2n tee coninued tntly i  of  pecimen  or dttt for 
 eice tee  ubject’  idenify i  retdily ideniftble to tee re etrceer, unle   tee IRB  tive  tei  requirement. 
a. De cribe your pltn  (if tnyn to re-obttin t  ent from ceildren. 
N/A
b. De cribe your pltn  (if tnyn to obttin con ent for ceildren  eo retce tee lewtl twe of con ent. 

If you pltn to obttin con ent, de cribe  ett you  ill do tbout no -tdult  ubject   eom you tre untble 
to conttct.  

If you do not pltn to obttin con ent or teink tett you  ill be untble to do  o, expltin  ey. 
N/A
7.6 Other renulatory requiremeits. (Tei  i  for your informtion only; no tn  er or re pon e i  required.n 
Re etrceer  tre re pon ible for determininw  eeteer teeir re etrce conducted in  ceool ,  ite  tudent record , 
or over tee Internet comply  ite permi  ion, con ent, tnd in pecion requirement  of tee follo inw federtl 
rewultion :

PPRA   Protecion of Pupil Riwet  Amendment

FERPA   Ftmily Eduction Riwet  tnd Privtcy Act

COPPA   Ceildren’  Online Privtcy Protecion Act
8 CONSENT OF ADULTS
Review the followiin defiiitois before aisweriin the questois ii this sectoi.
CONSENT
i  tee proce   of informinw potenitl  ubject  tbout tee re etrce tnd t kinw teem 
 eeteer teey  tnt to ptriciptte. It u utlly (but not tl ty n include  tn 
opportunity for  ubject  to t k que ion . It doe  not nece  trily include tee 
 iwninw of t con ent form. Tei  que ion i  tbout tee con ent proce  .
CONSENT DOCUMENTATION
refer  to eo  t  ubject’  deci ion to ptriciptte in tee re etrce i  documented. 
Tei  i  typictlly obttined by etvinw tee  ubject  iwn t con ent form.
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CONSENT FORM
i  t document  iwned by  ubject , by  eice teey twree to ptriciptte in tee 
re etrce t  de cribed in tee con ent form tnd in tee con ent proce  .
ELEMENTS OF CONSENT
tre  pecifc informtion tett i  required to be provided to  ubject .
PARENTAL PERMISSION
i  tee ptrent’  tcive permi  ion for tee ceild to ptriciptte in tee re etrce.  
Ptrenttl permi  ion i   ubject to tee  tme requirement  t  con ent, includinw 
 riten documenttion of permi  ion tnd required element .
SHORT FORM CONSENT
i  tn tlterntive  ty of obttininw  riten documenttion of con ent tett i  mo t 
commonly u ed  ite individutl   eo tre illitertte or  eo e ltnwutwe i  one for 
 eice trtn ltted con ent form  tre not tvtiltble.
WAIVER OF CONSENT
metn  teere i  IRB tpprovtl for not obttininw con ent or for not includinw  ome of 
tee element  of con ent in tee con ent proce  .
WAIVER OF DOCUMENTATION 
OF CONSENT
metn  tett teere i  IRB tpprovtl for not obttininw  riten documenttion of 
con ent.
8.1 Groups Idenify tee wroup  to  eice your tn  er  in tei   ecion tpply.
X
Adult  ubject 
X
Ptrent   eo tre providinw permi  ion for teeir ceildren to ptriciptte in re etrce
 If yot selected PARENTS, the word “consent” below shotld also be interpreted as applying to parental 
permission and “stbjects” shotld also be interpreted as applying to the parents.
8.2 The coiseit process. Tei   erie  of que ion  i  tbout  eeteer you  ill obttin con ent for tll procedure  except 
recruiinw tnd  creeninw tnd, if ye , eo .
The isste of consent for recrtitng and screening actvites is addressed in qteston 4.6. Yot do not need to repeat yotr answer 
to qteston 4.6.
a. Are teere tny procedure  for  eice you  ill not obttin con ent?
X
No
Yes
 If ye , u e tee ttble belo  to idenify tee procedure  for  eice you  ill not obttin con ent. 
“All” i  tn tccepttble tn  er for  ome  tudie .
Be stre to consider all research procedtres and plans, incltding ftttre contact, and sharing/banking of data and specimens 
for ftttre work.
Group1
Describe the procedures or 
data/specimei collectoi (if 
aiy) for which there will be NO 
coiseit process
Reasoi why you will iot obtaii 
coiseit
Will you 
provide 
subjects with 
iifo about the 
research afer 
they fiiish?
YES
NO
     
     
     
     
     
     
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Table footnotes
1.
If yotr answer is the same for all grotps yot can collapse yotr answer across the grotps and/or procedtres.
b. De cribe tee con ent proce  , if you  ill obttin con ent for tny or tll procedure , for tny or tll wroup . Addre   
wroup  tnd procedure   eptrttely if tee con ent proce  e  tre different.
Be stre to incltde 

The locaton/setting where consent will be obtained

Who will obtain consent (refer to positons, roles, or ttles, not names). 

Whether/how yot will provide an opporttnity for qtestons

How yot will provide an adeqtate opporttnity for the stbjects to consider all optons
When the subject returns the recruitment flyer to the check-in window, the principal investigator will meet the 
subject in the clinic’s waiting area to review the elements of the study and answer any questions.   
c. Compreeen ion. De cribe eo  you  ill en ure or te t tee  ubject ’ under ttndinw of tee informtion durinw tee 
con ent proce  .
After all questions are answered, the principal investigator will ask if the participant understands and would 
like to continue with being a participant in the study.
d. Influence. Doe  your re etrce involve tny  ubject wroup  tett miwet fnd it difcult to  ty “no” to your re etrce 
bectu e of tee  etnw or teeir reltion eip  ite you, even if you don’t pre  ure teem to ptriciptte?  
Examples  Sttdent partcipants being recrtited into their teacher’s research; patents being recrtited into their healthcare 
provider’s research, sttdy team members who are partcipants; ottpatents recrtited from an ottpatent strgery waitng 
room jtst prior to their strgery.
X
No
Yes
 If ye , de cribe  ett you  ill do, for etce of tee e  ubject wroup , to reduce tny effect of tee 
 etnw or reltion eip on teeir deci ion.
Examples  a sttdy coordinator will obtain consent instead of the stbjects’ physician; the researcher will 
not know which stbjects agreed to partcipate; stbjects will have two days to decide afer hearing abott 
the sttdy.
     
e. Onwoinw proce  . For re etrce tett involve  muliple or coninued intertcion  ite  ubject  over ime, de cribe 
tee opportuniie  (if tnyn you  ill wive  ubject  to t k que ion  or to cetnwe teeir mind  tbout ptriciptinw.
There will be a single administration of the selected medication.  If the participant decides that they do not wish 
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to complete the VAS workbook at any time they can do so at no consequence and may return the incomplete 
workbook or discard it in any manner that they chose. 
8.3 Writei documeitatoi of coiseit. Weice of tee  tttement  belo  de cribe  eeteer you  ill obttin 
documenttion of con ent? NOTE: Tei  que ion doe  not tpply to  creeninw tnd recruiinw procedure   eice 
etve tlretdy been tddre  ed in que ion 4.6.
Doctmentaton of consent that is obtained electronically is not considered writen consent tnless it is obtained by a method 
that allows verifcaton of the individtal’s signattre. In other words, saying “yes” by email is rarely considered to be writen 
doctmentaton of consent
a. Are you obttininw  riten documenttion of con ent for:
None of your re etrce procedure  
 U e tee ttble belo  to provide your ju ifction teen wo to 
questoi 
 
 8.4
 
 . 
All of your re etrce procedure  
 Do not complete tee ttble; wo to questoi 
 
 8.3.b.
 
 
X
Some of your re etrce procedure 
 U e tee ttble belo  to idenify tee procedure  for  eice you  ill 
not obttin  riten documenttion of con ent from your tdult 
 ubject . 
Adult subject 
nroup1
Describe the procedures or data/specimei collectoi (if aiy) for 
which there will be NO documeitatoi of coiseit
Will you 
provide them 
with a writei 
statemeit 
describiin the 
research 
(optoial)?
YES
NO
     
     
     
     
     
     
     
     
     
     
Table footnotes
1.
If yotr answer is the same for all adtlt grotps or all procedtres, yot can collapse yotr answer across the grotps and/or 
procedtres.
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8.4 Noi-Einlish-speakiin or -readiin adult subjects. Will you enroll tdult  ubject   eo do not  petk Enwli e or  eo 
ltck fluency or litertcy in Enwli e?
X
No
Yes
 If ye , de cribe tee proce   you  ill u e to en ure tett tee ortl tnd  riten informtion provided to 
teem durinw tee con ent proce   tnd terouweout tee  tudy  ill be in t ltnwutwe retdily 
under ttndtble to teem tnd (for  riten mtteritl   uce t  con ent form  or que ionntire n tt tn 
tppropritte retdinw/compreeen ion level.
     
a. Interprettion. De cribe eo  you  ill provide interprettion tnd  een. Al o, de cribe tee 
qutlifction  of tee interpreter( n   for extmple, btckwround, experience, ltnwutwe profciency 
in Enwli e tnd in tee oteer ltnwutwe, cerifction, oteer credenitl , ftmilitrity  ite tee 
re etrce-reltted voctbultry in Enwli e tnd tee ttrwet ltnwutwe. 
     
b. Trtn ltion . De cribe eo  you  ill obttin trtn ltion  of tll  tudy mtteritl  (not ju t con ent 
form n tnd eo  you  ill en ure tett tee trtn ltion  meet tee UW IRB’  requirement tett 
trtn ltted document   ill be linwui ictlly tccurtte, tt tn tppropritte retdinw level for tee 
ptriciptnt popultion, tnd culturtlly  en iive for tee loctle in  eice teey  ill be u ed. 
     
8.5 Barriers to writei documeitatoi of coiseit. Teere tre mtny po  ible btrrier  to obttininw  riten 
documenttion of con ent. Con ider, for extmple, individutl   eo tre funciontlly illitertte; do not retd Enwli e 
 ell; or etve  en ory or motor imptirment  tett mty impede tee tbility to retd tnd  iwn t con ent form.
a. De cribe your pltn  (if tnyn for obttininw  riten documenttion of con ent from potenitl  ubject   eo mty 
etve difculty  ite tee  ttndtrd documenttion proce   (tett i , retdinw tnd  iwninw t con ent formn. Skip tei  
que ion if you tre not obttininw  riten documenttion of con ent for tny ptrt of your re etrce. 
Examples of solttons  Translated consent forms; tse of the Short Form consent process; reading the form to the person; 
excltding individtals who cannot read and tnderstand the consent form.  
I will give the participants a copy of the consent form and ask them if they would like me to read it to them or 
explain any portion of the form before they sign it.
8.6 Deceptoi. Will you deliberttely  iteeold informtion or provide ftl e informtion to tny of tee  ubject ?
No
X
Yes
 If ye , de cribe  ett informtion tnd  ey.
Example  yot may wish to deceive stbjects abott the ptrpose of the sttdy.
In order to have a double-blind study design, neither the subject nor the principal investigator will 
have knowledge of the medication that each participant will receive.  
a. Will you debrief tee  ubject  ltter? (Note: tei  i  not required.n
X
No
Yes
 If ye , de cribe eo  you  ill debrief tee  ubject . Uplotd tny debriefnw 
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mtteritl , includinw ttlkinw point  or t  cript, to tee Coiseit Form aid 
Recruitmeit Materials SmtrtForm of Zipline.
     
8.7 Coniitvely impaired adults, aid other adults uiable to coiseit.
a. Coniitvely impaired adults aid other adults uiable to coiseit. Do you pltn to include  uce individutl  in 
your re etrce?
Examples  individtals with Tratmatc Brain Injtry (TBI) or dementa; individtals who are tnconsciots, or who are 
signifcantly intoxicated.
X
No
 If no, wo to que ion
 
  8.8
 
 .
Yes
 If ye , tn  er tee follo inw que ion .
a.1. Rtiontle. Provide your rtiontle for includinw tei  popultion in your re etrce. 
     
a.2. Ctptcity for con ent / deci ion mtkinw ctptcity. De cribe tee proce   you  ill u e to 
determine  eeteer t cowniively imptired individutl i  ctptble of con ent deci ion 
mtkinw  ite re pect to your re etrce protocol tnd  etnw.  If you  ill etve repetted 
intertcion   ite tee imptired  ubject  over t ime period  een cowniive ctptcity could 
incret e or dimini e, tl o de cribe eo  (if tt tlln you  ill re-t  e   deci ion-mtkinw 
ctptcity tnd con ent durinw tett ime.
     
a.3. Permi  ion ( urrowtte con entn. If you  ill include tdult   eo ctnnot con ent for 
teem elve , de cribe your proce   for obttininw permi  ion (“ urrowtte con ent”n from t 
lewtlly tuteorized repre enttive (LARn.  
For research condtcted in Washington State, see the SOP: Legally Authorized Representatve to 
learn which individtals meet the state defniton of “legally atthorized representatve”.
     
a.4. A  ent. De cribe  eeteer t  ent  ill be required of tll,  ome, or none of tee  ubject . If 
 ome, indictte  eice  ubject   ill be required to t  ent tnd  eice  ill not (tnd  ey 
notn. De cribe tny proce   you  ill u e to obttin tnd document t  ent from tee  ubject . 
     
a.5. Di  ent or re i ttnce. De cribe eo  you  ill idenify tee  ubject’  objecion or re i ttnce 
to ptriciption (includinw non-verbtln durinw tee re etrce, tnd  ett you  ill do in 
re pon e.
     
8.8 Coiseit-related materials. Uplotd to tee Coiseit Forms aid Recruitmeit Materials SmtrtForm of Zipline tll 
con ent  cript /ttlkinw point , con ent form , debriefnw  tttement , Informtion Stttement , Seort Form con ent 
form , ptrenttl permi  ion form , tnd tny oteer con ent-reltted mtteritl  you  ill u e.

Translatons mtst be incltded
 
 . However, yot are strongly encotraged to wait to provide them tntl yot know that the IRB 
will approve the English versions.

Combinaton forms
 
   It may be appropriate to combine parental permission with consent, if parents are stbjects as well as 
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providing permission for the partcipaton of their children. Similarly, a consent form may be appropriately considered an 
assent form for older children. 

For materials that cannot be tploaded
 
   tpload screenshots or writen descriptons that are stfcient to enable the IRB to 
tnderstand the types of data that will be collected and the nattre of the experience for the partcipant. Yot may also 
provide URLs (website addresses) or writen descriptons below. Examples of materials that tstally cannot be tploaded  
mobile apps; comptter-administered test; licensed and restricted standardized tests.
9 PRIVACY AND CONFIDENTIALITY
9.1 Privacy protectois. De cribe tee  tep  you  ill ttke, if tny, to tddre   po  ible privtcy concern  of  ubject  tnd 
potenitl  ubject .
Privacy refers to the sense of being in control of access that others have to otrselves. This can be an isste with respect to 
recrtitng, consentng, sensitvity of the data being collected, and the method of data collecton.
Examples  

Many stbjects will feel a violaton of privacy if they receive a leter asking them to partcipate in a sttdy becatse they  
have oooo medical conditon, when their name, contact informaton, and medical conditon were drawn from 
medical records withott their consent. Example  the IRB expects that “cold call” recrtitment leters will inform the 
stbject abott how their informaton was obtained.

Recrtitng stbjects immediately prior to a sensitve or invasive procedtres (e.g., in an ottpatent strgery waitng 
room) will feel like an invasion of privacy to some individtals.

Asking stbjects abott sensitve topics (e.g. details abott sextal behavior) may feel like an invasion of privacy to some  
individtals.
Patients already seeking orthodontic treatment at the University of Washington Graduate Orthodontics clinic will 
receive a recruitment flyer informing them of the study.  If they decide they want to participate then they will 
receive more information.
9.2 Ideitficatoi of iidividuals ii publicatois aid preseitatois. Do you pltn to u e potenitlly ideniftble 
informtion tbout  ubject  in publiction  tnd pre enttion , or i  it po  ible tett individutl ideniie  could be 
inferred from  ett you pltn to publi e or pre ent? 
X
No
Ye
s
 If ye ,  ill you obttin  ubject con ent for tei  u e?
Yes
No
 If no, de cribe tee  tep  you  ill ttke to protect  ubject  (or  mtll wroup  of 
 ubject n from beinw ideniftble.
     
9.3 State maidatory reportin. Etce  ttte et  reporinw lt   tett require  ome type  of individutl  to report  ome 
kind  of tbu e, tnd medictl condiion  tett tre under public eetlte  urveilltnce. Tee e include:

Ceild tbu e

Abu e, tbtndonment, newlect, or fntncitl exploittion of t vulnertble tdult

Sexutl t  tult

Seriou  pey ictl t  tult

Medictl condiion   ubject to mtndttory reporinw (noifctionn for public eetlte  urveilltnce
Are you or t member of your re etrce tetm likely to letrn of tny of tee tbove event  or circum ttnce   eile 
conducinw your re etrce AND feel obliwtted to report it to  ttte tuteoriie ?
X
No
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Yes
 If ye , tee UW IRB expect  you to inform  ubject  of tei  po  ibility in tee con ent form or durinw tee 
con ent proce  , unle   you provide t rtiontle for not doinw  o:
9.4 Reteitoi of ideitfiers aid data. Ceeck tee box belo  to indictte your t  urtnce tett you  ill not de troy tny 
idenifer  (or link  bet een idenifer  tnd dttt/ pecimen n tnd dttt tett tre ptrt of your re etrce record  unil 
tfer tee end of tee tpplictble record  retenion requirement  (e.w. Wt einwton Sttte; fundinw twency or  pon or; 
Food tnd Druw Admini trtionn for your re etrce. If you teink it i  importtnt for your  pecifc  tudy to  ty 
 ometeinw tbout de trucion of idenifer  (or link  to idenifer n in your con ent form,  ttte  ometeinw like “tee 
link bet een your idenifer tnd tee re etrce dttt  ill be de troyed tfer tee record  retenion period required by 
 ttte tnd/or federtl lt .”
This qteston can be lef black for conversion applicatons (existng paper applicatons that are being “converted” into a Zipline  
applicaton.)
See the “Research Data” sectons of the following website for UW Records management for the Washington State research 
rectords retenton schedtles that apply in general to the UW (not involving UW Medicine data)  
http://f2.washington.edu/fm/recmgt/retentonschedules/gs/general/uwgsResearchRR
 
  
See the “Research Data and Records” informaton in Secton 8 of this doctment for the retenton schedtles for UW Medicine 
Records  http://www.uwmedicine.org/about/Documents/UWRRRS-1.5.pdf
X
Coifirm
9.5 Certficates of Coifideitality. Do you etve or, tre you pltnninw to obttin, t federtl Cerifctte of Confdenitlity 
for your re etrce dttt?
X
No
Yes
9.6 Data aid specimei security protectois. Idenify your dttt clt  ifction  tnd tee  ecurity protecion  you  ill 
provide, referrinw to tee ZIPLINE GUIDANCE: Data aid Security Protectois for tee minimum requirement  for 
etce dttt clt  ifction level. You cannot answer this queston without reading this document. Data security 
protectons should not confict with records retenton requirements.
a. Weice level of protecion   ill you tpply to your dttt tnd  pecimen ? If you  ill u e more tetn one level, 
de cribe  eice level  ill tpply to  eice dttt tnd  eice  pecimen .
Since this is of very low risk or harm if disclosed (level 1), no specific protections are required above and 
beyond standard University expectations.
b. U e tei   ptce to provide tddiiontl informtion, dettil , or to de cribe protecion  tett do not ft into one of 
tee level .
No identifiers will be made on the workbook materials that each participant will return.  
Contact information for reminder notifications will be stored in a locked computer file that is separate than the 
data file.
Upon completion, the participant can elect to enter a raffle by writing their contact information on a ticket and 
place it into a locked box that will be stored securely behind the front office of the clinic.  No information 
pertaining to the study will be discerned from the raffle ticket except for the fact that that individual has 
completed a workbook for the study.
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10 RISK / BENEFIT ASSESSMENT
10.1 Aitcipated risks. De cribe tee ret ontbly fore eetble ri k  of etrm, di comfort , tnd etztrd  to tee  ubject  
tnd oteer  of tee re etrce procedure . For etce etrm, di comfort, or etztrd:

De cribe tee mtwnitude, probtbility, durtion, tnd/or rever ibility of tee etrm, di comfort, or etztrd, AND

De cribe eo  you  ill mtntwe or reduce tee ri k . Do not de cribe dttt  ecurity protecion  eere, tee e tre 
tlretdy de cribed in Que ion 9.6.

Consider physical, psychological, social, legal, and economic risks, incltding risks to fnancial standing, employability, 
instrability, edtcatonal advancement or repttaton.

Examples of “others”  embryo, fetts, or ntrsing child; family members; a specifc grotp. 

Do not incltde the risks of non-research procedtres that are already being performed. 

If the sttdy design specifes that stbjects will be assigned to a specifc conditon or interventon, then the conditon or 
interventon is a research procedtre - even if it is a standard of care. 

Examples of mitgaton strategies  incltsion/excltsion criteria; applying appropriate data sectrity meastres to prevent 
tnatthorized access to individtally identfable data; coding data; taking blood samples to monitor something that 
indicates drtg toxicity.

As with all qtestons on this applicaton, yot may refer to tploaded doctments.
Reactions or adverse effects of the medications involved are known and may occur in the subjects. All subjects 
will be assessed to ensure they are not contraindicated for these medications.  The consent form will outline 
possible adverse effects and will be made known to the subjects prior to initiation of the study.
The following are adverse reacts associated with the involved medications and typically occur when the 
medications used at high doses or chronically in <10% of the population:

Anemia

Kidney failure

Liver failure

Edema

Dizziness

Blurred vision

Headache 

Rash

Heartburn

Nausea

Cardiovascular thrombotic events

Ulcers

Bronchospasms
10.2 Reproductve risks. Are teere tny ri k  of tee  tudy procedure  to men tnd  omen ( eo tre  ubject , or ptrtner 
of  ubject n reltted to prewntncy, ferility, ltcttion or effect  on t fetu  or neontte?  
Examples  direct teratogenic efects; possible germline efects; efects on fertlity; efects on a woman’s ability to contnte a 
pregnancy; efects on ftttre pregnancies.
No
 If no wo to que ion 10.3
X
Yes
 If ye , tn  er tee follo inw que ion :
a. Risks. De cribe tee mtwnitude, probtbility, durtion tnd/or rever ibility of tee ri k .
 Ibuprofen used in late pregnancy should be avoided due possible causation of premature closure 
of the ductus arteriosus.
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b. Steps to miiimize risk. De cribe tee  pecifc  tep  you  ill ttke to minimize tee mtwnitude, 
probtbility, or durtion of tee e ri k .
Examples  inform the stbjects abott the risks and how to minimize them; reqtire a pregnancy test before 
and dtring the sttdy; reqtire stbjects to tse contracepton; advise stbjects abott banking of sperm and 
ova.
If yot will reqtire the tse of contracepton  describe the allowable methods and the tme period when 
contracepton mtst be tsed.
Female participants that are pregnant will be excluded from the study.
c. Preniaicy. De cribe  ett you  ill do if t  ubject (or t  ubject’  ptrtnern become  prewntnt
For example; will yot reqtire the stbject to immediately notfy yot, so that yot can discontnte or modify 
the sttdy procedtres, disctss the risks, and/or provide referrals or cotnseling?
The study requires only a single administration of a medication at the initiation of the study so 
there will be no risk if the subject becomes pregnant afterwards.
10.3 Uiforeseeable risks. Are teere tny re etrce procedure  tett mty etve ri k  tett tre currently unfore eetble?  
Example  tsing a drtg that hasn’t been tsed before in this stbject poptlaton.
No
X
Yes
 If ye , idenify tee procedure .
In the highly unlikely event that a patient has an unknown hypersensitivity to one of the 
medications, associated risks of hypersensitivities may occur.
10.4 Subjects who will be uider renioial or neieral aiesthesiolony. Will tny re etrce procedure  occur  eile 
 ubject -ptient  tre under wenertl or rewiontl tne tee it, or durinw tee 3 eour  precedinw wenertl or rewiontl 
tne tee it ( upplied for non-re etrce ret on n?
X
No
Yes
 If ye , ceeck tll tee boxe  tett tpply.
Admini trtion of tny druw for re etrce purpo e 
In erinw tn intrt-venou  (centrtl or peripeertln or intrt-trteritl line for re etrce purpo e 
Obttininw  tmple  of blood, urine, bone mtrro  or cerebro pintl fluid for re etrce purpo e 
Obttininw t re etrce  tmple from i  ue or orwtn  tett  ould not oteer i e be removed 
durinw  urwery
Admini trtion of t rtdio-i otope for re etrce purpo e **
Impltnttion of tn experimenttl device
Oteer mtnipultion  or procedure  performed  olely for re etrce purpo e  (e.w., 
experimenttl liver ditly i , experimenttl brtin  imultionn
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If you ceecked tny of tee boxe :
You mu t provide tee ntme tnd in ituiontl tflition of t pey icitn tne tee iolowi t  eo i  t 
member of your re etrce tetm or  eo  ill  erve t  t  tfety con ulttnt tbout tee intertcion  
bet een your re etrce procedure  tnd tee wenertl or rewiontl tne tee it of tee  ubject-
ptient . If your procedure   ill be performed tt t UW Medicine ftcility or tflitte, tee 
tne tee iolowi t mu t be t UW ftculty member. 
     
** If yot checked the box abott radio-isotopes  yot are responsible for informing in advance all 
appropriate clinical personnel (e.g., ntrses, technicians, anesthesiologists, strgeons) abott the 
administraton and tse of the radio-isotope, to enstre that any personal safety isstes (e.g., 
pregnancy) can be appropriately addressed. This is a conditon of IRB approval.
10.5 Data aid Safety Moiitoriin. A Dttt tnd Stfety Monitorinw Pltn (DSMPn i  required for clinictl tritl  (t  defned 
by NIHn. If required for your re etrce, uplotd your DSMP to tee Supportin Documeits SmtrtForm in Zipline. If 
it i  embedded in tnoteer document you tre uplotdinw (for extmple, t Study Protocol, u e tee text box belo  to 
ntme tee document tett et  tee DSMP.
N/A
10.6 Ui-bliidiin. If tei  i  t double-blinded or  inwle-blinded  tudy in  eice tee ptriciptnt tnd/or you do not kno  
tee wroup to  eice tee ptriciptnt i  t  iwned: de cribe tee circum ttnce  under  eice un-blindinw  ould be 
nece  try, tnd to  eom tee un-blinded informtion  ould be provided.
If a patient has an allergic response to their medication, they will be made aware of which medication they were 
administered.
10.7 Withdrawal of partcipaits. If tpplictble, de cribe tee tniciptted circum ttnce  under  eice ptriciptnt   ill be 
 itedrt n from tee re etrce  iteout teeir con ent. Al o, de cribe tny procedure  for orderly  itedrt tl of t 
ptriciptnt, rewtrdle   of tee ret on, includinw  eeteer it  ill involve ptritl  itedrt tl from procedure  tnd 
tny intervenion but coninued dttt collecion or lonw-term follo -up.
N/A
10.8 Aitcipated direct beiefits to partcipaits. If teere tre tny direct re etrce-reltted beneft  tett  ome or tll 
individutl ptriciptnt  tre likely to experience from ttkinw ptrt in tee re etrce, de cribe teem belo :
Do not incltde benefts to society or others, and do not incltde stbject payment (if any). Examples  medical benefts stch as 
laboratory tests (if stbjects receive the restlts); psychological resotrces made available to partcipants; training or edtcaton 
that is provided. 
Analgesia for pain induced by orthodontic tooth movement.
10.9 Iidividual subjects fiidiins.  
a. I  it likely tett your re etrce  ill uninteniontlly di cover t previou ly unkno n condiion  uce t  t di et e, 
 uicidtl intenion , or weneic predi po iion?
X
No
Yes
 If ye , expltin  eeteer tnd eo  you  ould  etre tee informtion  ite tee  ubject.
     
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b. Do you pltn to rouinely  etre tee individutl re ult  of your  tudy procedure   ite tee  ubject     uce t  
weneic te t re ult , ltborttory te t , etc.?
X
No
Yes
 If ye , complete tnd uplotd tee SUPPLEMENT: Partcipait Results Shariin to tee Supportin 
Documeits SmtrtForm of Zipline
10.10 Commercial products or pateits. If t commercitl product or pttent could re ult from tei   tudy, de cribe 
 eeteer  ubject  miwet receive tny remunertion/compen tion tnd, if ye , eo  tee tmount  ill be 
determined:
N/A
11 ECONOMIC BURDEN TO PARTICIPANTS
11.1 Fiiaicial respoisibility for research-related iijuries. An  er tei  que ion only if tee letd re etrceer i  not t 
UW  tudent,  ttff member, or ftculty member  eo e primtry ptid tppointment i  tt tee UW. 
De cribe  eo  ill be fntncitlly re pon ible for re etrce-reltted injurie  experienced by  ubject , tnd tny 
limittion . De cribe tee proce   (if tnyn by  eice ptriciptnt  mty obttin trettment/compen tion.  
N/A
11.2 Costs to subjects. De cribe tny re etrce-reltted co t  for  eice  ubject  mty be re pon ible (e.w., CT  ctn 
required for re etrce eliwibility  creeninw; co-pty ; co t of t device; trtvel tnd ptrkinw expen e  tett  ill not be 
reimbur edn.
None.
11.3 Reimbursemeit for costs. De cribe tny co t  to  ubject  tett  ill be reimbur ed ( uce t  trtvel expen e n.  
None.
12 RESOURCES
12.1 Faculty Advisor. (For re etrceer   eo tre  tudent , fello  , or po t-doc .n Provide tee follo inw informtion 
tbout your ftculty tdvi or. 

Advi or’  ntme

Your reltion eip  ite your tdvi or (for extmple: wrtdutte tdvi or; cour e in tructorn

Your pltn  for communiction/con ulttion  ite your tdvi or tbout prowre  , problem , tnd cetnwe . 
Dr. Anne-Marie Bollen
Research Advisor
Dr. Bollen is regularly available in the clinic in which the study will take place.
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12.2 Study team commuiicatoi. De cribe eo  you  ill en ure tett etce  tudy tetm member i  tdequttely trtined 
tnd informed tbout tee re etrce procedure  tnd requirement  (includinw tny cetnwe n t   ell t  teeir re etrce-
reltted duie  tnd funcion .
X
There is io study team.
     
13 OTHER APPROVALS, PERMISSIONS, aid REGULATORY ISSUES
13.1 Other renulatory approvals. Idenify tny oteer rewulttory tpprovtl  tett tre required for tei  re etrce, by 
ceeckinw tpplictble boxe 
Do not atach the approvals tnless reqtested by the IRB.  
Approval
Research for which this is required
Rtdition Stfety
Procedure  involvinw tee u e of rtdiotcive mtteritl  or tn ionizinw 
rtdition producinw mtceine rtdition, if teey tre conducted for re etrce 
rtteer tetn clinictl purpo e . Approvtl  need to be tttceed to tee 
Supporinw Document  ptwe in Zipline.
In ituiontl Bio tfety
Procedure  involvinw tee trtn fer/tdmini trtion of recombintnt DNA, 
DNA/RNA derived from recombintnt DNA, or  ynteeic DNA.
RDRC
Procedure  involvinw t rtdiotcive druw or biolowictl product tett i  not 
tpproved by tee FDA for tee re etrce purpo e tnd tett i  beinw u ed 
 iteout tn IND, for bt ic  cience re etrce (not to determine  tfety tnd 
effecivene  , or for immeditte teertpeuic or ditwno ic purpo e n.
ESCRO
Procedure  involvinw tee u e of  ome type  of eumtn embryonic  tem 
cell .
13.2 Approvals aid permissiois. Idenify tny oteer tpprovtl  or permi  ion  tett  ill be obttined.  For extmple:  
from t  ceool, externtl  ite/orwtniztion, fundinw twency, employee union, UW Medicine clinictl unit.  
Do not atach the approvals and permissions tnless reqtested by the IRB.
N/A
13.3 Fiiaicial Coifict of Iiterest. Doe  tny member of tee tetm etve t Fintncitl Conflict of Intere t (FCOIn in tei  
re etrce, t  defned by UW policy GIM 10?   
X
No
Yes
 If ye , uplotd tee Conflict Mtntwement Pltn for every tetm member  eo et  t FCOI  ite re pect 
to tei  re etrce, to tee Supportin Documeits ptwe of Zipline. If it i  not yet tvtiltble, u e tee text 
box to de cribe  eeteer tee Siwnifctnt Fintncitl Intere t et  been di clo ed tlretdy to tee UW 
Ofce of Re etrce.
     
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