iCanCope With Sickle Cell Disease: A Mobile Pain Management Intervention for Adolescents
Phase: NA
Conditions: Sickle Cell Disease
Sponsor: Seattle Children's Hospital

iCanCope With Sickle Cell Disease: A Mobile Pain Management Intervention for Adolescents 
National Clinical Trial (NCT) Identified Number: NCT03201874 
Principal Investigator: Tonya Palermo 
Sponsor: Seattle Children’s Research Institute 
 
Grant Title: iCanCope with Sickle Cell Disease 
Grant Number: R01HD086978 
Funded by: Eunice Kennedy Shriver National Institute of Child Health and Human Development 
Protocol Version 1.5: June 18, 2021 
Seattle Children’s IRB Number: STUDY00001578 
 

Principal Researcher: Tonya Palermo Ph.D.   
Protocol Version Number: 1.5   
Protocol Version Date: 6/4/2021 
 
 
 
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PROJECT TITLE: 
SCH iCanCope with SCD: User centered design of a web- and mobile-based pain self-management 
program for youth with sickle cell disease 
 
PRINCIPAL INVESTIGATOR: 
Tonya Palermo Ph.D. 
Center for Child Health, Behavior & Development 
 
 
 
 
 
 
 
 

Principal Researcher: Tonya Palermo Ph.D.   
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Contents 
1. 
Objectives ........................................................................................................................................ 3 
2. 
Background ..................................................................................................................................... 3 
3. 
Study Endpoints .............................................................................................................................. 8 
4. 
Drugs, Devices and Biologics........................................................................................................ 8 
5. 
Procedures Involved ....................................................................................................................... 9 
6. 
Data and Specimen Banking ........................................................................................................ 15 
7. 
Sharing of Results ........................................................................................................................ 16 
8. 
Study Timelines ............................................................................................................................. 16 
9. 
Study Population ........................................................................................................................... 16 
10. 
Number of Subjects ...................................................................................................................... 17 
11. 
Withdrawal of Subjects ................................................................................................................. 18 
12. 
Risks to Subjects .......................................................................................................................... 18 
13. 
Potential Benefits to Subjects ..................................................................................................... 19 
14. 
Data Analysis/Management .......................................................................................................... 19 
15. 
Confidentiality ............................................................................................................................... 22 
16. 
Provisions to Monitor Data to Ensure the Safety of Subjects .................................................. 23 
17. 
Use of Social Media ...................................................................................................................... 23 
18. 
Research Related Injury ............................................................................................................... 24 
19. 
Recruitment Methods ................................................................................................................... 24 
20. 
Consent/Assent Process .............................................................................................................. 25 
21. 
Process to Document Consent in Writing .................................................................................. 29 
22. 
HIPAA Authorization and RCW Criteria ...................................................................................... 29 
23. 
Payments/Costs to Subjects ........................................................................................................ 31 
24. 
Setting ............................................................................................................................................ 31 
25. 
Resources Available ..................................................................................................................... 31 
26. 
Coordinating Center Procedures................................................................................................. 32 
27. 
Good Clinical Practice .................................................................................................................. 32 
 
 
 
 
 

Principal Researcher: Tonya Palermo Ph.D.   
Protocol Version Number: 1.5   
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1. Objectives 
1.1. Purpose, specific aims, or objectives: 
 
Aim 1. To determine feasibility and initial effectiveness of iCanCope with Sickle Cell Pain in 
youth with SCD pain. 
 
Aim 2. To test if differences in self-efficacy, self-management behaviors, goal-setting, and 
perceived social support will predict changes in pain intensity and coping strategies in youth with 
SCD.  
 
Aim 3. To examine possible moderators of effects of iCanCope with Sickle Cell Pain including 
engagement with treatment, demographic factors (family income, age, sex), and disease 
characteristics (SCD pain burden). 
   
1.2. Hypotheses to be tested: 
   
Youth who receive iCanCope with Sickle Cell Pain will achieve greater increases in 
adaptive coping and significant reductions in symptoms of pain and pain-related 
disability (primary outcomes) as well as significant improvements in physical and 
emotional functioning and disease-specific health-related quality of life (secondary 
outcomes) at post-treatment and 6-month follow-up compared to youth who receive the 
attention-control condition. Feasibility and acceptability will be demonstrated by high 
levels of treatment engagement and high ratings of satisfaction with the intervention. 
 
   
2. Background 
2.1. Relevant prior experience and gaps in current knowledge: 
   
Limitations of Studies to 
Date 
Proposed iCanCope with Sickle Cell Pain Study 
 
• 
Poor user adherence.  
• 
Small patient 
samples and included 
those individuals with 
infrequent SCD pain. 
• 
Limited pain self-
management content  
 
 High accessibility using virtual delivery (app, website).  
 Targeted approach to deliver pain self-management to 
patients with identified pain burden.  
 Comprehensive self-management content based on other 
effective CBT pain programs that we have developed 
 Adequate sample size and inclusion of individuals with 
clinically relevant pain as per pain burden score. 
 
 
Advances Offered by iCanCope with Sickle Cell Pain Program for Youth with SCD Pain 
Based on completed needs assessment as well as a 2014 scoping review of pain apps,34 the 
proposed iCanCope with Sickle Cell Pain program will be comprised of personalized goal setting 
to improve pain and function, CBT-based pain self-management training and rehearsal, and 
peer-based social support through a closed online community for youth with SCD. These 
components will be delivered on the iCanCope smartphone app and be complemented by SCD 
self-management education on the iCanCope website. The website will also include specific 
modules designed to empower parents and caregivers to promote disease self-management in 
their adolescents. 
 
 
2.2. Relevant preliminary data:1 
   
Evaluation of Web-Based Management of Adolescent Pain (“Web-MAP”)  

Principal Researcher: Tonya Palermo Ph.D.   
Protocol Version Number: 1.5   
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Dr. Palermo has developed an Internet delivered CBT pain intervention called Web-MAP 
that includes 8 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 involving 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 Web-MAP compared to a wait-list 
control group.41 Following up on this initial trial, Dr. Palermo recently completed 
enrollment for a second large RCT of Web-MAP involving 273 youth (ages 10-17 years) 
with chronic pain (and their parents) recruited from pain centers around the U.S. and 
Canada.42 Adjunctive to pain clinic treatment, youth were randomized to one of two 
Internet treatment conditions, Web-MAP (CBT pain intervention, n=138) vs. Web-ED 
(education control, n=135). In our preliminary analyses, significant group-by-time 
interactions were found for effects of Web-MAP on children’s pain-related disability (p = 
.03), sleep quality (p = .02), pain-related anxiety (p < .05), and parent behavior (p < .001) 
and distress (p = .002) at 6 months. Youth receiving the Web-MAP intervention achieved 
greater improvements in outcomes at 6-month follow up compared to youth receiving 
Internet Education.  
Additional preliminary data have been collected from Web-MAP in youth with SCD to 
address concerns raised about youth’s receptivity to learning cognitive-behavioral pain 
management skills. Web-MAP was piloted in 12 youth (M age = 14.2, 68% female) with 
SCD and their parents recruited from Connecticut Children’s and Emory University 
(proposed sites in this application). Treatment engagement was high; youth logged into 
Web-MAP an average of 16.7 times (SD = 10.1, range 2-38) and parents logged in an 
average of 17.4 times (SD = 10.8, range = 3-43) over the 8-10 week treatment period. 
Youth completed an average of 6 out of 8 treatment modules and parents completed an 
average of 7 out of 8 treatment modules. To understand participants’ experience with 
Web-MAP, qualitative interviews were conducted with 8 parent-child dyads. Overall, 
participants reported that the CBT program was a helpful tool for coping with pain: “I 
learned a lot about pain management and things I can do to make my load a little bit 
easier”. However, they indicated a preference for a web program that is designed 
specifically for youth with SCD: “I thought Web-MAP was too simple or basic to help me. 
I want something more interactive that is a more real world experience”. When asked 
what could be done to improve the web program, participants suggested developing an 
app: “Maybe…you could make it more accessible on your phone - like an app. That 
would be cool because, you know, most young adults have apps and cell phones”. The 
proposed iCanCope with Sickle Cell Pain intervention will build upon the CBT pain 
content of Web-MAP, while significantly tailoring the program for the SCD population 
(largely of African descent) and to add symptom and goal tracking and peer-based 
social support. iCanCope with Sickle Cell Pain will also be delivered on an integrated 
smartphone and web-based platform, rather than the exclusively web-based format of 
Web-MAP.  
 
Development and Validation of “Sickle Cell Disease Pain Burden Interview-Youth” 
(SCPBI-Y) 
The SCPBI-Y is a brief, clinically relevant, multidimensional interview that has been 
validated to assess pain burden in youth aged 7-21 years with SCD.6 The construct of 
“pain burden” was defined to encompass pain, and its impact on physical function, 
social/community participation, and the emotional aspects of daily living. The SCPBI-Y 
was developed using a panel of field experts (physicians, nurses, psychologists, 
researchers), patients, and caregivers as well as review of existing functional 
assessment and pain impact tools in the literature. The validation study involved 129 

Principal Researcher: Tonya Palermo Ph.D.   
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youth recruited from the inpatient and outpatient clinics of 4 pediatric hospitals. The 
SCPBI-Y demonstrated strong internal consistency reliability (α=0.891; N=129), cross-
informant concordance (child-caregiver; n=40, r=0.78, p<0.001), and test-retest reliability 
(outpatient setting; n=47, r=0.80, p<0.001). Moderate construct validity was found with 
validated measures of functional ability, pain, and quality of life. These findings suggest 
that the SCPBI-Y scores are valid and reliable for evaluating pain burden in youth with 
SCD and will be used to screen youth in the proposed study.  
 
Development and Validation of a Web-Based Multi-Dimensional Pain Diary for Youth 
with SCD  
This study aimed to develop and establish the content validity of a web-based multi-
dimensional pain diary for young people with SCD and conduct an end-user review to 
refine the prototype. Diary items were adapted from the e-Ouch©, an electronic diary 
measure with evidence of content validity, construct validity and responsiveness in youth 
with arthritis.44–46 Experts in SCD, pain, and psychometrics reviewed the items for 
content, language, clinical relevance, comprehensiveness, and feasibility. Two iterative 
cycles of expert review were conducted with 15 experts in the first cycle and 12 in the 
second cycle. Subsequently, two iterative cycles of in-depth cognitive interviews with 
patients informed the diary design and guided the modification of items to ensure they 
were easy to understand, quick to complete, and useful in explaining pain. These 
potential end-users provided positive feedback on the design and prototype of the 
electronic diary. The next steps for the measure will be to evaluate construct validity and 
responsiveness. This study provided experience in daily monitoring of pain that will 
inform the approach used in the proposed RCT.  
 
“Teens Taking Charge: Managing Arthritis Online” Disease Self-Management Program  
Dr. Stinson, one of the study’s Co-PIs is currently completing a multi-center RCT to 
evaluate the effectiveness of Teens Taking Charge: Managing Arthritis Online, a 12-
week multi-component web-based program consisting of disease education, self-
management strategies, and social support designed for youth with arthritis and their 
parents.39 The program also includes weekly contact with telephone-based coaches 
(trained non-healthcare professionals). This program was developed and evaluated in 
English and French using a sequential phased approach, including iterative 
development, usability testing, and outcome evaluation. The current trial involves 324 
youth (12-18 years) and one of their caregivers from 11 pediatric hospitals. 330 
participants were randomized to the intervention or attention-control group. We are 
completing outcome data on HRQL, arthritis symptoms, treatment adherence, 
knowledge, and self-efficacy from both groups at baseline (T1), immediately following 
the intervention (T2), and at 6 (T3) and 12 (T4) months. Our group is also completing an 
NIH-funded trial of a Spanish version of the Teens Taking Charge program (n=300), and 
have adapted the program to meet the self-management needs of youth with cancer 
(Funded by CIHR) and hemophilia (Canadian Hemophilia Society). All of these web-
based interventions were built by AboutKidsHealth, the same team that will develop and 
ensure the sustainability of the iCanCope with Sickle Cell Pain website.  
Needs Assessment to Inform Development of iCanCope with Sickle Cell Pain Program  
This study aimed to qualitatively explore the perceived pain self-management needs of 
young people with SCD.12 A descriptive qualitative design was used with a purposive 
sample of young people aged 12-29 years with SCD (n=26), parents (n=5), and 
healthcare professionals (HCP; n=34). Our findings demonstrated that all young people 
had significant disease impact from SCD on their physical, emotional, role, and future 
functioning. Participants also described a lack of available resources to support disease 

Principal Researcher: Tonya Palermo Ph.D.   
Protocol Version Number: 1.5   
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self-management, especially pain, and indicated that the proposed iCanCope with Sickle 
Cell Pain program could address this need (See Table 2). This is one of the first studies 
to explore the perceived pain self-management needs of youth with SCD with the goal of 
informing development of a web- and app-based self-management intervention for this 
population. We anticipate that this early involvement of youth, parents, and HCPs will 
help to ensure that the content and format of the intervention is relevant, acceptable, 
and meets the needs of this underserved group.  
 
   
2.3. Scientific or scholarly background: 
   
Poor Pain Self-management in Youth with Sickle Cell Disease   
Sickle cell disease (SCD) is the most common genetic blood disease in North America and 
primarily affects people of African descent.1 The hallmark feature of SCD is recurrent episodes 
of acute severe pain due to vaso-occlusive crisis (VOC; blockage of red blood cells).1,2 SCD pain 
is reportedly worse than postoperative pain, as intense as terminal cancer pain, and has a 
negative impact on all aspects of health-related quality of life (HRQL).3–5 Youth experience 
increased SCD pain burden as they grow from childhood to adolescence and young adulthood.6 
In addition to acute pain from VOC, many youth with SCD also experience daily chronic pain.7 
The negative consequences of recurrent SCD pain include depression and anxiety, academic 
underachievement related to missing school, little or no opportunities for social interaction with 
peers, impaired physical activity, poor sleep, and high stress.8,9 The vast majority of SCD pain 
episodes (90%) are treated in the home setting;10 unfortunately, many of these episodes may 
not be optimally managed.11,12,13 Self-management has been defined as “the individual’s ability 
to manage the symptoms, treatment, physical, and psychological consequences and lifestyle 
changes inherent to living with a chronic illness”.14 The most successful self-management 
interventions are rooted in the principles of cognitive-behavioral therapy (CBT).15 CBT involves 
normalization of the patient’s experience through education, training in strategies for managing 
disease-related symptoms and other stressors, enhancing self-efficacy, and guidance on 
developing and maintaining a long-term self-management plan.16–18 Studies in pediatric and 
adult SCD patients demonstrate that CBT-based therapies that promote disease self-
management can lead to reduced symptoms, improved HRQL, and decreased healthcare 
utilization.19 Gaining skills in monitoring and managing their SCD pain at home is particularly 
critical to achieve during childhood because SCD is associated with worsening pain and 
disability in adulthood.19,20  
 
Barriers to Providing Pain Self-Management Care for Youth with SCD and their Caregivers 
Home-based pain management for SCD is typically inadequate due to a lack of appropriate 
training for patients and parents.11 Youth with SCD and their caregivers may be reluctant to seek 
out mental health services for pain management and when interested rarely have access to 
these services due to geographic restrictions (e.g., available only in tertiary centers), limited 
availability of trained clinicians to deliver the therapies, inaccessibility due to school and work 
schedules, as well as direct and indirect incurred costs if additional healthcare visits are used to 
provide this training.21–23 Moreover, these therapies tend to be delivered in individual or group 
sessions in specialty clinics by highly trained personnel, and are unsuitable for widespread 
distribution to community and home-based settings.24  
 
Rationale for Web and Mobile Technologies to Enhance Delivery of Pain Self-management Care 
Web and mobile technologies can be applied to enhance the accessibility of pain self-
management therapies.25,26 In addition to improving access, these technologies can empower 
youth to take an active role in managing their condition by providing “in the moment” access to 
pain coping strategies.27 These technologies can therefore be leveraged together to build a 

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tailored self-management program for youth with SCD that emphasizes empowerment, involves 
parents, facilitates the creation and tracking of personalized goals, and offers peer-based social 
support. A media-rich website delivered on a desktop/laptop computer is ideal for teaching 
complex CBT-related skills using animations, illustrations, and videos. Smartphones are deeply 
integrated into the daily life habits of most youth,28 and therefore offer an ideal platform to 
prompt practice of CBT-based coping skills as needed in the moment.  
 
Systematic and Meta-Analytic Reviews of Internet-Based Interventions for Pain Management 
Outcome data for web-based disease self-management interventions have rapidly increased 
over the past decade.29–31,32 Results from systematic and meta-analytic reviews suggest 
consistent efficacy for symptom reduction, knowledge attainment, and improved health 
behaviors in individuals with painful and other chronic health conditions. In the field of chronic 
pain, there is emerging evidence from two recent systematic reviews in adults32,33 (e.g., 11 RCTs 
with a pooled effect size of |0.285|; 95% confidence interval [CI]; |0.145 to 0.424|)33  and one in 
children/adolescents30 (4 RCTs with a pooled effect size of |0.41|; 95% CI; |0.74 to 0.07|) that 
self-guided treatments delivered over the Internet reduce pain intensity. However, there is little 
empirical data on the availability and effectiveness of web-based pain management interventions 
that target the unique developmental and disease-related needs of youth (aged 12-18 years) 
with SCD.  
 
Systematic Reviews of Smartphone-Based Interventions for Pain Management 
There are a growing number of smartphone-based pain self-management applications (“apps”) 
available for patients to download and use on their personal mobile devices. In 2014, we 
conducted a comprehensive scoping review of available pain self-management apps across the 
iPhone, Android, Windows, and BlackBerry stores.34 We identified 279 apps across stores with 
the majority (64%) designed for the Android platform. Pain self-care skill support was the most 
common self-management function (77.4%). Apps were also reported to provide pain education 
(45.9%), symptom self-monitoring (19%), social support (3.6%), and goal-setting (0.72%). No 
apps were comprehensive in terms of pain self-management content, with the majority of apps 
including only a single self-management function (58.5%). Other major limitations were noted: 
only 8.2% of apps included a healthcare professional in their development, patient engagement 
was limited, not a single app provided a theoretical rationale, and only 1 app underwent scientific 
evaluation.34   
Given that successful CBT requires strong patient engagement and consistent skills practice, it 
is critical that intervention content and design are relevant and appealing to end-users (i.e., 
youth with SCD and their families).35 There is a clear need to develop and test evidence-based 
apps to better support patients and families with accessible SCD pain self-management care. 
 
Existing Pain Self-Management Programs for Youth with SCD Pain  
To our knowledge, there is only one technology-based program (used in research but not 
publicly available) that provides pain self-management support to youth with SCD. The 
effectiveness of this program has been evaluated via wait-list control RCT in a sample of 46 
youth (aged 8-21 years) and their caregivers.36,37 The intervention involved a single session of 
in-person CBT training followed by 8 weeks of home-based practice using smartphones. In 
comparison to control, the primary study outcome of negative thinking in response to pain was 
unchanged.37 A major study limitation was that youth did not use the smartphone app frequently. 
On average, youth accessed the smartphone pain coping skills on only 12% of the total days 
that they had the device. The range of pain frequency reported by the patient sample [mean of 
15.2 pain days (SD 13.6) over 8 weeks] was relatively broad and thus some participants had 
relatively infrequent pain. Overall, the smartphone-assisted coping skills were used on less than 
25% of total pain days. Given this low usage, the authors identified a clear need for future 

Principal Researcher: Tonya Palermo Ph.D.   
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studies to build strategies for increasing engagement and for properly targeting SCD patients 
who need pain self-management.37 
There are currently no standardized recommendations related to the necessary content for web 
and app-based pain self-management programs. In our 2014 review, we catalogued existing 
pain apps in terms of the presence or absence of self-management functionalities based on 
elements that have evidence of effectiveness.18,38–40 To assess app comprehensiveness, the 
following functions were assessed: (a) pain tracking, (b) ability to set goals related to improving 
pain and functioning, (c) training in CBT-based pain self-management strategies, (d) social 
support, and (e) disease-specific education. 
Thus, while the one existing program36,37 for youth with SCD pain demonstrates the potential of 
using technology to promote pain coping in this group, it is limited by: (a) very low patient usage, 
(b) lack of demonstrated effectiveness for improving clinical outcomes, (c) lack of personalized 
goal-setting to improve functional outcomes, (d) lack of social support component, and (e) lack 
of SCD education delivered on the app. Importantly, this program also required an initial in-
person CBT training session, which presents barriers in terms of cost and accessibility to many 
patients. (See Table 1) There is currently no single technology-based program that provides 
comprehensive pain coping training for youth with SCD and their caregivers. 
   
2.4. Prior approvals: 
   
Currently participating sites received IRB approval, this is an extension of the approved study 
IRB #: STUDY00000693. Before beginning the referral process at any new sites, we will ensure 
that approvals have been obtained and we will maintain records of their approvals including all 
modifications. 
   
3. Study Endpoints2 
3.1. Primary and secondary endpoints: 
   
Primary endpoint is greater reductions in pain-related disability. Secondary endpoint is the 
reduction of pain and anxiety/depressive symptoms. 
   
3.2. Primary or secondary safety endpoints: 
   
There are no safety endpoints in this study.  
   
4. Drugs, Devices and Biologics3 
4.1. Manufacturer and name of all drugs, devices and biologics: 
   
The mobile medical application, iCanCope with Pain was developed by The Hospital for Sick 
Children in Ontario, Canada. 
   
4.2. Description and purpose of all drugs, devices and biologics: 
   
The iCanCope with Pain is a smartphone app to help young people manage persistent pain. It is 
comprised of personalized goal setting to improve pain and function, CBT-based pain self-
management training and rehearsal, and peer-based social support through a closed online 
community for youth with SCD. The app provides users with reminder and positive feedback on 
their progress to reaching their goals. The app will provide in-the-moment access to pain coping 
strategies to promote positive changes in mood, behavior, and pain. The app will also allow 
youth to track their symptoms in real-time and generate customized reports from their data to 
show clinicians. The parameters that will be tracked by the app include pain, pain impact, mood, 
and sleep. The app will use the diary input to push relevant advice to the user.  
   
4.3. Regulatory status of all drugs, devices and biologics:4 
   

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This study will be testing the initial effectiveness of the iCanCope app and website. These tools 
meet the definition of device because they intended to be used in the mitigation of disease. Per 
information found in the FDA published guidance for Mobile Medical Applications, this ‘device’ 
would be one for which the FDA would intend to exercise enforcement discretion - (meaning the 
FDA will not intend to enforce requirements under the FD&C Act and an IDE will not be needed 
for the study).  
   
4.3.1. 
Drugs or Biologics: 
☐ IND Exempt.  Explain:5 Click here to enter text. 
☐ IND. 
 
  
4.3.2. 
Devices: 
☐ IDE Exempt.  Explain:6  
☐ 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 multi-site parallel group pilot RCT of iCanCope with Sickle Cell Pain versus Attention Control 
Education will be conducted with 160 youth (age 12-18) with SCD and their caregiver. The sites 
will include Emory/CHOA, The Hospital for Sick Children, and Connecticut Children’s Medical 
Center, University of Mississippi, University of Florida, Boston Medical Center, Ann & Robert H. 
Lurie Children's Hospital of Chicago, Nationwide Children’s Hospital, C.S. Mott Children’s 
Hospital and Seattle Children’s Hospital. Participants will be randomized into one of two groups; 
experimental group or attention control group. The intervention phase will last 6-8 weeks, with 
participants given a maximum of 12 weeks to complete the intervention content. This treatment 
period is based upon the typical duration of chronic pain intervention trials.42,58 Outcome 
assessment will occur at baseline (T1), immediately after completion of the intervention (2 
months; T2), and repeated at 6 months post-intervention (T3) to allow for assessment of 
maintenance of treatment gains as youth with SCD may have fluctuations in their disease course 
that influence pain outcomes. 
   
5.2. Research procedures:9 
   
Experimental Group  
In addition to standard medical SCD care, youth will receive the iCanCope with Sickle Cell Pain 
intervention over a period of 6 to 8 weeks. Participants will be given a maximum of 12 weeks to 
complete the program if delays occur. The web and app intervention will be delivered on 
restricted password-protected applications that will allow us to track user engagement (detailed 
user level and aggregate analytics). Youth will be encouraged to log onto the app (via push 
notifications) to track their symptoms, develop and track functional goals, access coping 
strategies, and socially engage in the iCanCope community. Youth and their caregiver will also 
be encouraged to access the iCanCope website, which will contain interactive SCD education 
and self-management strategies. The youth website will be organized into 6 core modules and 2 
optional** modules, participants will complete one module per week (Table 3). Delivery of the 
optional modules will be based on response to the baseline measures. See Table 5 for a list and 

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description of all study measures. Eligibility to receive the option insomnia module will be based 
on insomnia symptoms evaluated using two questions from the Adolescent Sleep Wake Scale 
(ASWS) assessing difficulty falling asleep (“I have trouble going to sleep”) and difficulty 
maintaining sleep (“After waking up during the night, I have trouble going back to sleep”).  
Adolescents responding “quite often,” “frequently, if not always,” or “always” to either of these will 
be judged to have symptoms of insomnia, and receive the module. Eligibility for the optional 
negative emotions module will be determined by the baseline score on the 4-item PROMIS 
depressive symptoms scale, with a score of 9 or higher indicating eligibility to receive the 
optional module. Eligibility for the optional modules will be sent via secure email to SickKids from 
Seattle Children’s. Children’s staff will only indicate “yes” or “no” if they meet the criteria for the 
PROMIS and ASWS measures. There will also be content designed for caregivers to provide 
instruction in the best ways to support youth’s pain management skills and encourage adaptive 
coping, divided in to six modules (Table 3).  
 
**optional modules for this study are potentially two additional modules that would be given to 
youth only if they are randomized to Group A and if their baseline scores qualify them for one or 
both of them. This is not optional, but an addition to their modules, similarly to how branching 
logic works. 
 
Experimental Group Semi-Structured Interviews: Following the completion of the iCanCope with 
Sickle Cell Pain program, youth and parent participants will be invited to participate in a semi-
structured interview over the phone with the research staff from SCRI. The interviews will be 
conducted any time between the post-treatment (T2) and 6 month follow up assessment (T3). All 
participants that are within the timeframe stated above will be asked to participate.The semi-
structured interview will allow participants to qualitatively comment on the intervention. The 
research staff will follow a semi-structured interview guide with questions pertaining to their 
experience using the iCanCope with Sickle Cell Pain website and app (see attached guides in 
supporting documents). The interview will be audio-recorded and a research staff will transcribe 
the interview verbatim. The research staff will be trained on how to transcribe the interview and a 
different staff member will double check the transcription. 
 
The semi-structured interviews will determine (i) participants’ acceptability of and level of 
engagement in the iCanCope with Sickle Cell Pain program and (ii) their likes and dislikes of 
program, and improvements on the program content and design. The research staff will verify 
transcripts against the tapes and field notes taken during the interviews will be transcribed and 
included in the analytic process. All data will be read by multiple independent coders to obtain an 
overall understanding of the data and develop themes based on the research questions. This 
data will be used to refine the iCanCope with Sickle Cell Pain program for future trials. 
 
Table 3. Youth Intervention Web Content: iCanCope with Sickle Cell Pain 
Module 
Number 
Module Title 
Content/Skills 
1 
Introduction 
Intro, SMART Goals, 3Ps pain, types of psychological 
treatments 
2 
Managing stress 
Reduce negative thoughts: replace with positive and 
thought stopping 
3 
Relaxation 
Relaxation: deep breathing, muscle relaxation, imagery, 
mini relaxation 
4 
Sleep 
Pain and sleep, healthy sleep, ways to fall and stay asleep 

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5 
Communication and 
self-advocacy 
Communication skills, talking with healthcare team and 
school 
6 
Healthy lifestyle 
Pacing, graded activity, hydration 
7 
Optional: Insomnia 
Think differently about sleep, more falling and staying 
asleep strategies 
8 
Optional: Negative 
emotions 
Identify negative emotions, schedule pleasant activities, 
find the positives. 
Parent Intervention Web Content 
Module 
Number 
Module Title 
Content/Skills 
1 
Introduction 
What your teen will learn, SMART goals to support your 
teen 
2 
Behavioral plans 
Behavioral plans 
3 
Problem solving 1 
Bright IDEAS problem solving system 
4 
Problem solving 2 
Bright IDEAS problem solving system 
5 
Communication 
Strategies that can help you talk and listen to your teen, 
strategies to communicate with health care providers and 
school staff 
6 
Wrap-up 
Review 
 
Attention Control Group  
The control group is designed to account for potential effects on outcomes of time, attention, as 
well as computer use during the intervention period. In addition to standard medical care, youth 
in the attention control group will be provided with access to a self-guided education study 
website, called the Sickle Cell Library, which will contain static education about SCD (no self-
management skills, goal-setting, or social support content). Any site links will be monitored 
weekly to ensure that they do not add any “active ingredients” during the trial. We have 
completed a 2015 scoping review of existing SCD patient education websites (see above) to 
identify content to include in the control site.47 The control condition will be delivered over 8 
weeks on a restricted password-protected platform that will allow us to track usage and 
engagement similar to the experimental group. Participants will be encouraged to log onto the 
control website and complete all study outcome assessments online at the same time intervals 
as the experimental group. Participants in the control group will receive 4 check-in contacts 
(once every 2 weeks) by their preferred contact method to make sure they are not having any 
issues with the website and remind them to review content. 
 
Table 4. Control Website Content for Teens and Parents: Sickle Cell Library  
Section 
Number 
Title 
Education Content 
1 
Introduction 
Intro to program 
2 
About sickle cell disease 
What is SCD, symptoms and complications 
3 
Treatments and medication 
About medications, transfusions, pain medications, 
complementary medicines 
4 
Acute and chronic pain 
Acute pain, chronic pain, factors that influence pain 
experience 

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5 
Healthy lifestyle 
Diet, exercise, alcohol and drugs, school and hospital 
stays 
6 
Looking ahead and research 
Transition to adult care, clinical research 
 
 
Both Groups  
Both groups will complete baseline (T1) measures online prior to randomization. Participants will 
be randomly allocated to either the experimental (iCanCope with Sickle Cell Pain) or attention 
control education group. Following program completion at 2 months (T2), participants will be 
asked to complete post-test measures. Electronic and SMS text reminders will also be sent by 
the study team. Participants will be asked to complete the same measures at 6 months (T3) 
following completion of the intervention or control condition. All measures will be completed 
online, either at home or in clinic. Paper versions of measures will be available if online access is 
not possible. Participants in both groups will be able to contact staff for technical problems with 
the app or website. Research staff will also be available at routine clinic visits during the study 
period. 
   
5.3. Data sources that will be used to collect data about subjects:10 
   
 
 
Table 5. Study Measures 
Measure 
Description of Measure 
P=parent report, T=teen 
report 
Time to 
Complete 
T1 
 
T2 
 
T3 
 
 
Screening and background 
measures 
 
 
 
 
Sickle Cell Pain 
Burden Interview 
(SCPBI) 
The SCPBI will be used to 
screen for SCD pain burden.6 
(P, T) 
2-3 
minutes 
X 
X 
X 
Background 
questionnaire 
This questionnaire will assess 
sociodemographic variables 
(including family income), 
pain characteristics such as 
intensity, location, and 
temporal features (T) and 
access / use / comfort with 
smartphones and internet 
technology. (P, T) 
5 minutes 
X 
 
 
Treatment 
expectancies 
questionnaire 
7-item questionnaire to rate 
treatment expectancy. (P, T) 
3 minutes 
X 
 
 

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Adolescent Sleep 
Wake Scale 
2 items from the 
questionnaire will be used to 
screen for the optional 
website intervention module 
on insomnia.61 (T) 
1 minute 
X 
 
 
 
Primary outcome measures 
 
 
 
 
Daily pain diary (7 
day) 
Pain intensity (NRS-11), 
location, and 9-item CALI.62 
Completed daily for 7 days 
(T) 
3 minutes 
X 
X 
X 
Coping Strategies 
Questionnaire for 
Sickle Cell Disease 
(CSQ) 
The CSQ63 will assess use of 
different strategies to cope 
with pain (three primary 
scales: coping attempts, 
negative thinking, passive 
adherence). 
15 
minutes 
X 
X 
X 
 
Secondary outcome 
measures 
 
 
 
 
PROMIS-25 v1.1 
Pediatric Profile 
The PROMIS Pediatric Profile 
will be used to assess 
physical and emotional 
functioning. This is a 
collection of short forms 
containing 4 items from 
PROMIS domains (Depressive 
Symptoms, Anxiety, Mobility, 
Pain Interference, Fatigue, 
and Peer Relationships).64 (T) 
10 
minutes 
X 
X 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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items comprise each 
subscale.65 (P) 
 
  
 
 
 
 
 
 
 
 
Treatment 
Evaluation 
Inventory (TEI) 
The TEI will be used to access 
acceptability (P, T) 
3 minutes 
 
X 
 
Patient’s Global 
Impression of 
Change Scale 
Change in global health / 
quality of life.66 (T) 
2 minutes 
 
X 
X 
Bath Adolescent 
Pain 
Questionnaire – 
for parents (BAPQ-
P) 
The BAPQ is a measure to 
assess social functioning, 
physical functioning, 
depression, general anxiety, 
pain specific anxiety, family 
functioning and 
development. (P) 
15 
minutes 
X 
X 
X 
Symptom Checklist 
- 90 
The Symptom Checklist -90 
assesses a range of 
psychological symptoms, 
including obsessive 
compulsive, depression, 
anxiety, etc. (P) 
12-15 
minutes 
X 
X 
X 
Adult Responses 
to Child Symptoms 
(ARCS) 
This 13-item questionnaire 
assesses parent behavior 
including protectiveness, 
minimizing, and encouraging 
response to children’s pain 
behavior. (P) 
5 minutes 
X 
X 
X 
Client Service 
Receipt Inventory 
(CSRI) 
SCD healthcare utilization.67 
(P) 
10 
minutes 
X 
 
X 
Adverse events 
self-report 
assessment 
Adverse event form will be 
used. 
3 minutes 
X 
X 

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5.4. Data to be collected, including long–term follow–up data:11 
   
Outcome data are self-report and will be collected online using the study website (Table 5). All 
measures have evidence of reliability and validity in youth in this age range, and include the core 
measures recommended for pain clinical trials.60 T1= pre-treatment; T2 = post-treatment (2 
months); T3 = follow-up (6 months post-treatment).  
   
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  

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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 
   
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 
   
If requested by the participant, study results will be shared with participants after participation is 
complete and findings are published. These results would be in the form of a letter outlining 
study findings. 
   
8. Study Timelines 
8.1. Duration of an individual subject’s participation in the study: 
   
Subjects will be participating in the study for approximately 10 months. 
   
8.2. Duration anticipated to enroll all study subjects: 
   
Approximately 3.5 years. 
   
8.3. Estimated date for the investigators to complete this study: 
   
We estimate that December 2022 will be the final data collection date for primary outcome 
measure and will be conducting data analysis for another 1-2 years. 
   
9. Study Population19 
9.1. Inclusion criteria for each subject population (e.g., patients, parents, providers): 
   
Inclusion Criteria: Youth will be eligible if they (a) are aged between 12-18 years, (b) are 
diagnosed with any type of SCD, (c) are able to speak and read English, (d) score at least 4 on 

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the Sickle Cell Pain Burden Interview (SCPBI) 6, and (e) have access to the internet on a 
smartphone. Parents or caregivers will be eligible if they (a) are able to speak and read English 
and (b) have access to the internet on a smartphone or computer. 
   
9.2. Exclusion criteria for each subject population: 
   
Exclusion Criteria: Youth will be excluded if they have significant cognitive limitations that 
would impair their ability to use and understand the iCanCope with Sickle Cell Pain program, as 
per their healthcare provider or parent. Youth will also be excluded if they have previously 
received more than 4 sessions of outpatient psychological therapy for pain management in the 6 
months prior to the time of screening. 
   
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 SCD. 
   
☐ Children who are Wards of the State23 
Risk assessment specific to this vulnerable population and additional safeguards: 
   
Click here to enter text. 
   
☐ Adults Unable to Consent24 
Risk assessment specific to this vulnerable population and additional safeguards: 
   
Click here to enter text. 
   
☐ Neonates of Uncertain Viability or Non–Viable Neonates25 
Risk assessment specific to this vulnerable population and additional safeguards: 
   
Click here to enter text. 
   
☐ Pregnant Women26 
Additional safeguards: 
   
Click here to enter text. 
   
☐ Prisoners27 
Additional safeguards: 
   
Click here to enter text. 
   
10. Number of Subjects 
10.1. Total number of subjects to be enrolled locally:28 
   
60 dyads: children with SCD and their parents will be enrolled from Seattle Children’s Hospital. 
   
10.2. Total number of subjects to be enrolled across all participating sites:29 
   
160 dyads: children with SCD and their parents will be enrolled from participating sites.  
   

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10.3. Number of screened subjects versus the actual number enrolled in the research:30 
   
Participants will be recruited from pediatric centers with SCD patient populations. The patient 
populations at these centers provide access to about 500 patients who are likely eligible for 
recruitment into this study based on proposed inclusion criteria. We anticipate a 30-40% 
refusal rate based on our experience recruiting in this population. 
   
10.4. Power analysis: 
   
Based on prior and current study experience, and the pool of available study candidates, we 
plan to enroll a total of 160 subjects into the pilot RCT. With attrition conservatively estimated 
at 20% we expect a final sample size of 128. This proposed sample size is based on the 
following power calculation using preliminary data from investigator experience with prior pain 
trials and published trials in SCD: 
 
Calculations are based on expected differences in youth pain-related disability and pain 
intensity. Group sample sizes of 52 and 52 achieve 84% power to detect a difference of 1.0 in 
pain-related disability between the two treatment conditions, with three assessments, AR(1) 
covariance structure, SD=4, ICC=0.2, and alpha=0.05. If the difference is 1.5 between 
treatment arms, then 52 per group achieves 99% power with the same assumptions. For pain 
intensity, group sample sizes of 49 and 49 achieve 80% power to detect a difference of 0.75 in 
pain intensity (average over three time points) in a design with 3 repeated measurements 
having a AR(1) covariance structure, SD=2, ICC=0.2 and 0.05 alpha. 
   
11. Withdrawal of Subjects 
11.1. Anticipated circumstances under which subjects will be withdrawn from the research without 
their consent: 
   
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 

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distress. There is a potential risk of loss of confidentiality.  Some of the questionnaires include 
questions that could uncover depression or suicidal ideation. See below for plan.  
   
12.2. Procedures with unforeseeable risks: 
   
There are no anticipated harms associated with participating in this study. Participants 
may get upset when talking about their pain from SCD. This risk will be discussed 
when consent is provided, and participants will be reminded that if they become upset 
at any time during the course of the study they can talk to the research assistant and 
their health care team (for example, nurse, social worker, or psychologist). 
Participants may be inconvenienced with the amount of time required to participate in 
the study (2 months + 6 month follow up).        
   
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. In the course of the study, 
we may become aware that participants are an imminent threat to themselves. The PI 
will be available 24 hours a day to be called via cell phone to address crisis questions 
and the study team will follow the Critical Incident Protocol. Crises that are high risk 
and imminent will be acted upon immediately with staff linking participants to 
appropriate crisis services. Parent contact information will be used when appropriate. 
Lower risk and less imminent cases are also reviewed by the clinically responsible PI. 
All actions taken will be documented on a case report form and reported to the IRB. 
 
  
13. Potential Benefits to Subjects 
13.1. Potential benefits that individual subjects may experience from taking part in the research:31 
   
No immediate and direct benefits to individual participants are expected. However, some 
participants may improve their pain self-management skills from participating in education 
control or active intervention. The information acquired from this study also will allow 
researchers and health care providers to have a better understanding of the psychosocial 
factors associated with pain and functioning in SCD and how to best teach self-management 
skills. The information from this proposed project may be useful to clinicians who deal with 
SCD patients and families, who often request information about how to better manage pain 
and in the design of future interventions. 
   
14. Data Analysis/Management 
14.1. Data analysis plan, including statistical procedures: 
   

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Data analyses will be performed using SPSS v20.0 and SAS v9.3. 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 pilot 
RCT analysis will be an intent-to-treat analysis including all randomized subjects. 
 
Analytic plan for Aim 1  
Feasibility will be determined by calculating rates of accrual, drop out, compliance, and 
missing data with 95% CI’s. Criteria for feasibility success will be based on previous studies by 
our group39,72: accrual rates >70%, attrition rates <20%, minimal technical difficulties (i.e., 
reported by <10%), high acceptability and satisfaction (item mean score of 4 on AES), 
adherence rates >80%, and minimal missed responses. In Aim 1, we will also determine 
preliminary efficacy of the intervention. To account for clustering due to repeated assessments 
within individuals, generalized estimating equations (GEE) will be used. Interaction terms will 
be used to compare the mean change from pre-treatment to post-treatment for the iCanCope 
group with the corresponding mean change for the Attention Control Education group. Single 
degree of freedom contrasts will test if there is a statistically significant change in pain and 
coping from pre-treatment to immediate post-treatment for the two groups separately; 
additional contrasts will be computed to test if there is a statistically significant mean change 
from baseline to the 6-month follow-up for each group. Secondary treatment outcomes 
(physical and emotional function, HRQL) will also be examined using GEE to test significant 
mean changes over time and between groups by using interaction terms and contrasts. 
Treatment fidelity will be assessed by examining differential attrition (completers vs. non-
completers) between and within groups using chi-squared tests and logistic regression 
models.  
 
 
Analytic Approach for Aim 2 and 3  
Our working hypothesis related to Specific Aim 2 is that differences in self-efficacy, self-
management behaviors, goal-setting, and perceived social support will predict changes in pain 
intensity and coping strategies in youth with SCD. The test of this hypothesis will follow the 
recommendations for testing “moderated mediation” models described by Bauer, which 
permits specification of a single equation that furnishes the coefficients necessary for 
estimating total, direct, and indirect effects in a multilevel mediation model.84 The single 
equation is made possible by creating a new outcome variable (“Z”) that comprises both the 
outcome variable of interest (“Y”) and mediating variable (“M”) simultaneously; the two are 
distinguished by creating two specification variables (“S”) that take on the value of 0 and 1 
depending on whether the new outcome variable “Z” represents the mediating variable or 
outcome variable.  The single model is then specified as:  
.  The model permits the estimation of 
the indirect effect (ajbj) as a random effect, and by expressing this random effect as a linear 
function of a Level 2 variable (in this case, treatment group), it is possible to evaluate group 
differences in the proposed meditational model (i.e., “moderated mediation”).  The models will 
be specified with “time” as a predictor (“X”) of the outcomes pain intensity and coping 
strategies, with the self-efficacy, self-management behaviors, goal-setting, and perceived 
social support variables included as mediating variables (“M”). The indirect effect of time will 
then be specified to be predicted by treatment.  As such, this model will allow a test of whether 
an individual’s changes over time in pain outcomes are partly explained by changes in the 
ij
j
ij
j
ij
Z
ij
j
ij
j
Y
Y
ij
j
M
M
ij
e
X
c
M
b
d
S
X
a
d
S
Z
+
+
+
+
+
=
)
'
(
)
(

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hypothesized mediators and whether the strength of this indirect effect varies depending on 
group.  
 
To address Specific Aim 3, exploratory analysis will be used to examine possible moderators 
of effects of iCanCope with Sickle Cell Pain including engagement with treatment, 
demographic factors (family income, age, sex), and disease characteristics (SCD pain 
burden). To assess the moderation effect an interaction term will be included for each 
separate moderator variable and key predictor of interest (two-way interaction between 
moderator and group for cross-sectional analysis and three-way interaction between 
moderator, group and time for longitudinal analysis) in the regression models and test its 
significance using Wald t-test. 
   
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. 
 
iCanCope Program- The Toronto site will be responsible for maintaining the study iCanCope 
smartphone app, which will be used for some online data entry by study participants. The 
iCanCope app will be hosted at the Centre for Global eHealth Innovation at University Health 
Network (UHN). Data stored on the iCanCope server will be protected from data corruption as 
per policies of the UHN data center. Regular backups will be performed in order to prevent 
against unrecoverable corruption issues. All processes will be PHIPA compliant.  

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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 
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.  
No personally identifying health information is stored in the app. Users are given unique login 
IDs and use nicknames as usernames in the app. 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. All 
contact information and identifying data will be stored in a secure computer file within Dr. 
Palermo’s research lab at SCRI. Participant contact information and PHI will be sent to SickKids 
Toronto and it would be stored in a secure, password protected computer file within Dr. Stinson’s 
lab at SickKids. 
 
   
15.2. Location where the data and/or specimens will be stored: 
   
All contact information and identifying data will be stored in a secure, password protected 
computer file within the PI’s research lab at Seattle Children’s. Participant contact information 
and PHI will also be stored in a secure, password computer file within Dr. Stinson’s lab at 
SickKids for purposes of setting up the login information for the app and website and for 
programming the iCanCope ‘optional’ modules.   
   
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: 
   

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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: 
   
 Participant contact information is being sent to Sickkids Toronto so they can provide 
login information to the website and app. Seattle will also send information about ASWS 
and PROMIS depression score to Sickkids Toronto for programming the iCanCope 
‘optional’ modules. 
   
15.5.2. Individual(s) who will transmit data: 
   
Study coordinators at Seattle Children’s and SickKids Toronto will send this information in 
a secure email. Study staff at Seattle Children’s will comply with the Electronic 
Communication of PHI policy and procedures.  
   
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 
17.1. Types of social media to be used and how: 
   
We will be using Instagram and Facebook for recruitment purposes only. It will be used to 
share the study flyer, information and provide a link to the REDCap referral form where 
potential participants may contact the SCRI study team. 
   
17.2. Measures in place to protect the privacy or confidentiality of subjects:36 
   
Community members may voluntarily disclose their information on social media if they choose 
to because the comment section will be open to the public. Their participation in the study may 
also be disclosed if they choose to disclose that information. Participants will be encouraged to 
use the online referral form or email the study team instead of Instagram to contact the study 
team so that we can protect their privacy. 
   
17.3. Types of communications that will be submitted to the IRB for review:37 
   
All Instagram and Facebook study flyers will be uploaded for IRB review. 
   

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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: 
   
At Emory/CHOA, The Hospital for Sick Children, and Connecticut Children’s Medical Center, 
the potential subjects are recruited at their Sickle Cell clinics. Local study staff will mail a study 
introduction letter and follow up with a phone call. Study staff may also make an in-person 
clinic visit during the patients’ appointments. Once eligibility is confirmed and documented on 
the eligibility checklist, consent/assent will be obtained by a trained member of the research 
team. Consent/assent will preferably be obtained in person, or by telephone if the patient is 
not able to come to the hospital. If the patient is not able to come to the hospital in person to 
sign the consent forms, the research staff will review the forms over the phone with the patient 
and provide instructions to send the signed consent form back either by mail, fax, or SickKids 
secure file transfer. 
 
At Seattle and all other sites: Child participants will be receiving care from one of our study 
sites. Potential participants will be introduced to the study and given a flyer about the study by 
their provider. If interested in being contacted, their provider will send the potential 
participant’s contact information to the study team at Seattle Children’s. The potential 
participant will be contacted over the phone by Seattle Children’s to screen for eligibility. If 
eligible, consent forms will be emailed to participants and a consent call will be set up for a 
future time.  
 
Additional participants will be identified via the websites and social media outlets (Facebook 
and Instagram) of sickle cell disease community organizations such as 
 These 
participants will be able to view a study flyer, and if they are interested in participating, they 
may fill out the referral form through REDCap with their contact information and a few 
preliminary eligibility questions. They may also contact SCRI staff directly if they have 
questions about the study. SCRI staff will then contact these potential participants and screen 
them for eligibility over the phone. If eligible, consent forms will be emailed to participants and 
a consent call will be set up for a future time. 
 
   
19.2. Steps that will be taken to protect potential subjects’ privacy interests:40 
   
Participants will be asked by someone known to them if interested in participating before 
contact information is shared with the coordinating center for approach.  
Participants recruited from the community will have information stored and transmitted 
securely through REDCap. 
   
19.3. Sources of subjects:41 
   
Potential subjects will be identified by their clinic provider at participating sites. Additional 
participants will be recruited from sickle cell disease community organizations. 
   
19.4. Methods that will be used to identify potential subjects: 
   

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Potential participants will be introduced to the study and given a flyer about the study by their 
provider at the clinic. If interested in being contacted, their provider will send the potential 
participant’s contact information to the Seattle Children’s Research Institute study team using 
either a secure and direct fax line to the study staff or submitting a REDCap form online The 
contact information will be sent to Seattle Children’s using the referral form (see attached 
Referral Form document). Providers will only need to check Yes or No to the following 
eligibility criteria: age 12-18 years, has pain from sickle cell disease, able to speak and read 
English, and has access to the Internet. Study staff at SCRI will then screen for further 
eligibility during a phone call with the potential participants. Identifying potential subjects will 
rely on the identification by the patients’ care providers.  
 
Potential participants will also be able to contact the SCRI study team through the social 
media advertisement. 
   
19.5. Materials that will be used to recruit subjects:42  
 
Participants will receive a study flyer from their provider or see the flyer through social media. 
If the participant is interested in hearing more, the provider will use a referral form to send 
participant contact information. The participant may also contact the study team directly. The 
referral form will be submitted using a secure and direct fax line, secure email or as a REDCap 
survey online. 
   
19.6. Recruitment methods not controlled by Seattle Children’s: 
   
Emory/CHOA, The Hospital for Sick Children, and Connecticut Children’s Medical Center have 
their local IRB approval to screen for eligibility and enroll participants. Local study investigators 
(Zempsky, Dampier/Bakshi, or Odame) will be contacted to review eligibility if research staff 
have questions or concerns. Initial patient contact will be made either (1) through a mailed 
letter signed by a clinic staff, followed up by a telephone call from study staff, or (2) in-person 
during scheduled clinic visits.   If parent/youths are interested in learning more, study staff will 
explain the study and go over the Sickle Cell Pain Burden Interview (in person or over the 
telephone), as this is not currently a standard of care clinical measure. If they patient is not 
eligible, the results from the Sickle Cell Pain Burden Interview will not be used for the research 
study. We will only track how many patients did not meet the criteria, we will not store any data 
from the SCPBI.  See section 19.1 for further recruitment information for these sites. These 
recruitment methods will only be used at the sites listed in the beginning and not Seattle or 
any other sites. 
   
20. Consent/Assent Process 
20.1. Where the consent process will take place: 
   
At Emory/CHOA, The Hospital for Sick Children, and Connecticut Children’s Medical Center: 
Consent/assent will be obtained by a trained member of the research team. Consent/assent 
will preferably be obtained in person, or by telephone if the patient is not able to come to the 
hospital. If the patient is not able to come to the hospital in person to sign the consent forms, 
the research staff will review the forms over the phone with the patient and provide instructions 
to send the signed consent form back either by mail, fax, or SickKids secure file transfer. 
 
 
At Seattle Children’s and other participating sites: Consent will take place over the phone, 
after the family has had sufficient time to decide whether they would like to participate. We will 
go through the consent script with the parent and then the child and their electronic consent 
will be obtained on REDCap. 

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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 
   
20.7. Non-English Speaking Subjects45 
20.7.1. Anticipated preferred language(s) for subjects or their representatives:  
   
N/A 
   
20.7.2. Presentation of Research Information and Documentation: 
☐  Appendix A-10 of the Investigator Manual will be followed46  
☐  Short form procedures may be used per HRP-091. If so, choose applicable 
box(es): 
☐ Per section 5.5.1 
☐  Per section 5.5.2 
☐  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 iCanCope with Sickle Cell Pain Program is only available in English. 
    

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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 enrolling individuals under the age of 18, we will be collecting date of 
birth to determine age. Parent consent for their participation will be obtained. 
   
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 
   
N/A 
   
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 
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 15 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 
   

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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. The study staff will attempt to call until they reach the child 
participant and obtain verbal consent. If they completed all study timepoints 
including the last follow up, they will not be contacted since their participation in the 
study is complete. After the completion of the study, they are free to use the website 
and app as a user, not a participant of the research study. If they are still interested 
in participating in the study, we will obtain verbal consent using the procedures 
listed above before conducting further study procedures. 
   
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 subjects who turn 18 whose private 
identifiable information is still being used (but are not actively participating). This 
study is minimal risk and without the waiver, the study could not be practicably 
conducted. 
   
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: 
   
The study procedures only include surveys and a web program. The 
anticipated risks in this research are less than those our participants 
would ordinarily encounter in daily life.  
 
20.10.2.2. The waiver or alteration will not adversely affect the rights or welfare 
of the subjects because:59 
   
The study will not be collecting information that could put subjects or 
their families at harm, e.g., affect eligibility for insurance, 
employability, stigmatization; Their participation in the study would not 
alter or affect the subject’s care; 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. These participants 
would have already been assented to participate in the study and 

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would have used the website and/or app for purposes of the research. 
The continued use of their data for research analysis would not 
impact their rights or welfare. Participants always have the option to 
contact the research team and request to withdraw from the study. 
   
20.10.2.3. The research could not practicably be carried out without the waiver 
or alteration because:60 
   
Since the study time frame is about 5 years, most participants would 
turn 18 before data is finished being collected, analyzed and/or de-
identified. Once subjects turn 18, the study team may be unable to get 
in contact with participants who have already completed all active 
research participation. Due to the small scope of this project, it is 
important to retain all the data collected from all eligible patients for 
the results of the study to be meaningful. 
   
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 
  
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.  For this reason, we request a waiver of documentation of informed 
consent because the project would present no more than minimal risk to the research 
subjects and involves no procedures for which written consent is required outside of the 
research context.  
   
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.  

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☒  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. All identifying information will be stored in a secure database in 
a protected folder including the information of patients who were 
referred, but not enrolled in the study. These patients who were referred 
but did not enroll in the study will have a different ID so they are not 
approached after recruitment. 
 
   
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 This means that once all analysis of identifiable 
data for the study is complete, all identifiers will be destroyed. 
   
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 waiver 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 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.  
Because we will not be seeing the participants in person, we are asking for an 
alteration 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 authorization on a secure electronic form via REDCap. 
The study staff at SCRI will not have any in-person contact with any participants in 
this study. 

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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 
   
Each parent/child dyad will receive a $40 electronic gift card for each timepoint assessment 
they complete.   
   
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 
   
Subjects will be given the option to receive text message communications from the study 
team.  If the subject opts in, there may be a cost associated with the text messages.  Subjects 
will be informed of this possible cost.  
   
24. Setting 
24.1. Site(s) or location(s) where the research team will conduct the research: 
   
Patients from the following hospitals will have the opportunity to participate in the research: 
Emory/CHOA, The Hospital for Sick Children (SickKids), and Connecticut Children’s Medical 
Center (CCMC), University of Mississippi, University of Florida, Boston Medical Center, Ann & 
Robert H. Lurie Children's Hospital of Chicago, Nationwide Children’s Hospital, C.S. Mott 
Children’s Hospital and Seattle Children’s Hospital. SCRI, CHOA, SickKids, and CCMC are 
the only locations where research will be conducted. All participating sites will approach their 
IRB for review of their engagement on this research study. At SCRI, study staff will receive 
referrals from the participating clinics through email, fax, or REDCap. For participants, all 
survey assessments/diaries will be sent via REDCap for participants to complete in their 
home. All research activities conducted by SCH agents will be done at Dr. Palermo’s lab 
space.  
   
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: 
   
All other participating sites will be conducting the own IRB review and if there are 
any regulations, customs, etc. that might impact the research or this Protocol. 
CHOA, SickKids, and CCMC have already obtained IRB approval to conduct the 
research and we are aware of their site-specific regulations and customs. This study 
has been modified accordingly and SCH IRB will be consulted if any additional 
modifications are needed.  
   
24.3.2. Local scientific and ethical review structure: 
   
N/A 
   
25. Resources Available 

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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. 
   
25.2. Other resources available to conduct the research:76 
   
Each local site PI will be responsible for local study oversight, and review/management of any 
local adverse events, and reporting to their local IRB per their local requirements. Dr. Dampier, 
the PI at CHOA will serve as the study medical monitor and will provide each site with a yearly 
study-wide summary of safety events for continuing reviews by local IRBs. A Steering 
Committee consisting of the study and site PIs will meet monthly by teleconference and be 
responsible for overall study management. The progress of the study in terms of recruitment 
will be monitored via a data tracking system that will allow the PIs to review subject enrollment 
by age, gender and race. If requested by the NIH or by one of the local institutional IRBs, the 
AFLAC DSMB is available to review for the local site or all study sites on a quarterly schedule 
(as per their SOPs).  
   
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 
   
Seattle Children’s will coordinate monthly research coordinator and investigator 
teleconference meetings. An agenda and any additional documents will be sent via 
email to members of the study team.  
   
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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References: 
1. 
Hassell, K. L. Population Estimates of Sickle Cell Disease in the U.S. American Journal of 
Preventive Medicine 38, S512-S521 (2010). 
2. 
Franck, L. S., Treadwell, M., Jacob, E. & Vichinsky, E. Assessment of sickle cell pain in children 
and young adults using the adolescent pediatric pain tool. Journal of Pain and Symptom Management 23, 
114-120 (2002). 
3. 
Dampier, C. D. & Shapiro, B. S. in Pain in Infants, Children, and Adolescents, 2nd Edition (eds 
Schechter, N. L. & Berde, C. B.) 489-516 (Lippincott Williams & Wilkins, Philadelphia, 2003). 
4. 
Conner-Warren, R. L. Pain intensity and home pain management of children with sickle cell 
disease. Issues in Comprehensive Pediatric Nursing 19, 183-195 (1996). 
5. 
Bonner, M. J. Health related quality of life in sickle cell disease: just scratching the surface. 
Pediatric Blood Cancer 54, 1-2 (2010). 
6. 
Zempsky, W. T., O’Hara, E. A., Santanelli, J. P., Palermo, T. M., New, T., Smith-Whitley, K. & 
Casella, J. F. Validation of the Sickle Cell Disease Pain Burden Interview–Youth. The Journal of Pain 14, 
975-982 (2013). 
7. 
Dampier, C., Ely, B., Brodecki, D. & O’Neal, P. Characteristics of pain managed at home in 
children and adolescents with sickle cell disease by using diary self-reports. The Journal of Pain 3, 461-
470 (2002). 
8. 
Shapiro, B. S., Dinges, D. F., Orne, E. C., Bauer, N., Reilly, L. B., Whitehouse, W. G., Ohene-
Frempong, K. & Orne, M. T. Home management of sickle cell-related pain in children and adolescents: 
natural history and impact on school attendance. Pain 61, 139-144 (1995). 
9. 
Gil, K. M., Carson, J. W., Porter, L. S., Ready, J., Valrie, C., Redding-Lallinger, R. & Daeschner, 
C. Daily stress and mood and their association with pain, health-care use, and school activity in 
adolescents with sickle cell disease. Journal of pediatric psychology 28, 363-373 (2003). 
10. 
Smith, W. R. & Scherer, M. Sickle-Cell Pain: Advances in Epidemiology and Etiology. 
Hematology Am Soc Hematol Educ Program 2010, 409-415 (2011). 
11. 
Dampier, C., Ely, E., Brodecki, D. & O’Neal, P. Home management of pain in sickle cell disease: 
a daily diary study in children and adolescents. Journal of Pediatric Hematology Oncology 24, 643-647 
(2002). 
12. 
Stinson, J. N., Lalloo, C., Kirby-Allen, M., Odame, I., Friedman, J., Amaria, K., Campbell, F., 
Simpson, E., Zempsky, W., White, M., Arisan, K. & Nguyen, C. Exploring the pain self-management 
needs of adolescents with sickle cell disease to inform development of a web-based educational 
intervention. Abstract Presented at 15th World Congress on Pain (2014). 
13. 
Lanzkron, S., Carroll, P. C. & Haywood, C. The burden of emergency department use for sickle-
cell disease: an analysis of the national emergency department sample database. American Journal of 
Hematology 85, 797-799 (2010). 

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14. 
Barlow, J., Wright, C., Sheasby, J., Turner, A. & Hainsworth, J. Self-management approaches for 
people with chronic conditions: a review. Patient Educ Couns 48, 177-187 (2002). 
15. 
Jensen, M. P. A neuropsychological model of pain: research and clinical implications. J Pain 11, 
2-12 (2010). 
16. 
Eccleston, C., Williams, A. & Morley, S. Psychological therapies for the management of chronic 
pain (excluding headache) in adults. Cochrane database of systematic reviews (Online) CD007407 
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17. 
Fisher, E., Heathcote, L., Palermo, T. M., de C Williams, A. C., Lau, J. & Eccleston, C. Systematic 
Review and Meta-analysis: Psychological Therapies for Children with Chronic Pain. Journal of Pediatric 
Psychology 39, 763-782 (2014). 
18. 
Palermo, T. M., Eccleston, C., Lewandowski, A. S., Williams, A. C. & Morley, S. Randomized 
controlled trials of psychological therapies for management of chronic pain in children and adolescents: 
an updated meta-analytic review. Pain 148, 387-397 (2010). 
19. 
Chen, E., Cole, S. W. & Kato, P.M. A review of empirically supported psychosocial interventions 
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20. 
Quinn, C. T., Rogers, Z. R., McCavit, T. L. & Buchanan, G. R. Improved survival of children and 
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Rosen, D. S., Blum, R. W., Britto, M., Sawyer, S. M. & Siegel, D. M. Transition to adult health 
care for adolescents and young adults with chronic conditions. Journal of Adolescent Health 33, 309-311 
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Barlow, J. H. & Ellard, D. R. Psycho-educational interventions for children with chronic disease, 
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23. 
Peng, P., Stinson, J. N., Choinière, M., Dion, D., Intrater, H., Lefort, S., Lynch, M., Ong, M., 
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24. 
Peng, P., Choinière, M., Dion, D., Intrater, H., Lefort, S., Lynch, M., Ong, M., Rashiq, S., Tkachuk, 
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Ritterband, L., Gonder-Frederick, L., Cox, D., Clifton, A., West, R. & Borowitz, S. Internet 
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26. 
Demiris, G., Afrin, L. B., Speedie, S., Courtney, K. L., Sondhi, M., Vimarlund, V., Lovis, C., 
Goossen, W. & Lynch, C. Patient-centered applications: use of information technology to promote 
disease management and wellness. A white paper by the AMIA knowledge in motion working group. 
Journal of the American Medical Informatics Association: JAMIA 15, 8-13 (2008). 

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27. 
Klasnja, P. & Pratt, W. Healthcare in the pocket: Mapping the space of mobile-phone health 
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28. 
Madden, M., Lenhart, A., Duggan, M., Cortesi, S. & Gasser, U. Teens and Technology 2013. Pew 
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29. 
Stinson, J. N., Wilson, R., Gill, N., Yamada, J. & Holt, J. A systematic review of internet-based 
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30. 
Velleman, S., Stallard, P. & Richardson, T. A review and meta-analysis of computerized cognitive 
behaviour therapy for the treatment of pain in children and adolescents. Child Care Health Dev 36, 465-
472 (2010). 
31. 
Runge, C., Lecheler, J., Horn, M., Tews, J. & Schaefer, M. Outcomes of a Web-based patient 
education program for asthmatic children and adolescents. Chest 129, 581-593 (2006). 
32. 
Bender, J. L., Radhakrishnan, A., Diorio, C., Englesakis, M. & Jadad, A. R. Can pain be managed 
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33. 
Macea, D. D., Gajos, K., Daglia Calil, Y. A. & Fregni, F. The efficacy of Web-based cognitive 
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(2010). 
34. 
Lalloo, C., Jibb, L. A., Rivera, J., Agarwal, A. & Stinson, J. N. “There’s a Pain App for That”: 
Review of Patient-targeted Smartphone Applications for Pain Management. The Clinical Journal of Pain 
31, 557-563 (2015). 
35. 
Gil, K. M., Anthony, K. K., Carson, J. W., Redding-Lallinger, R., Daeschner, C. W. & Ware, R. E. 
Daily coping practice predicts treatment effects in children with sickle cell disease. Journal of Pediatric 
Psychology 26, 163-173 (2001). 
36. 
McClellan, C. B., Schatz, J. C., Puffer, E., Sanchez, C. E., Stancil, M. T. & Roberts, C. W. Use of 
Handheld Wireless Technology for a Home-based Sickle Cell Pain Management Protocol. Journal of 
Pediatric Psychology 34, 564-573 (2009). 
37. 
Schatz, J., Schlenz, A., McClellan, C. B., Puffer, E. S., Hardy, S., Pfeiffer, M. & Roberts, C. W. 
Changes in Coping, Pain and Activity following Cognitive-Behavioral Training. The Clinical Journal of Pain 
1 (2014). 
38. 
McGillion, M. H., Watt-Watson, J., Stevens, B., Lefort, S. M., Coyte, P. & Graham, A. 
Randomized controlled trial of a psychoeducation program for the self-management of chronic cardiac 
pain. J Pain Symptom Manage 36, 126-140 (2008). 
39. 
Stinson, J. N., McGrath, P. J., Hodnett, E. D., Feldman, B. M., Duffy, C. M., Huber, A. M., Tucker, 
L. B., Hetherington, C. R., Tse, S., Spiegel, L. R., Campillo, S., Gill, N. K. & White, M. E. An internet-
based self-management program with telephone support for adolescents with arthritis: a pilot randomized 
controlled trial. The Journal of Rheumatology 37, 1944-1952 (2010). 
40. 
Lorig, K. & Holman, H. Arthritis self-management studies: a twelve-year review. Health Educ Q 
20, 17-28 (1993). 

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41. 
Palermo, T. M., Wilson, A. C., Peters, M., Lewandowski, A. & Somhegyi, H. Randomized 
controlled trial of an Internet-delivered family cognitive-behavioral therapy intervention for children and 
adolescents with chronic pain. Pain 146, 205-213 (2009). 
42. 
Palermo, T. M., Law, E. F., Fales, J., Bromberg, M. H., Jessen-Fiddick, T. & Tai, G. Internet-
delivered Cognitive-behavioral Treatment for Adolescents with Chronic Pain and their Parents: A 
Randomized Controlled Multicenter Trial. Pain (2015). 
43. 
McCurdie, T., Taneva, S., Casselman, M., Yeung, M., McDaniel, C., Ho, W. & Cafazzo, J. 
mHealth consumer apps: the case for user-centered design. Biomed Instrum Technol Suppl, 49-56 
(2012). 
44. 
Stinson, J. N., Petroz, G. C., Tait, G., Feldman, B. M., Streiner, D., McGrath, P. J. & Stevens, B. 
J. e-Ouch: usability testing of an electronic chronic pain diary for adolescents with arthritis. Clin J Pain 22, 
295-305 (2006). 
45. 
Stinson, J. N., Petroz, G. C., Stevens, B. J., Feldman, B. M., Streiner, D., McGrath, P. J. & Gill, N. 
Working out the kinks: testing the feasibility of an electronic pain diary for adolescents with arthritis. Pain 
Res Manag 13, 375-382 (2008). 
46. 
Stinson, J. N., Stevens, B. J., Feldman, B. M., Streiner, D., McGrath, P. J., Dupuis, A., Gill, N. & 
Petroz, G. C. Construct validity of a multidimensional electronic pain diary for adolescents with arthritis. 
Pain 136, 281-292 (2008). 
47. 
Breakey, V. R., Harris, L., Davis, G. O., Akinnawo, E., Agarwal, A., Ouellette, C. & Stinson, J. N. 
The quality, content, accuracy and readability of information about sickle cell anemia on the Internet. 
Abstract Accepted to the 2016 Amercian Society of Hematology Annual Meeting. (2015). 
48. 
Charnock, D., Shepperd, S., Needham, G. & Gann, R. DISCERN: an instrument for judging the 
quality of written consumer health information on treatment choices. Journal of Epidemiology and 
Community Health 53, 105-111 (1999). 
49. 
McLaughlin, G. H. SMOG Grading-a New Readability Formula on JSTOR. Journal of Reading 12, 
639-646 (1969). 
50. 
Marks, R., Allegrante, J. P. & Lorig, K. A review and synthesis of research evidence for self-
efficacy-enhancing interventions for reducing chronic disability: implications for health education practice 
(part I). Health Promotion Practice 6, 37-43 (2005). 
51. 
Marks, R. A Review and Synthesis of Research Evidence for Self-Efficacy-Enhancing 
Interventions for Reducing Chronic Disability: Implications for Health Education Practice (Part II). Health 
promotion practice 6, 148-156 (2005). 
52. 
Jensen, M. P., Turner, J. A. & Romano, J. M. Self-efficacy and outcome expectancies: 
relationship to chronic pain coping strategies and adjustment. Pain 44, 263-269 (1991). 
53. 
Schunk, D. H. Enhancing self-efficacy and achievement through rewards and goals: Motivational 
and informational effects. The Journal of Educational Research 78, 29-34 (1984). 

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54. 
Bovend’Eerdt, T. J., Botell, R. E. & Wade, D. T. Writing SMART rehabilitation goals and achieving 
goal attainment scaling: a practical guide. Clin Rehabil 23, 352-361 (2009). 
55. 
King, D., Greaves, F., Exeter, C. & Darzi, A. ‘Gamification’: Influencing health behaviours with 
games. JRSM 106, 76-78 (2013). 
56. 
Hopko, D. R., Lejuez, C. W., LePage, J. P., Hopko, S. D. & McNeil, D. W. A brief behavioral 
activation treatment for depression. A randomized pilot trial within an inpatient psychiatric hospital. 
Behavior Modification 27, 458-469 (2003). 
57. 
Bandura, A. Social learning theory (Prentice Hall, Englewood Cliffs, 1971). 
58. 
Wong, S., Chan, F., Wong, R., Chu, M., Kitty Lam, Y., Mercer, S. & Ma, S. Comparing the 
effectiveness of mindfulness-based stress reduction and multidisciplinary intervention programs for 
chronic pain: a randomized comparative trial. The Clinical Journal of Pain 27, 724-734 (2011). 
59. 
Bennett, H. D., Coleman, E. A., Parry, C., Bodenheimer, T. & Chen, E. H. Health coaching for 
patients with chronic illness. Family Practice Management 17, 24-29 (2010). 
60. 
McGrath, P. J., Walco, G. A., Turk, D. C., Dworkin, R. H., Brown, M. T., Davidson, K., Eccleston, 
C., Finley, G. A., Goldschneider, K., Haverkos, L., Hertz, S. H., Ljungman, G., Palermo, T., Rappaport, B. 
A., Rhodes, T., Schechter, N., Scott, J., Sethna, N., Svensson, O. K., Stinson, J., von Baeyer, C. L., 
Walker, L., Weisman, S., White, R. E., Zajicek, A., Zeltzer, L. & PedIMMPACT. Core outcome domains 
and measures for pediatric acute and chronic/recurrent pain clinical trials: PedIMMPACT 
recommendations. J Pain 9, 771-783 (2008). 
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Palermo, T. M., Wilson, A. C., Lewandowski, A. S., Toliver-Sokol, M. & Murray, C. Behavioral and 
psychosocial factors associated with insomnia in adolescents with chronic pain. Pain 152, 89-94 (2011). 
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Palermo, T. M., Lewandowski, A., Long, A. C. & Burant, C. J. Validation of a self-report 
questionnaire version of the Child Activity Limitations Interview (CALI): The CALI-21. Pain 139, 644-652 
(2008). 
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Forrest, C., Bevans, K., Tucker, C., Riley, A. W., Ravens-Sieberer, U., Gardner, W. & Pajer, K. 
Commentary: the patient-reported outcome measurement information system (PROMIS®) for children 
and youth: application to pediatric psychology. Journal of Pediatric Psychology 37, 614-621 (2012). 
65. 
LeJeune, B., Beebe, D., Noll, J., Kenealy, L., Isquith, P. & Gioia, G. Psychometric support for an 
abbreviated version of the Behavior Rating Inventory of Executive Function (BRIEF) Parent Form. Child 
Neuropsychology 16, 182-201 (2010). 
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Hurst, H. & Bolton, J. Assessing the clinical significance of change scores recorded on subjective 
outcome measures. Journal of Manipulative and Physiological Therapeutics 27, 26-35 (2004). 
67. 
Romeo, R., Knapp, M. & Scott, S. Economic cost of severe antisocial behaviour in children--and 
who pays it. The British Journal of Psychiatry 188, 547-553 (2006). 

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68. 
Clay, O. J. & Telfair, J. Evaluation of a disease-specific self-efficacy instrument in adolescents 
with sickle cell disease and its relationship to adjustment. Child Neuropsychology 13, 188-203 (2007). 
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Zimet, G. D., Dahlem, N. W. & Zimet, S. G. The Multidimensional Scale of Perceived Social 
Support. Journal of Personality Assessment 52, 30-41 (1988). 
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Zempsky, W. T., O’Hara, E. A., Santanelli, J. P., New, T., Smith-Whitley, K., Casella, J. & 
Palermo, T. M. Development and validation of the Youth Acute Pain Functional Ability Questionnaire 
(YAPFAQ). The Journal of Pain 15, 1319-1327 (2014). 
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pain, mood and physical function in children hospitalized for sickle cell disease pain. Pain Res Manag 18, 
33-38 (2013). 
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Alman, B., Hopyan, S., Strahlendorf, C., Portwine, C., Johnston, D. L. & Orr, M. Development and Testing 
of a Multidimensional iPhone Pain Assessment Application for Adolescents with Cancer. Journal of 
Medical Internet Research 15, e51 (2013). 
 
 
 
 
 
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 

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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. 
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 

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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. 
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