Mobile Mental Health in Community-Based Organizations: A Stepped Care Approach to Women's Mental Health
Phase: NA
Conditions: Depression
Sponsor: University of Washington

1R21MH124073-01 Mobile Mental Health in Community Based Organizations 
Study Protocol with SAP and ICF 
NCT number: NCT04480021 
Date: 7-16-2024 

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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: 
Mobile Mental Health in Community-Based Organizations: A Stepped Care Approach to Women's 
Mental Health 

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1.1 Home institution. Identify the institution through which the lead researcher listed on the IRB application will 
conduct the research. Provide any helpful explanatory information. 
In general, the home institution is the institution (1) that provides the researcher’s paycheck and that considers him/her to be 
a paid employee, or (2) at which the researcher is a matriculated student. Scholars, faculty, fellows, and students who are 
visiting the UW and who are the lead researcher: identify your home institution and describe the purpose and duration of your 
UW visit, as well as the UW department/center with which you are affiliated while at the UW. 
 
Note that many UW clinical faculty members are paid employees of non-UW institutions. 
 
The UW IRB provides IRB review and oversight for only those researchers who meet the criteria described in the SOP: Use of 
the UW IRB. 
 
University of Washington 
1.2 Consultation history. Has there been any consultation with someone at HSD about this study? 
It is not necessary to obtain advance consultation. However, if advance consultation was obtained, answering this question 
will help ensure that the IRB is aware of and considers the advice and guidance provided in that consultation.   
 
 
No 
 
 
x 
Yes 
 If yes, briefly describe the consultation: approximate date, with whom, and method (e.g., by email, 
phone call, in-person meeting). 
 
 
 
 
Amritha Bhat communicated via phone with Jeffrey Love at HSD on 5/14/2020 about need for IRB 
review for JIT of NIH grant. 
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.  
 
 
No 
 
 
x 
Yes 
 If yes, briefly describe the urgency or deadline as well as the reason for it. 
 
 
 
The funder has requested that we provide IRB approval for the project as part of a Just in Time 
grant submission due by close of business on 5/25/2020. 
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). 
 
Background: Undiagnosed and untreated depression is a significant cause of morbidity and mortality in low-
middle-income countries (LMIC) such as India. The rates of diagnosis and treatment of depression among women 
in rural India are disproportionately low despite a primary care based task-sharing model of mental-health 
treatment. Stepped care approaches support appropriate treatment of symptoms while reducing the burden on 
healthcare systems and mobile technology can reduce the mental health treatment gap given its reach and easy 
access. However, as our preliminary study at a task-sharing care model in rural south India (Maanasi clinic, 
situated 60 miles from Bangalore city) revealed: illiteracy and the practice of sharing mobile phones as a family 
resource present hurdles to the adoption of mobile mental health (mHealth) based interventions. To date, the 
feasibility of an mHealth application to screen depression, track symptom severity and support the delivery of 
stepped care treatment has not been tested in LMIC.  
 
Specific Aim 1: In phase I of this exploratory study, we will adopt a user centered participatory approach to design 
and develop a multiple-user, voice-response, mobile application (“MITHRA”), to be used in community-based 
organizations for screening, tracking and supporting stepped care treatment for depression, including select 
modules of the Healthy Activity Program, a brief psychological intervention based on behavioral activation. The 
application will include audio, video and enhanced touchscreen capabilities, to overcome the barrier of illiteracy 
and lack of access.  
 
Specific Aim 2: In phase II, using a randomized-control design, we will examine feasibility and utility of 
“MITHRA” deployed at community-based organizations (n=3) vs enhanced usual care (n=3) in different villages 
supported by the Maanasi program (enrolling approximately 60 women). 
 
Specific aim 3: Throughout the duration of the funding period we will arrange for mentored participation of 
Psychiatry and Community Medicine residents from India in the research project. Community Health workers will 
benefit from regular videoconference didactic and case presentation (ECHO) sessions such as symptoms of and 
treatment for common mental disorders.  

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The grant will accomplish the goals of developing a unique mobile application that is scalable, examining its 
feasibility and building research capacity at the research site in India. 
1.6 Study design. Provide a one-sentence description of the general study design and/or type of methodology.   
Your answer will help HSD in assigning applications to reviewers and in managing workload. Examples: a longitudinal 
observational study; a double-blind, placebo-controlled randomized study; ethnographic interviews; web scraping from a 
convenience sample of blogs; medical record review; coordinating center for a multi-site study. 
 
Participatory design of an app and randomized controlled trial of the app. 
1.7 Intent. Check all the descriptors that apply to your activity. You must place an “X” in at least one box. 
This question is essential for ensuring that your application is correctly reviewed. Please read each option carefully. 
 
Descriptor 
 
 
1. Class project or other activity whose purpose is to provide an educational experience for the researcher 
(for example, to learn about the process or methods of doing research). 
 
 
 
 
 
 
2. Part of an institution, organization, or program’s own internal operational monitoring. 
 
 
 
 
 
 
3. Improve the quality of service provided by a specific institution, organization, or program. 
 
 
 
 
 
 
4. Designed to expand the knowledge base of a scientific discipline or other scholarly field of study, and 
produce results that: 
• 
Are expected to be applicable to a larger population beyond the site of data collection or the specific 
subjects studied, or 
• 
Are intended to be used to develop, test, or support theories, principles, and statements of 
relationships, or to inform policy beyond the study. 
 
x 
 
 
 
 
5. Focus directly on the specific individuals about whom the information or biospecimens are collected 
through oral history, journalism, biography, or historical scholarship activities, to provide an accurate and 
evidence-based portrayal of the individuals. 
 
 
 
 
 
 
6. A quality improvement or program improvement activity conducted to improve the implementation 
(delivery or quality) of an accepted practice, or to collect data about the implementation of the practice 
for clinical, practical, or administrative purposes. This does not include the evaluation of the efficacy of 
different accepted practices, or a comparison of their efficacy. 
 
 
 
 
 
 
7. Public health surveillance activities conducted, requested, or authorized by a public health authority for 
the sole purpose of identifying or investigating potential public health signals or timely awareness and 
priority setting during a situation that threatens public health. 
 
 
 
 
 
 
8. Preliminary, exploratory, or research development activities (such as pilot and feasibility studies, or 
reliability/validation testing of a questionnaire) 
 
 
 
 
 
 
9. Expanded access use of a drug or device not yet approved for this purpose 
 
 
 
 
 
 
10. Use of a Humanitarian Use Device 
 
 
 
 

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11. Other. Explain: 
 
 
 
 
 
 
 
N/A 
1.8 Background, experience, and preliminary work. Answer this question only if the proposed activity has one or 
more of the following characteristics. The purpose of this question is to provide the IRB with information that is 
relevant to its risk/benefit analysis. 
• 
Involves more than minimal risk (physical or non-physical) 
• 
Is a clinical trial, or 
• 
Involves having the subjects use a drug, biological, botanical, nutritional supplement, or medical 
device. 
“Minimal risk” means that the probability and magnitude of harm or discomfort anticipated in the research are not greater 
than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or 
tests. 
 
a. Background. Provide the rationale and the scientific or scholarly background for the proposed activity, based 
on existing literature (or clinical knowledge). Describe the gaps in current knowledge that the project is 
intended to address. 
 
This should be a plain language description. Do not provide scholarly citations. Limit your answer to less than one page, or 
refer to an attached document with background information that is no more than three pages long. 
 
Untreated depression is a significant cause of morbidity and mortality in low and middle-income countries 
(LMIC) such as India. The vast majority (75-85%) of people with depression in LMIC receive little or no 
treatment, resulting in a large 'treatment gap' of over 90%, which is greater in rural populations, especially 
among women. The alarmingly high treatment gap persists despite attempts to improve access by integrating 
mental health care with primary care as outlined in India’s Mental Health Policy. Mild to moderate depression 
can lead to significant health and economic burden, and self-management can be used effectively to manage 
mild and moderate depression. There is therefore an urgent need and opportunity to identify and treat mild to 
moderate depression without increasing burden on the strained healthcare system. Within a stepped care 
approach, self-administered treatments are an evidence based approach to mild to moderate depressive 
symptom when combined with regular monitoring of symptoms. This approach is especially useful in 
leveraging the available workforce in resource constrained settings. 
Mobile health (mHealth) has been recommended as a means to improve access to care due to ease of access 
and availability even in resource poor settings. Mobile apps have demonstrated high usability and feasibility, 
and mild to moderate effect sizes in the treatment of depression. This is particularly relevant to the Indian 
context - in India, most people have access to a mobile phone and network coverage. However, there are 
differences in usage patterns that need to be considered in developing mHealth strategies. For e.g., in rural 
India, while 87% of people own a cell phone, only 14% of them use text messaging perhaps because of the 
high rate of illiteracy. Furthermore, as we found in our qualitative work in rural India with women with 
depression, although women do report owning a mobile phone, this is often a shared family phone that is with 
the husband for most of the day. Therefore, to ensure adequate uptake, any mHealth program needs to account 
for barriers such as illiteracy and lack of access to a personal mobile device.  It is also critical to obtain end 
user or consumer feedback at every stage of development of mHealth solutions, as our work illustrates the 
need to contextualize mHealth by obtaining key stakeholder feedback to increase cultural relevance and 
acceptability.  
Community-based organizations (CBOs) for women (called “mahila mandals” or “sthree shakthi” – women 
power) are instrumental in increasing women’s empowerment and participation in microfinancing systems in 
rural India. They are self-help groups launched by the Department of Women and Child Development in the 
year 2000, implemented throughout India to empower rural women and make them self-reliant. Each group 

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consists of about 15 to 20 women members who are from below poverty line families, or landless agricultural 
labourers who meet regularly (weekly, biweekly or monthly). CBOs are used as platforms to deliver public 
health interventions including first aid training and prenatal education, and provide a unique opportunity for 
depression screening and intervention. In CBOs, using a stepped care approach to depression treatment that 
begins with offering education and self-administered treatments and allows for treatment intensification as 
required can provide invaluable opportunities to maximize treatment resources. This could also help address 
an important barrier to mental health treatment delivery, i.e., transportation, as many women would then 
receive depression screening, tracking and treatment support in their own village.  In previous studies, women 
cite travel times and inability to take time off from work as a significant barrier to seeking mental health care 
in the PHC, and as a reason for treatment discontinuation. This barrier is relevant throughout the country, as 
although India’s District Mental Health Program aims to provide community based accessible mental health 
care, 40% of patients still travel more than 10 km to access mental health services. 
We propose, with user centered design methodology, to develop and test the feasibility of deploying a mobile 
based app (MITHRA) in CBOs in rural India to screen, track and treat depression using a stepped care 
algorithm in order to address the treatment-gap in LMIC, especially focusing on mild to moderate 
depression.30-32,44,52  The stepped care approach will include education about depression and activity 
scheduling, based on the Healthy Activity Program (HAP), which is an evidence-based intervention that is 
acceptable, efficacious and cost effective in the treatment of depression and has been tested in rural India. It is 
effective in the treatment of moderate to severe depression and can also benefit mildly depressed individuals 
who may not require involvement of a mental health professional.  Based on key stakeholder input, depression 
screening and education can be included with a general health survey, or independently. The app will be a 
Multi user Interactive Health Response Application (MITHRA = “friend” in Kannada, the regional language) 
deployed in CBOs in rural south India. Considering the culture and context of LMIC, education and advice 
about behavioral activation delivered via the app as part of stepped care treatment of depression, is an 
appropriate, initial effective and cost-effective treatment.5 
 
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. 
 
 
Our multidisciplinary research team has a long working relationship and has carried out formative research 
underlying the current proposal. Our qualitative analysis in the same population proposed for study in the 
current project helped understand some of the barriers to mental health care access and attitudes to mobile 
mental health. The study team will consist of Dr. Bhat and Dr. Srinivasan as Principal Investigators, and Drs. 
Collins Tony Raj, Goud and Pradeep as co – Investigators.  In addition, in each year of the project, Psychiatry 
or Community Medicine residents will be selected from the St. John’s Medical College training program for 
mentored participation in our team.  Members of this team have collaborated on previous projects and in the 
development of this proposal and will continue to meet at regular intervals across the funding period for 
periodic review of progress and for problem solving.  
Dr. Bhat is the overall contact PI owing to her experience in integrated mental health care, task sharing, and 
women’s mental health. She has trained in both India and the US and has collaborated with Drs. Srinivasan, 
Goud and Pradeep in the past.   She will coordinate activities between University of Washington and St. 
John’s Medical College. Together with Dr. Srinivasan she will ensure that participating sites receive the 
necessary logistic and administrative support to implement the research plan. Dr. Srinivasan is the ideal India 
PI due to his understanding of the barriers and facilitators to community based mental health and because of 
his extensive experience on multiple studies examining the treatment of common mental disorders in India. 

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Many of these studies are collaborations with the United States and he is well versed in multiple PI projects 
such as the one we propose.  He will provide oversight and supervision to the Community Health Workers 
(CHWs) and residents working on the project and arrange for psychiatrist back up for the CHWs in case of 
study related emergencies. Dr. Collins has several years' experience in global mental health projects and in 
mixed methods analysis. She is also experienced in modification of evidence-based treatments for delivery by 
lay health workers. She will provide input on mixed methods analysis, CHW training and overall study 
conduct. She is the director of the Global Mental Health program in the Department of Psychiatry and 
Behavioral Sciences at the University of Washington and in this capacity meets monthly with Dr. Bhat. She 
will meet with Dr. Bhat additionally as outline in the proposal. Dr. Tony Raj will lead the informatics team 
and oversee the process of iterative app development with end user input, and usability and pilot testing 
Dr. Goud will supervise CBO and CHW activities in his capacity as the Head of the Department for 
Community Medicine at St. John’s Medical College. Dr. Johnson will ensure the smooth running of the day-
to-day activities of the trial included recruitment, conduct of focus groups and supervision of CHWs. He will 
coordinate the local IRB submission at the study site. 
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 
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 
ZIPLINE SUPPLEMENT: 
Genomic Data Sharing 
 
 
 
 
 
 
 
 
 
 
 
 
Medical device 
Procedures involve the use of any medical device, even if the device is 
not the focus of the proposed research, except when the device is FDA-
approved and is being used through a clinical facility in the manner for 
which it is approved 
ZIPLINE SUPPLEMENT: 
Devices 
 
 
 
 
 
 
 
 
 
 
 
 
SUPPLEMENT: Multi-site 
or Collaborative Research 
 
 
 
 

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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. 
 
 
 
 
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. 
 
For women's focus group: 
- Women 
- Age ≥ 18 years  
- Resident of the village (i.e. not a guest attendee at the CBO) 
 
For provider focus groups: 
- CHWs who have been in the community for at least 6 months and interact regularly with members of the CBO.  
- Administrators of the CBO who have been in the role for at least 6 months. 
- Mental health and primary care providers who have treated women with depression. 
 
For pilot RCT: 
- Age ≥ 18 years  
- Resident of the village (i.e. not a guest attendee) 
- Plans to attend CBO meetings regularly. 
2.2 Inclusion and exclusion criteria.  
a. Inclusion criteria. Describe the specific criteria that will be used to decide who will be included in the research 
from among interested or potential subjects. Define any technical terms in lay language. 
 
Inclusion for women's focus group: 
- Age ≥ 18 years  
- Resident of the village (i.e. not a guest attendee at the CBO) 
 
Inclusion for provider focus groups: 
- CHWs who have been in the community for at least 6 months and interact regularly with members of the 
CBO.  
- Administrators of the CBO who have been in the role for at least 6 months. 
- Mental health and primary care providers who have treated women with depression. 
 
- Age ≥ 18 years  
- Resident of the village (i.e. not a guest attendee) 
- Plans to attend CBO meetings regularly. 
 
 

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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. 
 
Exclusion criteria for focus groups: 
Unable to participate in informed consent discussion and did not complete PHQ-9. 
 
Exclusion criteria for RCT: 
- Diagnosed with severe mental illness such as bipolar disorder or schizophrenia 
- Suicide attempt or severe alcohol or substance use in the past 6 months 
- Unable to participate in informed consent discussion. 
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 

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 If yes, if a subject becomes a prisoner while participating in the study, will any study 
procedures and/or data collection related to the subject be continued while the subject is a 
prisoner? 
 
 
No 
 
 
 
Yes 
 If yes, describe the procedures and/or data collection that will continue with 
prisoner subjects 
 
 
 
      
2.4 Protected populations. IRB approval is required for the use of the subject populations listed here. Check the boxes 
for any of these populations that will be purposefully included. (In other words, being a part of the population is 
an inclusion criterion for the study.) 
The WORKSHEETS describe the criteria for approval but do not need to be completed and should not be submitted. 
 
Population 
Worksheet 
 
 
Fetuses in utero 
WORKSHEET: Pregnant Women 
 
 
 
 
 
 
Neonates of uncertain viability 
WORKSHEET: Neonates 
 
 
 
 
 
 
Non-viable neonates 
WORKSHEET: Neonates 
 
 
 
 
 
 
Pregnant women 
WORKSHEET: Pregnant Women 
 
 
 
 
a. If you check any of the boxes above, use this space to provide any information that may be relevant for the IRB 
to consider.  
 
N/A 
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. 
 
 
 
 
      

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2.6 Third party subjects. Will the research collect private identifiable information about other individuals from the 
study subjects? Common examples include: collecting medical history information or contact information about 
family members, friends, co-workers. 
“Identifiable” means any direct or indirect identifier that, alone or in combination, would allow you or another member of the 
research team to readily identify the person. For example, suppose that the research is about immigration history. If subjects 
are asked questions about their grandparents but are not asked for names or other information that would allow easy 
identification of the grandparents, then private identifiable information is not being collected about the grandparents and the 
grandparents are not subjects.  
 
 
x 
No 
 
 
 
Yes 
 If yes, these individuals are considered human subjects in the study. Describe them and what data 
will be collected about them. 
 
 
 
 
      
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 

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Provide numbers for the site(s) reviewed by the UW IRB 
and for the study-wide total number; example: 20/100 
 
Community health workers 
3 
 
Community based organization (CBO) administrators 
3 
 
Primary care and mental health providers 
3 
 
CBO participants for focus group 
6 
 
CBO participants for RCT 
60 
 
      
       
 
 
3 NON-UW RESEARCH SETTING  
Complete this section only if UW investigators and people named in the SUPPLEMENT: 
Non-UW Individual Investigators will conduct research procedures outside of UW and 
Harborview 
3.1 Reason for locations. Describe the reason(s) for choosing the locations.  
This is especially important when the research will occur in locations or with populations that may be vulnerable to 
exploitation. One of the three ethical principles the IRB must consider is justice: ensuring that reasonable, non-exploitative, 
and well-considered procedures are administered fairly, with a fair distribution of costs and potential benefits. 
 
This research is aimed at examining the feasibility of app-based screening and treatment of depression in women 
in rural settings with a high treatment gap such as at our India site.  
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  
 
Research will be conducted within CBOs, and consent will be obtained by community health workers who are 
known to the women. This approach has been used in previous studies in the same location and is acceptable to 
women and culturally appropriate. 
Study procedures will be explained in detail before obtaining informed consent with the option of using thumb 
impression instead of signature if illiteracy is a barrier.  

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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 
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? N/A 
 
 
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. 
 
End user focus group: Women for the end user focus group will be recruited from via i) advertisements ii) flyers iii) 
word of mouth and iv) community health workers (CHWs). We will oversample for women with depressive 
symptoms such that we have an equal number of women with Patient Health Questionnaire -9 (PHQ-9) score above 
5 and PHQ-9 score below 5. For prescreening, to identify women with a PHQ-9 above 5, community health workers 
located in the Community Based Organization (CBO) will use the PHQ-9 questionnaire, introduced with talking 
points which have been uploaded. 
 
Provider focus group: Primary care and mental health providers will be recruited from Anekal Primary Health Center 
and CHWs will be recruited from the Community Based Organizations (CBOs) and by contacting them through the 
parent Mahila Mandal Organization.  

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All advertisements and flyers will be reviewed and approved before use by the Human Subjects division at University 
of Washington. 
For the RCT, participants will be recruited from community-based organizations (CBOs) via i) advertisements ii) 
flyers iii) word of mouth and iv) community health workers (CHWs). Our recruitment strategies will enable us to 
recruit women with varying degrees of depression and to be representative of women in the villages covered by the 
CBO. 
All advertisements and flyers will be reviewed and approved before use by the Human Subjects division at 
University of Washington. 
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. 
 
Talking points for CHWs attached as appendix. 
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. 
 
 
 
      

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4.4 Payment to participants. Describe any payment that will be provided, including: 
• 
The total amount/value 
• 
Whether payment will be “pro-rated” so that participants who are unable to complete the research may still 
receive some part of the payment 
The IRB expects the consent process or study information provided to the subjects to include information about the number 
and amount of payments, and especially the time when subjects can expect to receive payment. One of the most frequent 
complaints received by HSD is from subjects who expected to receive cash or a check on the day that they completed a study 
and who were angry or disappointed when payment took 6-8 weeks to reach them.  
 
Do not include a description of any expenses that will be reimbursed.  
Subjects will be compensated for their time spent on participating in the focus groups and individual interviews. 
All women (including CHWs and CBO attendees) will receive Rs. 200 (approx. $3) each time they participate. 
This amount represents a payment for the time and potential stress associated with the study procedures and is 
comparable with other similar studies at this location. This amount of compensation is commensurate with the 
average income in this region and ensures that consent is not unduly influenced by financial consideration 
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.  
None 
4.6 Will data or specimens be accessed or obtained for recruiting and screening procedures prior to enrollment?  
Examples: names and contact information; the information gathered from records that were screened; results of screening 
questionnaires or screening blood tests; Protected Health Information (PHI) from screening medical records to identify possible 
subjects. 
 
 
No 
 If no, skip the rest of this section; go to question 5.1. 
 
x 
Yes 
 If yes, describe the data and/or specimens (including PHI) and whether it will be retained as part of 
the study data. 
 
 
 
For the CBO participant focus groups in Aim 1, potential participants will receive a paper based 
PHQ-9 to enable recruitment of up to 3 women with PHQ-9 scored of more than 5. The paper PHQ-
9s will not have identifying information and will be shredded immediately after the CHW has 
determined the total scores. We will however maintain a count of how many women were 
prescreened and how many of them had a score of more than 5. For the RCT we will administer 
PHQ-9 to all attendees of the CBO using the same talking points, to identify CBOs with more than 
one woman who scores positive on the PHQ-9. 

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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.  
 
 
No 
 If no, skip the rest of this section; go to question 5.1. 
 
x 
Yes 
 If yes, describe the consent process. 
 
 
 
CHWs will administer the PHQ9, if more than one woman PHQ9 positive then CHW will proceed 
with informed consent for all members of SHG. The CHW will use the attached talking points to 
obtain verbal consent from participants. 
 
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? 
 
x 
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. 
 
App development: Using a qualitative, user-centered design approach we will: (1) develop consensus on the desired 
features, content, and design of the MITHRA app; (2) develop an initial working prototype of MITHRA and conduct 
technical feasibility testing (3) iteratively refine and evaluate the app prototype based on usability testing. In parallel, 
Drs. Bhat, Johnson, and Srinivasan will use the HAP manual to develop the depression education and treatment 
modules that will be embedded in the MITHRA app.  We will explore with the design group the desirability of 
features such as including physical health questionnaires to improve user buy in and reduce stigma and include the 
validated Kannada version of the Patient Health Questionnaire – 9 (PHQ-9) depression screening questionnaire. The 
standard life cycle of software development, configuration and testing will be followed. The study team will train 
members of the CBO to use the app and the tablet devices.  We will obtain end user and stakeholder input as follows: 

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We will form three groups – 1 group with 3 CHWs and with CBO leadership, 1 group with 2 -3 primary and mental 
health care providers and 1 group with 6 – 7 CBO participants (2 -3 with PHQ-9 score of 5 or more). We will conduct 
1 focus group interview with each of the 3 groups and triangulate these to inform step (1) of developing consensus 
on desired features of the app. In addition to the current plan, we will conduct one to two focus groups with 
participants at conclusion of the trial.  Using a semi-structured interview guide, we will obtain inputs on design of 
the proposed app, keeping in mind the specifications of audio enabled, simplified touchscreen and follow up decision 
algorithm. We will include questions about introducing the PHQ-9 screen (as a depression screen on its own or as 
part of a more general health questionnaire), acceptable user interfaces, length of modules to be viewed, and women’s 
preferences regarding viewing HAP modules (for e.g. do they prefer viewing in the CBO or would they prefer an 
option to check out the tablet to their home for viewing). We will record and transcribe focus group content and 
analyze it using qualitative analysis software Nvivo. Using a thematic content analysis approach, we will identify 
common themes to help guide app development.  The informatics team will complete step (2) in consultation with 
Dr. Raj using the information obtained during step (1). For step (3) of iterative refinement of the app, we will conduct 
2 Participatory Design Group meetings alternating with modification of the prototype until saturation of issues raised 
in PDG meetings is reached.   
Randomized trial: We will randomize CBOs to use MITHRA (n=3) or enhanced usual care (EUC) (n=3) for 12 
weeks. Randomization will be clustered to account for distance from the PHC. The MITHRA CBOs will each have 
2 -3 tablets for use by all attendees. A CHW will be present at meetings and encourage women to use the MITHRA 
app. During their time at the meeting, women will complete the PHQ-9 screening and modules based on their 
individual depression score. Privacy will be ensured. They will also have the option to take turns checking out the 
tablet for viewing at home (if this is reported by the design group to be a desirable feature). In the EUC CBOs, CHWs 
will offer monthly group education (45 min) regarding the symptoms of depression, informed by training webinars 
led by study Investigators. We have the support of the CBO and PHC leadership for this project (see attached letters 
of support). In both MITHRA and EUC CBOs CHWs will conduct community outreach to encourage women to 
attend meetings, as depression can lead to amotivation and women with depression may be less likely to attend CBO 
meetings. All CHWs will receive training in depression, screening and common treatments, resources and referrals.  
Outcome Measures: CHWs will maintain rosters of CBO attendees at MITHRA CBOs and EUC CBOs. In 
monthly review sessions with the study investigators, the CHWs will review questionnaire completion and scores, 
and directly contact the woman (by phone or home visit or at a CBO meeting) if there is a need to step up care 
beyond that advised by the app. Women typically attend CBO meetings 2 -3 times a month and use at every 
attendance will be encouraged.   
 
MITHRA is an app which will be available on 2 -3 tablets placed in Community Based Organizations (CBOs). 
Women can log in to MITHRA using a unique password protected secure single user sign on (fingerprint sign in to 
account for varying levels of literacy) to complete the physical health questionnaire and the PHQ -9 (validated 
Kannada version of the PHQ-9) in an assigned private place in the CBO. On completion of the PHQ-9, each 
woman will receive a prompt based on her total score (see Fig). Women who score < 5 will watch general 
information on depression; women who score 5 – 10 will watch modules 1 and 2 (case descriptions, What is 
Depression? and Introduction to PHQ-9) Women who score 10 – 15 will watch modules 1, 2, and 3 (Connection 
between activity and mood). 
On repeat sign in, they will also receive questions on completion of behavioral activation homework. Women who 
score more than 15 will receive a prompt to view modules 1 through 4 which includes additional content on 
strategies for specific problems, and information on medications. They will receive information on how to seek 
mental health care. This ensures that women with mild to 
moderate depression receive initial treatment without having to overcome transportation barriers. The app will 
track, and graph PHQ-9 score change over time to inform need to step up care. Any woman who scores anything 
other than 0 on question 9 of the PHQ 9 (suicidal ideation item) will be asked to call the CHW associated with that 
CBO. For these women, the app will also trigger an alert to the CHW who will immediately call the patient to 
complete a risk assessment based on the study SI protocol. CHWs will be trained in the study safety protocol and a 
chain of contact will be established for each type of scenario.  The woman will be escorted to the PHC if needed. 
Modules described above will follow the content of the Healthy Activity Program manual and will be delivered in 

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short (10-15 min) interactive multimediabased modules. Depending on their PHQ-9 score, women will watch 4 to 8 
modules over the course of 1 to 3 months.  
 
 
 
 
 
 
 
Enhanced Usual Care (EUC): For EUC, CHWs will offer standardized monthly group education (45 min) 
regarding the symptoms of depression, informed by training from study Investigators. All CHWs will receive 
education on depression symptoms and referrals. 
 
 
5.2 Recordings. Does the research involve creating audio or video recordings? 
 
 
No 
 If no, go to question 5.3. 
 
x 
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. 
 
 
 
 
x 
Yes 
 
5.3 MRI scans. Will any subjects have a Magnetic Resonance Imaging (MRI) scan as part of the study procedures? 
This means scans that are performed solely for research purposes or clinical scans that are modified for research purposes (for 
example, using a gadolinium-based contrast agent when it is not required for clinical reasons).  
 
x 
No 
 If no, go to question 5.4. 
 
 
Yes 
 If yes, answer questions a through c. 

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a. Describe the MRI scan(s). Specifically: 
• 
What is the purpose of the scan(s)? Examples: obtain research data; safety assessment 
associated with a research procedure. 
• 
Which subjects will receive 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 
c. MRI facility. At which facility(ies) will the MRI scans occur? Check all that apply. 
 
 
UWMC Radiology/Imaging Services (the UWMC clinical facility) 

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DISC Diagnostic Imaging Sciences Center (UWMC research facility) 
 
 
BMIC Biomolecular Imaging Center (South Lake Union research facility) 
 
 
Harborview Radiology/Imaging Services (the Harborview clinical facility) 
 
 
SCCA Imaging Services 
 
 
Northwest Diagnostic Imaging 
 
 
Other: identify in the text box below: 
 
      
Personnel. For MRI scans that will be conducted at the DISC or BMIC research facilities: The role, qualifications, and 
training of individuals who will operate the scanner, administer the GBCA (if applicable), and/or insert and 
remove the IV catheter should be 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. 
 
1. App usage rates – measured at baseline and 3 months. We will obtain data on women's rates of use of the 
MITHRA app - this data will be obtained from the app, enabled by the single user sign on. 
2. Depression measured by Quick Inventory of Depressive Symptoms (QIDS SR) at baseline 3 months and 6 
months. QIDS SR will be collected by a blinded / masked research assistant. Research assessments will be 
conducted over the phone or in the Primary Health Center to avoid unblinding of CBO randomization 
status (presence of tablets in the CBOs) 
3. Behavioral Activation – Behavioral Activation Depression Scale (BADS). We will administer the BADS to 
all women to calculate adherence to behavioral activation recommendations (for intervention women) and 
to measure degree of behavioral activation (for Enhanced Usual Care women). 
4. Mental health services utilization – At baseline, 3 months and 6 months. We will obtain information on 
rates of utilization of mental health services including number of contacts with mental health providers and 
details of medications taken. 
Depression – clinical outcome (not research measure)- Patient Health Questionnaire – 9. We will obtain 
information on rates of utilization of mental health services including the number of contacts with mental health 
providers and details of medications taken. 
5.5 Data sources. For all types of data that will be accessed or collected for this research: Identify whether the data are 
being obtained from the subjects (or subjects’ specimens) or whether they are being obtained from some other 
source (and identify the source). 
If you have already provided this information in Question 5.1, you do not need to repeat the information here. 
 
All research measures will be obtained from subjects by research coordinators in person or by phone. 

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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.  
 
 
 
India research team members will have access to design group member names and contact 
information.  The UW research team will have access to the design group member names 
as part of the meeting attendance.  India research team members will have access to the 
audio recordings and transcripts of the focus group meetings and notes from design team 
meetings. India research team members will have access to the participant informed 
consents.  India team will have access to the app data.  India and UW research teams will 
have access to the de-identified data set. 
 
 
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. 
 
 
 
 
India research team members will obtain contact information for the design group 
members.  India research team members will obtain notes from the design group meetings 
and a recording and transcript of the design group meetings. India research team members 
will obtain the clinician and patient focus group consents. 
India research team members will obtain qualitative data from the focus group 
participants.  
India research team will obtain and create a data set of patient app data.  
 
UW research team - NA 
 
 
 
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 
 
 
 
 
Qualitative data:  Audio recordings of the focus group sessions will be collected by UW 
study staff.  Audio recordings will be transmitted to the transcriptionist via a HIPAA-
compliant FTP server and recordings will be transcribed with removal of as much 
personally identifiable information as possible. Once the transcriptions are confirmed to 
be accurate, the audio recordings will be destroyed. Electronic copies of the transcriptions 

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will only be available to members of the study team, and will be stored on a password-
protected computer server that is housed in a locked facility with restricted access.   The 
India team will translate the transcriptions. 
 
No identifying information will be attached to study data. Study data will be labeled with 
a unique study identification number.  Only the relevant project staff will have access 
to the master list linking subject names to study identification numbers. The master list 
will be kept separate from the de-identified study data.   
 
All identifying information collected as part of the study will be stored in a database on a 
secure server and will be password protected with limited access by the study team. 
Access will be limited to the research staff. 
 
App data: Patient data will be a limited data set (dates of service and date of birth). The 
de-identified limited data sets will be created by the India UW team and shared with 
the UW research team. We will adhere to all requirements imposed by the Institutional 
Review Board and legal requirements such as HIPAA.  
 
Participant consents: The India team will collect and manage participant consents.  
The consents will be stored in a secure locked drawer, separate from the de-identified 
data.   
 
 
 
Identifiers and study data will be stored separately, with no link between the identifiers 
and the study data. Describe the data to which this applies: 
 
 
 
 
 
 
      
d. Research collaboration. Will individuals who provide coded information or specimens for the research also 
collaborate on other activities for this research? If yes, identify the activities and provide the name of the 
collaborator’s institution/organization. 
Examples include but are not limited to: (1) study, interpretation, or analysis of the data that results from the coded 
information or specimens; and (2) authorship on presentations or manuscripts related to this work. 
Qualitative Data: Audio recordings of the focus group sessions will be collected by India study staff . Audio 
recordings will be transmitted to the transcriptionist via a HIPAA-compliant FTP server and recordings will 
be transcribed with removal of as much personally identifiable information as possible. Once the 
transcriptions are confirmed to be accurate, the audio recordings will be destroyed. Electronic copies of the 
transcriptions will only be available to members of the study team and will be stored on a password-protected 
computer server that is housed in a locked facility with restricted access.    
 
No identifying information will be attached to study data. Study data will be labeled with a unique study 
identification number.  Only the relevant project staff will have access to the master list linking subject 
names to study identification numbers. The master list will be kept separate from the de-identified study 
data.   
 
All identifying information collected as part of the study will be stored in a database on a secure server and 
will be password protected with limited access by the study team. Access will be limited to the research 
staff. 
 

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Patient data will be a limited data set (dates of service and date of birth). The de-identified limited data sets 
will be created by the India team and shared with the UW research team. We will adhere to all requirements 
imposed by the Institutional Review Board and legal requirements such as HIPAA 
 
The India investigators are listed below and have completed human subjects training.   
 
Srinivasan K, MD 
Ramakrishna Goud, MD 
Johnson Pradeep, MD 
Tony Raj, MD 
Dhinagaran Devadass MBBS 
Abhijeet Wagmare MBBS 
 
5.7 Protected Health Information (PHI). Will participants’ identifiable PHI be accessed, obtained, used, or disclosed for 
any reason (for example, to identify or screen potential subjects, to obtain study data or specimens, for study 
follow-up) that does not involve the creation or obtaining of a Limited Data Set? 
PHI is individually identifiable healthcare record information or clinical specimens from an organization considered a “covered 
entity” by federal HIPAA regulations, in any form or media, whether electronic, paper, or oral. You must answer yes to this 
question if the research involves identifiable health care records (e.g., medical, dental, pharmacy, nursing, billing, etc.), 
identifiable healthcare information from a clinical department repository, or observations or recordings of clinical 
interactions. 
 
x 
No 
 If no, skip the rest of this question; go to question 5.8 
 
 
Yes 
 If yes, answer all of the questions below. 
 
 
a. Describe the PHI and the reason for using it. Be specific. For example, will any “free text” fields 
(such as physician notes) be accessed, obtained, or used?   
 
      
b. Is any of the PHI located in Washington State? 
 
 
No 
 
 
 
Yes 
 
c. Describe the pathway of how the PHI will be accessed or obtained, starting with the 
source/location and then describing the system/path/mechanism by which it will be identified, 
accessed, and copied for the research. Be specific. For example: directly view records; search 
through a department’s clinical database; submit a request to Leaf. 
 
      
d. For which PHI will subjects provide HIPAA authorization before the PHI is accessed, obtained 
and/or used?  
 
      
 
Confirm by checking the box that the UW Medicine HIPAA Authorization form maintained on the 
HSD website will be used to access, obtain, use, or disclose any UW Medicine PHI. 
 
 
Confirmed 
 
 
e. For which PHI will HIPAA authorization NOT be obtained from the subjects? 
      

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Provide the following assurances by checking the boxes. 
 
 
The minimum necessary amount of PHI to accomplish the purposes described in this 
application will be accessed, obtained and/or used. 
 
 
 
 
 
 
The PHI will not be reused or disclosed to any other person or entity, except as required by 
law, for authorized oversight of the research study, or for other research for which the use or 
disclosure of PHI would be permitted. 
 
 
 
 
 
 
The HIPAA “accounting for disclosures” requirement will be fulfilled, if applicable. See UW 
Medicine Compliance Policy #104.  
 
 
 
 
 
 
 
 
There will be reasonable safeguards to protect against identifying, directly or indirectly, any 
patient in any report of the research. 
 
 
 
 
 
 
 
 
5.8 Genomic data sharing. Will the research obtain or generate genomic data? 
 
x 
No 
 
 
 
Yes 
 If yes, answer the question below. 
 
a. Will genomic data from this research be sent to a national database (for example, NIH’s dbGaP 
database)? 
 
 
 
No 
 
 
 
 
Yes 
 If yes, complete the 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  
5.10 Possible secondary use or sharing of information, specimens, or subject contact information. Is it likely that the 
obtained or collected information, specimens, or subject contact information will be used for any of the following: 
• 
Future research not described in this application (in other words, secondary research) 
• 
Submission to a repository, registry, or database managed by the study team, colleagues, or others for 
research purposes 
• 
Sharing with others for their own research 
Please consider the broadest possible future plans and whether consent will be obtained now from the subjects 
for future sharing or research uses (which it may not be possible to describe in detail at this time). Answer YES 
even if future sharing or uses will use de-identified information or specimens. Answer NO if sharing is unlikely or if 
the only sharing will be through the NIH Genomic Data Sharing described in question 5.8. 
Many federal grants and contracts now require data or specimen sharing as a condition of funding, and many journals require 
data sharing as a condition of publication. “Sharing” may include (for example): informal arrangements to share banked 
data/specimens with other investigators; establishing a repository that will formally share with other researchers through 
written agreements; or sending data/specimens to a third party repository/archive/entity such as the Social Science Open 
Access Repository (SSOAR), or the UCLA Ethnomusicology Archive. 
 
 
No 
 

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x 
Yes  If yes, answer all of the questions below. 
 
a. Describe what will be stored for future use, including whether any direct or indirect (e.g., subject 
codes) identifiers will be stored.  
 
De-identified data will be stored for future use. 
 
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.  
 
The award is subject to the data sharing guidance outlined in NOT-MH-14-015 and use of the 
NIMH Data Archive.  No direct identifiers will be shared. 
 
c. Who will oversee and/or manage the sharing?  
 
The UW research team will 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. 
 
Future uses might include other women’s mental health research projects. 
 
e. Consent. Will consent be obtained now from subjects for the secondary use, banking and/or 
future sharing?  
 
x 
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?  
 
x 
No 
 
 
 
Yes 
 If yes, describe how, and whether there are any limitations on withdrawal. 
 
Example: data can be withdrawn from the repository but cannot be retrieved after they 
are released. 
 
      
 
g. Agreements for sharing or release. Confirm by checking the box that the sharing or release will 
comply with UW (and, if applicable, UW Medicine) policies that require a formal agreement 
with the recipient for release of data or specimens to individuals or entities other than federal 
databases. 
 
Data Use Agreements or Gatekeeping forms are used for data; Material Transfer Agreements are used for 
specimens (or specimens plus data). Do not attach any template agreement forms; the IRB neither 
reviews nor approves them 
x 
Confirmed 

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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 India research team will have contact with the design team and focus group participants during the course of 
the study by phone, email and/or in person. No contact will occur between the research study team and the patients 
receiving care. 
 
The India and UW team will have contact with the design team participants during the course of the study during 
the design meetings, via the phone and in person.   
The India team will have contact with the RCT participants during the course of the trial by phone email or postal 
letters and in person. 
5.12 Future contact with subjects. Is there a plan to retain any contact information for subjects so that they can be 
contacted in the future? 
 
 
No 
 
 
x 
Yes 
 If yes, describe the purpose of the future contact, and whether use of the contact information will 
be limited to the study team; if not, describe who else could be provided with the contact 
information. Describe the criteria for approving requests for the information. 
 
 
 
Examples: inform subjects about other studies; ask subjects for additional information or medical record access 
that is not currently part of the study proposed in this application; obtain another sample. 
 
We will retain contact information to be able to inform subjects about future related studies. 
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 
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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.) 
 
All relevant materials have been uploaded 
 
6 CHILDREN (MINORS) and PARENTAL PERMISSION 
6.1 Involvement of minors. Does the research include minors (children)? 
Minor or child means someone who has not yet attained the legal age for consent for the research procedures, as 
described in the applicable laws of the jurisdiction in which the research will be conducted. This may or may not 
be the same as the definition used by funding agencies such as the National Institutes of Health. 
• 
In Washington State the generic age of consent is 18, meaning that anyone under the age of 18 is 
considered a child.  
• 
There are some procedures for which the age of consent is much lower in Washington State. 
• 
The generic age of consent may be different in other states, and in other countries.  
 
 
No 
 If no, go to Section 8. 
 
 
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. 
 
 
 
 

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Some of the research procedures 
 Use the table below to identify the procedures for which 
parental permission will not be obtained. 
 
 
 
 
Be sure to consider all research procedures and plans, including screening, future contact, and sharing/banking of data and 
specimens for future work. 
Children 
Group1 
Describe the procedures or 
data/specimen collection (if any) for 
which there will be NO parental 
permission2 
Reason why parental 
permission will not be 
obtained 
Will parents be 
informed about 
the research?3 
 
 
 
YES 
NO 
      
      
      
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
      
      
      
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
      
      
      
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
      
      
      
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
      
      
      
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
      
      
      
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Table footnotes 
1. If the answer is the same for all children groups or all procedures: collapse the answer across the groups and/or procedures. 
2. If identifiable information or biospecimens will be obtained without parent permission, any waiver granted by the IRB does not 
override parents’ refusal to provide broad consent (for example, through the Northwest Biotrust). 
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 
 

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Yes  If yes, an advocate may need to be appointed for each child who is a ward. The advocate must be in 
addition to any other individual acting on behalf of the child as guardian or in loco parentis. The 
same individual can serve as advocate for all children who are wards. 
 
 
 
Describe who will be the advocate(s). The description must address the following points: 
• 
Background and experience 
• 
Willingness to act in the best interests of the child for the duration of the research 
• 
Independence of the research, research team, and any guardian organization 
 
      
 
 
7 ASSENT OF CHILDREN (MINORS) 
Go to Section 8 if your research does not involve children (minors). 
7.1 Assent of children (minors). Though children do not have the legal capacity to “consent” to participate in 
research, they should be involved in the process if they are able to “assent” by having a study explained to them 
and/or by reading a simple form about the study, and then giving their verbal choice about whether they want to 
participate. They may also provide a written assent if they are older. See WORKSHEET: Children for circumstances 
in which a child’s assent may be unnecessary or inappropriate.   
a. Will assent be obtained for: 
 
 
All research procedures and child groups 
 Go to question 7.2. 
 
 
 
 
 
 
None of the research procedures and child groups 
 Use the table below to provide justification, 
then skip to question 7.6 
 
 
 
 
 
 
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 
      
      
      
      
      
      
      
      
      
      
      
      
      
      
      
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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 
 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. 

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7.6 Children who reach the legal age of consent during participation in longitudinal research.  
Children who were enrolled at a young age and continue for many years: It is best practice to re-obtain assent (or 
to obtain it for the first time, if 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 
 
 
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. 

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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 
 
 
Parents who are providing permission for their children to participate in research 
 
 If you selected PARENTS, the word “consent” below should also be interpreted as applying to parental 
permission and “subjects” should also be interpreted as applying to the parents. 
8.2 The consent process and characteristics. This series of questions is about whether consent will be obtained for all 
procedures except recruiting and screening and, if yes, how. 
The issue of consent for recruiting and screening activities is addressed in question 4.7. You do not need to repeat your answer 
to question 4.6. 
 
a. Are there any procedures for which consent will not be obtained? 
 
x 
No 
 
 
 
Yes 
 If yes, use the table below to identify the procedures for which consent will not be obtained. “All” 
is an acceptable answer for some studies. 
 
 

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Be sure to consider all research procedures and plans, including future contact, and sharing/banking of data and specimens for 
future work. 
Group1 
Describe the procedures or 
data/specimen collection (if any) 
for which there will be NO consent 
process 
Reason why consent will not be 
obtained 
Will subjects be 
provided with 
info about the 
research after 
they finish? 
 
 
 
YES 
NO 
      
      
      
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
      
      
      
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
      
      
      
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
      
      
      
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
      
      
      
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Table footnotes 
1. If the answer is the same for all groups, collapse your answer across the groups and/or procedures. 
b. Describe the consent process, if consent will be obtained for any or all procedures, for any or all groups. 
Address groups and procedures separately if the consent processes are different. 
Be sure to include: 
• 
The location/setting where consent will be obtained 
• 
Who will obtain consent (refer to positions, roles, or titles, not names) 
• 
How subjects will be provided sufficient opportunity to discuss the study with the research team and consider 
participation 
c 
Participatory Design Team: Providers and CBO participants –  India team research staff will approach 
community health workers, CBO administrators, primary care physicians, psychiatrists and CBO participants 
for consent to participate in focus group discussions of desirable features of an app and to provide feedback on 
iterative versions of the app.  
Each potential member of the design group will be provided a copy of the consent form (English, or translated 
Kannada version as appropriate) to review at the time that they are approached about the study and have an 
opportunity to ask questions.  Each will be instructed that their involvement in the design groups is voluntary 
and they may decline participation without any risk of negative effect on their work position or health care. 
Consent process will occur in the CBO or in the primary care clinic. 
 
Randomized trial: CBO participants:  Women who attend CBO meetings will be approached by community 
health workers to introduce the randomized trial . With their permission their contact information will be shared 
with the research coordinator who will then contact them to make an appointment for the informed consent 
discussion. They will be given the English or Kannada consent form to review and have the opportunity to ask 
questions. Each will be instructed that their involvement in the trial is voluntary and they may decline or 
discontinue participation without any risk of negative effect on their health care.. 
No non-English speaking subjects will be enrolled until the translated consent forms have been submitted as a 
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c. Comprehension. Describe the methods that will be used to ensure or test the subjects’ understanding of the 
information during the consent process. 
 
If English is not the first language, a Kannada translated version of the consent will be used.   The India 
research team speaks both English and Kannada and can answer any questions.  The India research team will 
provide study information at point of consent and offer to answer questions. Research staff will offer to 
walk/talk them through the consent process and answer any questions. If the research team has concerns about a 
participant’s comprehension, they will ask the participant to summarize their understanding of what they are 
consenting to do. 
 
d. Influence. Does the research involve any subject groups that might find it difficult to say “no” to participation 
because of the setting or their relationship with someone on the study team, even if they aren’t pressured to 
participate?   
Examples: Student participants being recruited into their teacher’s research; patients being recruited into their healthcare 
provider’s research, study team members who are participants; outpatients recruited from an outpatient surgery waiting 
room just prior to their surgery. 
 
x 
No 
 
 
 
Yes 
 If yes, describe what will be done to reduce any effect of the setting or relationship on the 
participation decision. 
 
 
 
 
Examples: a study coordinator will obtain consent instead of the subjects’ physician; the researcher will not 
know which subjects agreed to participate; subjects will have two days to decide after hearing about the 
study. 
 
      
e. Information provided is tailored to needs of subject population. Describe the basis for concluding that the 
information that will be provided to subjects (via written or oral methods) is what a reasonable member of the 
subject population(s) would want to know. If the research consent materials contain a key information section, 
also describe the basis for concluding that the  information presented in that section is that which is most likely 
to assist the selected subject population with making a decision. See GUIDANCE: Key Information for Consent 
Materials. 
 
For example: Consultation with publications about research subjects’ preferences, disease-focused nonprofit groups, patient 
interest groups, or other researchers/study staff with experience with the specific population. It may also involve directly 
consulting selected members of the study population. 
 
Information provided in the consent materials will be based on previous depression treatment studies conducted 
in the area and informed by questions participants have asked during these past studies. 
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. 
 
Information provided in the consent materials will be based on previous depression treatment studies conducted 
in the area and informed by questions participants have asked during these past studies. 

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8.3 Electronic presentation of consent information. Will any part of the consent-related information be provided 
electronically for some or all of the subjects? 
This refers to the use of electronic systems and processes instead of (or in addition to) a paper consent form. For example, an 
emailed consent form, a passive or an interactive website, graphics, audio, video podcasts. See GUIDANCE: Electronic Informed 
Consent for information about electronic consent requirements at UW. 
 
x 
No 
 If no, skip to question 8.4 
 
 
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. 
      
b. Describe how the information can be navigated (if relevant). For example, will the subject be able to 
proceed forward or backward within the system, or to stop and continue at a later time? 
 
      
c. In a standard paper-based consent process, the subjects generally have the opportunity to go 
through the consent form with study staff and/or to ask study staff about any question they may 
have after reading the consent form. Describe what will be done, if anything, to facilitate the 
subject’s comprehension and opportunity to ask questions when consent information is 
presented electronically. Include a description of any provisions to help ensure privacy and 
confidentiality during this process. 
Examples: hyperlinks, help text, telephone calls, text messages or other type of electronic messaging, video 
conference, live chat with remotely located study team members. 
      
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. 
      
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. 
 
       

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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. 
 
 
 
 
 
 
All of the research procedures  
 Do not complete the table; go to question 8.4.b. 
 
x 
 
 
 
 
Some of the research procedures 
 Use the table below to identify the procedures for which written 
documentation of consent will not be obtained from adult 
subjects.  
 
 
 
 
Adult 
subject 
group1 
Describe the procedures or data/specimen collection (if any) for which 
there will be NO documentation of consent 
Will they be 
provided with a 
written 
statement 
describing the 
research 
(optional)? 
 
 
YES 
NO 
      
      
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
      
      
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
      
      
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
      
      
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
      
      
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
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 
 

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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. 
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? 
 
 
No 
 
 
x 
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. 
 
 
 
For all the subjects, English is not the first language, and a Kannada translated version of the consent 
will be used.   The India research team speaks both English and Kannada and can answer any 
questions.  The India research team will provide study information at point of consent and offer to 
answer questions. Research staff will offer to walk/talk them through the consent process and answer 
any questions. If the research team has concerns about a participant’s comprehension, they will ask 
the participant to summarize their understanding of what they are consenting to do. 
 

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All staff engaged in research will receive training regarding the appropriate procedures for 
recruitment and consent, including training in how to explain the study in easy to understand 
language. 
 
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.  
 
India research staff obtaining consent will be local to the area and fluent in Kannada, the local 
language, and so will not require an interpreter. 
 
 
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.  
 
The questionnaires we propose to use have validated Kannada versions. For study specific 
demographic questionnaires we will collaborate with the India team to create study materials 
that are similarly appropriate to the patient population.  English study forms will be translated by 
the India team then back translated for accuracy.   
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. 
 
 See 8.5 for discussion of how consent will be obtained for participants who do not read English well. 
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). 
 
      

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a. Will subjects be informed beforehand that they will be unaware of or misled regarding the 
nature or purposes of the research? (Note: this is not necessarily required.) 
 
 
No 
 
 
 
Yes 
 
 
b. Will subjects be debriefed later? (Note: this is not necessarily required.) 
 
 
No 
 
 
 
Yes 
 If yes, describe how and when this will occur. Upload any debriefing materials, 
including talking points or a script, to Zipline. 
 
 
 
      
8.8 Cognitively impaired adults, and other adults unable to consent. Will such individuals be included in the 
research? 
Examples: individuals with Traumatic Brain Injury (TBI) or dementia; individuals who are unconscious, or who are significantly 
intoxicated. 
 
x 
No 
 If no, go to question 8.9. 
 
 
Yes 
 If yes, answer the following questions. 
 
a. Rationale. Provide the rationale for including this population.  
 
      
 
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”. 
 
 
      

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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. N/A 
 
 
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  
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. 
 
 

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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. 
 
The consent form list steps to ensure privacy of information. We will talk with participants about any concerns or 
questions they have of privacy protections. 
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. 
 
 
 
 
      
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: 
 
 
 
 
 
      

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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 
 
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. 
 
 
N/A 
 
 

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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. 
 
Participating in a depression research trial may lead to stigma within the subjects’ community. We will attempt to 
mitigate this by providing depression education within the broader community. Additionally, screening and 
stepped care treatment for depression will be within an app designed to screen for physical health as well, 
ensuring that women with depression are not singled out. 
10.2 Reproductive risks. Are there any risks of the study procedures to men and women (who are subjects, or partner 
of subjects) related to pregnancy, fertility, lactation or effects on a fetus or neonate? 
Examples: direct teratogenic effects; possible germline effects; effects on fertility; effects on a woman’s ability to continue a 
pregnancy; effects on future pregnancies. 
 
x 
No 
 If no go to question 10.3 
 
 
Yes 
 If yes, answer the following questions: 
 
a. Risks. Describe the magnitude, probability, duration and/or reversibility of the risks. 
 
 
 
      
 
b. Steps to minimize risk. Describe the specific steps that will be taken to minimize the 
magnitude, probability, or duration of these risks. 
Examples: inform the subjects about the risks and how to minimize them; require a pregnancy test before 
and during the study; require subjects to use contraception; advise subjects about banking of sperm and 
ova. 
 
If the use of contraception will be required: describe the allowable methods and the time period when 
contraception must be used. 
 
 
 
      
 
c. Pregnancy. Describe what will be done if a subject (or a subject’s partner) becomes pregnant 
For example; will subjects be required to immediately notify study staff, so that the study procedures can be 
discontinue or modified, or for a discussion of risks, and/or referrals or counseling? 
 
 
 
      

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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 
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 
10.4 Unforeseeable risks. Are there any research procedures that may have risks that are currently unforeseeable? 
Example: using a drug that hasn’t been used before in this subject population. 
 
x 
No 
 
 
 
Yes 
 If yes, identify the procedures. 
 
 
 
      
10.5 Subjects who will be under regional or general anesthesiology. Will any research procedures occur while 
patients are under general or regional anesthesia, or during the 3 hours preceding general or regional anesthesia 
(supplied for non-research reasons)? 
 
x 
No 
 
 
 
Yes 
 If yes, check all the boxes that apply. 
 
 
 
 
Administration of any drug for research purposes 
 
 
 
 
 
 
 
 
 
 
Inserting an intra-venous (central or peripheral) or intra-arterial line for research purposes 
 
 
 
 
 
 
Obtaining samples of blood, urine, bone marrow or cerebrospinal fluid for research 
purposes 
 
 
 
 
 
 
Obtaining a research sample from tissue or organs that would not otherwise be removed 
during surgery 
 
 
 
 
 
 
Administration of a radio-isotope for research purposes** 
 
 
 
 
 
 
Implantation of an experimental device 
 
 
 
 
 
 
Other manipulations or procedures performed solely for research purposes (e.g., 
experimental liver dialysis, experimental brain stimulation) 
 
 
 
 

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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.  
 
DSMP has been uploaded 
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 – app based study – participants will know what intervention they are getting  
10.8 Withdrawal of participants. If applicable, describe the anticipated circumstances under which participants will be 
withdrawn from the research without their consent. Also, describe any procedures for orderly withdrawal of a 
participant, regardless of the reason, including whether it will involve partial withdrawal from procedures and 
any intervention but continued data collection or long-term follow-up. 
 
Participants will be withdrawn from the trial in case of emergent suicidal ideation or new psychosis as they will 
be directed to a higher level of care. 
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.  
 
All participants will receive standardized depression education. Participants randomized to the intervention will 
receive the MITHRA intervention for the treatment of depression.  

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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. 
 
 
No 
 
 
x 
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. 
 
Research assessments include measures of depression which may indicate depression 
which will need treatment. We will inform subjects who score above the clinical cut off 
the results of their questionnaire and advise them to share these results with their 
primary care provider and seek treatment for depression. 
For all subjects, whether they score above the cut off or not, anyone who scores 
anything other than 0 on the 9th question of the PHQ-9 will be informed of this and will 
receive further assessment / intervention as outlined in the attached suicidality 
protocol. 
 
a.2. Explain which of these results will be offered to subjects.  
 
Depression scores 
Suicidal ideation / thoughts of self-harm 
 
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 
 
N/A 
 
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 

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 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. 
 
N/A 
 
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. 
 
N/A 
 
e. Describe any plans to share results with family members (e.g. in the event a subject becomes 
incapacitated or deceased). 
 
N/A 
 
f. Check the box to indicate that any plans for return of individual research results have been described in 
the consent document. If there are no plans to provide results to participants, this should be stated in the 
consent form. 
 
See the GUIDANCE Return of Individual Results for information about consent requirements. 
 
x Confirmed 
 
10.11 Commercial products or patents. Is it possible that a commercial product or patent could result from this 
study? 
 
x 
No 
 
 
 
Yes 
 If yes, describe whether subjects might receive any remuneration/compensation and, if yes, 
how the amount will be determined. 
 
 
 
 
      
 
 
11 ECONOMIC BURDEN TO PARTICIPANTS 
11.1 Financial responsibility for research-related injuries. Answer this question only if the lead researcher is not a 
UW student, staff member, or faculty member whose primary paid appointment is at the UW. 
 
For each institution involved in conducting the research: Describe who will be financially responsible for 
research-related injuries experienced by subjects, and any limitations. Describe the process (if any) by which 
participants may obtain treatment/compensation. 
 
N/A 

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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). 
 
N/A 
11.3 Reimbursement for costs. Describe any costs to subjects that will be reimbursed (such as travel expenses). 
 
N/A 
 
 
12 RESOURCES 
12.1 Faculty Advisor. (For researchers who are students, fellows, or post-docs.) Provide the following information 
about the faculty advisor.  
• 
Advisor’s name 
• 
Your relationship with your advisor (for example: graduate advisor; course instructor) 
• 
Your plans for communication/consultation with your advisor about progress, problems, and changes.  
 
N/A 
12.2 UW Principal Investigator Qualifications. Upload a current or recent Curriculum Vitae (CV), Biosketch (as 
provided to federal funding agencies), or similar document to the Local Site Documents page in Zipline. The 
purpose of this is to address the PI’s qualifications to conduct the proposed research (education, experience, 
training, certifications, etc.). 
For help with creating a CV, see http://adai.uw.edu/grants/nsf_biosketch_template.pdf and 
https://education.uwmedicine.org/student-affairs/career-advising/year-4/residency-applications/curriculum-vitae/  
 
x The CV will be uploaded. 
12.3 UW Study team qualifications. Describe the qualifications and/or training for each UW study team member to 
fulfill their role on the study and perform study procedures. (You may be asked about non-UW study team 
members during the review; they should not be described here.) You may list these individuals by name, 
however if you list an individual by name, you will need to modify this application if that individual is replaced. 
Alternatively, you can describe study roles and the qualifications and training the PI or study leadership will 
require for any individual who might fill that role. The IRB will use this information to assess whether risks to 
subjects are minimized because study activities are being conducted by properly qualified and trained 
individuals. 
Describe: The role (or name of person), the study activities they will perform, and the qualifications or 
training that are relevant to performing those study activities. 
 
 
 
 
 
 
 
Amritha Bhat, MD, MPH, PD/PI is Assistant Professor, Department of Psychiatry and Behavioral Sciences, 
University of Washington. She will oversee all aspects of the project along with the India PI. She will be 
responsible for data analyses and data interpretation. She has extensive experience in primary care based mental 
health care and women’s mental health. She has also previously worked in India, in rural settings, and in the 
community mental health clinic identified in the application. She has trained care managers in Behavioral 
Activation in several integrated mental health implementations. She will serve as the UW PI. She will establish 
policy on project operations and budget management, supervise data analyses, and finalize all reports. 

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Throughout the study Dr. Bhat will provide project oversight and meet weekly with staff and team leaders about 
study implementation and clinical issues. Additionally, she will be available for guidance on content development 
for the Behavioral Activation intervention and will coordinate the ECHO learning sessions. 
 
Pamela Collins, MD, Co I is Professor in the Departments of Psychiatry and Global Health and will serve as co 
Investogator on the study. She will provide support and oversight of the qualitative methodology in phase I of the 
app development. She has several years experience in global mental health, stigma reduction and competency-
based training of lay health workers for delivery of psychological interventions. She will meet regularly with the 
UW and India teams and participate actively in study conduct and mixed methods and in ECHO learning 
sessions. 
 
Research Coordinator TBD will be a bachelor’s level individual with experience in the conduct of research 
studies. They will assist with the day to day grant related activities at UW and help schedule meetings and 
training sessions. They will assist with IRB applications and ensure data collection activities, manuscript 
preparation and dissemination activities are occurring as outlined in the grant proposal timeline.  
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. 
 
 
 
 
All study team members will have copies of the current UW IRB procedures and requirements.  They 
will follow these guidelines in their related duties and functions. 
 
 
 
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. 
 
Institutional Ethics Committee (IEC), St.John's Medical College & Hospital, St.John's National Academy of 
Health Sciences, Sarjapur road, Bangalore-34, Karnataka, India 
 
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. 
 

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Statistical Methods: 
Assumptions of normality was assessed using Q-Q plot. Descriptive statistics, mean and standard 
deviation for normally distributed variables were used to describe the outcome parameters PHQ, QIDS. 
WHODAS and BADS. Chi-square test or Fisher’s exact tests as appropriate, was used to test the 
association between baseline characteristics between study groups. At each time of assessment, 
outcome parameters were compared between study groups using independent t test or Mann Whitney 
U test as appropriate. Change in the outcome at 3 and 6 months from baseline was compared between 
the study groups using Wilcoxon signed rank test. McNemar Chi-square test was used to compare the 
change in the proportion of depression categories from baseline within each study group. In addition, 
RMANOVA was performed to compare the change in the outcome scores over time between study 
groups. A p-value of < 0.05 was considered statistically significant. All analyses were performed using 
SPSS version 26.0. 
 

 
MITHRA 
Patient RCT consent form 
Ver 1 
1 
UNIVERSITY OF WASHINGTON 
CONSENT TO PARTICIPATE IN A RESEARCH STUDY 
 
STUDY TITLE: Mobile Mental Health in Community-Based Organizations: A Stepped Care Approach to 
Women's Mental Health 
 
This is a research study that aims to examine your experience and thoughts after using the app on the 
tablet in Community Based Organizations (CBO), (Multiuser Interactive Health Response Application 
(MITHRA) to help identify and provide information about treatment for common physical and mental 
problems. Srinivasan K, MD, St. John’s Medical College, Bangalore, India, and Amritha Bhat, MD, MPH, 
Department of Psychiatry and Behavioral Sciences, University of Washington Seattle, Seattle, Washington, 
are the principal investigators leading the study team. This study is funded by the National Institute of 
Health. 
 
RESEARCHER STATEMENT 
We are asking you to be in a research study.  The purpose of this consent form is to give you the 
information you will need to help you decide whether to be in the study or not.  Please read the form 
carefully.  You may ask questions about the purpose of the research, what we would ask you to do, the 
possible risks and benefits, your rights as a volunteer, and anything else about the research or this form 
that is not clear.  When we have answered all your questions, you can decide if you want to be in the study 
or not.  This process is called “informed consent.”  We will give you a copy of this form for your records. 
 
PURPOSE OF THE STUDY 
The purpose of this study is to  examine your expereince and thoughts after using the app on the tablet in 
Community Based Organizations (CBO), (Multiuser Interactive Health Response Application (MITHRA) This 
research is being done in order to improve  apps that can be used to identify depression and provide 
information about treatment among women attending community based organization meetings.  
 
NUMBER OF PARTICIPANTS 
There will be approximately 60 women this project. 30 women will receive depression education during 
their CBO meetings from the community health worker, and 30 women will use the app provided in the 
CBO which will have information and questions on physical and mental health.   
 
STUDY PROCEDURES 
You are being asked to take part in the research study because you attend meetings at the CBO.  If you 
agree to participate, the following procedures will occur:  
• 
You can continue to attend your CBO meetings.    
• 
In addition, you will receive education about depression by the community health worker in your 
CBO groups.  
• 
If your CBO is randomly chosen to receive the app, you will use the app every time you come into 
the CBO for a meeting. You will spend 15 -20 minutes using the app in privacy, answering questions 
and watching videos. You may be asked to complete some simple activities at home, such as going 
for regular walks.  

 
MITHRA 
Patient RCT consent form 
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• 
If the app identifies depression of higher severity, the CHW will help connect you to a doctor at the 
primary care clinic.  
• 
A research team member will call you or meet with you every 3 months and ask you questions 
about your mood and health – this will take approximately 15 minutes. 
• 
After the study ends, you may be invited to participate in one of 1-2 focus groups, where you 
will be asked about your perceptions and experiences with the mobile app. 
RISKS, STRESS, OR DISCOMFORT  
The primary risk in participating in the study is loss of privacy. In order to reduce this risk, all data will be 
transmitted and stored securely. No individual-level information related to the study will be made 
available in any communications, oral reports, or publications. 
 
ALTERNATIVES TO PARTICIPATION 
You can choose to not participate in the study – the alternative is to not enroll in the study and instead 
continue to participate in the CBO meeting as usual. 
 
RETURN OF RESULTS 
Research assessments include measures of depression which may indicate depression which may need 
treatment. We will inform you if you score high on these questionnaires so that you may share these 
results with your primary care provider and seek treatment for depression.  
 
BENEFITS OF THE STUDY 
You will receive depression education free of charge. We anticipate that you will receive useful 
information on mental health, depression and on helpful treatments.  There are no additional benefits to 
you related to the research project.  The results of the proposed study will provide critical generalizable 
knowledge regarding the feasibility and acceptability of providing parenting intervention to women 
engaged in depression treatment.  
 
USING YOUR DATA IN FUTURE RESEARCH 
The information that we obtain from you for this study might be used for future studies. We may remove 
anything that might identify you from the information. If we do so, that information and specimens may 
then be used for future research studies or given to another investigator without getting additional 
permission from you. It is also possible that in the future we may want to use or share study information 
that might identify you. If we do, a review board will decide whether or not we need to get additional 
permission from you.  
 
CONFIDENTIALITY OF RESEARCH INFORMATION 
All of the information you provide will be confidential.  However, we cannot guarantee total privacy. Your 
personal information may be given out if required by law. However, if we learn that you intend to harm 
yourself or others, we must report that to the authorities. If information from this study is published or 
presented at scientific meetings, your name and other personal information will not be used. Participation 
in research may involve a loss of privacy, but information about you will be handled as confidentially as 
possible.   Our study team at the University of Washington, will have access to your  data. 
 

 
MITHRA 
Patient RCT consent form 
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We have a Certificate of Confidentiality from the federal National Institute of Mental Health].  This helps 
us protect your privacy.  The Certificate means that we do not have to give out information, documents, or 
samples that could identify you even if we are asked to by a court of law.  We will use the Certificate to 
resist any demands for identifying information.   
 
We can’t use the Certificate to withhold your research information if you give your written consent to give 
it to an insurer, employer, or other person.  Also, you or a member of your family can share information 
about yourself or your part in this research if you wish. 
 
There are some limits to this protection. We will voluntarily provide the information to: 
• a member of the federal government who needs it in order to audit or evaluate the research; 
• individuals at the institution(s) conducting the research, the funding agency, and other groups involved 
in the research, if they need the information to make sure the research is being done correctly; 
• the federal Food and Drug Administration (FDA), if required by the FDA; 
• individuals who want to conduct secondary research if allowed by federal regulations and according to 
your consent for future research use as described in this form; 
•  Relevant authorities, if we learn of child abuse, elder abuse, or the intent to harm yourself or others.  
 
The Certificate expires when the NIMH funding for this study ends.  Currently this is 05/31/2023.  Any data 
collected after expiration is not protected as described above.  Data collected prior to expiration will 
continue to be protected.   
 
A description of this clinical trial will be available on http://www.clinicaltrials.gov, as required by U.S. Law.  
This Web site will not include information that can identify you. At most, the Web site will include a 
summary of the results. You can search this Web site at any time. 
 
All identifying information collected as part of the study will be stored in a database on a secure server and 
will be password protected with limited access. Study data and audio and video recordings will be labeled 
with a unique study identification numbers.  The link between your identifying information and the 
research data will be destroyed after the study is complete and the records retention period required by 
state and/or federal law has been met. 
 
 
OTHER INFORMATION 
You may refuse to participate and you are free to withdraw from this study at any time without penalty 
or loss of benefits to which you are otherwise entitled. 
This study will result in the development of an app which we hope to disseminate for use. We will not 
provide individual participants with the results of the study. This study has been funded by the National 
Institute of Mental Health. 
You will also receive compensation for your time participating in interviews (Rs.200 per interview).  This 
payment may take 6 – 8 weeks after completion of interview, to reach you. 
 
 

 
MITHRA 
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You can talk to the researcher(s) about any questions, concerns, or complaints you have about this study. 
Contact the study coordinator, or the principal investigator of the study, Dr. Srinivasan K at St. John’s 
Hospital +91 80 4946 6029. 
 
If you wish to ask questions about the study or your rights as a research participant to someone other 
than the researchers or if you wish to voice any problems or concerns you may have about the study, 
please call the University of Washington Human Subjects Division at 206-543-0098.  
 
CONSENT  
This study has been explained to me.  I volunteer to take part in this research.  I have had a chance to ask 
questions.  If I have questions later about the research, or if I have been harmed by participating in this 
study, I can contact one of the researchers listed on the first page of this consent form.  If I have questions 
about my rights as a research subject, I can call the Human Subjects Division at (206) 543-0098.  I will 
receive a copy of this consent form. 
 
 
 
_________________________________________________________________________________ 
Printed name of subject  
        Signature of subject 
 
 
 
Date 
 
 
 
__________________________________________________________________________________ 
 
Printed name of study staff obtaining consent 
      
Signature 
 
 
Date 
 
 
Copies to: Researcher 
 
 
Subject