Breast and Ovarian Catchment Pilot Grant: Clinical Outcomes for Offering Genetic Testing in a Tiered Approach
Phase: NA
Conditions: Breast Carcinoma, Colon Carcinoma, Malignant Solid Neoplasm, Ovarian Carcinoma, Pancreatic Carcinoma, Prostate Carcinoma
Sponsor: Fred Hutchinson Cancer Center

 
 
Official Title: 
Breast and Ovarian Catchment Pilot Grant: Clinical 
Outcomes for Offering Genetic Testing in a Tiered 
Approach   
NCT Number: 
NCT04902144 
Document Type:  
Study Protocol 
Date of the 
Document: 
05/15/2020 
 
 

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

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1.1 Home institution. Identify the institution through which the lead researcher listed on the IRB application will 
conduct the research. Provide any helpful explanatory information. 
In general, the home institution is the institution (1) that provides the researcher’s paycheck and that considers him/her to be 
a paid employee, or (2) at which the researcher is a matriculated student. Scholars, faculty, fellows, and students who are 
visiting the UW and who are the lead researcher: identify your home institution and describe the purpose and duration of your 
UW visit, as well as the UW department/center with which you are affiliated while at the UW. 
 
Note that many UW clinical faculty members are paid employees of non-UW institutions. 
 
The UW IRB provides IRB review and oversight for only those researchers who meet the criteria described in the SOP: Use of 
the UW IRB. 
 
The lead research will conduct the research through Seattle Cancer Care Alliance. 
1.2 Consultation history. Has there been any consultation with someone at HSD about this study? 
It is not necessary to obtain advance consultation. However, if advance consultation was obtained, answering this question 
will help ensure that the IRB is aware of and considers the advice and guidance provided in that consultation.   
 
 
No 
 
 
X Yes 
→ If yes, briefly describe the consultation: approximate date, with whom, and method (e.g., by email, 
phone call, in-person meeting). 
 
 
 
 
Virtual meeting via Zoom with Jennifer McBride and Bailey Bodell from UW Reliance department 
on 4/24/20. Marianne Dubard-Gault (study’s PI), Lauren Santos (study’s research coordinator), and 
Martha Horik-Pyne (UW Medical Genetics research coordinator) were also present. This 
consultation was to discuss the involved parties of this study as well as IRB review guidance. After 
review, it was determined that a complete protocol application must be submitted due to the type of 
grant that is funding this study. 
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. 
 
X 
No 
 
 
 
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. 
 
 
 
      

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1.4 Externally-imposed urgency or time deadlines. Are there any externally-imposed deadlines or urgency that affect 
the proposed activity? 
HSD recognizes that everyone would like their IRB applications to be reviewed as quickly as possible. To ensure fairness, it is 
HSD policy to review applications in the order in which they are received. However, HSD will assign a higher priority to 
research with externally-imposed urgency that is beyond the control of the researcher. Researchers are encouraged to 
communicate as soon as possible with their HSD staff contact person when there is an urgent situation (in other words, before 
submitting the IRB application). Examples: a researcher plans to test an experimental vaccine that has just been developed for 
a newly emerging epidemic; a researcher has an unexpected opportunity to collect data from students when the end of the 
school year is only four weeks away.  
 
HSD may ask for documentation of the externally-imposed urgency. A higher priority should not be requested to compensate 
for a researcher’s failure to prepare an IRB application in a timely manner. Note that IRB review requires a certain minimum 
amount of time; without sufficient time, the IRB may not be able to review and approve an application by a deadline.  
 
X   No 
 
 
 
Yes 
→ If yes, briefly describe the urgency or deadline as well as the reason for it. 
 
 
 
      
1.5 Objectives Using lay language, describe the purpose, specific aims, or objectives that will be met by this specific 
project. If hypotheses are being tested, describe them. You will be asked to describe the specific procedures in a 
later section. 
 
If this application involves the use of a HUD “humanitarian” device: describe whether the use is for “on-label” 
clinical patient care, “off-label” clinical patient care, and/or research (collecting safety and/or effectiveness data). 
 
This quality improvement research study aims to improve the utilization of genetic counseling and testing 
among providers at Olympic Medical Center (OMC) who are caring for their cancer patients in a rural and 
underserved area. SCCA will coach the OMC providers to offer eligible patients genetic counseling and testing in 
order to increase access and help the OMC site meet genetic recommendations and guidelines. Specifically, this 
study aims to (1) review and develop OMC’s clinical operations workflow to identify cancer patients who meets 
criteria for genetic counseling and testing; (2) measure uptake of genetic testing; and (3) document clinical and 
patient reported outcomes following genetic test results.  
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 a ssigning applications to reviewers and in managing workload. Examples: a longitudinal 
observational study; a double-blind, placebo-controlled randomized study; ethnographic interviews; web scraping from a 
convenience sample of blogs; medical record review; coordinating center for a multi-site study. 
 
This is a quality improvement research study in which SCCA will provide coaching to OMC providers to offer 
genetic counseling and testing in order to address current gaps in caring for their high-risk patients.  
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. 
 
 

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3. Improve the quality of service provided by a specific institution, organization, or program. 
 
X 
 
 
 
 
4. Designed to expand the knowledge base of a scientific discipline or other scholarly field of study, and 
produce results that: 
• 
Are expected to be applicable to a larger population beyond the site of data collection or the specific 
subjects studied, or 
• 
Are intended to be used to develop, test, or support theories, principles, and statements of 
relationships, or to inform policy beyond the study. 
 
 
 
 
 
 
5. Focus directly on the specific individuals about whom the information or biospecimens are collected 
through oral history, journalism, biography, or historical scholarship activities, to provide an accurate and 
evidence-based portrayal of the individuals. 
 
 
 
 
 
 
6. A quality improvement or program improvement activity conducted to improve the implementation 
(delivery or quality) of an accepted practice, or to collect data about the implementation of the practice 
for clinical, practical, or administrative purposes. This does not include the evaluation of the efficacy of 
different accepted practices, or a comparison of their efficacy. 
 
X 
 
 
 
 
7. Public health surveillance activities conducted, requested, or authorized by a public health authority for 
the sole purpose of identifying or investigating potential public health signals or timely awareness and 
priority setting during a situation that threatens public health. 
 
 
 
 
 
 
8. Preliminary, exploratory, or research development activities (such as pilot and feasibility studies, or 
reliability/validation testing of a questionnaire) 
 
 
 
 
 
 
9. Expanded access use of a drug or device not yet approved for this purpose 
 
 
 
 
 
 
10. Use of a Humanitarian Use Device 
 
 
 
 
 
 
11. Other. Explain: 
 
 
 
 
 
 
 
      
1.8 Background, experience, and preliminary work. Answer this question only if the proposed activity has one or 
more of the following characteristics. The purpose of this question is to provide the IRB with information that is 
relevant to its risk/benefit analysis. 
• 
Involves more than minimal risk (physical or non-physical) 
• 
Is a clinical trial, or 
• 
Involves having the subjects use a drug, biological, botanical, nutritional supplement, or medical 
device. 
“Minimal risk” means that the probability and magnitude of harm or discomfort anticipated in the research are not greater 
than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or 
tests. 

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a. Background. Provide the rationale and the scientific or scholarly background for the proposed activity, based 
on existing literature (or clinical knowledge). Describe the gaps in current knowledge that the project is 
intended to address. 
 
This should be a plain language description. Do not provide scholarly citations. Limit your answer to less than one page, or 
refer to an attached document with background information that is no more than three pages long. 
 
N/A 
 
b. Experience and preliminary work. Briefly describe experience or preliminary work or data (if any) that you, 
your team, or your collaborators/co-investigators have that supports the feasibility and/or safety of this study.   
 
It is not necessary to summarize all discussion that has led to the development of the study protocol. The IRB is interested 
only in short summaries about experiences or preliminary work that suggest the study is feasible and that risks are 
reasonable relative to the benefits. Examples: Your team has already conducted a Phase 1 study of an experimental drug 
which supports the Phase 2 study being proposed in this application; your team has already done a small pilot study 
showing that the reading skills intervention described in this application is feasible in an after-school program with 
classroom aides; your team has experience with the type of surgery that is required to implant the study device; the study 
coordinator is experienced in working with subjects who have significant cognitive impairment. 
 
 
N/A 
1.9 Supplements. Check all boxes that apply, to identify relevant Supplements that should be completed and 
uploaded to Zipline. 
This section is here instead of at the end of the form to reduce the risk of duplicating information in this IRB Protocol form that 
you will need to provide in these Supplements. 
 
Check all 
That Apply 
Type of Research 
Supplement Name 
 
 
 
 
Department of Defense 
The research involves Department of Defense funding, facilities, data, or 
personnel. 
ZIPLINE SUPPLEMENT: 
Department of Defense 
 
 
 
 
 
 
 
 
 
 
 
 
Department of Energy 
The research involves Department of Energy funding, facilities, data, or 
personnel. 
ZIPLINE SUPPLEMENT: 
Department of Energy 
 
 
 
 
 
 
 
 
 
 
 
 
Drug, biologic, botanical, supplement 
Procedures involve the use of any drug, biologic, botanical or 
supplement, even if the item is not the focus of the proposed 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 
ZIPLINE SUPPLEMENT: 
Genomic Data Sharing 
 
 
 
 

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Genomic data are being collected and will be deposited in an external 
database (such as the NIH dbGaP database) for sharing with other 
researchers, and the UW is being asked to provide the required 
certification or to ensure that the consent forms can be certified 
 
 
 
 
Medical device 
Procedures involve the use of any medical device, even if the device is 
not the focus of the proposed research, except when the device is FDA-
approved and is being used through a clinical facility in the manner for 
which it is approved 
ZIPLINE SUPPLEMENT: 
Devices 
 
 
 
 
 
 
 
 
 
 
 
 
Multi-site or collaborative study 
The UW IRB is being asked to review on behalf of one or more non-UW 
institutions in a multi-site or collaborative study. 
SUPPLEMENT: Multi-site 
or Collaborative Research 
 
 
 
 
 
 
 
 
 
 
 
 
Non-UW Individual Investigators 
The UW IRB is being asked to review on behalf of one or more non-UW 
individuals who are not affiliated with another organization for the 
purpose of the research. 
SUPPLEMENT: Non-UW 
Individual Investigators 
 
 
 
 
 
 
 
 
 
 
 
 
None of the above 
 
 
 
X 
 
 
 
 
 
 
 
 
2 PARTICIPANTS 
2.1 Participants. Describe the general characteristics of the subject populations or groups, including age range, 
gender, health status, and any other relevant characteristics. 
 
The subject groups for this study will consist of OMC medical oncology providers and OMC patients between 
19-90 years old with a diagnosis of cancer. 
2.2 Inclusion and exclusion criteria.  
a. Inclusion criteria. Describe the specific criteria that will be used to decide who will be included in the research 
from among interested or potential subjects. Define any technical terms in lay language. 
 
Participants will include medical oncology providers at OMC who see patients with an active diagnosis of 
breast, ovarian, prostate, colon, or pancreatic cancer. The OMC providers will be consenting to release their 
patients’ medical records to SCCA so that SCCA subject matter experts (cancer geneticist and/or genetic 
counselor) can identify patients with an underlying hereditary cancer syndrome to be offered genetic counseling 
and testing. 
b. Exclusion criteria. Describe the specific criteria that will be used to decide who will be excluded from the 
research from subjects who meet the inclusion criteria listed above. Define any technical terms in lay language. 
 
This study will exclude OMC providers who do not see patients with an active diagnosis of cancer. This study 
will exclude patients who are minors, patients without an active diagnosis of cancer, and patients 
with precancerous lesions such as ductal carcinoma in situ (the presence of abnormal cells inside a milk duct in 
the breast) or colon polyps (a small clump of cells that form on the lining of the colon or rectum).  

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2.3 Prisoners. IRB approval is required in order to include prisoners in research, even when prisoners are not an 
intended target population. 
a. Will the proposed research recruit or obtain data from individuals that are known to be prisoners? 
For records reviews: if the records do not indicate prisoner status and prisoners are not a target population, select “No”. See 
the WORKSHEET: Prisoners for the definition of “prisoner”. 
 
X 
No 
→ If no, skip the rest of part a. and continue to 2.3.b 
 
 
Yes 
→ If yes, answer the following questions (i – iv). 
 
i. Describe the type of prisoners, and which prisons/jails: 
 
      
 
ii. One concern about prisoner research is whether the effect of participation on prisoners’ 
general living conditions, medical care, quality of food, amenities, and/or opportunity for 
earnings in prison will be so great that it will make it difficult for prisoners to adequately 
consider the research risks. How will the chances of this be reduced? 
 
      
 
iii. Describe what will be done to make sure that (a) recruitment and subject selection 
procedures will be fair to all eligible prisoners and (b) prison authorities or other prisoners will 
not be able to arbitrarily prevent or require particular prisoners from participating. 
 
      
 
iv. If the research will involve prisoners in federal facilities or in state/local facilities outside of 
Washington State: check the box below to provide assurance that study team members will 
(a) not encourage or facilitate the use of a prisoner’s participation in the research to influence 
parole decisions, and (b) clearly inform each prisoner in advance (for example, in a consent 
form) that participation in the research will have no effect on his or her parole. 
 
 
Confirmed 
 
 
b. Is the research likely to have subjects who become prisoners while participating in the study?   
For example, a longitudinal study of youth with drug problems is likely to have subjects who will be prisoners at some 
point during the study. 
 
X No 
 
 
 
Yes 
→ If yes, if a subject becomes a prisoner while participating in the study, will any study 
procedures and/or data collection related to the subject be continued while the subject is a 
prisoner? 
 
 
 
 
No 
 
 
 
Yes 
→ If yes, describe the procedures and/or data collection that will continue with 
prisoner subjects 
 
 
 
      

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2.4 Protected populations. IRB approval is required for the use of the subject populations listed here. Check the boxes 
for any of these populations that will be purposefully included. (In other words, being a part of the population is 
an inclusion criterion for the study.) 
The WORKSHEETS describe the criteria for approval but do not need to be completed and should not be submitted. 
 
Population 
Worksheet 
 
 
Fetuses in utero 
WORKSHEET: Pregnant Women 
 
 
 
 
 
 
Neonates of uncertain viability 
WORKSHEET: Neonates 
 
 
 
 
 
 
Non-viable neonates 
WORKSHEET: Neonates 
 
 
 
 
 
 
Pregnant women 
WORKSHEET: Pregnant Women 
 
 
 
 
a. If you check any of the boxes above, use this space to provide any information that may be relevant for the IRB 
to consider.  
 
None of the populations listed above will be purposefully included in this study.  
2.5 Native Americans or non-U.S. indigenous populations. Will Native American or non-U.S. indigenous populations 
be actively recruited through a tribe, tribe-focused organization, or similar community-based organization? 
Indigenous people are defined in international or national legislation as having a set of specific rights based on their historical 
ties to a particular territory and their cultural or historical distinctiveness from other populations that are often politically 
dominant. 
 
Examples: a reservation school or health clinic; recruiting during a tribal community gathering 
 
X No 
 
 
 
Yes → If yes, name the tribe, tribal-focused organization, or similar community-based organization. The 
UW IRB expects that tribal/indigenous approval will be obtained before beginning the research. 
This may or may not involve approval from a tribal IRB. The study team and any 
collaborators/investigators are also responsible for identifying any tribal laws that may affect the 
research. 
 
 
 
 
      
2.6 Third party subjects. Will the research collect private identifiable information about other individuals from the 
study subjects? Common examples include: collecting medical history information or contact information about 
family members, friends, co-workers. 
“Identifiable” means any direct or indirect identifier that, alone or in combination, would allow you or another member of the 
research team to readily identify the person. For example, suppose that the research is about immigration history. If subjects 
are asked questions about their grandparents but are not asked for names or other information that would allow easy 
identification of the grandparents, then private identifiable information is not being collected about the grandparents and the 
grandparents are not subjects.  
 
 
X No 
 

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Yes 
→ If yes, these individuals are considered human subjects in the study. Describe them and what data 
will be collected about them. 
 
 
 
 
      
2.7 Number of subjects. Is it possible to predict or describe the maximum number of subjects (or subject units) 
needed to complete the study, for each subject group? 
Subject units mean units within a group. For most research studies, a group will consist of individuals. However, the unit of 
interest in some research is not the individual. Examples:   
• 
Dyads such as caregiver-and-Alzheimer’s patient, or parent and child 
• 
Families 
• 
Other units, such as student-parent-teacher 
Subject group means categories of subjects that are meaningful for the specific study. Some research has only one subject 
group – for example, all UW students taking Introductory Psychology. Some common ways in which subjects are grouped 
include: 
• 
By intervention – for example, an intervention group and a control group. 
• 
By subject population or setting – for example, urban versus rural families 
• 
By age – for example, children who are 6, 10, or 14 years old.  
 
The IRB reviews the number of subjects in the context of risks and benefits. Unless otherwise specified, if the IRB determines 
that the research involves no more than minimal risk: there are no restrictions on the total number of subjects that may be 
enrolled. If the research involves more than minimal risk: The number of enrolled subjects must be limited to the number 
described in this application. If it is necessary later to increase the number of subjects, submit a Modification. Exceeding the 
IRB-approved number (over-enrollment) will be considered non-compliance.  
 
 
No 
→ If no, provide the rationale in the box below. Also, provide any other available information about 
the scope/size of the research. You do not need to complete the table. 
 
 
 
 
Example: It may not be possible to predict the number of subjects who will complete an online survey 
advertised through Craigslist, but you can state that the survey will be posted for two weeks and the number 
who respond is the number who will be in the study. 
 
 
      
 
X Yes 
→ If yes, for each subject group, use the table below to provide the estimate of the maximum desired 
number of individuals (or other subject unit, such as families) who will complete the research. 
 
 
 
Group name/description 
Maximum desired number of individuals (or other 
subject unit, such as families) who will complete 
the research 
Provide numbers for the site(s) reviewed by the UW IRB 
and for the study-wide total number; example: 20/100 
 
  
      
 
OMC providers who see patients with an active diagnosis 
of breast, ovarian, prostate, colon, or pancreatic cancer 
6 (4 MDs, 1 PA-C, and 1 ARNP) 
 
Phase 1: Patients in the observational group in 
which SCCA collects data on OMC patients who 
follow their current processes (without intervention)  
60/120 
 
Phase 2: Patients in the monitoring group in which SCCA 
collect data on OMC patients who follow the tiered 
intervention (OMC providers receive coaching from 
SCCA subject matter experts)  
60/120 

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3 NON-UW RESEARCH SETTING  
Complete this section only if UW investigators and people named in the SUPPLEMENT: 
Non-UW Individual Investigators will conduct research procedures outside of UW and 
Harborview 
3.1 Reason for locations. Describe the reason(s) for choosing the locations.  
This is especially important when the research will occur in locations or with populations that may be vulnerable to 
exploitation. One of the three ethical principles the IRB must consider is justice: ensuring that reasonable, non-exploitative, 
and well-considered procedures are administered fairly, with a fair distribution of costs and potential benefits. 
 
OMC is the ideal site for this research study because of its rural and underserved location, which can pose many 
obstacles to their patients in accessing genetic evaluations for the treatment of their cancers and for their family 
members. OMC is an affiliate site of SCCA and this partnership, in which SCCA will provide coaching to OMC 
providers, will facilitate a more open line of communication between the sites. OMC providers will have the 
resources to increase access to genetic counseling and testing to its patients as well as refer their patients with 
more complicated cases to SCCA for genetic consultation services 
3.2 Local context. Culturally appropriate procedures and an understanding of local context are an important part of 
protecting subjects. Describe any site-specific cultural issues, customs, beliefs, or values that may affect the 
research, how it is conducted, or how consent is obtained or documented. 
Examples: It would be culturally inappropriate in some international settings for a woman to be directly contacted by a male 
researcher; instead, the researcher may need to ask a male family member for permission before the woman can be 
approached. It may be appropriate to obtain permission from community leaders prior to obtaining consent from individual 
members of a group. In some distinct cultural groups, signing forms may not be the norm. 
 
This federal site maintains an international list of human research standards and requirements: 
 http://www.hhs.gov/ohrp/international/index.html  
 
N/A 
3.3 Location-specific laws. Describe any local laws that may affect the research (especially the research design and 
consent procedures). The most common examples are laws about: 
• 
Specimens – for example, some countries will not allow biospecimens to be taken out of the country. 
• 
Age of consent – laws about when an individual is considered old enough to be able to provide consent vary 
across states, and across countries.   
• 
Legally authorized representative – laws about who can serve as a legally authorized representative (and who 
has priority when more than one person is available) vary across states and countries. 
• 
Use of healthcare records – many states (including Washington State) have laws that are similar to the 
federal HIPAA law but that have additional requirements. 
 
N/A. OMC is located in Sequim, Washington. The laws in this region are the same as the laws that apply to 
SCCA.  

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3.4 Location-specific administrative or ethical requirements. Describe local administrative or ethical requirements 
that affect the research.  
Example: A school district may require researchers to obtain permission from the head district office as well as school 
principals before approaching teachers or students; a factory in China may allow researchers to interview factory workers but 
not allow the workers to be paid for their participation. 
 
N/A 
3.5 If the PI is a student: Does the research involve traveling outside of the US?  
 
 
No 
 
 
 
Yes → If yes, confirm by checking the box that (1) you will register with the UW Office of Global Affairs 
before traveling; (2) you will notify your advisor when the registration is complete; and (3) you will 
request a UW Travel Waiver if the research involves travel to the list of countries requiring a UW 
Travel Waiver. 
 
Confirmed 
 
 
4 RECRUITING and SCREENING PARTICIPANTS 
4.1 Recruiting and Screening. Describe how subjects will be identified, recruited, and screened. Include information 
about: how, when, where, and in what setting. Identify who (by position or role, not name) will approach and 
recruit subjects, and who will screen them for eligibility. 
 
Before the study begins, the SCCA study team will identify OMC providers who meet eligibility criteria through 
the OMC website’s oncology providers page. A virtual meeting (via Zoom) will be set up by the study’s research 
coordinator to include the SCCA study team and OMC’s medical director and all the potential OMC provider 
subjects. During this meeting, the PI and research coordinator will explain the study’s target patient population, 
methods, procedures, and goals. OMC providers will be given time to introduce themselves and describe their 
patient population to ensure that they are eligible to participate.  
4.2 Recruitment materials.  
 
a. What materials (if any) will be used to recruit and screen subjects? 
Examples: talking points for phone or in-person conversations; video or audio presentations; websites; social media 
messages; written materials such as letters, flyers for posting, brochures, or printed advertisements; questionnaires filled 
out by potential subjects. 
 
The SCCA study team will recruit all eligible OMC providers via a virtual meeting (through Zoom), where the 
study will be described and discussed in detail. As part of recruitment, all potential OMC provider participants 
will be provided copies of the study’s research methods and procedures. After this meeting, the study’s research 
coordinator will then email a consent information sheet (attached in Zipline). The OMC providers who choose to 
participant will send an emailed consent to the study’s research coordinator. 
There is no recruitment process for OMC patients because the study team will have no contact with the patients 
at any point of the study. OMC patients will be screened by reviewing their clinical diagnosis and stage, 
pathology report features, and treatment options (after consent is given from their OMC provider to release their 
medical records). 

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b. Upload descriptions of each type of material (or the materials themselves) to Zipline. If letters or emails will be 
sent to any subjects, these should include a statement about how the subject’s name and contact information 
were obtained. No sensitive information about the person (such as a diagnosis of a medical condition) should 
be included in the letter. 
HSD encourages researchers to consider uploading descriptions of most recruitment and screening materials instead of the 
materials themselves. The goal is to provide the researchers with the flexibility to change some information on the materials 
without submitting a Modification for IRB approval of the changes. Examples: 
• 
Provide a list of talking points that will be used for phone or in-person conversations instead of a script.   
• 
For the description of a flyer, include the information that it will provide the study phone number and the name of a 
study contact person (without providing the actual phone number or name). This means that a Modification would 
not be necessary if/when the study phone number or contact person changes. Also, instead of listing the 
inclusion/exclusion criteria, the description below might state that the flyer will list one or a few of the major 
inclusion/exclusion criteria. 
• 
For the description of a video or a website, include a description of the possible visual elements and a list of the 
content (e.g., study phone number; study contact person; top three inclusion/exclusion criteria; payment of $50; 
study name; UW researcher).  
4.3 Relationship with participant population. Do any members of the study team have an existing relationship with 
the study population(s)?  
Examples: a study team member may have a dual role with the study population (for example, being their clinical care 
provider, teacher, laboratory directory or tribal leader in addition to recruiting them for his/her research). 
 
X 
No 
 
 
 
Yes 
→ If yes, describe the nature of the relationship. 
 
 
 
      
4.4 Payment to participants. Describe any payment that will be provided, including: 
• 
The total amount/value 
• 
Whether payment will be “pro-rated” so that participants who are unable to complete the research may still 
receive some part of the payment 
The IRB expects the consent process or study information provided to the subjects to include information about the number 
and amount of payments, and especially the time when subjects can expect to receive payment. One of the most frequent 
complaints received by HSD is from subjects who expected to receive cash or a check on the day that they completed a study 
and who were angry or disappointed when payment took 6-8 weeks to reach them.  
 
Do not include a description of any expenses that will be reimbursed.  
No payment will be provided to participants. 
4.5 Non-monetary compensation. Describe any non-monetary compensation that will be provided. Example: extra 
credit for students; a toy for a child. If class credit will be offered to students, there must be an alternate way for 
the students to earn the extra credit without participating in the research.  
No non-monetary compensation will be provided to participants. 

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4.6 Will data or specimens be accessed or obtained for recruiting and screening procedures prior to enrollment?  
Examples: names and contact information; the information gathered from records that were screened; results of screening 
questionnaires or screening blood tests; Protected Health Information (PHI) from screening medical records to identify possible 
subjects. 
 
X 
No 
→ If no, skip the rest of this section; go to question 5.1. 
 
 
Yes 
→ If yes, describe the data and/or specimens (including PHI) and whether it will be retained as part of 
the study data. 
 
 
 
 
4.7 Consent for recruiting and screening. Will consent be obtained for any of the recruiting and screening 
procedures? (Section 8: Consent of Adults asks about consent for the main study procedures). 
“Consent” includes: consent from individuals for their own participation; parental permission; assent from children; consent 
from a legally authorized representative for adult individuals who are unable to provide consent. 
 
Examples:   
• 
For a study in which names and contact information will be obtained from a registry: the registry should have consent 
from the registry participants to release their names and contact information to researchers. 
• 
For a study in which possible subjects are identified by screening records: there will be no consent process.  
• 
For a study in which individuals respond to an announcement and call into a study phone line: the study team person 
talking to the individual may obtain non-written consent to ask eligibility questions over the phone.  
 
X 
No 
→ If no, skip the rest of this section; go to question 5.1. 
 
 
Yes 
→ If yes, describe the consent process. 
 
 
 
 
 
a. Documentation of consent. Will a written or verifiable electronic signature from the subject on a 
consent form be used to document consent for the recruiting and screening procedures? 
 
 
No 
→ If no, describe the information that will be provided during the consent process 
and for which procedures. 
 
 
 
 
      
 
 
Yes 
→ If yes, upload the consent form to Zipline. 
 
 
 
 
 
5 PROCEDURES 
5.1 Study procedures. Using lay language, provide a complete description of the study procedures, including the 
sequence, intervention or manipulation (if any), drug dosing information (if any), use of records, time required, 
and setting/location. If it is available: Upload a study flow sheet or table to Zipline.  
For studies comparing standards of care: It is important to accurately identify the research procedures. See UW IRB POLICY: 
Risks of Harm from Standard Care and the draft guidance from the federal Office of Human Research Protections, “Guidance 
on Disclosing Reasonably Foreseeable Risks in Research Evaluating Standards of Care”; October 20, 2014. 

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This quality improvement research study is designed in two phases, each phase is done over a 3-month period for a 
total study duration of 6 months. The SCCA study team will be enrolling eligible OMC providers who will handle 
all patient interaction and communication. 
 
Phase 1: The first phase does not involve intervention; OMC will be following their existing processes. OMC will 
gather identified data on the patient’s clinic diagnosis and stage, pathology report features, and treatment options 
for patients with the above diagnose and offer patients the option to fill out a standardized Family History 
Questionnaire (FHQ) on the day of their initial visit if they decide to do so. The FHQ will be offered as part of 
clinical care up to the discretion of the OMC providers. OMC will also gather de-identified data on the number of 
patients seen with a diagnosis of breast, ovarian, prostate, colon, and pancreatic cancer. The above data will then be 
sent to the study’s research coordinator at SCCA (through secure email) which will be stored in a secured J-Drive 
folder within the SCCA network. The research coordinator will randomly assign all identified patient data to a 
unique participant ID before distributing to SCCA subject matter experts (cancer geneticist and/or genetic 
counselor) for review. From OMC’s collected data, SCCA subject matter experts will measure how many patients 
met NCCN criteria for testing how many patients were referred to genetic counseling and how many either had a 
test online or were seen at UWMC and the SCCA for a genetic evaluation. 
 
Phase 2: The second phase involves a tiered intervention in which SCCA subject matter experts will coach the 
OMC providers to provide guidance on providing genetic counseling and testing to their patients. Involvement in 
this study does not dictate how the OMC providers carry out clinical care, so it is up to the OMC providers to 
decide whether or not to implement the coaching in their practice. First, patients and their families fill out the 
standardized FHQ before their initial appointment, which will be sent via email by the team at OMC. OMC will 
gather the same patient information described in Phase 1 which will then be sent directly to the study’s research 
coordinator at SCCA, where the research coordinator will follow the same data storage, participant ID assignment, 
and distribution processes as in Phase 1. SCCA subject matter experts would then review this information with the 
OMC providers at bi-monthly virtual conferences before patients come for their initial visit at OMC. For patients 
who meet NCCN criteria, the oncology team at OMC would include in their initial visit workflow to discuss 
importance of cancer risk assessment and offer genetic testing. For the patients with a more complicated history, 
the OMC team would offer a referral to the SCCA for a complete cancer risk assessment evaluation.  
 
At the end of phase 2, SCCA subject matter experts will measure how many patients met NCCN criteria for testing 
how many patients were referred to genetic counseling and how many either had a test online or were seen at 
UWMC and the SCCA for a genetic evaluation. This data will then be compared with phase 1 data to measure the 
effectiveness of SCCA’s coaching for OMC’s providers as well as quality improvement of their processes. 
 
5.2 Recordings. Does the research involve creating audio or video recordings? 
 
X 
No 
→ If no, go to question 5.3. 
 
 
Yes 
→ If yes, describe what will be recorded (if not already described in 5.1) and answer question a. 
 
a. Before recording, will consent for being recorded be obtained from subjects and any other 
individuals who may be recorded? 
 
 
No 
→ If no, email hsdinfo@uw.edu before submitting this application in Zipline. In 
the email, include a brief description of the research and a note that 
individuals will be recorded without their advance consent. 
 
 
 
 
 
Yes 
 
5.3 MRI scans. Will any subjects have a Magnetic Resonance Imaging (MRI) scan as part of the study procedures? 
This means scans that are performed solely for research purposes or clinical scans that are modified for research purposes (for 
example, using a gadolinium-based contrast agent when it is not required for clinical reasons).  
 
X 
No 
→ If no, go to question 5.4. 

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Yes 
→ If yes, answer questions a through c. 
a. Describe the MRI scan(s). Specifically: 
• 
What is the purpose of the scan(s)? Examples: obtain research data; safety assessment 
associated with a research procedure. 
• 
Which subjects will receive an MRI scan? 
• 
Describe the minimum and maximum number of scans per subject, and over what time period 
the scans will occur. For example: all subjects will undergo two MRI scans, six months apart. 
 
      
b. Use of gadolinium. Will any of the MRI scans involve the use of a gadolinium-based contrast agent 
(GBCA?) 
 
 
No 
 
 
 
Yes 
→ If yes, which agents will be used? Check all that apply. 
 
Brand Name 
Generic Name 
Chemical Structure 
 
 
Dotarem 
Gadoterate meglumine 
Macrocylic 
 
 
Eovist / Primovist 
Gadoxetate disodium 
Linear 
 
 
Gadavist 
Gadobutro 
Macrocyclic 
 
 
Magnevist 
Gadpentetate dimeglumine 
Linear 
 
 
MultiHance 
Gadobenate dimeglumine 
Linear 
 
 
Omniscan 
Gadodiamide 
Linear 
 
 
OptiMARK 
Gadoversetamide 
Linear 
 
 
ProHance 
Gadoteridol 
Macrocyclic 
 
 
Other, provide name: 
      
 
1.) The FDA has concluded that gadolinium is retained in the body and brain for 
a significantly longer time than previously recognized, especially for linear 
GBCAs. The health-related risks of this longer retention are not yet clearly 
established. However, the UW IRB expects researchers to provide a 
compelling justification for using a linear GBCA instead of a macrocyclic 
GBCA, to manage the risks associated with GBCAs. 
 
Describe why it is important to use a GBCA with the MRI scan(s). Describe 
the dose that will be used and (if it is more than the standard clinical dose 
recommended by the manufacturer) why it is necessary to use a higher 
dose. If a linear GBCA will be used, explain why a macrocyclic GBCA cannot 
be used. 
 
       
 
2.) Information for subjects. Confirm by checking this box that subjects will be 
provided with the FDA-approved Patient Medication Guide for the GBCA 
being used in the research or that the same information will be inserted into 
the consent form. 
 
 
Confirmed 

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c. MRI facility. At which facility(ies) will the MRI scans occur? Check all that apply. 
 
 
UWMC Radiology/Imaging Services (the UWMC clinical facility) 
 
 
DISC Diagnostic Imaging Sciences Center (UWMC research facility) 
 
 
BMIC Biomolecular Imaging Center (South Lake Union research facility) 
 
 
Harborview Radiology/Imaging Services (the Harborview clinical facility) 
 
 
SCCA Imaging Services 
 
 
Northwest Diagnostic Imaging 
 
 
Other: identify in the text box below: 
 
      
Personnel. For MRI scans that will be conducted at the DISC or BMIC research facilities: The role, qualifications, and 
training of individuals who will operate the scanner, administer the GBCA (if applicable), and/or insert and 
remove the IV catheter should be described in question 12.3. 
5.4 Data variables. Describe the specific data that will be obtained (including a description of the most sensitive items). 
Alternatively, a list of the data variables may be uploaded to Zipline. 
 
OMC clinic outcomes data: report including the number of patients seen at OMC with a diagnosis of breast, 
ovarian, prostate, colon, and pancreatic cancer 
 
OMC patients’ Family History Questionnaire responses 
 
OMC patients’ identified data on clinical diagnosis and stage, pathology report features, and treatment options for 
patients with a diagnosis of breast, ovarian, prostate, colon, and pancreatic cancer 
5.5 Data sources. For all types of data that will be accessed or collected for this research: Identify whether the data are 
being obtained from the subjects (or subjects’ specimens) or whether they are being obtained from some other 
source (and identify the source). 
If you have already provided this information in Question 5.1, you do not need to repeat the information here. 
 
OMC clinic outcomes data: pulled from patients’ clinical charts e.g. “referred for genetic counseling”. Collected by 
OMC 
Family History Questionnaire responses: filled out directly by patients then collected by OMC 
OMC patients’ identified data/relevant medical records: pulled from Epic. Collected by OMC 

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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 the relevant compliance requirements. Review the 
following definitions before answering the questions: 
Access means to view or perceive data, but not to possess or record it. See, in contrast, the definition of “obtain”. 
Identifiable means that the identity of an individual is or may be readily (1) ascertained by the researcher or any other member 
of the study team from specific data variables or from a combination of data variables, or (2) associated with the information.  
Direct identifiers are direct links between a subject and data/specimens. Examples include (but are not limited to): name, date 
of birth, medical record number, email or IP address, pathology or surgery accession number, student number, or a collection 
of data that is (when taken together) identifiable.  
Indirect identifiers are information that links between direct identifiers and data/specimens. Examples: a subject code or 
pseudonym.   
Key refers to a single place where direct identifiers and indirect identifiers are linked together so that, for example, coded data 
can be identified as relating to a specific person. Example: a master list that contains the data code and the identifiers linked to 
the codes. 
Obtain means to possess or record in any fashion (writing, electronic document, video, email, voice recording, etc.) for research 
purposes and to retain for any length of time. This is different from accessing, which means to view or perceive data.  
a. Will you or any members of your team have access to any direct or indirect identifiers? 
 
X 
Yes 
→ If yes, describe which identifiers and for which data/specimens.  
 
 
 
OMC will have access to all of their patients’ identifiers as part of their standard processes 
of care. The SCCA study team will not have direct access to any direct or indirect 
identifiers unless sent to them by OMC.  
 
 
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 access.  
 
 
 
 
 
 
There is an agreement with the holder of the identifiers (or key) that prohibits the 
release of the identifiers (or key) to study team members under any circumstances. 
 
 
 
 
 
 
This agreement should be available upon request from the IRB. Examples: a Data Use Agreement, 
Repository Gatekeeping form, or documented email. 
 
 
There are written policies and procedures for the repository/database/data 
management center that prohibit the release of the identifiers (or identifying link). This 
includes situations involving an Honest Broker. 
 
 
 
 
 
 
There are other legal requirements prohibiting the release of the identifiers or key. 
Describe them below. 
 
 
 
 
 
 
      

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b. Will you or any study team members obtain any direct or indirect identifiers? 
 
X 
Yes 
→ If yes, describe which identifiers and for which data/specimens. 
 
 
 
 
The study’s research coordinator will obtain identifiers through OMC as included in the 
patients’ medical records. This will include medical record number, first and last name, 
and date of birth. 
 
 
No 
→ If no, select the reason(s) why you (and all members of your team) will not obtain direct or 
indirect identifiers. 
 
 
 
 
 
There will be no identifiers.  
 
 
 
 
 
 
Identifiers or the key have been (or will have been) destroyed before access.  
 
 
 
 
 
 
There will be an agreement with the holder of the identifiers (or key) that prohibits the 
release of the identifiers (or key) under any circumstances.   
 
 
 
 
 
 
This agreement should be available upon request from the IRB. Examples: a Data Use Agreement, 
Repository Gatekeeping form, or documented email. 
 
 
There are written policies and procedures for the repository/database/data 
management center that prohibit the release of the identifiers (or identifying link). This 
includes situations involving an Honest Broker. 
 
 
 
 
 
 
There are other legal requirements prohibiting the release of the identifiers or key. 
Describe them below.   
 
 
 
 
 
 
      
c. If any identifiers will be obtained, indicate how the identifiers will be stored (and for which data). NOTE: Do 
not describe the data security plan here – that information is requested in section 9.6. 
 
 
Identifiers will be stored with the data. Describe the data to which this applies: 
 
 
 
 
 
 
      
 
 
Identifiers and study data will be stored separately but a link will be maintained between 
the identifiers and the study data (for example, through the use of a code). Describe the 
data to which this applies: 
 
X
 
 
 
 
This will apply to FHQ results as well as data on patients’ clinical diagnosis and stage, 
pathology report features, and treatment options. The study’s research coordinator will 
use a tracking sheet to document patient identification and their assigned participant ID, 
which will be stored in a private SCCA network J-drive folder. 
 
 
Identifiers and study data will be stored separately, with no link between the identifiers 
and the study data. Describe the data to which this applies: 
 
 
 
 
 
 
 

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d. Research collaboration. Will individuals who provide coded information or specimens for the research also 
collaborate on other activities for this research? If yes, identify the activities and provide the name of the 
collaborator’s institution/organization. 
Examples include but are not limited to: (1) study, interpretation, or analysis of the data that results from the coded 
information or specimens; and (2) authorship on presentations or manuscripts related to this work. 
Yes: The study’s research coordinator will be involved in coordinating and organizing the bi-monthly 
conference meetings with the OMC provider subjects and SCCA study team. They will also be involved in 
the interpretation and analysis of the data that results from the coded information.  
5.7 Protected Health Information (PHI). Will participants’ identifiable PHI be accessed, obtained, used, or disclosed for 
any reason (for example, to identify or screen potential subjects, to obtain study data or specimens, for study 
follow-up) that does not involve the creation or obtaining of a Limited Data Set? 
PHI is individually identifiable healthcare record information or clinical specimens from an organization considered a “covered 
entity” by federal HIPAA regulations, in any form or media, whether electronic, paper, or oral. You must answer yes to this 
question if the research involves identifiable health care records (e.g., medical, dental, pharmacy, nursing, billing, etc.), 
identifiable healthcare information from a clinical department repository, or observations or recordings of clinical 
interactions. 
 
 
No 
→ If no, skip the rest of this question; go to question 5.8 
 
X 
Yes 
→ If yes, answer all of the questions below. 
 
 
a. Describe the PHI and the reason for using it. Be specific. For example, will any “free text” fields 
(such as physician notes) be accessed, obtained, or used?   
 
PHI will include patient’s free text medical records regarding their clinical diagnosis and stage, 
pathology report features, and treatment options. It will also include their responses to the FHQ. 
This identified information will be accessed and obtained by OMC and the study’s research 
coordinator at SCCA. The research coordinator will need access to the identified data in order to 
ensure seamless communication between OMC oncologists and the SCCA subject matter experts 
during meetings to identify and provide coaching on eligible patients for genetic counseling and 
testing.  
b. Is any of the PHI located in Washington State? 
 
 
No 
 
 
X Yes 
 
c. Describe the pathway of how the PHI will be accessed or obtained, starting with the 
source/location and then describing the system/path/mechanism by which it will be identified, 
accessed, and copied for the research. Be specific. For example: directly view records; search 
through a department’s clinical database; submit a request to Leaf. 
 
OMC will directly access PHI through their medical records system. These will be compiled into 
patient packets as a single PDF for each, which will then be sent via secure email to the study’s 
research coordinator at SCCA. The research coordinator will then securely store this information 
within a private SCCA network J-drive folder.  
d. For which PHI will subjects provide HIPAA authorization before the PHI is accessed, obtained 
and/or used?  
 
N/A. Subjects will not provide HIPAA authorization for any PHI 
 
Confirm by checking the box that the UW Medicine HIPAA Authorization form maintained on the 
HSD website will be used to access, obtain, use, or disclose any UW Medicine PHI. 
 
 
Confirmed 
 
 

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e. For which PHI will HIPAA authorization NOT be obtained from the subjects? 
HIPAA authorization will not be obtained for any PHI from the OMC patient subjects. OMC has 
an established connection with SCCA as an SCCA affiliate site and already transfers patients’ 
medical records to SCCA oncologists for review/second opinion. Transfer of PHI within the study 
will follow those same established guidelines. 
 
Provide the following assurances by checking the boxes. 
 
 
The minimum necessary amount of PHI to accomplish the purposes described in this 
application will be accessed, obtained and/or used. 
 
X 
 
 
 
 
The PHI will not be reused or disclosed to any other person or entity, except as required by 
law, for authorized oversight of the research study, or for other research for which the use or 
disclosure of PHI would be permitted. 
 
X 
 
 
 
 
The HIPAA “accounting for disclosures” requirement will be fulfilled, if applicable. See UW 
Medicine Compliance Policy #104.  
 
 
 
 
 
 
 
 
There will be reasonable safeguards to protect against identifying, directly or indirectly, any 
patient in any report of the research. 
 
 
 
X 
 
 
 
 
5.8 Genomic data sharing. Will the research obtain or generate genomic data? 
 
X 
No 
 
 
 
Yes 
→ If yes, answer the question below. 
 
a. Will genomic data from this research be sent to a national database (for example, NIH’s dbGaP 
database)? 
 
 
X 
No 
 
 
 
 
Yes 
→ If yes, complete the ZIPLINE SUPPLEMENT Genomic Data Sharing and upload 
it to Zipline. 
 
 
5.9 Whole genome sequencing. For research involving biospecimens: Will the research include whole genome 
sequencing? 
Whole genome sequencing is sequencing of a human germline or somatic specimen with the intent to generate the genome or 
exome sequence of that specimen. 
 
X No 
 
 
 
Yes  

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5.10 Possible secondary use or sharing of information, specimens, or subject contact information. Is it likely that the 
obtained or collected information, specimens, or subject contact information will be used for any of the following: 
• 
Future research not described in this application (in other words, secondary research) 
• 
Submission to a repository, registry, or database managed by the study team, colleagues, or others for 
research purposes 
• 
Sharing with others for their own research 
Please consider the broadest possible future plans and whether consent will be obtained now from the subjects 
for future sharing or research uses (which it may not be possible to describe in detail at this time). Answer YES 
even if future sharing or uses will use de-identified information or specimens. Answer NO if sharing is unlikely or if 
the only sharing will be through the NIH Genomic Data Sharing described in question 5.8. 
Many federal grants and contracts now require data or specimen sharing as a condition of funding, and many journals require 
data sharing as a condition of publication. “Sharing” may include (for example): informal arrangements to share banked 
data/specimens with other investigators; establishing a repository that will formally share with other researchers through 
written agreements; or sending data/specimens to a third party repository/archive/entity such as the Social Science Open 
Access Repository (SSOAR), or the UCLA Ethnomusicology Archive. 
 
X No 
 
 
 
Yes → If yes, answer all of the questions below. 
 
a. Describe what will be stored for future use, including whether any direct or indirect (e.g., subject 
codes) identifiers will be stored.  
 
      
 
b. Describe what will be shared with other researchers or with a repository/database/registry, 
including whether direct identifiers will be shared and (for specimens) what data will be 
released with the specimens.  
 
      
 
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. 
 
      

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e. Consent. Will consent be obtained now from subjects for the secondary use, 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 the answers to the consent questions in 
Section 8. 
 
 
f. Withdrawal. Will subjects be able to withdraw their data/specimens from secondary use, 
banking or sharing?  
 
 
No 
 
 
 
Yes 
→ If yes, describe how, and whether there are any limitations on withdrawal. 
 
Example: data can be withdrawn from the repository but cannot be retrieved after they 
are released. 
 
      
 
g. Agreements for sharing or release. Confirm by checking the box that the sharing or release will 
comply with UW (and, if applicable, UW Medicine) policies that require a formal agreement 
with the recipient for release of data or specimens to individuals or entities other than federal 
databases. 
 
Data Use Agreements or Gatekeeping forms are used for data; Material Transfer Agreements are used for 
specimens (or specimens plus data). Do not attach any template agreement forms; the IRB neither 
reviews nor approves them 
 
Confirmed 
5.11 Communication with subjects during the study. Describe the types of communication (if any) the research team 
will have with already-enrolled subjects during the study. Provide a description instead of the actual materials 
themselves.   
Examples: email, texts, phone, or letter reminders about appointments or about returning study materials such as a 
questionnaire; requests to confirm contact information.  
 
The SCCA study team will maintain communication with participating OMC provider subjects 
throughout the course of the study. This will involve email communications and virtual conference 
meetings. SCCA subject matter experts would meet with subjects via bi-monthly virtual conferences 
before patients come in for their initial visit to provide coaching on genetic counseling and testing for 
their patients. 
5.12 Future contact with subjects. Is there a plan to retain any contact information for subjects so that they can be 
contacted in the future? 
 
X 
No 
 
 
 
Yes 
→ If yes, describe the purpose of the future contact, and whether use of the contact information will 
be limited to the study team; if not, describe who else could be provided with the contact 
information. Describe the criteria for approving requests for the information. 
 
 
 
Examples: inform subjects about other studies; ask subjects for additional information or medical record access 
that is not currently part of the study proposed in this application; obtain another sample. 
 
      

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5.13 Alternatives to participation. Are there any alternative procedures or treatments that might be advantageous to 
the subjects? 
If there are no alternative procedures or treatments, select “No”. Examples of advantageous alternatives: earning extra class 
credit in some time-equivalent way other than research participation; obtaining supportive care or a standard clinical 
treatment from a health care provider instead of participating in research with an experimental drug.  
 
X 
No 
 
 
 
Yes 
→ If yes, describe the alternatives. 
 
 
 
      
5.14 Upload to Zipline all data collection forms (if any) that will be directly used by or with the subjects, and any 
scripts/talking points that will be used to collect the data. Do not include data collection forms that will be used 
to abstract data from other sources (such as medical or academic records), or video recordings. 
• 
Examples: survey, questionnaires, subject logs or diaries, focus group questions. 
• 
NOTE: Sometimes the IRB can approve the general content of surveys and other data collection instruments rather than 
the specific form itself. This prevents the need to submit a modification request for future minor changes that do not add 
new topics or increase the sensitivity of the questions. To request this general approval, use the text box below to identify 
the questionnaires/surveys/ etc. for which you are seeking this more general approval. Then briefly describe the scope of 
the topics that will be covered and the most personal and sensitive questions. The HSD staff person who screens this 
application will let you know whether this is sufficient or whether you will need to provide more information. 
• 
For materials that cannot be uploaded: upload screenshots or written descriptions that are sufficient to enable the IRB to 
understand the types of data that will be collected and the nature of the experience for the participant. You may also 
provide URLs (website addresses) or written descriptions below. Examples of materials that usually cannot be uploaded: 
mobile apps; computer-administered test; licensed and restricted standardized tests. 
• 
For data that will be gathered in an evolving way: This refers to data collection/questions that are not pre-determined 
but rather are shaped during interactions with participants in response to observations and responses made during those 
interactions. If this applies to the proposed research, provide a description of the process by which the data 
collection/questions will be established during the interactions with subjects, how the data collection/questions will be 
documented, the topics likely to be addressed, the most sensitive type of information likely to be gathered, and the 
limitations (if any) on topics that will be raised or pursued. 
Use this text box (if desired) to provide: 
• 
Short written descriptions of materials that cannot be uploaded, such as URLs 
• 
A description of the process that will be used for data that will be gathered in an evolving way. 
• 
The general content of questionnaires, surveys and similar instruments for which general approval is being 
sought. (See the NOTE bullet point in the instructions above.) 
 
Family History Questionnaire that identifies an individual’s relationship to the patient as well as their 
diagnosis. No PHI will be included. The purpose of this questionnaire is to identify eligible patient for 
genetic counseling and testing. 
Patient Satisfaction Questionnaire to assess patients’ experiences with genetic counseling and testing.  
 

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6 CHILDREN (MINORS) and PARENTAL PERMISSION 
6.1 Involvement of minors. Does the research include minors (children)? 
Minor or child means someone who has not yet attained the legal age for consent for the research procedures, as 
described in the applicable laws of the jurisdiction in which the research will be conducted. This may or may not 
be the same as the definition used by funding agencies such as the National Institutes of Health. 
• 
In Washington State the generic age of consent is 18, meaning that anyone under the age of 18 is 
considered a child.  
• 
There are some procedures for which the age of consent is much lower in Washington State. 
• 
The generic age of consent may be different in other states, and in other countries.  
 
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 
the study population(s). If there is more than one answer, explain.   
 
 
 
 
      
 
 
Don’t know 
→This means is it not possible to know the age of the subjects. For example, this may be true 
for some research involving social media, the Internet, or a dataset that is obtained from 
another researcher or from a government agency. Go to Section 8. 
 
 
6.2 Parental permission. Parental permission means actively obtaining the permission of the parents. This is not the 
same as “passive” or “opt out” permission where it is assumed that parents are allowing their children to 
participate because they have been provided with information about the research and have not objected or 
returned a form indicating they don’t want their children to participate. 
a. Will parental permission be obtained for: 
 
 
All of the research procedures 
→ Go to question 6.2b. 
 
 
 
 
 
 
None of the research procedures 
→ Use the table below to provide justification, and skip question 
6.2b. 
 
 
 
 
 
 
Some of the research procedures 
→ Use the table below to identify the procedures for which 
parental permission will not be obtained. 
 
 
 
 
Be sure to consider all research procedures and plans, including screening, future contact, and sharing/banking of data and 
specimens for future work. 
Children 
Group1 
Describe the procedures or 
data/specimen collection (if any) for 
which there will be NO parental 
permission2 
Reason why parental 
permission will not be 
obtained 
Will parents be 
informed about 
the research?3 
 
 
 
YES 
NO 
      
      
      
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
      
      
      
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
      
      
      
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
      
      
      
 
 
 
 
 
 
 
 
 
 
 
 

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Table footnotes 
1. If the answer is the same for all children groups or all procedures: collapse the answer across the groups and/or procedures. 
2. If identifiable information or biospecimens will be obtained without parent permission, any waiver granted by the IRB does not 
override parents’ refusal to provide broad consent (for example, through the Northwest Biotrust). 
3. Will parents be informed about the research beforehand even though active permission is not being obtained? 
b. Indicate the plan for obtaining parental permission. One or both boxes must be checked. 
 
 
Both parents, unless one parent is deceased, unknown, incompetent, or not reasonably available; or when 
only one parent has legal responsibility for the care and custody of the child 
 
 
 
 
 
 
One parent, even if the other parent is alive, known, competent, reasonably available, and shares legal 
responsibility for the care and custody of the child.  
 
 
 
 
 
 
This is all that is required for minimal risk research. 
 
If both boxes are checked, explain: 
 
      
6.3 Children who are wards. Will any of the children be wards of the State or any other agency, institution, or entity? 
 
 
No 
 
 
 
Yes 
→ If yes, an advocate may need to be appointed for each child who is a ward. The advocate must be in 
addition to any other individual acting on behalf of the child as guardian or in loco parentis. The 
same individual can serve as advocate for all children who are wards. 
 
 
 
Describe who will be the advocate(s). The description must address the following points: 
• 
Background and experience 
• 
Willingness to act in the best interests of the child for the duration of the research 
• 
Independence of the research, research team, and any guardian organization 
 
      
 
 
7 ASSENT OF CHILDREN (MINORS) 
Go to Section 8 if your research does not involve children (minors). 
7.1 Assent of children (minors). Though children do not have the legal capacity to “consent” to participate in 
research, they should be involved in the process if they are able to “assent” by having a study explained to them 
and/or by reading a simple form about the study, and then giving their verbal choice about whether they want to 
participate. They may also provide a written assent if they are older. See WORKSHEET: Children for circumstances 
in which a child’s assent may be unnecessary or inappropriate.   
a. Will assent be obtained for: 
 
 
All research procedures and child groups 
→ Go to question 7.2. 
 
 
 
 
 
 

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None of the research procedures and child groups 
→ Use the table below to provide justification, 
then skip to question 7.6 
 
 
 
 
Some of your research procedures and child groups 
→ Use the table below to identify the 
procedures for which assent will not be 
obtained.  
 
 
 
 
Be sure to consider all research procedures and plans, including screening, future contact, and sharing/banking of data and 
specimens for future work. 
Children Group1 
Describe the procedures or 
data/specimen collection (if 
any) for which assent will NOT 
be obtained 
Reason why assent will not be obtained 
      
      
      
      
      
      
      
      
      
      
      
      
      
      
      
Table footnotes 
1. If the answer is the same for all children groups or all procedures, collapse your answer across the groups and/or procedures. 
7.2 Assent process. Describe how assent will be obtained, for each child group. If the research involves children of 
different ages, answer separately for each group. If the children are non-English speakers, include a description of 
how their comprehension of the information will be evaluated. 
 
      
7.3 Dissent or resistance. Describe how a child’s objection or resistance to participation (including non-verbal 
indications) will be identified during the research, and what the response will be.  
 
      
7.4 E-consent. Will any electronic processes (email, websites, electronic signatures, etc.) be used to present assent 
information to subjects/and or to obtain documentation (signatures) of assent? If yes, describe how this will be 
done. 
 
      
7.5 Documentation of assent.  Which of the following statements describes whether documentation of assent will be 
obtained? 
 
 
None of the research procedures and child groups 
→ Use the table below to provide justification, 
then go to question 7.5.b 
 
 
 
 
 
 
All of the research procedures and child groups 
→ Go to question 7.5.a, do not complete the 
table 
 
 
 
 
 
 
Some of the research procedures and/or child groups 
 
 

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

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

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Parents who are providing permission for their children to participate in research 
 
→ If you selected PARENTS, the word “consent” below should also be interpreted as applying to parental 
permission and “subjects” should also be interpreted as applying to the parents. 
8.2 The consent process and characteristics. This series of questions is about whether consent will be obtained for all 
procedures except recruiting and screening and, if yes, how. 
The issue of consent for recruiting and screening activities is addressed in question 4.7. You do not need to repeat your answer 
to question 4.6. 
 
a. Are there any procedures for which consent will not be obtained? 
 
 
No 
 
 
X 
Yes 
→ If yes, use the table below to identify the procedures for which consent will not be obtained. “All” 
is an acceptable answer for some studies. 
 
 
Be sure to consider all research procedures and plans, including future contact, and sharing/banking of data and specimens for 
future work. 
Group1 
Describe the procedures or 
data/specimen collection (if any) 
for which there will be NO consent 
process 
Reason why consent will not be 
obtained 
Will subjects be 
provided with 
info about the 
research after 
they finish? 
 
 
 
YES 
NO 
Phase 1 
patients 
Data collection of patients’ medical 
records including clinical diagnosis and 
stage, pathology report features, and 
treatment options  
The study’s researchers will not have 
any contact with the patients at any 
point of the study. OMC providers will 
not obtain consent from their patients 
because they are not members of the 
study team, they are subjects 
themselves. OMC providers will 
consent to release their patients’ 
medical records to SCCA. 
 
 
 
 
 
 
 
 
 
 
X 
 
 
 
 
 
 
 
Phase 2 
patients 
Data collection of patients’ medical 
records including clinical diagnosis and 
stage, pathology report features, and 
treatment options  
The study’s researchers will not have 
any contact with the patients at any 
point of the study. OMC providers will 
not obtain consent from their patients 
because they are not members of the 
study team, they are subjects 
themselves. OMC providers will 
consent to release their patients’ 
medical records to SCCA. 
 
 
 
 
 
 
 
 
 
 
X 
 
 
 
 
 
 
 
      
      
      
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
      
      
      
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
      
      
      
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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Table footnotes 
1. If the answer is the same for all groups, collapse your answer across the groups and/or procedures. 
b. Describe the consent process, if consent will be obtained for any or all procedures, for any or all groups. 
Address groups and procedures separately if the consent processes are different. 
Be sure to include: 
• 
The location/setting where consent will be obtained 
• 
Who will obtain consent (refer to positions, roles, or titles, not names) 
• 
How subjects will be provided sufficient opportunity to discuss the study with the research team and consider 
participation 
 
Before the start of phase 1, the SCCA study team and the potential OMC provider subjects will have a virtual 
meeting to discuss details of the study and prospective timeline (phase 1 and 2). Time will be allocated for the 
OMC providers to ask questions to ensure that there is complete understanding of the research methods, 
procedure, and goals. After the meeting is completed, the study’s research coordinator will then email a consent 
information sheet to the OMC providers for review and provide a contact number if there are further questions 
or concerns. The OMC providers who agree to participate will send an emailed consent to the study’s research 
coordinator. 
c. Comprehension. Describe the methods that will be used to ensure or test the subjects’ understanding of the 
information during the consent process. 
 
The SCCA study team will host a virtual meeting with the potential OMC provider subjects to discuss the 
material and allow subjects to ask questions and address any concerns. After the meeting, all potential subjects 
will be provided a written copy of the study procedures, which will be clearly outlined and broken down by 
phase 1 and phase 2. The document will state the assigned responsibilities of the OMC providers and SCCA 
research team. The subjects will also be given a consent information sheet. 
d. Influence. Does the research involve any subject groups that might find it difficult to say “no” to participation 
because of the setting or their relationship with someone on the study team, even if they aren’t pressured to 
participate?   
Examples: Student participants being recruited into their teacher’s research; patients being recruited into their healthcare 
provider’s research, study team members who are participants; outpatients recruited from an outpatient surgery waiting 
room just prior to their surgery. 
 
X 
No 
 
 
 
Yes 
→ If yes, describe what will be done to reduce any effect of the setting or relationship on the 
participation decision. 
 
 
 
 
Examples: a study coordinator will obtain consent instead of the subjects’ physician; the researcher will not 
know which subjects agreed to participate; subjects will have two days to decide after hearing about the 
study. 
 
      

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e. Information provided is tailored to needs of subject population. Describe the basis for concluding that the 
information that will be provided to subjects (via written or oral methods) is what a reasonable member of the 
subject population(s) would want to know. If the research consent materials contain a key information section, 
also describe the basis for concluding that the  information presented in that section is that which is most likely 
to assist the selected subject population with making a decision. See GUIDANCE: Key Information for Consent 
Materials. 
 
For example: Consultation with publications about research subjects’ preferences, disease-focused nonprofit groups, patient 
interest groups, or other researchers/study staff with experience with the specific population. It may also involve directly 
consulting selected members of the study population. 
 
The oral and written information provided to the potential OMC provider subjects covers all points that they 
would want to know. The information provided will explain the justification and relevance of the study, details 
about what participation in this study involves, and a comprehensive overview of the OMC patients’ roles in the 
study specifically regarding medical records collection and analysis.  
 
The key information section of the consent information sheet that SCCA will be providing includes of (1) the 
fact that consent is being sought for research and that participation is voluntary, (2) the purposes of the research, 
the expected duration of the prospective subject’s participation, and the procedures to be followed in the 
research, (3) The most important, reasonable foreseeable risks or discomforts to the prospective subject and the 
benefits to the prospective subject or to others that may reasonably be expected. All of this information will 
assist the selected population with making a decision. 
f. Ongoing process. For research that involves multiple or continued interaction with subjects over time, describe 
the opportunities (if any) that will be given to subjects to ask questions or to change their minds about 
participating. 
 
The SCCA study team and participating OMC provider subjects will meet at bi-monthly virtual conferences to 
discuss patients. At each of these meetings, the OMC provider subjects will be given the opportunity to ask 
question or to change their minds about participating. 
8.3 Electronic presentation of consent information. Will any part of the consent-related information be provided 
electronically for some or all of the subjects? 
This refers to the use of electronic systems and processes instead of (or in addition to) a paper consent form. For example, an 
emailed consent form, a passive or an interactive website, graphics, audio, video podcasts. See GUIDANCE: Electronic Informed 
Consent for information about electronic consent requirements at UW. 
 
 
No 
→ If no, skip to question 8.4 
 
X 
Yes 
→ If yes, answer questions a through e 
a. Describe the electronic consent methodology and the information that will be provided. 
All informational materials must be made available to the IRB. Website content should be provided as a 
Word document. It is considered best practice to give subjects information about multi-page/multi-screen 
information that will help them assess how long it will take them to complete the process. For example, 
telling them that it will take about 15 minutes, or that it involves reading six screens or pages. 
The consent information sheet will be sent as an electronic PDF via secure email to all OMC 
provider subjects.  
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? 
 
N/A. Straightforward navigation by scrolling through the PDF document. 

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c. In a standard paper-based consent process, the subjects generally have the opportunity to go 
through the consent form with study staff and/or to ask study staff about any question they may 
have after reading the consent form. Describe what will be done, if anything, to facilitate the 
subject’s comprehension and opportunity to ask questions when consent information is 
presented electronically. Include a description of any provisions to help ensure privacy and 
confidentiality during this process. 
Examples: hyperlinks, help text, telephone calls, text messages or other type of electronic messaging, video 
conference, live chat with remotely located study team members. 
All key points of the consent information sheet will be discussed during the initial virtual 
meeting with the potential OMC provider subjects and SCCA study team before the start of the 
study. All will be provided with the study’s research coordinator’s contact information in case 
any questions or concerns arise when reviewing the consent information sheet.  
d. What will happen if there are individuals who wish to participate but who do not have access to 
the consent methodology being used, or who do not wish to use it? Are there alternative ways in 
which they can obtain the information, or will there be some assistance available? If this is a 
clinical trial, these individuals cannot be excluded from the research unless there is a compelling 
rationale. 
 
For example, consider individuals who lack familiarity with electronic systems, have poor eyesight or 
impaired motor skills, or who do not have easy email or internet access. 
If a participant cannot view the electronic consent form, the study’s research coordinator will 
mail a physical copy at request. Patients who wish to participate but cannot send an emailed 
consent can provide verbal consent by calling the study’s research coordinator (contact 
information is listed in the consent information sheet). 
e. How will additional information be provided to subjects during the research, including any 
significant new findings (such as new risk information) If this is not an issue, explain why. 
 
Additional information will be provided to the OMC provider subjects at the regular bi-monthly 
virtual conferences that will be hosted by the SCCA study team throughout the course of the 
study.  
8.4 Written documentation of consent. Which of the statements below describe whether documentation of consent 
will be obtained? NOTE: This question does not apply to screening and recruiting procedures which have already 
been addressed in question 4.7. 
Documentation of consent that is obtained electronically is not considered written consent unless it is obtained by a method 
that allows verification of the individual’s signature. In other words, saying “yes” by email is rarely considered to be written 
documentation of consent 
a. Is written documentation of consent being obtained for: 
 
 
None of the research procedures  
→ Use the table below to provide justification then go to question 
8.5. 
 
X 
 
 
 
 
All of the research procedures  
→ Do not complete the table; go to question 8.4.b. 
 
 
 
 
 
 
Some of the research procedures 
→ Use the table below to identify the procedures for which written 
documentation of consent will not be obtained from adult 
subjects.  
 
 
 
 

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Adult 
subject 
group1 
Describe the procedures or data/specimen collection (if any) for which 
there will be NO documentation of consent 
Will they be 
provided with a 
written 
statement 
describing the 
research 
(optional)? 
 
 
YES 
NO 
Phase 1 
patients 
Data collection of patients’ medical records including clinical diagnosis and stage, 
pathology report features, and treatment options. OMC providers will be 
consenting to release the patients’ medical records to the SCCA research team. 
 
 
 
 
 
 
 
 
 
 
X 
 
 
 
 
 
 
 
Phase 2 
patient 
Data collection of patients’ medical records including clinical diagnosis and stage, 
pathology report features, and treatment options. OMC providers will be 
consenting to release the patients’ medical records to the SCCA research team. 
 
 
 
 
 
 
 
 
 
 
X 
 
 
 
 
 
 
 
OMC 
Providers 
No documentation of consent for all aspects of this study. Per UW HSD, written 
documentation of consent for this minimal risk study is not needed. The SCCA 
study team will host a virtual meeting to offer OMC providers an opportunity to 
ask questions, discuss the study, and to consider participation. The SCCA study 
team will electronically distribute a PDF consent information sheet. 
 
 
 
 
 
 
 
X 
 
 
 
 
 
 
 
 
 
      
      
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
      
      
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Table footnotes 
1. If the answer is the same for all adult groups or all procedures, collapse the answer across the groups and/or procedures. 
b. Electronic consent signature. For studies in which documentation of consent will be obtained: will subjects use 
an electronic method to provide their consent signature? 
• 
FDA-regulated studies must use a system that complies with the FDA’s “Part 11” requirements about electronic 
systems and records. Note that the UW-IT supported DocuSign e-signature system does not meet this requirement. 
• 
Having subjects check a box at the beginning of an emailed or web-based questionnaire is not considered legally 
effective documentation of consent.  
 
X No 
 
 
 
Yes 
→ If yes, describe the methodology that will be used. 
See the GUIDANCE: Electronic Informed Consent for information about options (including the DocuSign 
system available through UW-IT) and requirements. 
      
b.1 Is this method legally valid in the jurisdiction where the research will occur? 
 
 
No 
 
 
 
Yes 
→ If yes, what is the source of information about legal validity? 
 
      
b.2 Will verification of the subject’s identity be obtained if the signature is not personally 
witnessed by a member of the study team? Note that this is required for FDA-regulated 
studies. 

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See the GUIDANCE: Electronic Informed Consent for information and examples 
 
 
No 
→If no, provide the rationale for why this is appropriate. Also, what would 
be the risks to the actual subject if somebody other than the intended 
signer provides the consent signature? 
 
      
 
 
Yes 
→If yes, how? 
 
      
b.3 How will the requirement be met to provide a copy of the consent information (consent 
form) to individuals who provide an e-signature? 
The copy can be paper or electronic and may be provided on an electronic storage device or via 
email. If the electronic consent information uses hyperlinks or other websites or podcasts to convey 
information specifically related to the research, the information in these hyperlinks should be 
included in the copy provided to the subjects and the website must be maintained for the duration 
of the entire study. 
      
8.5 Non-English-speaking or -reading adult subjects. Will the research enroll adult subjects who do not speak English 
or who lack fluency or literacy in English? 
 
X 
No 
 
 
 
Yes 
→ If yes, describe the process that will be used to ensure that the oral and written information 
provided to them during the consent process and throughout the study will be in a language readily 
understandable to them and (for written materials such as consent forms or questionnaires) at an 
appropriate reading/comprehension level. 
 
 
 
      
 
a. Interpretation. Describe how interpretation will be provided, and when. Also, describe the 
qualifications of the interpreter(s) – for example, background, experience, language proficiency 
in English and in the other language, certification, other credentials, familiarity with the research-
related vocabulary in English and the target language.  
 
      
 
b. Translations. Describe how translations will be obtained for all study materials (not just consent 
forms). Also, describe the method for ensuring that the translations meet the UW IRB’s 
requirement that translated documents will be linguistically accurate, at an appropriate reading 
level for the participant population, and culturally sensitive for the locale in which they will be 
used.  
 
      

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

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b. Capacity for consent / decision making capacity. Describe the process that will be used to 
determine whether a cognitively impaired individual is capable of consent decision making 
with respect to the research protocol and setting. 
 
 
      
 
b.1. If there will be repeated interactions with the impaired subjects over a time period when 
cognitive capacity could increase or diminish, also describe how (if at all) decision-
making capacity will be re-assessed and (if appropriate) consent obtained during that 
time. 
 
      
 
c. Permission (surrogate consent). If the research will include adults who cannot consent for 
themselves, describe the process for obtaining permission (“surrogate consent”) from a legally 
authorized representative (LAR).   
 
For research conducted in Washington State, see the GUIDANCE: Legally Authorized Representative to 
learn which individuals meet the state definition of “legally authorized representative”. 
 
 
      
 
d. Assent. Describe whether assent will be required of all, some, or none of the subjects. If some, 
indicate which subjects will be required to assent and which will not (and why not). Describe 
any process that will be used to obtain and document assent from the subjects.  
 
 
      
 
e. Dissent or resistance. Describe how a subject’s objection or resistance to participation 
(including non-verbal) during the research will be identified, and what will occur in response. 
 
 
      
8.9 Research use of human fetal tissue obtained from elective abortion. Federal and UW Policy specify some 
requirements for the consent process. If you are conducting this type of research, check the boxes to confirm 
these requirements will be followed. 
 
 
Informed consent for the donation of fetal tissue for research use will be obtained by someone other than  
the person who obtained the informed consent for abortion. 
 
 
Informed consent for the donation of fetal tissue for research use will be obtained after the informed  
consent for abortion. 
 
 
Participation in the research will not affect the method of abortion. 
 
 
No enticements, benefits, or financial incentives will be used at any level of the process to incentivize 
abortion or the donation of human fetal tissue. 
 
 
The informed consent form for the donation of fetal tissue for use in research will be signed by both the  

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woman and the person who obtains the informed consent. 
8.10 Consent-related materials. Upload to Zipline all consent scripts/talking points, consent forms, debriefing 
statements, Information Statements, Short Form consent forms, parental permission forms, and any other 
consent-related materials that will be used. Materials that will be used by a specific site should be uploaded to 
that site’s Local Site Documents page. 
• 
Translations must be submitted and approved before they can be used. However, we strongly encourage you to wait to 
provide them until the IRB has approved the English versions. 
• 
Combination forms: It may be appropriate to combine parental permission with consent, if parents are subjects as well as 
providing permission for the participation of their children. Similarly, a consent form may be appropriately considered an 
assent form for older children.  
• 
For materials that cannot be uploaded: upload screenshots or written descriptions that are sufficient to enable the IRB to 
understand the types of data that will be collected and the nature of the experience for the participant. URLs (website 
addresses) may also be provided, or written descriptions of websites. Examples of materials that usually cannot be 
uploaded: mobile apps; computer-administered test; licensed and restricted standardized tests. 
 
 
 
9 PRIVACY AND CONFIDENTIALITY 
9.1 Privacy protections. Describe the steps that will be taken, if any, to address possible privacy concerns of subjects 
and potential subjects. 
Privacy refers to the sense of being in control of access that others have to ourselves. This can be an issue with respect to 
recruiting, consenting, sensitivity of the data being collected, and the method of data collection. 
Examples:  
• 
Many subjects will feel a violation of privacy if they receive a letter asking them to participate in a study because they 
have ____ medical condition, when their name, contact information, and medical condition were drawn from medical 
records without their consent. Example: the IRB expects that “cold call” recruitment letters will inform the subject 
about how their information was obtained. 
• 
Recruiting subjects immediately prior to a sensitive or invasive procedure (e.g., in an outpatient surgery waiting 
room) will feel like an invasion of privacy to some individuals. 
• 
Asking subjects about sensitive topics (e.g. details about sexual behavior) may feel like an invasion of privacy to some 
individuals. 
 
This is a quality improvement research study that intends to improve the standard processes of care for OMC 
cancer patients regarding genetic counseling and genetic testing. All collection and review of patients’ 
information and medical records will be part of their clinical care and screening. The patients’ information will 
not be used for any type of enrollment or recruitment. The OMC providers (study’s subjects) will grant 
permissions for the release of their patients’ medical records to the SCCA study team by reviewing a consent 
information sheet and sending emailed consent to the study’s research coordinator.  
9.2 Identification of individuals in publications and presentations. Will potentially identifiable information about 
subjects be used in publications and presentations, or is it possible that individual identities could be inferred from 
what is planned to be published or presented?  
 
X 
No 
 
 
 
Yes → If yes, will subject consent be obtained for this use? 
 
 
Yes 
 
 
 
No 
→ If no, describe the steps that will be taken to protect subjects (or small groups of 
subjects) from being identifiable. 
 
 
 
 
      

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9.3 State mandatory reporting. Each state has reporting laws that require some types of individuals to report some 
kinds of abuse, and medical conditions that are under public health surveillance. These include: 
• 
Child abuse 
• 
Abuse, abandonment, neglect, or financial exploitation of a vulnerable adult 
• 
Sexual assault 
• 
Serious physical assault 
• 
Medical conditions subject to mandatory reporting (notification) for public health surveillance 
 
Are you or a member of the research team likely to learn of any of the above events or circumstances while 
conducting the research AND feel obligated to report it to state authorities? 
 
X No 
 
 
 
Yes 
→ If yes, the UW IRB expects subjects to be informed of this possibility in the consent form or during 
the consent process, unless you provide a rationale for not doing so: 
 
 
 
 
 
      
9.4 Retention of identifiers and data. Check the box below to indicate assurance that any identifiers (or links between 
identifiers and data/specimens) and data that are part of the research records will not be destroyed until after the 
end of the applicable records retention requirements (e.g. Washington State; funding agency or sponsor; Food 
and Drug Administration). If it is important to say something about destruction of identifiers (or links to identifiers) 
in the consent form, state something like “the link between your identifier and the research data will be destroyed 
after the records retention period required by state and/or federal law.” 
This question can be left blank for conversion applications (existing paper applications that are being “converted” into a Zipline 
application.) 
 
See the “Research Data” sections of the following website for UW Records management for the Washington State research 
rectords retention schedules that apply in general to the UW (not involving UW Medicine data): 
http://f2.washington.edu/fm/recmgt/gs/research?title=R 
 
See the “Research Records and Data” information in Section 8 of this document for the retention schedules for UW Medicine 
Records: https://www.uwmedicine.org/recordsmanagementuwm-records-retention-schedule.pdf 
 
X 
Confirm 
9.5 Certificates of Confidentiality. Will a federal Certificate of Confidentiality be obtained for the research data? 
NOTE: Answer “No” if the study is funded by NIH or the CDC, because all NIH-funded and CDC-funded studies 
automatically have a Certificate. 
 
X No 
 
 
 
Yes 
 
9.6 Data and specimen security protections. Identify the data classifications and the security protections that will be 
provided for all sites where data will be collected, transmitted, or stored, referring to the ZIPLINE GUIDANCE: 
Data and Security Protections for the minimum requirements for each data classification level. It is not possible 
to answer this question without reading this document. Data security protections should not conflict with 
records retention requirements. 
 
a. Which level of protections will be applied to the data and specimens? If more than one level will be used, 
describe which level will apply to which data and which specimens and at which sites. 
 
 
Level 4 

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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 will not be followed, list those 
here, including identifying the sites where this exception will apply. 
 
 
All level 4 data collected by OMC will be part of their standard processes of care. The only individual outside 
of OMC to have access to the identified data will be the study’s research coordinator at SCCA. The 
research coordinator will follow all user, device, server, and data transmission guidelines. Any information 
provided to the SCCA subject matter experts will be deidentified. 
 
 
10 RISK / BENEFIT ASSESSMENT 
10.1 Anticipated risks. Describe the reasonably foreseeable risks of harm, discomforts, and hazards to the subjects 
and others of the research procedures. For each harm, discomfort, or hazard: 
• 
Describe the magnitude, probability, duration, and/or reversibility of the harm, discomfort, or hazard, AND 
• 
Describe how the risks will be reduced or managed. Do not describe data security protections here, these are 
already described in Question 9.6. 
• 
Consider possible physical, psychological, social, legal, and economic harms, including possible negative effects on 
financial standing, employability, insurability, educational advancement or reputation. For example, a breach of 
confidentiality might have these effects. 
• 
Examples of “others”: embryo, fetus, or nursing child; family members; a specific group.  
• 
Do not include the risks of non-research procedures that are already being performed.  
• 
If the study design specifies that subjects will be assigned to a specific condition or intervention, then the condition or 
intervention is a research procedure - even if it is a standard of care.  
• 
Examples of mitigation strategies: inclusion/exclusion criteria; applying appropriate data security measures to prevent 
unauthorized access to individually identifiable data; coding data; taking blood samples to monitor something that 
indicates drug toxicity. 
• 
As with all questions on this application, you may refer to uploaded documents. 
 
Participation in this study involves a time commitment from the OMC provider subjects in which they are 
required to designate time from their schedule to participate in bi-monthly virtual conferences. If a participant 
decides to implement the coaching from SCCA in their clinical care, time will be required to discuss genetic 
counseling and testing with their eligible patients, ordering genetic testing, and allocating extra time at patient 
follow-up visits to review genetic results. This time commitment may cause stress in the OMC provider subjects 
because it will likely require them to change how they manage their schedules. 
This study requires OMC provider subjects to grant permissions to SCCA to collect their patients’ medical 
records, which may pose security concerns and a breach of confidentiality for their patients.  
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. 
 
 
 
      

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b. Steps to minimize risk. Describe the specific steps that will be taken to minimize the 
magnitude, probability, or duration of these risks. 
Examples: inform the subjects about the risks and how to minimize them; require a pregnancy test before 
and during the study; require subjects to use contraception; advise subjects about banking of sperm and 
ova. 
 
If the use of contraception will be required: describe the allowable methods and the time period when 
contraception must be used. 
 
 
 
      
 
c. Pregnancy. Describe what will be done if a subject (or a subject’s partner) becomes pregnant 
For example; will subjects be required to immediately notify study staff, so that the study procedures can be 
discontinue or modified, or for a discussion of risks, and/or referrals or counseling? 
 
 
 
      
10.3 MRI risk management. Answer this question only if the subjects will receive MRI scans. A rare but serious adverse 
reaction called nephrogenic systemic fibrosis (NSF) has been observed in individuals with kidney disease who 
received gadolinium-based contrast agents (GBCAs) for the scans. Also, a few healthy individuals have a severe 
allergic reaction to GBCAs. 
a. Describe how the renal function of subjects will be assessed prior to MRI scans and how that information will 
be used to exclude subjects at risk for NSF. 
 
N/A, subjects will not receive MRI scans 
b. Describe the protocol for handling a severe allergic reaction to the GBCA or any other medical 
event/emergency during the MRI scan, including who will be responsible for which actions.  
 
N/A, subjects will not receive MRI scans 
10.4 Unforeseeable risks. Are there any research procedures that may have risks that are currently unforeseeable? 
Example: using a drug that hasn’t been used before in this subject population. 
 
X No 
 
 
 
Yes 
→ If yes, identify the procedures. 
 
 
 
      
10.5 Subjects who will be under regional or general anesthesiology. Will any research procedures occur while 
patients are under general or regional anesthesia, or during the 3 hours preceding general or regional anesthesia 
(supplied for non-research reasons)? 
 
X No 
 
 
 
Yes 
→ If yes, check all the boxes that apply. 
 
 
 
 
Administration of any drug for research purposes 
 
 
 
 
 
 
 
 
 
 
Inserting an intra-venous (central or peripheral) or intra-arterial line for research purposes 
 
 
 
 
 
 
Obtaining samples of blood, urine, bone marrow or cerebrospinal fluid for research 
purposes 
 
 
 
 

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Obtaining a research sample from tissue or organs that would not otherwise be removed 
during surgery 
 
 
 
 
 
 
Administration of a radio-isotope for research purposes** 
 
 
 
 
 
 
Implantation of an experimental device 
 
 
 
 
 
 
Other manipulations or procedures performed solely for research purposes (e.g., 
experimental liver dialysis, experimental brain stimulation) 
 
 
 
 
 
 
If any of the boxes are checked: 
Provide the name and institutional affiliation of a physician anesthesiologist who is a 
member of the research team or who will serve as a safety consultant about the interactions 
between the research procedures and the general or regional anesthesia of the subject-
patients. If the procedures will be performed at a UW Medicine facility or affiliate, the 
anesthesiologist must be a UW faculty member, and  the Vice Chair of Clinical Research in 
the UW Department of Anesthesiology and Pain Medicine must be consulted in advance for 
feasibility, safety and billing. 
 
 
      
 
 
** If the box about radio-isotopes is checked: the study team is responsible for informing in advance 
all appropriate clinical personnel (e.g., nurses, technicians, anesthesiologists, surgeons) about the 
administration and use of the radio-isotope, to ensure that any personal safety issues (e.g., 
pregnancy) can be appropriately addressed. This is a condition of IRB approval. 
10.6 Data and Safety Monitoring. A Data and Safety Monitoring Plan (DSMP) is required for clinical trials (as defined 
by NIH). If required for this research, or if there is a DSMP for the research regardless of whether it is required, 
upload the DSMP to Zipline. If it is embedded in another document being uploading (for example, a Study 
Protocol) use the text box below to name the document that has the DSMP. Alternatively, provide a description 
of the DSMP in the text box below.  
 
The OMC provider subjects will be given detailed instructions (both written and verbal) on how to collect 
relevant patient data and send electronically to the study’s research coordinator (via secure email). Once 
received by the study’s research coordinator, the data will be stored in a secured J-Drive folder within the 
SCCA network. The research coordinator will randomly assign all identified patient data to a unique 
participant ID before distributing to SCCA subject matter experts (cancer geneticist and/or genetic 
counselor) for review. For the bi-monthly conference meetings in which the SCCA subject matter experts 
review patients’ medical records, the study’s research coordinator will order the patients for discussion 
(OMC providers will receive the meeting agendas that lists the patient discussion order which will include 
patient PHI. SCCA subject matter experts will also receive meeting agendas that lists the same patient 
discussion order but will only have access to the unique participant ID and no PHI). 
10.7 Un-blinding. If this is a double-blinded or single-blinded study in which the participant and/or relevant study 
team members do not know the group to which the participant is assigned: describe the circumstances under 
which un-blinding would be necessary, and to whom the un-blinded information would be provided. 
 
N/A. This is not a double-blinded or single-blinded study. 

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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. 
 
      
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.  
 
This research will improve patient access to genetic testing which would enable us to identify if there are any 
previously undetected genetic predispositions in a patient's family. As a result, we can offer participation 
in cancer screening, surveillance, and prevention programs for family members at risk of cancer to 
decrease their risk to as close to zero as possible. Overall, this study will improve utilization of genetic 
counseling and testing amongst OMC providers caring for their cancer patients. 
10.10 Return of individual research results. 
In this section, provide your plans for the return of individual results. An “individual research result” is any information 
collected, generated or discovered in the course of a research study that is linked to the identity of a research participant. 
These may be results from screening procedures, results that are actively sought for purposes of the study, results that are 
discovered unintentionally, or after analysis of the collected data and/or results has been completed. 
 
 See the GUIDANCE Return of Individual Results for information about results that should and should not be returned, validity 
of results, the Clinical Laboratory Improvement Amendment (CLIA), consent requirements and communicating results. 
 
a. Is it anticipated that the research will produce any individual research results that are clinically actionable? 
 
“Clinically actionable” means that there are established therapeutic or preventive interventions or other available 
actions that have the potential to change the clinical course of the disease/condition, or lead to an improved health 
outcome. 
 
In general, every effort should be made to offer results that are clinically actionable, valid and pose life-threatening or 
severe health consequences if not treated or addressed quickly. Other clinically actionable results should be offered if 
this can be accomplished without compromising the research. 
 
X No 
 
 
 
Yes 
→ If yes, answer the following questions (a.1-a.3). 
 
a.1. Describe the clinically actionable results that are anticipated and explain which results, 
if any, could be urgent (i.e. because they pose life-threatening or severe health 
consequences if not treated or addressed quickly). 
 
Examples of urgent results include very high calcium levels, highly elevated liver function test results, 
positive results for reportable STDs. 
 
      
 
a.2. Explain which of these results will be offered to subjects.  
 
      

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a.3. Explain which results will not be offered to subjects and provide the rationale for not 
offering these results.  
 
Reasons not to offer the results might include: 
• 
There are serious questions regarding validity or reliability  
• 
Returning the results has the potential to cause bias 
• 
There are insufficient resources to communicate the results effectively and appropriately 
• 
Knowledge of the result could cause psychosocial harm to subjects 
 
      
 
b. What is the plan (if any) for offering subjects any results that are not clinically actionable? 
 
Examples: non-actionable genetic results, clinical tests in the normal range, experimental and/or uncertain results. 
 
X No 
 
 
 
Yes 
→ If yes, explain which results will be offered to subjects and provide the rationale for 
offering these results. 
 
 
      
 
c. Describe the validity and reliability of any results that will be offered to subjects. 
 
The IRB will consider evidence of validity such as studies demonstrating diagnostic, prognostic, or predictive value, 
use of confirmatory testing, and quality management systems. 
 
The results that will be offered to the OMC provider subjects will be reliable due to the consistent, 
uniform processes in data collection and recommendation that will be followed throughout the entire 
course of this study. The results will be valid because the reporting of the numbers of patients meeting 
criteria, referrals for genetic counseling/testing, completed genetics appointments, and genetic testing 
results, will be recorded and tracked by the same research coordinator. 
 
d. Describe the process for communicating results to subjects and facilitating understanding of the results. In 
the description, include who will approach the participant with regard to the offer of results, who will 
communicate the result (if different), the circumstances, timing, and communication methods that will be 
used. 
 
Results will be communicated to the OMC provider subjects at the end of phase 1 and phase 2. The SCCA 
study team and subjects will meet to discuss the number of patients seen who were eligible for genetic 
testing, number of those patients who were referred for genetic counseling/testing, the number of those 
patients who complete a genetics appointment, and the number of those patients who chose to undergo 
genetic testing. The OMC provider subjects will also be sent this data for their review in order to assess 
their current clinic processes. 
 
e. Describe any plans to share results with family members (e.g. in the event a subject becomes 
incapacitated or deceased). 
 
N/A 
 
f. Check the box to indicate that any plans for return of individual research results have been described in 
the consent document. If there are no plans to provide results to participants, this should be stated in the 
consent form. 
 
See the GUIDANCE Return of Individual Results for information about consent requirements. 
 
 
Confirmed 
 
10.11 Commercial products or patents. Is it possible that a commercial product or patent could result from this 
study? 
 
X No 
 

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Yes 
→ If yes, describe whether subjects might receive any remuneration/compensation and, if yes, 
how the amount will be determined. 
 
 
 
 
      
 
 
11 ECONOMIC BURDEN TO PARTICIPANTS 
11.1 Financial responsibility for research-related injuries. Answer this question only if the lead researcher is not a 
UW student, staff member, or faculty member whose primary paid appointment is at the UW. 
 
For each institution involved in conducting the research: Describe who will be financially responsible for 
research-related injuries experienced by subjects, and any limitations. Describe the process (if any) by which 
participants may obtain treatment/compensation. 
 
N/A. The lead research is a UW staff member whose primary paid appointment is at the UW. 
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). 
 
      
11.3 Reimbursement for costs. Describe any costs to subjects that will be reimbursed (such as travel expenses). 
 
      
 
 
12 RESOURCES 
12.1 Faculty Advisor. (For researchers who are students, fellows, or post-docs.) Provide the following information 
about the faculty advisor.  
• 
Advisor’s name 
• 
Your relationship with your advisor (for example: graduate advisor; course instructor) 
• 
Your plans for communication/consultation with your advisor about progress, problems, and changes.  
 
N/A 
12.2 UW Principal Investigator Qualifications. Upload a current or recent Curriculum Vitae (CV), Biosketch (as 
provided to federal funding agencies), or similar document to the Local Site Documents page in Zipline. The 
purpose of this is to address the PI’s qualifications to conduct the proposed research (education, experience, 
training, certifications, etc.). 
For help with creating a CV, see http://adai.uw.edu/grants/nsf_biosketch_template.pdf and 
https://education.uwmedicine.org/student-affairs/career-advising/year-4/residency-applications/curriculum-vitae/  
 
X The CV will be uploaded. 
12.3 UW Study team qualifications. Describe the qualifications and/or training for each UW study team member to 
fulfill their role on the study and perform study procedures. (You may be asked about non-UW study team 
members during the review; they should not be described here.) You may list these individuals by name, 
however if you list an individual by name, you will need to modify this application if that individual is replaced. 

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Alternatively, you can describe study roles and the qualifications and training the PI or study leadership will 
require for any individual who might fill that role. The IRB will use this information to assess whether risks to 
subjects are minimized because study activities are being conducted by properly qualified and trained 
individuals. 
Describe: The role (or name of person), the study activities they will perform, and the qualifications or 
training that are relevant to performing those study activities. 
 
 
Examples:  
Research Study Coordinator: Obtain consent, administer surveys, blood draw. Will have previous experience 
coordinating clinical research and be a certified phlebotomist in WA. 
Undergraduate Research Assistant: Obtain consent, perform all study procedures. Will have had coursework in 
research methods, complete an orientation to human subjects protections given by the department, and will 
receive training from the PI or the graduate student project lead on obtaining consent and debriefing subjects. 
Acupuncturist: Perform acupuncture procedures and administer surveys. Must be licensed with WA State DoH 
and complete training in administering research surveys given by the project director, an experienced survey 
researcher. 
Co-Investigator: Supervise MRI and CT scan procedures and data interpretation, obtain consent. MD, specialty in 
interventional radiology and body imaging. 5-years clinical research experience.  
 
 
 
 
 
Research Study Coordinator (Lauren Santos): Will obtain and securely store all study data and distribute 
appropriately to SCCA subject matter experts for review, facilitate communications between OMC and 
SCCA, participate in data analysis of study’s result. Has completed the Human Subjects Learners and Good 
Clinical Practice and ICH (GCP) certification from the Collaborative Institutional Training Initiative (CITI). 
Has prior experience with data analysis and data visualization through UW’s Healthcare Analytics certificate 
program. Completed Microsoft Excel workshops and data organization/data science classes through Fred 
Hutch Learning.  
12.4 Study team training and communication. Describe how it will be ensured that each study team member is 
adequately trained and informed about the research procedures and requirements (including any changes) as 
well as their research-related duties and functions. 
 
 
There is no study team. 
 
 
 
 
The study team will meet bi-monthly to discuss and debrief research procedures and requirements as well 
as their research-related duties and function. The study team will also regularly meet with OMC to 
ensure complete understanding of data collection and distribution processes.  
 
 
13 OTHER APPROVALS, PERMISSIONS, and REGULATORY ISSUES 
13.1 Approvals and permissions. Identify any other approvals or permissions that will be obtained. For example: from 
a school, external site/organization, funding agency, employee union, UW Medicine clinical unit. 
Do not attach the approvals and permissions unless requested by the IRB. 
 
N/A 

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13.2 Financial Conflict of Interest. Does any UW member of the team have ownership or other Significant Financial 
Interest (SFI) with this research as defined by UW policy GIM 10? 
 
X No 
 
 
 
Yes 
→ If yes, has the Office of Research made a determination regarding this SFI as it pertains to the 
proposed research? 
 
 
 
 
No 
→ If no, contact the Office of Research (206.616.0804, research@uw.edu) for  
guidance on how to obtain the determination 
 
 
 
Yes 
→ If yes, upload the Conflict Management Plan for every UW team member who has 
a FCOI with respect to the research, to Zipline. If it is not yet available, use the text 
box to describe whether the Significant Financial Interest has been disclosed 
already to the UW Office of Research and include the FIDS Disclosure ID if 
available.