Developing a Tool to Support Shared Decision Making Post-Concussion Between Adolescents, Parents and Clinicians
Phase: NA
Conditions: Concussion, Brain
Sponsor: Seattle Children's Hospital

 
 
 
 
 
 
 
  
Developing a Tool to Support Shared Decision-Making Post-Concussion 
Between Adolescents,  Parents and Clinicians 
 
NCT Number: NCT04777864 
 
Document Date: 03/17/2022 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

Due to the smaller sample recruited we simplified our analytic plan to focus on between-
condition comparisons for the primary decision-related outcomes and no subgroup 
comparisons.  

Principal Researcher: Emily Kroshus   
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Protocol Version Date: 3/17/2022
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PROJECT TITLE:
Family shared decision making: Piloting a decision aid for adolescent sport
PRINCIPAL INVESTIGATOR:
Emily Kroshus, ScD, MPH
Child Health, Behavior, and Development
(206) 884-5326
Emily.Kroshus@seattlechildrens.org

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

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1.
Objectives
1.1. Purpose, specific aims, or objectives:
The purpose of this study is to understand the perspectives of adolescents, parents, and 
clinicians on the decision to resume or cease sport participation following recovery from a sport-
related concussion. Specifically, this study will test the effectiveness of created decision aids to 
help with this understanding and discussion. The specific aims of this study are four-fold:
Aim 1: Conduct surveys with clinicians (inclusive of pediatrician and family medicine 
providers) and families who have an adolescent recovering from a sport-related 
concussion (one parent and one adolescent) about their experiences discussing return to 
sport. Specifically, this aim will survey clinicians about their current knowledge and belief 
of concussion research, their experiences with discussing return to sport post-concussion 
with families, and their opinions for best practices and needs for creating an effective 
shared decision-making aid with families on this topic. This aim will also survey parent-
adolescent dyads about their experiences making the decision to return to sport. Findings 
from this aim will directly influence Aims 3 and 4.
Aim 2: First, this aim will include semi-structured interviews (inclusive of cognitive 
interviewing, qualitative interviewing) with families (one parent and one adolescent) in 
order to learn more about their experiences making decisions to resume or stop sport 
participation after recovery from a sport-related concussion . Second, this aim will 
conduct usability testing with families (one parent and one adolescent) and their clinicians 
with created parent and adolescent decision aids for enabling return to sport discussions 
following a sport-related concussion. Specifically, this aim will involve usability tests (i.e., 
interview + tasks) to evaluate the effectiveness of current decision aids for parent and 
adolescent and provide feedback on ways to tailor the current decision aids better. 
Findings from this aim will be used directly in Aim 4.
Aim 3: First, this aim will include semi-structured interviews (inclusive of cognitive 
interviewing, qualitative interviewing) in order to receive directed and specific clinician 
feedback on how to create a decision aid effectively for their use. 
Aim 3 (continued): Second, this aim will conduct usability testing with clinicians 
(including pediatricians and family medicine providers) for a clinician-specific decision 
aid. The findings from Aim 1 and Aim 2 will help inform the creation of a clinician-specific 
decision aid. Findings from this aim will be used directly in Aim 4.
Aim 4: This aim has two cohorts:
Aim 4a: Cohort 1 will evaluate how shared decision making currently occurs in a clinical 
appointment. This data will then be used to compare need and impact of the intervention 
group in Aim 4b. 
Aim 4b: Cohort 2  includes a pilot random control trial (RCT) of all three decision aids 
(i.e., parent, adolescent, clinician) to assess intervention efficacy of all decision aids in 
aiding family shared decision making in returning to sport post-sport related concussion.  
  
1.2. Hypotheses to be tested:

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This research is qualitative; therefore, we do not have any hypotheses to explicitly test. 
  
2.
Background
2.1. Relevant prior experience and gaps in current knowledge:
  
Sport-related concussion is a prevalent injury among U.S. youth. More than 1 million youth sport 
participants are diagnosed each year,1 with incidence highest in sports that involve routine contact and 
collision such as football, soccer and ice hockey.17 Most state and sport organization policies require 
clearance by a medical provider before an athlete returns to organized sport post-concussion,18 typically 
affirming that acute symptoms have resolved and no new symptoms present with a graded increase in 
physical activity.18 For most youth this occurs within one-month post-injury.19,20 The only absolute 
contraindication for returning to contact/collision sport is a structural brain abnormality visible on 
neuroimaging, which is rare and usually unrelated to the diagnosis of concussion.21,22 As a result, 
returning to contact/collision sport complies with current standards of care for nearly all children with 
resolution of acute concussive symptoms.
Medical clearance, however, does not mean that return to sport is free from risk. Even when 
athletes have recovered from their acute injury symptoms, they may be at risk of later-life neurologic 
dysfunction. Indeed, there is emerging evidence that the burden of concussion may be cumulative,23,24 
though there is no definitive evidence about a dose-response relationship for concussions sustained in 
youth sport and later-life harm, with data largely from short-term studies25 and retrospective cohort studies 
of professional athletes that may not generalize to youth populations.26 Possible later life harm 
notwithstanding, returning to contact/collision sport means risking sustaining an additional concussion, 
which is often accompanied by short-term psychosocial consequences, including impaired academic and 
social functioning,2 and there is evidence that individuals with prior concussions are at increased risk of 
future concussions.5 
Many U.S. families are concerned about concussion7 and seek counsel from clinicians about 
sport participation post-injury.27 Yet clinicians struggle with how to discuss with families whether or not 
child patients should return to contact sport post-concussion. In part this is because the evidence 
supporting each option is not definitive. It is also due to the fact that this decision is highly individualized. 
Influential factors in this decision include clinical variability (e.g., injury severity, recovery trajectory, type 
of functional impairment post-injury, the interval between prior injuries, the age at which injuries occurred, 
and premorbid health conditions),5,21 and different family tolerance for the uncertain risk of harm 
associated with sustaining an additional concussion relative to what they see as the benefits of returning 
to sport and the risks and benefits of substitute activities.7–10 Given this context, a recent report by the 
Institute of Medicine5 indicates a need for effective communication and dissemination strategies to 
facilitate decision-making post-concussion among athletes, parents and other stakeholders.
Shared decision-making is appropriate for return to sport decisions after concussions that do not 
result in medical disqualification. Not all options have to be equivalent in terms of their medical burden 
for shared decision making (SDM) to be appropriate, if all meet current standards of care.28 There are two 
main situations in which our formative interviews with clinicians indicate SDM would be appropriate: (1) 
the clinician believes that medical harms of returning to contact/collision sport outweigh benefits, but the 
burden does not reach the threshold of mandatory medical disqualification (“retirement recommended”), 
and (2) the clinician believes there is medical equipoise between the costs and benefits of returning to 
contact/collision sport but the family is concerned (“no recommendation”). In the “retirement 
recommended” condition, the clinician would share a recommended course of action (e.g., ceasing 
contact/collision sport) and attempt to help the family—adolescent and parents—embrace the values and 
preferences that align with this recommendation.28 In the “no recommendation” condition, SDM would 

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appropriately take a patient-led form, with the clinician in a facilitative role.28 While decision-making post-
concussion with minors will necessarily also involve parents, explicit efforts to elevate the voice of 
adolescents, particularly when there is medical equipoise in the decision, is developmentally appropriate29 
and supports growth in their efficacy in making healthcare related decisions.30 
 
A decision aid can help facilitate higher quality shared decision-making post-concussion. High 
quality decisions are facilitated by a decisional process where: all parties involved recognize that a 
decision has to be made, feel informed about the risks and benefits of key options, and are clear on what 
matters most to them.12,13 At present, these criteria are inconsistently met post-concussion. Many parents 
and adolescents are inadequately informed about the short- and long-term risks of concussion, with this 
deficit magnified among lower socioeconomic status families.9,31,32 Discussions about possible 
contact/collision sport retirement tend to occur when the clinician believes cessation would be medically 
beneficial, often around 4 concussions or after concussions with prolonged symptoms.9,33 However, we 
have found that most parents of youth football players would prefer this conversation to be initiated earlier 
after 1 or 2 concussions (Kroshus et al., under review). We have also found that timing of this 
conversation is influenced by the clinician’s subjective assessment of the athlete’s on field and academic 
potential.33 Use of a decision aid post-concussion could help clinicians have a better balanced discussion 
on the timing and nature of post-concussion communication about sport retirement, ensuring that all 
families are informed about relevant risks and benefits of different sport options. 
2.2. Relevant preliminary data:1
  
See section 2.1
  
2.3. Scientific or scholarly background:
  
See section 2.1
  
2.4. Prior approvals:
  
N/A
  
3.
Study Endpoints2
3.1. Primary and secondary endpoints:
  
Aim 1: Recruitment of participants will occur until thematic saturation, or until 500 participants 
are reached (100 clinicians, 200 parents, 200 adolescents). For each participant, the endpoint 
will be the conclusion of the survey. 
Aim 2: Recruitment of participants will occur until thematic saturation. For each participant, the 
endpoint will be the conclusion of the interview and/or usability testing. 
Aim 3: Recruitment of participants will occur until thematic saturation. For each participant, the 
endpoint will be the conclusion of the usability testing. 
Aim 4a and 4b: Recruitment will continue until 40 families agree to participate (20 per phase) 
and up to 20 healthcare providers (Aim 4b only). For each family, participation will conclude after 
completing the 3-month follow-up survey. For each healthcare provider, participation will 
conclude after completing the brief survey about tool implementation. 
 
  
3.2. Primary or secondary safety endpoints:
  
There are no primary or secondary safety endpoints for this study. 
  

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4.
Drugs, Devices and Biologics3
4.1. Manufacturer and name of all drugs, devices and biologics:
  
N/A
  
4.2. Description and purpose of all drugs, devices and biologics:
  
N/A
  
4.3. Regulatory status of all drugs, devices and biologics:4
  
N/A
  
4.3.1.
Drugs or Biologics:
☐ IND Exempt.  Explain:5 Click here to enter text.
☐ IND.
 
4.3.2.
Devices:
☐ IDE Exempt.  Explain:6 Click here to enter text.
☐ Abbreviated IDE / Non-Significant Risk.  Explain:7 Click here to enter text.
☐ IDE / Significant Risk.  
    
4.4. Plans to store, handle, and administer any study drugs, devices and biologics so they will be 
used only on subjects and be used only by authorized investigators:
  
N/A
  
5.
Procedures Involved
5.1. Study design:8
  
This study involves the following procedures:
Aim 1: Survey
Aim 2: Interviewing (i.e. qualitative) and Usability Testing
Aim 3: Interviewing (i.e., cognitive, qualitative) and Usability Testing 
Aim 4a and 4b: Consecutive cohort design (families). Healthcare providers will also complete a 
one-time survey.
  
5.2. Research procedures:9
  
Aim 1: Clinicians: This aim will survey clinicians about their current knowledge and belief of 
concussion research, their experiences with discussing return to sport post-concussion with 
families, and their opinions for best practices and needs for an effective shared decision-making 
aid with families on this topic. Participants will receive a link to an online survey, hosted on a 
survey-hosted site (e.g., REDCap). Before beginning the survey, participants will read an 
information sheet about the study and then proceed to the survey, which will ask them questions 
relating to the topics described above. After completing the survey, participants will be exited 
from the survey and data collection will end for this aim. Survey questions can be found in the 
attachment section on Click.

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Parents and adolescents: This aim will also survey families (one parent and one adolescent) 
about their experiences with discussing return to sport post-concussion and with deciding what 
sports and activities to participate in post-concussion. Parent participants will be contacted first 
and will receive a link to an online survey, hosted on a survey-hosted site (e.g., REDCap). 
Before beginning the survey, parents will read an information sheet about the study, indicate 
their agreement to participate and permission for their adolescent to participate, and then 
proceed to the survey, which will ask them questions relating to the topics described above. 
Adolescent participants will follow a similar process and indicate their assent to participate 
before continuing on to the survey. After completing the survey, participants will be exited from 
the survey and data collection will end for this aim. Survey questions can be found in the 
attachment section on Click. Surveys will be completed separately by parents and adolescents. 
Aim 2: This aim involves semi-structured interviews, and usability testing sessions(i.e., usability 
test interview + tasks) with families (parent and adolescent). as described below. Once a 
participant is enrolled in this aim, participants will participate in either a 60-minute interview (in-
person or online), and/or an in-person or online usability testing session. For semi-structured 
interviews, participants (i.e., parents and adolescents) will review an information sheet about the 
study prior to the interview. Then, they will be interviewed separately about their experiences 
making decisions to resume or stop sport participation after recovery from a sport-related 
concussion. All interview data will be audio recorded. All interviews conducted online will be 
done so through an online platform (i.e., Zoom) and their online session recorded. For in-person 
usability sessions, first, participants (i.e., parent-adolescent dyad) will be given a brief 
demographic questionnaire at the start of the usability testing session. Then, each parent-
adolescent dyad will take their respective decision-making tool. After taking the tool, they will be 
asked questions related to the tool usability. The entire usability testing session will be audio 
recorded. Participants will be given an information sheet about the study at the start (i.e., before 
demographic questionnaire) of the usability testing session. For online usability testing sessions, 
the same procedures will be followed as in person usability sessions, however, participants will 
be emailed the demographic questionnaire and information sheet and they will participate in the 
usability session via an online platform (i.e., Zoom). Their online session will be recorded. All 
documents used in this aim can be found in the attachment section on Click. 
Aim 3: This aim involves semi-structured interviews, and usability testing with clinicians as 
described below.  Usability testing will be informed by the interviews and will be submitted for 
IRB review after the interviews are complete.  Participants (i.e., clinicians) will participate in a 60-
minute interview, either in person or online. Prior to the start of the interview, participants will 
review an information sheet about the study that will either be emailed to them (if session is 
conducted online) or printed and handed in person (if session is conducted in person). Then, 
they will be interviewed (inclusive of cognitive interviewing, qualitative interviewing,) about 
specific clinician feedback on how to create a decision aid effectively for their use. All interview 
data will be audio recorded. All documents used in this aim can be found in the attachment 
section of Click. All interviews conducted online will be done so through an online platform (i.e., 
Zoom) and their online session will be recorded. 
Aim 4a and b: In the first data collection cohort (Aim 4a), there will be no change to the nature of 
provider communication with families seeking care for their child’s concussion. In the second 
cohort (Aim 4b), the study team will share the respective decision aids with the family and let 
them know to complete them before their appointment. After both the parent and adolescent 
complete their respective decision aids, a member of the study team will insert the clinician tool 
link in the patient’s chart and/or send a message with the link for the clinician to review, prior to 
the appointment. 

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Data will be collected about the experience that families have discussing the decision of what 
sports and activities they participate in after they recover from their injury and using their 
respective decision aids (intervention only). Survey data will be collected from parents and 
adolescents at several time points (baseline, post-visit(s)up to and including their final visit, 3-
months after initial visit). Survey data will also be collected from healthcare providers about their 
experiences sharing information with families and using the tool (intervention only) over this time 
period. Data will be collected at one time point (after a patient of the healthcare provider has 
completed the tool). 
  
5.3. Data sources that will be used to collect data about subjects:10
  
Interviews (inclusive of cognitive, and qualitative), surveys, usability testing. All data will be 
derived from participants. 
  
5.4. Data to be collected, including long–term follow–up data:11
  
Aim 1: Data will be derived from participants (i.e., clinicians – inclusive of pediatricians and 
family medicine providers, parents, adolescents). Data will come from online surveys. All the 
data to be collected is outlined in the enclosed data collection forms and may contain identifiable 
information- such as employment title (clinicians) or number of concussions (adolescents). 
Aim 2: Data will be derived from participants (i.e., parents, adolescents) who participate in either 
an in person or online interview and/or usability testing session. The source records that will be 
used to collect data from participants (e.g., interview guide, demographic questionnaire, usability 
testing guide, including post task semi-structured interviews) are attached to the Click 
Smartform. Data may contain identifiable information – such as number of concussions and/or 
zip code. The semi-structured interviews and/or usability testing sessions may change iteratively 
based on feedback from participants, but themes explored will remain the same, consistent with 
best practices qualitative data collection. 
Aim 3: Data will be derived from participants (i.e., clinicians – inclusive of pediatricians and 
family medicine providers) who participate in either in person or online interviews. Data may 
contain identifiable information- such as employment title. The source records that will be used 
to collect data from participants (e.g., demographic questionnaire,, including post task semi-
structured interviews and one-on-one interviews) are attached to the Click Smartform. Data may 
contain identifiable information – such as number of concussions and/or zip code. 
Aims 4a and 4b: Survey data will be collected from up to 40 families (parent + child) (20 per 
phase) at a minimum of 3 time points: their first visit, after each following visit up to and including 
their final visit, and 3-month follow-up (i.e., 3 months after their initial visit). Data will come from 
online surveys, completed online or in-person while at their visit (e.g., participants will be given a 
tablet to complete while waiting). If participants are not able to complete the relevant surveys in-
person at their visit, they will complete the follow up survey by telephone (call or text linking to a 
survey hosted on REDCap), or by email (linking to a survey hosted on REDCap). Survey data 
will also be collected from up to 20 healthcare providers at one time point (towards the end of 
family data collection) about their experiences using the tool. 

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For participants enrolled in the intervention group (4b only), online data will also be collected 
within their respective decision aids. See the online versions of “Parent Tool”, “Adolescent Tool”, 
and “Family Discussion Tool” attached to the Click SmartForm, to see the data that will be 
collected within the decision aids. 
  
6.
Data and Biospecimen Banking12
6.1. Complete list of the data and/or biospecimens to be included in the bank:13
  
N/A
  
6.2. Location of data and/or biospecimen storage:14
  
N/A
  
6.3. List of those with direct access to data and/or biospecimens in the bank:
  
N/A
  
6.4. Length of time data and/or biospecimens 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 biospecimens were collected:15
  
N/A
  
6.6. How the data and/or biospecimens will be made available for future use:
  
N/A
  
6.6.1.
Who can request data and/or biospecimens from the bank:
  
N/A
  
6.6.2.
Format in which data and/or biospecimens will be provided: 
  
N/A
  
6.6.3.
Process for investigators to request data and/or biospecimens:16
  
N/A
  
6.6.4.
Restrictions on future use:17
  
N/A
  
6.6.5.
Plan for providing data results from banked data/biospecimens:
  
N/A
  
7.
Sharing of Results 
7.1. Plan to share results with subjects/others:18
  
Aggregate data will be shared with members of the research team and disseminated via peer 
reviewed publication. No personal identifiers will be shared. 

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A subset of information from the individual parent and adolescent tools will be synthesized and 
presented in the family discussion tool to guide the conversation (see the online version of the 
“Family Discussion Tool” attached to the Click SmartForm). The link to the clinician tool will be 
inserted into the patient’s chart and/or sent to the clinician via a clinician coordination message 
for the clinician to review prior to their appointment. There is no other plan to share results with 
the research subjects. 
  
8.
Study Timelines
8.1. Duration of an individual subject’s participation in the study:
  
Aim 1: For each participant, the end point will be the conclusion of the survey.
Aim 2: For each participant, the end point will be the conclusion of the semi-structured interview 
and/or usability session (including interviewing).
Aim 3: For each participant, the end point will be the conclusion of the interview.
Aim 4a and Aim 4b: For each parent-adolescent dyad participant, the end point will be the 
conclusion of the 3-month follow-up survey. For healthcare providers (Aim 4b), the end point will 
be the conclusion of the survey. 
  
8.2. Duration anticipated to enroll all study subjects:
  
Aim 1: 3 months (up to 5 months)
Aim 2: 3 months (up to 5 months)
Aim 3: 3 months (up to 5 months)
Aim 4a: 6 months (potentially up to 12 months)
Aim 4b: 6 months (potentially up to 12 months) 
  
8.3. Estimated date for the investigators to complete this study:
  
Primary analyses will be completed about 2 years after the start of the study.
  
9.
Study Population19
9.1. Inclusion criteria for each subject population (e.g., patients, parents, providers):
  
Aim 1: Inclusion criteria for parents, adolescents, and clinicians (inclusive of pediatricians and 
family medicine providers): 
1)
Is an adolescent:
a.
Between the ages of 11-17 years (inclusive)
b.
Has sustained one concussion during the past 5 years
2)
Is a parent of an adolescent who meets inclusion criteria in point 1
3)
Is a clinician who has treated any of the above listed participant characteristics (point 
1) 
Aim 2: Inclusion criteria for parents, adolescents, and clinicians (inclusive of pediatricians and 
family medicine providers):
1)
Is an adolescent:
a.
Between the ages of 11-17 years (inclusive)
b.
Has sustained at least one concussions during the past 3 years
2)
Is a parent of an adolescent who meets inclusion criteria in point 1 

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3)
Is a clinician who has treated any of the above listed participant characteristics (point 
1). 
Aim 3: Inclusion criteria for clinicians (inclusive of pediatricians and family medicine providers):
1)
Treats adolescents between 11-17 years of age
2)
Has treated an adolescent who: 
a.
Is between the ages off 11-17 years (inclusive)
b.
Has sustained a concussion during the past 3 years
Aims 4a and 4b: Inclusion criteria for parents, adolescents, and clinicians (inclusive of 
pediatricians and family medicine providers):
1)
Is an adolescent:
a.
Between the ages of 11-17 (inclusive)
b.
Has sustained a concussion during the study period
2)
Is a parent of an adolescent who meetings inclusion criteria in point 1 
3)
Is a clinician who has treated any of the above listed participant characteristics (point 
1) and that family has enrolled in Aim 4b.  
  
9.2. Exclusion criteria for each subject population:
  
There are no exclusion criteria outside of those that do not meet the above listed inclusion 
criteria. 
  
9.3. Populations with special considerations, involved in the study:20
☒ Children/Teenagers21
Risk assessment specific to this vulnerable population and additional safeguards:22
Private and potentially identifiable data will be collected about adolescents. Even with this 
risk, the study still has minimal risk to adolescents. Additionally, adolescents will be able to 
contact a research study team member at any time to ask questions or stop participation. 
They will be reminded that all participation is voluntary, and they will be asked to assent to 
study participation. 
  
☐ Children who are Wards of the State23
Risk assessment specific to this vulnerable population and additional safeguards:
  
N/A
  
☐ Adults Unable to Consent 24
Risk assessment specific to this vulnerable population and additional safeguards:
  
N/A
  
☐ Neonates of Uncertain Viability or Non–Viable Neonates25
Risk assessment specific to this vulnerable population and additional safeguards:
  
N/A
  
☐ Pregnant Women26
Additional safeguards:
  
N/A
  
☐ Prisoners27
Additional safeguards:

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N/A
☐ Economically or educationally disadvantaged persons28
Additional safeguards:
N/A
  
10. Number of Subjects
10.1. Total number of subjects to be enrolled locally:29
  
Aim 1: We anticipate recruiting about 100 clinicians (inclusive of pediatricians and family 
medicine providers) and 200 parent-adolescent dyads.
Aim 2: We anticipate recruiting about 20 dyads (parent-adolescent) for semi-structured 
interviews and 20 dyads (parent-adolescent) or triads (parent-adolescent-clinician) for usability 
testing. 
Aim 3: We anticipate recruiting about 20 clinicians (inclusive of pediatricians and family 
medicine providers).
Aims 4a and 4b: We anticipate recruiting about 40 dyads (parent-adolescent) (i.e. 20 per 
phase) and 20 healthcare providers (Aim 4b only).  
  
10.2. Total number of subjects to be enrolled across all participating sites:30
  
N/A
  
10.3. Number of screened subjects versus the actual number enrolled in the research:31
  
Aim 1: We estimate that we will need to screen 400 clinicians to enroll 200 eligible participants 
and 400 parent-adolescent dyads to enroll 200 eligible participant dyads.
Aim 2: We estimate that we will need to screen 80 dyads and/or triads in order to enroll 40 
dyad and/or triad participants.
Aim 3: We estimate that we will need to screen 40 clinicians to enroll 20 participants.
Aims 4a and 4b: We estimate that we will need to screen 100 dyads or triads to enroll 40 
eligible participant dyads or triads (20 dyads or triads per phase). We estimate that we will need 
to screen 25 healthcare providers to enroll up to 20 (Aim 4b only). 
  
10.4. Power analysis:
  
Aim 1: This data is primarily being assessed for qualitative responses; therefore, no power 
analyses are being assessed.
Aims 2 & 3: This data is primarily qualitative, and thus a power calculation is not appropriate.
Aim 4a and b:  We anticipate enrolling 20 families per study phase; allowing for 15% attrition 
an estimated 17 per phase would complete the study. Conservatively estimating 15 families 
per phase, we will have ≥80% power to detect a difference in decisional regret (range: 0 to 
100 points) as small as 7.1, 3.0 and 1.2 points, for SD = 12, 5, and 2, respectively. These 
estimates assume an alpha of 0.05 and SD ranging from 1-12. The data from the healthcare 
provider survey is primarily qualitative, and thus a power calculation is not appropriate. 

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11. Withdrawal of Subjects
11.1. Anticipated circumstances under which subjects will be withdrawn from the research without 
their consent:
  
We do not anticipate circumstances under which participants will be withdrawn from the 
research without their consent.
  
11.2. Procedures for orderly termination:
  
N/A
  
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/biospecimen banking:
  
Participants may withdraw from the study at any time by notifying study personnel. Once a 
participant expresses their desire to withdraw, the researcher will terminate data collection. 
The study team will review, on a case-by-case basis, whether partial data collected will be 
used in the analysis. 
  
12. Risks to Subjects
12.1. Reasonably foreseeable risks to subjects (include each study population, each arm, and 
optional procedures): 
  
This study involves no more than minimal risk to participants. Potential risks include the risk of 
loss of confidentiality and the following:
Aim 1: Testing burden – participants may experience inconvenience associated with 
answering survey questions.
Aims 2 & 3: Loss of confidentiality – participants may provide identifiable information 
about themselves, and in the case of parents, their adolescent. 
Aims 4a and 4b: Testing burden- participants may experience inconvenience associated 
with answering survey questions; Loss of confidentiality—participants may provide 
identifiable information about themselves, and in the case of parents, their adolescent 
  
12.2. Procedures with unforeseeable risks:
  
N/A – there are no procedures that pose unforeseeable risks.   
  
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:
  
All data will be kept in secure and locked locations. Additionally, all participants will be given 
the option of speaking to a research study team member at any time, to ask questions or 
express concerns over research participation.  See section 15.1 for additional details on steps 
that will be taken to mitigate risks to confidentiality. 
 
13. Potential Benefits to Subjects
13.1. Potential benefits that individual subjects may experience from taking part in the research:32
  

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There is no anticipated benefit of participating in this study. 
  
14. Data Analysis/Management
14.1. Data analysis plan, including statistical procedures:
  
Aim 1: Survey responses will be reviewed with a focus on the psychometric properties of 
items and scales (e.g., how are items distributed), as well as evaluate what answers are 
correlated. We will compare responses across key characteristics (e.g., clinician 
characteristics, beliefs) to determine what key beliefs and feedback are across all clinicians, 
parents, and adolescents. 
Aim 2 & 3: Thematic analysis will be used to systematically code transcripts and identify 
emergent themes. Qualitative data will be digitally recorded and transcribed verbatim and 
coded for relevant themes using a thematic analysis approach. Coded segments may be 
entered into a qualitative coding software (e.g., Dedoose) to facility analysis or will be 
analyzed by quantified elements. Data will continue to be conducted until emergent results 
iteratively inform and clarify the final version of the decision aids. 
Aim 4a and b:  We will compare socio-demographic (e.g. age, sex, health literacy) and clinical 
characteristics (e.g. concussion history and severity at baseline) between the control and 
intervention groups. Differences in primary decision process and quality outcomes will be 
compared between treatment and control conditions using Structural Equation Modeling, 
where parent and child measures will be examined in parallel. Family level non-independence 
will be modeled by residual covariances between parent(s) and child measures. Outcomes will 
be pooled across the retirement recommended and equipoise conditions as decision process 
and quality measures are equally relevant in both conditions. Secondary analyses related to 
health behaviors (contact sport participation and physical activity) and health status outcomes 
at Time 3 will be compared between treatment and control conditions using logistic regression. 
Dyadic and triadic analyses. Dyadic/triadic concordance will first be described using 
contingency tables. Next, actor-partner interdependence models will be used to assess the 
effects of each family member’s decision process measures on their own decision quality 
measures and the rest of the family’s decision quality measures (“partner” effects). Healthcare 
provider survey responses will be reviewed and compared to determine key beliefs and 
feedback across all healthcare providers. 
  
14.2. Quality control procedures for collected data:33
  
The Principal Investigator and study Research Scientist will train any research assistant(s) and 
additional study team members on best practices for qualitative and quantitative data 
collection through workshops, practice interviews, and/or individual supervision. As an 
additional quality check, interviews will be audio-recorded and reviewed regularly to ensure 
high-quality data collection methods are used.
 
15. Confidentiality and Privacy34
15.1. Procedures to secure the data and/or biospecimens during storage, use, and transmission:
  
During data collection, all research materials containing personally identifiable information will 
be kept in a locked container or on a secure password protected server while not in use. 
Any data collected via survey will be collected by an online secured survey hosting site (e.g., 
REDCap). Survey data will only be accessible to members of the study team. All survey data 
will be password protected and the study PI and Research Scientist will be gatekeepers of 
access. 

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Information collected and/or presented via the decision aids (parent, adolescent, clinician) will 
be housed on it’s own website (valuedaction.com). ). All traffic to and from the Valued Action 
site is encrypted via SSL. All users of Valued Action have access only to their own or relevant 
data (as defined by the project requirements). Healthcare professionals can only access 
summary data relating to their patients. Direct database access is restricted to a local subnet, 
accessible only with a private key. All data is stored encrypted at rest. Every effort has been 
made to minimize the data stored, to only include data points specifically required to achieve 
the project goals.
As noted, any data that is collected via recording will be kept on password protected devices 
(i.e., the audio recordings will be on a password protected device). All interviews conducted in 
person will be recorded via a normal recording device not connected to the internet (either 
password protected or secured in a locked cabinet if not password protected) and all 
interviews conducted online will be recorded via the online platform (i.e. Zoom) and all data 
will be secured on Seattle Children’s servers. Transcribed audio-recorded interviews will be 
de-identified and stored on the secure Seattle Children’s servers, accessible only to the study 
team; a numeric code will be used to link audio interviews to participants.. Only coded 
segments (without identifiers) of recordings may be entered into a qualitative data software 
(e.g., Dedoose). The link between study code and participant information will be kept in a 
password-protected file, separate from the research data, and overseen by the Principal 
Investigator and study team Research Scientist. Data will not be transported outside of Seattle 
Children’s, unless data is being transmitted to contracted transcriptionists to transcribe audio 
data. 
When conducting study procedures online (i.e., interviews, usability testing), we will be using 
the latest version of Zoom, make the meetings private, require passwords for meeting entry, 
disabling private chat, and consent will be obtained prior to recording.  We will utilize the 
screen sharing function to share instruments (e.g., decision aids) with participants for 
feedback in interviews, usability testing sessions, etc. The original versions of the decision 
aids (that will be iteratively adapted throughout testing) to be shared have been uploaded to 
the Click platform.
After data is collected, any information which would identify the participant(s) will be removed 
and code numbers used instead. All identifiers will be destroyed within 6 months of completion 
of data collection. 
All recorded data will be recorded on one of the following: 1) virtually through Zoom (Aims 1-3 
if participant chooses to conduct participation online); 2) normal recording device that is not 
connected to the internet (Aims 1-3 if conducted in person). 
  
15.2. Steps that will be taken to protect the privacy interests of subjects:35
  
All data will be stored on password protected REDCap projects accessible only to members of 
the study team, secure Seattle Children’s servers and/or in locked containers at Seattle 
Children’s Research Institute. Participant identifiers will be kept in these secure storage 
options as well. Additionally, all interviews will take place either online, or at a location 
preferred by the participant for privacy or at a private location at a Seattle Children’s Hospital 
and/or affiliated clinic. If participating at a Seattle Children’s clinic, all participants will already 

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be affiliated with that clinic, as they will be attending it for an appointment. Private locations 
that are preferred by the participant will encourage comfortability, as well as privacy. 
  
15.3. Location where the data and/or biospecimens will be stored:
  
Data will be stored on secure password protected REDCap projects, Seattle Children’s 
servers and/or in locked containers at Seattle Children’s Research Institute.
  
15.4. Length of time data and/or biospecimens will be stored:
  
Data will be stored for 5 years.
  
15.5. Individuals with access to data and/or biospecimens:
  
Data will only be accessible to the study team members, as specified by the PI or study 
Research Scientist. 
  
15.6. Process for the transmission of data and/or biospecimens outside Seattle Children’s:
15.6.1.
List of data and/or biospecimens that will be transmitted:
  
Electronic data may be transmitted, and if so, it will only be transmitted if all data has 
been de-identified. 
  
15.6.2.
Individual(s) who will transmit data:
  
If any identifiable data is to be transported, it will be stored in a locked container until it 
returns to Seattle Children’s Research Institute. Study team members will make every 
attempt to remove any identifiable information before transporting data. Study team 
members may transmit de-identified data electronically.  
  
16. Provisions to Monitor Data to Ensure the Safety of Subjects36
16.1. Plan to periodically evaluate the data collected regarding both harms and benefits to 
determine whether subjects remain safe:37
  
The study PI will check the data periodically in order to ensure that data is being collected 
according to approved guidelines, as well as perform data checks to ensure proper procedure 
protocols are being followed for all study team interactions with participants.
  
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 provide a brief summary of the study and a link to a contact form (housed on REDCap) 
for potential participants to fill out to community and sport organizations to send to their 
members through regular distribution channels (such as email listservs, social media pages 

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such as Facebook and/or newsletters). We will also post widely on other websites, such as 
www.craigslist.org and community forums/Facebook groups such as the West Seattle Blog 
and others.
  
17.2. Measures in place to protect the privacy or confidentiality of subjects:38
  
Social media will only be used for advertising recruitment materials approved for the study. We 
will only communicate basic study information with potential participants (i.e. what’s in the 
relevant aim’s information sheet) and let them know they must contact the study team to 
enroll. 
  
17.3. Types of communications that will be submitted to the IRB for review:39
  
All advertisements on social media will use recruitment materials that have been approved by 
the IRB. 
  
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:
  
 Comment functions will be enabled. If any questions are asked, we will provide responses in 
line with what is included in the relevant aim’s information sheet and encourage the individual 
to reach out to the study team. After recruitment, we will update the post that recruitment is 
complete and disable the comment function. 
  
18. Research Related Injury40  
18.1. Available compensation in the event of research related injury:
  
N/A – there are no expected events of research that would relate or result in injury.
  
19. Recruitment Methods41
19.1. When, where, and how potential subjects will be recruited:
  
Aim 1: 
Clinicians:
When: We plan to begin recruitment as soon as the study is approved
Where: We plan to recruit clinicians who work in pediatric sports medicine and have 
experience treating youth with concussions 
How: We hope to recruit clinicians (inclusive of pediatricians and family medicine providers) 
through convenience and/or snowball sampling, and chart screening. We will begin recruiting 
clinicians from our own colleague referrals. After, we may utilize emails or web posting to 
additionally reach out to clinicians. We may send up to two recruitment emails per subject.
Parents and adolescents: 
When: We plan to begin recruitment as soon as the study is approved
Where: We plan to recruit participants from chart screening, self-referral, and/or clinician 
referral who have attended Seattle Children’s Hospital and/or an affiliated clinic during the last 
five years to be seen after sustaining at least one concussion.
How: We plan on asking Seattle Children’s clinicians, an approved Seattle Children’s medical 
professional (with approval), or an approved Seattle Children’s entity (i.e. Clinical Data 
Analytics) to review patient charts on our behalf (note: we will not be reviewing patient charts 
ourselves, rather, through a clinician or other staff) to suggest participants for our study. 
Potential parent participants will first be provided with a written (mailed) letter than contains a 
QR code or a link for a survey (attached to the Click Smartform), and then subsequently 

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contacted via telephone (call or text message). Once parents agree to participate and give 
parental permission, adolescents will be sent the survey via text or email.  
Aim 2: 
When: We plan to begin recruitment as soon as the study begins, possibly collecting data 
concurrently with Aim 1. 
Where: We plan to recruit participants from chart screening, self-referral, and/or clinician 
referral who have sustained a lease one concussion during the last three years. 
How: 
We hope to recruit parents, adolescents, and possibly their clinicians (inclusive of pediatricians 
and family medicine providers) through self-referral, convenience and/or snowball sampling. 
We plan on asking Seattle Children’s clinicians, an approved Seattle Children’s medical 
professional (with approval), or an approved Seattle Children’s entity (i.e. Clinical Data 
Analytics) to review patient charts on our behalf (note: we will not be reviewing patient charts 
ourselves, rather, through a clinician or other staff) to suggest participants for our study. When 
we contact potential participants, we will ask the following questions to confirm they meet 
inclusion criteria: (1) child’s age, (2) number of concussions, and (3) if child made a decision 
about return to sport as a result of their most recent concussion. We also hope to recruit 
participants from eligible survey participants in Aim 1 or Aim 4 who indicate they would be 
interested in participating in a qualitative interview about their experiences and/or usability 
testing session (after they have completed their time in their respective aim). We also will 
utilize contacts with coaches and community organizations (e.g., King County Play Equity 
Coalition, Greater Seattle Soccer League) to advertise and/or distribute our recruitment flyer in 
order to recruit individuals who sustained concussions and sought care outside of Seattle 
Children’s. This flyer will include ways to get in contact with the study team, including a link to 
a contact form interested individuals can fill out in order to get in touch with the study team 
(please see “Aim 2 Recruitment Flyer” and “Aim 2 Contact Form” for details). We may also 
post a brief summary of the study and a link to the contact form on social media platforms (see 
section 17 above). We may also utilize snowball sampling and ask participants if they would 
be willing to forward the recruitment email to anyone they know who they think would be 
interested (see “Aim 2 Usability Testing Guide” for how we will phrase the question). We will 
begin recruiting clinicians from our own colleague referrals. These clinicians can help identify 
clinicians for us to reach out to who work with our desired population. After, we may utilize 
emails or web posting to additionally reach out to participants, including flyers and parent 
recruitment emails. We may send up to two recruitment emails per subject. For parent 
participants without email addresses available, we will first provide them with a written (mailed) 
letter and subsequently contact them via telephone (call or text message).
Aim 3: 
When: We plan to begin recruitment after the completion of Aim 1.
Where: We plan to recruit clinicians who work in pediatric sports medicine and have 
experience treating youth with concussions
How: We hope to recruit clinicians (inclusive of pediatricians and family medicine providers) 
through convenience and/or snowball sampling, and chart screening. We plan on asking 
clinicians or approved Seattle Children’s medical professionals (with approval) to review 
patient charts on our behalf (note: we will not be reviewing patient charts ourselves, rather, 
through a clinician or their staff) to suggest clinicians who treat our desired patient participant 
population for our study. We will begin recruiting clinicians from our own colleague referrals. 

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After, we may utilize emails or web posting to additionally reach out to clinicians. We may 
send up to two recruitment emails per subject.
Aim 4a:
When: We plan to begin recruitment as soon as the study begins
Where: We plan to recruit participants from Seattle Children’s Sport Medicine 
How: We hope to recruit families through chart screening. The study team will review the 
providers’ schedules and identify patients who are being seen for sports-related concussions. 
Eligible families will be contacted by text or email, inviting them to participate. If interested, 
parents will be prompted to review a REDCap link with study documentation and fill out a 
contact form. Parents will have the option to speak with a member of the research team before 
agreeing to participate.. We may send up to three recruitment texts or emails per subject. 
Whenever possible, we will first contact eligible parents via email because we can get in 
contact with parents instantly, which is important when upcoming appointments may be within 
the same week. However, our partners in sports medicine have told us that parent emails are 
not always in the patient’s chart. In the case email is not available, we will contact parents via 
text as that is another form of contact to get in touch with parents instantly and will ensure 
equal opportunities for all eligible families to participate.   
Aim 4b: 
When: We plan to begin recruitment as soon as the study intervention (i.e. the decision aids) 
is developed based on feedback in Aims 2 and 3
Where: We plan to recruit participants from Seattle Children’s Sport Medicine 
How: We hope to recruit families through chart screening. We will follow the same process 
outlined above in Aim 4a. A purposive subset of healthcare providers who are exposed to the 
tool (i.e., their patient was enrolled in the study) will be invited via email to complete a brief 
survey.   
  
19.2. Steps that will be taken to protect potential subjects’ privacy during the recruitment process:42
For all aims: Prior to accessing the survey, participants will receive information about the 
purpose of the study and eligibility criteria for the study. They will be informed that all 
participation is voluntary and confidential (depending on aim). Recruitment will always occur in 
a private location (i.e., participants will receive information online and can look at it when they 
prefer or will be spoken to in private locations when they prefer). 
19.3. Sources of subjects:43
  
Seattle Children’s Hospital, Seattle Children’s Research Institute, Seattle Children’s affiliated 
clinic, Seattle community organizations (parents and adolescents only) and/or other nationally 
recognized sports medicine programs (clinicians only). See section 19.1 for additional details 
by Aim.
  
19.4. Methods that will be used to identify potential subjects:
  
Snowball sampling, Convenience Sampling, Self-referral, Clinician referral, and/or Chart 
Screening.
  
19.5. Materials that will be used to recruit subjects:44 

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Possible recruitment materials include: 1) Recruitment Email to Parents; 2) Recruitment Email 
to Clinicians; 3) Flyer; 4) Web post, 5) Recruitment Letter to parents, 6) Recruitment Phone 
Call or Text Message to parents 
  
19.6.
Recruitment methods not controlled by Seattle Children’s:
  
N/A  
  
20. Consent/Assent Process
Consent/assent process overview:45
Aims 1-3: Consent materials (and the assent form when applicable) will be attached to recruitment emails 
and/or sent with recruitment letters.  Additionally, after initial contact for recruitment is made, a link to 
REDCap, which will include the consent and assent materials appropriate to the given populations and 
aims, is emailed to participants prior to when their interviews/usability testing sessions occur.   This 
strategy ensures that consent and assent forms will be presented to potential participants before they 
complete any study procedures. 
In-person participants will be emailed consent materials (and the assent form when applicable) as an 
attachment to recruitment emails. Additionally, after initial contact for recruitment is made, a link to 
REDcap, which will include the consent and assent materials appropriate to the given populations and 
aims, is emailed to participants prior to when their usability testing sessions occur. When we meet in-
person with the participant before their usability testing session, they will additionally be given a hard copy 
of the consent (and assent when applicable) forms.
Aim 4: Consent/assent materials will be included in the REDCap link that will be attached to recruitment 
emails/texts and/or sent to parents via mail or email prior to consent. Additionally, consent and assent 
materials appropriate to the given populations will be included at the beginning of the first REDCap 
survey sent to participants, which will ensure that consent and assent forms will be presented to potential 
participants before they complete any study procedures. Similar procedures will be followed for 
healthcare providers (i.e., the information sheet will be attached to recruitment emails and will be included 
at the beginning of the REDCap survey).  
 
20.1. Where the consent/assent process will take place:
  
Aim 1: Consent will take place online, prior to the start of participation.  See section above for 
details..
Aims 2 & 3: Consent will take place either in person or online prior to the start of the 
interviews and/or usability testing sessions by reviewing an information sheet or assent form. 
See section above for details.  All interviews and usability testing consenting will take place 
online (if conducted online) or at a private location preferred by the participant (if conducted in 
person).  Before any research procedures begin (online or in person), the team member 
conducting the interview and/or usability session will explain that the participant may choose to 
skip any questions they do not want to answer, and they may discontinue the research study 
at any time. Every study team member will take steps to make the interview and usability 
session feel like a conversation, based on supervision and training from the Principal 
Investigator and Research Scientist. 
Aim 4a and 4b: All participants will review an information sheet online and have the option to 
consent/assent online or verbally during a phone call with a study team member, prior to the 

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start of any study procedures. If the participant wants to speak with a study team member, the 
study team will emphasize during the call that the participants may choose to skip any 
questions they do not want to answer, and they may discontinue the research study at any 
time. Participants will be provided with an opportunity to read through all documentation and to 
ask questions of the research team member involved in consent.   
  
20.2. Steps that will be taken to protect prospective subjects’ privacy during the consent/assent 
process:46
  
Aim 1: Participant survey data should remain confidential during the consent process. All 
consenting/assenting will take place online.  
Aims 2 & 3: All interviews and usability testing consenting will take place either online or at a 
private location preferred by the participant. 
Aim4a: All consenting will take place over the phone or online. If the participant wishes to 
speak to a study team member, the participant will be informed of the call beforehand so they 
can speak in a private location of their choosing. 
  
20.3. Waiting period available between approaching a prospective subject and obtaining 
consent/assent:
  
All Aims: There is no waiting period between consent/assent and research procedures; 
consent/assent will be obtained immediately prior to conducting research procedures.
  
20.4. Process to ensure ongoing consent/assent:
  
N/A
  
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:47
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 Subjects48
20.7.1.
Anticipated preferred language(s) for subjects or their representatives: 
  
Spanish

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20.7.2.
Presentation of Research Information and Documentation:
☒  Appendix A-10 of the Investigator Manual will be followed49 
☐  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:50
N/A
   
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):51
  
Aim 1: Chart screening 
Aim 2: The age of the adolescent will be determined by asking the participant their 
age prior to conducting the interview and/or usability testing session. We will 
primarily be asking participants to confirm they meet eligibility requirements prior to 
setting up an interview and/or usability testing session (i.e., asking parent child’s 
age; chart screening conducted by Seattle Children’s staff), however, we will also 
ask the adolescent before the start of the session.
Aim 3: N/A
Aim 4: Chart screening
  
20.8.2.
Parental permission will be obtained from:52
☐  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.53
  
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:54
  
N/A 
  
20.8.4.
Assent will be obtained from:55
☒
All children.  
☐
Some children.  Specify:  
Click here to enter text.

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☐
None of the children.  Explain: Click here to enter text.
20.8.5.
Procedures for obtaining and documenting assent:
  
Aim 1, 2, & 4: Children 13 and older will review an information sheet online on the 
survey hosting platform (e.g., REDCap). An assent form will be reviewed by children 
under the age of 13 years. An opportunity to ask questions with a study team 
member will be provided to the adolescent. Additionally, the information sheet 
provided to the adolescent will be the same one provided to their parent, so both are 
able to read in detail about the adolescent’s ability to assent to participate in this 
study and ask questions. All contact for recruitment will be through the parents (and 
in the event a child fills out the contact form in Aim 2, we will specifically ask for 
parent contact information to follow up), and links to REDCap are sent directly to 
parents, so parents will ultimately have control over whether or not their kids are 
permitted to enroll. Furthermore, parents who enroll electronically in Aim 4a must 
provide consent and parental permission before adolescents are approached (see 
Instrument #3 in Aim 4 REDCap Project Mock-up). Survey links will only be sent to 
adolescents once their parent submits this form confirming their own agreement to 
participate and permission for their child to participate. 
Aim 3: N/A 
  
20.8.6.
Plan for re-approaching children who have reached the age of majority to obtain 
consent:56
  
 Participants who turn 18 during data collection will be re-approached via their 
parent to obtain consent. The study team will contact the participant, review the 
information sheet again, and the participant will verbally consent to continue 
participation. 
Participants will not be contacted to obtain consent if they turn 18 after data 
collection for their involvement in the study ends. We are requesting a waiver of 
consent for participants who turn 18 once data collection for their involvement in the 
study ends. Please see justification for this in section 20.10 below.  
  
20.9. Cognitively Impaired Adults/Adults Unable to Consent57
20.9.1.
Process used to determine whether an individual is capable of consent:
  
N/A
  
20.9.2.
Individuals from whom permission will be obtained in order of priority:58
  
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: There will be no impaired adults/adults 
unable to consent in this study.
20.9.4.
Process for obtaining and documenting assent:59
  
N/A 

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20.10. Waiver or Alteration of Consent and/or Assent Process60
20.10.1. Reasons for requesting a waiver or alteration of informed consent/assent:61
  
We are requesting a waiver of consent for participants who turn 18 once their period 
of data collection has ended. 
  
20.10.2. Consent/Assent Waiver/Alteration Criteria justifications:62
20.10.2.1.
The research involves no more than minimal risk to the subjects 
because:
  
After data collection is complete, no new information will be collected 
about participants. This is a minimal risk study with appropriate 
confidentiality measures in place. 
20.10.2.2.
The waiver or alteration will not adversely affect the rights or welfare 
of the subjects because:63
  
Participants will have already assented to be part of the study and 
have received written study information for all procedures. We will not 
collect any further information about participants,.
  
20.10.2.3.
The research could not practicably be carried out without the waiver 
or alteration because:64
  
 After data collection is complete, we will not have any further contact 
with families. We may not be able to locate and therefore get in 
contact with all families again once the child reaches the age of 
majority since it may be far removed from study participation, and all 
eligible participants must be included in the study for results to be 
meaningful. 
20.10.2.4.
If the research involves using identifiable private information or 
identifiable biospecimens, the research could not practicably be 
carried out without using such information or biospecimens in an 
identifiable format because:65
 Identifiable information for the research is needed so that 
researchers can perform quality checks. 
  
20.10.2.5.
Whenever appropriate, the subjects will be provided with additional 
pertinent information after participation:
  
While we do not anticipate this, we will provide subjects with 
additional pertinent information after participation whenever 
appropriate. 
  
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:66
  
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.

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☒ 
“SOP: Written Documentation of Consent (HRP-091)” will not be followed. 
Process of documenting consent:67
 
N/A, Consent will not be documented in writing.  We are requesting a waiver of documentation 
of consent.  
Clinicians: do not typically provide written consent to engage with a process like this (surveys, 
develop tools, etc.), therefore, written consent is not normally required outside of the research 
or clinical context.
Parents & Children: no information will be provided in the clinical context for this population, 
and they do not typically provide written consent to engage with materials like these in the 
study (answer questions in an interview or survey, offer opinions to developed tools). 
Additionally, parents and children will be allowed to refuse to answer any question they are 
uncomfortable with, not typically requiring written consent since no questions are absolutely 
required. 
  
21.2. If consent will not be documented in writing (check all boxes that apply):68
☒ 
A written statement/information sheet describing the research will be provided to 
subjects.69
☐ 
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.70
XXXX
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).71
☐ 
HIPAA authorization will be obtained as part of a signed consent form. 
☒ 
The study will access PHI without prior authorization from subjects (including for 
recruitment purposes – e.g., reviewing the medical record to determine eligibility).  See 
21.2 below for required HIPAA waiver/alteration criteria.
☒ 
Subjects will review a written statement/information sheet with the appropriate HIPAA 
language but will not provide a written signature.  See 22.2 below for required HIPAA 
alteration criteria.72
☐ 
Other.  Explain:73
  
22.2. HIPAA Waiver/Alteration Criteria: 74  
22.2.1.
Reasons for requesting a waiver or alteration of HIPAA Authorization: 
We may utilize chart screening as a way to identify and recruit participants. As such, 
we will need to review medical records to determine eligibility for this study. For aims 
1-3, we plan on asking Seattle Children’s clinicians, an approved Seattle Children’s 
medical professional, or approved Seattle Children’s entity (i.e. Clinical Data 
Analytics) to review patient charts on our behalf to suggest participants for our 

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study. For Aim 4, the study team will be reviewing provider schedules and patient 
charts to determine eligibility for the study and to ensure participants are sent and/or 
respond to subsequent surveys at the appropriate time (e.g., after a follow-up visit). 
Additionally, we may obtain PHI that pertain to potential participants (i.e., their 
contact information and confirmation that they fit criteria for inclusion in the study 
based on their concussion history) prior to when they are enrolled. Some PHI may 
be also collected via our selected survey hosting platform (e.g., REDcap). 
We are also requesting a written signature waiver for Aims 1, 2 and 4. It is expected 
that most participants will select to participate online for this aim, making collection 
of written signatures difficult – particularly in the current environment of government 
ordered shelter in place orders - therefore written signature is requesting to be 
waived. Some PHI may be collected during this Aim via our selected survey hosting 
platform (e.g., REDcap) such as zip codes and number of concussions incurred in 
the past.
22.2.2.
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:
22.2.2.1.
An adequate plan to protect the identifiers from improper use and 
disclosure: 
  
The following information applies to both the waiver of HIPAA needed for 
screening medical records and the waiver of written consent: The study 
team affirms that there is an adequate plan in place to protect identifiers 
from improper use and disclosure. All study data will be stored on secure 
servers requiring password access on Seattle Children’s servers. 
Participant names, if collected, will be stored in a separate password 
protected file accessible only to study staff under the supervision of the 
Principle Investigator and study Research Scientist.
  
22.2.2.2.
An adequate plan to destroy identifiers at earliest opportunity consistent 
with conduct of research:
  
The following information applies to both the waiver of HIPAA needed for 
screening medical records and the waiver of written consent: All PHI and 
identifiers will be destroyed at the earliest opportunity consistent with the 
research protocol. We anticipate that this will mean destroying PHI and 
identifiers within 9 months of completion of data collection. If a participant 
chooses not to participate, identifiers will be destroyed within one week.
  
22.2.2.3.
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:
  
The following information applies to both the waiver of HIPAA needed for 
screening medical records and the waiver of written consent: The PHI 
will not be reused or disclosed to any other person or entity, except as 
required by law, for authorized oversight of the research study, or for 
other research for which the use or disclosure of protected health 
information for which an authorization or opportunity to agree or object is 
not required.
  

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22.2.3.
The research could not practicably be conducted without the waiver or alteration of 
authorization:
  
We are requesting a waiver of HIPAA because we will not be able to obtain written 
signature on an authorization of HIPAA form prior to collecting a limited set of 
information about potential participants to be used to determine whether or not they 
meet study eligibility criteria. It is not practical to get HIPAA authorization prior to 
accessing records for screening because it would make recruitment extremely 
challenging if we are unable to target participants. Additionally, due to COVID-19 
concerns, we plan on recruiting and enrolling participants remotely to minimize the 
possibility of transmission of the virus, which makes obtaining written signatures on 
an authorization of HIPAA form extremely challenging..
  
22.2.4.
The research could not practicably be conducted without access to and use of the 
PHI:75
  
The PHI collected during screening activities is necessary for the research. The 
research cannot be practicably conducted without the alteration because access to 
and use of PHI is necessary for screening purposes and given the number of 
potential participants and that they are spread across the Puget Sound region and 
potentially beyond, should gatekeeper and snowball recruitment result in self-
referral of participants.
Regarding the alteration of the signature requirement, the clinical nature of the study 
requires that some minimal health information about subjects is included in the data 
that will be collected. 
  
23. Payments/Costs to Subjects76
23.1. Amount, method, and timing of payments to subjects:77
  
Aim 1: For Seattle Children’s employees not paid through Seattle Children’s payroll, a gift card 
will be provided to each survey participant. The gift card will be $25 and will come through the 
form of a Seattle Children’s gift card. Participants will receive their gift card in the mail at the 
completion of their survey and after we receive a de-identified list of names and addresses of 
those who participated in the survey. Participant compensation for Seattle Children’s 
employees will be paid to their paycheck following receiving a de-identified list from the survey 
hosing site (i.e., survey responses will not be linked to names).For parent and adolescent 
participants, each population will be told that they will be entered for a chance to receive one 
of four $50 gift cards for completion of the 10-minute surveys. Drawing for gift card recipients 
will occur as soon as all data collection is complete. 
Aim 2: A gift card will be provided to each interview and/or usability testing participant (i.e. if a 
participant completes both tasks, they will a gift card each time). The gift cards will be $50 and 
will come through the form of a Seattle Children’s gift card. Participants will receive their gift 
card in the mail or via email at the completion of their interview and/or usability testing 
session.. 
Aim 3: For Seattle Children’s employees not paid through Seattle Children’s payroll and non-
Seattle Children’s employees, a gift card will be provided to each interview and/or usability 
testing participant. The gift cards will be $30 and will come through the form of a gift card. 
Participants will receive their gift card in the mail or via email at the completion of their 
interview and/or usability testing session. Participant compensation for Seattle Children’s 
employees will be paid to their paycheck following their interview and/or usability testing 
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Aim 4: Participants will be compensated at a minimum of three timepoints for survey 
completion: 1) $25 for completion of a baseline survey, 2) $25 for completion of follow-up 
survey(s) (up to and including their final clinic visit), and 3) $50 for completion of the 3-month 
follow-up survey (i.e. 3 months after their initial clinic visit). If participants have more than 5 
follow-up visits, they will be compensated an additional $5 for each additional visit for a 
maximum of 10 visits (i.e. an additional $25). Healthcare providers will be compensated $25 
for completing a brief survey. 
  
23.2. Reimbursement provided to subjects:78
  
Participants will be compensated for participating in their aim of the study. See section 23.1 for 
details on compensation. 
  
23.3. Additional costs that subjects may be responsible for because of participation in the 
research:79
  
N/A
  
24. Setting
24.1. Site(s) or location(s) where the research team will conduct the research:
  
Aim 1: Surveys will be conducted online via a survey hosting site (e.g., REDCap)
Aim 2: Usability testing sessions will be conducted either online, at a location preferred by the 
participation or at Seattle Children’s Research Institute, Seattle Children’s Hospital, or a 
Seattle Children’s affiliated clinic.
Aim 3: Interviews will be conducted either online, at a location preferred by the participation or 
at Seattle Children’s Research Institute, Seattle Children’s Hospital, or a Seattle Children’s 
affiliated clinic.
Aim 4: Surveys will be conducted online via survey hosting site (e.g., REDCap). If participant 
prefers, surveys can be filled out on a phone or tablet while waiting for their clinic visit. 
  
24.2. Composition and involvement of any community advisory board:
  
 The study will occur in consultation with an advisory board comprised of up to 10 clinicians. We will 
identify potential board members through our own colleague referrals. Board members will up to four 
times (in a group or as individuals) with compensation of $50 per meeting. The role of the advisory board 
will be to provide feedback about the material development and implementation strategy development 
process. 
  
24.3. For research conducted outside of the organization and its affiliates:80
24.3.1.
Site-specific regulations or customs affecting the research:
  
N/A
  
24.3.2.
Local scientific and ethical review structure:
  
N/A
  
25. Resources Available
25.1. Qualifications (e.g., training, education, experience, oversight) of investigator(s) to conduct 
and supervise the research:81
  

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The Principal Investigator is an Assistant Professor at the University of Washington, with 
expertise in parent and adolescent decision making. She has experience with qualitative and 
quantitative analysis, staffing, institutional review board management, and budgeting. 
The Research Scientist is a PhD graduate from the University of Washington. She has 
expertise in health communication and has been working with Dr. Kroshus on her other shared 
decision-making research. She has experience managing participant recruitment, conducting 
interviews and qualitative analyses, and working on research related to communication about 
health.
Any and all study staff will be located at Seattle Children’s Research Institute. 
  
25.2. Other resources available to conduct the research:82
  
N/A
  
26. Coordinating Center Procedures
26.1. Coordinating center institution:
  
N/A
  
26.2. If Seattle Children’s is the coordinating center:
26.2.1.
Process to ensure communication among sites:83
  
N/A
  
26.2.2.
Process to ensure all site investigators conduct the study according to the IRB 
approved protocol and report all non-compliance:
    
N/A     
  
26.2.3.
Process to ensure all required approvals are obtained at each site:
    
N/A
  
26.2.4.
Process to ensure all sites are informed of any problems and/or interim results:
  
N/A
  
27. International Center for Harmonization of Good Clinical Practice (ICH-GCP)
27.1. If you have committed to conducting the described study per ICH-GCP, check this box: ☐84

This is generally applicable for contracts with industry-sponsored studies or sponsor 
protocols. See your contract/agreement or Sponsor Documentation if you are unsure.

Note that completing GCP training is a separate activity and does not automatically mean 
that you have committed to conducting the study per ICH-GCP.

If you check the box, upload a current curriculum vitae (CV) for the PI to the “Other 
Attachments” section of the “Local Site Documents” SmartForm.
  

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1 Include information if this protocol is associated with other IRB-approved studies (e.g. is this application the next 
part/phase of a previously approved application.
2 In clinical trials, an endpoint is an event or outcome that can be measured objectively to determine whether the 
intervention being studied is beneficial. Some examples of endpoints are survival, improvements in quality of life, 
relief of symptoms, and disappearance of the tumor.  
3 Include information on a drug or biologic in this section if: (1) the study specifies the use of an approved drug or 
biologic; (2) the study uses an unapproved drug or biologic; (3) the study uses a food or dietary supplement to 
diagnose, cure, treat, or mitigate a disease or condition; or (4) data regarding subjects will be submitted to or held for 
inspection by the Food and Drug Administration (FDA).  Only include information on a device in this section if: (1) the 
study evaluates the safety or effectiveness of a device; (2) the study uses a humanitarian use device (HUD) for 
research purposes; or (3) data regarding subjects will be submitted to or held for inspection by the FDA.  Please note 
that mobile medical applications may meet the definition of a device – see FDA Guidance.
4 See the Investigator Manual HRP-103 for sponsor requirements for FDA-regulated research.
5 Explain what IND exemption category applies to the drug and why.  Note that a drug is not exempt from an IND 
unless all criteria for one category are met.  See “HRP-306: Drugs” for more information.
6 Explain what IDE exemption category applies to the device and why.  Note that a device is not exempt from an IDE 
unless all criteria for one category are met.  See “HRP-307: Devices” for more information.
7 Explain why the device is NOT a significant risk device.  A significant risk device means an investigational device 
that: (a) is intended as an implant and presents a potential for serious risk to the health, safety, or welfare of a 
subject; (b) is purported or represented to be for use supporting or sustaining human life and presents a potential for 
serious risk to the health, safety, or welfare of a subject; (c) is for a use of substantial importance in diagnosing, 
curing, mitigating, or treating disease, or otherwise preventing impairment of human health and presents a potential 
for serious risk to the health, safety, or welfare of a subject; or (d) otherwise presents a potential for serious risk to the 
health, safety, or welfare of a subject. 
8 Be sure to indicate if controls will be included and include information about why control arms are ethically 
acceptable.
9 Describe all of the research procedures being performed. Be sure to make it clear which procedures apply to each 
subject population. When applicable, describe how research procedures differ from standard of care and/or affect 
standard of care.  Describe any audio/video recording that will be involved.
10 Attach all surveys, scripts, and data collection forms to the “Supporting Documents” page.
11 Include information about the frequency of data collection.
12 See HRP-001 - SOP – Definitions for definition of banking.  Type N/A if not applicable.  If the data is subject to NIH 
Genomic Data Sharing Policies (e.g. you will submit data to dbGaP, NDAR, FITBIR), indicate here.  
13 If applicable, include a list of identifiers that will be banked.
14 Be general (e.g., researchers’ lab, clinic, etc.)
15 Generally, data and/or biospecimens should be released in a coded, non – identifiable manner.

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16 Include a description of the process used to verify and document that any required approvals have been obtained 
prior to release of data/biospecimens from the bank.
17 You can allow for use for broad purposes
18 This includes putting results and/or data in the subject medical records.
19 If your population will differ from the representative population where the study will take place (e.g., race, ethnic 
group, or gender), provide a rationale for the differences.
20 If you check a box below, be sure to include the additional safeguards associated with the population.
21 Refer to HRP-416 CHECKLIST: Children.  
22 If the study is minimal risk, explain why. Must also include, as applicable: (1) why direct benefits are anticipated, (2) 
why risks are justified by anticipated benefit and/or the relationship between risk and prospective benefit compared to 
available alternatives, (3) why risk represents only minor increase over minimal risk, (4) how study procedures are 
reasonably commensurate with those inherent to the child’s actual or expected conditions, (5) whether the 
interventions/procedures are likely to yield generalizable knowledge about the participant’s condition and why it is of 
“vital importance” to understanding or amelioration of the participant’s underlying disorder or condition, and (6) an 
explanation of what alternative methods/approaches were considered to make the above assessments (as 
applicable).
23 This population may be wards of the state or any other agency, institution, or entity. Refer to HRP-416 
CHECKLIST: Children, Section 6, for additional guidance on required considerations for this population.
24 This refers to both cognitive impairments and adults who are incapacitated for any other reason.  As applicable, 
refer to HRP-417 CHECKLIST: Cognitively Impaired Adults.
25 Refer to HRP-413 CHECKLIST: Neonates and HRP-414 CHECKLIST: Neonates of Uncertain Viability.
26 Refer to HRP-412 CHECKLIST: Pregnant Women.
27 Refer to HRP-415 CHECKLIST: Prisoners
28 Indicate how you will ensure that there is no coercion or undue influence
29 A subject is considered “enrolled” when they consent to be in the study.
30 Only applicable for multisite studies.
31 i.e., numbers of subjects excluding screen failures.
32 Payment for participation is not considered a benefit.
33 For example, data will be double entered, data will be reviewed by another study team member to ensure 
accuracy, etc.
34 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.

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35 Privacy refers to persons and their interests in controlling the access of others to themselves. For example, based 
on privacy interests, people want to control the time and place where they give information, the nature of the 
information they give and who receives and can use the information.
When providing a response, consider the subject population and nature of the study.  For example, persons might not 
want to be seen entering a place that might stigmatize them, such as a pregnancy counseling center that is clearly 
identified as such by signs on the building.
36 Applicable for studies that present more than minimal risk.
37 Include information about who (describe in terms of role or group) will review the data.
38 This should be specific to the social media you are using for the research.
39 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.  
40 Applicable if the research involves more than minimal risk to subjects.  If minimal risk, this section is N/A.
41 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.
42 For example, subjects will be initially approached in a private room or a letter rather than a postcard will be sent 
when the study name may disclose health information about the potential subject.
43 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.
44 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.
45Include how you will ensure that subjects and/or their parent/legally authorized representative have sufficient 
opportunity to discuss and consider whether or not to participate in the research.  .
46 For example, the consent discussion will take place in a private room.
47 This section describes the way(s) in which the processes for this study will not follow Seattle Children’s SOP.
48 See HRP-090, HRP-091, and Investigator Manual HRP-103 for more information.  
49 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.
50 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.  
51 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 

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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.
52 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.
53 If parental permission will not be obtained, please address this in the Waiver or Alteration of Consent Process 
below.
54 See HRP-013 for more information.
55 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.
56 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.
57 See “HRP-417 Cognitively Impaired Adults” for further information.  
58 For example: durable power of attorney for health care, court appointed guardian for health care decisions, spouse, 
and adult child.  If you are following HRP-013 in order to make this determination, simply state that in this section. For 
research conducted in the state, review “SOP: Legally Authorized Representatives, Children, and Guardians (HRP-
013)” to be aware of which individuals in the state meet the definition of “legally authorized representative.” For 
research conducted outside of the state, provide information that describes which individuals are authorized under 
applicable law to consent on behalf of a prospective subject to their participation in the procedure(s) involved in this 
research. One method of obtaining this information is to have a legal counsel or authority review your protocol along 
the definition of “legally authorized representative” in “SOP: Legally Authorized Representatives, Children, and 
Guardians (HRP-013).”  If the sites in other states in the study are conducting their own IRB review, you do not need 
to worry about this--type N/A.  If you are conducting research and are actively recruiting participants outside of 
Washington who are NOT coming to Washington to give consent and who will be covered under SCH IRB approval, 
this section should be addressed in your protocol.
59 The IRB may allow the person obtaining assent to document assent on the consent document.
60 Provide justifications/explanations for each subject population for which a waiver/alteration is being requested.  
61 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.
62 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.  

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63 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.
64 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 biospecimens 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.
65 For example, identifiers are necessary, so that researchers can perform quality checks or identifiers are necessary 
to link data from multiple sources.
66 See “HRP 419: Waiver of Consent for Emergency Research” for further information.
67 This section describes the ways in which the procedures will not be following Seattle Children’s SOP.
68 See “HRP-411: Waiver or Written Documentation of Informed Consent” for further information.
69 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.
70 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.
71 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.  
72 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).  
73 For example: altering HIPAA elements for international research.
74 Provide justifications/explanations for each subject population for which a waiver/alteration is being requested.  
75 Possible reason could be: the nature of the research is specific to individuals’ health and requires access to 
individuals’ health records.
76 See “HRP-316: Payments” for further information.
77 Methods of payment include check, ClinCard, gift cards, etc.  Provide details on who will be the recipient of the 
payment (parent or child).
78 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.  
79 This could include things like fuel/transportation costs, parking, and/or childcare.
80 Type N/A if this section does not apply.

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Protocol Version Date: 3/17/2022
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81 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. 
82 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.
83 Including communication between sites of current study document versions and modifications.
84 If you check the box, you are required to conduct your study according to the principles outlined at 
https://www.ich.org/products/guidelines/efficacy/efficacy-single/article/integrated-addendum-good-clinical-
practice.html.