Efficacy of a Telehealth Pain Self-Management Intervention in Employed Adults With Physical Disability: A Randomized Controlled Trial
Phase: NA
Conditions: Chronic Pain, Brain Injuries, Traumatic, Multiple Sclerosis, Spinal Cord Injuries, Amputation
Sponsor: University of Washington

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ZIPLINE APPLICATION: IRB Protocol 
 
 
 
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 your 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 your 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. 
• 
The word “you” refers to the researcher and all members of the research team, unless otherwise specified.  
• 
For collaborative research, describe only the information that is relevant to you unless you are requesting that the UW IRB 
provide the review and oversight for your collaborators 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: 
Efficacy of a Telehealth Pain Self-Management Intervention in Employed Adults 
with Physical Disability: A Randomized Controlled Trial 
 

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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 POLICY: Use of 
the UW IRB. 
 
The PI is housed out of University of Washington.  We are collaborating with people from Northwestern University 
and the Shirley Ryan AbilityLab. 
1.2 Consultation history. Have you consulted with anyone at HSD about this study? 
It is not necessary to obtain advance consultation. If you have: answering this question will help ensure that the IRB is aware 
of and considers the advice and guidance you were provided.   
 
 
No 
 
 
X Yes 
→ If yes, briefly describe the consultation: approximate date, with whom, and method (e.g., by email, 
phone call, in-person meeting). 
 
 
 
 
Study coordinator Carolyn Green spoke with Bailey Bodell over the phone on 6/11/2020 about 
establishing separate IRBs versus a single IRB of record. 
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. 
 
 
 
We are using the model from the “Telephone Intervention for Pain Study, “TIPS,” by Dawn Ehde 
but adapting it for persons with disability who are employed.  

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1.4 Externally-imposed urgency or time deadlines. Are there any externally-imposed deadlines or urgency that affect 
your 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.  
 
 
No 
 
 
X 
Yes 
→ If yes, briefly describe the urgency or deadline as well as the reason for it. 
 
 
 
We will not receive funding until the IRB is approved.   
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 your 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). 
 
Aim 1: Evaluate the efficacy of the telehealth pain self-management intervention, adapted for 
employees with physical disability, (“E-TIPS”), relative to a waitlist control in reducing pain 
interference (primary outcome) in adults with chronic pain and physical disability. 
Hypothesis 1.1. Participants randomized to E-TIPS will report greater improvements in pain interference 
(primary outcome, measured by PROMIS Pain Interference Scale) compared to participants assigned to 
control at post-treatment (12 weeks post-randomization, primary endpoint). 
Hypothesis 1.2. Improvements in pain interference will be maintained at 6 mo. post randomization. 
Although the long-term goal is to promote job retention and enhance employment in employees 
with chronic pain, we chose pain interference as the primary outcome due to its high association with 
disability and our ability to detect meaningful change within the study timeframe. We will conduct 
exploratory analyses to determine whether reductions in pain interference are associated with fewer 
missed days of work and other employment outcomes. 
Aim 2: Examine the effects of E-TIPS compared to control on secondary outcomes relevant to work, 
including self-efficacy for pain management, pain intensity, fatigue, mood, and days worked at 12 
weeks post-treatment and maintenance of effects at 6-month follow up. 
Hypothesis 2.1. Participants randomized to E-TIPS will report greater short-term (post-treatment) 
improvements in secondary outcomes compared with control. 
Hypothesis 2.2. Participants assigned to E-TIPS will retain treatment benefits at 6-months. 
Hypothesis 2.3. Within-subject outcome changes during the 12-week intervention period will be greater 
than during the waitlist time period. 
Aim 3: Evaluate factors, including treatment adherence, treatment satisfaction, and 
barriers/facilitators of implementation relevant to future dissemination and large-scale 

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implementation of E-TIPS in employed individuals with physical disabilities and chronic pain. We will 
collect measures of treatment adherence, satisfaction, and convenience from participants allocated to 
E-TIPS. We will assess barriers and facilitators to implementation from the participants’ perspectives by 
collecting information about other factors that influence participation. 
Hypothesis 3.1. Participants allocated to E-TIPS will demonstrate high treatment adherence (defined as 
attending > 6/8 sessions) and report being highly satisfied with the treatment (> 8 on 0-10 numeric 
rating scale). 
 
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. 
 
We propose a randomized (1:1), single blind parallel-group trial comparing the TIPS telehealth pain self-
management intervention, adapted to address employment issues (E-TIPS), to a waitlist control in 
adults with physical disabilities and chronic pain who are employed. 
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. 
 
 
 
 
 
 
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. 
 
 
 
 
 
 
 
 

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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: 
 
 
 
 
 
 
 
      
1.8 Background, experience, and preliminary work. Answer this question only if your 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 your proposed activity, based 
on existing literature (or clinical knowledge). Describe the gaps in current knowledge that your 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. 
 
Chronic pain is one of the most prevalent, disabling, and persistent comorbid conditions 
associated with physical disabilities, including LL, SCI, TBI, and chronic neurodegenerative conditions 
such as MS and PD.12 One-half to two-thirds of adults with these conditions experience chronic 
pain.12,16,18-20 In addition to being associated with disability,8,9 depression, 21,22 sleep disruption, and 
physical inactivity,11-14,84-89chronic pain has deleterious social and societal costs, including job loss 
and reliance on long-term disability programs.9,10 11 
Analgesic medications rarely provide adequate pain relief for people with chronic pain and 
physical disabilities24,30-35 and often have undesirable side-effects such as sedation or abuse 
disorders, which affect job performance and retention.36,37 Thus, people with physical disabilities 
are increasingly interested in nonpharmacological approaches to pain management.82 Paralleling 
this trend, pain self-management, based on cognitive behavioral theory (CBT) intervention 
strategies, is recognized increasingly as a valuable treatment for chronic pain and its effects on 
function, including for those with physical disabilities.83-86 Multiple meta-analyses have concluded 
that CBT is efficacious in reducing pain severity and interference and in improving functon in adults 
and children across a wide range of conditions.40,93 A National Academies of Sciences, Engineering, 

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and Medicine consensus report on pain management and the opioid epidemic8 concluded that 
nonpharmacologic interventions for pain, including physical therapy, exercise, CBT, and meditation 
may provide effective pain relief instead of, or in combination with medication. 
 
 
b. Experience and preliminary work. Briefly describe experience or preliminary work or data (if any) that you or 
your team 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: You have already conducted a Phase 1 study of an experimental drug which 
supports the Phase 2 study you are now proposing to do; you have already done a small pilot study showing that the 
reading skills intervention you plan to use is feasible in an after-school program with classroom aides; you have 
experience with the type of surgery that is required to implant the study device; you have a study coordinator who is 
experienced in working with subjects who have significant cognitive impairment. 
 
 
Ground-breaking research conducted by Dr. Ehde’s team supports the use of self-management 
interventions for chronic pain in people with physical disabilities. She has conducted multiple RCTs 
that demonstrated the benefits of CBT-based self-management interventions for reducing pain in 
adults with LL,87,88 MS,83,85,88,89 SCI,88 and TBI.90 Other outcomes relevant to employment also 
improved, such as reductions in pain interference, depression, and fatigue, and increases in self-
efficacy for managing pain. Across these trials, pain self-management interventions resulted in 
clinically meaningful reductions in pain intensity for 33%91 to 47% of participants. 
Pain self-management interventions are underutilized, both in the general population and in 
people with physical disabilities.31,32,35 One of the biggest barriers to their use is reliance on face-to-
face delivery, in a clinical setting, during business hours, which limits access to people with physical 
disabilities who are employed. They must take time off to attend multiple treatment sessions, 
overcome transportation barriers, and contend with the stigma of seeking behavioral healthcare. In 
addition, an insufficient number of clinicians are trained in behavioral pain interventions for 
individuals with physical disabilities.40 
Telehealth has considerable potential for expanding the reach of pain self-management 
interventions in employed people with physical disabilities. Remote technology can transcend 
geographical barriers and target larger populations. These approaches also have inherent scalability 
and are easy to centralize for public health dissemination.42 Remote delivery can reduce stigma and 
lower the threshold for treatment initiation, given that it can be used in the privacy of one’s home. 
Telehealth approaches are also less expensive than traditional psychotherapy.42 
Dr. Ehde’s team has conducted a series of RCTs demonstrating the efficacy and acceptability of 
telehealth interventions in diverse populations; for example, an 8-session, 1:1, telephone 
intervention resulted in significant reductions in pain, fatigue, and depressive symptoms in more 
than half of study participants with MS.83 Benefits were maintained at 6- and 12-months, and 
treatment adherence and satisfaction were high – 88% of participants completed all 8 sessions and 
94% completed at least 4. 
Dr. Ehde recently completed an RCT (N=188) on the efficacy of a telehealth pain self-
management intervention (Telephone Intervention for Pain Study, “TIPS”).88 Participants with MS, 
SCI, or LL were assigned randomly to either TIPS or a pain education intervention. All participants 
received 8, 45-minute individual sessions delivered telephonically by postdoctoral psychology 
fellows or psychologists. Participants allocated to TIPS had a statistically significant decrease in 

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average pain intensity from pre- to post-treatment; further reductions in average pain intensity 
were observed at 6- and 12-month. Furthermore, 36% of those assigned to TIPS had a clinically 
meaningful reduction in average pain intensity from pre- to post-treatment. Participants rated the 
treatment as highly helpful and telehealth delivery as convenient; 98.5% reported that they would 
recommend the treatment to a friend with physical disability. In sum, this study demonstrated: (1) a 
decrease in pain intensity over the 12- month course of treatment; (2) that therapeutic alliance was 
not compromised by telehealth delivery; and (3) that participants with disability and pain found the 
treatment highly beneficial and convenient. Adherence was excellent with 90% completing all 8 
sessions and 91% completing all assessments. 
 
1.9 Supplements. Check all boxes that apply, to identify Supplements you should complete and upload to the 
Supporting Documents SmartForm in 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. 
ZIPLINE SUPPLEMENT: 
Department of Defense 
 
 
 
 
 
 
 
 
 
 
 
 
Department of Energy 
The research involves Department of Energy funding, facilities, data, or 
personnel. 
ZIPLINE SUPPLEMENT: 
Department of Energy 
 
 
 
 
 
 
 
 
 
 
 
 
Drug, biologic, botanical, supplement 
Procedures involve the use of any drug, biologic, botanical or 
supplement, even if the item is not the focus of your research 
ZIPLINE SUPPLEMENT: 
Drugs 
 
 
 
 
 
 
 
 
 
 
 
 
Emergency exception to informed consent  
Research that requires this special consent waiver for research involving 
more than minimal risk 
ZIPLINE 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 you are asking the UW to provide the required 
certification or to ensure that the consent forms can be certified 
ZIPLINE SUPPLEMENT: 
Genomic Data Sharing 
 
 
 
 
 
 
 
 
 
 
 
 
Medical device 
Procedures involve the use of any medical device, even if the device is 
not the focus of your research, except when the device is FDA-approved 
and is being used through a clinical facility in the manner for which it is 
approved 
ZIPLINE SUPPLEMENT: 
Devices 
 
 
 
 
 
 
 
 
 
 
 
 
Multi-site study 
You are asking the UW IRB to review one or more sites in a multi-site 
study. 
ZIPLINE SUPPLEMENT: 
Participating Site in Multi-
Site Research 
 
 
 
 
 
 
 
 

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Participant results sharing 
Individual research results will be shared with subjects. 
ZIPLINE SUPPLEMENT: 
Participant Results 
Sharing 
 
 
 
 
 
 
 
 
 
 
 
 
None of the above 
 
 
 
x 
 
 
 
 
 
 
 
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. 
 
Adults with physical disabilities from across the US.   
2.2 Inclusion and exclusion criteria.  
a. Inclusion criteria. Describe the specific criteria you will use to decide who will be included in your study from 
among interested or potential subjects. Define any technical terms in lay language. 
 
(1) 18 years of age or older; (2) self-reported physical disability (including multiple sclerosis, spinal cord injury, 
traumatic brain injury, and/or amputation/limb loss) ; (3) chronic pain defined as daily pain of > 3 months 
duration and >3 average pain intensity in the past week on a 0-10 numerical rating scale;95 (4) experiences 
pain for more than 45 out of the past 90 days (defined as 50% of the time or greater); (5) reads, speaks and 
understands English; (6) has access and is able to communicate over the telephone and internet with or 
without assistive devices; and (7) is employed, working 15-20 hours per week or more, on average, or earning 
in excess of substantial gainful activity (approximately $1200/month).  
 
We will enroll individuals with a range of physical disabilities, because there is no evidence that the type of 
disability affects responsiveness to the proposed treatment;40 to maximize the generalizability of the results. 
b. Exclusion criteria. Describe the specific criteria you will use to decide who will be excluded from your study 
from subjects who meet the inclusion criteria listed above. Define any technical terms in lay language. 
 
(1) Under the age of 18; (2) cannot read, speak, or understand English; (3) no self-reported physical 
disability; (4) currently unemployed; (5) plans to retire or leave employment within the study period; 
(6) earning less than approximately $1200 per month and working fewer than 15-20 hours per week, 
on average; (7) cannot communicate or complete assessments over the phone or internet; (8) chronic 
pain defined as daily pain of ≤ 3 months duration and ≤ 3 average pain intensity in the past week on a 
0-10 numerical rating scale; (9) experiences pain for fewer than 45 out of the past 90 days (defined as 
50% of the time or less); (10) currently participating in another chronic pain study or cognitive 
behavioral therapy (CBT) study 
 
We elected to minimize exclusion criteria to maximize generalizability to the population of employed 
individuals with chronic pain. Participants may continue pharmacological treatments and other 
treatments for pain. 

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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 you recruit or obtain data from individuals that you know 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 
 
 
 
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 opportunity for 
earnings in prison will be so great that it will make it difficult for prisoners to adequately 
consider the research risks. What will you do to reduce the chances of this? 
 
      
 
iii. Describe what you will do to make sure that (a) your 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. 
 
      
 
iv. If your research will involve prisoners in federal facilities or in state/local facilities outside of 
Washington State: check the box below to provide your assurance that you 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 your research likely to have subjects who become prisoners while participating in your 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. 
 
x 
No 
 
 
 
Yes 
→ If yes, if a subject becomes a prisoner while participating in your study, will you continue the 
study procedures and/or data collection while the subject is a prisoner? 
 
 
 
 
No 
 
 
 
Yes 
→ If yes, describe the procedures and/or data collection you will continue with 
prisoner subjects 
 
 
 
      

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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 you will purposefully include in your research. (In other words, being a part of 
the population is an inclusion criterion for your 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 you think may be relevant for 
the IRB to consider.  
 
      
2.5 Native Americans or non U.S. indigenous populations. Will you actively recruit from Native American or non-U.S. 
indigenous populations 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 you will obtain tribal/indigenous approval before beginning your research. 
 
 
 
 
      
2.6 Third party subjects. Will you collect private identifiable information about other individuals from your 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 your 
research team to readily identify the person. For example, suppose that you are studying immigration history. If you ask your 
subjects several questions about their grandparents but you do not obtain names or other information that would allow you to 
readily identify the grandparents, then you are not collecting private identifiable information about the grandparents.  
 
 
No 
 
 
x 
Yes 
→ If yes, these individuals are considered human subjects in your study. Describe them and what 
data you will collect about them. 
 
 
 
 
We will collect collateral contact data from participants. We typically do this in case of needing 
other people to contact to get ahold of the subject during time of research.  

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2.7 Number of subjects. Can you predict or describe the maximum number of subjects (or subject units) you need to 
complete your 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 your research. 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 you plan to study in the context of risks and benefits. You may submit a Modification 
to increase this number at any time after you receive IRB approval. If the IRB determines that your research involves no more 
than minimal risk: you may exceed the approved number and it will not be considered non-compliance. If your research 
involves more than minimal risk: exceeding the approved number will be considered non-compliance.  
 
 
No 
→ If no, provide your rationale in the box below. Also, provide any information you can about the 
scope/size of the research. You do not need to complete the table. 
 
 
 
 
Example: you may not be able to predict the number of subjects who will complete an online survey 
advertised through Craigslist, but you can state that you will post your survey for two weeks and the number 
who respond is the number who will be in your study. 
 
 
      
 
x Yes 
→ If yes, for each subject group, use the table below to provide your 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 
*For clinical trials: provide numbers for your site and for 
the study-wide total number 
 
People with physical disabilities 
200 
 
      
      
 
      
      
 
      
      
 
      
      
 
      
       
 
 

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3 NON-UW RESEARCH SETTING  
Complete this section only if your research will take place outside of UW and Harborview 
3.1 Reason for sites. Describe the reason(s) why you selected the sites where you will conduct the research. 
 
The research will be conducted at the University of Washington because the UW Primary Investigator has been a 
professor here at the UW Rehabilitation Medicine Department for many years and has her own experienced 
team of research staff.  Furthermore, Dr. Ehde is the creator of the TIPS intervention. 
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 your 
research or how it is conducted. 
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. 
 
This federal site maintains an international list of human research standards and requirements: 
 http://www.hhs.gov/ohrp/international/index.html  
 
n/a 
3.3 Site-specific laws. Describe any local laws that may affect your 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. 
 
n/a 
3.4 Site-specific administrative or ethical requirements. Describe local administrative or ethical requirements that 
affect your research.  
Example: A school district may require you to obtain permission from the head district office as well as school principals before 
approaching teachers or students; a factory in China may allow you to interview factory workers but not allow you to pay 
them. 
 
n/a 
3.5 Students: Does your research involve traveling outside of the US?  
 
x 
No 
 

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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 your 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 you will identify, recruit, and screen subjects. 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. 
 
We will recruit from the UW Rehabilitation Research Registry of 8,000+ adults with physical 
disabilities from across the US, which includes adults with a range of physical disabilities, including 
LL/amputation, MS, SCI, and TBI. About 30% of persons in the UW Registry are employed, and >50% 
report chronic pain. Research study coordinators will prescreen the medical records of patients in this 
registry to ensure they meet basic eligibility criteria including age, disability diagnosis, and employment 
status.  
 
We will recruit participants from the waitlist for the ADAPT study (STUDY00004422). The ADAPT 
study currently has a waitlist of 300+ potential participants who have indicated interest in pain research 
and the ADAPT study (in addition to future interested participants), but is only able to enroll 
approximately 140 additional study participants. Research study coordinators will prescreen the 
medical records of patients on this list to ensure they meet basic eligibility criteria including age, 
disability diagnosis, and employment status. 
 
We will recruit participants with multiple sclerosis from clinic referrals from the UW MS Center and 
from the UW MS Center’s Research Pool (STUDY00005250) of approximately 400 adults with multiple 
sclerosis who have previously indicated interest in research. Research study coordinators will prescreen 
the medical records of patients in this pool to ensure they meet basic eligibility criteria including age, 
disability diagnosis, and employment status. 
 
We will recruit participants with multiple sclerosis, traumatic brain injury, spinal cord injury, and/or 
amputation/limb loss from social media websites including but not limited to Facebook, LinkedIn, 
Discord, Reddit, and Twitter. Social media posts on these pages may be posted on UW and SRALab-
associated pages or on the pages “liked” by members of our target audience, such as the MS Society’s 
Facebook page. The study may also be posted on relevant Facebook groups. The social media posts may 
include a graphic similar to the uploaded clinic flyer (modified to fit on the specific site), a description of 
the study similar to the uploaded web description, and a self-administered pre-screening survey (see 
Section 4.2) that will collect basic demographic and contact information from interested participants. 
 
We may recruit participants who are found ineligible for the TELEPOP Study at UW 
(STUDY00004135). The TELEPOP study recruits from the following sources: the Northwest Regional 
Spinal Cord Injury System (NWRSCIS) email list, Researchmatch.org, Facebook, SCI websites, and the 
NWRSCIS Model System database. The TELEPOP study also recruits participants who previously 

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participated in the SCI-CARE Study at UW (STUDY 43302) and consented to be contacted for future 
research. The primary recruitment source for the SCI-Care study was through pre-screening the clinical 
schedules for the UW and HMC rehabilitation clinics. We will receive names, contact information, and 
reasons for ineligibility from the TELEPOP Study lists. We may also recruit participants from the TBI Care 
Study at the University of Washington. We will receive names and contact information from lists 
generated by research staff involved with the TBI Care Study. Participants in the TBI Care study are 
asked on the consent form if they are willing to be contacted by other studies, and we will only be 
contacting those who respond, "yes." The TBI Care Study will also receive IRB approval to share their 
participant list with the E-TIPS Study team. 
 
The UW Medicine Rehabilitation Medicine clinics, the UW Rehabilitation Medicine Participant Pool, 
and NIDILRR TBI Model System and Healthy Aging RRTC are also potential recruitment sources. 
Participants may receive information about the study by mail or email from staff at these clinics, and 
study flyers will be posted in various areas around UW, SRALab, and other rehab hospitals. We will also 
recruit from SRALab’s VR and Day Rehabilitation programs which include individuals with a range of 
physical disabilities. We will advertise the study on ClinicalTrials.gov, the University of Washington 
Institute of Translational Health Services (ITHS) site, the UW MS Center site, in InMotion Magazine, and 
on consumer organization websites such as the National MS Society, ResearchMatch, the Amputee 
Coalition, ADA.gov, the South Carolina Spinal Cord Injury Association, other support and advocacy 
groups for people with disabilities, as well as any corresponding social media channels. We will also 
advertise the study as a potential opportunity for volunteers on Craigslist. Previous participants may 
share information about the study (such as study description, link to pre-screening survey, graphics and 
flyers) with others in their community. 
 
We will also use LEAF, a tool from the ITHS to identify potential participants. LEAF allows 
researchers and investigators to query the electronic health records of UW Medicine patients using 
search terms that are relevant to the research. For example, we may search for participants by age, 
employment status, and diagnosis. If a participant appears to be eligible based on our query in LEAF, we 
will then look up their MRN in EPIC and obtain their contact information for the purpose of recruitment. 
 
Recruitment and Enrollment. We will use procedures from past RCTs in which we have met our 
enrollment goals and retained >90% of our participants.83,85,94,96 Interested individuals will complete a 
telephone screening, during which they will learn about the study and have their eligibility confirmed by 
research staff. Research staff may email appointment confirmations and reminders to potential 
participants prior to screening.  
 
If potential participants are found to be ineligible during the telephone screening, we will offer to 
email a list of other studies they might be eligible for and interested in. Participants who were found to 
be ineligible at the initial screening may be contacted in the future to be re-screened. We will note 
whether or not a participant has been screened before in REDCap, and, if found eligible, they will follow 
the consent process before participating in the study. If found to be ineligible after enrollment (e.g., 
following completion of the baseline assessment), participants may be withdrawn. 
 

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4.2 Recruitment materials.  
 
a. What materials (if any) will you use 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. 
 
We will use social media posts, advertisements or announcements on relevant websites, written 
materials (such as flyers and brochures), emails, and letters. Social media posts may include a self-
administered pre-screening survey that will be used to collect demographic information such as age, 
employment status, disability diagnoses, average pain rating in the past week, name, email address, 
and phone number from interested participants. Participants who learn about the study via social 
media and click the pre-screening survey link in social media posts will be directed to complete the 
pre-screening survey in REDCap, WebQ, or Google Forms. Participants who complete the pre-
screening survey but do not meet the study criteria for pain, employment status, and disability 
diagnosis will receive an email informing them they are not eligible for the E-TIPS Study at this time, 
along with links to other resources for potential research participation. Participants who do appear to 
be eligible based on their responses to the pre-screening survey will be contacted by study staff and 
go through the usual screening and consent process. 
 
We have a recruitment script and screening form that research staff will use to conduct the screening. 
We request approval to make minor changes to recruitment materials (e.g. minor word changes, 
formatting and contact information) without submitting a modification. Any changes to ‘cold 
recruitment’ materials mailed to UW Medicine patients will be submitted for IRB approval. 
b. Upload descriptions of each type of material (or the materials themselves) to the Consent Forms and 
Recruitment Materials SmartForm of Zipline. If you will send letters to the subjects, the letter should include a 
statement about how you obtained the subject’s name, contact information, and any other subject-specific 
information (such as a health condition) that is mentioned 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: 
• 
You could 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, you might 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). In doing so, you would not 
need to submit a Modification if/when the study phone number or contact person changes. Also, instead of listing the 
inclusion/exclusion criteria, you 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, you might 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).  

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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). 
 
x 
No 
 
 
 
Yes 
→ If yes, describe the nature of the relationship. 
 
 
 
      
4.4 Payment to participants. Describe any payment you will provide, 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.  
Payment of $25 per assessment with a bonus of $25 for completion of all assessments (up to $125 total). 
Payment of $25 for those participants randomly selected for additional post treatment conversation. 
4.5 Non-monetary compensation. Describe any non-monetary compensation you will provide. Example: extra credit 
for students; a toy for a child. If you will be offering class credit to students, you must provide (and describe) an 
alternate way for the students to earn the extra credit without participating in your research.  
n/a 
4.6 Will you access or obtain data or specimens 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 any data and/or specimens (including PHI) you will access or obtain for recruiting 
and screening and whether you will retain it as part of the study data. 
 
 
 
Research staff may review medical records for pre-screening purposes without consent from 
patients. Specifically, research staff may access the medical records of UW Medicine patients to 
identify individuals with a physical disability such as MS, SCI, TBI, or amputation who may be 
appropriate for the study. We will access names and contact information of those who may be 
eligible. If available, we will also look in patients’ medical records for employment status and 
disability diagnosis.  
 
The pre-screening survey that interested participants may access through social media posts will 
collect demographic information such as age, employment status, disability diagnosis, and average 

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pain rating, as well as contact information such as full name, phone number, and email address. 
These data will be used for the purpose of recruitment and screening only. 
 
In addition, research staff will ask interested patients a set of formalized questions to determine 
eligibility based on the inclusion/exclusion criteria, including disability diagnosis, employment 
information, previous participation in pain and treatment studies, and pain characteristics. The 
staff will obtain non-written consent to ask the eligibility questions before initiating the screening 
process.    
 
We will retain responses to screening questions and, for those who decline or are ineligible, 
reasons for their ineligibility or for declination.  
 
If subjects are eligible but decline to participate, we will ask them some demographics questions. 
We request approval to make minor changes to screening materials (e.g. minor word changes, 
formatting, order of questions) without submitting a modification. 
4.7 Consent for recruiting and screening. Will you obtain consent 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.  
 
 
No 
→ If no, skip the rest of this section; go to question 5.1. 
 
x 
Yes 
→ If yes, describe the consent process. 
 
 
 
We will obtain verbal consent to ask questions to determine eligibility or to ask additional 
demographics questions if subjects decline participation. We are requesting a waiver of consent 
and documentation of consent for the self-administered pre-screening survey for potential 
participants who respond via social media. 
 
a. Documentation of consent. Will you obtain a written or verifiable electronic signature from the 
subject on a consent form to document consent for all of the recruiting and screening 
procedures? 
 
x 
No 
→ If no, describe the information you will provide during the consent process and 
for which procedures. 
 
 
 
 
See recruitment script. 
 
 
Yes 
→ If yes, upload the consent form to the Consent Forms and Recruitment Materials 
page of Zipline. 
 
 
 
 
 

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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), use of records, time required, 
and setting/location. If it is available and you think it would be helpful to the IRB: Upload a study flow sheet or 
table to the Supporting Documents SmartForm in 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. 
  
Subjects will be screened over the phone and, if found eligible, will arrange a date/time with the study 
coordinator for an additional phone call to review the consent form and engage in the consent process. After 
consenting to participate in the study, subjects will be asked by the coordinator over the phone any medication 
information, and will then be sent a link to complete a baseline survey online. The baseline survey will include 
demographic questions and questions about the participant’s diagnosis, employment, and pain history.  
 
Following completion of the survey, subjects will be randomized to either usual care or the treatment group (E-
TIPS). Study staff will inform subjects of their assignment and, for those assigned to the E-TIPS treatment, arrange 
a time for their first treatment session. Participants in both groups will complete REDCap assessments at baseline 
(within one month prior to randomization), six weeks after randomization, ten weeks after randomization, and 
six months from randomization. The E-TIPS group will also attend eight 45-60-minute teleconference sessions 
with therapists over the first 8-10 weeks of treatment and complete home activities between each session using 
the E-TIPS Participant Manual. Each REDCap assessment will take around 20-30 minutes to complete and each 
therapy session will last around 45 min-60 min. Therapists will also conduct one 10-15-minute “booster session” 
with participants approximately two weeks after the final treatment session. Therapy will be administered via 
telephone, therefore subjects will need to have access to a telephone as well as the Internet to complete surveys. 
Since the private telephone sessions may be recorded, therapists will make an announcement at the beginning of 
each session letting participants know that their communication will be recorded for purposes of treatment 
fidelity monitoring. The sessions will teach subjects a variety of cognitive behavioral skills for managing pain that 
have been used in our past research studies using the TIPS intervention. These including teaching them basic 
relaxation skills, strategies for pacing activities, managing pain flare ups, and learning how to change their 
thoughts to better manage their pain and become aware of how their thoughts can influence their emotions and 
physical state. They will also discuss in the sessions how to integrate these pain management skills into their daily 
lives, including at work as needed. The home activities will include relaxation exercises as well as “thought record 
forms (i.e., worksheets),” which are used in most CBT treatments. Participants may discuss the thought records 
and other home practice activities they complete using the Participant Manual with therapists, and therapists 
may use this discussion of home practice activities to gauge participant engagement. We request approval to 
make minor changes to the Participant Manual (e.g. minor word changes and formatting adjustments) without 
submitting a modification. 
 
After the 6-month assessment, the usual care group will be offered treatment. While in usual care, participants 
are free to continue or start any treatment they decide.  It is not necessary that they refrain from seeking out 
mental health or other services. 
 
We will randomly select up to 20 participants proportionally to the diagnostic group domain included in the 
broader sample and interview them about their experience with E-TIPS treatment. As this is qualitative research, 
the final sample size will be determined by the point we reach thematic saturation, meaning the point when we 
are no longer learning new information about the topic/question at hand. We will interview participants by 
audio-only Zoom using an interview guide. Audio-only Zoom has been selected for ease of recording and 

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obtaining transcripts for analyses. We will ask participants what they found helpful and not helpful about their 
treatment and about the barriers and facilitators to the treatment. We will then perform a content analysis. 
5.2 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 5.3. 
 
 
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 a 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. 
 
      
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: 
      

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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 your MRI scan(s). Describe 
the dose you will use and (if it is more than the standard clinical dose 
recommended by the manufacturer) why it is necessary to use a higher 
dose. If you plan to use a linear GBCA, explain why you cannot use a 
macrocyclic GBCA. 
 
       
 
2.) Information for subjects. Confirm by checking this box that you will either 
provide subjects with the FDA-approved Patient Medication Guide for this 
GBCA you are using 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: 
 
      
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 listed on the Study Team addendum. 
5.3 Data variables. Describe the specific data you will obtain (including a description of the most sensitive items). If 
you would prefer, you may upload a list of the data variables to the Supporting Documents SmartForm instead of 
describing the variables below. 
 
Baseline Data and Demographic Information 
After obtaining informed consent, research staff will ask the participant to provide demographic data (e.g., date 
of diagnosis, cause of injury, age, zip code, biological sex at birth, gender identity, ethnicity, Race, marital status 
and years of education) for descriptive purposes. We will also ask participants about pain type, quality, and 
location as well as activity levels and current pain medications and treatments.  
 
Personal Contact Information 
Research staff will collect the following information from participants: (1) contact information; (2) preferred 
telephone number to reach an individual if they have more than one line; (3) permission to leave message on 

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mobile/landline phones; (4) permission to send a text message reminder for treatment sessions and, if yes, cell 
phone carrier; (5) time zone and best times/days to reach participant; (6) email address; (7) home address; (8) zip 
code, (9) preferred communication method; (10) names and contact information of people staff are allowed to 
contact if participant is lost to follow-up or otherwise cannot be contacted (i.e., collateral contacts). 
 
Assessments 
Participants will be asked questions about pain interference, pain intensity, pain self-efficacy, fatigue severity, 
depressive symptoms, sleep disturbance, vocational outcomes, social roles and activities, pain anxiety, the 
impact of COVID-19, and more. Therapists will make note of treatment attendance via REDCap and ask 
participants about treatment satisfaction and adherence to home practice. Therapists will also note duration of 
session, where participant was located during session, and whether or not the call took place during working 
hours. 
 
Post-treatment qualitative interviews 
We will ask participants about their overall experience with E-TIPS treatment intervention, experience during the 
active phase of treatment, skill development and maintenance since ending E-TIPS, and access to pain self-
management treatment. 
5.4 Data sources. For all types of data that you will access or collect for this research: Identify whether you are 
obtaining the data from the subjects (or subjects’ specimens) or whether you are obtaining the data 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. 
 
We will be obtaining data from participants via telephone and online surveys administered through REDCap. We 
will prescreen the medical records of some participants in EPIC to obtain confirmation of disability diagnosis and, 
if eligible, employment information. 
5.5 Retrospective/prospective. For all types of data and specimens that you will access or collect for this research: do 
all data and specimens to be used in the research exist (for example, in subjects’ medical records) at the time this 
application is being submitted for initial review? 
 
x 
No 
 
 
 
Yes 
 
Include any necessary comments or explanation below (Note that for most studies this can be left blank): 
 
      

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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 to assist you in identifying 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 your 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.  
 
 
 
Study coordinators and assistants will be able to access identifiable information in the 
REDCap databases and the WebQ database (the main study database as well as the 
database used to collect information from the self-administered pre-screening survey)  in 
order to contact participants and collect assessments. Study coordinators will also have 
access to names, contact information, and medical record numbers from recruitment 
sources such as Participant Pools, clinic referrals, coding lists, and other studies. Clinicians 
will have access to names and contact info plus other identifying information in order to 
conduct the treatment sessions. 
 
 
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.  
 
 
 
 
 
 
Identifiers or the key have been (or will have been) destroyed before you have 
access.  
 
 
 
 
 
 
You have (or will have) entered into an agreement with the holder of the identifiers (or 
key) that prohibits the release of the identifiers (or key) to you under any circumstances. 
 
 
 
 
 
 
You should be able to produce this agreement for IRB upon request. 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 to 
you. Describe them below. 
 
 
 
 
 
 
      

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b. Will you obtain any direct or indirect identifiers? 
 
x 
Yes 
→ If yes, describe which identifiers and for which data/specimens. 
 
 
 
 
Research staff members will obtain first and last names, addresses, telephone numbers, 
and/or email addresses. For everyone we contact for recruitment purposes, we will 
also collect, at minimum, first and last name and a telephone number; if available, we 
will also collect mailing or email addresses as well as job title and job description. The 
one exception is if a prospective participant contacts researchers first and only 
provides limited information (e.g., a participant sees a flyer in a clinic and leaves a 
voicemail with only her first name and telephone number). 
 
 
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 you have 
access.  
 
 
 
 
 
 
You have (or will have) entered into an agreement with the holder of the identifiers (or 
key) that prohibits the release of the identifiers (or key) to you under any circumstances.   
 
 
 
 
 
 
You should be able to produce this agreement for IRB upon request. 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 to 
you. Describe them below.   
 
 
 
 
 
 
      
c. If you obtain any identifiers, indicate how the identifiers will be stored (and for which data). NOTE: Do not 
describe your data security plan here – we will ask for that information in section 9.6. 
 
 
You will store the identifiers with the data. Describe the data to which this 
applies: 
 
x 
 
 
 
 
Identifiers (first and last name, email, phone number) will be linked to responses to the 
pre-screening survey and stored in WebQ.  
 
 
You will store identifiers and study data separately but you will maintain a link 
between the identifiers and the study data (for example, through the use of a 
code). Describe the data to which this applies: 
 
x 
 
 
 
 
Participant identifiers will be kept in a password-protected database on the 
department's secure server and in the password-protected E-TIPS REDCap databases. 
The link between the study data and a participant's identity in the form of the unique 
study code will only exist in the password-protected database on the department's 
secure server (which only research staff members will know the password for) and in the 
password-protected REDCap databases. 
 
 
 
 

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You will store identifiers separately from the study data, with no link between 
the identifiers and the study data. Describe the data to which this applies: 
 
 
      
d. Research collaboration. Will individuals who provide you with coded information or specimens for 
your 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. 
      
5.7 Newborn dried blood spots. Will you use newborn dried bloodspots collected in the United States on or after 
March 18, 2015 AND will you obtain the bloodspots before January 21, 2019? 
 
x 
No 
 
 
 
Yes → If yes, is this research supported by any federal funding (including any fellowship or career 
development award that provides salary support)? 
 
 
 
 
 
No 
 
 
 
Yes 
→ If yes, describe how you will ensure that the bloodspots were collected with 
parental permission (in compliance with a 2015 law that applies to federal-funded 
research). 
 
 
      
5.8 Protected Health Information (PHI). Will you access, obtain, use, or disclose a participant’s identifiable PHI 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. If you will use UW Medical 
Records, you must answer yes to this question. 
 
 
No 
→ If no, skip the rest of this question; go to question 5.9 
 
x 
Yes 
→ If yes, answer all of the questions below. 
 
 
a. Describe the PHI you will access or obtain, and the reason for obtaining it. Be specific. 
 
We will access patient names, contact information (telephone number and email address), 
mailing address, employment status (if available), medical record numbers, and disability 
diagnosis for recruitment purposes.  
b. Is any of the PHI located in Washington State? 
 
 
No 
 
 
x 
Yes 
 
c. Describe how you will access or obtain the PHI. Be specific. 
 
PHI will be sent to us via referrals from physicians at the UW Medical Center or Harborview 
Medical Center or coding lists from UW Medicine. We will also access PHI for purposes of 
recruitment using the waitlist for the ADAPT study (STUDY00004422) and the UW MS Center’s 
Research Pool (STUDY00005250) as well as the Rehab Medicine Department Participant Pool, the 

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TELEPOP Study, or LEAF, a tool from the ITHS. We may access PHI by looking up the medical 
record numbers of potential participants in EPIC. 
d. For which PHI will you obtain HIPAA authorization from the subjects by having them sign a HIPAA 
Authorization form, before obtaining and using the PHI?  
 
None 
 
Confirm by checking the box that you will use the UW Medicine HIPAA Authorization form 
maintained on the HSD website if you will access, obtain, use, or disclose UW Medicine PHI. 
 
 
Confirmed 
 
 
e. For which PHI will you NOT obtain HIPAA authorization from the subjects? 
PHI obtained for recruitment, including PHI received through physician referrals, coding 
lists, the ADAPT Study waitlist, and the UW MS Center Participant Pool. We will pre-
screen medical records to assess criteria for eligibility and disclose our record review 
according to UW Medicine compliance. 
 
Provide the following assurances by checking the boxes. 
 
 
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. 
 
x 
 
 
 
 
You will fulfill the HIPAA “accounting for disclosures” requirement. See UW Medicine 
Compliance Policy #104. THIS IS ONLY FOR UW RECORDS. 
 
x 
 
 
 
 
 
 
There will be reasonable safeguards to protect against identifying, directly or indirectly, any 
patient in any report of the research. 
 
 
 
x 
 
 
 
 
5.9 Genomic data sharing. Will you obtain or generate genomic data (as defined at  
http://osp.od.nih.gov/scientific-sharing/genomic-data-sharing-faqs/ )? 
 
x 
No 
 
 
 
Yes 
→ If yes, answer the question below. 
 
a. Do you plan to send genomic data from this research to a national database (for example, NIH’s 
dbGaP database)? 
 
 
 
No 
 
 
 
 
Yes 
→ If yes, complete the ZIPLINE SUPPLEMENT Genomic Data Sharing and upload 
it to the Supporting Documents SmartForm of Zipline. 
 
 
5.10 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. 
 
x 
No 
 
 
 
Yes  

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5.11 Data and specimen sharing/banking. Are you likely to share some or all of the data, specimens, or subject 
contact information with other researchers or a repository/database for research purposes not related to this 
study, or to bank them for your own future unspecified research uses? You are strongly encouraged to consider 
the broadest possible future plans you might have, and whether you will obtain consent now from the subjects 
for future sharing or unspecified uses. Answer YES even if you will only share information without identifiers. 
Answer NO if you are unlikely to do any sharing, or if your only sharing will be through the NIH Genomic Data 
Sharing described in question 5.9. 
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: informal arrangements to share your banked 
data/specimens with other investigators; establishing a repository from which you formally share with others through written 
agreements; or sending your 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, including whether any direct or indirect (e.g., subject codes) 
identifiers will be stored.  
 
All study data will be stored in de-identified form indefinitely following the closure of the IRB 
application. Study researchers may conduct secondary analyses of the study data in de-
identified form following closure related to examining various aspects of the behavioral 
interventions, quality of life issues regarding individuals with disabilities 
 
In addition, direct identifiers including first and last names, phone numbers, mailing addresses, 
and email addresses will be stored indefinitely.  
 
b. Describe what will be shared, including whether direct identifiers will be shared and (for 
specimens) what data will be released with the specimens.  
 
Study data: Study data may be shared in de-identified form with outside researchers and 
collaborators as requested and deemed acceptable by study investigators.   
 
In addition, direct identifiers may be shared with other study researchers within the UW 
Department of Rehabilitation Medicine if a participant indicates they would like to be enrolled 
in the department participant pool and contacted regarding future opportunities to participate 
in research.  
 
Private identifiable data will not be shared with outside study researchers. The one exception 
would be oversight entities involved with the protection of human subjects and oversight of 
the research. 
 
c. Who will oversee and/or manage the sharing?  
 
The UW Principal investigator, Dawn Ehde 
 
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. 
 
As mentioned above, study data may be analyzed to answer a priori hypotheses related to 
various aspects of the study behavioral interventions and quality of life issues regarding 
individuals with disabilities within the context of rehabilitation medicine. 

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e. Consent. Will you obtain consent now from subjects for the 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 your answers to the consent questions in 
Section 8. 
 
 
f. Withdrawal. Will subjects be able to withdraw their data/specimens from banking or sharing?  
 
 
N
o  
 
x 
Y
e
s 
→ 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. 
 
Participants may change their mind and request they not be contacted in the future at a later 
time. This request will be coded accordingly so that study researchers will not disclose their 
identifiers in the future. Participant identifiers cannot be retrieved, however, after they are 
released. 
 
 
g. Agreements for sharing or release. Confirm by checking the box that you will comply with UW 
(and, if applicable, UW Medicine) policies that require a formal agreement between you and 
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 your template agreement forms; the IRB neither 
reviews nor approves them 
x 
Confirmed 
5.12 Communication with subjects during the study. Describe the types of communication (if any) you 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.  
 
Subjects will be contacted via email to complete online assessments and receive phone calls from study clinicians 
for treatment. Participants will also receive phone calls, emails, and/or texts for any study appointments, 
treatment sessions, and/or upcoming assessment periods. Study staff will email the dates and times of any 
treatment sessions or assessments for participants in both the E-TIPS intervention and the Usual Care group. The 
treatment schedules will also include the Zoom phone numbers that therapists will use to administer treatment 
to participants assigned to E-TIPS. 
 
Participant payments (in the form of checks) will be accompanied by a payment cover letter stating the amount 
enclosed and to which assessments the payment applies. 
 
If a participant is unable to be reached at any point during the study, research staff will use phone, text, email, 
secure messaging, and/or letters to try and get a hold of the participant. We may also call, email, or mail the 
collateral contacts for participants who provided such information if we are still unable to reach the participant.   

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5.13 Future contact with subjects. Do you plan to retain any contact information you obtain for your 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 your team; if not, describe who else could be provided with the contact information. 
Describe your 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. 
 
We would like to retain contact information so if a participant is interested in published results, we may notify 
him/her or send them information about the results. 
5.14 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. 
 
 
 
There are no specific alternative procedures. However, researchers will suggest in the consent form that 
participants discuss other options for pain management with their health care provider.  
5.15 Upload to the Supporting Documents SmartForm of Zipline all data collection forms (if any) that will be directly 
used by or with the subjects, and any scripts/talking points you will use 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 you will cover 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 your research, provide a description of the process by which you will establish the data 
collection/questions as you interact with subjects, how you will document your data collection/questions, the topics you 
plan to address, the most sensitive type of information you will plan to gather, and the limitations (if any) on topics you 
will raise or pursue. 

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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 you will use for data that will be gathered in an evolving way. 
• 
The general content of questionnaires, surveys and similar instruments for which you are seeking general 
approval. (See the NOTE bullet point in the instructions above.) 
 
We will have participants complete standardized measures asking about pain interference, pain intensity, pain 
self-efficacy, fatigue severity, depressive symptoms, sleep disturbance, vocational outcomes, social roles and 
activities, pain anxiety, and the impact of COVID-19 via REDCap surveys.  Therapists will make note of treatment 
attendance via REDCap and ask participants about treatment satisfaction and adherence to home practice. 
 
5.16 Send HSD a Confidentiality Agreement if you will obtain or use any private identifiable UW records without 
subject’s written consent (for example, screening medical records or class grades to identify possible subjects). 
The Confidentiality Agreement form must be completed, printed, signed, and mailed to the Human Subjects Division at Box 
359470. Your IRB application cannot be approved until we receive the Confidentiality Agreement. 
 
 
6 CHILDREN (MINORS) and PARENTAL PERMISSION 
6.1 Involvement of minors. Does your 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.  
 
x 
No 
→ If no, go to Section 8. 
 
 
Yes 
→ If yes, provide the age range of the minor subjects for this study and the legal age for consent in 
your population(s). If there is more than one answer, explain.   
 
 
 
 
      
 
 
Don’t know 
→This means is it not possible to know the age of your subjects. For example, this may be 
true for some research involving social media, the Internet, or a dataset that you obtain 
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 you obtain parental permission for: 
 
 
All of your research procedures 
→ Go to question 6.2b. 
 
 
 
 
 
 

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None of your research procedures 
→ Use the table below to provide your justification, and skip 
question 6.2b. 
 
 
 
 
Some of your research procedures 
→ Use the table below to identify the procedures for which you will 
not obtain written parental permission. 
 
 
 
 
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 you will not 
obtain parental 
permission 
Will you inform 
them about the 
research?3 
 
 
 
YES 
NO 
      
      
      
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
      
      
      
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
      
      
      
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
      
      
      
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
      
      
      
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
      
      
      
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Table footnotes 
1. If your answer is the same for all children groups or all procedures, you can collapse your answer across the groups and/or 
procedures. 
2. If you plan to obtain identifiable information or biospecimens without parent permission, any waiver granted by the IRB does 
not override parents’ refusal to provide broad consent (for example, through the Northwest Biotrust). 
3. Will you inform them about the research beforehand even though you are not obtaining active permission? 
b. Indicate by checking the appropriate box(es) your plan for obtaining parental permission 
 
 
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.  
 
 
 
 
 
 
This is all that is required for minimal risk research. 
 
If you checked both boxes, 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 
 

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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). Your answer 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 you obtain assent for: 
 
 
All of your research procedures and child groups 
→ Go to question 7.2. 
 
 
 
 
 
 
None of your research procedures and child groups 
→ Use the table below to provide your 
justification, then skip to question 7.5. 
 
 
 
 
 
 
Some of your research procedures and child groups 
→ Use the table below to identify the 
procedures for which you will not obtain 
assent.  
 
 
 
 
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 assent will NOT 
be obtained 
Reason why you will not obtain assent 
      
      
      
      
      
      
      
      
      
      
      
      
      
      
      
Table footnotes 
1. If your answer is the same for all children groups or all procedures, you can collapse your answer across the groups and/or 
procedures. 

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7.2 Assent process. Describe how you will obtain assent, for each child group. If your research involves children of 
different ages, answer separately for each group. If the children are non-English speakers, include a description of 
how you will ensure that they comprehend the information you provide. 
 
      
7.3 Dissent or resistance. Describe how you will identify a child’s objection or resistance to participation (including 
non-verbal indications) during the research, and what you will do in response.  
 
      
7.4 E-consent. Will you use any electronic processes (email, websites, electronic signatures, etc.) to present assent 
information to subjects/and or to obtain documentation (signatures) of assent? If yes, describe how you will do 
this. 
 
      
7.5 Documentation of assent.  Which of the following statements describes whether you will obtain documentation of 
assent? 
 
 
None of your research procedures and child groups 
→ Use the table below to provide your 
justification, then go to question 7.5.a 
 
 
 
 
 
 
All of your research procedures and child groups 
→ Go to question 7.5.a, do not complete the 
table 
 
 
 
 
 
 
Some of your research procedures and/or child groups 
→ 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 your answer is the same for all children groups or all procedures, you can collapse your answer across the groups and/or 
procedures. 
 
a. Describe how you will document assent. If the children are functionally illiterate or are not fluent in English, 
include a description of what you will do. 
 
 
      
 
b. Upload all assent materials (talking points, videos, forms, etc.) to the Consent Form and Recruitment 
Materials SmartForm of 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. 

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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 you did not at the beginning of their participation).  
Children who reach the legal age of consent: You must obtain informed consent 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 your plans (if any) to re-obtain assent from children.  
 
      
 
b. Describe your plans (if any) to obtain consent for children who reach the legal age of consent.  
• 
If you plan to obtain consent, describe what you will do about now-adult subjects whom you are unable 
to contact. 
• 
If you do not plan to obtain consent or think that you will be unable to do so, explain why.  
 
      
7.7 Other regulatory requirements. (This is for your 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 
 
 
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 usually (but not always) includes an 
opportunity for subjects to ask questions. It does not necessarily include the 
signing of a consent form. This question is about the consent process. 
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. 
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. 

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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 your answers in this section apply. 
 
x 
Adult subjects 
 
 
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. This series of questions is about whether you will obtain consent for all procedures except 
recruiting and screening and, if yes, how. 
The issue of consent for recruiting and screening activities is addressed in question 4.6. You do not need to repeat your answer 
to question 4.6. 
 
a. Are there any procedures for which you will not obtain consent? 
 
x 
No 
 
 
 
Yes 
→ If yes, use the table below to identify the procedures for which you will not obtain consent. “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 you will not obtain 
consent 
Will you 
provide 
subjects with 
info about the 
research after 
they finish? 
 
 
 
YES 
NO 
      
      
      
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
      
      
      
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
      
      
      
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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Table footnotes 
1. If your answer is the same for all groups you can collapse your answer across the groups and/or procedures. 
b. Describe the consent process, if you will obtain consent 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).  
• 
Whether/how you will provide an opportunity for questions 
• 
How you will provide an adequate opportunity for the subjects to consider all options 
 
Research staff (Research Study Assistant, Research Study Coordinator, and/or Research Coordinator) will 
participate in and obtain informed consent from research participants after screening but prior to 
commencement of any further study procedures. Prospective participants will also be asked for consent to 
complete the screening questions at the start of the screening process. The informed consent process will take 
place over the telephone at a time deemed mutually feasible for the participant and staff member and 
coordinated on a case-by-case basis.  
 
Prior to the informed consent process, research staff will email (or postal mail, if the participant prefers) a 
copy of an information statement for the participant to review as well as the date and time of the consent 
process appointment. Participants will be encouraged to read the information statement prior to the 
scheduled consent session and to be prepared with any questions. If the informed consent session is 
scheduled more than two business days in advance, research staff will call and/or email participants as a 
reminder. Participants will be requested to have the information statement in front of them during the 
consent session. 
 
A research staff member will review each section of the information statement approved by the UW IRB, 
inviting discussion to ensure comprehension. Staff will be trained by study investigators to ensure competency 
to discuss informed consent and strategies to ensure there is no coercion.  
 
Participants will be provided with as much time as needed to review the information statement and ask the 
research staff member questions about the information statement, their rights as human participants, and 
participation in the study. Potential participants will be fully informed of all risks and benefits prior to giving 
their verbal informed consent and prior to enrollment in the study. Potential participants will also be informed 
that providing consent for enrollment into the study does not guarantee assignment to the treatment 
intervention initially, as this is contingent on completing certain required baseline procedures (see Section 5.1 
– Procedures) and on being randomly assigned to the treatment group. They will be told that participants 
randomized to usual care will have the opportunity to receive the treatment at the end of the 6-month follow-
up assessment. 
 
If during the course of this contact the potential participant has questions that cannot be addressed by 
research staff, one of the study investigators or the research manager (depending on the nature of the 
questions) will follow up with the potential participant to answer the questions. Participants may take time to 
think about participating and render a decision at a subsequent time.  
 

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Potential participants will be asked to repeat back to research staff their understanding of the information 
statement material as necessary. Individuals will not be permitted to participate if there is any question as to 
whether a person has capacity to provide informed consent. 
 
When all questions have been answered, research staff will ask the participant if they would like to participate 
in the study. The participant will then be asked to provide verbal consent to participate. The participant will 
not need to sign the information statement, as we will be applying for a Waiver of Documentation of Informed 
Consent with this IRB application. 
 
c. Comprehension. Describe how you will ensure or test the subjects’ understanding of the information during the 
consent process. 
 
A staff member will review each section of the information statement (see document “Information 
Statement”). Participants will be provided with as much time as needed to review and ask questions about the 
information statement, their rights as human participants, and participation in the study. If the potential 
recruit has questions that cannot be addressed by staff, a study investigator or the Research Manager 
(depending on the nature of the questions) will follow up to answer the questions. Participants may take time 
to think about participating and render a decision at a later time. Staff will ask the participant to provide a 
summary of the study (e.g., purpose of the study, number/types of interventions, number/types of 
sessions/appointments, number/duration of assessment periods, length of study participation, etc.) to assess 
for comprehension as necessary. Inaccurate information will be corrected and re-explained until the 
participant understands. We will not enroll any participants who we feel do not have a good understanding of 
the study, its procedures, or what participation entails as these participants do not meet the criteria for 
“informed” consent. These participants will be thanked for their time and given additional resources (i.e., a 
Resource List). 
d. Influence. Does your research involve any subject groups that might find it difficult to say “no” to your research 
because of the setting or their relationship with you, even if you don’t pressure them 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 you will do, for each of these subject groups, to reduce any effect of the 
setting or relationship on their 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. Ongoing process. For research that involves multiple or continued interaction with subjects over time, describe 
the opportunities (if any) you will give subjects to ask questions or to change their minds about participating. 
 
At the beginning of the informed consent process, all participants will be told that participation in research is 
voluntary and they are not obligated to participate. Anyone can refuse to participate at any time and withdraw 
from the study at any time for whatever reason without penalty or loss of benefits (a participant can withdraw 
without even providing a reason, if s/he chooses). We will stress this at the beginning and end of the consent 

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session. We will also ask the participant if s/he has any questions before we ask for their decision to be in the 
study. Throughout our studies, we have always encouraged participants to ask questions when there is 
something they do not understand and will continue to encourage this by asking the participant if s/he has any 
questions before beginning any procedures (i.e., after explaining any procedure, ask the participant if s/he has 
any questions before starting). For assessments or questionnaires, we will always tell the participant at the 
beginning of the assessment they are free to not answer any question for whatever reason. We will always 
honor a participant's decision to stop any procedures, even after they have commenced. We will also re-
iterate the possibility of withdrawal without consequence if a participant expresses 
apprehension/dissatisfaction with completing study procedures. 
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. 
 
x 
No 
→ If no, skip to question 8.4 
 
 
Yes 
→ If yes, answer questions a through e 
a. Describe your 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. 
       
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. Will that be possible in your study? Also, describe what, if 
anything, you will do 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. 
      

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d. What will you do if you encounter individuals who wish to participate but who do not have access 
to the methodology you are using 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, you cannot exclude these individuals from your study unless you have 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. 
      
e. How will you provide additional information, including any significant new findings (such as new 
risk information) to subjects during the research? If this is not an issue, explain why. 
 
       
8.4 Written documentation of consent. Which of the statements below describe whether you will obtain 
documentation of consent? NOTE: This question does not apply to screening and recruiting procedures which have 
already been addressed in question 4.6. 
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. Are you obtaining written documentation of consent for: 
 
 
None of your research procedures  
→ Use the table below to provide your justification then go to 
question 8.5. 
 
x 
 
 
 
 
All of your research procedures  
→ Do not complete the table; go to question 8.5. 
 
 
 
 
 
 
Some of your research procedures 
→ Use the table below to identify the procedures for which you will 
not obtain written documentation of consent from your adult 
subjects.  
 
 
 
 
Adult 
subject 
group1 
Describe the procedures or data/specimen collection (if any) for which 
there will be NO documentation of consent 
Will you 
provide them 
with a written 
statement 
describing the 
research 
(optional)? 
 
 
YES 
NO 
      
      
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
      
      
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
      
      
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
      
      
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
      
      
 
 
 
 
 
 
 
 
 
 
 
 

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Table footnotes 
1. If your answer is the same for all adult groups or all procedures, you can collapse your 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 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 you will use. 
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 did you use as your source of information about legal validity? 
 
      
b.2 Will you obtain verification of the subject’s identity if the signature is not personally 
witnessed by a member of the study team? Note that this is required for FDA-regulated 
studies. 
See the GUIDANCE: Electronic Informed Consent for information and examples 
 
 
No 
→If no, provide your 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 you meet the requirement 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. 
      

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8.5 Non-English-speaking or -reading adult subjects. Will you enroll adult subjects who do not speak English or who 
lack fluency or literacy in English? 
 
x 
No 
 
 
 
Yes 
→ If yes, describe the process you will use 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 you will provide interpretation 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 you will obtain translations of all study materials (not just consent 
forms) and how you will ensure 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.  
 
      
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 your 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 you are not obtaining written documentation of consent for any part of your 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. 
 
      
8.7 Deception. Will you deliberately withhold information or provide false information to any of the subjects? Note: 
“Blinding” subjects to their study group/condition/arm is not considered to be deception. 
 
x No 
 
 
 Yes 
→ If yes, describe what information and why. 
 
 
Example: you may wish to deceive subjects about the purpose of the study. 
 
      

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a. Will you debrief the subjects later? (Note: this is not required.) 
 
 
No 
 
 
 
Yes 
→ If yes, describe how you will debrief the subjects. Upload any debriefing materials, 
including talking points or a script, to the Consent Form and Recruitment 
Materials SmartForm of Zipline. 
 
 
 
      
8.8 Cognitively impaired adults, and other adults unable to consent. Do you plan to include such individuals in your 
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 your rationale for including this population in your research.  
 
      
 
b. Capacity for consent / decision making capacity. Describe the process you will use to 
determine whether a cognitively impaired individual is capable of consent decision making 
with respect to your research protocol and setting. 
 
 
      
 
b.1. If you will have repeated interactions with the impaired subjects over a time period 
when cognitive capacity could increase or diminish, also describe how (if at all) you will 
reassess decision-making capacity and obtain consent during that time. 
 
      
 
c. Permission (surrogate consent). If you will include adults who cannot consent for themselves, 
describe your process for obtaining permission (“surrogate consent”) from a legally authorized 
representative (LAR).   
 
For research conducted in Washington State, see the SOP: 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 you will use to obtain and document assent from the subjects.  
 
 
      

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e. Dissent or resistance. Describe how you will identify the subject’s objection or resistance to 
participation (including non-verbal) during the research, and what you will do in response. 
 
 
      
8.9 Consent-related materials. Upload to the Consent Forms and Recruitment Materials SmartForm of 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 you will use. 
• 
Translations must be included. However, you are strongly encouraged to wait to provide them until you know that the IRB 
will approve 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. 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. 
 
 
9 PRIVACY AND CONFIDENTIALITY 
9.1 Privacy protections. Describe the steps you will take, 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 procedures (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. 
 
All prospective participants will be informed of how their information was obtained by telephone.  
 
All participants will be assigned a unique study code that serves as the link between the data collected for the 
study and participants' identity. Any hard copies of participants’ direct identifiers will be kept in a separate 
locked filing cabinet (in which only research staff will have keys) from study data. Participant identifiers will be 
kept in a password-protected database on the department's secure server and in the password-protected 
REDCAP databases. The link between the study data and a participant's identity in the form of the unique study 
code will only exist in the password-protected database on the department's secure server, which has restricted 
access, and in the password-protected REDCap databases.  
 
Treatment sessions (audio only) recorded for fidelity purposes and the recorded post-treatment qualitative 
interview may contain direct identifiers as voice data is an identifier; additionally, the clinician/staff member may 
state the participant’s first name during the session/interview. The audio recordings will not be labeled with any 
identifying information. These audio recordings will be stored on our department’s secure server. 

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9.2 Identification of individuals in publications and presentations. Do you plan to use potentially identifiable 
information about subjects in publications and presentations, or is it possible that individual identities could be 
inferred from what you plan to publish or present?  
 
x 
No 
 
 
 
Yes → If yes, will you obtain subject consent for this use? 
 
 
Yes 
 
 
 
No 
→ If no, describe the steps you will take to protect subjects (or small groups of 
subjects) from being identifiable. 
 
 
 
 
      
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 your research team likely to learn of any of the above events or circumstances while 
conducting your research AND feel obligated to report it to state authorities? 
 
x 
No 
 
 
 
Yes 
→ If yes, the UW IRB expects you to inform subjects of this possibility in the consent form or during the 
consent process, unless you provide a rationale for not doing so: 
 
 
 
 
 
      
9.4 Retention of identifiers and data. Check the box below to indicate your assurance that you will not 
destroy any identifiers (or links between identifiers and data/specimens) and data that are part of your 
research records until after the end of the applicable records retention requirements (e.g. Washington 
State; funding agency or sponsor; Food and Drug Administration) for your research. If you think it is 
important for your specific study to say something about destruction of identifiers (or links to identifiers) 
in your 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/about/Documents/UWM-Records-Retention-Schedule.pdf 
 
x 
Confirm 

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9.5 Certificates of Confidentiality. Are you planning to obtain a federal Certificate of Confidentiality for your research 
data? NOTE: Answer “No” if your study is NIH funded, because all NIH-funded studies automatically have a 
Certificate. 
 
x 
No 
 
 
 
Yes 
 
9.6 Data and specimen security protections. Identify your data classifications and the security protections you will 
provide, referring to the ZIPLINE GUIDANCE: Data and Security Protections for the minimum requirements for 
each data classification level. You cannot answer this question without reading this document. Data security 
protections should not conflict with records retention requirements. 
 
a. Which level of protections will you apply to your data and specimens? If you will use more than one level, 
describe which level will apply to which data and which specimens. 
 
 
Level 4 
 
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 you will not follow, list those here. 
 
 
The pre-screening survey is an exception to Level 4 security. Access to participant identifiers from the pre-
screening survey will be limited to research study coordinators involved with recruitment and all 
identifiers in WebQ will require a UW Net ID and password to access. After the data is no longer needed 
(i.e., participants have been contacted and/or screened), and the required records retention period has 
ended, the data will be deleted. 
 
 
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 you will manage or reduce the risks. 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. 
 
General/Reaction to Assessments 
Regarding research risks, participants may experience fatigue and/or boredom while completing the 
assessments and/or the treatment sessions.  
 
Some participants may also experience mild anxiety, frustration, and/or stress while answering sensitive 
questions about depression, pain, and mood. As a result of answering questions about pain, some participants 
may focus more on their pain, which may lead to a temporary increase in pain intensity.  

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Protections against risks: Participants will be informed during the consent process and throughout the study 
they do not have to discuss any topics they do not wish to during treatment or the assessment periods. In 
addition, participants will be informed in the consent process they are free to stop any session, treatment, or 
assessment at any time. Participants are informed they may refuse to answer any questions that make them feel 
uncomfortable.  
 
All participants will be clearly informed of their right to withdraw from the study at any point without adversely 
impacting their routine medical, psychiatric, or psychotherapeutic care. 
 
All participants will be offered the opportunity to discuss any situations or experiences associated with the study 
procedures that they deem uncomfortable or adverse with the UW PI, Dr. Ehde, who is a licensed clinical 
psychologist. Dr. Ehde is a trained psychologist who has experience assessing the level of distress of patients and 
proceeding accordingly whenever an adverse event should arise. 
 
Treatment 
The types of treatment involve discussions about disabilities and related topics that may make some individuals 
feel uncomfortable. Some participants may also experience mild anxiety, frustration, and/or stress during the 
course of treatment should any topics or activities prove difficult for them. Some individuals learning cognitive 
restructuring of thoughts may remember past experiences that are uncomfortable and/or cause distress, even 
after the session has ended.  
 
Protections against risks: Researchers will take multiple steps to ensure and monitor the well-being of 
participants during treatment. Study investigators, led by Dr. Ehde, will offer ongoing, scheduled supervision and 
consultation with study clinicians, including routine assessment of any potential problems or adverse events. 
 
Privacy and Confidentiality 
Participants may also worry about the confidentiality of their responses during the assessments. There is a risk of 
invasion of privacy in that the research staff directly involved with data collection will need to keep participants’ 
names, addresses (email and postal), and phone numbers for the duration of the study in order to contact them 
for the follow-up assessments.  
 
Protections against risks: We will take multiple steps to protect participants’ privacy and confidentiality. All of 
the data collected from participants will be kept in strict confidence. No information that is linked to a research 
participant’s identity will be provided to anyone outside of the study or regulatory entities responsible for 
oversight without permission from the participant.  
 
 
Mental Health Issues / Suicidality 
Although unlikely, it is possible that by participating in the study it may be discovered that a participant is 
suicidal or experiencing significant mental health issues. Please note that these conditions would also likely be 
detected in the course of usual care. 
  
Protections against risks: Although the study poses no serious risks to participants, participants may notify 
research personnel about pre-existing mental health issues that have not been previously identified. A suicide 
risk assessment protocol will be implemented by staff and, as indicated, the study clinicians and investigators 
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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 you will take 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 you will require the use of contraception: describe the allowable methods and the time period when 
contraception must be used. 
 
 
 
      
 
c. Pregnancy. Describe what you will do if a subject (or a subject’s partner) becomes pregnant 
For example; will you require the subject to immediately notify you, so that you can discontinue or modify 
the study procedures, discuss the risks, and/or provide referrals or counseling? 
 
 
 
      
10.3 MRI risk management. Answer this question only if your 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 you will assess the renal function of your subjects prior to MRI scans and how you will use that 
information to exclude subjects at risk for NSF. 
 
      
b. Describe your protocol for handling a sever allergic reaction to the GBCA or any other medical 
event/memergency during the MRI scan, including who will be responsible for which actions.  
 
      
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. 
 
 
 
      

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10.5 Subjects who will be under regional or general anesthesiology. Will any research procedures occur while 
subjects-patients are under general or regional anesthesia, or during the 3 hours preceding general or regional 
anesthesia (supplied for non-research reasons)? 
 
 
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 you checked any of the boxes: 
You must provide the name and institutional affiliation of a physician anesthesiologist who is 
a member of your research team or who will serve as a safety consultant about the 
interactions between your research procedures and the general or regional anesthesia of 
the subject-patients. If your procedures will be performed at a UW Medicine facility or 
affiliate, the anesthesiologist must be a UW faculty member, and you must consult with the 
Vice Chair of Clinical Research in the UW Department of Anesthesiology and Pain Medicine 
for feasibility, safety and billing. 
 
 
      
 
 
** If you checked the box about radio-isotopes: you are 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. 
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 your research, upload your DSMP to the Supporting Documents SmartForm in Zipline. If 
it is embedded in another document you are uploading (for example, a Study Protocol, use the text box below to 
name the document that has the DSMP. 
 
MONITORING PROCEDURES 
Dr. Ehde assures that informed consent is obtained prior to performing any research procedures, 
that all subjects meet eligibility criteria, and that the study is conducted according to the IRB-
approved research plan.   
Study data are accessible at all times for the PI and co-investigators to review. The PI and co-
investigators review(s) study conduct accrual, drop outs, deviations from protocol on a semi-annual 
basis.  The PI and co-investigators review(s) AEs individually real-time and in aggregate on a semi-

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annual basis.  The PI and co-investigators review(s) serious adverse events (SAEs) in real-time.  The PI 
ensures all protocol deviations, AEs, and SAEs are reported to the IRB according to the applicable 
regulatory requirements. 
COLLECTION AND REPORTING OF SAEs AND AEs 
For this study, the following standard AE definitions are used: 
Adverse event:  Any unfavorable and unintended sign (including an abnormal laboratory finding), 
symptom or disease temporally associated with the use of a medical treatment or procedure, 
regardless of whether it is considered related to the medical treatment or procedure. Staff will 
document any occurrence that meets this definition, is a new symptom/condition for the 
participant, and results in either self-treatment or treatment by a health care provider. 
Serious Adverse Event:  Any AE that results in any of the following outcomes: 
• 
Death 
• 
Life-threatening  
• 
Event requiring inpatient hospitalization or prolongation of existing hospitalization 
• 
Persistent or significant disability/incapacity 
AEs are graded according to the following scale: 
Mild:  An experience that is transient, & requires no special treatment or intervention.  The 
experience does not generally interfere with usual daily activities.  This includes transient 
laboratory test alterations. 
Moderate:  An experience that is alleviated with simple therapeutic treatments or minimal, 
local, and non-invasive intervention.  The experience impacts usual daily activities.  Includes 
laboratory test alterations indicating injury, but without long-term risk. 
Severe:  An experience that requires invasive intervention and/or medical attention.  The 
experience interrupts usual daily activities. If hospitalization (or prolongation of 
hospitalization) is required for treatment it becomes an SAE. A serious adverse event (SAE) is 
one that meets one or more of the following criteria: results in death; is life-threatening 
(places the participant at immediate risk of death from the event as it occurred); results in 
inpatient hospitalization or prolongation of existing hospitalization; results in a persistent or 
significant disability or incapacity; or results in a congenital anomaly or birth defect.* 
Life-threatening: the event is potentially fatal 
 
*Note: an important medical event that may not result in death, be life threatening, or 
require hospitalization may be considered an SAE when, based on appropriate medical 
judgment, the event may jeopardize the participant and may require medical or surgical 
intervention to prevent one of the outcomes listed in this definition. 
 
The study uses the following AE attribution scale: 
Unexpected or unanticipated: Unexpected in terms of nature, severity, or frequency given 
(a) the research procedures that are described in the protocol-related documents, such as the 
IRB-approved research protocol and informed consent document; and (b) the characteristics 
of the participant population being studied 
Not related:  The AE is clearly not related to the study procedures (i.e., another cause of the 
event is most plausible and/or a clinically plausible temporal sequence is inconsistent with 
the onset of the event).   

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Possibly related:  An event that follows a reasonable temporal sequence from the initiation 
of study procedures, but that could readily have been produced by a number of other factors. 
There is a reasonable possibility that the incident, experience, or outcome may have been 
caused by the procedures involved in the research. 
 
Related:  The AE is clearly related to the study procedures. May suggest that the research 
places participants or others at a greater risk of harm (including physical, psychological, economic, or 
social harm) than was previously known or recognized. 
AEs are identified during treatment sessions by asking subjects directly if they have experienced AEs. 
Other research staff may also identify AEs during recruitment calls, scheduling calls, or other 
conversations with participants. 
SAEs and specific procedure-associated AEs are reported to the IRB and sponsor within 24 hours.  In 
addition, all AEs are reported according to the UW IRB AE reporting guidelines.  
MANAGEMENT OF RISKS TO SUBJECTS 
Expected AEs 
Expected AEs associated with the study procedures include:   
• Discomfort when talking about pain 
• Boredom completing questionnaires 
AE Management 
Subjects may end any treatment without negative consequences whenever they want.  
DATA ANALYSIS PLANS 
Data will be kept in a secure database.  Data will be accessed by trained study members. The de-
identified data will be reviewed and analyzed by a trained statistician.  
PLAN FOR DATA MANAGEMENT  
Compliance of regulatory documents and study data accuracy and completeness will be maintained 
through an internal study team quality assurance process.  
Confidentiality throughout the trial is maintained by the research assistants, coordinators, and PI.  
Training and Fidelity. Dr. Ehde will train and supervise the therapists; she is a psychologist with >20 
years of expertise in the study populations and intervention. Therapists will receive 20 hours of 
training in E-TIPS which will include readings, didactic presentations, and practice sessions. Dr. Ehde 
will review recorded practice sessions and provide additional training as needed. A fidelity protocol 
will include protocol checklists of prescribed, proscribed, common, and unique elements; weekly 
supervision meetings; and ongoing review of randomly selected recordings from 20% of all sessions. If 
fidelity problems occur, Dr. Ehde will provide feedback, additional coaching, practice, and monitoring 
until the therapist delivers the treatment as intended. Similar procedures in past RCTs have yielded 
fidelity rates exceeding 98%. 
 
 
10.7 Un-blinding. If this is a double-blinded or single-blinded study in which the participant and/or you 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. 
 
      

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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. 
 
Participants could potentially be withdrawn without consent.  In the past this has been very rare.   Typically 
happening in instances where the participant becomes unable to contact despite frequent calls from study 
staff.  PIs also reserve the right to withdraw subjects if they feel it is in their best interest (in cases where 
procedures could be contributing to suicidal ideation). However, suicidal ideation is not expected to be a risk 
in this study. 
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.  
 
Previous studies with the therapeutic skills taught in the planned study support their efficacy in reducing pain 
interference and improving other pain-related outcomes. We anticipate based on this previous research that 
many of the participants will experience significant reductions in their daily pain interference and other 
benefits associated with the treatment.  
 
In our past research, many members have expressed satisfaction from receiving treatment in a caring and 
nonjudgmental environment. Thus, participants in treatment will take away from the study new skills and 
knowledge regarding chronic pain and how to manage it, and – given previous results of RCTs for psychosocial 
interventions for chronic pain – should experience some degree of relief from pain and suffering and increases 
in their quality of life. 
10.10 Individual subjects findings. 
 
a. Do you anticipate that the research will produce any urgent, clinically actionable results? 
 
These may be results from screening procedures, results that are actively sought for purposes of the study or they may 
be results that are discovered unintentionally. Examples include high calcium levels, liver function test results, and a 
mass on an MRI that may indicate a tumor, a diagnostic discrepancy, and suicidal intentions.  
 
x 
No 
 
 
 
Yes 
→ If yes, the results should be shared with the subject(s). Complete and upload the 
SUPPLEMENT: Participant Results Sharing to the Supporting Documents SmartForm of 
Zipline 
 
 
b. Do you plan to share any other results of your study procedures or findings with the subjects – such as 
genetic test results, laboratory tests, etc.? 
 
You should answer YES if your consent form says anything about sharing individual information with subjects. 
 
 
No 
 
 
 
Yes 
→ If yes, complete and upload the SUPPLEMENT: Participant Results Sharing to the 
Supporting Documents SmartForm of Zipline 
 
 

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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. 
 
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. 
 
      
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). 
 
      Because this study requires completion of treatment via telephone it is possible that there is usage of  
minutes if participant is using a smartphone.  Furthermore, if a participant indicates they want text 
reminders and don’t have unlimited texting plans there is a possibility they could be charged messaging 
fees. 
11.3 Reimbursement for costs. Describe any costs to subjects that will be reimbursed (such as travel expenses). 
 
      None. Researchers are not responsible for any messaging or data charges incurred by participants.  If the 
participant is unable to access the online treatment sessions because of a temporary issue such as a broken 
smartphone, tablet, computer, or other software or hardware issues, researchers will not be responsible 
for any costs incurred by participants to fix any of this technology. 
 
 
12 RESOURCES 
12.1 Faculty Advisor. (For researchers who are students, fellows, or post-docs.) Provide the following information 
about your 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 

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12.2 Study team communication. Describe how you will ensure 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. 
 
 
 
 
Dr. Ehde will oversee training of all study team members on the procedures and changes. All study team 
members are strongly encouraged to read both the sponsor grant proposal, the study protocol, and this IRB 
application (after it has been approved) before commencing any study-related activities. 
 
Changes to the project (i.e., modifications) will be informed to the study team by email, with specific 
instructions and links to any new/modified materials. We will also keep a document of changes approved 
through modification as well as a list of the most up-to-date materials that staff may review for their 
information. Old materials are archived (both in hard form and electronically) and all documents are labeled 
with version number and approval date. 
The study team will also meet regularly, at least once/week, to review recruitment/enrollment/retention 
reports, problem-solve any issues that arise, and discuss other study procedures. Dr. Ehde, the PI, will lead 
these meetings and provide ongoing training and supervision of staff in the study and human subjects research 
as needed. Our research lab also offers research staff professional development training in the conduct of 
research and encourages use of ITHS resources, both web-based and workshops.    
 
 
 
13 OTHER APPROVALS, PERMISSIONS, and REGULATORY ISSUES 
13.1 Other regulatory approvals. Identify any other regulatory approvals that are required for this research, by 
checking applicable boxes 
Do not attach the approvals unless requested by the IRB. 
 
Approval 
Research for which this is required 
 
 
Radiation Safety 
Procedures involving the use of radioactive materials or an ionizing 
radiation producing machine radiation, if they are conducted for research 
rather than clinical purposes. Approvals need to be attached to the 
Supporting Documents page in Zipline. 
 
 
 
 
 
 
Institutional Biosafety 
Procedures involving the transfer/administration of recombinant DNA, 
DNA/RNA derived from recombinant DNA, or synthetic DNA. 
 
 
 
 
 
 
RDRC 
Procedures involving a radioactive drug or biological product that is not 
approved by the FDA for the research purpose and that is being used 
without an IND, for basic science research (not to determine safety and 
effectiveness, or for immediate therapeutic or diagnostic purposes). 
 
 
 
 
 
 
ESCRO 
Procedures involving the use of some types of human embryonic stem 
cells. 
 
 
 
 

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13.2 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. 
 
n/a 
13.3 Financial Conflict of Interest. Does any 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 your 
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 team member who has a 
FCOI with respect to the research, to the Supporting Documents page of 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.