A Randomized Trial of a Web-based Non-pharmacological Pain Intervention for Pediatric Chronic Pancreatitis
Phase: NA
Conditions: Chronic Pancreatitis, Acute Recurrent Pancreatitis
Sponsor: Seattle Children's Hospital

Principal Researcher: Tonya Palermo  
Protocol Version Date: 11/4/2024
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PROJECT TITLE:
Web-MAP for children with chronic pancreatitis (WebMAP- CP)
PRINCIPAL INVESTIGATOR:
Name: Dr. Tonya Palermo 
Department: Child Health, Behavior and Development
Telephone Number: 206-884- 4208
Email Address: tonya.palermo@seattlechildrens.org

Principal Researcher: Tonya Palermo  
Protocol Version Date: 11/4/2024
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Contents
1.
Objectives........................................................................................................................................4
2.
Background.....................................................................................................................................4
3.
Study Endpoints .............................................................................................................................7
4.
Drugs, Devices and Biologics .......................................................................................................7
5.
Procedures Involved ......................................................................................................................7
6.
Data and Specimen Banking .........................................................................................................9
7.
Sharing of Results ........................................................................................................................10
8.
Study Timelines ............................................................................................................................10
9.
Study Population ..........................................................................................................................10
10.
Number of Subjects......................................................................................................................11
11.
Withdrawal of Subjects ................................................................................................................11
12.
Risks to Subjects..........................................................................................................................12
13.
Potential Benefits to Subjects .....................................................................................................13
14.
Data Analysis/Management .........................................................................................................13
15.
Confidentiality...............................................................................................................................14
16.
Provisions to Monitor Data to Ensure the Safety of Subjects..................................................15
17.
Use of Social Media ......................................................................................................................16
18.
Research Related Injury...............................................................................................................16
19.
Recruitment Methods ...................................................................................................................16
20.
Consent/Assent Process .............................................................................................................17
21.
Process to Document Consent in Writing..................................................................................19
22.
HIPAA Authorization and RCW Criteria......................................................................................20
23.
Payments/Costs to Subjects .......................................................................................................21
24.
Setting............................................................................................................................................21
25.
Resources Available.....................................................................................................................21
26.
Coordinating Center Procedures ................................................................................................22
27.
Good Clinical Practice..................................................................................................................22

Principal Researcher: Tonya Palermo  
Protocol Version Date: 11/4/2024
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1.
Objectives
1.1. Purpose, specific aims, or objectives:
This project will deliver a first ever randomized, double-blinded and placebo controlled 
nonpharmacological pain intervention to children with CP/ARP and potentially identify patient-specific 
biological and psychosocial factors associated with favorable versus poor responsiveness to CBT to 
enable precision medicine approaches, consistent with priorities of the Federal Pain Research Strategy.
Aim 1. To determine the efficacy of web-based CBT in children with CP/ARP. 
Aim 2. To identify the genetic co-variants associated with treatment response to web-based CBT. 
Aim 3. To identify clinical and psychosocial factors associated with treatment benefit from web-based 
CBT. 
  
1.2. Hypotheses to be tested:
  
Hypothesis 1: Children receiving CBT will have greater reductions in pain-related disability (primary 
outcome), pain, anxiety and depressive symptoms, opioid use, and HRQOL (secondary outcomes) 
compared to the education control group. To test this hypothesis, we will conduct a randomized and 
double-blinded controlled trial of web-based CBT (WebMAP) vs education (WebED). We will evaluate 
changes in pain, HRQOL, emotional functioning, medication use, health care utilization at baseline, 2 
months, and 6 months. 
Hypothesis 2: Genetic co-variants associated with pancreatitis, inflammation, lipid and drug metabolism 
will predict response to therapy. To test this hypothesis, we will evaluate targeted next generation 
sequencing of genes involved in pancreatitis risk (CASR, CFTR, CTRC, SBDS, SBDSP – pseudogene, 
SPINK1, CEL, CELP – pseudogene, CPA1, CLDN1 (key SNPs), PRSS1, PRSS2, PRSS3, PRSS1-2 
locus, GGT1 and UBR1)), lipid metabolism (APOA5, APOC2, FABP, LPL), inflammation (IL10, IL22, 
IL22RA1, 
IL22RA2, IL23R) and drug metabolism (COMT, HTR2A, CYP2C19, CYP2D6, 
CYP3A4, CYP3A5, OPRD1 and OPRM1) in children with CP/ARP who undergo WebMAP vs WebED. 
Risk stratification analysis will be done to identify genotypic factors that will predict response to treatment. 
Hypothesis 3: Baseline clinical characteristics (i.e. demographics, age at diagnosis, abdominal pain 
frequency and severity, number of pancreatitis attacks, imaging findings), and baseline emotional and 
family functioning will predict pain and health outcomes at 6 months. 
  
2.
Background
2.1. Relevant prior experience and gaps in current knowledge:
  
Current state of the science: pediatric pain self-management interventions. Psychological 
treatments for pediatric chronic pain have included predominantly cognitive-behavioral therapy (CBT) 
self-management interventions such as pain education, relaxation training, cognitive skills, behavioral 
activation, and relapse prevention. Psychological therapies are effective in reducing pain intensity and 
pain-related disability of children and adolescents with chronic pain, including abdominal pain 15. To date, 
there are no established pediatric pain self-management interventions for pediatric CP/ARP.
Challenges to provide pain self-management interventions. Despite the effectiveness of pain self-
management programs, many barriers prevent children from receiving self-management for chronic pain: 
i) children/caregivers may be reluctant to seek out mental health services for pain management, ii) access 
may be limited due to geographic restrictions (e.g., available only in tertiary centers), iii) small number of 
trained clinicians are available to deliver the therapies, iv) families often experience burden in taking time 
off school and work, and v) direct and indirect costs of therapy visits are often prohibitive. Highly trained 
personnel deliver

Principal Researcher: Tonya Palermo  
Protocol Version Date: 11/4/2024
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these therapies in individual or group sessions in specialty clinics; therefore, services are not widely 
available for community and home-based settings. These barriers have led our group to develop a highly 
successful and well-accepted childhood pain self-management intervention delivered via Internet.
Rationale for web and mobile technologies to enhance delivery of pain self-management care for 
pediatric CP/ARP. We took advantage of information and communication technology to expand 
opportunities for intervening with families remotely, thus greatly extending the reach of clinical services for 
pain self-management. There is now strong evidence for internet-delivered chronic pain self-management 
interventions in both adult and pediatric populations 16 with improvement in pain and disability. In addition 
to improving access, these technologies empower youth to take an active role in managing their condition 
by providing “in the moment” access to pain coping strategies. 
2.2. Relevant preliminary data:1
  
Evaluation of Web-Based Management of Adolescent Pain (WebMAP). Dr. Palermo developed an 
Internet delivered CBT pain intervention called WebMAP that includes 8-10 weeks of online modules to 
teach relaxation skills, pain coping strategies, and parent behavioral and communication techniques to 
youth with mixed chronic pain conditions. In the initial RCT with 48 youth (11–17 years) with a variety of 
pain conditions (e.g., headache, stomachache, musculoskeletal pain), significant reductions in pain and 
disability were found for youth receiving WebMAP compared to a wait-list control group.51 Following up 
on this initial trial, Dr. Palermo recently completed a second large multicenter RCT of WebMAP involving 
273 adolescents (ages 11-17 years) with chronic pain and their parents from 14 centers in the U.S. and 
Canada 23. Adjunctive to treatment in pain clinic, youth were randomized to one of two Internet 
treatments, WebMAP (adolescent and parent CBT pain intervention, n=138) vs WebED (education 
control, n=135). Close tracking and monitoring procedures led to an excellent retention rate in the trial 
(94.2% post-treatment, 92.4% at 6-months, and 92.4% at 12-months), and superb compliance (> 80%) 
with both treatment conditions (education
and CBT).  In support of our primary hypotheses, youth receiving Internet CBT achieved greater 
improvement in pain-related disability compared to the Internet Education group from baseline to 6-month 
follow-up (b= -1.13, p = 0.03, d = -0.25). There were small effects of Internet CBT on improving 
depression in the Internet CBT group (relative to Internet Education) from baseline to post-treatment (b = 
-0.59, p = 0.04, d = -0.09). Similarly, adolescents receiving Internet CBT showed a significant reduction in 
pain-related anxiety relative to the Internet Education group from baseline to post-treatment (b = -1.33, p 
= 0.04, d = -0.13). As hypothesized, there were significant, small to medium effects of treatment on 
reducing maladaptive parent behaviors. Parents in the Internet CBT group demonstrated a significantly 
greater reduction in protective behaviors compared to the Internet Education group from baseline to post-
treatment (b = -0.26,
p < 0.001, d = -0.49) and from baseline to six-month follow-up (b = -0.19, p = 0.001, d = -0.40). Effects 
were maintained through the 12-month follow-up 26. WebMAP has been adapted and tested in several 
other pediatric painful disorders including a completed trial in chronic headache 25, sickle cell disease 
(Palermo, et al, in press) and an ongoing trial with 300 youth with functional abdominal pain (NIH 
R01HD076983, PI: Lynn S. Walker). Our data and experience so far confirm WebMAP as an efficient, 
easily accessible tool with great potential to reduce pain-related disability and parental maladaptive 
behaviors that perpetuate and sustain painful disorders.
Pilot WebMAP study in children with ARP and CP. For this application, we collected preliminary data 
from WebMAP delivered to 2 youth with ARP and 4 youth with CP to assess feasibility and interest in 
learning cognitive-behavioral pain management skills. Youth were ages 11-16 years and recruited from 
Seattle Children’s Hospital and University of Pittsburgh (2 of the 21 sites proposed in this application). 
Treatment engagement was good; youth logged into WebMAP an average of 8 times (range 2 - 21) and 
parents logged in an average of 10 times (range = 2 - 18) over the 8-10 week treatment period. Youth and 
parents completed a mean of 5.2 treatment modules (4 of 6 families completed the full program). On the 
Treatment Evaluation

Principal Researcher: Tonya Palermo  
Protocol Version Date: 11/4/2024
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Inventory, children’s ratings indicated moderate acceptability (M = 28.2, scores > 27 indicate moderate 
acceptability). Similarly, parents rated moderate acceptability (M = 31.3). To understand participants’ 
experience with WebMAP, we conducted qualitative interviews with 3 parent-child dyads. Overall, 
participants reported that the CBT program was a helpful tool for coping with pain. We learned that some 
children with ARP and their parents were less likely to complete the WebMAP program due to lack of 
experienced pain during the course of the intervention, which reduced the relevance of the treatment 
program. Because WebMAP is designed for treatment of chronic pain, this pilot work informed our 
decision to focus the proposed trial on youth with CP/ARP with pain frequency once per month or greater. 
Our preliminary data support that web-based self-management of pain is acceptable to children with 
CP/ARP and their parents.
  
2.3. Scientific or scholarly background:
  
Chronic pancreatitis causes significant burden in the pediatric population. Recent studies estimate 
an increase in the incidence of childhood acute pancreatitis (AP) at 3.6-16.1 cases per 100,000 children 
per year1, 2, which is similar to the incidences reported in adults 3. Most children with pancreatitis have a 
single acute episode that resolves without complications. However, 15-35% of children with AP develop 
acute recurrent pancreatitis (ARP) and some progress to chronic pancreatitis (CP, incidence ~0.5-2.73 
per 100,000 per year) 4-7. Many children with CP/ARP are admitted to the hospital for recurrent attacks 
of AP 7. In the INSPPIRE  cohort, children with CP/ARP have high disease burden, including abdominal 
pain, frequent emergency room visits, missed school days and recurrent hospitalizations 8, 9. The 
estimated average annual cost of pediatric CP/ARP is $40,589 per child in the INSPPIRE cohort 10. By 
extrapolating these costs, pediatric CP/ARP may result in ~ $64 million to the US healthcare system per 
year. Although relatively uncommon, pediatric CP/ARP is associated with high
disease burden and healthcare costs.
The etiology of CP is complex. CP is a syndrome of progressive inflammation, remodeling, fibrosis and 
failure of the exocrine and endocrine pancreas over time. There are multiple etiologies linked to 
environmental and genetic factors, with genetics being a major factor in at least 75% of children 8, 9. 
Genetic factors define multiple pathogenic pathways, as well as disease modifiers and risk of 
complications, including fibrosis, diabetes, exocrine pancreatic insufficiency and pain 11. Thus, assessing 
genetic and environmental risk and mechanisms as cofactors in complex disease models is critical.
Pain is associated with high disease burden and economic costs in pediatric CP/ARP. Eighty-one 
percent of children report abdominal pain (~43% some form of constant pain) and pain is the major driver 
of cost in the INSPPIRE population 10. Children with constant pain experience more emergency room 
visits, miss more school, and require more hospitalizations compared to those without chronic pain 8, 10. 
Forty-one percent of children with CP in our cohort use an opioid to control pain. Despite the frequency of 
pain and its relevance to high socioeconomic burden, there are no non-pharmacologic pain interventions 
available for children with CP/ARP. As the disease progresses and pancreatic tissue is replaced with 
fibrosis, intrapancreatic nerves undergo neuropathic changes and become “sensitized” to transmit stimuli 
even after the painful stimulus is removed 12. This “central sensitization” is the main reason why pain 
persists even after the pancreas is resected 13, 14, rendering therapies such as total pancreatectomy 
and islet autotransplantation (TPIAT) ineffective for pain control for many patients. Children with chronic 
pancreatitis urgently need effective, early therapies delivered in childhood to reduce pain, pain-related 
disability and exposure to narcotics. Large and well-established cohorts, such as INSPPIRE allow us to 
test the effectiveness of non-pharmacological pain interventions in children with CP/ARP.
Impact of proposed project on improving scientific knowledge and clinical care. To maximize 
efficiency, this chronic pain self-management program is geared to the unique developmental and 
informational needs of youth with CP/ARP. The intervention is expected to enhance awareness and 
empower self-management early in the disease course. Given that the burden of pain worsens with age, 

Principal Researcher: Tonya Palermo  
Protocol Version Date: 11/4/2024
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early intervention is critically important for interrupting negative cycles of pain and associated functional 
impairments. This will be the first project to 
test the efficacy of an early, non-pharmacological pain intervention in children with CP/ARP and 
potentially to identify modifiers of treatment effects.
  
2.4. Prior approvals:
  
We conducted a pilot study IRB # STUDY00000137.
  
3.
Study Endpoints2
3.1. Primary and secondary endpoints:
  
  
3.2. Primary or secondary safety endpoints:
  
For section 3.1: Primary endpoint is greater reductions in pain-related disability. Secondary 
endpoint is the reduction of pain, anxiety/depressive symptoms, opioid use, and HRQOL.
For section 3.2: There are no safety endpoints in this study.
  
4.
Drugs, Devices and Biologics3
4.1. Manufacturer and name of all drugs, devices and biologics:
  
N/A
  
4.2. Description and purpose of all drugs, devices and biologics:
  
N/A
  
4.3. Regulatory status of all drugs, devices and biologics:4
  
N/A
  
4.3.1.
Drugs or Biologics:
☐ IND Exempt.  Explain:5 Click here to enter text.
☐ IND.
 
4.3.2.
Devices:
☐ IDE Exempt.  Explain:6 Click here to enter text.
☐ Abbreviated IDE / Non-Significant Risk.  Explain:7 Click here to enter text.
☐ IDE / Significant Risk.  
    
4.4. Plans to store, handle, and administer any study drugs, devices and biologics so they will be 
used only on subjects and be used only by authorized investigators:
  
N/A
  
5.
Procedures Involved
5.1. Study design:8
  
A randomized controlled double-blinded trial will be conducted. Families will be randomized to 
either WebMAP or WebED (education control). 260 children (ages 10-19 years) with CP/ARP and 
their parents/caregivers (if possible) will be recruited from the INSPPIRE network and 
pancreatitis-related community organizations such as the National Pancreas Foundation (NPF) 
and Mission Cure. The intervention phase will last 8-12 weeks. Assessments will occur at 
baseline (T1), immediately after intervention (2 months; T2), and repeated at 6 months 
postintervention (T3) to assess maintenance of treatment gains. Primary outcome is pain-related 
disability (T2, T3).

Principal Researcher: Tonya Palermo  
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5.2. Research procedures:9
  
Recruitment Study Procedure. 1) referral to the Web-MAP CP study by a collaborating INSPPIRE 
center or completion of community interest form, 2) telephone intake interview to determine study 
eligibility and explain study procedures, 3) coordinator will conduct informed consent over the 
phone and via secure REDCap link, 
Study Procedure. 1) complete T1 (Baseline) study assessment via REDCap, 2) randomization to 
WebMAP or WebED program 3) phone instructional session for logging into the website and 
using the program. 4) participation in the randomized condition (see information below on each 
program), 5) complete T2 (about 2 months after baseline) via REDCap and 6) completing T3 6-
month follow-up evaluation via REDCap.
Randomization Procedures. Using block randomization, children and parents will be randomized 
to two groups: WebMAP or WedED. Both groups will continue to receive standard medical care 
from a specialized pediatric pain clinic. We will generate a random numbers table using an online 
calculator to derive a randomization assignment in blocks of 4 for ID numbers. 
WebMAP Group: The Web-MAP program teaches relaxation skills, pain coping strategies 
and parent behavioral and communication techniques to youth with chronic pain. Child 
participants will practice 8 skills. The skills included in Web-MAP are: 1) education about 
chronic pain and pain management, 2) recognizing stress and negative emotions, 3) 
relaxation and deep breathing, 4) implement coping skills at school, 5) cognitive skills, 6) 
lifestyle interventions, 7) staying active, and 8) relapse prevention. Parents will practice 
skills including: 1) education about chronic pain, 2) recognizing stress and negative 
emotions, 3) operant strategies I – attention and praise for positive coping, 4) operant 
strategies II –rewards for positive coping and reaching school goals, 5) modeling, 6) 
lifestyle, 7) communication, and 8) relapse prevention. Participants can also track daily 
activities and skills they used on the computer. Participants randomized to the WebMAP 
program will be practicing one of the 8 skills each week and will be contacted if they have 
not completed that skill after a week has passed. Mixed methods (email/text/phone calls 
if given permission by participant) will be used to contact participants to give reminders to 
continue logging into the program. Participants will receive their usual care and Web-
MAP will not take the place of any aspect of their standard treatment
WebED Group. The purpose of the patient education control group is to control for time, attention, 
and computer usage. This group will serve as an attention control condition. Children will continue 
with the standard medical care that has been prescribed for their pain problem. Children and 
parents will be provided with access to a revised version of the Web-MAP study website, which 
will have two functional components: 1) information from publicly available educational websites 
about pediatric chronic pain management, 2) diary and assessments. This version of the website 
differs from the one accessed by the treatment condition in that it does not provide access to 
behavioral and cognitive skills training via treatment modules for children and parents. 
During participation, a member of the study team would call/email/text to check in and
to see if there are any problems or questions about using the program.

Principal Researcher: Tonya Palermo  
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5.3. Data sources that will be used to collect data about subjects:10
  
Measures
Description
T1
T2
T3
Rater
Family 
Information Form
Parents report on demographic and 
socioeconomic information, and adolescent 
health history. 
X
 
 
Parent
Pediatric 
Pancreatitis 
Questionnaire
Parents report on acute/chronic pancreatitis 
clinical history and diagnosis. 
X
Parent
Pain Intensity, 
frequency, and 
duration
Pain intensity will be rated on the online diary 
using an 11-point NRS. Pain frequency and 
duration are averaged over each seven-day 
measurement period.
X
 X
X
Child
Child Activity 
Limitation 
Interview (CALI-9)
Daily diary version of the CALI-9 will be used to 
rate perceived difficulty in completing 9 daily 
activities as a measure of pain-related disability.
X
 X
X
Child
PROMIS Pediatric 
Emotional 
Distress Scales
8-item scale of anxiety that assesses fear (e.g., 
fearfulness), anxious misery (e.g., worry) and 
hyperarousal (e.g., nervousness) and 8-item 
scale of depressive symptoms.
X
 X
X
Child
Pain Self-Efficacy
The Pain Self-Efficacy Scale is a 7-item measure 
that assesses the child’s beliefs in carrying out 
activities when in pain. The scale has 
demonstrated good internal consistency, cross-
informant reliability with parent report, and 
strong construct validity.
X
 X
X
Child
PROMIS Pain 
interference
Pediatric Short Form assesses pain-related 
interference
X
 X
X
Child
Bath Adolescent 
Pain 
Questionnaire–
Parent Impact
Assesses changes in perception of burden, family 
functioning, and emotional distress associated 
with parenting youth with chronic pain.
 X
X
 X
Parent
Health-related 
quality of life
Pediatric Quality of Life Inventory will assess 
broad impact of health on child and family
 X
X
 X
Parent, 
Child
Health services 
utilization
Client Services Receipt Inventory for Pain 
assesses inpatient and outpatient visits, 
medications, other treatments, and indirect costs 
as reported by the parent
X
 
X
Parent
Treatment 
satisfaction and 
engagement
Treatment satisfaction (10 item measure with 
Likert ratings and open-ended items about 
content and delivery method) (P, A); Web usage 
 X
n/a

Principal Researcher: Tonya Palermo  
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(logins, completion of assignments, etc.) 
collected from the administrative website
Adverse events
Adverse event form will be used.
 
 X
X
Parent, 
Child
Abdominal Pain 
Index
Assesses child abdominal pain frequency, 
duration, and intensity.
X
X
X
Parent, 
Child
Information collected from INSPPIRE 2 study will be used in this study.  This information 
includes information about abdominal pain, frequency and severity of pancreatitis attacks, 
treatments used, hospital and emergency room visits, and blood draw for testing subjects’ CP 
genetic variants. This information will not be collected for community participants who are not 
involved in INSPPIRE2. 
  
5.4. Data to be collected, including long–term follow–up data:11
  
Data will be collected at three time points. Assessments will occur at baseline (T1), immediately 
after intervention (about 2 months; T2), and repeated at 6 months postintervention (T3).
  
6.
Data and Specimen Banking12
6.1. Complete list of the data and/or specimens to be included in the bank:13
  
N/A
  
6.2. Location of data and/or specimen storage:14
  
N/A
  
6.3. List of those with direct access to data and/or specimens in the bank:
  
N/A
  
6.4. Length of time data and/or specimens will be stored in the bank:
  
N/A
  
6.5. Procedures for protecting the confidentiality and privacy of the subjects from whom the data 
and/or specimens were collected:15
  
N/A
  
6.6. How the data and/or specimens will be made available for future use:
  
N/A
  
6.6.1.
Who can request data and/or specimens from the bank:
  
N/A
  
6.6.2.
Format in which data and/or specimens will be provided: 
  
N/A
  
6.6.3.
Process for investigators to request data and/or specimens:16
  
N/A
  

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6.6.4.
Restrictions on future use:17
  
N/A
  
6.6.5.
Plan for providing data results from banked data/specimens:
  
N/A
  
7.
Sharing of Results 
7.1. Plan to share results with subjects/others:18
  
Study results will be shared with all enrolled participants after active participant study 
involvement is complete and study analyses are finished. These results would be in the form of a 
one-time letter outlining study findings (sent via email).
  
8.
Study Timelines
8.1. Duration of an individual subject’s participation in the study:
  
Approximately 9 Months 
  
8.2. Duration anticipated to enroll all study subjects:
  
Approximately 3 years
  
8.3. Estimated date for the investigators to complete this study:
  
This will be a 5 year study so approximately Winter 2024
  
9.
Study Population19
9.1. Inclusion criteria for each subject population (e.g., patients, parents, providers):
  
Study participants in the RCT will include 260 children with chronic or acute recurring pancreatitis, along 
with one participating parent/caregiver. Youth age 18 or 19 can enroll in the study even if they do not 
have a parent/primary caregiver who can participate. Inclusion criteria include: (a) diagnosis of CP or 
ARP, (b) ages 10-19 years, (c)  at least 4 AP flare-ups/attacks in past year, or at least 1 instance of 
moderate (4/10 pain) pancreatitis/abdominal pain in the past month, and (d) access to the Internet on any 
web-enabled device.
  
9.2. Exclusion criteria for each subject population:
  
Exclusion criteria include parent report of the following: (a) non-English speaking, (b)
inability to read at the 5th grade level due to learning or developmental delays; (c) children with cystic 
fibrosis who have pancreatic insufficiency at the time of diagnosis; (d) patients with Shwachman-Bodian-
Diamond Syndrome; (e) ARP with no evidence of chronic or persistent pain. (f) anticipated surgery 
(TPIAT or other) during study participation (6 month timeframe); (g) other severe systemic disease.
  
9.3. Vulnerable populations involved in the study:20
☒ Children/Teenagers21
Risk assessment specific to this vulnerable population and additional safeguards:22
The research is considered minimal risk as the probability and magnitude of psychological 
and physical risks anticipated in this research are not greater than those ordinarily 
encountered in daily life or during the performance of routine physical or psychological 
examinations or tests.  The relaxation skills and pain coping strategies taught in the online 
program is comparable to what is taught within clinical programs. The participant has the 
option of withdrawing participation at any time during the study.  Knowledge gained through 
this research will guide future research and interventions to help adolescents with chronic 
pancreatitis.
  

Principal Researcher: Tonya Palermo  
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☐ Children who are Wards of the State23
Risk assessment specific to this vulnerable population and additional safeguards:
  
N/A
  
☐ Adults Unable to Consent24
Risk assessment specific to this vulnerable population and additional safeguards:
  
N/A
  
☐ Neonates of Uncertain Viability or Non–Viable Neonates25
Risk assessment specific to this vulnerable population and additional safeguards:
  
N/A
  
☐ Pregnant Women26
Additional safeguards:
  
N/A
  
☐ Prisoners27
Additional safeguards:
N/A
  
10. Number of Subjects
10.1. Total number of subjects to be enrolled locally:28
  
30 dyads- children with CP/ARP and their parents/caregivers (if available)
  
10.2. Total number of subjects to be enrolled across all participating sites:29
  
260 dyads- children with CP/ARP and their parents/caregivers (if available)
  
10.3. Number of screened subjects versus the actual number enrolled in the research:30
  
We anticipate that screening 381 children with CP/ARP will enable us to enroll 260 into this 
study.
  
10.4. Power analysis:
  
Based on our historical data, the estimate of the standard deviation for the primary outcome pain-
related disability is approximately 4. We expect a difference of 1.5 between WebMAP and 
WebED in the mean score of pain-related disability. At the significance level of 0.05, we need 112 
subjects per group to have 80% power to detect a difference. Results indicate sufficient power to 
detect relatively small differences between children receiving WebMAP compared to WebED. 
Taking into account 10-15% attrition, we will enroll 130 patients per group. Because Aims 2 and 3 
employ the LMM regression approach, the power calculation is complicated and requires re-
specifying model parameters that are virtually unknown a priori. Therefore, we take a simple 
approach based on correlation coefficient. Given the sample size of 112 subjects, we have 80% 
power to detect the correlation of 0.27 between gene (or baseline clinical characteristics) and 
pain-related disability, at the significance level of 0.05. As the LMM is more efficient, the actual 
power will be greater. Power to detect correlations between genetic/clinical characteristics and 
pain-related disability may be lowered depending on the number of community participants 
enrolled.
  
11. Withdrawal of Subjects
11.1. Anticipated circumstances under which subjects will be withdrawn from the research without 
their consent:
  

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The PI may decide to withdraw participants from the study if a family is not able to comply 
with study procedures or do not understand study instructions.
  
11.2. Procedures for orderly termination:
  
If a participant must be withdrawn from all study procedures the study staff would contact 
the family to explain the cause for study withdrawal and finalized study termination. 
  
11.3. Procedures that will be followed when subjects withdraw from the research, including partial 
withdrawal from procedures with continued data collection and withdrawal from data/specimen 
banking:
  
Full Withdrawal: If a participant must be withdrawn from all study procedures the study 
staff would contact the family to explain the cause for study withdrawal and finalized 
study termination. 
Partial Withdrawal: If a participant partially withdraws from the procedures, study staff 
would contact the family to discuss family’s interest in participation. If the family is 
interested, the study procedures will be continued, if the family is not interested, this will 
be considered a full withdrawal. 
  
12. Risks to Subjects
12.1. Reasonably foreseeable risks to subjects (include each study population, each arm, and 
optional procedures): 
  
This study is minimal risk. There are potential risks around emotional distress, time 
commitment, and confidentiality. Although asking about physical symptoms and 
mood/behavior does not typically result in any distress, there is a small risk of emotional 
distress. There is a potential risk of loss of confidentiality. 
  
12.2. Procedures with unforeseeable risks:
  
N/A 
  
12.3. Procedures with risks to an embryo or fetus should the subject be or become 
pregnant:
  
N/A
  
12.4. Risks to others who are not subjects:
  
N/A
  
12.5. Procedures performed to lessen the probability or magnitude of risks:
  
Participants will be advised they can skip any questions they feel uncomfortable 
answering. To support confidentiality, adolescents will be asked to complete 
questionnaires independently. We will make every effort to protect this data. For 
example, all data will be coded with a unique ID number. Participants will be informed of 
their right to refuse to participate in any part of the data collection and given the phone 
numbers of the PI and the Seattle Children’s IRB in the event that they desire further 
information or would like to issue a formal complaint.
 
13. Potential Benefits to Subjects
13.1. Potential benefits that individual subjects may experience from taking part in the research:31

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Participation in this research study may or may not benefit the subject. The 8-week Web-
MAP program may help to increase daily functioning and decrease pain intensity in 
children and teens who complete this program as it has shown effectiveness in other 
youth with chronic pain.
  
14. Data Analysis/Management
14.1. Data analysis plan, including statistical procedures:
  
Distributions of primary and secondary outcome variables at each time point (and on difference 
scores between time points) will be examined first with summary statistics and graphical tools. 
For outcome variables with highly skewed distributions, we will either apply transformation or non-
parametric test procedures. Preliminary work will also involve computation of scale reliabilities 
(e.g., internal consistency using Cronbach’s alpha) of all of the self report measures. The RCT 
analysis will be an intent-to-treat analysis including all randomized subjects. Two-sample t-test 
will be used to test the difference between the WebMAP group and WebED group in pain-related 
disability and other outcomes (e.g., anxiety, depression and HRQOL) at baseline, 2 months and 6 
months. In the case that the outcome is categorical, the chi-squared test will be used. The pre-
post change in pain-related disability will also be assessed within and between groups using one-
sample or two-sample t-test. Linear mixed models (LMM) will be further used to compare the 
change in pain-related disability over time (from baseline to follow-ups) between WebMAP and 
WebED. The LMM is ideally suited for analysis of repeated measures because it allows for more 
specific estimation of the correlation structure of the residuals, it efficiently handles unbalanced 
designs and missing data, without excluding participants or imputing values. The repeated 
measures of pain-related disability will be treated as the dependent variable. Measurement time,
intervention condition, and their interaction will be included in the LMM as covariates. We will 
include biological covariates of age and sex in all models and will include other demographic and 
clinical factors, as needed to adjust for potential confounding effects. Fit statistics (e.g., Akaike's 
Information Criterion) will be evaluated for all models to ascertain the best fit of the correlation 
structure of the dataset. We will use a computer program, PROC MIXED (SAS v9.3 SAS Institute 
Inc, Cary, NC) to estimate and test the models with continuous dependent measures. Results will 
be summarized with the estimates of model parameters and p-values. For a binary endpoint of 
clinically significant reduction in pain (i.e., achieved 50% or greater reduction in pain intensity), we 
will employ the generalized linear mixed model (GLMM) to model and compare the changes over 
time (from baseline to follow-ups) between WebMAP and WebEd. We will use SAS PROC 
GLMIMX, which provides an adaptation to the LMM approach for categorical data.
Blood draw and collection will be done by the INSPPIRE 2 study, but will not be done for patients 
recruited from community organizations who are not participating in INSPPIRE 2. The data we 
need will be pulled from that study for analysis. LMM will be our primary analytic tool to 
investigate the association between genetic co-variants and treatment response in internet-based 
CBT. In the LMM, repeated measures of painrelated disability will be used as the dependent 
variable. The covariates include time, gene and demographic variables (e.g., sex) when 
necessary. In the initial evaluation, “genetic signatures” will be used as covariants. This approach 
markedly reduces complexity by combining known pathogenic variants in a class into an object 
such as “CFTR-related disorders”, “Pathologic Trypsins”, “Unfolded protein response (UPR)”, 
“Lipotoxicity”, “idiopathic” and “others” for etiology, as well as “opiate pharmacogenetics defect”, 
“pain receptor” and others for modifiers. In addition, pathogenic variants with large effects (e.g. 
PRSS1 p.R122H, SPINK1 p.N34S) or high frequency (e.g. CTRC g.60G haplotype) will be 
evaluated as independent covariates. To investigate multiple genes and genetic signatures, we 
will conduct univariate gene analysis by regressing each gene independently on the pain-related 
disability outcome to see if there is reasonable signal of association between the gene and pain-
related disability. Using this procedure, we screen out the genes with p value > 0.1. We then build 

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a multivariate model based on the genes with p value < 0.1 in the univariate analysis. In the case 
that the number of genes included in the multivariate model is still large, model selection (e.g., 
using LASSO) will be performed to obtain a parsimonious model and identify the genes that are 
significantly associated with the outcome pain-related disability. Further analysis utilizing machine 
learning programs for cluster analysis, such as principle component analysis, will be conducted 
as complementary and confirmatory analyses.
  
14.2. Quality control procedures for collected data:32
  
The PI will supervise the study coordinator in collating and storing data and overseeing 
the integrity of study records. Data will be maintained on a network server with password 
protection and daily backup of data performed. The primary source of data will come from 
online assessments conducted on the REDCap website provided through ITHS at UW. 
REDCap has extensive security precautions appropriate for the storage of PHI. REDCap 
was developed specifically around HIPAA-Security guidelines and is recommended for 
use by researchers. In 2010 the Institute of Translational Health Sciences Biomedical 
Informatics Core (ITHS BMI) began supporting an installation of REDCap (Research 
Electronic Data Capture), which is software specifically designed for electronic data 
capture (EDC) for clinical trials. REDCap features include differentiated user roles and 
privileges, user authentication and authorization security, electronic signatures, SSL 
encryption, and comprehensive auditing to record and monitor access and data changes. 
PIs can configure REDCap User Rights and Data Access Groups to provide granular 
study data access to authorized study personnel. Access to servers is restricted to 
authorized ITHS BMI support personnel. The servers are located on ITHS-owned 
hardware in a secure server room at the University of Washington. This server room 
meets the technical requirements for HIPAA compliance and hosts other servers 
containing Protected Health Information (PHI). The Operating System of each server will 
be kept fully patched and firewalled in accordance with UW Medicine Information Security 
Policy. All identifying information will be removed from all electronic data, thus protecting 
the identities of participating families. Data will be kept for a minimum of seven years.
To ensure the accuracy of the data the following processes will be implemented:

The study coordinator will check all data from REDCap questionnaires for 
completeness.

REDCap will be exported directly to SPSS statistical software, to ensure the 
participant’s responses are accurately entered into the database used for 
analyses. This will be secure and stored locally at Seattle Children's.
 
15. Confidentiality33
15.1. Procedures to secure the data and/or specimens during storage, use, and transmission:
  
All participant data will be coded with a unique identification number, thus ensuring the 
subject’s identity as a participant in this study will remain confidential. The research 
records will be kept confidential and protected health information will be safeguarded as 
required by Seattle Children’s IRB and HIPAA regulations. The research staff and Seattle 
Children’s IRB will be allowed to inspect the information collected from this study. Data 
collection online through REDCap will also be private and confidential. REDCap was 
developed specifically around HIPAA-Security guidelines and is recommended for use by 
researchers. In 2010 the Institute of Translational Health Sciences Biomedical Informatics 
Core (ITHS BMI) began supporting an installation of REDCap (Research Electronic Data 

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Capture), which is software specifically designed for electronic data capture (EDC) for 
clinical trials. REDCap features include differentiated user roles and privileges, user 
authentication and authorization security, electronic signatures, SSL encryption, and 
comprehensive auditing to record and monitor access and data changes. PIs can 
configure REDCap User Rights and Data Access Groups to provide granular study data 
access to authorized study personnel. Access to servers is restricted to authorized ITHS 
BMI support personnel. The servers are located on ITHS-owned hardware in a secure 
server room at the University of Washington. This server room meets the technical 
requirements for HIPAA compliance and hosts other servers containing Protected Health 
Information (PHI). The Operating System of each server will be kept fully patched and 
firewalled in accordance with UW Medicine Information Security Policy. 
  
15.2. Location where the data and/or specimens will be stored:
  
All contact information and identifying data will be stored in a secure location within the PI’s 
research lab
  
15.3. Length of time data and/or specimens will be stored:
  
Data will be kept for a minimum of seven years.
  
15.4. Individuals with access to data and/or specimens:
  
Only the research staff and Seattle Children’s IRB will be allowed to inspect the information 
collected from this study
  
15.5. Process for the transmission of data and/or specimens outside Seattle Children’s:
15.5.1.
List of data and/or specimens that will be transmitted:
  
N/A
  
15.5.2.
Individual(s) who will transmit data:
  
N/A
  
16. Provisions to Monitor Data to Ensure the Safety of Subjects34
16.1. Plan to periodically evaluate the data collected regarding both harms and benefits to 
determine whether subjects remain safe:35
  
N/A
  
16.2. Data reviewed to ensure safety of subjects:
  
N/A
  
16.3. Safety information collection procedures:
  
N/A
  
16.4. Frequency of cumulative data review:
  
N/A
  
16.5. Conditions that trigger an immediate suspension of the research:
  
N/A
  
17. Use of Social Media

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17.1. Types of social media to be used and how:
  
Facebook, Instagram, Twitter, and LinkedIn will be used for recruitment purposes only - to 
share the study flyer information and provide a link to a REDCap community interest form 
where potential study participants can contact the study team if interested. 
  
17.2. Measures in place to protect the privacy or confidentiality of subjects:36
  
The only transmission of confidential information will occur via secure REDCap form. This will 
only happen when a community member is interested in the study and voluntarily discloses 
this information to the study team with the intention of being contacted about the study.
  
17.3. Types of communications that will be submitted to the IRB for review:37
  
All study information included on social media websites will be copied from the IRB 
reviewed/approved study flyer. Advertisements for Facebook, Twitter and Instagram will be 
submitted to the IRB for their review.
  
17.4. If user-generated content will be active, how it will be monitored and what actions will be taken 
to ensure subject safety and study integrity:
  
N/A
  
18. Research Related Injury38  
18.1. Available compensation in the event of research related injury:
  
N/A
  
19. Recruitment Methods39
19.1. When, where, and how potential subjects will be recruited:
  
Child participants with CP/ARP will be recruited from one of the 21 sites in the INSPPIRE 
cohort registry. Potential participants who are participating in the INSPPIRE 2 study and have 
consented to the sharing of their contact information for related research studies will be 
referred by their provider/research coordinator at their institution. Referring staff will send the 
potential participating family’s contact information to the study team at Seattle Children’s via 
secure email or REDCap form. The potential participant will be sent a letter and flyer 
describing the study, then if unresponsive, will be contacted over the phone/email/text by 
Seattle Children’s to screen for eligibility and assess interest. We will contact participants up to 
8 times in total, spread out over a period of 8 weeks. Participants will be given multiple 
opportunities to opt out of future contact, in their introductory letter and future contact 
attempts. Based on our prior experience recruiting from this population, this number of contact 
attempts is often necessary to make contact, even if patients have been referred by their 
provider after explicitly expressing interest. Fewer attempts would significantly reduce our 
chances of reaching a family. Furthermore, this study has potential to directly benefit patients.  
If participants are interested and eligible, consent forms will be emailed to participants and a 
consent call will be set up for a future time. 
INSPPIRE2 participants who enroll in this study will be contacted to see if they would like to 
participate in a brief related follow-up study, STUDY00002765. This study consists of a single 
survey. See the STUDY00002765 protocol and related documents for further details about 
how these participants will be contacted. STUDY00002765 is conducted by the same PI and 
study team members.
Additional community participants will be identified via the websites and social media outlets 
(Facebook, Instagram, and Twitter) of pancreatitis patient advocacy groups such as the 
National Pancreas Foundation (NPF) and Mission Cure, through advertisements on Facebook 

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and Instagram, and through distribution of study flyers via interested gastroenterology 
clinics/providers. These participants will be able to view the study flyer, and if they are 
interested in participating, they may “self-refer” by filling out a secure REDCap form with their 
contact information and a few preliminary eligibility questions (see separate form). They may 
also call SCH staff directly if they have questions about the study. SCH staff will then contact 
these potential participants and screen them for eligibility over the phone/email/text. If eligible, 
consent forms will be emailed to participants and a consent call will be set up for a future time.
Additional potentially eligible participants will be identified from SCH clinic schedules and 
electronic medical records. Potential participants and their parents will receive an initial mailing 
with a letter informing them of potential study eligibility and giving them the option to decline 
contact. This letter will also include a flyer outlining study details. All potential participants will 
be approached two weeks after mailing the letter with a phone call, email, or text message 
from study staff inviting them to participate, screening for eligibility criteria, and completing the 
consent process for participants who agree to participate. Study staff will attempt to contact 
potential participants a total of three times over the phone, email, and/or text message. 
  
19.2. Steps that will be taken to protect potential subjects’ privacy interests:40
  
All information will be stored and transmitted securely through REDCap. Participants will be 
given opportunities to decline any further contact.
Recruitment of patients will involve private mailings to their home and private phone calls, 
emails or text messages. Families have the option of calling to decline participation and any 
further contact before they are contacted via phone.  Consent will take place in the privacy of 
the participants’ home after the family has had sufficient time to decide whether or not they 
would like to participate. There is no time constraint on a parent or youth’s decision to 
participate, families can take as much time as they need to review consent/assent documents 
and ask questions about the study.  In addition, study staff will emphasize participation in this 
study is voluntary and will not impact the patient’s care.
  
19.3. Sources of subjects:41
  
Child participants will be receiving care from one of the 21 sites in the INSPPIRE cohort 
registry. Additional participants will be recruited from patient advocacy groups such as the 
NPF or Mission Cure, social media advertisements, and through gastroenterology clinics. 
Additional participants will be identified through SCH clinic schedules and records.
  
19.4. Methods that will be used to identify potential subjects:
  
Potential subjects will be identified if they are already part of the INSPPIRE2 study and 
receiving care, if they respond to online advertisements through patient advocacy 
groups/social media, or if they respond to flyers at their gastroenterology clinic, or if they have 
sought care for acute recurring/chronic pancreatitis at SCH (through SC clinic schedule and 
medical records
  
19.5. Materials that will be used to recruit subjects:42 
INSPPIRE2 participants will receive a study flyer and letter describing the study. 
Some participants will receive a flyer from a patient advocacy group website/social media 
site/GI clinic, and will fill out a secure REDCap community interest form to pass their contact 
information on to Seattle Children’s staff it they are interested in participating.
SCH patients will receive a letter from the study team and a study flyer for their initial contact.

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The study team will use phone calls/voicemails (recruitment script), and/or email/text 
messages to approach subjects who are referred, self-referred, or identified from SC clinic 
schedules/medical records. 
  
19.6.
Recruitment methods not controlled by Seattle Children’s:
  
N/A  
  
20. Consent/Assent Process
20.1. Where the consent process will take place:
  
Consent will take place over the phone, after the family has had sufficient time to decide 
whether they would like to participate.
  
20.2. Steps that will be taken to protect prospective subjects’ privacy interests:43
  
Consent will be done over the phone while the participant is in the privacy of their own home.
  
20.3. Waiting period available between approaching a prospective subject and obtaining consent:
  
Each participant will be given sufficient time to read, review and ask questions before 
obtaining consent. 
  
20.4. Process to ensure ongoing consent:
We will ask youth and parents questions about the study so they fully understand their 
involvement over the course of the study. We will be touching base with them at each time 
point to answer questions and let them know next steps. 
  
  
20.5. If this box is checked, “SOP: Informed Consent Process for Research (HRP-090)” will be 
followed:  ☒
  
20.6. If “SOP: Informed Consent Process for Research (HRP-090)” will not be followed, address the 
following:44
20.6.1.
Role of the individuals listed in the application as being involved in the consent 
process:
    
N/A
  
20.6.2.
Time that will be devoted to the consent discussion:
  
N/A
  
20.6.3.
Steps that will be taken to minimize the possibility of coercion or undue influence:
  
N/A
  
20.6.4.
Steps that will be taken to ensure the subject’s understanding:
N/A
  

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20.7. Non-English Speaking Subjects45
20.7.1.
Language(s) other than English are understood by prospective subjects or 
representatives:
  
N/A
  
20.7.2.
If non-English speaking subjects will be included in the research (check one):
☐  Appendix A-10 of the Investigator Manual will be followed46 
☐  Appendix A-10 of the Investigator Manual will not be followed.  Explanation of 
procedures not following Appendix A-10:
Click here to enter text.
  
20.7.3.
Justification if non-English speaking subjects will be excluded from the research:47
The WebMAP program is only available in English. 
   
20.8. Subjects Who Are Not Yet Adults (Infants, Children, Teenagers) 
20.8.1.
Process used to determine whether an individual has not attained the legal age of 
consent under the applicable law of the jurisdiction in which the research will be 
conducted (e.g., individuals under the age of 18 years):48
  
We will be collecting date of birth to determine age. Parent consent for their 
participation will be obtained for all individuals under the age of 18.
  
20.8.2.
Parental permission will be obtained from:49
☐  Both parents unless one parent is deceased, unknown, incompetent, or not 
reasonably available, or when only one parent has legal responsibility for the 
care and custody of the child.
☒ One parent even if the other parent is alive, known, competent, reasonably 
available, and shares legal responsibility for the care and custody of the child.
☐ Neither parent.50
  
20.8.3.
Process used to determine an individual’s authority to consent to each child’s 
general medical care if permission will be obtained from someone other than 
parents:51
  
Caregivers who are not biological parents must be legal guardians in order to 
participate in the study and provide consent for their child’s participation.
  
20.8.4.
Assent will be obtained from:52
☒
All children.  
☐
Some children.  Specify:  
Click here to enter text.
☐
None of the children.  Explain: Click here to enter text.
20.8.5.
Procedures for obtaining and documenting assent:
  
Consent forms will be read and completed at the participants’ home, while speaking 
to a SCRI study coordinator on the phone.  This phone conference will be used to 
answer additional questions, further explain the study, and obtain consent. After 
going through the consent script, participants will be asked to indicate their consent 
and authorization on an electronic form. 
During the consent script, the study coordinator will discuss information about study 
procedures, study risks, potential benefits, and the voluntary nature of the study. In 

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addition, the study coordinator will assess how well potential participants understand 
the study through the types of questions raised during the discussion of the protocol. 
The study coordinator will use lay language when speaking with the participant (and 
parent). For participants under 18, the study coordinator will obtain consent of the 
parent first.  The study coordinator will document the day and time of consent in the 
participant database. The participant will then be asked to document their consent 
on a secure electronic form via REDCap.  The process will take about 20-30 
minutes. 
If a phone conference cannot be arranged at the same time for the parent and child 
participants, the study coordinator will speak with the parent and child separately 
over the phone. The study coordinator will only speak with the child after speaking 
with the parent. 
  
20.8.6.
Plan for re-approaching children who have reached the age of majority to obtain 
consent:53
  
It is possible that some child participants will turn 18 between the time they are 
enrolled in the study and the time they complete follow-up assessments. If this 
occurs, these participants will be re-approached when they are scheduled to 
complete a follow-up. If they are still interested in participating in the study, we will 
send these participants a study consent form and obtain their electronic signed re-
consent to continue participating in the study, if they are still willing. 
We will obtain a waiver of re-consent for participants who reach the age of majority 
after their study participation is complete and prior to completion of the study and 
data analysis.
  
20.9. Cognitively Impaired Adults/Adults Unable to Consent54
20.9.1.
Process used to determine whether an individual is capable of consent:
  
Cognitively impaired adults/adults unable to consent will not be enrolled in the study. 
  
20.9.2.
Individuals from whom permission will be obtained in order of priority:55
  
N/A
  
20.9.3.
Assent will be obtained from:
☐
All of these subjects.
☐
Some of these subjects.  Specify: Click here to enter text.
☐
None of these subjects.  Explain: Click here to enter text.
20.9.4.
Process for obtaining and documenting assent:56
  
N/A
  
20.10. Waiver or Alteration of Consent Process
20.10.1. Reasons for requesting a waiver or alteration of informed consent:57
  
We are requesting a waiver of consent for children who turn 18 whose private 
identifiable information is still being used for data analysis purposes, but are no 
longer actively participating in the study. The justifications for this waiver are here: 

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20.10.2. Consent Waiver/Alteration Criteria justifications:58
20.10.2.1.
The research involves no more than minimal risk to the subjects 
because:
Participants are only asked to complete online surveys and log in to a 
website that would provide either education about chronic pain or 
skills training to manage chronic pain. There are no significant risks 
involved in participation. Furthermore, data analysis involves no 
additional risk to participants whatsoever, as participants do not 
complete any activities and are no longer involved. 
20.10.2.2.
The waiver or alteration will not adversely affect the rights or welfare 
of the subjects because:59
  
The waiver of consent would not adversely affect the rights or welfare 
of subjects because any publication of research results would never 
reveal an individual's identity either directly or indirectly. Furthermore, 
all survey responses will be linked with a unique study ID to protect 
participant confidentiality, and all study documents/information will be 
stored in secure, password/firewall-protected servers and databases.
  
20.10.2.3.
The research could not practicably be carried out without the waiver 
or alteration because:60
Due to the age range of the study, most participants would turn 18 
before data collection & analysis is complete, so the research could 
not be practicably carried out if the study team had to contact all of 
them again and re-consent. Additionally, study staff will not be in 
contact with participants after their study participation is complete, 
and it would be impracticable to conduct the research if the study 
team had to reach participants for the purposes of obtaining consent 
due to significant time lapse between participant completion, turning 
18, and data collection/analysis, along with changing contact 
information or life circumstances. In addition, not including data from 
the entire participant population would bias study results. 
  
20.10.2.4.
Whenever appropriate, the subjects will be provided with additional 
pertinent information after participation:
  
N/A
  
20.10.3. If the research involves a waiver of the consent process for emergency research, 
provide sufficient information for the IRB to make it determinations:61
  
N/A
  
21. Process to Document Consent in Writing
21.1. If consent will be documented in writing (check one):
☐ 
“SOP: Written Documentation of Consent (HRP-091)” will be followed.
☒ 
“SOP: Written Documentation of Consent (HRP-091)” will not be followed. 
Process of documenting consent:62
 

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The study coordinator will document the day and time of consent in the participant 
database. The participant will then be asked to document their  consent on an electronic 
form via REDCap, 
  
21.2. If consent will not be documented in writing (check all boxes that apply):63
☒ 
A written statement/information sheet describing the research will be provided to 
subjects.64
☐ 
A written statement/information sheet describing the research will not be provided to 
subjects.  Explain: Click here to enter text.
☐ 
A consent script will be used.65
22. HIPAA Authorization and RCW Criteria
22.1. HIPAA Authorization (check all boxes that apply):
☐ 
The study does not involve the receipt, creation, use and/or disclosure of protected health 
information (PHI).66
☐ 
HIPAA authorization will be obtained as part of a signed consent form. 
☒ 
The study will access PHI without prior authorization from subjects (including for 
recruitment purposes – e.g., reviewing the medical record to determine eligibility).  See 
21.2 below for required HIPAA waiver/alteration criteria.
☒ 
Subjects will review a written statement/information sheet with the appropriate HIPAA 
language but will not provide a written signature.  See 21.2 below for required HIPAA 
alteration criteria.67
☐ 
Other.  Explain:68
Click here to enter text.
  
22.2. HIPAA Waiver/Alteration Criteria: Explain why:
22.2.1.
The use or disclosure of PHI involves no more than a minimal risk to privacy of 
individuals, based on, at least the presence of the following elements:
22.2.1.1.
An adequate plan to protect the identifiers from improper use and 
disclosure: 
  
We will protect all identifiers by using unique study ID numbers on all PHI 
and only study team members will have access to a subject’s PHI and ID 
number.
  
22.2.1.2.
An adequate plan to destroy identifiers at earliest opportunity consistent 
with conduct of research:
  
All identifiers will be destroyed at the earliest opportunity consistent with 
conduct of this research.
  
22.2.1.3.
Assurances that PHI will not be reused or disclosed to any other party or 
entity, except as required by law or for authorized oversight of the 
research:
  
PHI will not be reused or disclosed to any other person or entity.
  
22.2.2.
The research could not practicably be conducted without the waiver or alteration of 
authorization:
  
Without the alteration of authorization, study sites would not be able to obtain 
patient contact and eligibility information. The study would have limited eligible 
patients if patients were given the option to contact the study staff first. Study staff 

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would not be able to contact potentially eligible participants for screening purposes 
without access or use of their PHI. Obtaining PHI is necessary for the 
characterization of the groups of the individuals who screen out of the study. Since 
we will not be seeing the participants in person, we are asking for the waiver for 
online authorization. Without it, study time lines would be delayed and participant 
interest would decrease waiting for mailed consent forms. The participant will 
document their consent on a secure electronic form via REDCap that meets 
state/international laws.  
  
22.2.3.
The research could not practicably be conducted without access to and use of the 
PHI:69
  
The nature of this research is specific to the participant’s health. 
  
23. Payments/Costs to Subjects70
23.1. Amount, method, and timing of payments to subjects:71
  
Youth and parents will each receive a $50 electronic gift card for each timepoint assessment 
they complete.  They will receive this gift card after completing each time point. 
  
23.2. Reimbursement provided to subjects:72
  
N/A
  
23.3. Additional costs that subjects may be responsible for because of participation in the 
research:73
  
We do not anticipate any costs. 
  
24. Setting
24.1. Site(s) or location(s) where the research team will conduct the research:
  
SCRI study staff will receive referrals from the participating clinics. All survey 
assessments/diaries will be sent via REDCap/WebMAP for participants to complete in their 
home.
  
24.2. Composition and involvement of any community advisory board:
  
N/A
  
24.3. For research conducted outside of the organization and its affiliates:74
24.3.1.
Site-specific regulations or customs affecting the research:
  
N/A
  
24.3.2.
Local scientific and ethical review structure:
  
N/A
  
25. Resources Available
25.1. Qualifications (e.g., training, education, experience, oversight) of investigator(s) to conduct 
and supervise the research:75
  
The PI and study staff of SCRI have years of experience in the recruitment methods used in 
this study and skills needed to organize, track, and follow this many participants through the 
completion of the study. All study procedures will be done under the supervision of the PI who 
assumes responsibility for all study related actions and events. The PI will be available to 
clarify recruitment eligibility, answer questions, etc. throughout the course of the study.
  

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25.2. Other resources available to conduct the research:76
  
As this study presents minimal risk to participants, we do not anticipate participants needing 
medical or psychological resources consequently to study procedures. However, if a 
participant voluntarily requests additional services, the study team will provide SCH-based or 
community-based resources
  
26. Coordinating Center Procedures
26.1. Coordinating center institution:
  
Seattle Children’s
  
26.2. If Seattle Children’s is the coordinating center:
26.2.1.
Process to ensure communication among sites:77
  
We will hold monthly between site investigator phone meetings. to discuss study 
progress, answer questions, and ensure proper study conduct.
  
26.2.2.
Process to ensure all site investigators conduct the study according to the IRB 
approved protocol and report all non-compliance:
    
Our monthly calls will be to discuss study progress, answer questions, and ensure 
proper study conduct.
  
26.2.3.
Process to ensure all required approvals are obtained at each site:
    
Before beginning the research, we will ensure that required approvals have been 
obtained at all sites, and we will maintain a record of their approvals including all 
modifications.
  
26.2.4.
Process to ensure all sites are informed of any problems and/or interim results:
  
These will be discussed at monthly phone meetings.
  
27. Good Clinical Practice
27.1. If you have committed to conducting the described study per International Center for 
Harmonization of Good Clinical Practice (ICH-GCP), check this box: ☐78
  

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1 Include information if this protocol is associated with other IRB-approved studies (e.g. is this application the next part/phase of a previously approved 
application.
2 In clinical trials, an endpoint is an event or outcome that can be measured objectively to determine whether the intervention being studied is 
beneficial. Some examples of endpoints are survival, improvements in quality of life, relief of symptoms, and disappearance of the tumor.  
3 Include information on a drug or biologic in this section if: (1) the study specifies the use of an approved drug or biologic; (2) the study uses an 
unapproved drug or biologic; (3) the study uses a food or dietary supplement to diagnose, cure, treat, or mitigate a disease or condition; or (4) data 
regarding subjects will be submitted to or held for inspection by the Food and Drug Administration (FDA).  Only include information on a device in this 
section if: (1) the study evaluates the safety or effectiveness of a device; (2) the study uses a humanitarian use device (HUD) for research purposes; or 
(3) data regarding subjects will be submitted to or held for inspection by the FDA.  Please note that mobile medical applications may meet the definition 
of a device – see FDA Guidance.
4 See the Investigator Manual HRP-103 for sponsor requirements for FDA-regulated research.
5 Explain what IND exemption category applies to the drug and why.  Note that a drug is not exempt from an IND unless all criteria for one category are 
met.  See “HRP-306: Drugs” for more information.
6 Explain what IDE exemption category applies to the device and why.  Note that a device is not exempt from an IDE unless all criteria for one category 
are met.  See “HRP-307: Devices” for more information.
7 Explain why the device is NOT a significant risk device.  A significant risk device means an investigational device that: (a) is intended as an implant 
and presents a potential for serious risk to the health, safety, or welfare of a subject; (b) is purported or represented to be for use supporting or 
sustaining human life and presents a potential for serious risk to the health, safety, or welfare of a subject; (c) is for a use of substantial importance in 
diagnosing, curing, mitigating, or treating disease, or otherwise preventing impairment of human health and presents a potential for serious risk to the 
health, safety, or welfare of a subject; or (d) otherwise presents a potential for serious risk to the health, safety, or welfare of a subject. 
8 Be sure to indicate if controls will be included and include information about why control arms are ethically acceptable.
9 Describe all of the research procedures being performed. Be sure to make it clear which procedures apply to each subject population. When 
applicable, describe how research procedures differ from standard of care and/or affect standard of care.  Describe any audio/video recording that will 
be involved.
10 Attach all surveys, scripts, and data collection forms to the “Supporting Documents” page.
11 Include information about the frequency of data collection.
12 See HRP-001 - SOP – Definitions for definition of banking.  Type N/A if not applicable.  If the data is subject to NIH Genomic Data Sharing Policies 
(e.g. you will submit data to dbGaP, NDAR, FITBIR), indicate here.  
13 If applicable, include a list of identifiers that will be banked.
14 Be general (e.g., researchers’ lab, clinic, etc.)
15 Generally, data and/or specimens should be released in a coded, non – identifiable manner.
16 Include a description of the process used to verify and document that any required approvals have been obtained prior to release of data/specimens 
from the bank.
17 You can allow for use for broad purposes
18 This includes putting results and/or data in the subject medical records.
19 If your population will differ from the representative population where the study will take place (e.g., race, ethnic group, or gender), provide a 
rationale for the differences.
20 If you check a box below, be sure to include the additional safeguards associated with the population.
21 Refer to HRP-416 CHECKLIST: Children.  
22 If the study is minimal risk, explain why. Must also include, as applicable: (1) why direct benefits are anticipated, (2) why risks are justified by 
anticipated benefit and/or the relationship between risk and prospective benefit compared to available alternatives, (3) why risk represents only minor 
increase over minimal risk, (4) how study procedures are reasonably commensurate with those inherent to the child’s actual or expected conditions, (5) 
whether the interventions/procedures are likely to yield generalizable knowledge about the participant’s condition and why it is of “vital importance” to 
understanding or amelioration of the participant’s underlying disorder or condition, and (6) an explanation of what alternative methods/approaches were 
considered to make the above assessments (as applicable).
23 This population may be wards of the state or any other agency, institution, or entity. Refer to HRP-416 CHECKLIST: Children, Section 6, for 
additional guidance on required considerations for this population.
24 This refers to both cognitive impairments and adults who are incapacitated for any other reason.  As applicable, refer to HRP-417 CHECKLIST: 
Cognitively Impaired Adults.
25 Refer to HRP-413 CHECKLIST: Neonates and HRP-414 CHECKLIST: Neonates of Uncertain Viability.
26 Refer to HRP-412 CHECKLIST: Pregnant Women.
27 Refer to HRP-415 CHECKLIST: Prisoners
28 A subject is considered “enrolled” when they consent to be in the study.
29 Only applicable for multisite studies.
30 i.e., numbers of subjects excluding screen failures.
31 Payment for participation is not considered a benefit.
32 For example, data will be double entered, data will be reviewed by another study team member to ensure accuracy, etc.
33 If your study is multisite and there are differences in how confidentiality will be maintained by the coordination center and our local site, this should 
be explained in this section (e.g. local site will have samples that are linked to a person’s name, but the coordination center will only receive coded 
samples without any links).  Confidentiality regarding use of Social Media will be explained in a protocol section below.
34 Applicable for studies that present more than minimal risk.
35 Include information about who (describe in terms of role or group) will review the data.
36 This should be specific to the social media you are using for the research.
37 All communications that are directed towards subjects and specific to a particular study will require prior IRB review and approval.  All non-IRB 
reviewable communications can be described in general terms by category – news stories, relevant publications – and representative examples of 
each can be provided.  
38 Applicable if the research involves more than minimal risk to subjects.  If minimal risk, this section is N/A.
39 If this is a multicenter study and subjects will be recruited by methods not under the control of the local site (e.g., call centers, national 
advertisements) those methods should also be described here.
40 “Privacy interest” refers to a person’s desire to place limits on whom they interact or whom they provide personal information.
41 For example: medical records, CIS, clinical databases, other study records. If the study will access PHI for recruitment purposes without prior 
authorization from subjects, please address this in the HIPAA Authorization section below.

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42 Attach copies of these documents to the Recruitment Materials section of the study SmartForm. For printed advertisements, attach the final copy. 
For online advertisements, attach the final screen shots (including any images).  When advertisements are taped for broadcast, send the final 
audio/video tape to IRB@seattlechildrens.org. You may attach the wording of the advertisement to the SmartForm prior to taping to preclude re-taping 
because of inappropriate wording, provided the IRB reviews the final audio/video tape.
43 “Privacy interest” refers to a person’s desire to place limits on whom they interact or whom they provide personal information.
44 This section describes the way(s) in which the processes for this study will not follow Seattle Children’s SOP.
45 See HRP-090, HRP-091, and Investigator Manual HRP-103 for more information.  
46 Note the Short Form Consent may only be used when certain conditions are met.  See HRP-091 for requirements for Short Form consent form use.
47 Seattle Children’s IRB prohibits the exclusion of non-English speaking populations from research unless there is sufficient justification for the 
exclusion.  See Investigator Manual HRP-103 for more information.  
48 For research conducted in the state, review “SOP: Legally Authorized Representatives, Children, and Guardians (HRP-013)” to be aware of which 
individuals in the state meet the definition of “children.”  The age of majority in Washington is 18; however, sometimes younger children have ability to 
consent for certain types of care (e.g. sexual reproduction/health; mental health; drug/alcohol treatment).  For research conducted outside of the state, 
provide information that describes which persons have not attained the legal age for consent to treatments or procedures involved the research, under 
the applicable law of the jurisdiction in which research will be conducted. One method of obtaining this information is to have a legal counsel or 
authority review your protocol along the definition of “children” in “SOP: Legally Authorized Representatives, Children, and Guardians (HRP-013).”  If 
the sites in other states in the study are conducting their own IRB review, you do not need to worry about this--type N/A.  If you are conducting 
research and are actively recruiting participants outside of Washington who are NOT coming to SCH to give consent and who will be covered under 
SCH IRB approval, this section should be addressed in your protocol.
49 For minimal risk studies and greater than minimal risk studies that offer a prospect of benefit, the IRB generally requires one parent to provide 
permission for the child to participate.
50 If parental permission will not be obtained, please address this in the Waiver or Alteration of Consent Process below.
51 See HRP-013 for more information.
52 The IRB generally follows the following guidelines for written assent: children 7-12 should provide written assent on the “simple” assent form (HRP-
502G); children 13-17 should provide written assent by co-signing the parental permission form (HRP-502A).  The IRB will consider other assent 
scenarios (e.g. verbal assent for some or all children; not requiring assent for some or all children; or waiving assent): please provide details about the 
plan for your study.  See HRP-090 and HRP-416 for more information on waiving assent and when assent is not necessary.
53 See Appendix A-13 of the Investigator Manual HRP-103 for requirements for re-consent at age 18.  If you think you meet the conditions for a waiver 
at 18, please address this in the Waiver or Alteration of Consent Process below.
54 See “HRP-417 Cognitively Impaired Adults” for further information.  
55 For example: durable power of attorney for health care, court appointed guardian for health care decisions, spouse, and adult child.  If you are 
following HRP-013 in order to make this determination, simply state that in this section. For research conducted in the state, review “SOP: Legally 
Authorized Representatives, Children, and Guardians (HRP-013)” to be aware of which individuals in the state meet the definition of “legally authorized 
representative.” For research conducted outside of the state, provide information that describes which individuals are authorized under applicable law 
to consent on behalf of a prospective subject to their participation in the procedure(s) involved in this research. One method of obtaining this 
information is to have a legal counsel or authority review your protocol along the definition of “legally authorized representative” in “SOP: Legally 
Authorized Representatives, Children, and Guardians (HRP-013).”  If the sites in other states in the study are conducting their own IRB review, you do 
not need to worry about this--type N/A.  If you are conducting research and are actively recruiting participants outside of Washington who are NOT 
coming to Washington to give consent and who will be covered under SCH IRB approval, this section should be addressed in your protocol.
56 The IRB may allow the person obtaining assent to document assent on the consent document.
57 For example: consent/parental permission will not be obtained, required information will not be disclosed, the research involves deception, waiver for 
participants who turn 18, waiver for information collected about a non-present parent, or other waivers as necessary.
58 The IRB needs to make all the waiver findings and key to this determination is that the IRB understand why it is not practicable to do the research 
without a waiver of consent.  You need to provide a rationale in order for the IRB to consider whether the waiver criteria are met. See “HRP-410: 
Waiver or Alteration of the Consent Process” for further information.  
59 Possible reasons might include: a) you are not collecting information that could put subjects or their families at harm, e.g., affect eligibility for 
insurance, employability, stigmatization; b) you are not collecting information that would alter or affect the subject’s care; c) any publication or 
presentation of research results would be done in a manner that would never reveal an individual’s identity either directly or indirectly.
60 Possible reasons could be: a) inability to locate families because of the lengthy time period over which the records/samples were created; b) many of 
the subjects whose records, data, or specimens will be used may have died and contacting the families about the research could cause harm and 
anguish to families; c) all eligible patients must be included in the study for the results to be meaningful.
61 See “HRP 419: Waiver of Consent for Emergency Research” for further information.
62 This section describes the ways in which the procedures will not be following Seattle Children’s SOP.
63 See “HRP-411: Waiver or Written Documentation of Informed Consent” for further information.
64 An information sheet template can be found in the Click IRB Library and should be attached to the consent form of the study SmartForm.  For 
internet research, the information sheet can be translated to an on-line format, if desired.
65 The IRB sometimes requires a script if you are having the consent conversation over the phone rather than in person.  Templates for a consent 
script are available on the IRB website on the Participant Recruitment page and should be attached to the study SmartForm.
66 PHI is health information that is also identifiable because it includes one or more of the 18 HIPAA identifiers.  See Investigator Manual HRP-103 for 
the list of HIPAA identifiers.  
67 If your study involves using or creating PHI and your only contact with participants is online, you can request an alteration of HIPAA authorization to 
remove the signature requirement.  As an alternative to a waiver of documentation of consent and an alteration of HIPAA authorization, you must 
demonstrate that the electronic consent signatures are compliant with applicable state/international law (in Washington, see RCW 19.34.300).  
68 For example: altering HIPAA elements for international research.
69 Possible reason could be: the nature of the research is specific to individuals’ health and requires access to individuals’ health records.
70 See “HRP-316: Payments” for further information.
71 Methods of payment include check, ClinCard, gift cards, etc.  Provide details on who will be the recipient of the payment (parent or child).
72 Reimbursement is used when the subject is paid back for travel expenses such as transportation, food, childcare, or lodging.  Reimbursement is 
generally distributed to person who incurred cost (usually parent) and requires receipts to be submitted.  
73 This could include things like fuel/transportation costs, parking, and/or childcare.
74 Type N/A if this section does not apply.

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75 Provide enough information to convince the IRB that  the principal and/or co-investigator(s) are appropriately qualified to conduct and supervise the 
proposed research. When applicable, describe their prior clinical experience with the test article or study-related procedures, or describe their 
knowledge of the local study sites, culture, and society. 
76 For example, as appropriate: (1) Justify the feasibility of recruiting the required number of suitable subjects within the agreed recruitment period. For 
example, how many potential subjects do you have access to? What percentage of those potential subjects do you need to recruit? (2) Describe the 
time that you will devote to conducting and completing the research. (3) Describe the facilities in which the research will be conducted. (4) Describe the 
availability of medical or psychological resources that subjects might need as a result of an anticipated consequences of the human research. (5) 
Describe your process to ensure that all persons assisting with the research are adequately informed about the protocol, the research procedures, and 
their duties and functions.
77 Including communication between sites of current study document versions and modifications.
78 See your contract/agreement or Sponsor Documentation if you are unsure