Early Powered Mobility for Toddlers With Cerebral Palsy: A Comparative Case Series of the Permobil® Explorer Mini and a Modified Ride-On Car
Phase: NA
Conditions: Cerebral Palsy
Sponsor: University of Washington

ID: 
STUDY00011386 
    Early Powered Mobility for Toddlers With 
Cerebral Palsy Using the Permobil® Explorer 
Mini and a Modified Ride-On Car 
 
 
 
 
Protocol Document 
Approval Date: 12/1/2020 
    NCT04684576 
 
 
 

4333 Brooklyn Ave. NE, Box 359470 Seattle, WA 98195-9470
main 206.543.0098   fax 206.543.9218   hsdinfo@u.washington.edu   www.washington.edu/research/hsd
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IRB APPROVAL OF APPLICATION
December 1, 2020
Dear Heather Feldner:
On 12/1/2020, University of Washington IRB Committee B reviewed the following application:
Type of Review:
Initial Study
Title of Study:
Early Powered Mobility for Toddlers with Cerebral Palsy: A Comparative 
Case Series of the Permobil® Explorer Mini and a Modified Ride-On Car
Investigator:
Heather Feldner
IRB ID:
STUDY00011386
Funding:
Name: National Institute of Child Health and Human Development (NICHD)
Grant Office ID: A162382
Funding Source ID: P2C HD101912
Pass-through institution: Virginia Polytechnic Institute and State University 
IND, IDE, or HDE:
None
IRB Approval
Under FWA #00006878, the IRB approved your activity. 

Depending on the nature of your study, you may need to obtain other approvals or 
permissions to conduct your research. For example, you might need to apply for access to 
data or specimens (e.g., to obtain UW student data). Or, you might need to obtain 
permission from facilities managers to approach possible subjects or conduct research 
procedures in the facilities (e.g., Seattle School District; the Harborview Emergency 
Department).

COVID NOTE: Researchers must comply with current infection control requirements and 
complete a self-assessment that activities fit within allowable research as described on the 
HSD website. 

Your application qualified for expedited review (“minimal risk”; Categories 1, 6, & 7)).

Under the Revised Common Rule this IRB approval is valid until study completion. In other 
words, there is no expiration date and you are not required to submit Continuing Review 
Reports to maintain your approval. However, you are still required to (1) obtain IRB 
approval before making any changes (modifications) to your research, and (2) provide the 
IRB with any Reportable New Information such as breaches of confidentiality or 
unanticipated problems. 

This approval applies only to the activities described in your application (including any 
references to specific grant sections). It does not include other activities that may be 
described in your grant or contract.

This approval applies only to the generic protocol and the UW site. You will receive a 
separate approval notice for each additional participating site.

4333 Brooklyn Ave. NE, Box 359470 Seattle, WA 98195-9470
main 206.543.0098   fax 206.543.9218   hsdinfo@u.washington.edu   www.washington.edu/research/hsd
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
Your study automatically has a Certificate of Confidentiality (CoC), because you have NIH 
funding. A description of the CoC protections and responsibilities has been placed in your 
study’s Documents section.

If you plan to continue data collection past the expiration of your NIH funding and the CoC, 
contact the Human Subjects Division prior to the end of your funding. We will help you 
determine whether you need to apply for a CoC extension. 
Determinations, waivers, and regulations 
The IRB made the determinations and waivers listed in the table below. Note that any granted 
waivers of consent or parent permission do not override a subject’s refusal to provide broad 
consent.
Requirement
Determination or Waiver
Required elements of consent
Waived or altered for the initial eligibility screening
Documentation of consent
Waived for all study procedures
Involvement of children
Approved
Parental permission
Permission of only one parent is required
Documentation of parental permission
Waived
Assent
Assent is not required
Location of documents
Use the consent materials that were approved and stamped by the IRB. They can be downloaded 
from the Final column under the Documents tab in Zipline.
In addition, HSD has uploaded the following documents to the Documents tab in Zipline: 

Certificate of Confidentiality Acknowledgement Letter
Thank you for your commitment to ethical and responsible research. We wish you great success!
Sincerely,
Bailey Bodell, CIP
Human Subjects Reliance Administrator  
4333 Brooklyn Ave NE, Box 359470, Seattle, WA 98195
p: 206.221.7918     f: 206.543.9218     bbell3@uw.edu

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APPLICATION IRB Protocol 
 
 
 
The Human Subjects Division (HSD) strives to ensure that people with disabilities have access to all services and content. If you 
experience any accessibility-related issues with this form or any aspect of the application process, email 
hsdinfo@uw.edu for assistance. 
 
INSTRUCTIONS 
• 
This form is only for studies that will be reviewed by the UW IRB. Before completing this form, check HSD’s website to 
confirm that this should not be reviewed by an external (non-UW) IRB. 
• 
If you are requesting a determination about whether the planned activity is human subjects research or qualifies for exempt 
status, you may skip all questions except those marked with a          . For example 1.1 must be answered. 
• 
Answer all questions. If a question is not applicable to the research or if you believe you have already answered a question 
elsewhere in the application, state “NA” (and if applicable, refer to the question where you provided the information). If you 
do not answer a question, the IRB does not know whether the question was overlooked or whether it is not applicable. This 
may result in unnecessary “back and forth” for clarification. Use non-technical language as much as possible.  
• 
To check a box, place an “X” in the box. To fill in a text box, make sure your cursor is within the gray text box bar before 
typing or pasting text. 
• 
For collaborative or multi-site research, describe only the UW activities unless you are requesting that the UW IRB provide 
the review and oversight for non-UW collaborators or co-investigators as well.  
• 
You may reference other documents (such as a grant application) if they provide the requested information in non-technical 
language. Be sure to provide the document name, page(s), and specific sections, and upload it to Zipline. Also, describe any 
changes that may have occurred since the document was written (for example, changes that you’ve made during or after the 
grant review process). In some cases, you may need to provide additional details in the answer space as well as referencing a 
document.  
 
INDEX 
1 Overview 
6 Children (Minors) and Parental Permission 
10 Risk / Benefit Assessment 
2 Participants 
7 Assent of Children (Minors) 
11 Economic Burden to Participants 
3 Non-UW Research Setting 
8 Consent of Adults 
12 Resources 
4 Recruiting and Screening Participants 
9 Privacy and Confidentiality 
13 Other Approvals, Permissions, and 
Regulatory Issues 
5 Procedures 
 
 
 
1 OVERVIEW 
Study Title: 
Early Powered Mobility for Toddlers with Cerebral Palsy: A Comparative Case Series of the 
Permobil® Explorer Mini and a Modified Ride-On Car 

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1.1 Home institution. Identify the institution through which the lead researcher listed on the IRB application will 
conduct the research. Provide any helpful explanatory information. 
In general, the home institution is the institution (1) that provides the researcher’s paycheck and that considers him/her to be 
a paid employee, or (2) at which the researcher is a matriculated student. Scholars, faculty, fellows, and students who are 
visiting the UW and who are the lead researcher: identify your home institution and describe the purpose and duration of your 
UW visit, as well as the UW department/center with which you are affiliated while at the UW. 
 
Note that many UW clinical faculty members are paid employees of non-UW institutions. 
 
The UW IRB provides IRB review and oversight for only those researchers who meet the criteria described in the SOP: Use of 
the UW IRB. 
 
University of Washington  
1.2 Consultation history. Has there been any consultation with someone at HSD about this study? 
It is not necessary to obtain advance consultation. However, if advance consultation was obtained, answering this question 
will help ensure that the IRB is aware of and considers the advice and guidance provided in that consultation.   
 
 
No 
 
 
X Yes 
→ If yes, briefly describe the consultation: approximate date, with whom, and method (e.g., by email, 
phone call, in-person meeting). 
 
 
 
 
The lead PI, Heather Feldner, both emailed and spoke via phone call with HSD Team S member and 
IRB Reliance Administrator Jenny Maki. Jenny described the process for applying for sIRB status 
based on the details of our study and grant funding mechanism (NIH), and provided guidance about 
the nature of sIRB, UW approval processes, and required forms. She discussed our study with the 
Reliance team and communicated approval for UW to serve as the single IRB.  
1.3 Similar and/or related studies. Are there any related IRB applications that provide context for the proposed 
activities? 
Examples of studies for which there is likely to be a related IRB application: Using samples or data collected by another study; 
recruiting subjects from a registry established by a colleague’s research activity; conducting Phase 2 of a multi-part project, or 
conducting a continuation of another study; serving as the data coordinating center for a multi-site study that includes a UW 
site. 
 
Providing this information (if relevant) may significantly improve the efficiency and consistency of the IRB’s review. 
 
 
No 
 
 
X 
Yes 
→ If yes, briefly describe the other studies or applications and how they relate to the proposed 
activities. If the other applications were reviewed by the UW IRB, please also provide: the UW IRB 
number, the study title, and the lead researcher’s name. 
 
 
 
Please also see active STUDY00004383, titled ‘Investigating the impacts of adapted ride-on car 
use by children with disabilities and their families’, also by PI Feldner. This expedited review 
study uses much of the same participant population, materials, and methods as the new study. The 
new study will incorporate an additional commercial pediatric powered mobility device, and a few 
additional outcome assessments.  

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1.4 Externally-imposed urgency or time deadlines. Are there any externally-imposed deadlines or urgency that affect 
the proposed activity? 
HSD recognizes that everyone would like their IRB applications to be reviewed as quickly as possible. To ensure fairness, it is 
HSD policy to review applications in the order in which they are received. However, HSD will assign a higher priority to 
research with externally-imposed urgency that is beyond the control of the researcher. Researchers are encouraged to 
communicate as soon as possible with their HSD staff contact person when there is an urgent situation (in other words, before 
submitting the IRB application). Examples: a researcher plans to test an experimental vaccine that has just been developed for 
a newly emerging epidemic; a researcher has an unexpected opportunity to collect data from students when the end of the 
school year is only four weeks away.  
 
HSD may ask for documentation of the externally-imposed urgency. A higher priority should not be requested to compensate 
for a researcher’s failure to prepare an IRB application in a timely manner. Note that IRB review requires a certain minimum 
amount of time; without sufficient time, the IRB may not be able to review and approve an application by a deadline.  
 
X 
No 
 
 
 
Yes 
→ If yes, briefly describe the urgency or deadline as well as the reason for it. 
 
 
 
      
1.5 Objectives Using lay language, describe the purpose, specific aims, or objectives that will be met by this specific 
project. If hypotheses are being tested, describe them. You will be asked to describe the specific procedures in a 
later section. 
 
If this application involves the use of a HUD “humanitarian” device: describe whether the use is for “on-label” 
clinical patient care, “off-label” clinical patient care, and/or research (collecting safety and/or effectiveness data). 
 
The use of powered mobility devices for young children with cerebral palsy (CP) has been gaining traction, with 
evidence that the use of powered mobility at young ages complements (rather than detracts from) other 
interventions focused on more traditional mobility skills such as crawling and walking. This study will collect 
preliminary data (both numeric and opinion/perception data) to investigate device use patterns, caregiver 
perceptions, and developmental outcomes of children with CP as families are introduced to two early powered 
mobility interventions: the Permobil® Explorer Mini, and a modified ride-on toy car. Specific Aims include: Aim 1: 
Evaluate a powered mobility intervention to understand developmental, activity and participation outcomes of 
young children with CP. Aim 2: Compare the use patterns (frequency, duration, environment) and acceptability, 
feasibility, and intervention appropriateness of two powered mobility options: The Explorer Mini and a modified 
ride-on car. 
1.6 Study design. Provide a one-sentence description of the general study design and/or type of methodology.   
Your answer will help HSD in assigning applications to reviewers and in managing workload. Examples: a longitudinal 
observational study; a double-blind, placebo-controlled randomized study; ethnographic interviews; web scraping from a 
convenience sample of blogs; medical record review; coordinating center for a multi-site study. 
 
This is a mixed-methods, randomized, counterbalanced AB crossover intervention study.  

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1.7 Intent. Check all the descriptors that apply to your activity. You must place an “X” in at least one box. 
This question is essential for ensuring that your application is correctly reviewed. Please read each option carefully. 
 
Descriptor 
 
 
1. Class project or other activity whose purpose is to provide an educational experience for the researcher 
(for example, to learn about the process or methods of doing research). 
 
 
 
 
 
 
2. Part of an institution, organization, or program’s own internal operational monitoring. 
 
 
 
 
 
 
3. Improve the quality of service provided by a specific institution, organization, or program. 
 
X 
 
 
 
 
4. Designed to expand the knowledge base of a scientific discipline or other scholarly field of study, and 
produce results that: 
• 
Are expected to be applicable to a larger population beyond the site of data collection or the specific 
subjects studied, or 
• 
Are intended to be used to develop, test, or support theories, principles, and statements of 
relationships, or to inform policy beyond the study. 
 
X 
 
 
 
 
5. Focus directly on the specific individuals about whom the information or biospecimens are collected 
through oral history, journalism, biography, or historical scholarship activities, to provide an accurate and 
evidence-based portrayal of the individuals. 
 
 
 
 
 
 
6. A quality improvement or program improvement activity conducted to improve the implementation 
(delivery or quality) of an accepted practice, or to collect data about the implementation of the practice 
for clinical, practical, or administrative purposes. This does not include the evaluation of the efficacy of 
different accepted practices, or a comparison of their efficacy. 
 
X 
 
 
 
 
7. Public health surveillance activities conducted, requested, or authorized by a public health authority for 
the sole purpose of identifying or investigating potential public health signals or timely awareness and 
priority setting during a situation that threatens public health. 
 
 
 
 
 
 
8. Preliminary, exploratory, or research development activities (such as pilot and feasibility studies, or 
reliability/validation testing of a questionnaire) 
 
 
 
 
 
 
9. Expanded access use of a drug or device not yet approved for this purpose 
 
 
 
 
 
 
10. Use of a Humanitarian Use Device 
 
 
 
 
 
 
11. Other. Explain: 
 
 
 
 
 
 
 
      

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1.8 Background, experience, and preliminary work. Answer this question only if the proposed activity has one or 
more of the following characteristics. The purpose of this question is to provide the IRB with information that is 
relevant to its risk/benefit analysis. 
• 
Involves more than minimal risk (physical or non-physical) 
• 
Is a clinical trial, or 
• 
Involves having the subjects use a drug, biological, botanical, nutritional supplement, or medical 
device. 
“Minimal risk” means that the probability and magnitude of harm or discomfort anticipated in the research are not greater 
than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or 
tests. 
 
a. Background. Provide the rationale and the scientific or scholarly background for the proposed activity, based 
on existing literature (or clinical knowledge). Describe the gaps in current knowledge that the project is 
intended to address. 
 
This should be a plain language description. Do not provide scholarly citations. Limit your answer to less than one page, or 
refer to an attached document with background information that is no more than three pages long. 
 
      
 
b. Experience and preliminary work. Briefly describe experience or preliminary work or data (if any) that you, 
your team, or your collaborators/co-investigators have that supports the feasibility and/or safety of this study.   
 
It is not necessary to summarize all discussion that has led to the development of the study protocol. The IRB is interested 
only in short summaries about experiences or preliminary work that suggest the study is feasible and that risks are 
reasonable relative to the benefits. Examples: Your team has already conducted a Phase 1 study of an experimental drug 
which supports the Phase 2 study being proposed in this application; your team has already done a small pilot study 
showing that the reading skills intervention described in this application is feasible in an after-school program with 
classroom aides; your team has experience with the type of surgery that is required to implant the study device; the study 
coordinator is experienced in working with subjects who have significant cognitive impairment. 
 
 
 
1.9 Supplements. Check all boxes that apply, to identify relevant Supplements that should be completed and 
uploaded to Zipline. 
This section is here instead of at the end of the form to reduce the risk of duplicating information in this IRB Protocol form that 
you will need to provide in these Supplements. 
 
Check all 
That Apply 
Type of Research 
Supplement Name 
 
 
 
 
Department of Defense 
The research involves Department of Defense funding, facilities, data, or 
personnel. 
SUPPLEMENT 
Department of Defense 
 
 
 
 
 
 
 
 
 
 
 
 
Department of Energy 
The research involves Department of Energy funding, facilities, data, or 
personnel. 
SUPPLEMENT 
Department of Energy 
 
 
 
 
 
 
 
 
 
 
 
 

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Drug, biologic, botanical, supplement 
Procedures involve the use of any drug, biologic, botanical or 
supplement, even if the item is not the focus of the proposed research 
SUPPLEMENT Drugs 
 
 
 
 
 
 
 
 
Emergency exception to informed consent  
Research that requires this special consent waiver for research involving 
more than minimal risk 
SUPPLEMENT Exception 
from Informed Consent 
for Emergency Research 
(EFIC) 
 
 
 
 
 
 
 
 
 
 
 
 
Genomic data sharing 
Genomic data are being collected and will be deposited in an external 
database (such as the NIH dbGaP database) for sharing with other 
researchers, and the UW is being asked to provide the required 
certification or to ensure that the consent forms can be certified 
SUPPLEMENT Genomic 
Data Sharing 
 
 
 
 
 
 
 
 
 
 
 
 
Medical device 
Procedures involve the use of any medical device, even if the device is 
not the focus of the proposed research, except when the device is FDA-
approved and is being used through a clinical facility in the manner for 
which it is approved 
SUPPLEMENT Devices 
 
 
X 
 
 
 
 
 
 
 
 
 
Multi-site or collaborative study 
The UW IRB is being asked to review on behalf of one or more non-UW 
institutions in a multi-site or collaborative study. 
SUPPLEMENT: Multi-site 
or Collaborative Research 
 
 
X 
 
 
 
 
 
 
 
 
 
Non-UW Individual Investigators 
The UW IRB is being asked to review on behalf of one or more non-UW 
individuals who are not affiliated with another organization for the 
purpose of the research. 
SUPPLEMENT: Non-UW 
Individual Investigators 
 
 
 
 
 
 
 
 
 
 
 
 
None of the above 
 
 
 
X 
 
 
 
 
 
1.10 Confirm by checking the box below that you will comply with these basic COVID infection and risk control 
measures, OR that you have an exception granted by the HSD Director:  (a) the only in-person interactions are 
essential for the study; (b) study team members and participants will wear face coverings throughout all 
procedures; (c) all study staff and participants will be screened for COVID-19 just prior to each research visit; and 
(d) no participants over the age of 85 years will be enrolled if their in-person participation is not connected with a 
clinical visit. See this webpage for details, including what “screening” means.  
Review the HSD website for current guidelines about which in-person research activities are allowable. 
 
 
X 
Confirmed 
 
 
2 PARTICIPANTS 
2.1 Participants. Describe the general characteristics of the subject populations or groups, including age range, 
gender, health status, and any other relevant characteristics. 
 
Participants will include children of all genders, ages 12-36 months, with diagnoses of cerebral palsy or who are 
at risk for cerebral palsy, and their parent or legal guardian of all genders ages 18 and above. 

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2.2 Inclusion and exclusion criteria.  
a. Inclusion criteria. Describe the specific criteria that will be used to decide who will be included in the research 
from among interested or potential subjects. Define any technical terms in lay language. 
 
Inclusion criteria for the study: 1) The child will be between 12-36 months old; 2) have a medical diagnosis of 
CP with any level (I-V) of associated motor ability according to the Gross Motor Function Classification 
System (GMFCS) or be at risk for CP according to birth history and current developmental status; 3) be able 
to attain a seated position with or without support; 4) be able to tolerate upright sitting with or without support 
while moving through space for 30 minutes; 5) and live in a household where English is spoken proficiently; 
Adults will 1) be 18 years or older and be the legal caregiver for the child participant; and 2) demonstrate 
proficiency in English. Inclusion criteria will be secured via caregiver report using screening questions. 
b. Exclusion criteria. Describe the specific criteria that will be used to decide who will be excluded from the 
research from subjects who meet the inclusion criteria listed above. Define any technical terms in lay 
language. 
 
Children will be excluded from the study if: 1) they have not been given a medical diagnosis of CP or are not 
at risk for CP (per parent report of birth history and current developmental status); 2) if they cannot attain a 
seated position with or without support; 3) if they cannot tolerate upright sitting with or without support for 30 
minutes; 4) all participants will be excluded if they are not proficient in English (determined per screening 
process).  
 
2.3 Prisoners. IRB approval is required in order to include prisoners in research, even when prisoners are not an 
intended target population. 
a. Will the proposed research recruit or obtain data from individuals that are known to be prisoners? 
For records reviews: if the records do not indicate prisoner status and prisoners are not a target population, select “No”. 
See the WORKSHEET Prisoners for the definition of “prisoner”. 
 
X No 
→ If no, skip the rest of part a. and continue to 2.3.b 
 
 
Yes → If yes, answer the following questions (i – iv). 
 
i. Describe the type of prisoners, and which prisons/jails: 
 
      
 
ii. One concern about prisoner research is whether the effect of participation on prisoners’ 
general living conditions, medical care, quality of food, amenities, and/or opportunity for 
earnings in prison will be so great that it will make it difficult for prisoners to adequately 
consider the research risks. How will the chances of this be reduced? 
 
      
 
iii. Describe what will be done to make sure that (a) recruitment and subject selection 
procedures will be fair to all eligible prisoners and (b) prison authorities or other prisoners 
will not be able to arbitrarily prevent or require particular prisoners from participating. 
 
      

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iv. If the research will involve prisoners in federal facilities or in state/local facilities outside of 
Washington State: check the box below to provide assurance that study team members will 
(a) not encourage or facilitate the use of a prisoner’s participation in the research to 
influence parole decisions, and (b) clearly inform each prisoner in advance (for example, in a 
consent form) that participation in the research will have no effect on his or her parole. 
 
 
Confirmed 
 
 
b. Is the research likely to have subjects who become prisoners while participating in the study?   
For example, a longitudinal study of youth with drug problems is likely to have subjects who will be prisoners at some 
point during the study. 
 
 
No 
 
 
 
Yes 
→ If yes, if a subject becomes a prisoner while participating in the study, will any study 
procedures and/or data collection related to the subject be continued while the subject is a 
prisoner? 
 
 
 
No 
 
 
 
Yes 
→ If yes, describe the procedures and/or data collection that will continue with 
prisoner subjects 
 
 
 
      
2.4 Protected populations. IRB approval is required for the use of the subject populations listed here. Check the 
boxes for any of these populations that will be purposefully included. (In other words, being a part of the 
population is an inclusion criterion for the study.) 
The WORKSHEETS describe the criteria for approval but do not need to be completed and should not be submitted. 
 
Population 
Worksheet 
 
 
Fetuses in utero 
WORKSHEET Pregnant Women 
 
 
 
 
 
 
Neonates of uncertain viability 
WORKSHEET Neonates 
 
 
 
 
 
 
Non-viable neonates 
WORKSHEET Neonates 
 
 
 
 
 
 
Pregnant women 
WORKSHEET Pregnant Women 
 
 
 
 
a. If you check any of the boxes above, use this space to provide any information that may be relevant for the IRB 
to consider.  
 
N/A 

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2.5 Native Americans or non-U.S. indigenous populations. Will Native American or non-U.S. indigenous populations 
be actively recruited through a tribe, tribe-focused organization, or similar community-based organization? 
Indigenous people are defined in international or national legislation as having a set of specific rights based on their 
historical ties to a particular territory and their cultural or historical distinctiveness from other populations that are often 
politically dominant. 
 
Examples: a reservation school or health clinic; recruiting during a tribal community gathering 
 
X No 
 
 
 
Yes → If yes, name the tribe, tribal-focused organization, or similar community-based organization. The 
UW IRB expects that tribal/indigenous approval will be obtained before beginning the research. 
This may or may not involve approval from a tribal IRB. The study team and any 
collaborators/investigators are also responsible for identifying any tribal laws that may affect the 
research. 
 
 
 
 
      
2.6 Third party subjects. Will the research collect private identifiable information about other individuals from the 
study subjects? Common examples include: collecting medical history information or contact information about 
family members, friends, co-workers. 
“Identifiable” means any direct or indirect identifier that, alone or in combination, would allow you or another member of 
the research team to readily identify the person. For example, suppose that the research is about immigration history. If 
subjects are asked questions about their grandparents but are not asked for names or other information that would allow 
easy identification of the grandparents, then private identifiable information is not being collected about the grandparents 
and the grandparents are not subjects.  
 
 
X No 
 
 
 
Yes 
→ If yes, these individuals are considered human subjects in the study. Describe them and what 
data will be collected about them. 
 
 
 
 
      

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2.7 Number of subjects. Is it possible to predict or describe the maximum number of subjects (or subject units) 
needed to complete the study, for each subject group? 
Subject units mean units within a group. For most research studies, a group will consist of individuals. However, the unit of 
interest in some research is not the individual. Examples:   
• 
Dyads such as caregiver-and-Alzheimer’s patient, or parent and child 
• 
Families 
• 
Other units, such as student-parent-teacher 
Subject group means categories of subjects that are meaningful for the specific study. Some research has only one subject 
group – for example, all UW students taking Introductory Psychology. Some common ways in which subjects are grouped 
include: 
• 
By intervention – for example, an intervention group and a control group. 
• 
By subject population or setting – for example, urban versus rural families 
• 
By age – for example, children who are 6, 10, or 14 years old. 
 
The IRB reviews the number of subjects in the context of risks and benefits. Unless otherwise specified, if the IRB determines 
that the research involves no more than minimal risk: there are no restrictions on the total number of subjects that may be 
enrolled. If the research involves more than minimal risk: The number of enrolled subjects must be limited to the number 
described in this application. If it is necessary later to increase the number of subjects, submit a Modification. Exceeding the 
IRB-approved number (over-enrollment) will be considered non-compliance.  
 
 
No 
→ If no, provide the rationale in the box below. Also, provide any other available information about 
the scope/size of the research. You do not need to complete the table. 
 
 
 
 
Example: It may not be possible to predict the number of subjects who will complete an online survey 
advertised through Craigslist, but you can state that the survey will be posted for two weeks and the number 
who respond is the number who will be in the study. 
 
 
      
 
X Yes 
→ If yes, for each subject group, use the table below to provide the estimate of the maximum 
desired number of individuals (or other subject unit, such as families) who will complete the 
research. 
 
 
 
Group name/description 
Maximum desired number of individuals (or other 
subject unit, such as families) who will complete 
the research 
Provide numbers for the site(s) reviewed by the UW IRB 
and for the study-wide total number; example: 20/100 
 
Children with CP or at risk for CP 
18 
 
Parent/Legal Guardian 
18 
 
      
      
 
      
      
 
      
      
 
      
       
2.8 COVID-19 Screening. If there will be any in-person interactions with the subjects, describe how you will screen 
them for COVID-19 symptoms within the 24 hours before the interaction. Also, describe the COVID-19 screening 
procedures for the study staff who will interact with the subjects. 

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Acceptable procedures include some type of symptom check or attestation, or a SARS-CoV-2 test with quick access to 
results. Symptom attestation involves an individual reviewing a list of symptoms and declaring the presence or absence 
of those symptoms. HSD strongly encourages adapting this Washington State Department of Health Screening Tool  
https://www.doh.wa.gov/Portals/1/Documents/1600/coronavirus/Employervisitorscreeningguidance.pdf or the UW 
EH&S Example Symptom Self-Attestation in this document: 
https://www.ehs.washington.edu/system/files/resources/guidance-symptom-monitoring-COVID-19.pdf. If you will test 
for the virus, you must also describe here whether the testing lab is CLIA-certified and how the results will be reported to 
the subjects. 
 
In-person interactions will be minimal, limited to 3 visits across the study period, and may be conducted largely 
using social distance of 6 feet. All participants will complete a COVID symptom attestation within 24 hours 
prior to contact with researchers. Participants in Washington will complete the Washington State Department of 
Health Screening Tool. Participants in Oregon or Michigan will complete the state recommended equivalent 
tool for COVID screening. Research team members will also complete a COVID self-attestation within 24 
hours of the study visit and will be required to wear masks and eye protection and use standard hand hygiene 
protocols. Adult participants will also be required to wear a mask, and children will be requested to wear a 
mask if possible based on age and medical status. If participants do not have their own masks, single-use, 
disposable masks will be provided by the research team. All hard-surface equipment provided to participants 
for study use will appropriately disinfected according to the UW Environmental Health & Safety protocols, 
prior to delivery and upon return to the research team.  
 
 
3 NON-UW RESEARCH SETTING  
Complete this section only if UW investigators and people named in the SUPPLEMENT: 
Non-UW Individual Investigators will conduct research procedures outside of UW and 
Harborview 
3.1 Reason for locations. Describe the reason(s) for choosing the locations.  
This is especially important when the research will occur in locations or with populations that may be vulnerable to 
exploitation. One of the three ethical principles the IRB must consider is justice: ensuring that reasonable, non-exploitative, 
and well-considered procedures are administered fairly, with a fair distribution of costs and potential benefits. 
 
This study is a multi-site collaboration which involves two additional co-investigators and research sites: Dr. Sam 
Logan at Oregon State University, and Dr. Lisa Kenyon at Grand Valley State University. These locations have 
been selected due to an ongoing collaborative relationship with Drs. Logan and Kenyon, who, together with Dr. 
Feldner from UW have a history of research collaboration and publication in the field of early powered mobility 
for children with disabilities. This project allows for a diverse demographic and geographic study sample which 
will strengthen the rigor of our work.  
3.2 Local context. Culturally appropriate procedures and an understanding of local context are an important part of 
protecting subjects. Describe any site-specific cultural issues, customs, beliefs, or values that may affect the 
research, how it is conducted, or how consent is obtained or documented. 
Examples: It would be culturally inappropriate in some international settings for a woman to be directly contacted by a male 
researcher; instead, the researcher may need to ask a male family member for permission before the woman can be 
approached. It may be appropriate to obtain permission from community leaders prior to obtaining consent from individual 
members of a group. In some distinct cultural groups, signing forms may not be the norm. 
 
This federal site maintains an international list of human research standards and requirements: 
 http://www.hhs.gov/ohrp/international/index.html  

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We do not anticipate any site-specific cultural issues to impact this work.  
3.3 Location-specific laws. Describe any local laws that may affect the research (especially the research design and 
consent procedures). The most common examples are laws about: 
• 
Specimens – for example, some countries will not allow biospecimens to be taken out of the country. 
• 
Age of consent – laws about when an individual is considered old enough to be able to provide consent vary 
across states, and across countries.   
• 
Legally authorized representative – laws about who can serve as a legally authorized representative (and who 
has priority when more than one person is available) vary across states and countries. 
• 
Use of healthcare records – many states (including Washington State) have laws that are similar to the 
federal HIPAA law but that have additional requirements. 
 
All study sites fall within US states with laws that state that age of consent is 18 yrs or older. This study does not 
involve the collection of health information that falls under HIPAA law. No healthcare records will be accessed 
and the child’s diagnostic information will be provided directly by parent report to determine eligibility for the 
study.  
3.4 Location-specific administrative or ethical requirements. Describe local administrative or ethical requirements 
that affect the research.  
Example: A school district may require researchers to obtain permission from the head district office as well as school 
principals before approaching teachers or students; a factory in China may allow researchers to interview factory workers but 
not allow the workers to be paid for their participation. 
 
N/A 
3.5 If the PI is a student: Does the research involve traveling outside of the US?  
 
X 
No 
 
 
 
Yes → If yes, confirm by checking the box that (1) you will register with the UW Office of Global Affairs 
before traveling; (2) you will notify your advisor when the registration is complete; and (3) you will 
request a UW Travel Waiver if the research involves travel to the list of countries requiring a UW 
Travel Waiver. 
 
Confirmed 
 
 
4 RECRUITING and SCREENING PARTICIPANTS 
4.1 Recruiting and Screening. Describe how subjects will be identified, recruited, and screened. Include information 
about: how, when, where, and in what setting. Identify who (by position or role, not name) will approach and 
recruit subjects, and who will screen them for eligibility. 
 
Participants will be recruited by the research team via social media postings, emails to known rehabilitation 
professionals in the WWAMI, Oregon, and Michigan areas, and via fliers hung-up and passed out at local 
healthcare clinics and hospitals. The research team will also send emails to past research participants who had 
shared their email address and had agreed to be contacted for future studies. Potential participants will self-elect to 
call or email the research team to hear more about the study to determine whether or not they are interested in 
participating. Interested potential participants would then be screened for eligibility by a member of the research 
team. 

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4.2 Recruitment materials.  
 
a. What materials (if any) will be used to recruit and screen subjects? 
Examples: talking points for phone or in-person conversations; video or audio presentations; websites; social media 
messages; written materials such as letters, flyers for posting, brochures, or printed advertisements; questionnaires filled 
out by potential subjects. 
 
Written materials, such as flyers for posting and an email script will be used to recruit and screen subjects. 
Talking points for a phone or in-person conversation will be used. Descriptions of these materials are included as 
attachments to this application. 
b. Upload descriptions of each type of material (or the materials themselves) to Zipline. If letters or emails will be 
sent to any subjects, these should include a statement about how the subject’s name and contact information 
were obtained. No sensitive information about the person (such as a diagnosis of a medical condition) should 
be included in the letter. 
HSD encourages researchers to consider uploading descriptions of most recruitment and screening materials instead of the 
materials themselves. The goal is to provide the researchers with the flexibility to change some information on the materials 
without submitting a Modification for IRB approval of the changes. Examples: 
• 
Provide a list of talking points that will be used for phone or in-person conversations instead of a script.   
• 
For the description of a flyer, include the information that it will provide the study phone number and the name of a 
study contact person (without providing the actual phone number or name). This means that a Modification would 
not be necessary if/when the study phone number or contact person changes. Also, instead of listing the 
inclusion/exclusion criteria, the description below might state that the flyer will list one or a few of the major 
inclusion/exclusion criteria. 
• 
For the description of a video or a website, include a description of the possible visual elements and a list of the 
content (e.g., study phone number; study contact person; top three inclusion/exclusion criteria; payment of $50; 
study name; UW researcher).  
4.3 Relationship with participant population. Do any members of the study team have an existing relationship with 
the study population(s)?  
Examples: a study team member may have a dual role with the study population (for example, being their clinical care 
provider, teacher, laboratory directory or tribal leader in addition to recruiting them for his/her research). 
 
 
No 
 
 
X 
Yes 
→ If yes, describe the nature of the relationship. 
 
 
 
All investigators have done previous research work with this population and may reach out to 
previously known participants who meet the inclusion criteria and who have provided their written 
consent to be contacted about future research opportunities. None of the investigators have or will 
have a dual role or other type of relationship.  

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4.4 Payment to participants. Describe any payment that will be provided, including: 
• 
The total amount/value 
• 
Whether payment will be “pro-rated” so that participants who are unable to complete the research may still 
receive some part of the payment 
The IRB expects the consent process or study information provided to the subjects to include information about the number 
and amount of payments, and especially the time when subjects can expect to receive payment. One of the most frequent 
complaints received by HSD is from subjects who expected to receive cash or a check on the day that they completed a study 
and who were angry or disappointed when payment took 6-8 weeks to reach them.  
 
Do not include a description of any expenses that will be reimbursed.  
Participants will receive monetary compensation in the amount of $75.00. This will be prorated based on $25.00 
per visit for each of the three scheduled research visits, and will be delivered electronically immediately following 
each study visit.  
4.5 Non-monetary compensation. Describe any non-monetary compensation that will be provided. Example: extra 
credit for students; a toy for a child. If class credit will be offered to students, there must be an alternate way for 
the students to earn the extra credit without participating in the research.  
Child participants will receive a developmentally appropriate toy at the end of the study.  
4.6 Will data or specimens be accessed or obtained for recruiting and screening procedures prior to enrollment?  
Examples: names and contact information; the information gathered from records that were screened; results of screening 
questionnaires or screening blood tests; Protected Health Information (PHI) from screening medical records to identify possible 
subjects. 
 
 
No 
→ If no, skip the rest of this section; go to question 5.1. 
 
X 
Yes 
→ If yes, describe the data and/or specimens (including PHI) and whether it will be retained as part of 
the study data. 
 
 
 
Prior to enrollment, families will be screened to ensure they meet the inclusion criteria of the study.  
4.7 Consent for recruiting and screening. Will consent be obtained for any of the recruiting and screening 
procedures? (Section 8: Consent of Adults asks about consent for the main study procedures). 
“Consent” includes: consent from individuals for their own participation; parental permission; assent from children; consent 
from a legally authorized representative for adult individuals who are unable to provide consent. 
 
Examples:   
• 
For a study in which names and contact information will be obtained from a registry: the registry should have consent 
from the registry participants to release their names and contact information to researchers. 
• 
For a study in which possible subjects are identified by screening records: there will be no consent process.  
• 
For a study in which individuals respond to an announcement and call into a study phone line: the study team person 
talking to the individual may obtain non-written consent to ask eligibility questions over the phone.  
 
X 
No 
→ If no, skip the rest of this section; go to question 5.1. 
 
 
Yes 
→ If yes, describe the consent process. 
 
 
 
      

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a. Documentation of consent. Will a written or verifiable electronic signature from the subject on a 
consent form be used to document consent for the recruiting and screening procedures? 
 
 
No 
→ If no, describe the information that will be provided during the consent process 
and for which procedures. 
 
 
 
 
      
 
 
Yes 
→ If yes, upload the consent form to Zipline. 
 
 
 
 
 
5 PROCEDURES 
5.1 Study procedures. Using lay language, provide a complete description of the study procedures, including the 
sequence, intervention or manipulation (if any), drug dosing information (if any), blood volumes and frequency of 
draws (if any), use of records, time required, and setting/location. If it is available: Upload a study flow sheet or 
table to Zipline.  
For studies comparing standards of care: It is important to accurately identify the research procedures. See UW IRB POLICY: 
Risks of Harm from Standard Care and the draft guidance from the federal Office of Human Research Protections, “Guidance 
on Disclosing Reasonably Foreseeable Risks in Research Evaluating Standards of Care”; October 20, 2014. 
Information about pediatric blood volume and frequency of draws that would qualify for expedited review can be found in this 
reference table on the Seattle Children’s IRB website. 
 
Research Design and TImeline: We will conduct our work using a mixed-methods, counterbalanced AB crossover 
design, where intervention A is use of the Explorer Mini, and intervention B is use of the modified ride-on car. All 
participants at all sites will undergo the same research procedures. Participants will receive both powered 
mobility interventions, and randomization into two groups at each site will occur to determine which 
intervention participants will receive first (Modified ride-on car: n = 3; Explorer Mini: n = 3). Three research visits 
will be scheduled during the study. Baseline assessment (T0) will consist of initial device training and safety 
checkoff, interview, and administration of outcome measures. Intervention phase 1 will take place for 8 weeks, 
followed by a mid-study assessment (T1) at which time interviews and outcome measures will be repeated and 
parent perception/satisfaction with device will be assessed. Training and safety checkoff on the second device 
will occur. No washout period between devices is indicated because both devices provide self-initiated mobility. 
Intervention phase 2 will take place for 8 weeks, followed by the final study assessments (T2), where devices will 
be removed from the participants’ homes and a final set of interviews and outcome measures will be 
administered. During each 8-week study phase, the researchers will conduct two virtual check-ins with each 
family to answer questions and provide support and standard activity suggestions for device use (i.e. open 
exploration, switch/joystick play, goal-directed driving). 
Equipment: 
Modified Ride-On Cars. Commercially available, off-the-shelf, battery-operated ride-
on toy cars will be modified. Switch activation. Unmodified, a child uses their foot to 
press a pedal or their finger to press a small switch located on the steering wheel to 
activate the ride-on car which is difficult for young children with CP. Modifications of 
ride-on cars will include installation of an easy-to-press switch that has a large 
surface area and responds to a light touch for activation. Seating support. Common 
materials, such as PVC pipe, swimming kickboards, and Velcro will be used to build a 
customized supportive seating system. Seatbelts are added in all cars, and five-
point harnesses are available if needed for appropriate postural support. Cars 
Figure 1. Child with CP using 
a modified ride-on car.    

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operate using a rechargeable 6-volt battery, allow for 45-60 minutes of driving, and a maximum speed of 2.5 
mph.  
 
Explorer Mini. The Explorer Mini (Permobil AB, Sweden) is a commercially available, 
FDA approved powered mobility device intended for young children between 12-36 
months of age with mobility limitations (weight limit: 35 lbs; height limit: 39.4 inches). 
It is lightweight (52 lbs. including battery) and fits in most automobiles (length: 25 
inches; width: 19 inches; adjustable height: 29-37 inches). The Explorer Mini runs on a 
12-volt battery with a driving range of 3.5 miles and a maximum speed of 1.5 mph, is 
controlled via a joystick with a 360-degree turning radius, has proportional speed 
control with 5 speed options, and can be used in a seated or standing position.  
 
Safety Training: A detailed device operation and safety training, home safety 
assessment, and check-off procedure will be completed by the research team at 
the initial research visit to ensure that families are ready to keep the modified 
ride-on car or Explorer Mini at their home and provide their child with 
opportunities to use the devices per the study protocol. These activities will be 
conducted at the first and second scheduled in-person research visits. Families will also have access to 
supplementary training videos throughout the study if a refresher is needed.  
 
Dependent Measures 
Aim 1: Developmental, self-care, and participation outcomes 
Bayley Scales of Infant Development (BSID), 4th Edition. 30-70 minutes to administer. The BSID-IV is an 
internationally recognized, norm referenced set of tests designed to assess developmental domains from one 
month to 42 months of age. The BSID-IV includes assessment of cognitive, motor (fine motor and gross motor), 
social-emotional, adaptive, and language (receptive and expressive communication) subscales. All domains and 
subscales will be assessed. The administration of the developmental items on the Bayley will be conducted 
together with a researcher trained in the administration of the measure, the caregiver, and the child. 
Administration will be video-taped and scored at a later time in order to minimize length of in-person contact. 
The BSID-IV is a newly released version of the BSID-III, of which the score sheet and description are included in 
this application as attachments. We do not yet have access to the BSID-IV equivalents of these materials as the 
release of our funding to purchase the BSID IV is contingent on IRB approval. However, the differences between 
the III and the IV are noted in this publisher webinar (available at: https://youtu.be/Rp3QRz7qHhg ) and are 
listed in the attached publisher presentation. These differences include shorter administration time, fewer items 
in several of the domains, a digital option for administration and scoring, and a more sensitive scoring scheme to 
identify disability. Similar to the III, the IV continues to allow for administration of structured test items in the 
five developmental domains described above using a standard kit, direct observation of behaviors and 
milestones, and active participation of the caregiver in the evaluation process. The BSID-IV has strong 
psychometric properties and has been empirically validated for our study population. Once the BSID-IV has been 
purchased, our research team will submit the scoring and overview materials upon a subsequent IRB 
modification.  
Child Engagement in Daily Life (CEDL). 10 minutes to complete. The CEDL is a caregiver survey tool that assesses 
participation in family and recreational activities and uses a 5-point Likert scale to assess frequency of 
participation and enjoyment of participation. The CEDL also assesses participation in self-care behaviors and 
uses a 5-point Likert scale to assess the degree to which the child participates in the daily self-care activities of 
feeding, dressing, bathing, and toileting. Caregivers will complete the CEDL remotely.  
Young Children’s Participation & Environment Measure (YC-PEM). 20 minutes to complete. The YC-PEM is a 
caregiver survey tool that has 3 sections: home, daycare/preschool, and community, with each section assessing 
participation and the environment. For participation items, parents are asked how often their child has 
Figure 2. Child with CP 
using the Explorer Mini.    

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participated in different types of activities, how involved their child is when participating in activities of this type, 
and if parents would like their child’s participation to change. For environment items, parents are asked if 
specific aspects of the environment facilitate or hinder their child’s participation and if specific supports are 
available and/or adequate to support their child’s participation. Caregivers will complete the YC-PEM remotely.  
 
Aim 2: Use patterns (frequency, duration, environment) & families’ perspective and experiences 
Assessment of Learning Powered Mobility Use (ALP v. 2.0). 10 minutes or less to complete. The ALP is an 
observational performance assessment focused specifically on stages of learning and proficiency with powered 
mobility devices. The tool uses eight descriptive, behavior-based categories ranging from Novice to Expert across 
five performance domains, including Attention, Activity and Movement, Understanding of Tool Use, Expressions 
and Emotions, and Interaction and Communication. These eight categories are grouped into three learning 
stages: Explore Function (categories 1-3), Explore Sequence (categories 4-5), Explore Performance (categories 6-
8). Members of the research team will observe each child participant in their natural setting for up to 10 minutes 
to identify a child’s performance categories and learning stage during the three scheduled research visits. They 
will provide each family with associated ALP strategies for facilitating device use based on the learning stage of 
the child. This activity may be done during the scheduled in-person visits or remotely, and will be video-recorded 
for scoring by the research staff at a later time.  
 
Daily driving log. Less than five minutes to complete. Caregivers will complete a daily driving log that indicates 
the date, time, and environment of Explorer Mini (A) or modified ride-on car use (B). Caregivers will also make 
notes about the child’s enjoyment level and general activities while using each device. To supplement caregiver 
reported data, automated device use data such as frequency and duration of activation, average speed, and 
distance traveled, will be collected either via a custom data logger (mounted on the modified ride-on car) or 
through integrated device systems (built-in to the Explorer Mini) which allow designated users (in this case, 
members of the research team) to access device use data via mobile Apps and secure servers. Driving logs will be 
completed remotely.  
 
Semi-structured interviews. 30-45 minutes to complete. At the baseline, midpoint, and conclusion of the study a 
researcher will lead interviews with caregivers using a semi-structured interview guide to understand their 
experiences using the respective powered mobility devices, barriers encountered and solutions discovered, and 
perceptions of self-efficacy and behavioral capacity. Two key questions asked at each interview will provide 
insight as to caregiver perceptions of their child’s emerging agency and powered mobility devices over time: 
“Can you describe [child’s name] for me?” and “How do you think your child will respond/responded to power 
mobility device use?”.64,65 All interviews will be audio recorded and de-identified transcriptions will be created. 
Interviews will be conducted remotely.   
 
Acceptability, Intervention Appropriateness, and Feasibility. 5 minutes to complete. After each intervention 
period, caregivers will complete a 3-measure perceptual implementation outcome survey. All measures are 4-
item likert-scale surveys. The Acceptability of Intervention Measure (AIM) is designed to measure how receptive 
stakeholders are to adopting an intervention, the Intervention Appropriateness Measure (IAM) is designed to 
measure suitability of the intervention in a given environment or circumstance, and the Feasibility of 
Intervention Measure (FIM) is designed to measure how possible and likely stakeholders are to adopt an 
intervention. The AIM-IAM-FIM will be completed remotely.  
 
Study Timeline/Flowsheet:  
 
 

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All sites will complete all study procedures listed above.  
5.2 Recordings. Does the research involve creating audio or video recordings? 
 
 
No 
→ If no, go to question 5.3. 
 
X Yes 
→ If yes, verify that you have described what will be recorded in 5.1 and answer question a. 
 
a. Before recording, will consent for being recorded be obtained from subjects and any other 
individuals who may be recorded? 
 
 
No 
→ If no, email hsdinfo@uw.edu before submitting this application in Zipline. In 
the email, include a brief description of the research and a note that 
individuals will be recorded without their advance consent. 
 
 
 
 
X Yes 
 
5.3 MRI scans. Will any subjects have a Magnetic Resonance Imaging (MRI) scan as part of the study procedures? 
This means scans that are performed solely for research purposes or clinical scans that are modified for research purposes (for 
example, using a gadolinium-based contrast agent when it is not required for clinical reasons).  
 
X No 
→ If no, go to question 5.4. 
 
 
Yes 
→ If yes, answer questions a through c. 
a. Describe the MRI scan(s). Specifically: 
• 
What is the purpose of the scan(s)? Examples: obtain research data; safety assessment 
associated with a research procedure. 
• 
Which subjects will receive an MRI scan? 
• 
Describe the minimum and maximum number of scans per subject, and over what time period 
the scans will occur. For example: all subjects will undergo two MRI scans, six months apart. 
 
      

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b. Use of gadolinium. Will any of the MRI scans involve the use of a gadolinium-based contrast agent 
(GBCA?) 
 
 
No 
 
 
 
Yes 
→ If yes, which agents will be used? Check all that apply. 
 
Brand Name 
Generic Name 
Chemical Structure 
 
 
Dotarem 
Gadoterate meglumine 
Macrocylic 
 
 
Eovist / Primovist 
Gadoxetate disodium 
Linear 
 
 
Gadavist 
Gadobutro 
Macrocyclic 
 
 
Magnevist 
Gadpentetate dimeglumine 
Linear 
 
 
MultiHance 
Gadobenate dimeglumine 
Linear 
 
 
Omniscan 
Gadodiamide 
Linear 
 
 
OptiMARK 
Gadoversetamide 
Linear 
 
 
ProHance 
Gadoteridol 
Macrocyclic 
 
 
Other, provide name: 
      
 
1.) The FDA has concluded that gadolinium is retained in the body and brain for 
a significantly longer time than previously recognized, especially for linear 
GBCAs. The health-related risks of this longer retention are not yet clearly 
established. However, the UW IRB expects researchers to provide a 
compelling justification for using a linear GBCA instead of a macrocyclic 
GBCA, to manage the risks associated with GBCAs. 
 
Describe why it is important to use a GBCA with the MRI scan(s). Describe 
the dose that will be used and (if it is more than the standard clinical dose 
recommended by the manufacturer) why it is necessary to use a higher 
dose. If a linear GBCA will be used, explain why a macrocyclic GBCA cannot 
be used. 
 
       
 
2.) Information for subjects. Confirm by checking this box that subjects will be 
provided with the FDA-approved Patient Medication Guide for the GBCA 
being used in the research or that the same information will be inserted into 
the consent form. 
 
 
Confirmed 
c. MRI facility. At which facility(ies) will the MRI scans occur? Check all that apply. 
 
 
UWMC Radiology/Imaging Services (the UWMC clinical facility) 
 
 
DISC Diagnostic Imaging Sciences Center (UWMC research facility) 
 
 
BMIC Biomolecular Imaging Center (South Lake Union research facility) 
 
 
Harborview Radiology/Imaging Services (the Harborview clinical facility) 
 
 
SCCA Imaging Services 
 
 
Northwest Diagnostic Imaging 
 
 
Other: identify in the text box below: 

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Personnel. For MRI scans that will be conducted at the DISC or BMIC research facilities: The role, qualifications, and 
training of individuals who will operate the scanner, administer the GBCA (if applicable), and/or insert and 
remove the IV catheter should be described in question 12.3. 
5.4 Data variables. Describe the specific data that will be obtained (including a description of the most sensitive items). 
Alternatively, a list of the data variables may be uploaded to Zipline. 
 
Data variables include: demographic information, developmental outcome measures (Bayley IV Scales), caregiver 
survey measures (YC-PEM, CEDL, AIM-FIM-IAM), powered mobility observational assessment levels 
(ALP), qualitative interview data, and quantitative device use data (caregiver and automated driving logs).  
5.5 Data sources. For all types of data that will be accessed or collected for this research: Identify whether the data are 
being obtained from the subjects (or subjects’ specimens) or whether they are being obtained from some other 
source (and identify the source). 
If you have already provided this information in Question 5.1, you do not need to repeat the information here. 
 
All data sources will be obtained directly from study participants.  
5.6 Identifiability of data and specimens. Answer these questions carefully and completely. This will allow HSD to 
accurately determine the type of review that is required and the relevant compliance requirements. Review the 
following definitions before answering the questions: 
Access means to view or perceive data, but not to possess or record it. See, in contrast, the definition of “obtain”. 
Identifiable means that the identity of an individual is or may be readily (1) ascertained by the researcher or any other member 
of the study team from specific data variables or from a combination of data variables, or (2) associated with the information.  
Direct identifiers are direct links between a subject and data/specimens. Examples include (but are not limited to): name, date 
of birth, medical record number, email or IP address, pathology or surgery accession number, student number, or a collection 
of data that is (when taken together) identifiable.  
Indirect identifiers are information that links between direct identifiers and data/specimens. Examples: a subject code or 
pseudonym.   
Key refers to a single place where direct identifiers and indirect identifiers are linked together so that, for example, coded data 
can be identified as relating to a specific person. Example: a master list that contains the data code and the identifiers linked to 
the codes. 
Obtain means to possess or record in any fashion (writing, electronic document, video, email, voice recording, etc.) for research 
purposes and to retain for any length of time. This is different from accessing, which means to view or perceive data.  
a. Will you or any members of your team have access to any direct or indirect identifiers? 
 
X 
Yes 
→ If yes, describe which identifiers and for which data/specimens.  
 
 
 
Members of the research team will have access to direct identifiers via name and contact 
information, in order to recruit subjects. Indirect identifiers will then be assigned from a 
master list of subjects. The research team will have access to indirect identifiers via a 
subject code after consent is obtained. The research team will have access to audio 
recordings of interviews, video recordings of Bayley developmental assessments and de-
identified study data.  
 
 
No 
→ If no, select the reason(s) why you (and all members of your team) will not have access to 
direct or indirect identifiers. 
 
 
There will be no identifiers.  
 
 
 
 

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Identifiers or the key have been (or will have been) destroyed before access.  
 
 
 
 
 
 
There is an agreement with the holder of the identifiers (or key) that prohibits the 
release of the identifiers (or key) to study team members under any circumstances. 
 
 
 
 
 
 
This agreement should be available upon request from the IRB. Examples: a Data Use Agreement, 
Repository Gatekeeping form, or documented email. 
 
 
There are written policies and procedures for the repository/database/data 
management center that prohibit the release of the identifiers (or identifying link). This 
includes situations involving an Honest Broker. 
 
 
 
 
 
 
There are other legal requirements prohibiting the release of the identifiers or key. 
Describe them below. 
 
 
 
 
 
 
      
b. Will you or any study team members obtain any direct or indirect identifiers? 
 
X 
Yes 
→ If yes, describe which identifiers and for which data/specimens. 
 
 
 
 
Members of the research team will obtain direct identifiers via name and contact 
information, in order to recruit subjects. Indirect identifiers will then be assigned 
from a master list of subjects. The research team will obtain indirect identifiers via a 
subject code after consent is documented. The research team will obtain audio 
recordings of interviews and video recordings of the Bayley developmental 
assessments which may include direct identifiers. We will also obtain study data in 
the form of surveys, developmental assessments, and observational assessment 
which will use indirect identification. 
 
 
No 
→ If no, select the reason(s) why you (and all members of your team) will not obtain direct 
or indirect identifiers. 
 
 
There will be no identifiers.  
 
 
 
 
 
 
Identifiers or the key have been (or will have been) destroyed before access.  
 
 
 
 
 
 
There will be an agreement with the holder of the identifiers (or key) that prohibits the 
release of the identifiers (or key) under any circumstances.   
 
 
 
 
 
 
This agreement should be available upon request from the IRB. Examples: a Data Use Agreement, 
Repository Gatekeeping form, or documented email. 
 
 
There are written policies and procedures for the repository/database/data 
management center that prohibit the release of the identifiers (or identifying link). This 
includes situations involving an Honest Broker. 
 
 
 
 
 
 
There are other legal requirements prohibiting the release of the identifiers or key. 
Describe them below.   
 
 
 
 
 
 
      

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c. If any identifiers will be obtained, indicate how the identifiers will be stored (and for which data). NOTE: Do 
not describe the data security plan here – that information is requested in section 9.6. 
 
 
Identifiers will be stored with the data. Describe the data to which this applies: 
 
X
 
 
 
 
Because we are collecting audio and video data, this may be inherently identifiable. This 
data will be stored directly on a secured and encrypted university server.  
 
 
Identifiers and study data will be stored separately but a link will be maintained between 
the identifiers and the study data (for example, through the use of a code). Describe the 
data to which this applies: 
 
X
 
 
 
 
For all remaining data, each subject will be assigned an indirect identifier in the form of a 
participant code and pseudonym. A master list of the subject’s direct and indirect 
identifiers will be kept separately from the data, in a locked file cabinet inside a locked 
office, or electronically on a secure and encrypted university server. This applies to all 
data collected in the study. 
 
 
Identifiers and study data will be stored separately, with no link between the identifiers 
and the study data. Describe the data to which this applies: 
 
 
 
 
 
 
      
d. Research collaboration. Will individuals who provide coded information or specimens for the research also 
collaborate on other activities for this research? If yes, identify the activities and provide the name of the 
collaborator’s institution/organization. 
Examples include but are not limited to: (1) study, interpretation, or analysis of the data that results from the coded 
information or specimens; and (2) authorship on presentations or manuscripts related to this work. 
N/A 
5.7 Protected Health Information (PHI). Will participants’ identifiable PHI be accessed, obtained, used, or disclosed for 
any reason (for example, to identify or screen potential subjects, to obtain study data or specimens, for study 
follow-up) that does not involve the creation or obtaining of a Limited Data Set? 
PHI is individually identifiable healthcare record information or clinical specimens from an organization considered a “covered 
entity” by federal HIPAA regulations, in any form or media, whether electronic, paper, or oral. You must answer yes to this 
question if the research involves identifiable health care records (e.g., medical, dental, pharmacy, nursing, billing, etc.), 
identifiable healthcare information from a clinical department repository, or observations or recordings of clinical 
interactions. 
 
X No 
→ If no, skip the rest of this question; go to question 5.8 
 
 
Yes 
→ If yes, answer all of the questions below. 
 
 
a. Describe the PHI and the reason for using it. Be specific. For example, will any “free text” fields 
(such as physician notes) be accessed, obtained, or used?   
 
      
b. Is any of the PHI located in Washington State? 
 
 
No 
 
 
 
Yes 
 

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c. Describe the pathway of how the PHI will be accessed or obtained, starting with the 
source/location and then describing the system/path/mechanism by which it will be identified, 
accessed, and copied for the research. Be specific. For example: directly view records; search 
through a department’s clinical database; submit a request to Leaf. 
 
      
d. For which PHI will subjects provide HIPAA authorization before the PHI is accessed, obtained 
and/or used?  
 
      
 
Confirm by checking the box that the UW Medicine HIPAA Authorization form maintained on the 
HSD website will be used to access, obtain, use, or disclose any UW Medicine PHI. 
 
 
Confirmed 
 
 
e. For which PHI will HIPAA authorization NOT be obtained from the subjects? 
 
      
 
Provide the following assurances by checking the boxes. 
 
 
The minimum necessary amount of PHI to accomplish the purposes described in this 
application will be accessed, obtained and/or used. 
 
 
 
 
 
 
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 PHI would be permitted. 
 
 
 
 
 
 
The HIPAA “accounting for disclosures” requirement will be fulfilled, if applicable. See UW 
Medicine Compliance Policy #104.  
 
 
 
 
 
 
 
 
There will be reasonable safeguards to protect against identifying, directly or indirectly, any 
patient in any report of the research. 
 
 
 
 
 
 
 
 
5.8 Genomic data sharing. Will the research obtain or generate genomic data? 
 
X No 
 

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Yes 
→ If yes, answer the question below. 
 
a. Will genomic data from this research be sent to a national database (for example, NIH’s dbGaP 
database)? 
 
 
 
No 
 
 
 
 
Yes 
→ If yes, complete the SUPPLEMENT Genomic Data Sharing and upload it to 
Zipline. 
5.9 Whole genome sequencing. For research involving biospecimens: Will the research include whole genome 
sequencing? 
Whole genome sequencing is sequencing of a human germline or somatic specimen with the intent to generate the genome or 
exome sequence of that specimen. 
 
 No 
 
 
 Yes  
5.10 Possible secondary use or sharing of information, specimens, or subject contact information. Is it likely that the 
obtained or collected information, specimens, or subject contact information will be used for any of the following: 
• 
Future research not described in this application (in other words, secondary research) 
• 
Submission to a repository, registry, or database managed by the study team, colleagues, or others for 
research purposes 
• 
Sharing with others for their own research 
Please consider the broadest possible future plans and whether consent will be obtained now from the subjects 
for future sharing or research uses (which it may not be possible to describe in detail at this time). Answer YES 
even if future sharing or uses will use de-identified information or specimens. Answer NO if sharing is unlikely or if 
the only sharing will be through the NIH Genomic Data Sharing described in question 5.8. 
Many federal grants and contracts now require data or specimen sharing as a condition of funding, and many journals require 
data sharing as a condition of publication. “Sharing” may include (for example): informal arrangements to share banked 
data/specimens with other investigators; establishing a repository that will formally share with other researchers through 
written agreements; or sending data/specimens to a third party repository/archive/entity such as the Social Science Open 
Access Repository (SSOAR), or the UCLA Ethnomusicology Archive. 
 
 No 
 
 
X Yes → If yes, answer all of the questions below. 
 
a. Describe what will be stored for future use, including whether any direct or indirect (e.g., subject 
codes) identifiers will be stored.  
 
De-identified data will be stored for future use, including interview transcriptions, score 
report data from participation and developmental measures, and device use reports.  
 
b. Describe what will be shared with other researchers or with a repository/database/registry, 
including whether direct identifiers will be shared and (for specimens) what data will be 
released with the specimens.  
 
Because this study meets the criteria for an NIH clinical trial, de-identified data will be 
submitted to Clinicaltrials.gov.  
 
c. Who will oversee and/or manage the sharing?  
 
The study PI will oversee and manage the sharing until deposited with clinicaltrials.gov.  

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d. Describe the possible future uses, including limitations or restrictions (if any) on future uses or 
users. As stated above, consider the broadest possible uses. 
 
Examples: data will be used only for cardiovascular research; data will not be used for research on 
population origins. 
 
Data will be used for scientific presentations, publications, and in future grant 
applications.  
 
e. Consent. Will consent be obtained now from subjects for the secondary use, banking and/or 
future sharing?  
 
 
No 
 
 
X 
Yes 
→ If yes, be sure to include the information about this consent process in the 
consent form (if there is one) and in the answers to the consent questions in 
Section 8. 
 
 
f. Withdrawal. Will subjects be able to withdraw their data/specimens from secondary use, 
banking or sharing?  
 
X 
No 
 
 
 
Yes 
→ If yes, describe how, and whether there are any limitations on withdrawal. 
 
Example: data can be withdrawn from the repository but cannot be retrieved after they 
are released. 
 
      
 
g. Agreements for sharing or release. Confirm by checking the box that the sharing or release will 
comply with UW (and, if applicable, UW Medicine) policies that require a formal agreement 
with the recipient for release of data or specimens to individuals or entities other than federal 
databases. 
 
Data Use Agreements or Gatekeeping forms are used for data; Material Transfer Agreements are used for 
specimens (or specimens plus data). Do not attach any template agreement forms; the IRB neither reviews nor 
approves them 
X Confirmed 
5.11 Communication with subjects during the study. Describe the types of communication (if any) the research team 
will have with already-enrolled subjects during the study. Provide a description instead of the actual materials 
themselves.   
Examples: email, texts, phone, or letter reminders about appointments or about returning study materials such as a 
questionnaire; requests to confirm contact information.  
 
Participants enrolled in the study will be contacted via email, phone, or text (as requested) about 
appointments for study procedures and to answer questions or provide reminders about study materials.  

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5.12 Future contact with subjects. Is there a plan to retain any contact information for subjects so that they can be 
contacted in the future? 
 
 
No 
 
 
X Yes 
→ If yes, describe the purpose of the future contact, and whether use of the contact information will 
be limited to the study team; if not, describe who else could be provided with the contact 
information. Describe the criteria for approving requests for the information. 
 
 
 
Examples: inform subjects about other studies; ask subjects for additional information or medical record access 
that is not currently part of the study proposed in this application; obtain another sample. 
 
Contact information will be limited to the research team, and be used to either obtain additional 
information, or to inform subjects about other studies if they elect to be contacted.  
5.13 Alternatives to participation. Are there any alternative procedures or treatments that might be advantageous to 
the subjects? 
If there are no alternative procedures or treatments, select “No”. Examples of advantageous alternatives: earning extra class 
credit in some time-equivalent way other than research participation; obtaining supportive care or a standard clinical 
treatment from a health care provider instead of participating in research with an experimental drug.  
 
X No 
 
 
 
Yes 
→ If yes, describe the alternatives. 
 
 
 
      
5.14 Upload to Zipline all data collection forms (if any) that will be directly used by or with the subjects, and any 
scripts/talking points that will be used to collect the data. Do not include data collection forms that will be used 
to abstract data from other sources (such as medical or academic records), or video recordings. 
• 
Examples: survey, questionnaires, subject logs or diaries, focus group questions. 
• 
NOTE: Sometimes the IRB can approve the general content of surveys and other data collection instruments rather than 
the specific form itself. This prevents the need to submit a modification request for future minor changes that do not add 
new topics or increase the sensitivity of the questions. To request this general approval, use the text box below to identify 
the questionnaires/surveys/ etc. for which you are seeking this more general approval. Then briefly describe the scope of 
the topics that will be covered and the most personal and sensitive questions. The HSD staff person who screens this 
application will let you know whether this is sufficient or whether you will need to provide more information. 
• 
For materials that cannot be uploaded: upload screenshots or written descriptions that are sufficient to enable the IRB to 
understand the types of data that will be collected and the nature of the experience for the participant. You may also 
provide URLs (website addresses) or written descriptions below. Examples of materials that usually cannot be uploaded: 
mobile apps; computer-administered test; licensed and restricted standardized tests. 
• 
For data that will be gathered in an evolving way: This refers to data collection/questions that are not pre-determined 
but rather are shaped during interactions with participants in response to observations and responses made during those 
interactions. If this applies to the proposed research, provide a description of the process by which the data 
collection/questions will be established during the interactions with subjects, how the data collection/questions will be 
documented, the topics likely to be addressed, the most sensitive type of information likely to be gathered, and the 
limitations (if any) on topics that will be raised or pursued. 

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Use this text box (if desired) to provide: 
• 
Short written descriptions of materials that cannot be uploaded, such as URLs 
• 
A description of the process that will be used for data that will be gathered in an evolving way. 
• 
The general content of questionnaires, surveys and similar instruments for which general approval is being 
sought. (See the NOTE bullet point in the instructions above.) 
 
      
5.15 SARS-CoV-2 testing. Will the subjects be tested for the SARS-CoV-2 coronavirus? 
If the only testing is to screen the subjects (question 2.8), you do not need to answer this question 
 
X No 
 
 
 
Yes 
→ If yes: 
• 
Name the testing lab 
• 
Confirm that the lab and its use of this test is CLIA-certified or certified by the Washington 
State Department of Health 
• 
Describe whether you will return the results to the participants and, if yes, who will do it and 
how (including any information you would provide to subjects with positive test results). 
 
 
 
 
      
5.16 Research equipment and COVID-19. Does you research involve any equipment that will be used on more than 
one subject that is not part of a clinical facility? 
Examples: a computer tablet, a portable research ultra-sound device). 
 
 
No 
 
 
X Yes 
→ If yes: confirm by checking the box below that the disinfection and cleaning of the equipment will 
meet the enhanced UW Environmental Health & Safety requirements described here: 
https://www.ehs.washington.edu/system/files/resources/cleaning-disinfection-protocols-covid-
19.pdf 
 
X Confirmed 
 
 
6 CHILDREN (MINORS) and PARENTAL PERMISSION 
6.1 Involvement of minors. Does the research include minors (children)? 
Minor or child means someone who has not yet attained the legal age for consent for the research procedures, as 
described in the applicable laws of the jurisdiction in which the research will be conducted. This may or may not 
be the same as the definition used by funding agencies such as the National Institutes of Health. 
• 
In Washington State the generic age of consent is 18, meaning that anyone under the age of 18 is 
considered a child.  
• 
There are some procedures for which the age of consent is much lower in Washington State. 
• 
The generic age of consent may be different in other states, and in other countries.  
 
 
No 
→ If no, go to Section 8. 

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X 
Yes 
→ If yes, provide the age range of the minor subjects for this study and the legal age for consent in 
the study population(s). If there is more than one answer, explain.   
 
 
 
 
Children ages 12-36 months. Due to their young age, parental permission will be sought and 
consent and permission will be provided by a legal caregiver over 18 years of age.  
 
 
Don’t know 
→This means is it not possible to know the age of the subjects. For example, this may be true 
for some research involving social media, the Internet, or a dataset that is obtained from 
another researcher or from a government agency. Go to Section 8. 
 
 
6.2 Parental permission. Parental permission means actively obtaining the permission of the parents. This is not the 
same as “passive” or “opt out” permission where it is assumed that parents are allowing their children to 
participate because they have been provided with information about the research and have not objected or 
returned a form indicating they don’t want their children to participate. 
a. Will parental permission be obtained for: 
 
 
All of the research procedures 
→ Go to question 6.2b. 
 
X 
 
 
 
 
None of the research procedures 
→ Use the table below to provide justification, and skip question 
6.2b. 
 
 
 
 
 
 
Some of the research procedures 
→ Use the table below to identify the procedures for which 
parental permission will not be obtained. 
 
 
 
 
Be sure to consider all research procedures and plans, including screening, future contact, and sharing/banking of data and 
specimens for future work. 
Children 
Group1 
Describe the procedures or 
data/specimen collection (if any) for 
which there will be NO parental 
permission2 
Reason why parental 
permission will not be 
obtained 
Will parents be 
informed about 
the research?3 
 
 
 
YES 
NO 
      
      
      
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
      
      
      
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
      
      
      
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
      
      
      
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
      
      
      
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
      
      
      
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Table footnotes 
1. If the answer is the same for all children groups or all procedures: collapse the answer across the groups and/or procedures. 
2. If identifiable information or biospecimens will be obtained without parent permission, any waiver granted by the IRB does not 
override parents’ refusal to provide broad consent (for example, through the Northwest Biotrust). 
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b. Indicate the plan for obtaining parental permission. One or both boxes must be checked. 
 
 
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.  
 
X 
 
 
 
 
This is all that is required for minimal risk research. 
 
If both boxes are checked, explain: 
 
      
6.3 Children who are wards. Will any of the children be wards of the State or any other agency, institution, or entity? 
 
X 
No 
 
 
 
Yes 
→ If yes, an advocate may need to be appointed for each child who is a ward. The advocate must be in 
addition to any other individual acting on behalf of the child as guardian or in loco parentis. The 
same individual can serve as advocate for all children who are wards. 
 
 
 
Describe who will be the advocate(s). The description must address the following points: 
• 
Background and experience 
• 
Willingness to act in the best interests of the child for the duration of the research 
• 
Independence of the research, research team, and any guardian organization 
 
      
 
 
7 ASSENT OF CHILDREN (MINORS) 
Go to Section 8 if your research does not involve children (minors). 
7.1 Assent of children (minors). Though children do not have the legal capacity to “consent” to participate in 
research, they should be involved in the process if they are able to “assent” by having a study explained to them 
and/or by reading a simple form about the study, and then giving their verbal choice about whether they want to 
participate. They may also provide a written assent if they are older. See WORKSHEET Children for circumstances 
in which a child’s assent may be unnecessary or inappropriate.   
a. Will assent be obtained for: 
 
 
All research procedures and child groups 
→ Go to question 7.2. 
 
 
 
 
 
 
None of the research procedures and child groups 
→ Use the table below to provide justification, 
then skip to question 7.6 
 
X 
 
 
 
 
Some of your research procedures and child groups 
→ Use the table below to identify the 
procedures for which assent will not be 
obtained.  
 
 
 
 
Be sure to consider all research procedures and plans, including screening, future contact, and sharing/banking of data and 
specimens for future work. 

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Children Group1 
Describe the procedures or 
data/specimen collection (if 
any) for which assent will NOT 
be obtained 
Reason why assent will not be obtained 
Children ages 12-36 months 
All research procedures 
Reason 46.108(a)/50.55- The capability of the 
children is limited by age that they cannot reliably 
be consulted for assent. Parent consent/permission 
will be documented 
      
      
      
      
      
      
      
      
      
      
      
      
Table footnotes 
1. If the answer is the same for all children groups or all procedures, collapse your answer across the groups and/or procedures. 
7.2 Assent process. Describe how assent will be obtained, for each child group. If the research involves children of 
different ages, answer separately for each group. If the children are non-English speakers, include a description of 
how their comprehension of the information will be evaluated. 
 
      
7.3 Dissent or resistance. Describe how a child’s objection or resistance to participation (including non-verbal 
indications) will be identified during the research, and what the response will be.  
 
Although we will not be seeking assent due to child age, as pediatric rehabilitation professionals the research 
team is well-trained to recognize signs of dissent or resistance, such as negative facial expressions or crying. 
When this behavior occurs, the research team will temporarily discontinue research activities and/or cue 
caregivers to discontinue research activities and provide a break before resuming activities. It is anticipated that 
these behaviors may be more prevalent at the onset of research activities and new experiences, but will diminish 
over time. If this does not occur, caregivers will be provided with resources and suggestions to mitigate these 
behaviors using play-based, developmental strategies. If these behaviors persist after these strategies are 
implemented, caregivers will be reminded of their right to withdraw from the study at any time.  
7.4 E-consent. Will any electronic processes (email, websites, electronic signatures, etc.) be used to present assent 
information to subjects/and or to obtain documentation (signatures) of assent? If yes, describe how this will be 
done. 
 
      
7.5 Documentation of assent.  Which of the following statements describes whether documentation of assent will be 
obtained? 
 
 
None of the research procedures and child groups 
→ Use the table below to provide justification, 
then go to question 7.5.b 
 
 
 
 
 
 
All of the research procedures and child groups 
→ Go to question 7.5.a, do not complete the 
table 
 
 
 
 
 
 
Some of the research procedures and/or child groups 
 
 

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→ Complete the table below and then to go 
question 7.5.a 
Children 
Group1 
Describe the procedures or data/specimen collection (if any) for which assent 
will NOT be documented 
      
      
      
      
      
      
      
      
      
      
Table footnotes 
1. If the answer is the same for all children groups or all procedures, collapse the answer across the groups and/or procedures. 
 
a. Describe how assent will be documented. If the children are functionally illiterate or are not fluent in English, 
include a description of the documentation process for them. 
 
 
      
 
b. Upload all assent materials (talking points, videos, forms, etc.) to Zipline. Assent materials are not required to 
provide all of the standard elements of adult consent; the information should be appropriate to the age, 
population, and research procedures. The documents should be in Word, if possible. 
7.6 Children who reach the legal age of consent during participation in longitudinal research.  
Children who were enrolled at a young age and continue for many years: It is best practice to re-obtain assent (or 
to obtain it for the first time, if it was not obtained at the beginning of their participation).  
Children who reach the legal age of consent: Informed consent must be obtained from the now-adult subject for 
(1) any ongoing interactions or interventions with the subjects, or (2) the continued analysis of specimens or data 
for which the subject’s identify is readily identifiable to the researcher, unless the IRB waives this requirement.  
 
a. Describe the plans (if any) to re-obtain assent from children.  
 
N/A 
 
b. Describe the plans (if any) to obtain consent for children who reach the legal age of consent.  
• 
If adult consent will be obtained from them, describe what will happen regarding now-adult subjects 
who cannot be contacted. 
• 
If consent will not obtained or will not be possible: explain why.  
 
N/A 
7.7 Other regulatory requirements. (This is for information only; no answer or response is required.) Researchers are 
responsible for determining whether their research conducted in schools, with student records, or over the 
Internet comply with permission, consent, and inspection requirements of the following federal regulations: 
• 
PPRA – Protection of Pupil Rights Amendment 
• 
FERPA – Family Education Rights and Privacy Act 
• 
COPPA – Children’s Online Privacy Protection Act 

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8 CONSENT OF ADULTS 
Review the following definitions before answering the questions in this section. 
CONSENT 
is the process of informing potential subjects about the research and asking them 
whether they want to participate. It does not necessarily include the signing of a 
consent form. 
CONSENT DOCUMENTATION 
refers to how a subject’s decision to participate in the research is documented. 
This is typically obtained by having the subject sign a consent form. 
CONSENT FORM 
is a document signed by subjects, by which they agree to participate in the 
research as described in the consent form and in the consent process. 
ELEMENTS OF CONSENT 
are specific information that is required to be provided to subjects. 
CHARACTERISTICS OF CONSENT 
are the qualities of the consent process as a whole. These are: 
• 
Consent must be legally effective. 
• 
The process minimizes the possibility of coercion or undue influence. 
• 
Subjects or their representatives must be given sufficient opportunity to 
discuss and consider participation. 
• 
The information provided must: 
o Begin with presentation of key information (for consent materials 
over 2,000 words) 
o Be what a reasonable person would want to have 
o Be organized and presented so as to facilitate understanding 
o Be provided in sufficient detail 
o Not ask or appear to ask subjects to waive their rights 
PARENTAL PERMISSION 
is the parent’s active permission for the child to participate in the research. 
Parental permission is subject to the same requirements as consent, including 
written documentation of permission and required elements. 
SHORT FORM CONSENT 
is an alternative way of obtaining written documentation of consent that is most 
commonly used with individuals who are illiterate or whose language is one for 
which translated consent forms are not available. 
WAIVER OF CONSENT 
means there is IRB approval for not obtaining consent or for not including some of 
the elements of consent in the consent process. 
 
NOTE: If you plan to obtain identifiable information or identifiable biospecimens 
without consent, any waiver granted by the IRB does not override a subject’s 
refusal to provide broad consent (for example, the Northwest Biotrust). 
WAIVER OF DOCUMENTATION 
OF CONSENT 
means that there is IRB approval for not obtaining written documentation of 
consent. 
8.1 Groups Identify the groups to which the answers in this section apply. 
 
X Adult subjects 

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X Parents who are providing permission for their children to participate in research 
 
→ If you selected PARENTS, the word “consent” below should also be interpreted as applying to parental 
permission and “subjects” should also be interpreted as applying to the parents. 
8.2 The consent process and characteristics. This series of questions is about whether consent will be obtained for all 
procedures except recruiting and screening and, if yes, how. 
The issue of consent for recruiting and screening activities is addressed in question 4.7. You do not need to repeat your answer 
to question 4.6. 
 
a. Are there any procedures for which consent will not be obtained? 
 
X 
No 
 
 
 
Yes 
→ If yes, use the table below to identify the procedures for which consent will not be obtained. “All” 
is an acceptable answer for some studies. 
 
 
Be sure to consider all research procedures and plans, including future contact, and sharing/banking of data and specimens for 
future work. 
Group1 
Describe the procedures or 
data/specimen collection (if any) 
for which there will be NO consent 
process 
Reason why consent will not be 
obtained 
Will subjects be 
provided with 
info about the 
research after 
they finish? 
 
 
 
YES 
NO 
      
      
      
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
      
      
      
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
      
      
      
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
      
      
      
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
      
      
      
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Table footnotes 
1. If the answer is the same for all groups, collapse your answer across the groups and/or procedures. 
b. Describe the consent process, if consent will be obtained for any or all procedures, for any or all groups. 
Address groups and procedures separately if the consent processes are different. 
Be sure to include: 
• 
The location/setting where consent will be obtained 
• 
Who will obtain consent (refer to positions, roles, or titles, not names) 
• 
How subjects will be provided sufficient opportunity to discuss the study with the research team and consider 
participation 
 
Consent procedures will be conducted over the phone or via Zoom video conference. Only members of the 
research team will obtain consent and parent permission. The research team will provide the consent and 

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permission form for review prior to the time of consent. All consent and permission documents and verbal 
explanations will be conducted using lay language, in English. Information in the consent document will be 
verbally explained, followed by an opportunity for the potential subjects to ask questions about the research or 
the consent document itself. The research team member obtaining consent will review all sections of the 
consent and permission document, and clearly explain that potential subjects have the option to participate or 
not participate in the study without penalty. After document review, the parent will be asked to provide verbal 
consent for themselves and permission for their child to participate in the study. The date and time of verbal 
consent will be documented by the research team. 
c. Comprehension. Describe the methods that will be used to ensure or test the subjects’ understanding of the 
information during the consent process. 
 
During the consent process, each potential subject will be asked to repeat back the main purpose of the study, 
using the English language. The subject will be asked to verify that they understand they have a choice to 
participate or not, and asked whether they recall if and when they can withdraw from the study. 
d. Influence. Does the research involve any subject groups that might find it difficult to say “no” to participation 
because of the setting or their relationship with someone on the study team, even if they aren’t pressured to 
participate?   
Examples: Student participants being recruited into their teacher’s research; patients being recruited into their healthcare 
provider’s research, study team members who are participants; outpatients recruited from an outpatient surgery waiting 
room just prior to their surgery. 
 
X 
No 
 
 
 
Yes 
→ If yes, describe what will be done to reduce any effect of the setting or relationship on the 
participation decision. 
 
 
 
 
Examples: a study coordinator will obtain consent instead of the subjects’ physician; the researcher will not 
know which subjects agreed to participate; subjects will have two days to decide after hearing about the 
study. 
 
      
e. Information provided is tailored to needs of subject population. Describe the basis for concluding that the 
information that will be provided to subjects (via written or oral methods) is what a reasonable member of the 
subject population(s) would want to know. If the research consent materials contain a key information section, 
also describe the basis for concluding that the information presented in that section is that which is most likely 
to assist the selected subject population with making a decision. See GUIDANCE Key Information for Consent 
Materials. 
 
For example: Consultation with publications about research subjects’ preferences, disease-focused nonprofit groups, patient 
interest groups, or other researchers/study staff with experience with the specific population. It may also involve directly 
consulting selected members of the study population. 
 
Information provided is tailored to the needs of the participant population based on the research team’s 
extensive experience as rehabilitation clinicians and researchers with this population, as well as consultation 
with publications and previous feedback from past research participants.   

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f. Ongoing process. For research that involves multiple or continued interaction with subjects over time, describe 
the opportunities (if any) that will be given to subjects to ask questions or to change their minds about 
participating. 
 
Upon each subsequent research encounter, the subject will be asked for verbal confirmation of their consent to 
continue participating in the research, as well as be reminded that they can withdraw from the research at any 
time without penalty. 
8.3 Electronic presentation of consent information. Will any part of the consent-related information be provided 
electronically for some or all of the subjects? 
This refers to the use of electronic systems and processes instead of (or in addition to) a paper consent form. For example, an 
emailed consent form, a passive or an interactive website, graphics, audio, video podcasts. See GUIDANCE Electronic Informed 
Consent for information about electronic consent requirements at UW. 
 
 
No 
→ If no, skip to question 8.4 
 
X 
Yes 
→ If yes, answer questions a through e 
a. Describe the electronic consent methodology and the information that will be provided. 
All informational materials must be made available to the IRB. Website content should be provided as a 
Word document. It is considered best practice to give subjects information about multi-page/multi-screen 
information that will help them assess how long it will take them to complete the process. For example, 
telling them that it will take about 15 minutes, or that it involves reading six screens or pages. 
The research team will provide a copy of the consent information via email, and verbally present 
the consent and permission document remotely via video conference (i.e. Zoom) or phone to the 
parent/legal guardian. The potential participant will have a chance to review an electronic copy 
of the consent/permission document and ask the research team questions.  
b. Describe how the information can be navigated (if relevant). For example, will the subject be able to 
proceed forward or backward within the system, or to stop and continue at a later time? 
 
 
c. In a standard paper-based consent process, the subjects generally have the opportunity to go 
through the consent form with study staff and/or to ask study staff about any question they may 
have after reading the consent form. Describe what will be done, if anything, to facilitate the 
subject’s comprehension and opportunity to ask questions when consent information is 
presented electronically. Include a description of any provisions to help ensure privacy and 
confidentiality during this process. 
Examples: hyperlinks, help text, telephone calls, text messages or other type of electronic messaging, video 
conference, live chat with remotely located study team members. 
This process will occur via video conference in the same manner it would take place if using an 
in-person paper document.  

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d. What will happen if there are individuals who wish to participate but who do not have access to 
the consent methodology being used, or who do not wish to use it? Are there alternative ways in 
which they can obtain the information, or will there be some assistance available? If this is a 
clinical trial, these individuals cannot be excluded from the research unless there is a compelling 
rationale. 
 
For example, consider individuals who lack familiarity with electronic systems, have poor eyesight or 
impaired motor skills, or who do not have easy email or internet access. 
Sharing of study information and review of the consent and permission document is able to be 
conducted in person or remotely. If a participant does not have access to appropriate technology, 
these procedures will be conducted in person using social distance precautions. The research staff 
may read the document to the participant over the phone or in person should it be necessary.  
e. How will additional information be provided to subjects during the research, including any 
significant new findings (such as new risk information) If this is not an issue, explain why. 
 
New information will be provided to the participant via their preferred method of communication 
(phone, email, video conference, in-person visit)  
8.4 Written documentation of consent. Which of the statements below describe whether documentation of consent 
will be obtained? NOTE: This question does not apply to screening and recruiting procedures which have already 
been addressed in question 4.7. 
Documentation of consent that is obtained electronically is not considered written consent unless it is obtained by a method 
that allows verification of the individual’s signature. In other words, saying “yes” by email is rarely considered to be written 
documentation of consent 
a. Is written documentation of consent being obtained for: 
 
 
None of the research procedures  
→ Use the table below to provide justification then go to question 
8.5. 
 
X 
 
 
 
 
All of the research procedures  
→ Do not complete the table; go to question 8.4.b. 
 
 
 
 
 
 
Some of the research procedures 
→ Use the table below to identify the procedures for which written 
documentation of consent will not be obtained from adult 
subjects.  
 
 
 
 
Adult 
subject 
group1 
Describe the procedures or data/specimen collection (if any) for which 
there will be NO documentation of consent 
Will they be 
provided with a 
written 
statement 
describing the 
research 
(optional)? 
 
 
YES 
NO 
Parent 
participants 
over the age 
of 18 yrs 
Verbal consent and permission will be conducted for all research procedures. The 
research team will document the date and time that verbal consent and permission 
was obtained. 
 
 
 
 
 
 
 
X 
 
 
 
 
 
 
 
 
 
 
      
      
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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Table footnotes 
1. If the answer is the same for all adult groups or all procedures, collapse the answer across the groups and/or procedures. 
b. Electronic consent signature. For studies in which documentation of consent will be obtained: will subjects use 
an electronic method to provide their consent signature? 
• 
FDA-regulated studies must use a system that complies with the FDA’s “Part 11” requirements about electronic 
systems and records. Note that the UW-IT supported DocuSign e-signature system does not meet this requirement. 
• 
Having subjects check a box at the beginning of an emailed or web-based questionnaire is not considered legally 
effective documentation of consent. 
 
X No 
 
 
 
Yes 
→ If yes, describe the methodology that will be used. 
See the GUIDANCE Electronic Informed Consent for information about options (including the DocuSign 
system available through UW-IT) and requirements. 
 
b.1 Is this method legally valid in the jurisdiction where the research will occur? 
 
 
No 
 
 
 
Yes 
→ If yes, what is the source of information about legal validity? 
 
      
b.2 Will verification of the subject’s identity be obtained if the signature is not personally 
witnessed by a member of the study team? Note that this is required for FDA-regulated 
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See the GUIDANCE Electronic Informed Consent for information and examples 
 
 
No 
→If no, provide the rationale for why this is appropriate. Also, what would 
be the risks to the actual subject if somebody other than the intended 
signer provides the consent signature? 
 
 
 
 
Yes 
→If yes, how? 
 
 
b.3 How will the requirement be met to provide a copy of the consent information (consent 
form) to individuals who provide an e-signature? 
The copy can be paper or electronic and may be provided on an electronic storage device or via 
email. If the electronic consent information uses hyperlinks or other websites or podcasts to convey 
information specifically related to the research, the information in these hyperlinks should be 
included in the copy provided to the subjects and the website must be maintained for the duration 
of the entire study. 
 
8.5 Non-English-speaking or -reading adult subjects. Will the research enroll adult subjects who do not speak English 
or who lack fluency or literacy in English? 
 
X 
No 
 
 
 
Yes 
→ If yes, describe the process that will be used to ensure that the oral and written information 
provided to them during the consent process and throughout the study will be in a language readily 
understandable to them and (for written materials such as consent forms or questionnaires) at an 
appropriate reading/comprehension level. 
 
 
 
      
 
a. Interpretation. Describe how interpretation will be provided, and when. Also, describe the 
qualifications of the interpreter(s) – for example, background, experience, language proficiency 
in English and in the other language, certification, other credentials, familiarity with the research-
related vocabulary in English and the target language.  
 
      
 
b. Translations. Describe how translations will be obtained for all study materials (not just consent 
forms). Also, describe the method for ensuring that the translations meet the UW IRB’s 
requirement that translated documents will be linguistically accurate, at an appropriate reading 
level for the participant population, and culturally sensitive for the locale in which they will be 
used.  
 
      

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8.6 Barriers to written documentation of consent. There are many possible barriers to obtaining written 
documentation of consent. Consider, for example, individuals who are functionally illiterate; do not read English 
well; or have sensory or motor impairments that may impede the ability to read and sign a consent form. 
a. Describe the plans (if any) for obtaining written documentation of consent from potential subjects who may 
have difficulty with the standard documentation process (that is, reading and signing a consent form). Skip this 
question if written documentation of consent is not being obtained for any part of the research.  
Examples of solutions: Translated consent forms; use of the Short Form consent process; reading the form to the person 
before they sign it; excluding individuals who cannot read and understand the consent form. 
 
N/A  
8.7 Deception. Will information be deliberately withheld, or will false information be provided, to any of the subjects? 
Note: “Blinding” subjects to their study group/condition/arm is not considered to be deception, but not telling them ahead of 
time that they will be subject to an intervention or about the purpose of the procedure(s) is deception. 
 
X No 
 
 
 Yes 
→ If yes, describe what information and why. 
 
 
Example: It may be necessary to deceive subjects about the purpose of the study (describe why). 
 
      
 
a. Will subjects be informed beforehand that they will be unaware of or misled regarding the 
nature or purposes of the research? (Note: this is not necessarily required.) 
 
 
No 
 
 
 
Yes 
 
 
b. Will subjects be debriefed later? (Note: this is not necessarily required.) 
 
 
No 
 
 
 
Yes 
→ If yes, describe how and when this will occur. Upload any debriefing materials, 
including talking points or a script, to Zipline. 
 
 
 
      
8.8 Cognitively impaired adults, and other adults unable to consent. Will such individuals be included in the 
research? 
Examples: individuals with Traumatic Brain Injury (TBI) or dementia; individuals who are unconscious, or who are significantly 
intoxicated. 
 
X 
No 
→ If no, go to question 8.9. 
 
 
Yes 
→ If yes, answer the following questions. 
 
a. Rationale. Provide the rationale for including this population.  
 
      

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b. Capacity for consent / decision making capacity. Describe the process that will be used to 
determine whether a cognitively impaired individual is capable of consent decision making 
with respect to the research protocol and setting. 
 
 
      
 
b.1. If there will be repeated interactions with the impaired subjects over a time period when 
cognitive capacity could increase or diminish, also describe how (if at all) decision-
making capacity will be re-assessed and (if appropriate) consent obtained during that 
time. 
 
      
 
c. Permission (surrogate consent). If the research will include adults who cannot consent for 
themselves, describe the process for obtaining permission (“surrogate consent”) from a legally 
authorized representative (LAR).   
 
For research conducted in Washington State, see the GUIDANCE Legally Authorized Representative to 
learn which individuals meet the state definition of “legally authorized representative”. 
 
 
      
 
d. Assent. Describe whether assent will be required of all, some, or none of the subjects. If some, 
indicate which subjects will be required to assent and which will not (and why not). Describe 
any process that will be used to obtain and document assent from the subjects.  
 
 
      
 
e. Dissent or resistance. Describe how a subject’s objection or resistance to participation 
(including non-verbal) during the research will be identified, and what will occur in response. 
 
 
      
8.9 Research use of human fetal tissue obtained from elective abortion. Federal and UW Policy specify some 
requirements for the consent process. If you are conducting this type of research, check the boxes to confirm 
these requirements will be followed. 
 
 
Informed consent for the donation of fetal tissue for research use will be obtained by someone other than  
the person who obtained the informed consent for abortion. 
 
 
Informed consent for the donation of fetal tissue for research use will be obtained after the informed  
consent for abortion. 
 
 
Participation in the research will not affect the method of abortion. 
 
 
No enticements, benefits, or financial incentives will be used at any level of the process to incentivize 
abortion or the donation of human fetal tissue. 
 
 
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woman and the person who obtains the informed consent. 
8.10 Consent-related materials. Upload to Zipline all consent scripts/talking points, consent forms, debriefing 
statements, Information Statements, Short Form consent forms, parental permission forms, and any other 
consent-related materials that will be used. Materials that will be used by a specific site should be uploaded to 
that site’s Local Site Documents page. 
• 
Translations must be submitted and approved before they can be used. However, we strongly encourage you to wait to 
provide them until the IRB has approved the English versions. 
• 
Combination forms: It may be appropriate to combine parental permission with consent, if parents are subjects as well as 
providing permission for the participation of their children. Similarly, a consent form may be appropriately considered an 
assent form for older children.  
• 
For materials that cannot be uploaded: upload screenshots or written descriptions that are sufficient to enable the IRB to 
understand the types of data that will be collected and the nature of the experience for the participant. URLs (website 
addresses) may also be provided, or written descriptions of websites. Examples of materials that usually cannot be 
uploaded: mobile apps; computer-administered test; licensed and restricted standardized tests. 
 
 
9 PRIVACY AND CONFIDENTIALITY 
9.1 Privacy protections. Describe the steps that will be taken, if any, to address possible privacy concerns of subjects 
and potential subjects. 
Privacy refers to the sense of being in control of access that others have to ourselves. This can be an issue with respect to 
recruiting, consenting, sensitivity of the data being collected, and the method of data collection. 
Examples:  
• 
Many subjects will feel a violation of privacy if they receive a letter asking them to participate in a study because they 
have ____ medical condition, when their name, contact information, and medical condition were drawn from medical 
records without their consent. Example: the IRB expects that “cold call” recruitment letters will inform the subject 
about how their information was obtained. 
• 
Recruiting subjects immediately prior to a sensitive or invasive procedure (e.g., in an outpatient surgery waiting 
room) will feel like an invasion of privacy to some individuals. 
• 
Asking subjects about sensitive topics (e.g. details about sexual behavior) may feel like an invasion of privacy to some 
individuals. 
 
Potential subjects will self-identify and self-refer to participate in the study. All subjects will be assigned a 
participant code and pseudonym to protect privacy. 
9.2 Identification of individuals in publications and presentations. Will potentially identifiable information about 
subjects be used in publications and presentations, or is it possible that individual identities could be inferred from 
what is planned to be published or presented?  
 
X 
No 
 
 
 
Yes → If yes, will subject consent be obtained for this use? 
 
 
Yes 
 
 
 
No 
→ If no, describe the steps that will be taken to protect subjects (or small groups of 
subjects) from being identifiable. 
 
 
 
 
      

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9.3 State mandatory reporting. Each state has reporting laws that require some types of individuals to report some 
kinds of abuse, and medical conditions that are under public health surveillance. These include: 
• 
Child abuse 
• 
Abuse, abandonment, neglect, or financial exploitation of a vulnerable adult 
• 
Sexual assault 
• 
Serious physical assault 
• 
Medical conditions subject to mandatory reporting (notification) for public health surveillance 
 
Are you or a member of the research team likely to learn of any of the above events or circumstances while 
conducting the research AND feel obligated to report it to state authorities? 
 
 
No 
 
 
X Yes 
→ If yes, the UW IRB expects subjects to be informed of this possibility in the consent form or during 
the consent process, unless you provide a rationale for not doing so: 
 
 
 
 
 
Members of the research team are licensed rehabilitation professionals and considered mandated 
reporters of suspected or witnessed abuse. Although it is not anticipated that the research team is 
likely to learn of these events while conducting the research, if they are suspected or witnessed, 
we are obligated to report. Language describing this process is included in the 
consent/permission document.  
9.4 Retention of identifiers and data. Check the box below to indicate assurance that any identifiers (or links between 
identifiers and data/specimens) and data that are part of the research records will not be destroyed until after the 
end of the applicable records retention requirements (e.g. Washington State; funding agency or sponsor; Food 
and Drug Administration). If it is important to say something about destruction of identifiers (or links to identifiers) 
in the consent form, state something like “the link between your identifier and the research data will be destroyed 
after the records retention period required by state and/or federal law.” 
This question can be left blank for conversion applications (existing paper applications that are being “converted” into a Zipline 
application.) 
 
See the “Research Data” sections of the following website for UW Records management for the Washington State research 
rectords retention schedules that apply in general to the UW (not involving UW Medicine data): 
http://f2.washington.edu/fm/recmgt/gs/research?title=R 
 
See the “Research Records and Data” information in Section 8 of this document for the retention schedules for UW Medicine 
Records: https://www.uwmedicine.org/recordsmanagementuwm-records-retention-schedule.pdf 
 
X 
Confirm 
9.5 Certificates of Confidentiality. Will a federal Certificate of Confidentiality be obtained for the research data? 
NOTE: Answer “No” if the study is funded by NIH or the CDC, because all NIH-funded and CDC-funded studies 
automatically have a Certificate. 
 
X No 
 
 
 
Yes 
 

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9.6 Data and specimen security protections. Identify the data classifications and the security protections that will be 
provided for all sites where data will be collected, transmitted, or stored, referring to the GUIDANCE Data and 
Security Protections for the minimum requirements for each data classification level. It is not possible to answer 
this question without reading this document. Data security protections should not conflict with records 
retention requirements. 
 
a. Which level of protections will be applied to the data and specimens? If more than one level will be used, 
describe which level will apply to which data and which specimens and at which sites. 
 
 
Level 3 data security protections will be used across all sites.  
 
b. Use this space to provide additional information, details, or to describe protections that do not fit into one of 
the levels. If there are any protections within the level listed in 9.6.a which will not be followed, list those 
here, including identifying the sites where this exception will apply. 
 
 
      
 
 
10 RISK / BENEFIT ASSESSMENT 
10.1 Anticipated risks. Describe the reasonably foreseeable risks of harm, discomforts, and hazards to the subjects 
and others of the research procedures. For each harm, discomfort, or hazard: 
• 
Describe the magnitude, probability, duration, and/or reversibility of the harm, discomfort, or hazard, AND 
• 
Describe how the risks will be reduced or managed. Do not describe data security protections here, these are 
already described in Question 9.6. 
• 
Consider possible physical, psychological, social, legal, and economic harms, including possible negative effects on 
financial standing, employability, insurability, educational advancement or reputation. For example, a breach of 
confidentiality might have these effects. 
• 
Examples of “others”: embryo, fetus, or nursing child; family members; a specific group.  
• 
Do not include the risks of non-research procedures that are already being performed.  
• 
If the study design specifies that subjects will be assigned to a specific condition or intervention, then the condition or 
intervention is a research procedure - even if it is a standard of care.  
• 
Examples of mitigation strategies: inclusion/exclusion criteria; applying appropriate data security measures to prevent 
unauthorized access to individually identifiable data; coding data; taking blood samples to monitor something that 
indicates drug toxicity. 
• 
As with all questions on this application, you may refer to uploaded documents. 
 
The risks of participating in this study are minimal. There are no identifiable social or legal risks associated with 
the proposed research. Ride-on cars are a common toy and many families with small children use the cars. 
Similarly, the Explorer Mini is an FDA-approved Class II Medical Device commonly used for children with 
mobility impairments. The foreseeable risks are primarily physical or psychological risks. This study is designed 
to reduce known potential risks. There are no known alternative procedures that can further reduce risk and 
provide the same type of scientific information.  
The potential risks to the subject are: 1) physical injury as a result of unsupervised device use; 2) fatigue resulting 
from device use; 3) electrical shock associated with battery-powered devices; 4) loss of confidentiality as a result 
of unauthorized access to participant data; and 5) emotional duress resulting from the discussion of potentially 
sensitive topics such as disability or child medical history. 
To mitigate these risks, 1) subjects will undergo safety and operations training and check-offs for appropriate 
device use; 2) Subjects will undergo training to limit device use as appropriate based on child’s individual 
fatigue/tolerance, and will be instructed to remove the child from the device if child is showing signs of 
discomfort or fatigue. 3) Any malfunctions, adjustments, repairs, or damages to the devices must be reported 
immediately to the research staff, and all repairs or replacements will be completed by trained research staff with 
expertise in engineering and rehabilitation. 4) All research-related documentation will use indirect identifiers of 

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subject codes and pseudonyms and be stored on a password encrypted computer and transferred to secure 
university servers, with the master list of subjects and subject codes stored in a separate, locked file cabinet in a 
locked office. 5)  Subjects will be reminded at each research session that their participation is voluntary and that 
they do not have to answer any question that might cause discomfort or stress. Further, the researchers will discuss 
discontinuation of participation with the subject, should the subject demonstrate visible signs of psychological or 
emotional stress. Each device will be registered with the research team contact information using the 
manufacturer-included product registration form, to ensure direct and timely notification of any product safety 
warnings/recalls.  
 
10.2 Reproductive risks. Are there any risks of the study procedures to men and women (who are subjects, or partner 
of subjects) related to pregnancy, fertility, lactation or effects on a fetus or neonate? 
Examples: direct teratogenic effects; possible germline effects; effects on fertility; effects on a woman’s ability to continue a 
pregnancy; effects on future pregnancies. 
 
X No 
→ If no go to question 10.3 
 
 
Yes 
→ If yes, answer the following questions: 
 
a. Risks. Describe the magnitude, probability, duration and/or reversibility of the risks. 
 
 
 
      
 
b. Steps to minimize risk. Describe the specific steps that will be taken to minimize the 
magnitude, probability, or duration of these risks. 
Examples: inform the subjects about the risks and how to minimize them; require a pregnancy test before 
and during the study; require subjects to use contraception; advise subjects about banking of sperm and 
ova. 
 
If the use of contraception will be required: describe the allowable methods and the time period when 
contraception must be used. 
 
 
 
      
 
c. Pregnancy. Describe what will be done if a subject (or a subject’s partner) becomes pregnant 
For example; will subjects be required to immediately notify study staff, so that the study procedures can be 
discontinue or modified, or for a discussion of risks, and/or referrals or counseling? 
 
 
 
      
10.3 MRI risk management. Answer this question only if the subjects will receive MRI scans. A rare but serious adverse 
reaction called nephrogenic systemic fibrosis (NSF) has been observed in individuals with kidney disease who 
received gadolinium-based contrast agents (GBCAs) for the scans. Also, a few healthy individuals have a severe 
allergic reaction to GBCAs. 
a. Describe how the renal function of subjects will be assessed prior to MRI scans and how that information will 
be used to exclude subjects at risk for NSF. 
 
      
b. Describe the protocol for handling a severe allergic reaction to the GBCA or any other medical 
event/emergency during the MRI scan, including who will be responsible for which actions.  
 
      

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10.4 Unforeseeable risks. Are there any research procedures that may have risks that are currently unforeseeable? 
Example: using a drug that hasn’t been used before in this subject population. 
 
X No 
 
 
 
Yes 
→ If yes, identify the procedures. 
 
 
 
      
10.5 Subjects who will be under regional or general anesthesiology. Will any research procedures occur while 
patients are under general or regional anesthesia, or during the 3 hours preceding general or regional anesthesia 
(supplied for non-research reasons)? 
 
X No 
 
 
 
Yes 
→ If yes, check all the boxes that apply. 
 
 
 
 
Administration of any drug for research purposes 
 
 
 
 
 
 
 
 
 
 
Inserting an intra-venous (central or peripheral) or intra-arterial line for research purposes 
 
 
 
 
 
 
Obtaining samples of blood, urine, bone marrow or cerebrospinal fluid for research 
purposes 
 
 
 
 
 
 
Obtaining a research sample from tissue or organs that would not otherwise be removed 
during surgery 
 
 
 
 
 
 
Administration of a radio-isotope for research purposes** 
 
 
 
 
 
 
Implantation of an experimental device 
 
 
 
 
 
 
Other manipulations or procedures performed solely for research purposes (e.g., 
experimental liver dialysis, experimental brain stimulation) 
 
 
 
 
 
 
If any of the boxes are checked: 
Provide the name and institutional affiliation of a physician anesthesiologist who is a 
member of the research team or who will serve as a safety consultant about the interactions 
between the research procedures and the general or regional anesthesia of the subject-
patients. If the procedures will be performed at a UW Medicine facility or affiliate, the 
anesthesiologist must be a UW faculty member, and  the Vice Chair of Clinical Research in 
the UW Department of Anesthesiology and Pain Medicine must be consulted in advance for 
feasibility, safety and billing. 
 
 
      
 
 
** If the box about radio-isotopes is checked: the study team is responsible for informing in advance 
all appropriate clinical personnel (e.g., nurses, technicians, anesthesiologists, surgeons) about the 
administration and use of the radio-isotope, to ensure that any personal safety issues (e.g., 
pregnancy) can be appropriately addressed. This is a condition of IRB approval. 

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10.6 Data and Safety Monitoring. A Data and Safety Monitoring Plan (DSMP) is required for clinical trials (as defined 
by NIH). If required for this research, or if there is a DSMP for the research regardless of whether it is required, 
upload the DSMP to Zipline. If it is embedded in another document being uploading (for example, a Study 
Protocol) use the text box below to name the document that has the DSMP. Alternatively, provide a description 
of the DSMP in the text box below.  
 
This study is a clinical trial funded by the NIH. The required DSMP will be uploaded to zipline.  
10.7 Un-blinding. If this is a double-blinded or single-blinded study in which the participant and/or relevant study 
team members do not know the group to which the participant is assigned: describe the circumstances under 
which un-blinding would be necessary, and to whom the un-blinded information would be provided. 
 
N/A 
10.8 Withdrawal of participants. If applicable, describe the anticipated circumstances under which participants will be 
withdrawn from the research without their consent. Also, describe any procedures for orderly withdrawal of a 
participant, regardless of the reason, including whether it will involve partial withdrawal from procedures and 
any intervention but continued data collection or long-term follow-up. 
 
We do not anticipate the need to withdraw any participants involuntarily, however, in cases where significant 
and consistent emotional distress of the child or caregiver is observed by the researcher, this would warrant 
withdrawal from the study without consent. Because participants will be temporarily using a ride-on car 
and Explorer Mini Device, procedures for orderly withdrawal and removal of the devices will include: 1) 
written and verbal communication of set use periods for each device (8 weeks +/- 5 day grace period). 
Written or verbal communication of device drop off and removal plan (set date for device drop off and 
pickup, explain pickup and disinfection procedures).  
10.9 Anticipated direct benefits to participants. If there are any direct research-related benefits that some or all 
individual participants are likely to experience from taking part in the research, describe them below: 
Do not include benefits to society or others, and do not include subject payment (if any). Examples: medical benefits such as 
laboratory tests (if subjects receive the results); psychological resources made available to participants; training or education 
that is provided.  
 
A direct benefit for participants will be to receive training, education, and trial use of two pediatric powered 
mobility devices.   
10.10 Return of individual research results. 
In this section, provide your plans for the return of individual results. An “individual research result” is any information 
collected, generated or discovered in the course of a research study that is linked to the identity of a research participant. 
These may be results from screening procedures, results that are actively sought for purposes of the study, results that are 
discovered unintentionally, or after analysis of the collected data and/or results has been completed. 
 
 See the GUIDANCE Return of Individual Results for information about results that should and should not be returned, validity 
of results, the Clinical Laboratory Improvement Amendment (CLIA), consent requirements and communicating results. 
 
a. Is it anticipated that the research will produce any individual research results that are clinically actionable? 
 
“Clinically actionable” means that there are established therapeutic or preventive interventions or other available 
actions that have the potential to change the clinical course of the disease/condition, or lead to an improved health 
outcome. 
 

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In general, every effort should be made to offer results that are clinically actionable, valid and pose life-threatening or 
severe health consequences if not treated or addressed quickly. Other clinically actionable results should be offered if 
this can be accomplished without compromising the research. 
 
X No 
 
 
 
Yes 
→ If yes, answer the following questions (a.1-a.3). 
 
a.1. Describe the clinically actionable results that are anticipated and explain which results, 
if any, could be urgent (i.e. because they pose life-threatening or severe health 
consequences if not treated or addressed quickly). 
 
Examples of urgent results include very high calcium levels, highly elevated liver function test results, 
positive results for reportable STDs. 
 
      
 
a.2. Explain which of these results will be offered to subjects.  
 
      
 
a.3. Explain which results will not be offered to subjects and provide the rationale for not 
offering these results.  
 
Reasons not to offer the results might include: 
• 
There are serious questions regarding validity or reliability  
• 
Returning the results has the potential to cause bias 
• 
There are insufficient resources to communicate the results effectively and appropriately 
• 
Knowledge of the result could cause psychosocial harm to subjects 
 
      
 
b. Is there a plan for offering subjects any results that are not clinically actionable? 
 
Examples: non-actionable genetic results, clinical tests in the normal range, experimental and/or uncertain results. 
 
 
No 
 
 
X Yes 
→ If yes, explain which results will be offered to subjects and provide the rationale for 
offering these results. 
 
 
For qualitative interview methods, it is common to provide subjects with de-identified, 
aggregate data summaries of main themes or findings as a way of Member Checking, 
which is a technique used to ensure data accuracy and avoid researcher 
misinterpretation of data. Broad themes, and not individual quotes, will be shared.  
 
c. Describe the validity and reliability of any results that will be offered to subjects. 
 
The IRB will consider evidence of validity such as studies demonstrating diagnostic, prognostic, or predictive value, 
use of confirmatory testing, and quality management systems. 
 
Member checking as described above, is part of the process of determining credibility and consistency of 
results, which in the qualitative research paradigm is akin to establishing validity and reliability.  
 
d. Describe the process for communicating results to subjects and facilitating understanding of the results. In 
the description, include who will approach the participant with regard to the offer of results, who will 
communicate the result (if different), the circumstances, timing, and communication methods that will be 
used. 
 
The research team will send a summary email to participants (using individual emails or BCC) describing 
the themes derived from the qualitative findings and encourage feedback or clarifying questions from the 
participants.  

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e. Describe any plans to share results with family members (e.g. in the event a subject becomes 
incapacitated or deceased). 
 
N/A 
 
f. Check the box to indicate that any plans for return of individual research results have been described in 
the consent document. If there are no plans to provide results to participants, this should be stated in the 
consent form. 
 
See the GUIDANCE Return of Individual Results for information about consent requirements. 
 
X Confirmed 
 
10.11 Commercial products or patents. Is it possible that a commercial product or patent could result from this 
study? 
 
X No 
 
 
 
Yes 
→ If yes, describe whether subjects might receive any remuneration/compensation and, if yes, 
how the amount will be determined. 
 
 
 
 
      
 
 
11 ECONOMIC BURDEN TO PARTICIPANTS 
11.1 Financial responsibility for research-related injuries. Answer this question only if the lead researcher is not a 
UW student, staff member, or faculty member whose primary paid appointment is at the UW. 
 
For each institution involved in conducting the research: Describe who will be financially responsible for 
research-related injuries experienced by subjects, and any limitations. Describe the process (if any) by which 
participants may obtain treatment/compensation. 
 
N/A 
11.2 Costs to subjects. Describe any research-related costs for which subjects and/or their health insurance may be 
responsible (examples might include: CT scan required for research eligibility screening; co-pays; surgical costs 
when a subject is randomized to a specific procedure; cost of a device; travel and parking expenses that will not 
be reimbursed). 
 
There are no research-related costs to participants of the study. Devices used in the study will be temporarily 
provided to families at no cost.  
11.3 Reimbursement for costs. Describe any costs to subjects that will be reimbursed (such as travel expenses). 
 
N/A 
 
 

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12 RESOURCES 
12.1 Faculty Advisor. (For researchers who are students, fellows, or post-docs.) Provide the following information 
about the faculty advisor.  
• 
Advisor’s name 
• 
Your relationship with your advisor (for example: graduate advisor; course instructor) 
• 
Your plans for communication/consultation with your advisor about progress, problems, and changes.  
 
N/A 
12.2 UW Principal Investigator Qualifications. Upload a current or recent Curriculum Vitae (CV), Biosketch (as 
provided to federal funding agencies), or similar document to the Local Site Documents page in Zipline. The 
purpose of this is to address the PI’s qualifications to conduct the proposed research (education, experience, 
training, certifications, etc.). 
For help with creating a CV, see http://adai.uw.edu/grants/nsf_biosketch_template.pdf and 
https://education.uwmedicine.org/student-affairs/career-advising/year-4/residency-applications/curriculum-vitae/  
 
X The CV will be uploaded. 
12.3 UW Study team qualifications. Describe the qualifications and/or training for each UW study team member to 
fulfill their role on the study and perform study procedures. (You may be asked about non-UW study team 
members during the review; they should not be described here.) You may list these individuals by name, 
however if you list an individual by name, you will need to modify this application if that individual is replaced. 
Alternatively, you can describe study roles and the qualifications and training the PI or study leadership will 
require for any individual who might fill that role. The IRB will use this information to assess whether risks to 
subjects are minimized because study activities are being conducted by properly qualified and trained 
individuals. 
Describe: The role (or name of person), the study activities they will perform, and the qualifications or 
training that are relevant to performing those study activities. 
 
 
Examples:  
Research Study Coordinator: Obtain consent, administer surveys, blood draw. Will have previous experience 
coordinating clinical research and be a certified phlebotomist in WA. 
Undergraduate Research Assistant: Obtain consent, perform all study procedures. Will have had coursework in 
research methods, complete an orientation to human subjects protections given by the department, and will 
receive training from the PI or the graduate student project lead on obtaining consent and debriefing subjects. 
Acupuncturist: Perform acupuncture procedures and administer surveys. Must be licensed with WA State DoH 
and complete training in administering research surveys given by the project director, an experienced survey 
researcher. 
Co-Investigator: Supervise MRI and CT scan procedures and data interpretation, obtain consent. MD, specialty in 
interventional radiology and body imaging. 5-years clinical research experience.  
 
 
 
 
 
Research Study Coordinator: Perform eligibility screening, obtain consent, administer surveys, maintain 
communication with families. Will have previous experience coordinating clinical research.  
Undergraduate or Graduate Research Assistant: Perform screenings, obtain consent, perform all study 
procedures. Will have had coursework in research methods, complete an orientation to human subjects 
protections given by the department, and will receive training from the PI regarding all study procedures.  

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Co-Investigator: Obtain consent, perform all study procedures. Will be a licensed rehabilitation professional (i.e. 
PT or OT and/or a PhD level investigator with required human subjects research training and past experience 
participating in or leading human subjects research.  
 
 
12.4 Study team training and communication. Describe how it will be ensured that each study team member is 
adequately trained and informed about the research procedures and requirements (including any changes) as 
well as their research-related duties and functions. 
 
 
There is no study team. 
 
 
 
 
Each member of the research team has a current CITI training certificate, and are versed in the 
management of subject data and ethics involved in human subjects research. Regular team meetings 
will occur throughout the research to ensure all team members are appropriately informed about the 
research procedures and data, as well as any unanticipated changes. Bi-monthly progress meetings 
will be held with all members of the research team. 
 
 
13 OTHER APPROVALS, PERMISSIONS, and REGULATORY ISSUES 
13.1 Approvals and permissions. Identify any other approvals or permissions that will be obtained. For example: from 
a school, external site/organization, funding agency, employee union, UW Medicine clinical unit. 
Do not attach the approvals and permissions unless requested by the IRB. 
 
UW will serve as the single IRB administrator for this study, and the UW HSD Reliance Team will coordinate 
additional approvals or permissions directly with Oregon State University and Grand Valley State University. 
13.2 Financial Conflict of Interest. Does any UW member of the team have ownership or other Significant Financial 
Interest (SFI) with this research as defined by UW policy GIM 10? 
 
X No 
 
 
 
Yes 
→ If yes, has the Office of Research made a determination regarding this SFI as it pertains to the 
proposed research? 
 
 
 
 
No 
→ If no, contact the Office of Research (206.616.0804, research@uw.edu) for  
guidance on how to obtain the determination 
 
 
 
Yes 
→ If yes, upload the Conflict Management Plan for every UW team member who has 
a FCOI with respect to the research, to Zipline. If it is not yet available, use the text 
box to describe whether the Significant Financial Interest has been disclosed 
already to the UW Office of Research and include the FIDS Disclosure ID if 
available.