Prevention of Pressure Injuries During Aeromedical Evacuation or Prolonged Field Care
Phase: NA
Conditions: Pressure Injury, Military Activity
Sponsor: University of Washington

4333 Brooklyn Ave. NE, Box 359470 Seattle, WA 98195-9470
main 206.543.0098   fax 206.543.9218   hsdinfo@u.washington.edu   www.washington.edu/research/hsd
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IRB APPROVAL OF APPLICATION
January 4, 2019
Dear Dr. Bridges:
On 1/4/2019, University of Washington IRB Committee D reviewed the following application:
Type of Review:
Initial Study
Title of Study:
Prevention of Pressure Injuries During Aeromedical Evacuation or 
Prolonged Field Care
Investigator:
Elizabeth Bridges
IRB ID:
STUDY00006022
Funding:
Name: Triservice Nursing Research Program, Grant Office ID: A132067, 
Funding Source ID: 6057994690000
IND, IDE, or HDE:
None
The modification required to secure approval was reviewed and the application fully approved on 
1/4/2019.
IRB Approval
Under FWA #00006878, the IRB approved your activity from 1/4/2019 to 1/3/2020. 

Your application qualified for expedited review (minimal risk; Category 9).

This approval applies only to the activities described in your application (including any 
references to specific grant sections). It does not include other activities that may be described 
in your grant or contract.

Depending on the nature of your study, you may need to obtain other approvals or 
permissions to conduct your research. For example, you might need to apply for access to 
data or specimens (e.g., to obtain UW student data). Or, you might need to obtain permission 
from facilities managers to approach possible subjects or conduct research procedures in the 
facilities (e.g., Seattle School District; the Harborview Emergency Department).
Determinations, waivers, and regulations 
The IRB made the determinations and waivers listed in the table below. Note that any granted 
waivers of consent do not override a subject’s refusal to provide broad consent.
Requirement
Determination or Waiver
Documentation of consent
Waived – for phone screening
Location of documents
Use the consent form approved and stamped by the IRB. It can be downloaded from the Final 
column under the Documents tab in Zipline.

4333 Brooklyn Ave. NE, Box 359470 Seattle, WA 98195-9470
main 206.543.0098   fax 206.543.9218   hsdinfo@u.washington.edu   www.washington.edu/research/hsd
Implemented 11/30/2018 – Version 2.0 - Page 2 of 2
Thank you for your commitment to ethical and responsible research. We wish you great success!
Sincerely,
Ariana
Ariana Chantée, CIP
Human Subjects Review Administrator
achantee@uw.edu | 206-616-9690

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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: 
Prevention of Pressure Injuries During Aeromedical Evacuation or Prolonged Field Care 

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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. 
 
University of Washington School of Nursing 
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.   
 
X No 
 
 
 
Yes 
 If yes, briefly describe the consultation: approximate date, with whom, and method (e.g., by email, 
phone call, in-person meeting). 
 
 
 
 
      
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. 
 
 
 
UW IRB 49693 – Mitigation of Pressure Ulcer Development during Combat Evacuation.  PI 
Elizabeth Bridges.  Previous research that used study methods similar to those outlined in this 
proposal. Specific methods that are similar are interface pressure measurements, transcutaneous 
tissue oxygen and skin temperature measurements. We will use the same recruitment screening 
process for the consent process. We are also using the same interventions – Mepilex and LiquiCell 
(both FDA approved). The previous study was characterized as minimal risk. 

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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.  
 
x 
No 
 
 
 
Yes 
 If yes, briefly describe the urgency or deadline as well as the reason for it. 
 
 
 
We anticipate the funds will be available after 1 October – pending receipt of IRB approval.  
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). 
 
The purpose of this study is to explore the effectiveness of interventions that may be useful during aeromedical 
evacuation (AE) or prolonged filed care (PFC).  
 
Skin cellular injury, skin perfusion, and skin microclimate will be tested with and without Mepilex sacral dressing or 
LiquiCell pads on 3 transport surfaces. Note: A litter is a stretcher.  
 
Aeromedical Evacuation (AE) conditions 
• 
Mepilex:  Litter + AE mattress + 30° backrest 
• 
Without Mepilex:  Litter + AE mattress + 30° backrest 
• 
Mepilex: Vacuum Spine Board (VSB) placed on AE mattress 
• 
Without Mepilex:  Vacuum Spine Board (VSB) placed on AE mattress 
 
Prolonged Field Care (PFC) conditions 
• 
LiquiCell:  Talon Litter 
• 
Without LiquiCell:  Talon Litter 
 
Aim 1. Under conditions simulating aeromedical evacuation (stretcher + mattress or stretcher + mattress + 
vacuum spine board) compare the effects of with/without Mepilex (multilayered dressing) on the buttocks/lower 
back (sacrum) on indicators of skin injury, skin blood flow and oxygenation, skin temperature and moisture and 
pressure between the support surface and the skin (interface pressure).  
 
Aim 2. Under conditions simulating prolonged field care (field stretcher without a mattress pad) evaluate the 
effect of with/without LiquiCell (a pad with fluid-filled pocked of liquid) placed under the back and bottom on 
indictors of skin injury, blood flow, oxygenation, temperature, moisture and interface pressure. 

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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. 
 
Stratified randomized control trial with subjects assigned to either the AE or Prolonged Field Care arms with or 
without the intervention. Stratification will be based on body fat percentage. 
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. 
 
 
 
 
 
 
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 
 
 
 
 

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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. 
 
This military unique proposal seeks to identify a feasible strategy to augment pressure injury prevention 
during AE or prolonged field care. 
 
Between 2001 and 2014, 137,433 patients were moved on 210,863 flights in the US Air Force Aeromedical 
Evacuation (AE) system. On average, 19% of these patients were immobile on a litter, placing them at high 
risk for a skin pressure injury. A very high-risk group are casualties who require spinal immobilization using 
the vacuum spine board (VSB - a beanbag type stretcher). A military unique aspect of nursing care for these 
critically ill/injured patients is pressure injury prevention during the 8 to 16- hour transports from the 
battlefield to Germany and the US. A skin pressure injury is defined as localized damage to the skin and 
underlying soft tissue due to intense or prolonged pressure or shear on bony prominences (e.g., heels, 
sacrum/buttocks). Other factors that increase the risk of pressure injuries are changes in skin temperature, 
moisture, and perfusion (blood flow and oxygen delivery). During aeromedical evacuation, patients are 
transported on a 23 x 72-inch mesh litter, with or without a 30° removable backrest. If possible, a 2.5-inch 
mattress (AE mattress) is placed on the litter. The only care recommendations for pressure injury prevention 
during AE are to use the AE mattress and to reposition the patient and elevate their heels. For patients 
transported in the VSB, additional care instructions include log rolling the patient (rolling with flexing the 
body) and releasing pressure in the VSB. However, these interventions are only partially effective in 
preventing pressure injuries. Between 2009-2012, 141 (4.9%) of critically injured patients transported from 
the combat zone developed a pressure injury, and in casualties transported on the VSB, the incidence was 
10%. In addition to directly affecting their treatment and recovery, a conservative cost estimate for these 141 
pressure injuries is $1.1 million dollars. In civilian high-risk intensive care patients, recent studies document a 
decrease in pressure injuries related to the use of a multilayered dressing placed on the buttocks/sacrum 
dressing (Mepilex, Mölnlycke Healthcare). The use of the Mepilex dressing offers an intervention that is 
potentially relevant and feasible for use during AE. Existing studies have not addressed the effects of this 
dressing on factors associated with tissue injury or how the dressing performs under AE conditions. 
 

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A second area where combat casualties are at increased risk for pressure injuries is under the setting of 
prolonged field care (PFC). Prolonged field care is defined broadly as care for a combat casualty under field 
conditions for longer than four hours. A recent review of 54 cases found a median time before transport to a 
medical facility of 10 hours (range 4-120 hours). Among these 54 cases, 52 were in remote or austere 
locations (mountains, desert, maritime). Care was provided outdoors (37%), in a hardened non-medical 
structure (37%), on a ship/boat (18.5%), rotary wing aircraft (16.7%), fixed wing aircraft (16.7%), or ground 
vehicle (14.8%). Only 1.9% were in a tent. These patients were at high-risk for pressure injuries, with 36/54 
(67%) with life-threatening injuries or illnesses. General nursing care was identified as important in the care 
of these patients, but no documentation was provided specific to pressure injury prevention. Although not 
reported in this paper, the support surface for PFC would generally be an unpadded litter or possibly the 
ground. An additional risk is that the litter used by the US military under PFC conditions (is the Talon II Model 
90C Collapsible Handle Litter).  The surface of this stretcher is ridged, which may cause areas of increased 
pressure. A recent review paper3 on nursing care in PFC recommended that the best possible care would 
involve padding and positioning the patient with pillows, blankets or towels if available. Of note, previous 
research conducted by the PI found no benefit from using blankets or towels as padding and lateral rotation 
to offload the sacrum and buttocks was associated with increased pressure on the hip. No research has been 
conducted on strategies for pressure injury prevention under PFC conditions.  
 
Rationale for proposed interventions. In our previous study, LiquiCell pads were evaluated with the subjects 
on a litter plus AE mattress. There was no significant difference in skin interface pressure or tissue perfusion 
between the groups with/without LiquiCell. However, the sacral interface pressure was relatively low under 
all conditions. We do not know if LiquiCell might offer some relief from pressure or friction/shear under 
conditions consistent with PFC (Talon litter only; no mattress). Mepilex was also studied in our previous 
research. Although there are studies demonstrating decrease incidence of pressure injuries in patients with 
sacral Mepilex, we did not find any difference in skin pressure or perfusion with/without Mepilex. These 
results suggest that its beneficial effects may be in the reduction of skin pressure injury related to friction 
and shear. Friction and shear occurs most often with backrest elevation. For our current study we will be 
using a 30-degree backrest and additional physiological indicators of tissue injury. No research has been on 
strategies to decrease sacral pressure injuries when an individual is transported on a VSB. In this case, 
Mepilex may provide protection without interfering with the stabilizing capabilities of the VSB.  
 
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. 
 
 
In our previous study UW IRB 49693 – Mitigation of Pressure Ulcer Development during Combat Evacuation 
we studied subjects for 40-minutes (to simulate the median time for transport from a field hospital to a 
larger military hospital). Because the TcPO2 electrode is heated to 44°C, there is a minor risk for a thermal 
injury (skin burn). In our previous work the protocol specified that the temperature on the weighted 
electrode will decrease to 98.6 (37C) if skin blood flow under the electrode decreases to 0. We had no cases 
where skin blood flow decreased to zero and no cases where there was any alteration in skin integrity under 
the heated electrode. Additionally, there were no complaints related to remaining supine or issues regarding 
placement of the Mepilex dressing. We will use the same measures in this proposed study. The previous 

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research was considered minimal risk. See 1.8a for results of study that have informed our current protocol 
and rationale for the study. 
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 
 
 
x 
 
 
 
 
 
 
 
 
 
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 
 
 
x 
 
 
 
 
 
 
 
 
 
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 
 
 
 
 
 
 
 
 
 
 
 
 
Participant results sharing 
Individual research results will be shared with subjects. 
ZIPLINE SUPPLEMENT: 
Participant Results 
Sharing 
 
 
 
 
 
 
 
 
 
 
 
 
None of the above 
 
 
 
 
 
 
 
 
 
 
 
2 PARTICIPANTS 

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2.1 Participants. Describe the general characteristics of the subject populations or groups, including age range, 
gender, health status, and any other relevant characteristics. 
 
Up to 84 subjects (non-military) will be recruited at the University of Washington (goal 72 subjects 12/group).  
Subjects will be randomly assigned to one of the six study groups. Characteristics described below. 
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. 
 
Men and women aged 18 to 55 who meet the physical standards for military personnel and weigh 
less than 250 pounds (maximum allowable weight on the litter). Subjects must be able to remain in 
the study position for the duration of the study.  
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) previous injuries to sacrum/buttocks with scarring, 2) history of pressure injuries, 3) cardiovascular 
disease, 4) neurological disease that would affect vascular response, 5) diabetes, 6) history of 
malignancy, 7) current skin condition (e.g., eczema or psoriasis) which may interfere with the skin 
cytokine levels, 8) current neck/back pain or history of chronic neck/back pain, 9) known 
vertebral/spinal cord disease/injury (scoliosis, kyphosis, or lordosis), 10) self-reported pregnancy or 
11) concern about their ability to remain in the vacuum spine board for 120 minutes. All subjects will 
be asked to refrain from the use of nonsteroidal anti-inflammatory medications for seven days 
before the experiment, to abstain from sun bathing for 24-hours before the experiment, to abstain 
from ingesting caffeine or smoking for six hours before the experiment, to avoid eating for 2 hours 
before the study (to increase accuracy of body fat measurement) and to not use any skin care 
products on the day of testing. Subjects will be informed of these requirements at the time of 
screening. 
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? 
 
      

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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. 
 
 
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 
 
 
 
      
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.  
 
      

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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.  
 
x 
No 
 
 
 
Yes 
 If yes, these individuals are considered human subjects in your study. Describe them and what 
data you will collect about them. 
 
 
 
 
      
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. 
 
 

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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. 
 
 
Our goal is 12 subjects/group (N = 72). At the direction of the funding agency, we have added 12 
additional subjects to account for any possible attrition.  (Total recruitment = up to 84). Note: In our 
previous study, which used similar methods with subjects in supine position for 40 minutes, we did 
not have any subjects discontinue their participation. 
 
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 
 
Group 1: Litter + mattress (no Mepilex) 
12 
 
Group 2: Litter + mattress (with Mepilex) 
12 
 
Group 3: Litter + mattress + vacuum spine board (with 
Mepilex) 
12 
 
Group 4: Litter + mattress + vacuum spine board (no 
Mepilex) 
12 
 
Group 5: Talon litter + LiquiCell 
12 
 
Group 6: Talon litter – no LiquiCell 
12 
 
 
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. 
 
N/A – all research will be conducted at UW 
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  
 
No  

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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. 
 
No site specific laws - subjects will be age 18 or older who will provide their own consent.  No HIPAA laws apply 
to this study.  
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. 
 
No site-specific administrative or ethical requirements apply. 
3.5 Students: Does your research involve traveling outside of the US?  
 
x 
No 
 
 
 
Yes  If yes, confirm by checking the box that (1) you will register with the UW Office of Global Affairs 
 
before traveling; (2) you will notify your advisor when the registration is complete; and (3) you will 
request a UW Travel Waiver if 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. 
 
Advertisements for participation will be placed throughout the Health Sciences Center with contact information 
provided. People interested in participating in the study will contact study staff. Study staff will discuss inclusion 
criteria allowing potential subjects to self-identify any criteria that would exclude them from the study. 

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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. 
 
Subjects will be recruited from the local community. A recruitment flyer (attached) with contact information 
will be placed in approved elevators and bulletin boards in common area of the Health Sciences Center. The 
content in these recruitment documents is similar to our previous study.  
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).  
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. 
 
 
 
      

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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.  
Subjects will receive $50 for completion of all study procedures. They will be reimbursed $25 for 
completion of half and $10 if they complete only the placement of the sensors.  Subjects will also be 
reimbursed up to $9 for parking at the University of Washington.  
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.  
None 
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. 
 
 
 
The potential subject will contact a study team member. We will not obtain any information prior to 
contact with the subject as a part of screening. During the screening process we will obtain 
information related to inclusion/exclusion criteria as specified in the Screening Call Form (see 
attached). PHI will include age, medical conditions as provided by the potential subject. We will 
also record name and contact information for study coordination.   
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. 

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x 
Yes 
 If yes, describe the consent process. 
 
 
 
Study staff will discuss the purpose of the study and screening with subjects over the phone per 
the attached screening form. On the day of the study, subjects will be given the consent form for 
review, discussion with study staff and signature. 
 
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? 
 
 
No 
 If no, describe the information you will provide during the consent process and 
for which procedures. 
 
 
 
 
      
 
x 
Yes 
 If yes, upload the consent form to the Consent Forms and Recruitment Materials 
page of Zipline. 
 
 
 
 
 
5 PROCEDURES 
5.1 Study procedures. Using lay language, provide a complete description of the study procedures, including the 
sequence, intervention or manipulation (if any), drug dosing information (if any), 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. 

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The study will take place in a temperature-controlled room (~72°F) at the University of Washington School of 
Nursing. Subjects will be assigned to one of six groups. Each subject will be clothed in a single layer of cotton like 
clothing (scrubs) and undergarments and socks. Height and weight will be obtained using a standup calibrated 
device and body fat will be measured using the InBody 570 Body Composition Analyzer. This device is used for 
medical research and in health clubs and involves standing on a scale.  
 
Group Assignment: Subjects will first be stratified based on body fat percentage (< 10%, 10%-20%; > 20%). Using 
close block stratification, subjects will be randomly assigned to one of six groups to ensure distribution based on 
body composition.  
Aeromedical Evacuation (AE) conditions 
• 
Group 1: Mepilex:  Litter + AE mattress + 30° backrest 
• 
Group 2: Without Mepilex:  Litter + AE mattress + 30° backrest 
• 
Group 3: Mepilex: Vacuum Spine Board (VSB) placed on AE mattress 
• 
Group 4: Without Mepilex:  Vacuum Spine Board (VSB) placed on AE mattress 
 
Prolonged Field Care (PFC) conditions 
• 
Group 5: LiquiCell:  Talon Litter 
• 
Group 6: Without LiquiCell:  Talon Litter 
 
All Groups 
Acclimation: All subjects will complete a 20-minute acclimation period in the study room.  
Placement of Sensors: After completion of the height, weight and body fat measurements, the subject will lie 
down on the study surface and the temperature/oxygen sensors will be placed on the lower aspect of their back 
and one oxygen sensor placed on their chest (approximately 2 inches below the collar bone on the left chest). 
The transcutaneous oxygen (TcPO2) probes will heat up to 111°F, as recommended by the device manufacturer.  
The subject will rest on their side for approximately 15 minutes while the measurements from the sensors to 
stabilize. These sensors allow for continuous measurement of skin tissue oxygenation and temperature. 
Stabilization: Following acclimation, the subject will be assisted to a side lying position (unloaded) and the 
temperature and TcPO2 probes will be placed. Based on our previous research, it takes approximately 15 minutes 
for the sacral probe to stabilize (TcPO2 < ± 2 mm Hg for 4 minutes).  

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Cytokine/Skin Moisture Measurements: After stabilization four small pieces of 
tape (Sebutape) will be placed on the lower back for 1 minute for the 
measurement of interleukin 1/Total protein. The Sebutape (size: 0.75 x 1.1 
inches) will be placed in four quadrants (sacrum/buttocks). Sebutape has been 
used to measure IL-α in studies related to pressure and shear; including the 
evaluation of Mepilex under conditions of pressure and shear. Removal of the 
tape causes minimal stripping of the stratum corneum and discomfort to the 
subject. The Sebutape will be handled using blunt tweezers and gloved hands to 
avoid any cross contamination. Four patches will be applied (two on 
sacrum/two on buttocks) to intact, unblemished skin that is free of excessive 
hair,55 which allows us to characterize potential injury on the buttocks and 
sacrum (areas of pressure injuries noted in Mok’s study). After the one-minute 
sampling period the Sebutape will be removed using blunt tweezers and will be 
placed flat (avoid any crumpling or folding) into an individually labeled vial and 
immediately frozen on ice. 
 
Skin Moisture. We will also use a noninvasive probe to measure the amount of moisture in the skin on the lower 
back/sacrum. Two components of skin moisture will be measured: 1) Epidermal moisture, which reflects 
perspiration and 2) subepidermal moisture using a Delfin MoistureMeter D (Delfin Technologies, LTD, Grennwich, 
CT) dermal phase meter (http://www.delfintech.com/en/product_information/moisturemeterd/). Epidermal 
moisture (stratum corneum) will be measured at 0.5 mm below the skin surface and subepidermal moisture (i.e., 
below the epidermal stratum corneum layer) will be measured at a depth of 2.5 mm. The device consists of a 
control unit (signal producer) and a probe (open-ended coaxial transmission line), which is placed in contact with 
the skin The skin moisture will be measured at a standardized site, mid-sacrum, approximately 2 cm above the 
gluteal fold (avoiding the sites of the Sebutape). This location will be marked with ink pen to assure the same 
location for repeat measurement. For each depth, the probe will be placed on the skin surface and held for 5 
seconds.  
 
After these measurements are complete, subjects in the Mepilex dressing groups will have the dressing placed on 
their lower back/buttocks. All subjects will then complete an additional 5 minutes in the side-lying position, after 
which they will lie on their back on the designated surface. After positioning a sheet will be placed over the 
subject for comfort. A pillow may be placed under the head and heels at the subject’s discretion.  
 
The skin interface pressure will be measured continuously during the loaded period using the XSensor™ System 
(Crown Therapeutics, Belleville IL) with X3 Medical v6.0 software. This pad, which is similar to a sheet, will be 
positioned on the surface. Peak skin-interface pressure, which is the highest measured pressure for each body 
region and the Peak Pressure Index (PPI), which is the average of a 3 x 3 sensor area representing the highest 
pressure (including the peak pressure cell). The sacrum/buttocks will be divided into four quadrants based on the 
vertebral column and top of the gluteal cleft.55 For the Mepilex groups, the pressure on the surface of the 
Mepilex will be recorded. Although this procedure does not directly measure skin interface pressure, which may 
be decreased by the Mepilex, it is not possible to place the pressure mat between the Mepilex and the skin. 
 
Unique Procedures by Study Group 
For all groups the stretcher is placed on the bedframe of a standard hospital bed. The stretcher is secured to the 
bed frame. This elevation on the bedframe is for ease of access for the subjects. The bedframe is in the low 
position, such that the subjects will be approximately 2-3 feet off the floor. 
Aeromedical Evacuation (AE) conditions 
Group 1: Mepilex:  Litter + AE mattress + 30° backrest elevation. Subjects will be positioned supine on the litter 
plus AE mattress. Mepilex will be placed on sacrum/buttocks region. Subjects will be asked to lie supine with 
Position of sensors and Sebutape on 
posterior surface. TcPO2 also on 
anterior chest 

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limited motion for 120 minutes. After completion of the 120-minute supine period, subject will be positioned 
side-lying. After 5 minutes side-lying, the Mepilex will be removed and the skin moisture and skin cytokine 
measurements will be obtained. After completion of the 15-minute side-lying phase, the skin sensors will be 
removed, and the study will be complete 
 
Group 2: Without Mepilex:  Litter + AE mattress + 30° backrest. Subjects will be positioned supine on the litter 
plus AE mattress. Subjects will be asked to lie supine with limited motion for 120 minutes. No Mepilex will be 
used. After completion of the 120-minute supine period, subject will be positioned side-lying. After 5 minutes 
side-lying the skin moisture and skin cytokine measurements will be obtained. After completion of the 15-minute 
side-lying phase, the skin sensors will be removed, and the study will be complete 
 
AE Conditions with Vacuum Spine Board  
Subjects in Groups 3 and 4 will be positioned on the vacuum spine board 
(VSB), which will be place on top of the litter + AE mattress. The litter will 
be elevated to 30 degrees (consistent with current practice). The vacuum 
will be applied according to manufacturer’s recommendations. After 
creation of the vacuum, the VSB will be loosened around the head and feet 
to allow for movement for comfort. These steps do not interfere with the 
thoracolumbar stabilization or the interface pressure over the 
sacrum/buttocks. To simulate en-route care the vacuum will be maintained 
for 30 minutes (simulate movement to the aircraft). At 30 minutes, the 
vacuum will be released with the straps in place (simulate current en route practice). At 90 minutes, the vacuum 
will be reapplied for 30 minutes to simulate descent and landing phase of flight (total time 120 minutes).  
 
The VSB straps will be in place but loosened (the photo shows the straps tightened – as they would be during 
transport). The subject’s arms will be free (the additional litter straps – seen as olive green in the photo across 
the upper legs and chest will not be used). The straps will remain clipped to enhance stability of the VSB, but the 
subject will be able to move their arms and legs and release the straps if so desired.  
 
Group 3: Mepilex: Vacuum Spine Board (VSB) placed on litter + AE mattress. Subject will complete above 
procedure. Mepilex will be placed on sacrum/buttocks before positioning on VSB. After completion of the 120-
minute supine period, the vacuum will be released, and the subject will be positioned side-lying. After 5 minutes 
side-lying, the Mepilex will be removed and the skin moisture and skin cytokine measurements will be obtained. 
After completion of the 15-minute side-lying phase, the skin sensors will be removed, and the study will be 
complete. 
 
Group 4: Without Mepilex:  Vacuum Spine Board (VSB) placed on litter + AE mattress: Subject will complete 
above procedure. No Mepilex. After completion of the 120-minute supine period, the vacuum will be released, 
and the subject will be positioned side-lying. After 5 minutes side-lying, the skin moisture and skin cytokine 
measurements will be obtained. After completion of the 15-minute side-lying phase, the skin sensors will be 
removed, and the study will be complete 
 
Prolonged Field Care (PFC) conditions 

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Subjects in the prolonged field care groups (Groups 5 and 6) will lie on the Talon litter supine (no mattress/no 
head of bed elevation). Pillows may be placed under the head/heels for comfort. Subjects will be asked to remain 
as still as possible during the 120-minute supine period. Upon completion of the supine period, subjects will be 
positioned side-lying for 15 minutes. Skin moisture and skin cytokine measurements will be obtained 5 minutes 
after the subject is positioned side-lying. After completion of the 15-minute side-lying phase, the skin sensors will 
be removed, and the study will be complete 
 
Group 5: LiquiCell: Talon Litter: Subjects will be positioned supine on the Talon litter plus 
a LiquiCell mat (see photo) will be positioned under the buttocks/sacrum. Subjects will 
be asked to lie supine with limited motion for 120 minutes. After completion of the 120-
minute supine period, subject will be positioned side-lying. After 5 minutes side-lying 
the skin moisture and skin cytokine measurements will be obtained. After completion of 
the 15-minute side-lying phase, the skin sensors will be removed, and the study will be 
complete.  
 
Group 6: Without LiquiCell:  Talon Litter: Subjects will be positioned supine on the Talon litter. Subjects will be 
asked to lie supine with limited motion for 120 minutes. No LiquiCell pad will be used. After completion of the 
120-minute supine period, subject will be positioned side-lying. After 5 minutes side-lying the skin moisture and 
skin cytokine measurements will be obtained. After completion of the 15-minute side-lying phase, the skin 
sensors will be removed, and the study will be complete 
 
Pressure/Discomfort (All Groups): At Time 0 (supine) and every 30 minutes during the supine position, the subject 
will be asked to rate their discomfort using a standardized scale.  
 
 
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. 

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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: 
      
 
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) 

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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. 
 
As outlined in section 5.1 the following variables will be obtained: Height, weight, gender, percent body fat. 
Physiological variables that will be collected either continuously or intermittently include transcutaneous 
tissue oxygen on sacrum/chest, skin temperature on sacrum, skin moisture on sacrum, IL-1 (cytokine) 
obtained from epidermis of sacrum. We will also measure skin interface pressure on the buttocks/sacrum 
and subjects report of comfort/discomfort will be obtained every 30 minutes during the supine position.  
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. 
 
Only the data outlined in the study procedures will be used in this study (height, weight, gender, body fat, skin 
oxygenation, skin temperature, skin moisture, cytokines from epidermis, skin interface pressure). 
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.  
 
 
 
The subjects name will be recorded as a part of the consent/screening process. All study 
data will be coded using a unique identifier. The link between the study data and the 
identifiers will be broken upon completion of the study.  
 
 
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. 
 
 
 
 
Identifiers (name) will be collected during screening and consent. All study data will be 
coded using a unique identifier. The link between the study data and the identifiers will 
be broken upon completion of the study. 
 
 
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: 
 
 
 
 
 
 
      
 
 
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: 
 
 
 
 
 
 
      
 
 
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: 
 
 
 
 
 
 
      

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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. 
 
x 
No 
 If no, skip the rest of this question; go to question 5.9 
 
 
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. 
 
      
b. Is any of the PHI located in Washington State? 
 
 
No 
 
 
 
Yes 
 
c. Describe how you will access or obtain the PHI. Be specific. 
 
      
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?  
 
      
 
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 
 
 

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e. For which PHI will you NOT obtain HIPAA authorization from the subjects? 
      
 
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. 
 
 
 
 
 
 
You will fulfill the HIPAA “accounting for disclosures” requirement. See UW Medicine 
Compliance Policy #104. THIS IS ONLY FOR UW RECORDS. 
 
 
 
 
 
 
 
 
There will be reasonable safeguards to protect against identifying, directly or indirectly, any 
patient in any report of the research. 
 
 
 
 
 
 
 
 
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  
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. 
 
x 
No 
 

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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.  
 
      
 
b. Describe what will be shared, including whether direct identifiers will be shared and (for 
specimens) what data will be released with the specimens.  
 
      
 
c. Who will oversee and/or manage the sharing?  
 
      
 
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. 
 
      
 
e. Consent. Will you obtain consent now from subjects for the banking and/or future sharing?  
 
 
No 
 
 
 
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?  
 
 
No 
 
 
 
Yes 
 If yes, describe how, and whether there are any limitations on withdrawal. 
 
Example: data can be withdrawn from the repository but cannot be retrieved after they 
are released. 
 
      
 
g. Agreements for sharing or release. Confirm by checking the box that 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 
 
Confirmed 

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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.  
 
The only contact with the subject will be for screening, scheduling the date/time for the study and 
during study participation. No additional communication is planned.  
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? 
 
x 
No 
 
 
 
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. 
 
      
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. 
 
 
 
      
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 

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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. 
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.) 
 
      
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. 
 
 

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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. 
 
 
 
 
 
 
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. 

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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? 
 
 
No 
 
 
 
Yes  If yes, an advocate may need to be appointed for each child who is a ward. The advocate must be in 
addition to any other individual acting on behalf of the child as guardian or in loco parentis. The 
same individual can serve as advocate for all children who are wards. 
 
 
 
Describe who will be the advocate(s). 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 
      
      
      
      
      
      
      
      
      
      
      
      

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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. 
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. 
 
 
      

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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. 
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. 

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PARENTAL PERMISSION 
is the parent’s active permission for the child to participate in the research.  
Parental permission is subject to the same requirements as consent, including 
written documentation of permission and required elements. 
SHORT FORM CONSENT 
is an alternative way of obtaining written documentation of consent that is most 
commonly used with individuals who are illiterate or whose language is one for 
which translated consent forms are not available. 
WAIVER OF CONSENT 
means there is IRB approval for not obtaining consent or for not including some of 
the elements of consent in the consent process. 
 
NOTE: If you plan to obtain identifiable information or identifiable biospecimens 
without consent, any waiver granted by the IRB does not override a subject’s 
refusal to provide broad consent (for example, the Northwest Biotrust). 
WAIVER OF DOCUMENTATION 
OF CONSENT 
means that there is IRB approval for not obtaining written documentation of 
consent. 
8.1 Groups Identify the groups to which 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 
 
The PI or approved study team member will meet with the subject at the University of Washington School of 
Nursing lab where the study will occur. At this time, the subject will be provided the consent form for their 
review. The study team member will also review all of the procedures for the study and answer any questions 
the subject may have. The consent form will be completed and the study procedures will occur on the same day. 
c. Comprehension. Describe how you will ensure or test the subjects’ understanding of the information during the 
consent process. 
 
The subject’s comprehension of the study will be tested by asking them to describe the general study 
procedures, where the monitoring devices will be positioned and what they will be asked to do during the 
study.  
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. 
 
Not applicable 

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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. 
      
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. 
 
       

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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. 
 
 
 
 
 
 
All of your research procedures  
 Do not complete the table; go to question 8.5. 
 
x 
 
 
 
 
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 
      
      
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
      
      
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
      
      
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
      
      
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
      
      
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
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 
 

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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. 
      
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. 
 
 
 
      

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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. 
 
If a subject indicates they are functionally illiterate or do not read English well, the consent form will be read 
to them. Confirmation of understanding of the consent will be performed by asking the subject to explain 
what general procedures will happen during the study and what is required of them.   
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. 
 
      
 
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. 
 
 
 
      

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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.  
 
 
      
 
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. 
 
 
      

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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 study data will be coded with a unique identifier. The link between identifiers (name) will be broken upon 
completion of the study. During the screening call, subjects will be asked about specific conditions that would 
exclude them from the study. A subject may choose to not answer a question. All study procedures will be 
performed in a controlled research area. The study room has an external door that will be closed during the 
placement of the study probes. To place the probes the subject will be required to expose the lower portion 
of their back. The subject will be draped during this procedure for privacy. A chaperone will be available. 
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. 
 
 
 
 
      

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9.3 State mandatory reporting. Each state has reporting laws that require some types of individuals to report some 
kinds of abuse, and medical conditions that are under public health surveillance. These include: 
• 
Child abuse 
• 
Abuse, abandonment, neglect, or financial exploitation of a vulnerable adult 
• 
Sexual assault 
• 
Serious physical assault 
• 
Medical conditions subject to mandatory reporting (notification) for public health surveillance 
 
Are you or a member of 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 
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. 
 
 
The data being collected are Level 3 (e.g., weight, demographics – non-sensitive personal health information). 
We will follow all of the recommendations outlined in the Data Security Protection guidance.  

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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. 
 
 
      
 
 
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. 
 
Because the TcPO2 (tissue oxygen) electrode is heated to 44°C (111°F), there is a minor risk for a thermal injury 
(skin redness or a minor skin burn) under a less than quarter size area. In our previous study, where the subjects 
were supine for 55 minutes with the electrode heated to 44°C (40-minutes loaded conditions/15 minutes 
unloaded condition), we had no alterations in skin integrity or subject reports of adverse events. In this current 
study, the electrode will be in contact with the subject at the maximum temperature for 135 minutes (120 
minutes loaded condition and 15 minutes unloaded).  
The TcPO2 electrode is used in clinical practice in both healthy and critically ill neonates and adults. Relevant to 
this proposal are studies that use TcPO2 under loaded conditions. In studies where the electrode is exposed to a 
pressure load, there have been no reports of thermal injuries. For example, in a study by Wong, nine patients in 
a long term care facility (age 85 ± 11 years) had TcPO2 electrodes placed on their sacrum (distal to the coccyx 
but proximal to the anus), trochanters (hip – 2 inches medial to the great trochanters) and on the plantar surface 
of the heels (note – the electrode will be on the sacrum for this proposed study). The subjects were 1) placed 
lateral for 30 minutes and 2) turned to supine position with the head of bed at 30° for 2 hours with both the 
sacrum and heels on the bed surface (low-air-loss), and 3) positioned lateral for 2 hours (unloading). Total data 
collection was approximately 5 hours. Although five subjects had a low TcPO2 (< 40 mm Hg), which indicates 
impaired perfusion, there were no reports of alteration in skin integrity associated with the electrodes. Two 
actions that have been successfully used in other protocols (including our previous study) will be taken to 
minimize the risk. The sacral electrode will be surrounded by a callus pad to offload any pressure directly on the 
electrode. If the TcPO2 on the weighted electrode decreases to 0 mm Hg, the temperature on the electrode will 
be decreased to 37°C for the remainder of the loaded period. At the completion of the study and removal of the 
TcPO2 sensor, the skin will be inspected. If there is redness that persists, the subject will be instructed to apply 
topical (such as aloe vera) if so desired. It they are concerned regarding skin condition, the study monitor (a 
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Another strategy to decrease the risk will be repeated assessment of the subject’s perceptions of perceived 
pressure or discomfort using the Category Partitioning Scale (CP-50), 
which is a verbal scale that describes discomfort/pressure under each 
condition. Use of this scale may be more appropriate than a “pain scale” 
as a subject may or may not experience pain, but rather sense pressure 
or discomfort. Using the CP-50, the subject is first asked to describe using 
verbal terms the pressure intensity or discomfort associated with the 
stimulus (i.e., sacral/buttocks pressure or discomfort). The subject can 
then fine-tune their assessment using the numeric scores. The final score 
is the analog number. For purposes of this research, at baseline and every 
30 minutes, we will ask the subject to limit their evaluation to the 
pressure/discomfort sensed on the sacrum/buttocks, but we will also ask 
the subjects to identify on their body where they are experiencing the 
most pressure/discomfort. 
To protect the subject from undo perceived pressure or discomfort, a 
threshold of CP-50 score of 40 will be established as the maximum score. 
If the subject reports a CP-50 score greater than 40, the experiment will 
be stopped. The subjects will not be informed of this cutoff. (This 
threshold is consistent with Games study, where a threshold of 45 was 
used in a study of discomfort associated with prolonged sitting in an 
unpadded seat.  
 
The CP-50 was used in two studies of Black Hawk UH-60 crewmembers 
exposed to four hours of sitting in a simulated cockpit on an unpadded 
seat.9,10 The CP-50 score increased significantly at each time point (every 
30 minutes), and at 240 minutes the score had increased an average of 
30 points. In the second study,10 healthy subjects were exposed to 36 kPA 
(270 mm Hg) and 44 kPA (330 mm Hg) on the ischial tuberosity and 
poster thigh for 10 minutes. Application of pressure was associated with 
increased discomfort on the posterior thigh (5.5 points at 36 kPA and 7.5 
points at 44 kPA) and ischial tuberosity (3.1 points/4.2 points, 
respectively), with increased discomfort at higher pressures. Of 
importance, in this proposed study the skin interface pressure will be 
much lower, thus we anticipate lower levels of perceived pressure and 
discomfort. Based on our previous work, the average sacral/buttocks 
pressure on the litter plus mattress was 42 ± 12 mm Hg and 60-70 mm Hg 
on the vacuum spine board.11  
 
Because the area of the body we are interested in is the lower back/buttocks, we will provide pillows for the 
head and to elevate the heels.  
Placement of the Mepilex and performance of the monitoring will require the subject to expose the lower half of 
their back and upper aspect of their buttocks. The procedures will be conducted with the subject lying face-
down. The subject will be appropriately draped to minimize exposure. All procedures will be performed in a 
screened area and the subject will be asked if they would like a chaperone present during these procedures. 
Figure 3. Category 
Partitioning Scale (CP-50).7 

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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. 
 
Not applicable 
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.  
 
Not applicable 
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)? 
 
X No 
 
 
 
Yes 
 If yes, check all the boxes that apply. 
 
 
 
 
Administration of any drug for research purposes 
 
 
 
 
 
 
 
 
 
 
Inserting an intra-venous (central or peripheral) or intra-arterial line for research purposes 
 
 
 
 
 
 
Obtaining samples of blood, urine, bone marrow or cerebrospinal fluid for research 
purposes 
 
 
 
 
 
 
Obtaining a research sample from tissue or organs that would not otherwise be removed 
during surgery 
 
 
 
 
 
 
Administration of a radio-isotope for research purposes** 
 
 
 
 
 
 
Implantation of an experimental device 
 
 
 
 
 
 
Other manipulations or procedures performed solely for research purposes (e.g., 
experimental liver dialysis, experimental brain stimulation) 
 
 
 
 
 
 
If 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. 
 
In our previous research, which used similar methods, the IRB determined that the study was minimal risk and 
a medical monitor/DSMB was not required. DSMP v1 (Bridges) is attached. 
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. 
 
Not applicable 

Document Date & Version 
 
Researcher Date & Version 
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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. 
 
The subject will be withdrawn in they report discomfort about the specified threshold. Although we do not 
anticipate a subject having intolerance to lying in the stiff vacuum spine board, if they indicate 
intolerance to the compression (e.g., a sense of claustrophobia), we will offer them the opportunity to 
discontinue their participation. We will obtain post-measures (skin cytokines and moisture) and record 
final tissue oxygen and skin temperature measurements at the time of withdrawal. All study data will be 
retained.  
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.  
 
There is no direct benefit to participants. 
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. 
 
x 
No 
 
 
 
Yes 
 If yes, complete and upload the SUPPLEMENT: Participant Results Sharing to the 
Supporting Documents SmartForm of Zipline 
 
 
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. 
 
 
 
 
      
 
 

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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). 
 
No costs to subject 
11.3 Reimbursement for costs. Describe any costs to subjects that will be reimbursed (such as travel expenses). 
 
Subjects will be reimbursed for parking (up to $9) or cost of public transportation on the day of the study 
 
 
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.  
 
      
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. 
 
 
 
 
We will hold regular study team meetings. During these meetings we will ensure study team members are 
informed and have the opportunity to perform all required study procedures as appropriate. We used this 
same method in our previous study to ensure ongoing adherence with all study protocols.  
 
 

Document Date & Version 
 
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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. 
 
 
 
 
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. 
 
      
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.